memo_number: QSO-26-08-NH

posting_date: Wed, 08 Apr 2026 16:00:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: Clarification regarding Nurse Aide Training Competency Evaluation Program (NATCEP) and Nurse Aide Competency Evaluation Program (CEP) requirements and allowable flexibilities

memo_number: QSO-26-07-Hospitals/CAHs

posting_date: Fri, 27 Mar 2026 12:30:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Interpretive Guidance for Hospital and Critical Access Hospital Emergency Services Protocols and Training - Obstetrical Services Conditions of Participation

memo_number: QSO-26-05-[OPO & Transplant]

posting_date: Wed, 11 Mar 2026 20:30:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: Organ Procurement Organizations (OPOs) and Donor Hospitals’ Responsibilities

memo_number: QSO-26-06-OPO

posting_date: Wed, 11 Mar 2026 13:00:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: Revisions to the Organ Procurement Organization (OPO) Interpretive Guidance – State Operations Manual Appendix Y (Advance Copy)

memo_number: QSO-26-04-ALL

posting_date: Mon, 02 Feb 2026 14:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: Contingency Plans – State Survey & Certification Activities in the Event of Federal Government Shutdown

memo_number: QSO-26-03-NH REVISED

posting_date: Fri, 03 Apr 2026 16:00:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: REVISED: Revisions to the State Operations Manual (SOM) Chapters 5 and 7

memo_number: S&C-12-20-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 16:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Implementing the Individualized Quality Control Plan (IQCP) for Clinical Laboratory Improvement Amendments (CLIA)

memo_number: QSO-26-02-ALL

posting_date: Mon, 24 Nov 2025 20:00:00 -0500

summary: Memorandum Summary On November 12, 2025, Congress enacted Public Law 119-37, providing for a continuing appropriation until January 30, 2026, with retroactive authority back to October 1, 2025. Attached are responses to questions we received from States and providers with regard to the manner in which survey, enforcement & certification activities should accommodate the effects of the federal government shutdown that occurred from October 1, 2025, through November 12, 2025. On November 12, 2025, Congress enacted Public Law 119-37, providing for a continuing appropriation (“continuing resolution”) through January 30, 2026, with retroactive authority back to October 1, 2025. Attached are answers to questions we received after the shutdown ended. The answers provide special procedures applicable only to the period of the federal government shutdown and subsequent steps necessary to recover from the shutdown. We appreciate that Congress provided for retroactive application of the Continuing Resolution. This enables States to be reimbursed for survey activities conducted during the shutdown period. Such action provides critical support to States that continued to maintain vital public protections despite the federal government shutdown. Thank you for your patience during this time of uncertainty, and for your daily diligence in offering Medicare and Medicaid beneficiaries the protections and quality assurance upon which they rely. Effective Date: October 1, 2025. This policy should be communicated to all survey and certification staff, their managers and the State/Regional Office training coordinators immediately. Questions regarding this communication should be sent to the CMS Location.

title: Questions + Answers for State Recovery after the Federal Government Shutdown

memo_number: QSO-26-01-ALL REVISED

posting_date: Fri, 31 Oct 2025 13:00:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: REVISED: Contingency Plans – State Survey & Certification Activities in the Event of Federal Government Shutdown

memo_number: QSO-25-27-RHC

posting_date: Fri, 26 Sep 2025 16:00:00 -0400

summary: Memorandum Summary The Centers for Medicare & Medicaid Services (CMS) is revising the survey process following regulatory updates to 42 CFR Part 491 – Provision of Services: • Updated Process for Provision of Services – Surveyors will no longer review if Rural Health Centers (RHCs) are “primarily engaged” in the delivery of primary care, • RHCs are no longer required to provide hemoglobin and hematocrit testing or examination of stool specimens for occult blood. • RHCs do not have to perform "primary culturing" on site, but they are required to collect specimens for culture and transmit them to a certified lab.

title: Rural Health Clinic (RHC) Changes in Regulations for Primary Care Services and Laboratory Requirements

memo_number: QSO-25-25-AO/CLIA

posting_date: Fri, 05 Sep 2025 16:00:00 -0400

summary: Memorandum Summary Annual Report to Congress: The 2022 annual RTC details the review, validation, and oversight of the FY 2021 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results. • The release timeline for the 2022 annual RTC was adjusted in response to COVID-19 Public Health Emergency considerations. To ensure stakeholders have access to the most current and comprehensive information available, CMS will expand the next RTC to include oversight data from 2022-2024.

title: FY 2022 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: QSO-25-24-Hospitals

posting_date: Fri, 05 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: Revisions to Hospital – Appendix A of the State Operations Manual

memo_number: QSO-25-23-ALL

posting_date: Wed, 30 Jul 2025 16:00:00 -0400

summary: Memorandum Summary REVISION TO QSO-23-13-ALL ORIGINALLY RELEASED ON May 01, 2023 • Social Security Act Section 1135 emergency waivers for health care providers will terminate with the end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. • Certain regulations or other policies included in Interim Final Rules with Comments (IFCs) will be modified with the ending the PHE. Certain policies, such as the Acute Hospital at Home initiative and telehealth flexibilities have been extended by Congress through December 31, 2024. • Long Term Care and Acute and Continuing Care providers are expected to be in compliance with the requirements according to the timeframes listed below. • Focused infection control surveys are no longer part of the standard survey process. Any COVID-19 or infection control concerns should be conducted through complaint investigations outside of the LTCSP process.

title: REVISED: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

memo_number: QSO-25-22-CLIA

posting_date: Fri, 27 Jun 2025 16:00:00 -0400

summary: Memorandum Summary • Updates to the SOM, Chapter 5 Sections 5500-5590: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Chapter 5 Sections 5500-5590 that provides guidance on complaint procedures related to Clinical Laboratory Improvement Amendments of 1988 (CLIA). • Updates include: • Procedures for conducting complaint investigations in laboratories for all certificate types and temporary testing sites • Revisions to complaint investigations and enforcement timelines • Reporting and investigating of transfusion-related fatalities (TRF)

title: State Operations Manual (SOM), Chapter 5 - Complaint Procedures

memo_number: QSO-25-10-CLIA REVISED

posting_date: Mon, 23 Jun 2025 13:00:00 -0400

summary: REVISION TO QSO-25-10 CLIA ORIGINALLY RELEASED ON December 06, 2024 • Updates to the SOM: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Appendix C of the SOM for laboratories and laboratory services. Appendix C provides interpretative guidance on the laboratory requirements at 42 CFR Part 493. • Updates to Appendix C: The updates to Appendix C: • Remove survey protocols found in SOM Chapter 6; • Provide guidance and new and revised D-tags for the regulations finalized in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing – Analytes and Acceptable Performance Final Rule (CMS-3355-F) and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories Final Rule (CMS-3326-F); • Incorporate guidance and information from several previously released QSO (previously S&C) and Admin Info memos; • Added an approved HHS training program for neuromuscular pathology; and • Incorporate feedback previously received from stakeholders. • Updates to the advance copy of Appendix C: The updates include: • Removing and adding guidance as outlined below in the discussion section; and • Correcting clerical errors. • Several previously released QSO (previously S&C) memos are now expired. Memos: S&C: 17-11-CLIA (incorporated into the SOM), S&C: 16-02-CLIA (incorporated into the SOM), and S&C: 15-17-CLIA (incorporated into the SOM) are now expired. CMS will note the expiration date on these memos, which are currently on the CMS website. This memo and the associated SOM updates supersede the expired memos upon the Effective Date.

title: REVISED: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA)) – Advance Copy

memo_number: QSO-25-21-CLIA

posting_date: Mon, 23 Jun 2025 13:00:00 -0400

summary: Memorandum Summary • Enforcement discretion of personnel regulations – CMS will be exercising enforcement discretion in the following limited circumstances with respect to certain regulatory personnel qualification requirements and plans to address these changes in future notice-and-comment rulemaking: • CMS will allow laboratory directors qualifying under §493.1405(b)(2) to have either at least 1 year of experience directing or supervising nonwaived laboratory testing or 20 Continuing Education (CE) credit hours in laboratory director responsibilities. • CMS will not require the additional 20 CE credit hours currently required under §§493.1405(b)(3)(ii), 493.1405(b)(4)(iv), 493.1405(b)(5)(iv), 493.1443(b)(2)(iii), and 493.1443(b)(3)(iv). o As such, any individual previously qualified as a clinical consultant will be able to continue to qualify without taking an additional 20 CE credits; • CMS will allow for individuals qualified as technical supervisors under §493.1449(f)(2)(i) to qualify as high complexity laboratory directors for testing in dermatopathology. • Clarification of personnel regulations - In addition, CMS is clarifying and plans to address in future notice-and-comment rulemaking that: • “[A]n approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” as required under §§493.1405(b)(3)(i)(B)(2), 493.1405(b)(4)(i)(C)(2), 493.1443(b)(3)(i)(B)(2), and 493.1449(c)(4)(i)(C)(2) does not need to be on human subjects, as most research is performed on animal models. • The requirements under §493.1443(b)(3)(iii) for high complexity laboratory directors to require a total of two, not four, years of laboratory training or experience and laboratory experience directing or supervising high complexity testing.

title: Clinical Laboratory Improvement Amendment (CLIA) Enforcement Discretion and Clarification on Personnel Regulations

memo_number: QSO-25-20-NH REVISED

posting_date: Wed, 10 Sep 2025 12:15:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Updates to Nursing Home Care Compare REVISED

memo_number: QSO-25-19-All

posting_date: Wed, 18 Jun 2025 09:00:00 -0400

summary: Memorandum Summary • CMS is committed to the transparency of quality of care findings, so that patients, residents, and their families can make informed health care decisions. • The official Form CMS-2567: Statement of Deficiencies and Plan of Correction (CMS-2567) will be publicly releasable within 14 days after receipt by the provider, supplier, or lab. In other words, the CMS-2567 can be immediately released upon receipt by the provider/supplier. • This update aligns with the Nursing Home CMS-2567 process, which per regulation, are releasable within 14 days of transmission to the facility (See 42 CFR 488.325). • This guidance does not apply to Accrediting Organization (AO) survey findings, except those related to surveys of Hospice and Home Health Agencies.

title: Release of CMS-2567: Statement of Deficiencies and Plan of Correction

memo_number: QSO-23-21-NH EXPIRED

posting_date: Thu, 05 Jun 2025 16:00:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Updates to Nursing Home Care Compare Staffing and Quality Measures

memo_number: QSO-20-29-NH EXPIRED

posting_date: Thu, 05 Jun 2025 16:00:00 -0400

summary: Memo Expiration Information: Expiration Date: December 31, 2024 Expiration Information: This memo was superseded by QSO-25-11-NH Long-Term Care (LTC) Facility Acute Respiratory Illness Reporting Requirements released 12/21/2024. See QSO-25-11-NH for current requirements regarding respiratory illness reporting.

title: EXPIRED: Interim Final Rule Updating Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes

memo_number: QSO-25-07-NH EXPIRED

posting_date: Thu, 05 Jun 2025 16:00:00 -0400

summary: Memo Expiration Information: Expiration Date: January 15, 2025 Expiration Information: Refer to QSO-25-14-NH: REVISED: Revised Long-Term Care (LTC) Surveyor Guidance: Significant revisions to enhance quality and oversight of the LTC survey process

title: EXPIRED: Revised Long-Term Care (LTC) Surveyor Guidance: Significant revisions to enhance quality and oversight of the LTC survey process

memo_number: QSO-25-12-NH EXPIRED

posting_date: Thu, 05 Jun 2025 16:00:00 -0400

summary: Memo Revision Information: Expiration Date: March 10, 2025 Expiration Information: Refer to QSO-25-14-NH: REVISED: Revised Long-Term Care (LTC) Surveyor Guidance: Significant revisions to enhance quality and oversight of the LTC survey process

title: EXPIRED: Revised Long-Term Care (LTC) Surveyor Guidance: Significant revisions to enhance quality and oversight of the LTC survey process

memo_number: QSO-22-22-Hospitals-RESCINDED as of 05/292025

posting_date: Fri, 30 May 2025 13:00:00 -0400

summary: Memorandum Summary CMS is rescinding this memo (QSO-22-22-Hospitals), effective May 29, 2025, consistent with Administration policy and Executive Order 14192.

title: Rescinded Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss

memo_number: QSO-21-22-Hospitals-RESCINDED as of 05/29/2025

posting_date: Fri, 30 May 2025 13:00:00 -0400

summary: Memorandum Summary CMS is rescinding this memo (QSO-21-22-Hospitals), effective May 29, 2025, consistent with Administration policy and Executive Order 14192.

title: Rescinded Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss

memo_number: QSO-25-18-CLIA

posting_date: Fri, 30 May 2025 16:00:00 -0400

summary: Memorandum Summary • CLIA Applicability Clarified: This memorandum provides guidance on the applicability of CLIA regulations to testing associated with blood, cells/tissue, and organs for transfusion, implantation, infusion, or transplantation. CLIA Applicability Table-Organs Intended for Transplantation has been revised to reflect the applicability of testing performed on a potential donor (Brain or Circulatory Death) for determining donor suitability and testing performed for the assessment of isolated in-vivo or ex-vivo perfusion of organ for transplant. Testing on a potential donor (brain or circulatory death) is subject to CLIA regulations, while testing perfusates from isolated in-vivo or ex-vivo organs for transplant is not subject to CLIA regulations. • Based on CLIA Definition of Laboratory: The basis for determining CLIA applicability is the definition of a laboratory in the CLIA regulations.

title: REVISED: Clinical Laboratory Improvement Amendments of 1988 (CLIA)-CLIA Applicability for Laboratory Testing Associated with Blood, Cells/Tissue, and Organs

memo_number: QSO-25-14-NH

posting_date: Mon, 10 Mar 2025 20:21:50 -0400

summary: Memorandum Summary: Revised Surveyor Guidance: CMS is releasing the following revised guidance for nursing home surveyors: Admission, Transfer & Discharge, Chemical Restraints/Unnecessary Psychotropic Medication, Resident Assessment, Nursing Services, Payroll Based Journal, Quality of Life and Quality of Care, Administration, Quality Assurance Performance Improvement (QAPI), Infection Prevention and Control, and other areas. Clarifications and technical corrections have also been made throughout Appendix PP. Associated Training and Resources: Training on this guidance will be available upon release of this memorandum for surveyors and providers. Advance copy of the Critical Element Pathways are attached to this memo. Advanced copy of Appendix PP is attached to this memo. Revised Survey Resources will be posted on April 28, 2025. Effective Date: Revised to move implementation from March 24, 2025 to April 28, 2025. Surveyors will begin using this guidance to determine compliance with requirements on surveys beginning April 28, 2025. This allows ample time for surveyors and nursing home providers to be trained on this new information. Added revised guidance and training for Nursing Services and Payroll Based Journal to the updates for Appendix PP and the Long-Term Care Survey Process and revised the effective date of implementation for all new guidance to April 28, 2025.

title: REVISED: Revised Long-Term Care (LTC) Surveyor Guidance: Significant revisions to enhance quality and oversight of the LTC survey process

memo_number: QSO-25-13-CLIA

posting_date: Fri, 17 Jan 2025 21:00:00 -0500

summary: Memorandum Summary • Updates to the SOM, Chapter 6: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Chapter 6. Chapter 6 provides guidance on special procedures for laboratories. • Updates include: • Revisions to survey and enforcement timelines; • Revisions with respect to budget responsibilities; • Incorporation of current procedures and practices for federal monitoring surveys, State Agency Performance Reviews, and revisit surveys. • Removal of the use of Form CMS-1557 in the survey process; and • Incorporation of several previous memos and regulatory updates. • Several previously released memos are now expired. Memos: QSO 19-20-CLIA, S&C 16-18-CLIA, S&C 10-07-CLIA, and Admin Info 23-05-CLIA are now expired. CMS will note the expiration date on these memos that are currently on the CMS website. This memo and the associated updates to Chapter 6 supersede the expired memos upon the Effective Date of this memo.

title: State Operations Manual (SOM), Chapter 6 – Special Procedures for Laboratories

memo_number: QSO-25-12-NH

posting_date: Thu, 16 Jan 2025 16:00:00 -0500

summary: Memorandum Summary Revised Surveyor Guidance: CMS is releasing the following revised guidance for nursing home surveyors: • Admission, Transfer & Discharge, Chemical Restraints/Unnecessary Psychotropic Medication, Resident Assessment, Nursing Services, Payroll Based Journal, Quality of Life and Quality of Care, Administration, Quality Assurance Performance Improvement (QAPI), Infection Prevention and Control, and other areas. • Clarifications and technical corrections have also been made throughout Appendix PP. Associated Training and Resources: • Training on this guidance will be available upon release of this memorandum for surveyors and providers. • Advance copy of the Critical Element Pathways are attached to this memo. • Advanced copy of Appendix PP is attached to this memo. • Revised Survey Resources will be posted on March 24, 2025. Effective Date: Surveyors will begin using this guidance to determine compliance with requirements on surveys beginning March 24, 2025. This allows ample time for surveyors and nursing home providers to be trained on this new information. Added revised guidance and training for Nursing Services and Payroll Based Journal to the updates for Appendix PP and the Long-Term Care Survey Process and revised the effective date of implementation for all new guidance to March 24, 2025.

title: REVISED: Revised Long-Term Care (LTC) Surveyor Guidance: Significant revisions to enhance quality and oversight of the LTC survey process

memo_number: QSO-25-11-NH

posting_date: Tue, 31 Dec 2024 14:00:00 -0500

summary: Memorandum Summary • Acute Respiratory Illness Reporting Requirements: The LTC facility requirements for reporting COVID-19-related data expired on December 31, 2024, except for reporting COVID-19 resident and staff vaccination status. On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year 2025 Home Health Prospective Payment System Rate Update. The rule broadens the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) reporting requirements for nursing homes. Beginning on January 1, 2025, LTC facilities are required to electronically report information about COVID-19, influenza, and respiratory syncytial virus (RSV) in a standardized format and frequency specified by the Secretary. • Survey Process and Enforcement: CMS expects LTC facilities to comply with all facility requirements. These requirements will be incorporated into the survey process once guidance to LTC facility surveyors is released.

title: Long-Term Care (LTC) Facility Acute Respiratory Illness Reporting Requirements

memo_number: QSO-25-10-CLIA

posting_date: Fri, 06 Dec 2024 16:00:00 -0500

summary: Memorandum Summary • Updates to the SOM: The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Appendix C of the SOM for laboratories and laboratory services. Appendix C provides interpretative guidance on the laboratory requirements at 42 CFR Part 493. • Updates to Appendix C: The updates to Appendix C: • Remove survey protocols found in SOM Chapter 6; • Provide guidance and new and revised D-tags for the regulations finalized in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing – Analytes and Acceptable Performance Final Rule (CMS-3355-F) and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories Final Rule (CMS-3326-F); • Incorporate guidance and information from several previously released QSO (previously S&C) and Admin Info memos; • Added an approved HHS training program for neuromuscular pathology; and • Incorporate feedback previously received from stakeholders. • Several previously released QSO (previously S&C) memos are now expired. Memos: S&C: 17-11-CLIA (incorporated into the SOM), S&C: 16-02-CLIA (incorporated into the SOM), and S&C: 15-17-CLIA (incorporated into the SOM) are now expired. CMS will note the expiration date on these memos, which are currently on the CMS website. This memo and the associated SOM updates supersede the expired memos upon the Effective Date.

title: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA)) – Advance Copy

memo_number: QSO-25-07-NH

posting_date: Mon, 18 Nov 2024 14:00:00 -0500

summary: Memorandum Summary Revised Surveyor Guidance: CMS is releasing the following revised guidance for nursing home surveyors: • Admission, Transfer & Discharge, Chemical Restraints/Unnecessary Psychotropic Medication, Resident Assessment, Quality of Life and Quality of Care, Administration, Quality Assurance Performance Improvement (QAPI), Infection Prevention and Control, and other areas. • Clarifications and technical corrections have also been made throughout Appendix PP. Associated Training and Resources: • Training on this guidance will be available upon release of this memorandum for surveyors and providers. • Advance copy of the Critical Element Pathways are attached to this memo. • Advanced copy of Appendix PP is attached to this memo. • Revised Survey Resources will be posted on February 24, 2025. Effective Date: Surveyors will begin using this guidance to determine compliance with requirements on surveys beginning February 24, 2025. This allows ample time for surveyors and nursing home providers to be trained on this new information.

title: Revised Long-Term Care (LTC) Surveyor Guidance: Significant revisions to enhance quality and oversight of the LTC survey process

memo_number: QSO-25-06-Hospice

posting_date: Wed, 13 Nov 2024 16:00:00 -0500

summary: Memorandum Summary While the primary purpose of CMS’ health and safety surveys is to determine compliance with the Medicare Hospice CoPs, there are several elements of the survey process that can uncover concerns that may necessitate a referral to CMS for potential fraud. It is important that all elements of the survey process, and especially those listed below, be consistently performed to safeguard hospice patients and ensure the integrity of Medicare funding for hospice care.

title: Ensuring Consistency in the Hospice Survey Process to Identify Quality of Care Concerns and Potential Fraud Referrals

memo_number: QSO-25-08-CAH

posting_date: Wed, 20 Nov 2024 16:00:00 -0500

summary: Memorandum Summary • CMS is committed to assisting CAHs that partner with other providers in the health care system to deliver high-quality care in rural communities. • This guidance clarifies expectations related to space sharing arrangements, including time-sharing and leased space between CAHs and other health care entities.

title: Guidance for Time-share and Leased Space Arrangements in Critical Access Hospitals (CAHs)

memo_number: QSO-25-05-Hospitals/CAHs

posting_date: Tue, 22 Oct 2024 13:00:00 -0400

summary: Memorandum Summary • CMS is committed to taking critical steps to ensure America’s healthcare facilities have appropriate insight related to evolving infection prevention and control needs. • CMS has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and standardized format, as specified by the Secretary. • Failure to report the specified data related to COVID-19, influenza, and respiratory syncytial virus (RSV), including confirmed infections of respiratory illnesses among hospitalized patients, hospital bed census and capacity (both overall and by hospital setting and population group [adult or pediatric]), and limited patient demographic information, including age, may lead to the termination of a hospital’s participation from the Medicare and Medicaid programs.

title: Updates to the Condition of Participation (CoP) Requirements for Hospitals and Critical Access Hospitals (CAHs) To Report Acute Respiratory Illnesses

memo_number: QSO-25-04-Transplant

posting_date: Thu, 10 Oct 2024 16:00:00 -0400

summary: Memorandum Summary • Outcome requirements: The transplant program Conditions of Participation (CoPs) for initial approval at 42 C.F.R. §488.61 require compliance with all data submission, clinical experience, and outcome requirements under §482.80, with limited exceptions. • Data delay: Since the outcome requirements §482.80(c) must include one-year post transplant data, there may be a delay in the availability of the outcomes data at the time of the applicant program’s request for initial Medicare approval. • Data availability: Centers for Medicare & Medicaid Services (CMS) and State Survey Agencies (SA) must confirm the availability of outcomes data before initiating an onsite survey. If the outcomes data is not available, an onsite survey cannot be initiated and the SA should notify the prospective provider that the initial survey will occur once the data becomes available.

title: Outcome Requirements for Initial Transplant Program Approval

memo_number: QSO-25-03-Transplant

posting_date: Fri, 11 Oct 2024 01:00:00 -0400

summary: Memorandum Summary • Updates to the State Operations Manual - The Centers for Medicare & Medicaid Services (CMS) is releasing updates to Chapters 2 and 9, and to Appendix X of the SOM for transplant programs. This guidance provides a consistent approach to the transplant survey process and certification activities and incorporates feedback previously received from stakeholders. • Survey tools and resources: Following the release of these updates, additional tools and resources, e.g., transplant survey workbook, will be provided to aid the state survey team in navigating the survey process for organ transplant programs. • Several previously released QSO (previously S&C) memos are now obsolete. Memos: S&C 17-04-Transplant (incorporated into the SOM), S&C 17-13-Transplant (outdated), S&C: 16-24-Hospitals (outdated), and QSO-19-05-Transplant (incorporated into the SOM) are now expired. CMS will note the expiration date on these memos, which are currently on the CMS website. This memo and the associated SOM updates will supersede the expired memos.

title: Revisions to the State Operations Manual (SOM), Chapter 2- The Certification Process; SOM Appendix X, Guidance to Surveyors: Organ Transplant Programs; and SOM Chapter 9- Exhibits – Advance Copy

memo_number: QSO-25-01-NH

posting_date: Fri, 04 Oct 2024 13:00:00 -0400

summary: REVISIONS TO QSO-23-21-NH, ORIGINALLY RELEASED ON September 20, 2023. • Adjustment to Staffing and Quality Measures: CMS will update the staffing level case-mix adjustment methodology and replace some of the Quality Measures (QMs) used on Nursing Home Care Compare, in order to accommodate changes to the Minimum Data Set (MDS). Additionally, CMS will discontinue the CMS-672 form since the section G MDS data, used to populate this form, is being eliminated. • Penalty for Providers that Fail to Submit Staffing Data: To incentivize providers to submit accurate staffing data, CMS will revise the staffing rating methodology so providers that fail to submit staffing data or submit erroneous data receive the lowest score possible for corresponding staffing turnover measures. • Revised the timeline for adjusting the quality measures so that all affected quality measures are updated at the same time.

title: REVISED: Updates to Nursing Home Care Compare Staffing and Quality Measures

memo_number: QSO-24-21-NH

posting_date: Fri, 27 Sep 2024 01:00:00 -0400

summary: Memorandum Summary • The Centers for Medicare & Medicaid Services (CMS) is affirming the regulatory expectation that ensures nursing home residents have the unimpeded ability to exercise their right to vote as a citizen of the United States. • Nursing homes must ensure residents are able to exercise their Constitutional right to vote without interference, coercion, discrimination, or reprisal from the facility. • States, localities, and nursing home owners and administrators should collaborate to support a resident’s right to vote.

title: Compliance with Residents’ Rights Requirement related to Nursing Home Residents’ Right to Vote

memo_number: QSO-24-20-REH

posting_date: Sat, 07 Sep 2024 01:00:00 -0400

summary: Memorandum Summary REVISIONS TO QSO-23-07 REH ORIGINALLY RELEASED ON January 26, 2023 CMS is dedicated to improving access to health care in rural communities and addressing the issues which contribute to health inequities impacting these communities. • The Consolidated Appropriations Act (CAA), 2021 established Rural Emergency Hospitals (REHs) as a new Medicare provider and allows REHs to participate in the Medicare program and receive payment for items and services furnished on or after January 1, 2023. • CMS published a final rule establishing REHs as a new Medicare provider and codified the Conditions of Participation (CoP) that REHs must meet in order to participate in the Medicare and Medicaid programs along with REH payment policies, quality measures and enrollment policies. • CMS is providing revised guidance regarding the REH enrollment and conversion process for eligible facilities and updated Frequently Asked Questions (FAQs). The final interpretive guidance for REHs is pending and will be provided in a future release. • The national survey database system has been updated to include the REH tags and corresponding regulatory text. CMS will release REH Basic Surveyor Training via the Quality Safety Education Portal (QSEP) website when available.

title: REVISED: Guidance for Rural Emergency Hospital Provisions, Conversion Process and Conditions of Participation

memo_number: QSO-24-19-OPO

posting_date: Thu, 29 Aug 2024 16:00:00 -0400

summary: Organ Procurement Organization (OPO) Conditions for Coverage – Reporting Data Related to Pancreata Procured for Research

title: Organ Procurement Organization (OPO) Conditions for Coverage – Reporting Data Related to Pancreata Procured for Research

memo_number: QSO-24-18-OPT

posting_date: Fri, 23 Aug 2024 13:00:00 -0400

summary: Memorandum Summary • The Centers for Medicare & Medicaid Services (CMS) is revising survey and certification expectations for Outpatient Physical Therapy (OPT)/ Speech-Language Pathology (SLP) programs related to extension locations. Specifically, CMS is clarifying requirements for: • Primary Site and Extension Location Surveys; • Surveying All Extension Locations; • Surveying All Conditions of Participation at Extension Locations; and, • Extension Locations beyond a 30-mile radius. • CMS has also revised Forms CMS-381 and CMS-1856 to align with the recent certification transition work (Admin Info 24-22-ALL) and to further streamline enrollment and certification processes for OPTs, such as adding extension site locations. See: https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms381.pdf • CMS is currently in the process of revising Chapter 2 and Appendix E of the State Operations Manual (SOM) to incorporate these changes.

title: Revisions and clarifications for survey and certification activities for the Outpatient Physical Therapy (OPT)/ Speech-Language Pathology (SLP) Programs

memo_number: QSO-24-17-EMTALA

posting_date: Tue, 13 Aug 2024 15:00:00 -0400

summary: Memorandum Summary • CMS is dedicated to safeguarding the health and safety of millions of individuals, a commitment that includes enforcing federal laws including EMTALA. • CMS regulations require Medicare-participating hospitals to post signage outlining patients’ rights under EMTALA in the emergency department and areas where patients will be examined or treated, or wait to be examined or treated, for emergency medical conditions (EMCs). • CMS is releasing updated model signage that hospitals may use to meet this obligation.

title: Updated Model Signage for the Emergency Medical Treatment and Labor Act (EMTALA)

memo_number: QSO-24-16-ESRD

posting_date: Wed, 10 Jul 2024 16:00:00 -0400

summary: Memorandum Summary • Professional board certification is a voluntary process by which a physician (or other professional) demonstrates advanced knowledge and skills beyond minimal standards. The Medicare Conditions for Coverage (CfCs) for End-Stage Renal Disease facilities at 42 CFR §494.140(a)(1) require dialysis facility medical directors to be a physician who is “board-certified’’ in internal medicine or pediatrics, has completed a board-approved training program in nephrology, and has at least 12 months of experience providing care to patient receiving dialysis. • This memo is clarifies that the Centers for Medicare & Medicaid Services (CMS) expects the board certifying the physician to be a nationally recognized professional board, while not explicit on the particular Board from which certification must be obtained. • CMS is clarifying in this guidance the expectations for determining compliance with the requirements at 42 CFR §494.140(a)(1).

title: Clarification of Medical Director Board Certification Requirements

memo_number: QSO-24-15-CLIA

posting_date: Tue, 09 Jul 2024 01:00:00 -0400

summary: REVISIONS TO QSO-22-21-CLIA ORIGINALLY RELEASED ON JULY 11, 2022 Memorandum Summary • Publication of Final Rule: CMS-3355-F was published on July 11, 2022. This final rule implements revised regulations to update those that the Centers for Medicare & Medicaid Services (CMS) has identified as unnecessary, obsolete, or excessively burdensome on laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). • Effective Date: The regulations §§ 493.2 and 493.801 through 493.959 are effective two years after publication in the Federal Register [July 11, 2024]; amendments to 42 CFR §§ 493.20 and 493.25 related to laboratories performing tests of moderate complexity and high complexity testing that also perform waived testing and proficiency testing enrollment will be effective 30 days after the publication date of this final rule, and are effective August 10, 2022. • This revision updates the table found on page 4 of this memo to correctly list two analytes, Cancer antigen (CA) 125 and Carcinoembryonic antigen (CEA), under Endocrinology (§§ 493.933). • This revision also corrects the reported units for CEA from “ng/dL” to “ng/mL”. The units were previously revised in the Federal Register, and this memo reflects the revision on page 9.

title: REVISED: Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing - Analytes and Acceptable Performance Final Rule (CMS-3355-F)

memo_number: QSO-24-14-NH

posting_date: Mon, 01 Jul 2024 13:00:00 -0400

summary: Memorandum Summary • Update Nursing Home Guides Posted on the Medicare.gov Care Compare website: CMS will post new guides for consumers on the Medicare.gov Nursing Home Care Compare website to further support consumers choosing a nursing home and those already admitted to a nursing home. • Implement the New Staffing Level Case-Mix Methodology: CMS will implement the new staffing level case-mix adjustment methodology, announced in September 2023 (QSO-23-21-NH), for staffing measures reported on Nursing Home Care Compare. • Revise the Staffing Turnover Methodology: CMS will revise the nursing home staffing turnover methodology so that employees who are on leave for 90 days or less are not counted as staff turnover. • Post Facility Data: To increase transparency CMS, will post data on characteristics of nursing homes and their residents on data.cms.gov.

title: Nursing Home Data and Care Compare Updates

memo_number: QSO-24-13-NH

posting_date: Wed, 19 Jun 2024 01:00:00 -0400

summary: Memorandum Summary • Under the “Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting” final rule, the requirements for Facility Assessment have been revised. These revised requirements have been moved to 42 CFR 483.71. Existing regulations at 42 CFR 483.70(f) through (q) have been redesignated as paragraphs (e) through (p), respectively. • CMS is issuing revised guidance for State Survey Agencies and long-term care facilities (LTC) on the revised requirements.

title: Revised Guidance for Long-Term Care Facility Assessment Requirements

memo_number: QSO-24-11-HHA & Hospice

posting_date: Fri, 03 May 2024 16:00:00 -0400

summary: Revisions to the State Operations Manual (SOM) Chapter 10 –Informal Dispute Resolution (IDR) and Enforcement Procedures for Home Health Agencies and Hospice Programs

title: Revisions to the State Operations Manual (SOM) Chapter 10 –Informal Dispute Resolution (IDR) and Enforcement Procedures for Home Health Agencies and Hospice Programs

memo_number: QSO-24-10-Hospitals

posting_date: Tue, 02 Apr 2024 01:00:00 -0400

summary: Memorandum Summary • Based on increasing concerns about the absence of informed patient consent prior to allowing practitioners or supervised medical, advanced practice provider, or other applicable students to perform training- and education-related examinations outside the medically necessary procedure (such as breast, pelvic, prostate, and rectal examinations), particularly on anesthetized patients, we are reinforcing hospitals’ informed consent obligations. • Requirements related to informed consent for hospitals are found throughout the Hospital Conditions of Participation (CoPs): the Patient’s Rights CoP at 42 CFR 482.13(b)(2); the Medical Record Services CoP at 482.24(c)(4)(v); and the Surgical Services CoP at 482.51(b)(2). • Surveyors must ensure that a hospital’s patient informed consent policy and process, as well as its informed consent forms, contain elements and information that allow for a patient, or his or her representative, to make fully informed decisions about their care. • CMS is revising its hospital interpretive guidance about informed consent in the State Operations Manual, Appendix A-Hospitals, to address this.

title: Revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent

memo_number: QSO-24-09-EMTALA

posting_date: Wed, 27 Mar 2024 16:00:00 -0400

summary: Memorandum Summary • CMS is clarifying procedures related to the release of the Quality Improvement Organization’s (QIO) 60-day report, requested for CMS’s referral of an EMTALA case to the HHS Office of the Inspector General (OIG) and for OIG’s investigation of the case. • Specifically, the 60-day report may not be released to the affected physician and/or hospital until after the OIG investigation is completed and the OIG closes the case.

title: Clarification on Release of 60-Day Quality Improvement Organization Reports by CMS

memo_number: QSO-24-08-NH EXPIRED

posting_date: Tue, 02 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Enhanced Barrier Precautions in Nursing Homes to Prevent Spread of Multidrug-resistant Organisms (MDROs)

memo_number: QSO-24-07-HHA

posting_date: Sat, 16 Mar 2024 01:00:00 -0400

summary: Memorandum Summary • Updates to the State Operations Manual (SOM) Appendix B - Guidance for Surveyors: Home Health Agencies – The Centers for Medicare & Medicaid Services (CMS) is releasing interpretive guidelines and updates to Appendix B of the SOM because several final rules have amended the Home Health Agency (HHA) Conditions of Participation (CoPs). We made conforming revisions to the regulatory tags and interpretive guidelines. We are also combining the HHA survey protocol and interpretive guidelines into one document, updating Level 1 tags, and making clarifications and technical corrections to other guidance areas based on stakeholder feedback. • Several previously released S&C, QSO, and Admin Info memos that are now obsolete with the revision of Appendix B. Memos: Admin Info 19-07, QSO-18-13, QSO-18-25, SC11-11, SC12-15, SC14-14, SC15-51, and SC15-52 are now expired. CMS will note the expiration date on these memos that are currently on the CMS website. This memo and the associated Appendix B update will supersede the expired memos.

title: Revisions to Home Health Agencies (HHA) – Appendix B of the State Operations Manual

memo_number: QSO-24-06-CMHC

posting_date: Sat, 02 Mar 2024 02:00:00 -0500

summary: Memorandum Summary • SOM Chapter 2 and Appendix F: CMS has revised the SOM to reflect changes associated with the November 22, 2023, release of the Hospital Outpatient Perspective Payment System (OPPS) final rule (CMS-1786-FC). These regulations include new requirements for intensive outpatient (IOP) services, new definitions added to personnel qualifications, and adding additional practitioners who may lead interdisciplinary team meetings as necessary. Additionally, the survey process is revised, and other revisions are included for clarity.

title: Revisions to Chapter 2 and Appendix F of the State Operations Manual (SOM) –Community Mental Health Centers (CMHCs)

memo_number: QSO-24-05-Hospital/CAH

posting_date: Fri, 09 Feb 2024 02:00:00 -0500

summary: Memorandum Summary • Texting patient information and the texting of patient orders among members of the health care team is permissible, if accomplished through a HIPAA compliant secure texting platform (STP) and in compliance with the Conditions of Participation (CoPs). • Computerized Provider Order Entry (CPOE) continues to be the preferred method of order entry by a provider.

title: Texting of Patient Information and Orders for Hospitals and CAHs

memo_number: QSO-24-04-[OPO]

posting_date: Fri, 19 Jan 2024 02:00:00 -0500

summary: Memorandum Summary • Donor Definition: CMS is clarifying the definition of “donor” in the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs). This clarification addresses the use of the pancreata for islet cell research that are included in the definition (emphasis added). • Data Verification: OPOs must maintain information on the disposition of pancreas organs and islet cells submitted for pancreatic islet cell research.

title: Organ Procurement Organization (OPO) Conditions for Coverage – Definition Clarification

memo_number: QSO-24-03-CLIA

posting_date: Thu, 28 Dec 2023 13:00:00 -0500

summary: Memorandum Summary • Publication of Final Rule: CMS-3326-F was published on December 28, 2023. This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. Specifically, the final rule will: 1) implement a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees; 2) amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes; and 3) amend the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions against non-compliant laboratories operating under Certificates of Waiver, rather than being limited only to imposing principal sanctions of revocation, suspension or limitation of a laboratory’s CLIA certificate. • Effective Dates: These regulations are effective January 27, 2024, except for instruction 3, amending § 493.2; instructions 14 through 19, amending §§ 493.945, 493.1273, 493.1274, 493.1278, 493.1359, and 493.1405; instruction 20 removing § 493.1406; instructions 21 through 30, amending §§ 493.1407, 493.1411, 493.1417, 493.1423, 493.1443, 493.1445, 493.1449, 493.1451, 493.1455, and 493.1461; instruction 31 removing § 493.1462; and instructions 32 through 36, amending §§ 493.1463, 493.1469, 493.1483, 493.1483, 493.1489, and 493.1491, which are effective December 28, 2024.

title: Final Rule- Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F)

memo_number: QSO-24-02-Hospitals/CAHs/REH/EMTALA

posting_date: Sat, 09 Dec 2023 02:00:00 -0500

summary: Memorandum Summary • CMS is reinforcing EMTALA requirements and the existing flexibilities available for hospitals experiencing an extraordinary surge in demand for Emergency Department (ED) services in anticipation of possible increases in cases of influenza, COVID-19, and RSV this fall and winter season. • The attached fact sheet reinforces previous guidance regarding the options hospitals may utilize to increase surge capacity in their facilities and assist in maintaining compliance with the EMTALA requirements at 42 CFR 489.24 and the related requirements at 42 CFR 489.20 (l), (m), (q) and (r) when EDs are experiencing extraordinary surges in demand. • State Agencies will continue to follow the routine complaint and survey procedures outlined in State Operations Manual, Chapter 5 Complaint Procedures and Appendix V Interpretive Guidelines – Responsibilities of Medicare Participating Hospitals in Emergency Cases. • State Agencies and surveyors responsible for EMTALA enforcement are expected to be aware of the flexibilities permissible under EMTALA. These flexibilities will be considered when evaluating a hospital’s compliance with the EMTALA requirements. during a survey. • CMS expects healthcare staff and surveyors (contractors, Federal, State, and Local) to comply with basic infection control practices to prevent and minimize the transmission of infection within these healthcare facilities while also adhering to the applicable infection control requirements for their respective provider type.

title: Reminder of Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Guidance for Hospitals in a Disaster

memo_number: QSO-24-01-REH

posting_date: Sat, 04 Nov 2023 01:00:00 -0400

summary: Memorandum Summary • On November 23, 2022, CMS published a final rule (87 FR 72293) that established REHs as a new Medicare provider type, effective January 1, 2023, and codified the Conditions of Participation (CoPs) that REHs must meet to participate in the Medicare and Medicaid programs. The rule also established REH payment and enrollment requirements. • All REH surveys will be conducted by State Survey Agencies (SAs) for at least the first three years from the date on which the first REH has been certified. • A deeming option for the REH program will be considered by CMS after we have had adequate time and opportunity to effectively monitor and evaluate the program but will be no earlier than three years from the date on which the first REH has been certified.

title: Oversight of Rural Emergency Hospitals (REHs)

memo_number: QSO-23-24-Hospital

posting_date: Sat, 30 Sep 2023 01:00:00 -0400

summary: Memorandum Summary Survey activities to assess for compliance with the regulations for QAPI programs require surveyors to review the facility’s documentation to demonstrate the ongoing and sustainable actions taken to provide for patient safety and prevent adverse events. PSWP do not include the information to be disclosed to comply with CMS’ Condition of Participation (CoP) or Condition for Coverage (CfC) requirements. Facilities may choose to identify certain documents as PSWP that cannot be disclosed and used in the assessment of compliance but are still required to provide alternate documentation to demonstrate compliance with the CoPs.

title: Patient Safety Work Products (PSWP), Survey Process, and Quality Assessment and Performance Improvement (QAPI) Survey Documents

memo_number: QSO-23-22-Hospital

posting_date: Thu, 21 Sep 2023 13:00:00 -0400

summary: Memorandum Summary • CMS is committed to improving access and quality care for pregnant and postpartum individuals and their infants. • Hospital governing body requirements at §482.12(c)(1), (2), and (4) apply exclusively to Medicare patients/beneficiaries. • For non-Medicare beneficiaries, including patients receiving Medicaid, hospitals may develop policies to permit nurse midwives to be credentialed and privileged to admit and care for hospital inpatients in accordance with State licensure laws. • Critical Access Hospital (CAH) requirements for physician review and signature of records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants apply to all patients of the CAH.

title: Reinforcement of Interpretive Guidance for Nurse Midwives

memo_number: QSO-23-21-NH

posting_date: Wed, 20 Sep 2023 16:00:00 -0400

summary: Memorandum Summary • Adjustment to Staffing and Quality Measures: CMS will update the staffing level case-mix adjustment methodology and replace some of the Quality Measures (QMs) used on Nursing Home Care Compare, in order to accommodate changes to the Minimum Data Set (MDS). Additionally, CMS will discontinue the CMS-672 form since the section G MDS data, used to populate this form, is being eliminated. • Penalty for Providers that Fail to Submit Staffing Data: To incentivize providers to submit accurate staffing data, CMS will revise the staffing rating methodology so providers that fail to submit staffing data or submit erroneous data receive the lowest score possible for corresponding staffing turnover measures.

title: Updates to Nursing Home Care Compare Staffing and Quality Measures

memo_number: QSO-25-26-NH

posting_date: Mon, 29 Sep 2025 20:15:00 -0400

summary: Memorandum Summary CMS is committed to reinvesting civil money penalty (CMP) funds in projects that support nursing home residents and protect or improve their quality of care and life. Therefore, we are updating the Civil Money Penalty Reinvestment Program (CMPRP), including: • CMPRP Application – CMS has developed a standardized Application Form to streamline the review and approval process, ensuring consistency and reducing administrative burden. • Project Funding Cap – CMS has increased per-project funding limits across all categories to account for inflation and program evolution, supporting enhanced quality improvement initiatives while encouraging more funding requests from nursing facilities. • Allowable Technology Parameters - CMS has updated and clarified the allowable technology parameters to support high-quality resident-centered projects. • Mental and Behavioral Health Projects - CMS is accepting applications for Mental and Behavioral Health projects following the conclusion of the Center of Excellence collaborative initiative with the Substance Abuse and Mental Health Services Administration. • Workforce Enhancement Projects - CMS is accepting workforce enhancement project applications focused on improving competency, education, and training for direct care workers in nursing homes. • Project Results – CMS is updating project reporting parameters to require demonstrated success in meeting project goals and objectives before allowing project duplication in other nursing homes or states, while streamlining reporting timelines and improving measurable outcomes. • State Plans: Public Posting Enhancement – CMS is enhancing transparency by posting additional key elements of State Plans, including the State's CMP fund balance.

title: Civil Money Penalty Reinvestment Program (CMPRP) Updates

memo_number: QSO-23-20-RHC

posting_date: Thu, 27 Jul 2023 01:00:00 -0400

summary: REVISIONS TO QSO-23-12-RHC ORIGINALLY RELEASED ON MARCH 31, 2023 Memorandum Summary • Census Bureau’s (CB’s) March 2022 regulatory changes - CMS is providing an interim process while it considers options to align the Medicare Rural Health Clinic (RHC) Program’s rural location determinations with the CB’s regulatory changes for determining urban areas. • Interim Process for Rural Location Determination - Until further notice, the Centers for Medicare and Medicaid Services (CMS) will use the 2010 and 2020 Census urban criteria when making rural location determinations. The attached document provides instructions and screenshots to assist with searching for an address on the CB’s TIGERweb Decennial website.

title: REVISED: Interim CMS Rural Health Clinic (RHC) Rural Location Determinations due to Census Bureau (CB) Regulatory Changes

memo_number: QSO-23-19-Hospitals

posting_date: Tue, 18 Jul 2023 01:00:00 -0400

summary: Memorandum Summary •Patients in Medicare-certified hospitals have a right, by regulation, to receive care in a safe setting. •Hospitals can demonstrate compliance with this standard through appropriate patient assessments, adequate staffing and monitoring, and mitigation of environmental risks.

title: Ligature Risk and Assessment in Hospitals

memo_number: QSO-23-18-NH

posting_date: Thu, 29 Jun 2023 01:00:00 -0400

summary: Memorandum Summary • Posting Nursing Home Affiliation on Nursing Home Care Compare: CMS will include ownership and operatorship affiliation information on our Nursing Home Care Compare website. • Posting Aggregate Nursing Home Performance Data on data.cms.gov: CMS will publish combined inspection, staffing, quality, and other performance metrics across groups of nursing homes with shared ownership and operatorship on data.cms.gov.

title: Posting of Nursing Home Ownership/Operatorship Affiliation Data on Nursing Home Care Compare Website and data.cms.gov

memo_number: QSO-23-17-CAH

posting_date: Fri, 09 Jun 2023 10:00:00 -0400

summary: Memorandum Summary • Medicare-certified CAHs are required to meet the annual 96-hour average patient length of stay standard for acute inpatient care under the CAH Conditions of Participation (CoPs) at 42 CFR §485.620(b). • During the COVID-19 Public Health Emergency (PHE), CMS waived the requirement that CAHs limit the annual average patient length of stay to 96 hours. This waiver was in effect from March 1, 2020, through the end of the PHE on May 11, 2023. • The purpose of this memo is to provide guidance to the SAs of a one-time change to the CAH 96-hour patient length of stay calculation to account for the time period of the PHE.

title: One-Time Change to Critical Access Hospital (CAH) Annual Average 96-hour Patient Length of Stay Calculations to Account for the COVID-19 Public Health Emergency (PHE)

memo_number: QSO-23-16-Hospitals

posting_date: Tue, 06 Jun 2023 16:00:00 -0400

summary: CMS is committed to ensuring that the health and safety of patients are protected when discharges from hospitals and transfers to post-acute care providers occur. Therefore, we are providing the following information: • Reminding state agencies (SAs), accrediting organizations (AOs), and hospitals of the regulatory requirements for discharges and transfers to post-acute care providers. • Highlighting the risks to patients’ health and safety that can occur due to an unsafe discharge. • Recommendations that hospitals can leverage to improve their discharge policies and procedures to improve and protect patients’ health and safety.

title: Requirements for Hospital Discharges to Post-Acute Care Providers

memo_number: QSO-23-15-CLIA REVISED

posting_date: Tue, 23 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the most current version of the memo.

title: REVISED Clinical Laboratory Improvement Amendments of 1988 (CLIA) Post-Public Health Emergency (PHE) Guidance

memo_number: QSO-23-14-AO/CLIA

posting_date: Thu, 11 May 2023 01:00:00 -0400

summary: Annual Report to Congress: The 2021 annual RTC details the review, validation, and oversight of the FY 2020 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results.

title: FY 2021 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: QSO-23-13-ALL

posting_date: Mon, 01 May 2023 16:00:00 -0400

summary: Memorandum Summary · Social Security Act Section 1135 emergency waivers for health care providers will terminate with the end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. · Certain regulations or other policies included in Interim Final Rules with Comments (IFCs) will be modified with the ending the PHE. Certain policies, such as the Acute Hospital at Home initiative and telehealth flexibilities have been extended by Congress through December 31, 2024. · Long Term Care and Acute and Continuing Care providers are expected to be in compliance with the requirements according to the timeframes listed below.

title: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

memo_number: QSO-23-12-RHC

posting_date: Sat, 01 Apr 2023 01:00:00 -0400

summary: Census Bureau’s (CB’s) March 2022 regulatory changes - CMS is providing an interim process while it considers options to align the Medicare Rural Health Clinic (RHC) Program’s rural location determinations with the CB’s regulatory changes for determining urban areas. • Interim Process for Rural Location Determination - Until further notice, the Centers for Medicare and Medicaid Services (CMS) will use the 2010 and 2020 Census urban critieria when making rural location determinations.

title: Interim CMS Rural Health Clinic (RHC) Rural Location Determinations due to Census Bureau (CB) Regulatory Changes

memo_number: QSO-23-11-LSC

posting_date: Sat, 01 Apr 2023 01:00:00 -0400

summary: Various CMS regulations governing certain providers and certified suppliers require compliance with the 2012 edition of the National Fire Protection Association (NFPA) Health Care Facilities Code (NFPA 99). • 2012 edition of NFPA 99 requires emergency power for an essential electric system (EES) to be supplied by a generator or battery system. • 2021 edition of the NFPA 99 permits emergency power for an EES to be supplied by sources other than a generator or battery system, including a health care microgrid system (HCMS) • HCMSs are small-scale electrical grids where the sources of electricity can be provided by clean energy technologies (e.g., fuel cells, solar, wind, energy storage, etc.). • Except as noted below, CMS is issuing a categorical waiver permitting new and existing health care facilities subject to CMS requirements to utilize alternate sources of power other than a generator set or battery system only if in accordance with the 2021 edition of the NFPA 99, 2023 edition of the National Electric Code (NFPA 70), and associated references. • The categorical waiver excludes long-term care (LTC) facilities that provide life support as the LTC requirements at 42 CFR 483.90(c)(2) requires these facilities to have an emergency generator without exception.

title: Categorical Waiver – Health Care Microgrid Systems (HCMSs)

memo_number: QSO-18-24-ESRD REVISED

posting_date: Wed, 22 Mar 2023 16:00:00 -0400

summary: • Dialysis Services in a Long-Term Care (LTC) Facility: In 2018, CMS issued guidance that addressed care at home provisions for nursing home residents that were receiving home dialysis. Since that time, CMS has received questions, comments, and feedback from the state survey agencies, the dialysis provider community, as well as other Federal and non-Federal stakeholders. This memorandum addresses those questions and incorporates the feedback that we received. • Survey Process for Evaluation of Home Dialysis in an LTC Facility: The End-Stage Renal Disease (ESRD) Core Survey Process has been updated to include additional survey activities which evaluate dialysis services provided by an ESRD facility to residents in an LTC facility. • Attachments: Included as an attachment to this memorandum is an advance copy of the survey procedures for ESRD surveyors reviewing dialysis in nursing homes.

title: Guidance and Survey Process for Reviewing Home Dialysis Services in a Nursing Home

posting_date: Thu, 09 Mar 2023 16:00:00 -0500

summary: • CMS is committed to consistent implementation and oversight of the QAPI requirements as a part of our patient safety initiative. • QAPI Guidance Released: CMS is releasing the updated interpretive guidance for State Operations Manual (SOM) Hospital Appendix A for the QAPI CoP • The QAPI CoP requires a hospital to “maintain and demonstrate evidence of its QAPI program for review by CMS, as well as the governing body oversight of the program in an effort to deliver safe, quality patient care and prevent adverse events and patient harm.” (42 CFR 482.21)

title: Revision to State Operations Manual (SOM), Hospital Appendix A - Interpretive Guidelines for 42 CFR 482.21, Quality Assessment & Performance Improvement (QAPI) Program

memo_number: QSO-23-08-HOSPICE

posting_date: Fri, 27 Jan 2023 09:00:00 -0500

summary: • Revisions to Appendix M and complementary revisions to the CMS Hospice Basic Surveyor Training will equip surveyors from all surveying entities (State Agencies and Accrediting Organizations) to focus on the quality of care and facilitate consistency. • Surveyors who have previously taken the CMS Hospice Basic Surveyor Training will take an abbreviated training that explains the new approach, while all surveyors (State Agencies and Accrediting Organizations) who have not taken an earlier version of the CMS Hospice Basic Surveyor Training will take the full revised training.

title: Revisions to Hospice-Appendix M of the State Operations Manual and the Hospice Basic Surveyor Training

memo_number: QSO-23-06-ALL

posting_date: Fri, 20 Jan 2023 02:00:00 -0500

summary: Quality in Focus: CMS developed a series of short (10–15 minutes), Quality in Focus interactive videos tailored for specific provider types. The series aims to increase the quality of care for people with Medicare and Medicaid by reducing the deficiencies most commonly cited during the CMS survey process, such as infection control and accident prevention.

title: Provider and Supplier Compliance Education Through Quality in Focus (QIF) Trainings

memo_number: QSO-23-05-NH

posting_date: Thu, 19 Jan 2023 02:00:00 -0500

summary: • Adjusting Quality Measure Ratings: CMS will be conducting audits of schizophrenia coding in the Minimum Data Set data and, based upon the results, adjust the Nursing Home Care Compare quality measure star ratings for facilities whose audits reveal inaccurate coding. • Posting Citations Under Dispute: To be more transparent, CMS will now display citations under informal dispute on the Nursing Home Care Compare website.

title: Updates to the Nursing Home Care Compare Website and Five Star Quality Rating System: Adjusting Quality Measure Ratings Based on Erroneous Schizophrenia Coding, and Posting Citations Under Dispute

memo_number: QSO-23-07-REH

posting_date: Fri, 27 Jan 2023 02:00:00 -0500

summary: CMS is dedicated to improving access to health care in rural communities and addressing the issues which contribute to health inequities impacting these communities. • The Consolidated Appropriations Act (CAA), 2021 established Rural Emergency Hospitals (REHs) as a new Medicare provider and allows REHs to participate in the Medicare program and receive payment for items and services furnished on or after January 1, 2023. • CMS published a final rule establishing REHs as a new Medicare provider and codified the Conditions of Participation (CoP) that REHs must meet in order to participate in the Medicare and Medicaid programs along with REH payment policies, quality measures and enrollment policies. • CMS is providing guidance regarding the REH enrollment and conversion process for eligible facilities, Frequently Asked Questions (FAQs), and a newly developed State Operations Manual Appendix (Appendix O) with survey procedures and CoP regulatory text. The interpretive guidance for REHs is pending and will be provided in a future release. • The national survey database system has been updated to include the REH tags and corresponding regulatory text. CMS will release REH Basic Surveyor Training via the Quality Safety Education Portal (QSEP) website when available.

title: Guidance for Rural Emergency Hospital Provisions, Conversion Process and Conditions of Participation

memo_number: QSO-23-10-NH EXPIRED EFFECTIVE: July 30, 2025

posting_date: Wed, 30 Jul 2025 16:00:00 -0400

summary: Memo Expiration Information: Expiration Date: 07/30/2025 Expiration Information: More information on the requirements regarding F880 and F887 can be found in Appendix PP of the State Operations Manual, F880 (42 CFR 483.80(a)(1) and 483.80(a)(2)(i) and §483.80(g)(1)(viii)-(ix). CMS has rescinded memorandum QSO-20-31-ALL, the Enhanced Enforcement for Infection Control Deficiencies, and replaced it with memorandum QSO-23-10-NH, revised guidance for Strengthened Enhanced Enforcement for Infection Control Deficiencies. This revised guidance strengthens enforcement efforts for noncompliance with infection control deficiencies. The enhanced enforcement actions are more stringent for infection control deficiencies that result in actual harm or immediate jeopardy to residents. In addition, the criteria for enhanced enforcement on infection control deficiencies that result in no resident harm has been expanded to include enforcement on noncompliance with Infection Prevention and Control (F880) combined with COVID-19 Vaccine Immunization Requirements for Residents and Staff (F887). • CMS is providing guidance to the State Survey Agencies and CMS locations on handling enforcement cases before and after the revisions of Enhanced Enforcement for Infection Control Deficiencies. • Quality Improvement Organizations have been strategically refocused to assist nursing homes in combating COVID-19 through such efforts as education and training, creating action plans based on infection control problem areas, and recommending steps to establish a strong infection control and surveillance program.

title: EXPIRED: Strengthened Enhanced Enforcement for Infection Control Deficiencies and Quality Improvement Activities in Nursing Homes

posting_date: Fri, 14 Mar 2025 17:00:00 -0400

summary: CMS is rescinding this memo (QSO-23-03-All), effective on 01/20/2025 as referenced in Executive Order 13997. Providers and suppliers, especially those delivering care in congregate care settings, should ensure their patients and residents are protected against transmission of COVID-19 within their facilities, as well as receiving appropriate treatment when tested positive for the virus. Further, all providers and suppliers should continue to implement appropriate infection control protocols for COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection- control.html) and Influenza (https://www.cdc.gov/flu/professionals/infectioncontrol/index.htm). This memo discusses the importance of the timely use of available COVID-19 therapeutics, particularly for high-risk patients who test positive for the virus.

title: RESCIND The Importance of Timely Use of COVID-19 Therapeutics

memo_number: QSO-23-04-Hospitals

posting_date: Tue, 29 Nov 2022 02:00:00 -0500

summary: • Workers in hospitals, nursing homes, and other healthcare settings face risks of workplace violence. Many factors contribute to this risk, including working directly with people who have a history of aggressive behavior, behavioral issues, or may be under the influence of drugs. • An April 2020 Bureau of Labor Statistics Fact Sheet found that healthcare workers accounted for 73 percent of all nonfatal workplace injuries and illnesses due to violence in 2018. This number has been steadily growing since tracking of these specific events began in 2011. • Exposure to workplace violence hazards come at a high cost; however, with appropriate controls in place, it can be addressed. • CMS will continue to enforce the regulatory expectations that patient and staff have an environment that prioritizes their safety to ensure effective delivery of healthcare.

title: Workplace Violence-Hospitals

memo_number: 17-15-LSC Revised

posting_date: Thu, 27 Oct 2022 01:00:00 -0400

summary: • Fire Safety Requirements: The Centers for Medicare and Medicaid Services (CMS) has adopted the 2012 Life Safety Code (LSC) and the 2012 Health Care Facilities Code (HCFC) through regulation (see 81 FR 26872, 5/4/16), effective July 5, 2016. CMS has adopted changes through regulation to allow existing Medicare or Medicaid certified Nursing Facilities (NF)/Skilled Nursing Facilities (SNF) before July 5, 2016 that previously used the FSES for compliance, to use the scoring values in the mandatory values chart in NFPA 101, 2001 edition (see 87 CFR 47502, 8/3/22), effective October 1, 2022. • FSES Edition to be USED to Meet Fire Safety Requirements: If the FSES is being used to demonstrate compliance with the fire safety requirements, the version of the FSES for Health Care Occupancies and Board and Care Occupancies found in the 2013 edition of the Guide on Alternative Approaches to Life Safety, NFPA 101A must be used. A facility that achieves a passing score on the 2013 edition of the FSES will be considered to meet the fire safety requirement for certification and recertification with the Medicare and Medicaid programs. If an existing NF/SNF had an approved FSES on record prior to July 5, 2016 the NF/SNF may use the mandatory values in NFPA 101A, 2001 edition, to meet the fire safety requirements for recertification. • Survey Start Date: CMS began surveying for compliance with the 2012 LSC and HCFC on November 1, 2016. Facilities may now use NFPA 101A, 2013 edition, of the FSES. As of October 1, 2022, existing NF/SNF certified and with a previously approved FSES prior to July 5, 2016 may now use the mandatory values in NFPA 101A, 2001 edition. • Time Limited Waiver for Corrective Action: Time limited waivers previously allowed for existing NF/SNF that had an FSES on record prior to July 5, 2016 are rescinded with the adoption of the FSES mandatory values in NFPA 101A, 2001 edition.

title: Use of the Fire Safety Evaluation System (FSES), National Fire Protection Association (NFPA) 101A, Guide on Alternative Approaches to Life Safety, 2013 Edition by Health Care Occupancies and Board and Care Occupancies

memo_number: QSO-23-02-ALL EXPIRED

posting_date: Wed, 26 Jul 2023 01:00:00 -0400

summary: EXPIRATION INFORMATION: CMS PUBLISHED A FINAL RULE WHICH ENDED THE REQUIREMENTS RELATED TO STAFF VACCINATION FOR ALL PROVIDER TYPES, EFFECTIVE ON 8/05/23. ADDITIONALLY, THIS RULE STATES THAT CMS WILL NOT BE ENFORCING THE STAFF VACCINATION PROVISIONS BETWEEN 6/05/23 AND 8/04/23. EFFECTIVE 6/05/23, SURVEYORS WILL NO LONGER ASSESS COMPLIANCE WITH THESE REQUIREMENTS FOR ANY PROVIDERS. Memorandum Summary • CMS is committed to taking critical steps to protect vulnerable individuals to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On November 5, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes requirements regarding COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers. • CMS is revising its guidance and survey procedures for all provider types related to assessing and maintaining compliance with the staff vaccination regulatory requirements. • This memorandum replaces memoranda QSO 22-07-ALL Revised, and QSO 22-09-ALL Revised, and QSO 22-11-ALL Revised to consolidate the information into a single memorandum. The guidance in this memorandum applies to all states.

title: EXPIRED: Revised Guidance for Staff Vaccination Requirements

memo_number: QSO-23-01-NH REVISED

posting_date: Wed, 28 Jan 2026 13:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: REVISED: Revisions to the Special Focus Facility (SFF) Program

memo_number: QSO-22-24-ESRD

posting_date: Sat, 24 Sep 2022 01:00:00 -0400

summary: The Centers for Medicare & Medicaid Services generates a Dialysis Facility Outcomes List annually at the start of each Federal Fiscal Year. This list establishes the Tier 2 survey workload for state agencies. • For FY2023, the Outcomes List will include, for the first time, the Percent of Prevalent Patients Waitlisted (PPPW) measure in its methodology. The inclusion of this measure aims to evaluate the dialysis facility’s efforts toward the maintenance of each of its patient’s active status on the organ transplant waiting list. • State Agencies are expected to survey 100% of the facilities that are identified on the Outcomes List for their respective state.

title: FY2023 Dialysis Facility Outcomes List

memo_number: QSO-22-25-CLIA Rescinded 10/7/2022

posting_date: Fri, 07 Oct 2022 10:00:00 -0400

summary: This memo has been rescinded.

title: CMS Rescinds December 7, 2020, Enforcement Discretion for the Use of SARS-CoV-2 Tests on Asymptomatic Individuals Outside of the Test’s Instructions for Use (RESCINDED)

memo_number: QSO-22-15-NH & NLTC & LSC REVISED 08/29/2022 (EXPIRED)

posting_date: Tue, 05 Aug 2025 01:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) CMS continues to review the need for existing emergency blanket waivers issued in response to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Over the course of the COVID-19 PHE, skilled nursing facilities/nursing facilities (SNFs/NFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end-stage renal disease (ESRD) facilities have developed policies or other practices that we believe mitigates the need for certain waivers. • Applicable waivers will remain in effect for hospitals and critical access hospitals (CAH). • CMS will end the specified waivers in two groups: o 60 days from issuance of this memorandum o 30 days from issuance of this memorandum • CMS is providing more information related to waivers of the Nurse Aide Training Competency and Evaluation requirements.

title: EXPIRED: Update to COVID-19 Emergency Declaration Blanket Waivers for Specific Providers REVISED

posting_date: Fri, 26 Aug 2022 01:00:00 -0400

summary: Pursuant to the preliminary injunction in Texas v. Becerra, No. 5:22-CV-185-H (N.D. Tex.), HHS may not enforce the following interpretations contained in the July 11, 2022, CMS guidance (and the corresponding letter sent the same day by HHS Secretary Becerra): (1) HHS may not enforce the Guidance and Letter’s interpretation that Texas abortion laws are preempted by EMTALA; and (2) HHS may not enforce the Guidance and Letter’s interpretation of EMTALA—both as to when an abortion is required and EMTALA’s effect on state laws governing abortion—within the State of Texas or against the members of the American Association of Pro Life Obstetricians and Gynecologists (AAPLOG) and the Christian Medical and Dental Association (CMDA).

title: Preliminary injunction in Texas v. Becerra, No. 5:22-CV-185-H (N.D. Tex.)

memo_number: QSO-22-19-NH

posting_date: Thu, 30 Jun 2022 01:00:00 -0400

summary: •Revised Surveyor Guidance: CMS is releasing the following guidance and associated training for nursing home surveyors: Phase 2 and 3 Requirements: Clarifications and technical corrections of Phase 2 guidance issued in 2017, and new guidance for Phase 3requirements which went into effect in November 28, 2019. Arbitration Requirements: Guidance on the new requirements which became effective September 16, 2019. •Effective Date: Surveyors will begin using this guidance to identify noncompliance on October 24, 2022. This will allow for ample time for surveyors and facilities to be trained on this new information. •Training Resources: Training on guidance for surveyors and providers will be available upon release of this memorandum. •Complaint and Facility Reported Incidents (FRIs): CMS revised the guidance in Chapter 5 and related exhibits of the State Operations Manual (SOM) to strengthen the oversight of nursing home complaints and FRIs. CMS also revised its guidance for all Medicare-certified provider/supplier types to improve consistency across the State agencies in their communication to complainants. •Psychosocial Outcome Severity Guide: CMS revised guidance to clarify the reasonable person concept and examples across the different severity levels.

title: Revised Long-Term Care Surveyor Guidance

memo_number: QSO-22-18-ALL

posting_date: Thu, 16 Jun 2022 16:00:00 -0400

summary: CMS is rescinding and hereby removing the January 25, 2022 Memo regarding Vaccination Expectations for Surveyors Performing Federal Oversight (QSO-22-10-ALL) from HHS’s guidance repository.

title: Recission of the January 25, 2022 Memo Regarding Vaccination Expectations for Surveyors Performing Federal Oversight (QSO-22-10-ALL) and Removal from its Guidance Repository

memo_number: QSO-22-17-ALL

posting_date: Wed, 15 Jun 2022 01:00:00 -0400

summary: CMS is committed to taking critical steps to protect vulnerable individuals to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Survey oversight of the staff vaccination requirement for Medicare and Medicaid-certified providers and suppliers will continue to be performed during initial and recertification surveys, but will now only be performed in response to complaints alleging non-compliance with this requirement, not all surveys. Under prior guidance, all surveys included oversight of the staff vaccination requirement. • CMS will revise QSO 22-11 to ensure deficiency determinations reflect good faith efforts implemented by providers and suppliers and incorporate harm or potential harm to patients and residents resulting from any non-compliance.

title: Surveys for Compliance with Omnibus COVID-19 Health Care Staff Vaccination Requirements

posting_date: Tue, 05 Apr 2022 21:00:00 -0400

summary: Memorandum Summary: Effective 10-26-22, this memo has been superseded by QSO-23-02-ALL, Revised Guidance for Staff Vaccination Requirements. • CMS is committed to ensuring America’s healthcare facilities respond effectively in an evidence-based way to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On November 05, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes requirements regarding COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers. • CMS is providing guidance and survey procedures for assessing and maintaining compliance with these regulatory requirements. • The guidance in this memorandum specifically applies to the following state: Texas. • States that are not identified above are expected to continue under the timeframes and parameters identified in either the December 28, 2021 or January 14, 2022 memoranda (QSO-22-07-ALL-Revised and QSO 22-09-ALL-Revised).

title: Revised Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

posting_date: Tue, 05 Apr 2022 21:00:00 -0400

summary: Memorandum Summary Effective 10-26-22, this memo has been superseded by QSO-23-02-ALL, Revised Guidance for Staff Vaccination Requirements. • CMS is committed to ensuring America’s healthcare facilities respond effectively in an evidence-based way to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On November 05, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes requirements regarding COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers. • CMS is providing guidance and survey procedures for assessing and maintaining compliance with these regulatory requirements. • The guidance in this memorandum specifically applies to the following states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming. • The guidance in this memorandum does not apply to the following state at this time: Texas. Surveyors in Texas should not undertake any efforts to implement or enforce the IFC. • States that are not identified above are expected to continue under the timeframes and parameters identified in the December 28, 2021 memorandum (QSO-22-07-ALL-Revised)

title: Revised Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

posting_date: Tue, 05 Apr 2022 21:00:00 -0400

summary: Memorandum Summary • Effective 10-26-22, this memo has been superseded by QSO-23-02-ALL, Revised Guidance for Staff Vaccination Requirements. CMS is committed to ensuring America’s healthcare facilities respond effectively in an evidence-based way to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On November 05, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes requirements regarding COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers. • CMS is providing guidance and survey procedures for assessing and maintaining compliance with these regulatory requirements. • The guidance in this memorandum does not apply to the following states at this time: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming. Surveyors in these states should not undertake any efforts to implement or enforce the IFC.

title: Revised Guidance for the Interim Final Rule -Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

memo_number: QSO-22-12-ALL

posting_date: Thu, 10 Feb 2022 02:00:00 -0500

summary: The 1864 Agreement is the agreement between CMS and the State survey agency to carry out the provisions of Sections 1864, 1874, and related provisions of the Social Security Act (Act). This 1864 Agreement specifies the functions to be performed by the State. • Specifically, under Article II, A.1. (c), the State duties include “surveying for the purpose of certifying to the Secretary the compliance or non-compliance of providers and suppliers of services and resurveying such entities, at such times and manner as the Secretary may direct.” • CMS, as delegated by the Secretary, designates the content of the survey process to be followed by States.

title: State Obligations to Survey to the Entirety of Medicare and Medicaid Health and Safety Requirements under the 1864 Agreement

memo_number: QSO-22-08-NH

posting_date: Sat, 08 Jan 2022 02:00:00 -0500

summary: CMS will begin posting the following information for each nursing home on the Medicare.gov Care Compare website: • Weekend Staffing: The level of total nurse and registered nurse (RN) staffing on weekends provided by each nursing home over a quarter. • Staff Turnover: The percent of nursing staff and number of administrators that stopped working at the nursing home over a 12-month period. This information will be added to the Care Compare website in January 2022 and used in the Nursing Home Five Star Quality Rating System in July 2022. • Posting Detailed Staffing Data: CMS will begin posting the submitted employee-level staffing data for all nursing homes. • Reminder for Nursing Homes to Link Employee Identifiers when they are changed due to the changes in the facility’s staffing data systems.

title: Nursing Home Staff Turnover and Weekend Staffing Levels

memo_number: QSO-22-03-ASC & Hospital (EXPIRED)

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL: Guidance for the Expiration of the COVID-19 Public Health Emergency CMS continues to review the need for existing waivers and flexibilities issued in response to the Public Health Emergency (PHE). Over the course of the PHE, states and hospitals have developed policies or other practices that we believe mitigate the need for certain flexibilities created to address surge capacity. •CMS is announcing it is ending the flexibility of a streamlined process to allow Ambulatory Surgery Centers (ASCs) and licensed Independent Free standing Emergency Departments (IFEDs) to temporarily enroll as hospitals during theCOVID-19 PHE. •Effective upon issuance of this memo, no new ASC or licensed IFED requests to temporarily enroll as hospitals will be accepted. •Those facilities that are temporarily enrolled as hospitals under this flexibility can continue providing inpatient and outpatient hospital services until: o They voluntarily terminate from temporary hospital enrollment; or o CMS initiates enforcement action for any facility that is non-compliant with applicable participation requirements, to the extent not waived; or oThe Secretary of the Department of Health and Human Services (Secretary)determines there is no longer a PHE due to COVID-19; or oCMS provides additional public notice that this guidance has ceased to be effective.

title: EXPIRED: Ending the Streamlined Process for Ambulatory Surgical Centers and Independent Freestanding Emergency Departments to Temporarily Enroll as Hospitals during the COVID-19 Public Health Emergency

memo_number: QSO-19-13-Hospital REVISED

posting_date: Sat, 13 Nov 2021 02:00:00 -0500

summary: • CMS is committed to providing the information hospitals need to make decisions about how they partner with other providers in the health care system to deliver high-quality care. We are releasing the final guidance for the evaluation of compliance with Medicare Conditions of Participation (CoPs) related to shared space and services for hospitals co-located with other hospitals or health care entities. • State Operations Manual Appendix A will be updated to include co-location guidance as a component of the hospital survey process.

title: Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities (Revised)

memo_number: QSO-22-02-ALL

posting_date: Sat, 13 Nov 2021 02:00:00 -0500

summary: • CMS remains committed to taking critical steps to protect vulnerable Americans to ensure the nation’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • CMS is announcing steps to assist State Survey Agencies (SAs) in addressing the backlog of complaint and recertification surveys. These steps include: o Revising the criteria for conducting COVID-19 Focused Infection Control (FIC) Surveys; o Guidance for resuming recertification surveys; and o Temporary guidance and minor flexibilities related to complaint investigations. • CMS is increasing oversight in nursing homes to allow a more focused review of quality-of-life and quality-of-care concerns.

title: Changes to COVID-19 Survey Activities and Increased Oversight in Nursing Homes

memo_number: QSO-22-01-Hospice

posting_date: Thu, 21 Oct 2021 01:00:00 -0400

summary: • CMS is committed to taking necessary steps to ensure the quality and safety of hospice care. CMS is currently engaged in rulemaking to implement Section 407 of the Consolidated Appropriations Act (CAA 2021), which was signed into law on December 27, 2020. • Regulatory Requirements: CMS has introduced a proposed rule (86 FR 35874) through the CY 2022 Home Health Prospective Payment System Rate Update (HH PPS). This proposed rule is expected to be finalized and effective on January 1, 2022.

title: Upcoming rulemaking for survey and enforcement requirements for hospice programs.

memo_number: QSO-21-23-OPO

posting_date: Thu, 30 Sep 2021 16:00:00 -0400

summary: Memorandum Summary • OPO Performance Outcome Measures: New outcome measures for OPO performance were effective March 30, 2021, under the Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations Final Rule published on December 2, 2020: (https://www.govinfo.gov/content/pkg/FR-2020-12-02/pdf/2020-26329.pdf) • Public Reporting: The OPO rule requires CMS to publicly report OPO performance outcomes, annually.

title: Public Reporting of Organ Procurement Organizations’ (OPO) Performance Measures

memo_number: QSO-21-22-HOSPITALS (Revised)

posting_date: Mon, 03 Oct 2022 13:00:00 -0400

summary: PURSUANT TO THE PRELIMINARY INJUNCTION IN TEXAS V. BECERRA, NO. 5:22-CV-185-H (N.D. TEX.), HHS MAY NOT ENFORCE THE FOLLOWING INTERPRETATIONS CONTAINED IN THE JULY 11, 2022, CMS GUIDANCE (AND THE CORRESPONDING LETTER SENT THE SAME DAY BY HHS SECRETARY BECERRA): (1) HHS MAY NOT ENFORCE THE GUIDANCE AND LETTER’S INTERPRETATION THAT TEXAS ABORTION LAWS ARE PREEMPTED BY EMTALA; AND (2) HHS MAY NOT ENFORCE THE GUIDANCE AND LETTER’S INTERPRETATION OF EMTALA—BOTH AS TO WHEN AN ABORTION IS REQUIRED AND EMTALA’S EFFECT ON STATE LAWS GOVERNING ABORTION—WITHIN THE STATE OF TEXAS OR AGAINST THE MEMBERS OF THE AMERICAN ASSOCIATION OF PRO LIFE OBSTETRICIANS AND GYNECOLOGISTS (AAPLOG) AND THE CHRISTIAN MEDICAL AND DENTAL ASSOCIATION (CMDA). • The Emergency Medical Treatment and Labor Act (EMTALA) provides rights to any individual who comes to a hospital emergency department and requests examination or treatment. In particular, if such a request is made, hospitals must provide an appropriate medical screening examination to determine whether an emergency medical condition (EMC) exists or whether the person is in active labor. If an EMC is found to exist, the hospital must provide either stabilizing treatment or an appropriate transfer to another hospital that has the capabilities to provide stabilizing treatment. • Hospitals should ensure all staff who may come into contact with a patient seeking emergency care are aware of the hospital’s obligation under EMTALA. • A physician’s professional and legal duty to provide stabilizing medical treatment to a patient who presents to the emergency department and is found to have an emergency medical condition preempts any directly conflicting state law or mandate that might otherwise prohibit or prevent such treatment. • Patients, including pregnant people, are entitled to the full rights and protections afforded under this federal statute.

title: Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss (Revised)

memo_number: QSO-21-21-ICFIID

posting_date: Mon, 23 Aug 2021 16:00:00 -0400

summary: Memorandum Summary • CMS is committed to taking critical steps to ensure America’s healthcare facilities continue to respond effectively to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On May 11, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes Long-Term Care (LTC) Facility Vaccine Immunization Requirements for Residents and Staff. This includes new requirements for educating clients or client representatives and staff regarding the benefits and potential side effects associated with the COVID-19 vaccine, and offering the vaccine. Furthermore, ICFs/IID are encouraged to report COVID-19 vaccine and therapeutics treatment information to the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN).

title: Interim Final Rule - COVID-19 Vaccine Immunization Requirements for Clients and Staff in Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)

memo_number: QSO-21-20-NH

posting_date: Wed, 28 Jul 2021 16:00:00 -0400

summary: Memorandum Summary CMS is hereby removing the July 7, 2017 Memo (S&C 17-37-NH) from its guidance repository.

title: Removal of the July 7, 2017 Memo (S&C 17-37-NH) from its guidance repository

memo_number: QSO-20-41-ALL EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) • Emergency Preparedness Training and Testing Program Exemption - CMS regulations for Emergency Preparedness (EP) require facilities to conduct exercises to test the facility’s EP plan to ensure that it works and that staff are trained appropriately about their roles and the facility’s processes. During or after an actual emergency, the regulations allow for a one-year exemption from the requirement that the facility perform testing exercises. • This worksheet presents guidance for surveyors, as well as providers and suppliers, with assessing a facility’s compliance with the EP requirements, in light of many of the response activities associated with the COVID-19 Public Health Emergency (PHE). • As the PHE continues, many facilities continue to operate under their respective activated emergency plans. Therefore, CMS is providing additional guidance related to the exercise requirements (full-scale/functional drills and exercises) for inpatient and outpatient providers/suppliers. • This exemption only applies to the next required full-scale exercise (not the exercise of choice), based on the facility’s 12-month exercise cycle. The cycle is determined by the facility (e.g. calendar, fiscal or another 12-month timeframe).

title: EXPIRED: Guidance related to Emergency Preparedness- Exercise Exemption based on A Facility’s Activation of their Emergency Plan

memo_number: QSO-21-14-ICF/IID & PRTF REVISED 06/03/2021 (EXPIRED)

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Visitation Guidance: CMS is issuing new guidance for visitation in ICFs/IID and PRTFs during the COVID-19 PHE to include the impact of COVID-19 vaccination. The guidance below provides ways an ICF/IID and PRTF can more safely facilitate in-person visitation and address the psychosocial needs of clients/residents. • Coordination with the Centers for Disease Control and Prevention (CDC) and public health departments - We encourage all ICFs/IID and PRTFs to monitor the CDC website for information and resources and contact their health department when needed (CDC Resources for Health Care Facilities: Management of Visitors to Healthcare Facilities in the Context of COVID-19: Non-US Healthcare Settings | CDC)

title: EXPIRED: Visitation at Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) and Psychiatric Residential Treatment Facilities (PRTFs) - Coronavirus Disease -2019 (COVID-19) (REVISED)

posting_date: Thu, 02 Dec 2021 02:00:00 -0500

summary: Memorandum Summary Survey and Enforcement of the Vaccine Requirement for Health Care Staff in Medicare- and Medicaid-certified Providers and Suppliers Suspended While Court Ordered Injunctions are in Effect: The Centers for Medicare & Medicaid Services (CMS) will not enforce the new rule regarding vaccination of health care workers or requirements for policies and procedures in certified Medicare/Medicaid providers and suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider types covered by the rule) while there are court-ordered injunctions in place prohibiting enforcement of this provision.

title: Vaccination Regulation: Enforcement of Rule Imposing Vaccine Requirement for Health Care Staff in Medicare- and Medicaid-certified Providers and Suppliers is Suspended so Long as Court Ordered Injunctions Remain in Effect

memo_number: QSO-22-05-Hospitals (ADVISORY)

posting_date: Wed, 08 Dec 2021 02:00:00 -0500

summary: The Condition of Participation for Quality Assessment and Performance Improvement Program (§482.21) requires that hospitals develop, implement, and maintain an effective, ongoing, hospital wide, data-driven quality assessment and performance improvement program. • CMS is encouraging hospitals to consider implementation of evidence-based best practices for the management of obstetric emergencies, along with interventions to address other key contributors to maternal health disparities, to support the delivery of equitable, high-quality care for all pregnant and postpartum individuals.

title: Evidence-based best practices for hospitals in managing obstetric emergencies and other key contributors to maternal health disparities

memo_number: QSO-22-06-AO-CLIA

posting_date: Thu, 16 Dec 2021 02:00:00 -0500

summary: Annual Report to Congress: The 2020 annual RTC details the review, validation, and oversight of the FY 2019 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results.

title: FY 2020 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: QSO-22-07-ALL

posting_date: Wed, 29 Dec 2021 02:00:00 -0500

summary: Effective 10-26-22, this memo has been superseded by QSO-23-02-ALL, Revised Guidance for Staff Vaccination Requirements. CMS is committed to ensuring America’s healthcare facilities respond effectively in an evidence-based way to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). •On November 05, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes requirements regarding COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers. •CMS is providing guidance and survey procedures for assessing and maintaining compliance with these regulatory requirements. •The guidance in this memorandum does not apply to the following states at this time: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming. Surveyors in these states should not undertake any efforts to implement or enforce the IFC.

title: Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

memo_number: QSO-22-09-ALL

posting_date: Sat, 15 Jan 2022 02:00:00 -0500

summary: Effective 10-26-22, this memo has been superseded by QSO-23-02-ALL, Revised Guidance for Staff Vaccination Requirements. • CMS is committed to ensuring America’s healthcare facilities respond effectively in an evidence-based way to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On November 05, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes requirements regarding COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers. • CMS is providing guidance and survey procedures for assessing and maintaining compliance with these regulatory requirements. • The guidance in this memorandum specifically applies to the following states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia and Wyoming. • The guidance in this memorandum does not apply to the following state at this time: Texas. Surveyors in Texas should not undertake any efforts to implement or enforce the IFC. • States that are not identified above are expected to continue under the timeframes and parameters identified in the December 28, 2021 memorandum (QSO-22-07-ALL).

title: Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

memo_number: QSO-22-11-ALL

posting_date: Fri, 21 Jan 2022 02:00:00 -0500

summary: Effective 10-26-22, this memo has been superseded by QSO-23-02-ALL, Revised Guidance for Staff Vaccination Requirements. • CMS is committed to ensuring America’s healthcare facilities respond effectively in an evidence-based way to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On November 05, 2021, CMS published an interim final rule with comment period (IFC). This rule establishes requirements regarding COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers. • CMS is providing guidance and survey procedures for assessing and maintaining compliance with these regulatory requirements. • The guidance in this memorandum specifically applies to the following state: Texas. • States that are not identified above are expected to continue under the timeframes and parameters identified in either the December 28, 2021 or January 14, 2022 memoranda (QSO-22-07-ALL and QSO 22-09-ALL).

title: Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

memo_number: QSO-21-08-NLTC REVISED 09.26.2022

posting_date: Mon, 26 Sep 2022 18:30:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) continues to review the existing flexibilities, waivers, and survey guidance issued in response to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) and is committed to ensuring America’s healthcare facilities provide safe, high quality care. • COVID-19 Focused Infection Control (FIC) Survey Tool: SAs and AOs have returned to the existing standard survey processes and continue to assess infection prevention and control by focusing on the regulatory requirements. Surveyors must no longer use the special FIC survey and tool on a national or case by case basis. • Visitation Restrictions: Continued federal guidance regarding visitation restrictions for ACC facilities are no longer necessary. Facilities should continue to review their own infection prevention and control policies and practices to prevent the spread of infectious disease and illness, including COVID-19, consistent with national standards of practice. This CMS memo supersedes several previously issued COVID-19 IPC guidance memos as noted here, including: QSO-20-13-Hospitals-CAHs REVISED, QSO-20-15 Hospital/CAH/EMTALA REVISED, QSO-20-16-Hospice, QSO-20-18-HHA, QSO-20-19-ESRD - REVISED, QSO-20-22- ASC, CORF, CMHC, OPT, RHC/FQHCs, QSO-20-23-ICF/IID & PRTF, QSO-20-36-ESRD.

title: COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care Providers and Suppliers (REVISED)

memo_number: QSO-22-13-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 16:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Clinical Laboratory Improvement Amendments (CLIA) Guidance for Temporary Testing Sites under the Multiple Site Exception

memo_number: QSO-22-14-CLIA

posting_date: Wed, 23 Mar 2022 01:00:00 -0400

summary: CMS remains committed to taking critical steps to ensure America’s clinical laboratories are in compliance with the CLIA regulations amid the public health emergency (PHE) caused by Coronavirus Disease 2019 (COVID-19). • CMS is issuing this memorandum to CLIA State Agencies to provide updated guidance on actions to fully resume CLIA survey activities. These steps include: o Guidance for on-site surveys o Guidance for enforcement actions and PT review.

title: Clinical Laboratory Improvement Amendments of 1988 (CLIA) CMS Location and State Agency Updates to COVID-19 Survey Prioritization Guidance

memo_number: QSO-22-15-NH & NLTC & LSC

posting_date: Thu, 07 Apr 2022 10:00:00 -0400

summary: Memorandum Summary • CMS continues to review the need for existing emergency blanket waivers issued in response to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Over the course of the COVID-19 PHE, skilled nursing facilities/nursing facilities (SNFs/NFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end-stage renal disease (ESRD) facilities have developed policies or other practices that we believe mitigates the need for certain waivers. • Applicable waivers will remain in effect for hospitals and critical access hospitals (CAH). • CMS will end the specified waivers in two groups: o 60 days from issuance of this memorandum o 30 days from issuance of this memorandum

title: Update to COVID-19 Emergency Declaration Blanket Waivers for Specific Providers

memo_number: QSO-21-10-CLIA REVISED

posting_date: Sat, 16 Apr 2022 01:00:00 -0400

summary: • CMS is committed to taking critical steps to ensure America’s healthcare facilities continue to be prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On September 2, 2020, an interim final rule with comment period (CMS-3401-IFC) was published in the Federal Register (85 FR 54820). • CLIA regulations have been updated to require all laboratories to report SARS-CoV-2 test results in a standardized format and at a frequency specified by the Secretary. • CMS is providing surveyor guidance for State Agency and CMS Branch Location surveyors related to the CMS-3401-IFC CLIA SARS-CoV-2 test reporting requirements. • The Secretary published updated reporting guidance on March 8, 2022. As a result, CMS has updated the CLIA Surveyor Guidance and Frequently Asked Questions.

title: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting (REVISED)

memo_number: QSO-22-16-ASC

posting_date: Sat, 04 Jun 2022 01:00:00 -0400

summary: • Updates to the SOM Appendix L - Guidance for Surveyors- CMS published several final rules which amended the Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs). We made conforming revisions to the regulatory tags and interpretive guidelines. We are also making clarifications and technical corrections to other guidance areas based on stakeholder feedback, including minor, non-substantive edits to Exhibit 351.

title: Updated Guidance for Ambulatory Surgical Centers - Appendix L of the State Operations Manual (SOM)

memo_number: QSO-21-03-Hospitals/CAHs Revised

posting_date: Sat, 28 May 2022 01:00:00 -0400

summary: • CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On September 2, 2020, the Federal Register published an interim final rule with comment period (IFC) (85 FR 54820). • CMS has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19. • CMS has revised the frequency of reporting specific to psychiatric and rehabilitation hospitals • Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.

title: Updates to Interim Final Rule (IFC), CMS-3401-IFC; Requirements and Enforcement Process for Reporting of COVID-19 Data Elements for Hospitals and Critical Access Hospitals

memo_number: QSO-22-21-CLIA

posting_date: Tue, 12 Jul 2022 01:00:00 -0400

summary: • Publication of Final Rule: CMS-3355-F was published on July 11, 2022. In this final rule we implement revised regulations to update those that the Centers for Medicare & Medicaid Services (CMS) has identified as unnecessary, obsolete, or excessively burdensome on laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). • Effective Date: The regulations §§ 493.2 and 493.801 through 493.959 are effective two years after publication in the Federal Register [July 11, 2024]; amendments to 42 CFR §§ 493.20 and 493.25 related to laboratories performing tests of moderate complexity and high complexity testing that also perform waived testing and proficiency testing enrollment will be effective 30 days after the publication date of this final rule, and are effective August 10, 2022.

title: Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing - Analytes and Acceptable Performance Final Rule (CMS-3355-F)

memo_number: QSO-22-20-Hospitals

posting_date: Thu, 07 Jul 2022 01:00:00 -0400

summary: Updates to interpretive guidance for hospital requirements– CMS published the final rule Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction Final Rule which revised the regulatory requirements for hospitals related to infection prevention and control and antibiotic stewardship programs. We made conforming revisions to the interpretive guidelines.

title: Infection Prevention and Control and Antibiotic Stewardship Program Interpretive Guidance Update

memo_number: QSO-22-22-Hospitals

posting_date: Tue, 12 Jul 2022 01:00:00 -0400

summary: PURSUANT TO THE PRELIMINARY INJUNCTION IN TEXAS V. BECERRA, NO. 5:22-CV-185-H (N.D. TEX.), HHS MAY NOT ENFORCE THE FOLLOWING INTERPRETATIONS CONTAINED IN THE JULY 11, 2022, CMS GUIDANCE (AND THE CORRESPONDING LETTER SENT THE SAME DAY BY HHS SECRETARY BECERRA): (1) HHS MAY NOT ENFORCE THE GUIDANCE AND LETTER’S INTERPRETATION THAT TEXAS ABORTION LAWS ARE PREEMPTED BY EMTALA; AND (2) HHS MAY NOT ENFORCE THE GUIDANCE AND LETTER’S INTERPRETATION OF EMTALA—BOTH AS TO WHEN AN ABORTION IS REQUIRED AND EMTALA’S EFFECT ON STATE LAWS GOVERNING ABORTION—WITHIN THE STATE OF TEXAS OR AGAINST THE MEMBERS OF THE AMERICAN ASSOCIATION OF PRO LIFE OBSTETRICIANS AND GYNECOLOGISTS (AAPLOG) AND THE CHRISTIAN MEDICAL AND DENTAL ASSOCIATION (CMDA). • The Emergency Medical Treatment and Labor Act (EMTALA) provides rights to any individual who comes to a hospital emergency department and requests examination or treatment. In particular, if such a request is made, hospitals must provide an appropriate medical screening examination to determine whether an emergency medical condition exists or whether the person is in labor. If an emergency medical condition is found to exist, the hospital must provide available stabilizing treatment or an appropriate transfer to another hospital that has the capabilities to provide stabilizing treatment. The EMTALA statute requires that all patients receive an appropriate medical screening examination, stabilizing treatment, and transfer, if necessary, irrespective of any state laws or mandates that apply to specific procedures. • The determination of an emergency medical condition is the responsibility of the examining physician or other qualified medical personnel. An emergency medical condition may include a condition that is likely or certain to become emergent without stabilizing treatment. Emergency medical conditions involving pregnant patients may include, but are not limited to, ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe features. • Hospitals should ensure all staff who may come into contact with a patient seeking examination or treatment of a medical condition are aware of the hospital’s obligation under EMTALA. • A physician’s professional and legal duty to provide stabilizing medical treatment to a patient who presents under EMTALA to the emergency department and is found to have an emergency medical condition preempts any directly conflicting state law or mandate that might otherwise prohibit or prevent such treatment. • If a physician believes that a pregnant patient presenting at an emergency department is experiencing an emergency medical condition as defined by EMTALA, and that abortion is the stabilizing treatment necessary to resolve that condition, the physician must provide that treatment. When a state law prohibits abortion and does not include an exception for the life of the pregnant person — or draws the exception more narrowly than EMTALA’s emergency medical condition definition — that state law is preempted.

title: Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss (UPDATED JULY 2022)

memo_number: QSO-21-19-NH EXPIRED

posting_date: Tue, 02 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Interim Final Rule - COVID-19 Vaccine Immunization Requirements for Residents and Staff EXPIRED

memo_number: QSO-21-18 Hospitals/CAHs

posting_date: Fri, 07 May 2021 14:00:00 -0400

summary: Memorandum Summary Hospital/Psychiatric Hospital Interpretive Guidance Update- Attached is an advance copy of the hospital interpretive guidance for the admission, discharge, and transfer notification requirements outlined in the Interoperability and Patient Access final rule. This interpretive guidance will also be published in an updated Appendix A of the State Operations Manual (SOM). CAH Interpretive Guidance Update- Attached is an advance copy of the hospital interpretive guidance for the admission, discharge, and transfer notification requirements outlined in the Interoperability and Patient Access final rule. This interpretive guidance will also be published in an updated Appendix W of the State Operations Manual (SOM).

title: Advance Copy- Interoperability and Patient Access Rule- Admission, Discharge, and Transfer Notifications for Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs) Interpretive Guidance

memo_number: QSO-20-38-NH REVISED 09/23/2022

posting_date: Fri, 23 Sep 2022 16:00:00 -0400

summary: • CMS is committed to taking critical steps to ensure America’s healthcare facilities continue to respond effectively to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On August 25, 2020, CMS published an interim final rule with comment period (IFC). This rule establishes Long-Term Care (LTC) Facility Testing Requirements for Staff and Residents. Specifically, facilities are required to test residents and staff, including individuals providing services under arrangement and volunteers, for COVID-19 based on parameters set forth by the HHS Secretary. This memorandum provides guidance for facilities to meet the new requirements. • Routine testing of asymptomatic staff is no longer recommended but may be performed at the discretion of the facility. • Updated recommendations for testing individuals who have recovered from COVID-19.

title: Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements

memo_number: QSO-21-17-NH EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Updates to Long-Term Care (LTC) Emergency Regulatory Waivers issued in response to COVID-19

memo_number: QSO-21-16-Hospitals EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Resuming Hospital Survey Activities Following 30-day Restrictions

memo_number: QSO-20-14-NH Revised memo UPDATE: 03/10/2021

posting_date: Tue, 28 Mar 2023 12:05:16 -0400

summary: EXPIRED. EFFECTIVE 03/28/2023 THE GUIDANCE IN THIS MEMO IS NO LONGER IN EFFECT. CMS is committed to taking critical steps to ensure America’s health care facilities and clinical laboratories are prepared to respond to the threat of the COVID-19. Guidance for Infection Control and Prevention of COVID-19 - CMS is providing additional guidance to nursing homes to help them improve their infection control and prevention practices to prevent the transmission of COVID-19, including revised guidance for visitation. . Coordination with the Centers for Disease Control (CDC) and local public health departments - We encourage all nursing homes to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019ncov/healthcare-facilities/index.html.

title: Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED)

memo_number: QSO-21-15-ALL

posting_date: Sat, 27 Mar 2021 01:00:00 -0400

summary: Burden Reduction Final Rule Interpretive Guidelines: The Centers for Medicare & Medicaid Services (CMS) is releasing interpretive guidelines and updates to Appendix Z of the State Operations Manual (SOM) as a result of the revisions of the Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CoPs) (CMS 3346-F) Final Rule. • Expanded Guidance related to Emerging Infectious Diseases (EIDs): CMS is also providing additional guidance based on best practices, lessons learned and general recommendations for planning and preparedness for EID outbreaks.

title: Updated Guidance for Emergency Preparedness-Appendix Z of the State Operations Manual (SOM)

memo_number: QSO-20-39-NH EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) • CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Visitation Guidance: CMS is issuing new guidance for visitation in nursing homes during the COVID-19 PHE. • Visitation is allowed for all residents at all times. • Updated guidance for face coverings and masks during visits. • Removed vaccination status from the guidance.

title: EXPIRED: Nursing Home Visitation - COVID-19 (REVISED)

memo_number: QSO-21-14-ICF-IID-PRTF

posting_date: Thu, 11 Feb 2021 02:00:00 -0500

summary: • CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Visitation Guidance: CMS is issuing new guidance for visitation in ICF/IIDs and PRTFs during the COVID-19 PHE. The guidance below provides ways an ICF/IID and PRTF can more safely facilitate in-person visitation and address the psychosocial needs of clients/residents. • Coordination with the Centers for Disease Control and Prevention (CDC) and public health departments - We encourage all ICF/IIDs and PRTFs to monitor the CDC website for information and resources and contact their health department when needed (CDC Resources for Health Care Facilities: Management of Visitors to Healthcare Facilities in the Context of COVID-19: Non-US Healthcare Settings | CDC).

title: Visitation at Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IIDs) and Psychiatric Residential Treatment Facilities (PRTFs) - Coronavirus Disease -2019 (COVID-19)

memo_number: QSO-21-13-Hospitals (Revised)

posting_date: Thu, 21 Jan 2021 12:00:00 -0500

summary: • CMS is extending the hospital survey limitations for an additional thirty (30) days from the date of issuance of this revised memo (March 22, 2021). • CMS is committed to taking critical steps to protect vulnerable individuals to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Hospital Survey and Oversight Expectations – As states and communities continue to be impacted by the COVID-19 PHE, CMS is clarifying expectations of State Survey Agencies and Accrediting Organizations charged with surveying hospitals for compliance with quality of care requirements. • This policy memorandum also outlines expectations for states to contact their CMS Survey Operations Group location when their hospitals implement Crisis Standards of Care.

title: Hospital Survey Priorities (Revised)

memo_number: QSO-21-10-CLIA

posting_date: Sat, 09 Jan 2021 02:00:00 -0500

summary: • CMS is committed to taking critical steps to ensure America’s healthcare facilities continue to be prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On September 2, 2020, an interim final rule with comment period (CMS-3401-IFC) was published in the Federal Register (85 FR 54820). • CLIA regulations have been updated to require all laboratories to report SARS-CoV-2 test results in a standardized format and at a frequency specified by the Secretary. • CMS is providing surveyor guidance for State Agency and CMS Branch Location surveyors related to the CMS-3401-IFC CLIA SARS-CoV-2 test reporting requirements.

title: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting

memo_number: QSO-21-08-NLTC

posting_date: Thu, 31 Dec 2020 02:00:00 -0500

summary: • CMS is committed to taking critical steps to ensure America’s health care facilities are prepared to respond to the COVID-19 Public Health Emergency. • Revised COVID-19 Focused Infection Control Survey Tool: CMS is making revisions to the non-long term care (NLTC) focused infection control survey tool for acute and continuing care providers to reflect COVID-19 guidance updates, provide clarifications to existing information, and update the appropriate CMS regulatory tag considerations if a citation is warranted.

title: Revised COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care

memo_number: QSO-21-09-ASC EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Providing flexibility for exceeding the 24-hour time frame for patients in Ambulatory Surgical Centers (ASCs) during the COVID-19 Public Health Emergency

memo_number: QSO-21-06-NH

posting_date: Sat, 05 Dec 2020 02:00:00 -0500

summary: The Centers for Medicare & Medicaid Services (CMS) is committed to being transparent with the public about changes in publicly reported information related to long term care facilities (i.e., nursing homes) through the COVID-19 public health emergency (PHE). Changes to the Nursing Home Compare Website and Five Star Quality Rating System: • CMS will resume calculating nursing homes Health Inspection and Quality Measure ratings on January 27, 2021. • C MS is completing its transition to the new Care Compare website.

title: Updates to the Nursing Home Compare website and Five Star Quality Rating System

memo_number: QSO-21-07-Psych Hospital, PRTF & ICF/IID EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) CMS is committed to taking critical steps to protect all Americans including those with intellectual and developmental disabilities to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • CMS is providing guidance to psychiatric hospitals, Psychiatric Residential Treatment Facilities (PRTFs) and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to improve their infection control and prevention practices, in part, to prevent or lessen the need for use of seclusion and restraint as an infection control intervention. • All Psychiatric hospitals, PRTFs and ICF/IIDs should monitor the CDC website for information and resources, and contact the local health department, when necessary (CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019- ncov/healthcare-facilities/index.html).

title: EXPIRED: COVID-19 Infection Control for Psychiatric and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)

memo_number: QSO-21-12-AO-CLIA

posting_date: Wed, 20 Jan 2021 04:00:00 -0500

summary: Annual Report to Congress: The 2019 annual RTC details the review, validation, and oversight of the FY 2018 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results.

title: FY 2019 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: QSO-21-05-ESRD

posting_date: Sat, 05 Dec 2020 02:00:00 -0500

summary: • On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced changes to data submission requirements for dialysis facilities in order to reduce data collection and reporting burden on providers responding to the COVID-19 pandemic. • CMS waived data submission from January 1, 2020 through June 30, 2020 (Q1-Q2) for performance or payment programs. In addition, no data reflecting services provided January 1, 2020 through June 30, 2020 will be used in CMS’s calculations for the Medicare quality reporting and value-based purchasing programs. • Due to the waiver of data submission requirements and its potential impact on measure calculations, the Q1 and Q2 DFR distributions will be cancelled.

title: FY2021 Quarter 1/Quarter 2 Dialysis Facility Report (DFR) - Update

memo_number: QSO-20-24-ASC-REVISED EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: EXPIRED: Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) CMS is committed to taking critical steps to ensure America’s health care facilities are prepared to respond to the COVID-19 Public Health Emergency (PHE). • Waivers: CMS waivers adopted under the 1135 emergency waiver authority create additional flexibilities to allow enrolled ASCs to temporarily enroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients. • CMS Regional Office Processing of Attestations: This memorandum outlines the steps for processing attestations and certification kits for existing Medicare certified ASCs that choose to temporarily enroll as a hospital during the COVID-19 PHE.

title: EXPIRED: Guidance for Processing Attestation Statements from Ambulatory Surgical Centers (ASCs) Temporarily Enrolling as Hospitals during the COVID-19 Public Health Emergency ***REVISED***

memo_number: QSO-21-03-Hospitals/CAHs

posting_date: Wed, 07 Oct 2020 01:00:00 -0400

summary: • CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On September 2, 2020, the Federal Register published an interim final rule with comment period (IFC) (85 FR 54820). • CMS has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19. • Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.

title: Interim Final Rule (IFC), CMS-3401-IFC; Requirements and Enforcement Process for Reporting of COVID-19 Data Elements for Hospitals and Critical Access Hospitals

memo_number: QSO-21-01-Hospice

posting_date: Mon, 05 Oct 2020 15:00:00 -0400

summary: • Extraordinary Circumstances as Related to Hospice Staffing Requirements: A hospice may use contracted staff, if necessary, to supplement hospice employees in order to meet the needs of patients under extraordinary or other non-routine circumstances. The regulation allows the hospice to utilize these services temporarily without a waiver or exemption from the State Survey Agency (SA) or the CMS Location. • Compliance Determination: CMS is updating previous guidance that the hospice agency must notify the CMS of its use of contracted staff during extraordinary circumstances and submit justification for such use to its SA or CMS Location. This notification/justification is not required by 42 CFR 418.64. Compliance with the regulation for use of contracted staff is reviewed as a part of the routine survey process. • Hospice Responsibility: When contract services are utilized, the hospice agency maintains all professional, financial and administrative responsibility for the services. • This policy memorandum supersedes previously issued SC17-01-Hospice.

title: Nursing Shortage as an “Extraordinary Circumstance” per 42 CFR 418.64

memo_number: QSO-21-04-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 16:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Clinical Laboratory Improvement Amendments of 1988 (CLIA) CMS Locations and State Agency Remote Survey Guidance - Optional Process

memo_number: QSO-21-02-NH

posting_date: Mon, 05 Oct 2020 17:24:45 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) is affirming the continued right of nursing home residents to exercise their right to vote. • While the COVID-19 Public Health Emergency has resulted in limitations for visitors to enter the facility to assist residents, nursing homes must still ensure residents are able to exercise their Constitutional right to vote. • States, localities, and nursing home owners and administrators are encouraged to collaborate to ensure a resident’s right to vote is not impeded.

title: Compliance with Residents’ Rights Requirement related to Nursing Home Residents’ Right to Vote

memo_number: QSO-20-40-LSC

posting_date: Fri, 25 Sep 2020 01:00:00 -0400

summary: • CMS regulation requires compliance with the 2012 edition of the NFPA Health Care Facilities Code (NFPA 99) for Ambulatory Surgical Centers, Critical Access Hospitals, End-Stage Renal Disease, Hospitals, Inpatient Hospice, Intermediate Care Facilities for Intellectuals with Disabilities, Long-term Care, Programs for All-Inclusive Care of the Elderly, and Religious Nonmedical Health Care Institutions facilities. • The 2012 NFPA 99 requires medical gas and vacuum system tubing to be rigid copper tubing and does not allow for the use of corrugated medical tubing (CMT). • In certain applications, the inability to use CMT may be considered an unreasonable hardship as the installation of CMT may be more efficient and economical. • CMS is issuing a categorical waiver to allow the use of CMT in new and existing health care facilities based on provisions provided in the 2018 NFPA 99.

title: Categorical Waiver – Corrugated Medical Tubing

memo_number: QSO-20-41-ALL

posting_date: Tue, 29 Sep 2020 01:00:00 -0400

summary: • Emergency Preparedness Testing Exemption and Guidance - CMS regulations for Emergency Preparedness require specific testing exercises be conducted to validate the facility’s emergency program. During or after an actual emergency, the regulations allow for an exemption to the testing requirements based on real world actions taken by providers and suppliers. • This worksheet presents guidance for surveyors, as well as providers and suppliers, with relevant scenarios on meeting the testing requirements in light of many of the response activities associated with the COVID-19 Public Health Emergency (PHE).

title: Guidance related to the Emergency Preparedness Testing Exercise Requirements- Coronavirus Disease 2019 (COVID-19)

memo_number: QSO-20-39 EXPIRED

posting_date: Wed, 29 Mar 2023 01:00:00 -0400

summary: EXPIRED. EFFECTIVE 03/20/2021, THIS MEMO WAS REPLACED BY QSO-20-39-NH REVISED, SEE THE REVISED MEMO FOR CURRENT VISITATION GUIDANCE DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. • CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Visitation Guidance: CMS is issuing new guidance for visitation in nursing homes during the COVID-19 PHE. The guidance below provides reasonable ways a nursing home can safely facilitate in-person visitation to address the psychosocial needs of residents. • Use of Civil Money Penalty (CMP) Funds: CMS will now approve the use of CMP funds to purchase tents for outdoor visitation and/or clear dividers (e.g., Plexiglas or similar products) to create physical barriers to reduce the risk of transmission during in-person visits.

title: Nursing Home Visitation - COVID-19

memo_number: QSO-20-38-NH EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) EXPIRED EFFECTIVE 05/11/2023 • CMS is committed to taking critical steps to ensure America’s healthcare facilities continue to respond effectively to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On August 25, 2020, CMS published an interim final rule with comment period (IFC). This rule establishes Long-Term Care (LTC) Facility Testing Requirements for Staff and Residents. Specifically, facilities are required to test residents and staff, including individuals providing services under arrangement and volunteers, for COVID-19 based on parameters set forth by the HHS Secretary. This memorandum provides guidance for facilities to meet the new requirements. • Revised COVID-19 Focused Survey Tool -To assess compliance with the new testing requirements, CMS has revised the survey tool for surveyors. We are also adding to the survey process the assessment of compliance with the requirements for facilities to designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility's infection prevention and control program (IPCP) at 42 CFR § 483.80(b). In addition, we are making a number of revisions to the survey tool to reflect other COVID-19 guidance updates.

title: EXPIRED: Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool

memo_number: QSO-20-37-CLIA,NH

posting_date: Thu, 27 Aug 2020 01:00:00 -0400

summary:  CMS is committed to taking critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE).  On August 25, 2020, an interim final rule with comment period (IFC) went on display at the Federal Register.  CLIA regulations have been updated to require all laboratories to report SARS-CoV-2 test results in a standardized format and at a frequency specified by the Secretary.  Failure to report SARS-CoV-2 test results will result in a condition level violation of the CLIA regulation and may result the imposition of a Civil Money Penalty (CMP) as required under §§ 493.1804 and 493.1834.  Long-Term Care (LTC) Enforcement requirements at 42 CFR part 488 have been revised to include requirements specific to the imposition of a CMP for nursing homes that fail to report requisite COVID-19 related data to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) per §483.80(g)(1) and (2).  LTC Facility Testing Requirements for Staff and Residents- Facilities are required to test staff and to offer testing to all nursing home residents.

title: Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by (CLIA) of 1988 Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

memo_number: QSO-20-36-ESRD EXPIRED

posting_date: Mon, 04 Aug 2025 16:00:00 -0400

summary: EXPIRED Memo Expiration Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) •The Centers for Medicare & Medicaid Services (CMS) is dedicated to ensuring the continued health and safety of patients receiving care within Medicare participating dialysis facilities during the COVID-19 pandemic. COVID-19 refers to the novel coronavirus causing the coronavirus disease 2019. •CMS Updates: This memorandum updates and clarifies CMS guidance related to dialysis facility patients residing in Long Term Care (LTC) facilities; home dialysis services and essential procedures for dialysis patients is also included in this memo. •Dialysis Guidance and Actions - To assist in preventing the transmission of COVID-19 within the dialysis population, CMS is reinforcing infection control guidance based upon the current Centers for Disease Control and Prevention (CDC) recommendations for dialysis facilities which include screening for COVID-19, patient patient placement, personal protective equipment, isolation, cleaning and disinfection.

title: EXPIRED: Key Components for Continued COVID-19 Management for Dialysis Facilities

memo_number: QSO-20-31-All RESCINDED

posting_date: Mon, 01 Jun 2020 22:01:20 -0400

summary: QSO-20-31-ALL RESCINDED AS OF 3/30/23

title: RESCINDED (3/30/23): COVID-19 Survey Activities, CARES Act Funding, Enhanced Enforcement for Infection Control deficiencies, and Quality Improvement Activities in Nursing Homes

memo_number: QSO 20-34-NH

posting_date: Fri, 26 Jun 2020 01:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) is committed to transparency about changes in publicly reported information on nursing homes during the COVID-19 public health emergency. Changes to the Nursing Home Compare Website and Five Star Quality Rating System: • Staffing Measures and Ratings Domain: On July 29, 2020, Staffing measures and star ratings will be held constant, and based on data submitted for Calendar Quarter 4 2019. o Also, CMS is ending the waiver of the requirement for nursing homes to submit staffing data through the Payroll-Based Journal System. Nursing homes must submit data for Calendar Quarter 2 by August 14, 2020. • Quality Measures: On July 29, 2020, quality measures based on a data collection period ending December 31, 2019 will be held constant.

title: Changes to Staffing Information and Quality Measures Posted on the Nursing Home Compare Website and Five Star Quality Rating System due to the COVID-19 Public Health Emergency

memo_number: QSO 20-33-NH

posting_date: Fri, 05 Jun 2020 01:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) is committed to taking critical steps to ensure America’s nursing homes are prepared to respond to the threat caused by the COVID-19 pandemic. • Nursing Home Inspections: CMS will post health inspection (i.e., surveys) results that were conducted on or after March 4th, 2020, which is the first date that CMS altered the way that inspections are scheduled and conducted. This includes inspections related to complaints and facility-reported incidents (FRIs) that were triaged at the Immediate Jeopardy (IJ) level, and the streamlined Infection Control inspection process that was developed based on the guidance for preventing the spread of COVID-19. • The information will be available in the “Spotlight” section of the Nursing Home Compare home page on June 4th, 2020.

title: Posting of Nursing Home Inspections

memo_number: QSO 20-32-NH

posting_date: Fri, 05 Jun 2020 01:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) is committed to taking critical steps to ensure America’s nursing homes are prepared to respond to the threat caused by the COVID-19 pandemic. • Nursing Home COVID-19 Information: CMS will post COVID-19 data submitted by facilities via the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN). The information will be posted on June 4th, 2020 at the following locations: • A link to the information in the “Spotlight” section of the Nursing Home Compare home page. • The information will also be available at https://data.cms.gov/Covid19-nursing-home-data

title: Release of COVID-19 Nursing Home Data

memo_number: QSO-20-30-NH

posting_date: Tue, 28 Mar 2023 21:30:00 -0400

summary: EXPIRED. EFFECTIVE 03/10/2021, THE GUIDANCE IN THIS MEMO IS NO LONGER IN EFFECT. CMS is committed to taking critical steps to ensure America’s nursing homes are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • Recommendations for State and Local Officials: CMS is providing recommendations to help determine the level of mitigation needed to prevent the transmission of COVID-19 in nursing homes. The recommendations cover the following items: o Criteria for relaxing certain restrictions and mitigating the risk of resurgence: Factors to inform decisions for relaxing nursing home restrictions through a phased approach. o Visitation and Service Considerations: Considerations allowing visitation and services in each phase. o Restoration of Survey Activities: Recommendations for restarting certain surveys in each phase.

title: Nursing Home Reopening Recommendations for State and Local Officials

memo_number: QSO-20-18-HHA REVISED 4/23/2020 (EXPIRED)

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: EXPIRED: Memo Revision Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) CMS is committed to protecting American patients and residents by ensuring health care facilities have up-to-date information to respond to COVID-19 concerns. • Coordination with the Centers for Disease Control and Prevention (CDC) and local public health departments - We encourage all Home Health Agencies to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html). • Home Health Guidance and Actions - CMS regulations and guidance support Home Health Agencies (HHAs) taking appropriate action to address potential and confirmed COVID cases and mitigate transmission including screening, treatment, and transfer to higher level care (when appropriate). This guidance applies to both Medicare and Medicaid providers; additional information about CMS waivers and regulations, and CDC guidance are added for optimizing personal protective equipment and return to work criteria for healthcare personnel with confirmed or suspected COVID-19. • Recommendations for Visitation in Residential Facilities not Certified by Medicare: CMS is providing recommendations to home health care personnel who care for patients in residential settings such as assisted and independent living facilities. • Medicare Participating Religious Nonmedical Healthcare Institutions (RNHCIs) and Actions- CMS is providing additional guidance for RNHCIs related to addressing potential and confirmed COVID cases and mitigating transmission including screening, treatment, and transfer to higher level care (when appropriate).

title: EXPIRED: Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs) and Religious Nonmedical Healthcare Institutions (RNHCIs)

memo_number: QSO-20-27-Hospitals EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Guidance for Licensed Independent Freestanding Emergency Departments (EDs) to Participate in Medicare and Medicaid during the COVID-19 Public Health Emergency

memo_number: QSO-20-28-NH REVISED

posting_date: Fri, 10 Jul 2020 01:00:00 -0400

summary: CMS is committed to taking critical steps to ensure America’s nursing homes are prepared to respond to the threat of the COVID-19. • Nursing Home Compare website & Nursing Home Five Star Quality Rating System: We are announcing that the inspection domain will be held constant temporarily due to the prioritization and suspension of certain surveys, to ensure the rating system reflects fair information for consumers. • Posting of surveys: CMS will post a list of the surveys conducted after the prioritization of certain surveys, and their findings, through a link on the Nursing Home Compare website. • Nursing Home Staff: CMS is publishing a list of the average number of nursing and total staff that work onsite in each nursing home, each day. This information can be used to help direct adequate personal protective equipment (PPE) and testing to nursing homes. • Access to Ombudsman: We are reminding facilities that providing ombudsman access to residents is required per 42 CFR § 483.10(f)(4)(i) and per the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). • Frequently Asked Questions (FAQ): We are releasing a list of FAQs to clarify certain actions we have taken related to visitation, surveys, waivers, and other guidance.

title: Nursing Home Five Star Quality Rating System updates, Nursing Home Staff Counts, Frequently Asked Questions, and Access to Ombudsman (REVISED)

memo_number: QSO-20-29-NH

posting_date: Thu, 07 May 2020 01:00:00 -0400

summary: • CMS is committed to taking critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE). • On May 8, 2020, CMS will publish an interim final rule with comment period. • COVID-19 Reporting Requirements: CMS is requiring nursing homes to report COVID-19 facility data to the Centers for Disease Control and Prevention (CDC) and to residents, their representatives, and families of residents in facilities. • Enforcement: Failure to report in accordance with 42 CFR §483.80(g) can result in an enforcement action. • Updated Survey Tools: CMS has updated the COVID-19 Focused Survey for Nursing Homes, Entrance Conference Worksheet, COVID-19 Focused Survey Protocol, and Summary of the COVID-19 Focused Survey for Nursing Homes to reflect COVID-19 reporting requirements. • COVID-19 Tags: F884 and F885. • Transparency: CMS will begin posting data from the CDC National Healthcare Safety Network (NHSN) for viewing by facilities, stakeholders, or the general public. The COVID-19 public use file will be available on https://data.cms.gov/.

title: Interim Final Rule Updating Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes

memo_number: QSO-20-28-NH

posting_date: Sat, 25 Apr 2020 01:00:00 -0400

summary: • CMS is committed to taking critical steps to ensure America’s nursing homes are prepared to respond to the threat of the COVID-19. • Nursing Home Compare website & Nursing Home Five Star Quality Rating System: We are announcing that the inspection domain will be held constant temporarily due to the prioritization and suspension of certain surveys, to ensure the rating system reflects fair information for consumers. • Posting of surveys: CMS will post a list of the surveys conducted after the prioritization of certain surveys, and their findings, through a link on the Nursing Home Compare website. • Nursing Home Staff: CMS is publishing a list of the average number of nursing and total staff that work onsite in each nursing home, each day. This information can be used to help direct adequate personal protective equipment (PPE) and testing to nursing homes. • Frequently Asked Questions (FAQ): We are releasing a list of FAQs to clarify certain actions we have taken related to visitation, surveys, waivers, and other guidance.

title: Nursing Home Five Star Quality Rating System updates, Nursing Home Staff Counts, and Frequently Asked Questions

memo_number: QSO-20-26-NH

posting_date: Wed, 29 Mar 2023 01:00:00 -0400

summary: EXPIRED. EFFECTIVE 05/06/2020, THIS MEMO WAS REPLACED BY QSO-20-29-NH NOTIFICATION OF CONFIRMED AND SUSPECTED COVID-19 CASES AMONG RESIDENTS AND STAFF IN NURSING HOMES. • CMS is committed to taking critical steps to ensure America’s health care facilities are prepared to respond to the 2019 Novel Coronavirus (COVID-19) Public Health Emergency (PHE). • Communicable Disease Reporting Requirements: To ensure appropriate tracking, response, and mitigation of COVID-19 in nursing homes, CMS is reinforcing an existing requirement that nursing homes must report communicable diseases, healthcare-associated infections, and potential outbreaks to State and Local health departments. In rulemaking that will follow, CMS is requiring facilities to report this data to the Centers for Disease Control and Prevention (CDC) in a standardized format and frequency defined by CMS and CDC. Failure to report cases of residents or staff who have confirmed COVID -19 and Persons under Investigation (PUI) could result in an enforcement action. This memorandum summarizes new requirements which will be put in place very soon. • Transparency: CMS will also be previewing a new requirement for facilities to notify residents’ and their representatives to keep them up to date on the conditions inside the facility, such as when new cases of COVID-19 occur.

title: Upcoming Requirements for Notification of Confirmed COVID-19 (or COVID-19 Persons under Investigation) Among Residents and Staff in Nursing Homes

memo_number: QSO-20-25-NH EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the Public Health Emergency

title: EXPIRED: 2019 Novel Coronavirus (COVID-19) Long-Term Care Facility Transfer Scenarios

memo_number: QSO-20-24-ASC

posting_date: Sat, 04 Apr 2020 01:00:00 -0400

summary: • CMS is committed to taking critical steps to ensure America’s health care facilities are prepared to respond to the COVID-19 Public Health Emergency (PHE). • Waivers: CMS waivers adopted under the 1135 emergency waiver authority create additional flexibilities to allow enrolled ASCs to temporarily enroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients. • CMS Regional Office Processing of Attestations: This memorandum outlines the steps for processing attestations and certification kits for existing Medicare certified ASCs that choose to temporarily enroll as a hospital during the COVID-19 PHE.

title: Guidance for Processing Attestations from Ambulatory Surgical Centers (ASCs) Temporarily Enrolling as Hospitals during the COVID-19 Public Health Emergency

memo_number: QSO-20-13-Hospitals-CAHs REVISED (EXPIRED)

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: EXPIRED: Memo Revision Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) The Centers for Medicare & Medicaid Services (CMS) is committed to taking critical steps to ensure America’s health care facilities and clinical laboratories are prepared to respond to the threat of the COVID-19. • Coordination with the Centers for Disease Control (CDC) and local public health departments - We encourage all hospitals, psychiatric hospitals, and CAHs to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html). • Hospital/CAH Guidance and Actions - CMS regulations and guidance support hospitals and CAHs taking appropriate action to address potential and confirmed COVID-19 cases to mitigate transmission and prepare for community spread transmission, including screening, discharge and transfers from the hospital, mitigation of staffing crises, and visitation. • Hospital/CAH Flexibilities – Under Section 1135 of the Social Security Act (Act), CMS has waived a number of hospital/CAH requirements following the President’s declaration of a national state of emergency and the Secretary’s declaration of a Public Health Emergency to facilitate increasing hospital capacity, establishing alternate care sites, and removing administrative burdens.

title: EXPIRED: Guidance for Infection Control and Prevention of Coronavirus Disease (COVID-19) in Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs): FAQs, Considerations for Patient Triage, Placement, Limits to Visitation and Availability of 1135 waivers.

memo_number: QSO-20-15 Hospital/CAH/EMTALA REVISED

posting_date: Tue, 31 Mar 2020 01:00:00 -0400

summary: COVID-19 and EMTALA Requirements: This Memorandum conveys information in response to inquiries from hospitals and critical access hospitals (CAHs) concerning implications of COVID-19 for their compliance with EMTALA. The memo was revised to include additional guidance related to the establishment of drive through testing sites, clarification of expectations in relation to the triage process and the medical screening examination, and use of telehealth. • EMTALA Screening Obligation: Every hospital or CAH with a dedicated emergency department (ED) is required to conduct an appropriate medical screening examination (MSE) of all individuals who come to the ED, including individuals who are suspected of having COVID-19, regardless of whether they arrive by ambulance or are walk-ins. Every ED is expected to have the capability to apply appropriate COVID-19 screening criteria when applicable, to immediately identify and isolate individuals who meet the screening criteria to be a potential COVID-19 patient and to contact their state or local public health officials to determine next steps when an individual meeting the screening criteria is found. • EMTALA Stabilization, Transfer & Recipient Hospital Obligations: In the case of individuals with suspected or confirmed COVID-19, hospitals and CAHs are expected to consider the current guidance of CDC and public health officials in determining whether they have the capability to provide appropriate isolation required for stabilizing treatment and/or to accept appropriate transfers. In the event of any EMTALA complaints alleging inappropriate transfers or refusal to accept appropriate transfers, CMS will take into consideration the public health guidance in effect at the time.

title: Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID-19) (Revised)

memo_number: QSO-20-23-ICF/IID & PRTF EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IIDs) and Psychiatric Residential Treatment Facilities (PRTFs)

memo_number: QSO-20-22- ASC, CORF, CMHC, OPT, RHC/FQHCs (EXPIRED)

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: EXPIRED: Memo Revision Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) CMS is committed to taking critical steps to ensure America’s healthcare facilities can respond to the threat of COVID-19. • Coordination with the Centers for Disease Control and Prevention (CDC) and local public health departments - We encourage all healthcare facilities to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities). • Guidance for Infection Control and Prevention of COVID-19 and Actions - CMS regulations and guidance support Ambulatory Surgical Centers (ASCs), Community Mental Health Centers (CMHCs), Comprehensive Outpatient Rehabilitation Facilities (CORFs), Outpatient Physical Therapy or Speech Pathology Services (OPTs), Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) taking appropriate action to address potential and confirmed COVID-19 cases. This guidance discusses recommendations to mitigate transmission including screening, restricting visitors, cleaning and disinfection, and possible closures. Supply scarcity guidance and FDA recommendations are also included within this memo.

title: EXPIRED: Guidance for Infection Control and Prevention of Coronavirus Disease (COVID- 19) in Outpatient Settings: FAQs and Considerations

memo_number: QSO-20-21-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 16:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency

memo_number: QSO-20-35-ALL EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the Public Health Emergency

title: EXPIRED: Enforcement Cases Held during the Prioritization Period and Revised Survey Prioritization

memo_number: QSO-20-19-ESRD REVISED (EXPIRED)

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: EXPIRED: Memo Revision Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) CMS is dedicated to the continued health and safety of patients obtaining care within dialysis facilities to ensure facilities are prepared to respond to the threat of COVID-19. • Dialysis Guidance and Actions - CMS is providing additional guidance to dialysis facilities to help them focus their infection control and prevention practices to prevent the transmission of COVID-19 including guidance related to 1135 waivers and Special Purpose Renal Dialysis Facilities (SPRDFs). • Coordination with the Centers for Disease Control and Prevention (CDC) and local public health departments - We ask all dialysis facilities to monitor the CDC website for information and resources and to contact their local health department if needed for local information. (CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html).

title: EXPIRED: Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in dialysis facilities (Revised)

memo_number: QSO-20-20-All EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Remove the language that is currently there and replace it with: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Prioritization of Survey Activities

memo_number: QSO-20-18-HHA

posting_date: Wed, 11 Mar 2020 00:00:00 -0400

summary: CMS is committed to protecting American patients and residents by ensuring health care facilities have up-to-date information to adequately respond to COVID-19 concerns. • Coordination with the Centers for Disease Control and Prevention (CDC) and local public health departments - We encourage all Home Health Agencies to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html). • Home Health Guidance and Actions - CMS regulations and guidance support Home Health Agencies taking appropriate action to address potential and confirmed COVID cases and mitigate transmission including screening, treatment, and transfer to higher level care (when appropriate). This guidance applies to both Medicare and Medicaid providers.

title: Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs)

memo_number: QSO-20-19-ESRD

posting_date: Wed, 11 Mar 2020 00:00:00 -0400

summary: CMS is dedicated to the continued health and safety of patients obtaining care withindialysis facilities to ensure facilities are prepared to respond to the threat of COVID-19. •Dialysis Guidance and Actions - CMS is providing additional guidance to dialysisfacilities to help them focus their infection control and prevention practices to prevent thetransmission of COVID-19. •Coordination with the Centers for Disease Control (CDC) and local public healthdepartments - We encourage all dialysis facilities to monitor the CDC website forupdated information and resources and contact their local health department when needed(CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html).

title: Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in dialysis facilities

memo_number: QSO-20-17-All EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Guidance for use of Certain Industrial Respirators by Health Care Personnel

memo_number: QSO-20-15 Hospital/CAH/EMTALA REVISED (EXPIRED)

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: EXPIRED: Memo Revision Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) COVID-19 and EMTALA Requirements: This Memorandum conveys information in response to inquiries from hospitals and critical access hospitals (CAHs) concerning implications of COVID-19 for their compliance with EMTALA. This guidance applies to both Medicare and Medicaid providers. • EMTALA Screening Obligation: Every hospital or CAH with a dedicated emergency department (ED) is required to conduct an appropriate medical screening examination (MSE) of all individuals who come to the ED, including individuals who are suspected of having COVID-19, and regardless of whether they arrive by ambulance or are walk-ins. Every ED is expected to have the capability to apply appropriate COVID-19 screening criteria when applicable, to immediately identify and isolate individuals who meet the screening criteria to be a potential COVID-19, to contact their state or local public health officials to determine next steps. • EMTALA Stabilization, Transfer & Recipient Hospital Obligations: In the case of individuals with suspected or confirmed COVID-19, hospitals and CAHs are expected to consider current guidance of CDC and public health officials in determining whether they have the capability to provide appropriate isolation required for stabilizing treatment and/or to accept appropriate transfers. In the event of any EMTALA complaints alleging inappropriate transfers or refusal to accept appropriate transfers, CMS will take into consideration the public health guidance in effect at the time.

title: EXPIRED: Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID-19) (Revised)

memo_number: QSO-20-16-Hospice EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) by Hospice Agencies

memo_number: QSO-20-14-NH REVISED

posting_date: Tue, 28 Mar 2023 13:00:00 -0400

summary: EXPIRED. EFFECTIVE 03/28/2023 THE GUIDANCE IN THIS MEMO IS NO LONGER IN EFFECT. CMS is committed to taking critical steps to ensure America’s health care facilities andclinical laboratories are prepared to respond to the threat of the COVID-19.•Guidance for Infection Control and Prevention of COVID-19 -CMS is providingadditional guidance to nursing homes to help them improve their infection control andprevention practices to prevent the transmission of COVID-19, including revisedguidance for visitation. .•Coordination with the Centers for Disease Control (CDC) and local public health departments - We encourage all nursing homes to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities:https://www.cdc.gov/coronavirus/2019-ncov/hcp/facility-planning-operations.html.

title: Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in nursing homes (REVISED)

memo_number: QSO-20-14-NH

posting_date: Tue, 28 Mar 2023 23:00:00 -0400

summary: EXPIRED. EFFECTIVE 03/13/2020, THIS MEMO WAS REPLACED BY QSO-20-14-NH REVISED, SEE THE REVISED MEMO FOR CURRENT COVID-19 TESTING REQUIREMENTS AND GUIDANCE.

title: Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in nursing homes

memo_number: QSO-20-12-All EXPIRED

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: Please check the downloads section for the latest version of the memo. This memo expired: 2023-05-01 Expiration Information: Refer to QSO-25-23-ALL released on 2025-07-30: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE)

title: EXPIRED: Suspension of Survey Activities

memo_number: 20-11-NH

posting_date: Fri, 14 Feb 2020 15:30:00 -0500

summary: The Centers for Medicare & Medicaid Services (CMS) is announcing the release of two toolkits that align with the CMS strategic initiative to Ensure Safety and Quality in Nursing Homes. • Developing a Restful Environment Action Manual (DREAM) Toolkit – CMS has created a toolkit that offers education and person-centered, practical interventions that nursing home administrators, directors of nursing, and bedside staff can implement to promote high-quality sleep for residents living with dementia. • Head-to-Toe Infection Prevention (H2T) Toolkit – CMS has created a toolkit that offers educational materials and practical interventions for bedside staff designed to prevent common infections by improving activities of daily living (ADL) care.

title: Release of Additional Toolkits to Ensure Safety and Quality in Nursing Homes

memo_number: QSO-20-10-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 21:30:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for use in CDC Qualified Laboratories

memo_number: QSO-20-09-ALL (EXPIRED)

posting_date: Mon, 04 Aug 2025 13:00:00 -0400

summary: EXPIRED: Memo Revision Information: Expiration Date: May 1, 2023 Expiration Information: Refer to QSO-25-23-ALL released on July 30, 2025: Guidance for the Expiration of the COVID-19 Public Health Emergency (PHE) Information Regarding Patients with Possible Coronavirus Illness: the U.S. Centers for Disease Control and Prevention (CDC) has issued information on the respiratory illness caused by the 2019 Novel Coronavirus (2019-nCoV). Links to these documents are provided. • Healthcare Facility Expectations: CMS strongly urges the review of CDC’s guidance and encourages facilities to review their own infection prevention and control policies and practices to prevent the spread of infection.

title: EXPIRED: Information for Healthcare Facilities Concerning 2019 Novel Coronavirus Illness (2019-nCoV)

memo_number: 20-08-CLIA

posting_date: Fri, 10 Jan 2020 11:00:00 -0500

summary: Staining of Cytology/Histopathology slides is considered part of specimen preparation and not part of the “examination” referenced in the CLIA definition of a laboratory. As such, entities that only conduct these preparatory steps to testing are not considered laboratories, and would not be subject to CLIA. • For purposes of Proficiency Testing (PT) referral, if a laboratory merely sends PT slides to a separate entity for staining and the slides are returned to the original laboratory for examination, CMS would not consider this to be PT referral.

title: Applicability of Proficiency Testing (PT) Referral to Cytology/Histopathology Slide Staining by a Separate Entity

memo_number: 20-07-All

posting_date: Fri, 20 Dec 2019 12:00:00 -0500

summary: On September 30, 2019, the Centers for Medicare & Medicaid Services (CMS) publishedthe Medicare and Medicaid Programs; Regulatory Provisions to Promote ProgramEfficiency, Transparency, and Burden Reduction Final Rule, as well as the Revisions toRequirements for Discharge Planning for Hospitals, Critical Access Hospitals, and HomeHealth Agencies Final Rule. •This policy memorandum provides guidance to the CMS Regional Offices (ROs), theState Survey Agencies (SAs) and the Accrediting Organizations (AOs) regarding thechanges to the regulations and our approach for updating the State Operations Manual(SOM) and applicable surveyor systems.

title: Burden Reduction-Discharge Planning SOM Package

memo_number: 20-06-Hospitals/CAHs

posting_date: Wed, 18 Dec 2019 10:45:00 -0500

summary: • In the Fiscal Year (FY) 2019 Inpatient Prospective Payment System (IPPS)/Long-Term Care Hospital PPS (LTCH PPS) final rule, the Centers for Medicare & Medicaid Services (CMS) revised regulations to specify that, effective with cost-reporting periods beginning on or after October 1, 2019, an IPPS-excluded hospital may have an excluded psychiatric and/or rehabilitation unit. • To align with the payment regulations, CMS is updating sections of SOM Chapters 2 & 3 where the certification process for excluded hospitals and units are discussed. These updates address the process for complying with the regulations, including the assignment of CMS Certification Numbers (CCNs).

title: Updates to the State Operations Manual (SOM) Chapters 2 and 3 Related to Excluded Hospitals with Excluded Units

memo_number: QSO-20-05-CMHC

posting_date: Fri, 06 Dec 2019 09:30:00 -0500

summary: SOM Chapter 2 Revised: Revisions have been made to the SOM to reflect the changes associated with the October 2014 effective date of CMHC Conditions of Participation (CoPs) and other revisions for clarity. • Appendix F Added to the SOM: A new Appendix F has been developed and added to the SOM to provide survey instructions and Interpretive Guidelines associated with the CoPS for CMHCs. The Interpretative Guidance for the CMHC CoP on Emergency Preparedness (§ 485.920) is addressed separately in Appendix Z, Emergency Preparedness CoPs.

title: Revisions to Chapter 2 and Addition of Appendix F in the State Operations Manual (SOM) –Community Mental Health Centers (CMHC)

memo_number: QSO 20-04-Hospital-CAH DPU-REVISED

posting_date: Mon, 02 Dec 2019 09:00:00 -0500

summary: The electronic Form CMS-10455, Report of a Hospital Death Associated with the Use of Restraint or Seclusion is replacing the paper version of the Form starting December 2, 2019. Hospitals and/or Critical Access Hospital (CAH) Distinct Part Units (DPUs) will be able to insert the URL below into any browser and click to access the electronic Form CMS-10455. https://restraintdeathreport.gov1.qualtrics.com/jfe/form/SV_5pXmjIw2WAzto8J. A brief Instructional Video on how to complete and submit the electronic Form CMS-10455 is available on the Quality, Safety & Education Portal (QSEP) at https://qsep.cms.gov/pubs/CourseMenu.aspx?cid=0CMSRHDRS_ONL. The Instructional Slides are attached.

title: Electronic Form CMS-10455, Report of a Hospital Death Associated with Restraint or Seclusion

memo_number: QSO-20-03-NH

posting_date: Fri, 22 Nov 2019 08:00:00 -0500

summary: The Centers for Medicare & Medicaid Services (CMS) is announcing updates and initiatives aligning with the CMS strategic initiative to Ensure Safety and Quality in Nursing Homes. These updates and initiatives include: • Phase 3 Interpretive Guidance: CMS will be releasing updated Interpretive Guidance and training for the Requirements for Participation for Long-Term Care (LTC) Facilities. However, this guidance will not be released by the November 28, 2019 implementation date of the regulations. We will be releasing the guidance in the second quarter of calendar year 2020, along with information on training and implementing related changes to The Long Term Care Survey Process (LTCSP). While the regulations will be effective, our ability to survey for compliance with these requirements will be limited until the Interpretive Guidance is released. • Medicare and Medicaid Programs; Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements: On July 18, 2019, the Department of Health and Human Services (HHS) published a final rule establishing requirements related to the use of binding arbitration agreements. This final rule amends the requirements that Long-Term Care (LTC) facilities must meet to participate with Medicare and Medicaid. The final rule can be found at: https://www.govinfo.gov/content/pkg/FR-2019-07-18/pdf/2019-14945.pdf • Actions to Improve Infection Prevention and Control in LTC Facilities: CMShas created a nursing home antibiotic stewardship program training; updated the Nursing Home Infection Control Worksheet as a self-assessment tool for facilities; and is reminding facilities of available infection control resources. • Release of Toolkit 3, “Guide to Improving Nursing Home Employee Satisfaction”: CMS has created a toolkit that helps facilities improve employee satisfaction.

title: Updates and Initiatives to Ensure Safety and Quality in Nursing Homes

memo_number: 17-01- Hospice

posting_date: Fri, 21 Oct 2016 00:00:00 -0400

summary: • Extraordinary Circumstances due to Nursing Shortage: The period of time has been extended for a hospice agency to elect an exemption to allow for the contracting of nurses pursuant to “extraordinary circumstance” as noted at 42 CFR 418.64 when it believes that the nursing shortage has affected its ability to directly hire sufficient numbers of nurses. • Extension: This policy is effective through September 30, 2018.

title: Impact of Nursing Shortage on Hospice Care

memo_number: QSO-20-02-NH

posting_date: Mon, 07 Oct 2019 12:00:00 -0400

summary: • We are also advising providers we will be updating the thresholds for quality measure ratings, according to the plan introduced in CMS Memorandum QSO-19-08-NH, in which the thresholds will be updated every six months. The first update will take place April 2020.<br />• We are listing the dates the Nursing Home Compare website and the Five Star Rating System will be updated over the next few months.

title: Updates to the Nursing Home Compare website and the Five Star Quality Rating SystemUpdates to the Nursing Home Compare website and the Five Star Quality Rating System

memo_number: QSO-20-01-NH

posting_date: Mon, 07 Oct 2019 12:00:00 -0400

summary: • Abuse Indicator –CMS is updating the Nursing Home Compare website to make it easier for consumers to identify facilities with instances of non-compliance related to abuse.<br /> • Consumer Alert for Oregon Nursing Homes – CMS will be adding a consumer alert on the Nursing Home Compare website for all Oregon facilities indicating that incidents of abuse may not be reflected on the Nursing Home Compare website. This action is in response to a recommendation by the Government Accountability Office (GAO).

title: Consumer Alerts added to the Nursing Home Compare website and the Five Star Quality Rating System

memo_number: 19-20-CLIA- EXPIRED EFFECTIVE: January 17, 2025

posting_date: Wed, 26 Mar 2025 12:00:00 -0400

summary: EXPIRED AS OF JANUARY 17, 2025. FOR CURRENT GUIDANCE REFER TO QSO-25-13-CLIA SOM, CHAPTER 6-SPECIAL PROCEDURES FOR LABORATORIES • The Centers for Medicare & Medicaid Services (CMS) is issuing a revised State Operations Manual (SOM), Chapter 6 “Special Procedures for Laboratories” which includes a comprehensive revision to establish quality laboratory policies and procedures to ensure accurate and reliable test results to protect patients and improve the quality of health care. • All sections of the SOM Chapter 6 have been aligned with the information within the SOM Chapter 6 Appendix C – Interpretive Guidelines

title: EXPIRED: Revisions to State Operations Manual (SOM), Chapter 6 – Special Procedures forLaboratories

memo_number: 19-18- RHC

posting_date: Tue, 03 Sep 2019 12:00:00 -0400

summary: ? RHC Appendix G Revision: The Centers for Medicare & Medicaid Services (CMS) is updating the medical emergency guidance as it pertains to the availability of drugs and biologicals commonly used in life saving procedures.

title: Revised Rural Health Clinic (RHC) Guidance Updating Emergency Medicine Availability?State Operations Manual (SOM) Appendix G- Advanced Copy

memo_number: 19-19-NH

posting_date: Wed, 04 Sep 2019 12:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) has updated and added CMP reinvestment resources on the CMP Reinvestment Resource Web Page, available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/LTC-CMP-Reinvestment.html • Updated resources include the following: o CMP reinvestment application resources o CMP reinvestment state plan resources o State CMP reinvestment projects funded in calendar years (CY) 2017 and 2018 o Examples of CMP funded projects as well as non-allowable uses of CMP funding

title: Updates to Civil Money Penalty (CMP) Reinvestment Resource Materials

memo_number: 19-17-AO/CLIA

posting_date: Tue, 20 Aug 2019 12:00:00 -0400

summary: Annual Report to Congress: The 2018 annual RTC details the review, validation, and oversight of the FY 2017 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results.

title: FY 2018 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: 19-16-CAH

posting_date: Thu, 08 Aug 2019 12:00:00 -0400

summary: Updates to the State Operations Manual (SOM) Chapter 2: The Centers for Medicare & Medicaid Services (CMS) updated the SOM Chapter 2 for CAHs adding a provider-based location: • SOM Chapter 2 Section 2004 - Provider-Based Determinations: A sentence has been added to the end of the section instructing “For Critical Access Hospitals (CAHs) adding a provider-based location - also see SOM Chapter 2 Section 2256H - Off-Campus CAH Facilities – Process Requirements.” • SOM Chapter 2 Section 2256H - Off-Campus CAH Facilities: This section has been updated to clarify the process for CAHs adding a provider-based location to ensure the inclusion of verifying the CAH’s continued compliance with the distance requirements at 42 CFR 485.610(e)(2).

title: Critical Access Hospitals (CAHs) Adding a Provider-based Location

memo_number: QSO-25-09-ALL

posting_date: Thu, 21 Nov 2024 16:00:00 -0500

summary: REVISION TO QSO-19-09-ALL REVISED ORIGINALLY RELEASED ON MARCH 5, 2019 • Core Appendix Q and Subparts - Appendix Q to the State Operations Manual (SOM), which provides guidance for identifying immediate jeopardy, has been revised. The revision creates a Core Appendix Q that will be used by surveyors for all provider and supplier types to determine when to cite immediate jeopardy. • All guidance for laboratories that was previously in Appendix Q will be moved to the new Subpart XI: Clinical Laboratory Improvement Amendments of 1988 (CLIA). • CMS has drafted subparts to Appendix Q that focus on immediate jeopardy concerns occurring in nursing homes and clinical laboratories since those provider types have specific policies related to immediate jeopardy. Appendix Q has been revised to reinsert language referring criminal acts to local law enforcement. • Subpart XI has been revised to reflect that laboratories can cease testing to remove the immediacy of the Immediate Jeopardy. Laboratories must determine and correct the root cause of the deficiency, issue corrected reports as applicable, and establish a mechanism to monitor the effectiveness of the actions before determination of compliance. • Key Components of Immediate Jeopardy – To cite immediate jeopardy, surveyors determine that (1) noncompliance, (2) caused or created a likelihood that serious injury, harm, impairment, or death to one or more recipients would occur or recur, and (3) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment, or death to one or more recipients. • Immediate Jeopardy Template – A template has been developed to assist surveyors in documenting the information necessary to establish each of the key components of immediate jeopardy. Survey teams must use the immediate jeopardy template attached to Appendix Q to document evidence of each component of immediate jeopardy and use the template to convey information to the surveyed entity.

title: REVISED: Revisions to Appendix Q, Guidance on Immediate Jeopardy

memo_number: 19-15-EMTALA

posting_date: Tue, 02 Jul 2019 12:00:00 -0400

summary: • EMTALA and Psychiatric Hospitals: Medicare-participating psychiatric hospitals are required to comply with EMTALA requirements. • Frequently Asked Questions: CMS is providing the attached Frequently Asked Questions document to address common inquiries from psychiatric hospitals regarding compliance with EMTALA.

title: Frequently Asked Questions on the Emergency Medical Treatment and Labor Act (EMTALA) and Psychiatric Hospitals

memo_number: 05-26 (REVISED) - EMTALA

posting_date: Thu, 27 Jun 2019 12:00:00 -0400

summary: ***NOTE: This memorandum is being reissued to remind hospitals of their obligation to comply with EMTALA as it relates to the Born-Alive Infant Protection Act. This is NOT new policy.*** • The Born-Alive Infants Protection Act of 2002 (Pub. L. 107-207) adds to the United States Code a definition of the term “individual” to include every infant who is born alive, at any stage of development; it also adds a definition of the term “born alive.” • The Emergency Medical Treatment and Labor Act (EMTALA) provides certain rights to “any individual” who comes to an emergency department and “any individual” who comes to a hospital. In particular, hospitals must provide an appropriate medical screening examination to any individual who comes to an emergency department, and either stabilizing treatment or an appropriate transfer for an individual who comes to a hospital and who is determined to have an emergency medical condition. • Attachment: The attached Guidance provides direction to regional office and state survey agency personnel on how to apply EMTALA in investigations when the Born-Alive Infants Protection Act is potentially implicated.

title: Interaction of the Emergency Medical Treatment and Labor Act (EMTALA) and the Born-Alive Infants Protection Act of 2002

memo_number: 19-14-Hospitals, CAHs

posting_date: Tue, 04 Jun 2019 12:00:00 -0400

summary: • Complaint Investigation Timelines: The timeline for investigations in hospitals and critical access hospitals (CAH) for complaints specific to EMTALA and deaths associated with restraint or seclusion is being changed for the Centers for Medicare & Medicaid (CMS) Regional Office (RO) and State Survey Agency (SA) surveyors from completion in five working days to onsite within two business days. This change brings these two categories of complaint investigations in line with other potential immediate jeopardy (IJ) investigations in Medicare-participating non-long term care facilities. • Appendix V Revisions: SOM Appendix V contains the EMTALA regulations, interpretive guidelines and survey process. Part I – Investigative Procedures of Appendix V is being revised to address the change in complaint investigation timelines along with other minor clarifications to the survey process.

title: State Operations Manual (SOM) Emergency Medical Treatment and Labor Act (EMTALA) and Death Associated With Restraint or Seclusion Complaint Investigation Timeline Revisions

memo_number: 19-13-Hospital

posting_date: Fri, 03 May 2019 12:00:00 -0400

summary: • Hospital Co-location Interpretive Guidance: CMS is focused on ensuring the health and safety of patients as it relates to the use of shared space and contracted services by hospitals co-located with another hospital or health care entity. CMS is committed to providing the information hospitals need to make decisions about how they partner with other providers in the health care system to deliver high-quality care.• This Guidance is Being Released in Draft: To ensure that CMS is fully aware of how our guidance will impact hospital providers, we are releasing the guidance in draft and welcome comments.• We seek comment on these draft revised policies by July 2, 2019 (60 days from the date of this release)

title: Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities

memo_number: 19-11-Transplant

posting_date: Fri, 29 Mar 2019 12:00:00 -0400

summary: • All survey activity for approval and re-approval of Medicare transplant programs was transitioned back to the State Survey Agencies (SAs) as of January 1, 2019. These surveys were conducted by a federal contractor from 2013 until September, 2018. • The SAs also assumed responsibility for communications between the approved transplant programs and the Centers for Medicare & Medicaid Services (CMS), to include recommendations to the CMS Regional Offices (ROs) regarding denials/approvals of new applicants, re-approval of approved programs, and/or termination of approvals. • Funds were added to the State Agency budgets for FY 2019 for the additional survey activity.

title: Transplant Program Survey Activity Transition

memo_number: 19-08-NH

posting_date: Tue, 05 Mar 2019 12:00:00 -0500

summary: April 2019 Improvements to Nursing Home Compare include: •Ending the Freeze on Health Inspection Star Ratings - In April 2019, the Centers for Medicare & Medicaid Services (CMS) will end the freeze on the health inspection domain of the Five Star Quality Rating System. We will resume the traditional method of calculating health inspection scores by using three cycles of inspections. Inspections occurring on or after November 28, 2017, will be included in each facility’s star rating. •Quality Measure (QM) Domain Improvements – CMS is introducing separate ratings for short- and long-stay measures to reflect the level of quality provided for these two subpopulations in nursing homes. We are also revising the thresholds for ratings, adding a system for regular updates to thresholds every six months, and weighting and scoring individual QMs differently. Additionally, we are adding the long-stay hospitalization measure and a measure of long-stay emergency department (ED) transfers to the rating system. Two measures from the Skilled Nursing Facility Quality Reporting Program (QRP) will be adopted to replace duplicative existing measures. •Staffing Domain Improvements – CMS is adjusting the thresholds for staffing ratings. Also, the threshold for the ‘number of days without a registered nurse (RN) onsite’ that triggers an automatic downgrade to one star will be reduced from seven to four days.

title: April 2019 Improvements to Nursing Home Compare and the Five Star Rating System

memo_number: 19-09-ALL

posting_date: Tue, 05 Mar 2019 12:00:00 -0500

summary: • Core Appendix Q and Subparts - Appendix Q to the State Operations Manual (SOM), which provides guidance for identifying immediate jeopardy, has been revised. The revision creates a Core Appendix Q that will be used by surveyors of all provider and supplier types in determining when to cite immediate jeopardy. CMS has drafted subparts to Appendix Q that focus on immediate jeopardy concerns occurring in nursing homes and clinical laboratories since those provider types have specific policies related to immediate jeopardy. • Key Components of Immediate Jeopardy – To cite immediate jeopardy, surveyors determine that (1) noncompliance (2) caused or created a likelihood that serious injury, harm, impairment or death to one or more recipients would occur or recur; and (3) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment or death to one or more recipients. •Immediate Jeopardy Template – A template has been developed to assist surveyors in documenting the information necessary to establish each of the key components of immediate jeopardy. Survey teams must use the immediate jeopardy template attached to Appendix Q to document evidence of each component of immediate jeopardy and use the template to convey information to the surveyed entity.

title: Revisions to Appendix Q, Guidance on Immediate Jeopardy

memo_number: 19-10-NH

posting_date: Mon, 11 Mar 2019 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) collaborated on the development of a free on-line training course in infection prevention and control for nursing home staff in the long-term care setting. • The training provides approximately 19 hours of continuing education credits as well as a certificate of completion. • The "Nursing Home Infection Preventionist Training Course" is located on CDC's TRAIN website (https://www.train.org/cdctrain/training_plan/3814). • This memo supersedes memo Quality, Safety & Oversight policy memorandum QSO 18-15-NH.

title: Specialized Infection Prevention and Control Training for Nursing Home Staff in the Long-Term Care Setting is Now Available

memo_number: 19-07-NH EXPIRED EFFECTIVE: July 30, 2025

posting_date: Wed, 30 Jul 2025 12:00:00 -0400

summary: Memo Expiration Information: Expiration Date: July 30, 2025 Expiration Information: Refer to QSO 25-14-NH for the revised the Long-Term Care Surveyor Guidance, State Operations Manual, Appendix PP, integrating guidance on unnecessary psychotropics into the chemical restraints regulation (F605), streamlining regulatory structures, and emphasizing and strengthening the requirement. EXPIRED • The National Partnership & Identification of Late Adopters – Since 2011, the Centers for Medicare & Medicaid Services (CMS) has seen a reduction of 38.9 percent in long-stay nursing home residents who were receiving an antipsychotic medication. Despite the success of the National Partnership, CMS identified approximately 1,500 facilities that had not improved their antipsychotic medication utilization rates for long-stay nursing home residents, referred to as late adopters. In December 2017, CMS notified these facilities of this identification. • Enforcement for A Segment of Non-Improving Late Adopters with Multiple Citations - As of January 2019, there are 235 late adopter nursing homes that have been cited for noncompliance with federal regulations related to unnecessary medications or psychotropic medications two or more times since January 1, 2016, and who have not shown improvement in their long-stay antipsychotic medication rates. If these facilities are determined not to be in substantial compliance with requirements for Chemical Restraints, Dementia Care, or Psychotropic Medications during a survey, they will be subject to enforcement remedies for such noncompliance. • Corporate Engagement - CMS is also looking for opportunities to engage with corporate chains that have significant numbers of nursing homes identified as late adopters.

title: EXPIRED: Enhanced Oversight and Enforcement of Non-Improving Late Adopters

memo_number: 19-06-ALL

posting_date: Fri, 01 Feb 2019 12:00:00 -0500

summary: • Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers: On September 16, 2016, the Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (Emergency Preparedness Rule) final rule was published in the Federal Register. • Health care providers and suppliers affected by the rule were required comply and implement all regulations by November 15, 2017. • We are updating Appendix Z of the SOM to reflect changes to add emerging infectious diseases to the definition of all-hazards approach, new Home Health Agency (HHA) citations and clarifications under alternate source power and emergency standby systems.

title: Emergency Preparedness- Updates to Appendix Z of the State Operations Manual (SOM)

memo_number: QSO-19-05-Transplant (EXPIRED)

posting_date: Mon, 18 Nov 2024 12:00:00 -0500

summary: EXPIRED AS OF 11/18/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-03-Transplant: Revisions to the State Operations Manual (SOM), Chapter 2- The Certification Process; SOM Appendix X, Guidance to Surveyors: Organ Transplant Programs; and SOM Chapter 9- Exhibits – Advance Copy for current guidance • Pancreas Transplant Centers - An adult or pediatric pancreas transplant center may be Medicare approved, with no independent survey activity, if the program operates as a component of a Medicare approved kidney transplant center. • Intestine Transplant Centers - An adult or pediatric intestine transplant center may be Medicare approved, with no independent survey activity, if the program operates as a component of a Medicare approved liver transplant center. • Pancreas and intestine transplant patients will be incorporated into the kidney and liver program survey reviews. Noncompliance with the care or services to pancreas or intestine transplant patients will result in noncompliance by the associated kidney or liver programs, respectively.

title: EXPIRED: Survey and Approval of Pancreas and Intestine Transplant Centers

memo_number: 19-04-NH-HHA-CLIA

posting_date: Tue, 22 Jan 2019 12:00:00 -0500

summary: • Adjustment of Civil Monetary Penalties (CMP) for Inflation: The Department of Health and Human Services (HHS) has published in the Federal Register on October 11, 2018, a final rule which adjusts for inflation CMP amounts authorized under the Social Security Act (See Adjustment of Civil Monetary Penalties for Inflation). • New CMP Amounts: The final rule lists the new CMP amounts and ranges and are effective as of October 11, 2018. • Selected Providers Highlighted: The CMPs under the authority of HHS affects multiple areas, but we are highlighting only on those CMPs assessed for Skilled Nursing Facilities (SNFs), Nursing Facilities (NFs), SNFs/NFs, Home Health Agencies (HHAs), and Clinical laboratories effective October 11, 2018.

title: Notice of Final Rule Adjusting Civil Monetary Penalties (CMPs) for Inflation

memo_number: 19-03-Hospice

posting_date: Fri, 21 Dec 2018 12:00:00 -0500

summary: • Extraordinary Circumstances as Related to Hospice Staffing Requirements: The Centers for Medicare & Medicaid Services (CMS) has extended its designation of the national nursing shortage as an extraordinary circumstance for an additional two (2) years. This designation enables those hospice agencies, which are unable to provide a sufficient number of nursing staff directly to meet the needs of its patients due to the national shortage, to utilize contracted staff in addition to their full time nursing staff. • Compliance Determination: CMS is eliminating the previous requirement that the hospice agency must notify CMS of its use of contacted staff during extraordinary circumstances and submit justification for such use to its State Survey Agency. This notification/justification is not required by 42 CFR 418.64. Compliance with the regulation for use of contracted staff will be reviewed as a part of the routine survey process. • Hospice Responsibility: When contract services are utilized, the hospice agency maintains all professional, financial and administrative responsibility for the services. • This policy memorandum serves as an extension and supersedes previously issued SC17-01-Hospice.

title: Extension of the Designation of the Current Nursing Shortage as an “Extraordinary Circumstance” per 42 CFR 418.64 Core Services

memo_number: 19-02-NH

posting_date: Fri, 30 Nov 2018 12:00:00 -0500

summary: • Notification to States – The Centers for Medicare & Medicaid Services (CMS) will provide CMS Regional Offices (ROs) and State Survey Agencies with a list of facilities with potential staffing issues to support survey activities for evaluating sufficient staffing and improving resident health and safety. • Updates in the PBJ Policy Manual and Frequently Asked Questions (FAQs) – We are expanding the guidance on the meal breaks policy to ensure consistency. In addition, we are adding guidance regarding reporting hours for “Universal Care Workers.” • Additional Technical Support for Facilities – New MDS-based census reports in the Certification and Survey Provider Enhanced Reporting (CASPER) system.

title: Payroll Based Journal (PBJ) Policy Manual Updates, Notification to States and New Minimum Data Set (MDS) Census Reports

memo_number: 19-01-AO/CLIA

posting_date: Thu, 04 Oct 2018 12:00:00 -0400

summary: Annual Report to Congress: The 2017 annual RTC details the review, validation, and oversight of AOs FY 2016 Medicare accreditation programs and the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results. Additional AO Oversight Initiatives: • To increase transparency for consumers, CMS will post new information on the CMS.Gov website, including the latest quality of care deficiency findings following complaint surveys at facilities accredited by AOs, a list of providers determined by CMS to be currently out of compliance that also references the provider’s AO, and overall performance data for the AOs themselves. • CMS is also testing a more streamlined, effective way to assess AOs’ ability to ensure that facilities and suppliers comply with CMS requirements.

title: FY 2017 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: QSO-18-25-HHA (EXPIRED)

posting_date: Fri, 31 Aug 2018 12:00:00 -0400

summary: EXPIRATION DATE 3/15/24. • The Centers for Medicare & Medicaid Services (CMS) is releasing the final (Advanced Copy) of the HHA Interpretive Guidelines associated with the new Conditions of Participation (CoPs) for HHAs that became effective on January 13, 2018. • The Interpretive Guidelines will be incorporated into the State Operations Manual (SOM), Appendix B.

title: EXPIRED: Home Health Agency (HHA) Interpretive Guidelines

memo_number: 18-26-Hospital-CAH

posting_date: Fri, 31 Aug 2018 12:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) is providing updated guidance to surveyors for the special requirements for Hospital and CAH providers of long-term care services (LTC), also known as “swing beds”. • For Hospitals: Appendix T has been deleted and will no longer be used for the special requirements for hospital providers of LTC services (“swing beds”). The guidance for the special requirements for hospital providers of LTC services are now located in Appendix A under §482.58. • For CAHs: The special requirements for CAH providers of LTC services (“swing beds”) in Appendix W at §485.645 have been revised to reflect the provisions of the final rule that revised the requirements for LTC facilities in 2017. The CAH Survey Protocol has also been significantly revised

title: Guidance to Hospitals and Critical Access Hospital (CAH) Surveyors Addressing Revisions to Swing-Bed Requirements

memo_number: 18-20-CLIA

posting_date: Wed, 01 Aug 2018 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) is clarifying the operation of multiple laboratories at the same location and the discontinued use of the term “shared laboratory” related to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certification.  Multiple laboratories with separate CLIA numbers may operate at one location as long as it can be demonstrated that each laboratory is operating as a separate and distinct entity. They are not to be referred to as “shared laboratories”.  This memorandum supersedes all prior guidance regarding the registration of shared laboratories for CLIA.

title: Clarification of the Operation of Multiple Laboratories at the Same Location and the Discontinued Use of the Term “Shared Laboratory”

memo_number: 18-21-Hospitals

posting_date: Wed, 01 Aug 2018 12:00:00 -0400

summary: Proposed Psychiatric Task Force: The Proposed Psychiatric Task Force to address the environmental risks associated with the care of psychiatric inpatients is not the most appropriate vehicle to foster the changes that are required. • Ligature Risks Compromise Psychiatric Patients’ Right to Receive Care in a Safe Setting: The care and safety of psychiatric patients and the staff that provide that care are our primary concerns. CMS is incorporating the outcomes of the TJC Suicide Panel (in which CMS participated) into comprehensive ligature risk interpretive guidance to provide improved direction and clarity for state survey agencies (SAs) and accrediting organizations (AOs). • Interim Guidance: Until CMS’ comprehensive ligature risk interpretive guidance is released, the SAs and AOs may use their judgment as to the identification of ligature and other safety risk deficiencies, the level of citation for those deficiencies, as well as the approval of the facility’s corrective action and mitigation plans to minimize risk to patient safety and remedy the identified deficiencies.

title: CMS Clarification of Psychiatric Environmental Risks

memo_number: 18-23-OPO

posting_date: Fri, 10 Aug 2018 12:00:00 -0400

summary: The Centers for Medicare and Medicaid Services (CMS) has included a new survey protocol in Appendix Y of the SOM. In addition, revisions were also made to update and clarify interpretive guidance in Appendix Y.

title: New Organ Procurement Organization (OPO) Survey Protocol and Guidance Revisions in Appendix Y of the State Operations Manual (SOM)

memo_number: 18-22-ESRD

posting_date: Fri, 10 Aug 2018 12:00:00 -0400

summary: • The SOM operationalizes the oversight activities of State Survey Agencies (SAs) and Centers for Medicare & Medicaid Services (CMS) Regional Offices (ROs) for certified Medicare providers and suppliers. Chapter 2 of the SOM includes guidance and instructions on procedures for ESRD facilities. • CMS has completed a comprehensive update to the SOM Chapter 2, ESRD section to incorporate current Conditions for Coverage (CfC) and CMS policies for ESRD issued previously through memoranda.

title: Revisions to the State Operations Manual (SOM), Chapter 2, End Stage Renal Disease (ESRD) Program

memo_number: 18-24-ESRD

posting_date: Fri, 17 Aug 2018 12:00:00 -0400

summary: Dialysis Services in a LTC Facility: Medicare participating End Stage Renal Disease(ESRD) facilities must comply with the Conditions for Coverage at 42 CFR Part 494.Under this provision, Medicare-approved ESRD facilities may provide dialysis services toLTC residents in a LTC facility with an approved Home Training and Support modality.ESRD facilities that provide home hemodialysis or peritoneal dialysis services to LTCresidents must maintain compliance with these requirements, including the requirementsset forth at §494.100: Care at home. •Survey Process for Evaluation of Home Dialysis in a LTC Facility: The ESRDCore Survey Process has been updated to include additional survey activities whichaddress dialysis services provided by an ESRD facility to residents in a LTCfacility. •Attachments: Included as an attachment to this memorandum is Exhibit IV: SurveyProcess for ESRD Surveyors Reviewing Dialysis in Nursing Homes for evaluation ofhome dialysis services provided in a LTC facility.

title: Survey Process for Reviewing Home Dialysis Services in a Long Term Care (LTC) Facility

memo_number: 18-19-CLIA

posting_date: Wed, 01 Aug 2018 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) is providing guidance to surveyors, specifically if surveyors find a laboratory using an assay without an EUA that is testing for the same agent for which an emergency has been declared, or a modified EUA assay, they should notify their Regional Office (RO).  Assays that have been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) remain subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) CLIA Regulations  At the onset of a public health emergency, there may be a very limited number of positive samples available for the verification of performance specifications. This does not necessarily prevent laboratories from utilizing assays authorized by an EUA.  Centers for Disease Control (CDC) Developed Assays: Laboratories using a CDC assay authorized for emergency use should follow any and all instructions provided for verifying performance specifications.  Non-CDC Developed Assays: For other non-CDC EUA assays, the Laboratory Director (LD) should determine the acceptable number of positive and negative samples needed for their laboratory to verify performance specifications of the EUA assay. In accordance with 42 CFR §493.1252(a), any manufacturer’s instructions for verification, if provided, must also be followed. The surveyor should confirm that the laboratory has followed its procedures for verification.

title: Performance Specification Verification of Assays Authorized Under Emergency Use (EUA)

memo_number: 18-18-NH

posting_date: Fri, 15 Jun 2018 12:00:00 -0400

summary: This memo replaces the following Survey & Certification (S&C) Memos: 16-31-NH released July 22, 2016 and revised on July 29, 2016, and S&C: 18-01-NH, released in draft on October 27, 2017. The October 2017 memo solicited comments on a proposed directive requiring, for certain situations, immediate imposition of federal remedies on Medicare and Medicaid participating skilled nursing facilities. After reviewing comments, CMS is issuing a final version of the directive. Substantive revisions to the prior Immediate Imposition of Federal Remedies guidance include: •When the current survey identifies Immediate Jeopardy (IJ) that does not result in serious injury, harm, impairment or death, the CMS Regional Offices may determine the most appropriate remedy; •We clarified that Past Noncompliance deficiencies (as described in §7510.1 of this chapter) are not included in the criteria for Immediate Imposition of Remedies; and, •For Special Focus Facilities (SFFs), S/S level “F” citations under tags F812, F813 or F814 are excluded from immediate imposition of remedies. •Revisions to Chapter 7 of the State Operations Manual (SOM) (Attachment): The Centers for Medicare & Medicaid Services (CMS) has revised guidance in Chapter 7 of the SOM related to the Immediate Imposition of Federal Remedies as noted in this memo and its attachment. Other sections of Chapter 7 have been revised to ensure conformity and consistency with these revisions.

title: Final Revised Policies Regarding the Immediate Imposition of Federal Remedies

memo_number: 18-17-NH

posting_date: Fri, 06 Apr 2018 12:00:00 -0400

summary: • Transition to Payroll-Based Journal (PBJ) Data – Starting in April, 2018, CMS will use PBJ data to determine each facility’s staffing measure on the Nursing Home Compare tool on Medicare.gov website, and calculate the staffing rating used in the Nursing Home Five Star Quality Rating System. • Staffing data audits - We are providing lessons-learned from audits conducted, and guidance to facilities for improving their accuracy. Nursing homes whose audit identifies significant inaccuracies between the hours reported and the hours verified, or facilities who fail to submit any data by the required deadline will be presumed to have low levels of staff. This will result in a one-star rating in the staffing domain, which will drop their overall (composite) star rating by one star for a quarter. • Requirement for registered nurse (RN) staffing – We are reminding nursing homes of the importance of RN staffing and the requirement to have an RN onsite 8 hours a day, 7 days a week. Nursing homes reporting 7 or more days in a quarter with no RN hours will receive a one-star rating in the staffing domain, which will drop their overall (composite) star rating by one star for a quarter. This action will be implemented in July 2018, after the May 15, 2018 submission deadline for data for 2018 Calendar Quarter 1, 2018 (January – March, 2018) data. • Technical assistance – CMS is continuing its efforts to help nursing homes submit accurate data, and there are a variety of ways described below in which facilities can seek support. • Future Actions – As of June 1, 2018, we will no longer collect facility staffing data through the CMS-671 form, and we will announce other future activities.

title: Transition to Payroll-Based Journal (PBJ) Staffing Measures on the Nursing Home Compare tool on Medicare.gov and the Five Star Quality Rating System

memo_number: 18-16-ICF/IID

posting_date: Fri, 06 Apr 2018 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) has revised the survey protocol in Part I of Appendix J of the SOM. • The survey process will refocus the surveyor’s time on increased observation time and more effective use of interviews and client record reviews. • The fundamental survey is revised to be a focused fundamental survey accomplished through the concept of key standards and corresponding standards within the Conditions of Participation (CoPs). • The survey procedures for tasks one, two and three are revised.

title: Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) Survey Protocol – State Operations Manual (SOM) Appendix J Revised

memo_number: 18-15-NH

posting_date: Fri, 16 Mar 2018 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) are collaborating on the development of a free on-line training course in infection prevention and control for nursing home staff in the long-term care setting

title: Specialized Infection Prevention and Control Training for Nursing Home Staff in the Long-Term Care Setting

memo_number: 18-14-CLIA

posting_date: Fri, 16 Mar 2018 12:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) is providing clarification related to FNA and ROSE under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). • A slide assessment that provides only a determination of specimen adequacy is not considered to be a slide examination for purposes of determining workload limits in accordance with 42 CFR 493.1274(d). • Thus, when establishing workload limits for qualified individuals during specimen adequacy assessment or during diagnostic slide examination, workload limits should be determined as described herein.

title: Clarification Regarding Fine Needle Aspiration (FNA) Specimen Adequacy Assessment, Rapid On-site Evaluation (ROSE) and Workload Limits

memo_number: 18-10-Hospitals/CAHs

posting_date: Fri, 05 Jan 2018 12:00:00 -0500

summary: ***Revised to clarify providers affected by this policy are Hospitals and CAHs*** • Texting patient information among members of the Hospital and CAHs health care team is permissible if accomplished through a secure platform. • Texting of patient orders is prohibited regardless of the platform utilized. • Computerized Provider Order Entry (CPOE) is the preferred method of order entry by a provider.

title: Texting of Patient Information among Healthcare Providers

memo_number: QSO-18-13-HHA (EXPIRED)

posting_date: Wed, 17 Jan 2018 12:00:00 -0500

summary: EXPIRATION DATE 3/15/2024. This memorandum revises Appendix B of the SOM pursuant to new Conditions of Participation (CoPs) for HHA which are effective January 13, 2018: New Aspen tags for each condition and standard for the new CoPs are attached to this memorandum. These tags will be used by the surveyors to enter survey data into the system as of January 13, 2018. Revised Level I and Level II standards, based on the new CoPs, are attached to this memorandum. The surveyors must use Level I and II standards to conduct standard and partially extended HHA surveys per Appendix B of the SOM. ***Revised Attachments A & B to Reflect Removal of Tags G670, G700, G848 and G940; Addition of G956 and G984***

title: EXPIRED: Home Health Agency (HHA) Survey Protocol – State Operations Manual (SOM) Appendix B Revised

memo_number: QSO 18-12-Deemed Providers/Suppliers REVISED

posting_date: Wed, 25 Mar 2026 15:00:00 -0400

summary: Memorandum Summary Please check the downloads section for the latest version of the memo.

title: REVISED: Clarification of the Accrediting Organization’s (AO’s) and State’s Roles when a Provider or Supplier’s Deemed Status has been Temporarily Removed

memo_number: 18-11-CLIA

posting_date: Fri, 05 Jan 2018 12:00:00 -0500

summary: • The Centers for Medicare & Medicaid Services (CMS) published an RFI on January 5, 2018. • The RFI is seeking public comment and information related to the following areas: o Personnel requirements: nursing and physical science degrees, competency assessment, laboratory training and experience requirements and documentation; o Proficiency testing referral: Discretion for Category 1, alternative sanctions imposed for Certificate of Waiver (CoW); o Histocompatibility; and, o Compliance and additional fees.

title: Clinical Laboratory Improvement Amendments (CLIA) Release of Request for Information (RFI)

memo_number: 18-10-Hospitals, CAHs

posting_date: Fri, 22 Dec 2017 12:00:00 -0500

summary: ***Revised to clarify providers affected by this policy are Hospitals and CAHs*** • Texting patient information among members of the health care team is permissible if accomplished through a secure platform. • Texting of patient orders is prohibited regardless of the platform utilized. • Computerized Provider Order Entry (CPOE) is the preferred method of order entry by a provider.

title: Texting of Patient Information among Healthcare Providers

memo_number: 18-09-RHC

posting_date: Wed, 27 Dec 2017 12:00:00 -0500

summary: RHC Appendix G Comprehensively Updated: The Centers for Medicare & Medicaid Services (CMS) has updated SOM Appendix G for RHCs. The update includes the following features: • Addition of a Survey Process Component: Appendix G now is divided into two parts, with Part 1 outlining the survey process to be followed for RHC surveys. • Guidance Reorganized: Part 2 of Appendix G is now organized to include Automated Survey Processing Environment (ASPEN) “Tag” numbers, with specific regulatory text, interpretive guidance and survey procedures associated with each Tag. • Renumbered Tags: The ASPEN tag numbering system currently in use for RHCs is being completely revised, to reflect the fact that the Appendix now breaks down various RHC Conditions for Certification (CfCs) into separate components for purposes of surveyor assessment of compliance. • Guidance Clarified and Updated: The guidance for all of the RHC CfCs has been reviewed for its precision and clarity in interpreting the regulatory requirements and, where applicable, consistency with current standards of practice. • Timing of ASPEN Changes: We are working to make implementing changes in ASPEN as soon as possible.

title: Revised Rural Health Clinic (RHC) Guidance—State Operations Manual (SOM) Appendix G- Advanced Copy

memo_number: 18-08-NH

posting_date: Tue, 26 Dec 2017 12:00:00 -0500

summary: • Federal regulations allow facilities to initiate discharges of residents only in specific instances. Despite these protections, discharges which violate Federal regulations continue to be one of the most frequent complaints made to State Long Term Care Ombudsman Programs. • The Centers for Medicare & Medicaid Services (CMS) has begun an initiative to examine and mitigate facility-initiated discharges that violate federal regulations. CMS is examining State survey agency’s intake and triage practices for these type of discharge complaints, developing examples of inappropriate and appropriate discharges for surveyors, identifying best practices for nursing homes, developing training and evaluating enforcement options for these types violations. • Civil Money Penalty (CMP) Reinvestment Projects Assistance. CMS is encouraging States to pursue CMP-funded projects that may help prevent facility initiated discharges that violate federal regulations.

title: An Initiative to Address Facility Initiated Discharges that Violate Federal Regulations

memo_number: 18-07-CLIA

posting_date: Fri, 15 Dec 2017 12:00:00 -0500

summary: • Clarification of Proficiency Testing (PT) Referral: The final regulations implementing the Taking Essential Steps for Testing Act (“TEST Act”) include three categories for PT Referral which are based on severity and extent of the violation.

title: CLIA Proficiency Testing (PT) Referral Categories

memo_number: 18-06-Hospitals

posting_date: Fri, 08 Dec 2017 12:00:00 -0500

summary: • Ligature Risks Compromise Psychiatric Patients’ Right to Receive Care in a Safe Setting: The care and safety of psychiatric patients and the staff that provide that care are our primary concerns. The Centers for Medicare & Medicaid Services (CMS) is in the process of drafting comprehensive ligature risk interpretive guidance to provide direction and clarity for Regional offices (RO), State Survey Agencies (SAs), and accrediting organizations (AOs). • Definition of a Ligature Risk: A ligature risk (point) is defined as anything which could be used to attach a cord, rope, or other material for the purpose of hanging or strangulation. Ligature points include shower rails, coat hooks, pipes, and radiators, bedsteads, window and door frames, ceiling fittings, handles, hinges and closures. • Focus of Ligature Risks: The focus for a ligature “resistant” or ligature “free” environment is primarily aimed at Psychiatric units/hospitals. • Interim Guidance: Until CMS’ comprehensive ligature risk interpretive guidance is released, the ROs, SAs and AOs may use their judgment as to the identification of ligature and other safety risk deficiencies, the level of citation for those deficiencies, as well as the approval of the facility’s corrective action and mitigation plans to minimize risk to patient safety and remedy the identified deficiencies. • Timeframe for Correction of Ligature Risk Deficiencies: All deficiencies are expected to be corrected within the timeframe designated by the CMS RO, SA or AO. In cases where it is determined that it is not reasonable to expect compliance within the designated timeframe, only CMS may grant additional time for correction. • Ligature Risk Deficiencies Do Not Qualify for Life Safety Code (LSC) Waivers: Ligature risks are not LSC deficiencies. Therefore, a LSC waiver may not be granted. • Monitoring of Progress: When additional time for correction is granted, the hospital is required to provide monthly electronic progress reports to the SA or AO, including substantiating evidence of progress towards compliance. The SA or AO will update the RO or Central Office (CO) monthly, respectively.

title: Clarification of Ligature Risk Policy

memo_number: 18-05-NH

posting_date: Fri, 24 Nov 2017 12:00:00 -0500

summary: The new computer-based LTCSP will be effective November 28, 2017. • Appendix P will no longer be available: Beginning with surveys occurring on November 28, 2017, Appendix P will no longer be accessible. The LTCSP procedure guide will replace Appendix P as the procedural and technical guide for conducting LTC standard surveys. Chapter 7 of the State Operations Manual (SOM) will be revised to include survey policy. • Survey Resources: A link to resources surveyors will need to conduct LTC surveys will be made available on November 17, 2017. Surveyors must download items included on this link to their survey laptops by November 28, 2017.

title: Preparation for Launch of New Long-Term Care Survey Process (LTCSP)

memo_number: 18-04-NH

posting_date: Fri, 24 Nov 2017 12:00:00 -0500

summary: • Temporary moratorium on imposing certain enforcement remedies for specific Phase 2 requirements: CMS will provide an 18 month moratorium on the imposition of certain enforcement remedies for specific Phase 2 requirements. This 18 month period will be used to educate facilities about specific new Phase 2 standards. • Freeze Health Inspection Star Ratings: Following the implementation of the new LTC survey process on November 28, 2017, CMS will hold constant the current health inspection star ratings on the Nursing Home Compare (NHC) website for any surveys occurring between November 28, 2017 and November 27, 2018. • Availability of Survey Findings: The survey findings of facilities surveyed under the new LTC survey process will be published on NHC, but will not be incorporated into calculations for the Five-Star Quality Rating System for 12 months. CMS will add indicators to NHC that summarize survey findings. • Methodological Changes and Changes in Nursing Home Compare: In early 2018, NHC health inspection star ratings will be based on the two most recent cycles of findings for standard health inspection surveys and the two most recent years of complaint inspections

title: Temporary Enforcement Delays for Certain Phase 2 F-Tags and Changes to Nursing Home Compare

memo_number: 18-03-HHA

posting_date: Fri, 17 Nov 2017 12:00:00 -0500

summary: • New HHA Conditions of Participation, which will be effective January 13, 2018, no longer contain a definition for HHA Subunits. • The Subunits existing at the time of the effective date of the regulations will become freestanding HHAs unless they notify the State Survey Agency (SA) and the Medicare Administrative Contractor (MAC) that they wish to become a Branch of the Parent.

title: Home Health Agency (HHA) Subunits

memo_number: 18-01-NH

posting_date: Fri, 27 Oct 2017 12:00:00 -0400

summary: • This policy memo replaces S&C: 16-31-NH released July 22, 2016 and the revision on July 29, 2016. • Revisions to Chapter 7 of the State Operations Manual (SOM) (Attachment): The Centers for Medicare & Medicaid Services (CMS) has revised guidance relating to the Immediate Imposition of Federal Remedies. Other sections of Chapter 7 have been revised to ensure consistency with these revisions. Major revisions include: • We specify that when the current survey identifies Immediate Jeopardy (IJ) that does not result in serious injury, harm, impairment or death, the CMS Regions may determine the most appropriate remedy; • We clarified that Past Noncompliance deficiencies as described in §7510.1 of this chapter, are not included in the criteria for Immediate Imposition of Remedies; • For Special Focus Facilities (SFFs), we now exclude any S/S level “F” citations under tags F812, F813 or F814 from the tags that require immediate imposition of remedies. • This memo is being released in draft. We seek comment on this policy by December 1, 2017.

title: Revised Policies regarding the Immediate Imposition of Federal Remedies- FOR ACTION

memo_number: 18-02-NH

posting_date: Fri, 27 Oct 2017 12:00:00 -0400

summary: ? Existing Waiver and Appeal Authorities: The Centers for Medicare & Medicaid Services (CMS) is providing clarification regarding existing statutory and regulatory authority regarding waivers and appeals of NATCEP/CEP prohibition or loss.

title: Clarification regarding Nurse Aide Training and Competency Evaluation Program (NATCEP/CEP) Waiver and Appeal Requirements

memo_number: 17-47-ALL

posting_date: Fri, 29 Sep 2017 12:00:00 -0400

summary: • National Background Check Program: The goal of the program is to prohibit the hiring of employees who have histories of abuse or relevant criminal violations to serve the vulnerable long term care population. • Application Deadline: We are providing advance notice that the deadline for States to apply to the ninth (and final) solicitation for the NBCP will be December 15, 2017. • Solicitation: The solicitation is posted at: https://www.grants.gov.

title: Advance Notice Solicitation Deadline - National Background Check Program

memo_number: 17-46-CLIA

posting_date: Fri, 29 Sep 2017 12:00:00 -0400

summary: • Controls as Calibration Materials: Controls provided by manufacturers in a test kit are considered to be calibration materials if they are used to calculate the cutoff value of a test or a patient test result. • Testing of Additional External Controls: If the manufacturer’s instructions include a formula which uses the positive and/or negative controls included in the kit to determine the cutoff, additional external positive and/or negative controls must also be tested. • Guidance for Surveyors: The laboratory director is responsible for the determination of what control materials to use in his/her laboratory. Surveyors will ensure that the laboratory is following its own established policies, specifically its Quality Control (QC) procedures.

title: Clarification Regarding the Use of Control Materials as Calibrators to Determine Test Cut-off Values

memo_number: 17-45-NH

posting_date: Mon, 25 Sep 2017 12:00:00 -0400

summary: • CMS will begin posting Payroll-Based Journal public use files which will be accessible at https://data.cms.gov/ on November 1, 2017. • The Nursing Home Compare website indicates whether providers have submitted data by the required deadline, and if providers have submitted, complete, incomplete, or inaccurate data. • We are updating the data submission specifications to give providers the ability to link employee IDs for an employee that has changed employee IDs within a facility. • We will post an updated PBJ policy manual and related information by October 1, 2017 at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html.

title: Electronic Staffing Submission - Payroll-Based Journal (PBJ) Public Use File

memo_number: 17-42-ALL

posting_date: Fri, 18 Aug 2017 12:00:00 -0400

summary: • Termination Notices: As of October 1, 2017 (for Ambulatory Surgical Centers [ASCs], Federally Qualified Health Centers [FQHCs], Rural Health Clinics [RHCs] and Organ Procurement Organizations [OPOs]), and August 18, 2017 for all other certified providers, suppliers, and laboratories, public notice of termination will be posted on the Survey & Certification website at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Termination-Notices.html

title: Termination Notices Available via the Survey & Certification Website

memo_number: 17-43-ALL

posting_date: Tue, 22 Aug 2017 12:00:00 -0400

summary: ? New Website Platform and Data System: The Centers for Medicare & Medicaid Services (CMS) is releasing information related to the new QCOR website in an overarching initiative for increased transparency.

title: Quality and Certification Oversight Reports (QCOR) Website Launch

memo_number: 17-44-All Hospitals

posting_date: Fri, 27 Oct 2017 12:00:00 -0400

summary: ***Change to the Average Daily Census Timelines *** The Centers for Medicare & Medicaid Services (CMS) is clarifying guidance under Appendix A of the State Operations Manual (SOM) to address the following: • The Social Security Act, (the Act) Section 1861(e) defines the statutory definition of a hospital. • A hospital is primarily engaged in providing inpatient services under section 1861(e)(1) of the Act when it is directly providing services to inpatients. • In order to qualify for a provider agreement as a hospital under Medicare and Medicaid, an entity must meet and continue to meet all of the statutory provisions of §1861(e) of the Act, including the Condition of Participation (CoP) requirements. See also 42 CFR 488.3(a)(1) and 42 CFR 489.12. (Note: This requirement does not apply to Psychiatric Hospitals or Critical Access Hospitals (CAH), as defined at section 1861(f) of the Act) • A hospital must have inpatients at the time of survey in order for surveyors to directly observe the actual provision of care and services to patients, and the effects of that care. • The use of benchmarks for average daily census (ADC) and average length of stay (ALOS) data for the hospital will be two factors, in addition to other factors, utilized to determine if the hospital is primarily engaged.

title: Advanced Copy- Revisions to State Operations Manual (SOM) Hospital Appendix A

memo_number: 17-41-NH

posting_date: Fri, 04 Aug 2017 12:00:00 -0400

summary: • Survey Team Composition and Investigation of Complaints: On July 31, 2017, the Federal Register issued the final rule Medicare Program: Prospective Payment - System and Consolidated Billing for Skilled Nursing Facilities (SNF) for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Correction of the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020. These regulations are effective on October 1, 2017. • The Final Rule published on August 4, 2017 and can be found at https://www.federalregister.gov/documents/2017/08/04/2017-16256/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities.

title: Notification of Final Rule Published—Survey Team Composition and Investigation of Complaints

memo_number: 17-38-LSC

posting_date: Fri, 28 Jul 2017 12:00:00 -0400

summary: • In health care occupancies, fire door assemblies are required to be annually inspected and tested in accordance with the 2010 National Fire Protection Association (NFPA) 80. • In health care occupancies, non-rated doors assemblies including corridor doors to patient care rooms and smoke barrier doors are not subject to the annual inspection and testing requirements of either NFPA 80 or NFPA 105. • Non-rated doors should be routinely inspected as part of the facility maintenance program. • Full compliance with the annual fire door assembly inspection and testing in accordance with 2010 NFPA 80 is required by January 1, 2018. • Life Safety Code (LSC) deficiencies associated with the annual inspection and testing of fire doors should be cited under K211 – Means of Egress - General.

title: Fire and Smoke Door Annual Testing Requirements in Health Care Occupancies

memo_number: 17-39-CMHC

posting_date: Fri, 28 Jul 2017 12:00:00 -0400

summary: • Provision of CMHC Services: 42 CFR 485.918(b)(1)(iii) Provision of Services requires that a CMHC provide either day treatment, (the provision of partial hospitalization services other than in an individual’s home or in an inpatient or residential setting), or psychosocial rehabilitation services. The certified CMHC must provide one of the above referenced services to be in compliance with the Standard. • Medicare Provider Agreements: However, 42 CFR 489.2(c)(2) states that CMHCs may enter into provider agreements under Medicare only to furnish partial hospitalization services. Therefore, a CMHC may not enter into or continue a provider agreement with the Centers for Medicare & Medicaid Services (CMS) unless the CMHC provides, at a minimum, partial hospitalization services consistent with the requirements in §485.918(f).

title: Community Mental Health Centers (CMHC) - Clarification on the Provision of Services

memo_number: 17-40-AO

posting_date: Fri, 28 Jul 2017 12:00:00 -0400

summary: Annual Report to Congress: The 2016 annual RTC details the review, validation, and oversight of the FY 2015 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results.

title: FY 2016 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: 17-36-NH

posting_date: Thu, 29 Jun 2017 12:00:00 -0400

summary: • Revised Interpretive Guidance: In September 2016, the Centers for Medicare & Medicaid Services (CMS) released revised Requirements for Participation under the Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities rule. CMS is releasing revised Interpretive Guidance to be effective November 28, 2017. • Revised F Tags: The revisions to the regulations caused many of the prior regulatory citations to be re-designated. As such, CMS was required to re-number the F-Tags used to identify each regulatory part. Those new F-Tags are described here. • Training Resources: CMS is providing several training resources on our website and on an MLN Connect call on July 25, 2017 from 1:30 to 3:00pm EST. • Enforcement and Nursing Home Compare Considerations: To address concerns related to the scope and timing of the changes, CMS will be providing limited enforcement remedies for certain Phase 2 provisions and will be holding constant the Nursing Home Compare health inspection rating for one year.

title: Revision to State Operations Manual (SOM) Appendix PP for Phase 2, F-Tag Revisions, and Related Issues

memo_number: 17-37-NH

posting_date: Fri, 07 Jul 2017 12:00:00 -0400

summary: CMS is hereby removing the July 7, 2017 Memo (S&C 17-37-NH) from its guidance repository. In that memo, CMS instructed CMS Locations (formerly “Regional Offices”) to impose civil monetary penalties for prior noncompliance solely on a per-instance basis. Upon further consideration, CMS has determined that the agency should retain the discretion at this time to impose a per-day penalty where appropriate to address specific circumstances of prior noncompliance. We will work within CMS operations to apply such discretion, and any final notice of noncompliance will set forth the penalty, and the reason(s) for imposing per-instance or per-day penalties.

title: Revision of Civil Money Penalty (CMP) Policies and CMP Analytic Tool

memo_number: 17-33-ESRD

posting_date: Fri, 16 Jun 2017 12:00:00 -0400

summary: • Infection Control: The Conditions for Coverage (CfCs) for End Stage Renal Disease (ESRD) facilities include infection control requirements for the safety of each dialysis patient, their family and staff members. • HCV Screening: Recommendations for infection control, developed by the Centers for Disease Control and Prevention (CDC), are incorporated by reference into the ESRD CfCs and must be followed (with the exception of HCV screening per 42 CFR 494.30(a)(1)(i)) by all Medicare certified ESRDfacilities.

title: Infection Control: Clarification of Hepatitis C (HCV) ScreeningException

memo_number: 17-34-ALL

posting_date: Fri, 16 Jun 2017 12:00:00 -0400

summary: • Format for Plans of Corrections (PoCs)/Allegations of Compliance (AOC): Providers/Suppliers and Clinical Laboratory Improvement Amendments (CLIA) Laboratories will no longer be required to write their PoC (for CLIA, this includes AOCs) on the right side of the CMS Form 2567. Providers/Suppliers or CLIA Laboratories may submit their PoC/AOC as a separate document attachment or may continue to document the PoC on the right side of the CMS Form 2567. • Signature on First Page: The Laboratory Director or Provider/Supplier Representative’s signature is still required on the first page of the CMS Form 2567 for the PoC/AOC. The PoC/AOC can be sent as an attachment to the signed first page of the CMS Form 2567.

title: New Guidance for the Formatting of the Plans of Correction

memo_number: 17-35-ALL

posting_date: Fri, 16 Jun 2017 12:00:00 -0400

summary: ?Reasonable assurance will be applied to providers and suppliers once a terminationaction has been initiated by a State Survey Agency and the entity was allowed toterminate Medicare participation voluntarily before the termination action wasmade effective. See Section 2016 and 2017 of the State Operations Manual (SOM).

title: Reasonable Assurance Will Apply to Providers and Suppliers Who Voluntarily Terminate and Seek New Certification If a Termination Action by the State Agency Had Been Initiated

memo_number: 17-29-ALL

posting_date: Fri, 02 Jun 2017 12:00:00 -0400

summary: • Advanced Copy of Interpretive Guidelines: The Centers for Medicare & Medicaid Services (CMS) is releasing a new Appendix Z of the State Operations Manual (SOM) which contains the interpretive guidelines and survey procedures for the Emergency Preparedness Final Rule. • Affects all 17 providers and suppliers: Appendix Z applies to all 17 providers and suppliers included in the Final Rule.

title: Advanced Copy- Appendix Z, Emergency Preparedness Final Rule Interpretive Guidelines and Survey Procedures

memo_number: S&C17-30-Hospitals/CAHs/NHs EXPIRED

posting_date: Tue, 02 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Requirement to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires’ Disease (LD) EXPIRED

memo_number: 17-32-ESRD

posting_date: Fri, 02 Jun 2017 12:00:00 -0400

summary: • Cleaning the ESRD station between patients: The Centers for Disease Control and Prevention (CDC) has recommended that a dialysis station, in order to prevent cross contamination, be completely vacated by the previous patient before the ESRD staff may begin cleaning and disinfection of the station and set up for the next patient. • Precaution: CMS reiterates that patients should not be moved from the dialysis station until they are clinically stable.

title: End Stage Renal Disease (ESRD) Facilities: Cleaning the Patient Station

memo_number: 17-31-ESRD

posting_date: Fri, 02 Jun 2017 12:00:00 -0400

summary: REVISED 09.08.2017 to clarify that single dose containers may not be used to prepare more than one syringe •Preparation of Medications: ESRD facilities must follow aseptic technique when preparing and administering intravenous medications; including the filling of syringes with sterile saline for use during the dialysis procedure. • Filling Saline Syringes at the Station: Pursuant to current recommendations from the Centers for Disease Control (CDC), ESRD facilities may not fill syringes with saline from the single dose saline bag or IV tubing connected to the patient at the dialysis station. To comply with recommended safe injection practices, the facility may acquire pre-filled syringes or may prepare saline syringes for an individual patient in a clean area away from the patient treatment area.

title: End Stage Renal Disease (ESRD) Facilities: Filling Saline Syringes at the Patient Treatment Station

memo_number: 17-27-NH

posting_date: Fri, 12 May 2017 12:00:00 -0400

summary: • New Definition for SQC: A new regulatory definition was published in the Centers for Medicare & Medicaid Services (CMS) 2016 Final Long-term Care Rule and became effective on November 28, 2016. • Implementing SQC: The new regulatory definition will affect which F-tags and regulatory groupings are considered to be SQC in both Phase 1 and Phase 2 of the Final Rule implementation process. • Notice Before Transfer or Discharge Requirements: CMS is also providing clarification in advance of formal interpretive guidance of 42 CFR §483.15(c)(3)(i) which requires facilities to send a copy of the notice of transfer or discharge to the Office of the State Long-Term Care Ombudsman.

title: Implementation Issues, Long-Term Care Regulatory Changes: Substandard Quality of Care (SQC) and Clarification of Notice before Transfer or Discharge Requirements

memo_number: 17-28-PRTF

posting_date: Fri, 12 May 2017 12:00:00 -0400

summary: • During the recent PRTF training courses many questions were received from attendees regarding survey expectations in applying the PRTF Condition of Participation (CoP) and regulatory requirements. • PRTF FAQs: Attached is a list of the questions we received and our responses which are provided to support surveyor consistency nationwide.

title: Psychiatric Residential Treatment Facilities (PRTF) Frequently Asked Questions (FAQs)

memo_number: 17-26-NH

posting_date: Fri, 28 Apr 2017 12:00:00 -0400

summary: Memorandum Summary • Notice of Proposed Rule Making (NPRM): The Centers for Medicare & Medicaid Services (CMS) published a proposed regulation Medicare Program; FY 2018 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Proposed Rule which displayed on the Federal Register on April 27, 2017. • CMS Proposed Changes: CMS proposed four changes to the Survey Team Composition within the NPRM which, include revision of the definitions of “complaint survey” and “abbreviated standard survey,” relocation of requirements related to complaint surveys, and revision of survey team composition requirements as outlined below. • The Regulation is available for display on the Federal Register at https://www.federalregister.gov/public-inspection.

title: Notice of Proposed Regulation Changes to Requirements Related to Survey Team Composition and Investigation of Complaints

memo_number: 17-25-NH

posting_date: Fri, 21 Apr 2017 12:00:00 -0400

summary: • Mandatory staffing data submission through the Payroll-Based Journal began July 1, 2016. Providers are reminded that they have until the 45th day after the end of each quarter to submit data. • To help providers improve their submissions, the Centers for Medicare & Medicaid Services (CMS) is providing feedback on each facility’s data through their monthly Provider Preview reports. • The Nursing Home Compare website now reflects whether providers have submitted data by the required deadline. Additionally, providers that have not submitted any data for two consecutive deadlines will have their overall and staffing star ratings suppressed. • We are updating the data submission requirements related to hire and termination dates, and converting three job codes as optional for submission.

title: Electronic Staffing Submission - Payroll-Based Journal Update

memo_number: 17-24-ALL

posting_date: Fri, 14 Apr 2017 12:00:00 -0400

summary: • Notice of Proposed Rule Making (NPRM): The Centers for Medicare & Medicaid Services (CMS) published a proposed regulation Medicare Program; Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates on April 14, 2017. • CMS Proposed Changes: CMS proposed two changes within the NPRM open for public comment. These changes include a requirement for AOs with CMS-approved accreditation programs to post survey reports, as well as changes in termination notices for and Ambulatory Surgical Centers (ASCs), Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs) and Organ Procurement Organizations (OPOs), outlined below. • The Regulation is available for display on the Federal Register at https://www.federalregister.gov/public-inspection.

title: Notice of Proposed Regulation Changes for Accrediting Organizations (AOs) Transparency and Termination Notices

memo_number: 17-21-ALL

posting_date: Fri, 24 Mar 2017 12:00:00 -0400

summary: Information for Implementation: The Centers for Medicare & Medicaid Services (CMS) is providing information to assist providers and suppliers in meeting the Training and Testing requirements of the new Emergency Preparedness Final Rule that was published on September 16, 2016 (81 FR 63860) and became effective on November 15, 2016.

title: Information to Assist Providers and Suppliers in Meeting the New Training and Testing Requirements of the Emergency Preparedness Requirements for Medicare & Medicaid Participating Providers and Suppliers Final Rule

memo_number: 17-23-NH/HHA/CLIA

posting_date: Fri, 31 Mar 2017 12:00:00 -0400

summary: • Adjustment of Civil Monetary Penalties for Inflation: The Department of Health and Human Services (HHS) has published in the Federal Register on February 3, 2017, a final rule which adjusts for inflation CMP amounts authorized under the Social Security Act. • The final rule lists the new CMP amounts and ranges and are effective on February 3, 2017. • The CMPs under the authority of HHS affects multiple areas, but we are highlighting only on those CMPs assessed for Skilled Nursing facilities (SNFs), Nursing Facilities (NFs), SNFs/NFs, Home Health Agencies (HHAs), and Clinical laboratories effective February 3, 2017.

title: Notice of Final Rule Adjusting Civil Monetary Penalties (CMPs) for Inflation

memo_number: 17-22-ALL

posting_date: Fri, 24 Mar 2017 12:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) MLN will host a NPC for the Emergency Preparedness Requirements for Medicare & Medicaid Participating Providers and Suppliers Final Rule. • The calls are open to providers, suppliers, State Survey Agencies (SAs), Regional Offices (ROs) and the general public.

title: Save the Date- Medicare Learning Network (MLN) Conference Call National Provider Call (NPC) for Emergency Preparedness Requirements for Medicare & Medicaid Participating Providers and Suppliers Final Rule

memo_number: 17-20-NH

posting_date: Thu, 02 Mar 2017 12:00:00 -0500

summary: • Total SFF slots and candidates for each State: The number of designated slots and candidates for FY 2017 (see Appendix A) will not change from those effective since May 1, 2014. • Initial selection notice: The State Survey Agency (SA) must notify the provider in writing of their SFF selection and conduct a meeting (either onsite or via telephone) with the nursing home’s accountable parties, and the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO), if the RO wants to be included. • Graduation from the SFF program: Once an SFF has completed two consecutive standard surveys with no deficiencies cited at a scope and severity of “F” or greater (or “G” or greater for Life Safety Code (LSC) deficiencies), and has had no complaint surveys with deficiencies at “F” or greater (or “G” or greater for Life Safety Code (LSC) deficiencies) in between those two standard surveys, the facility will graduate from the SFF program. However, if the only deficiency preventing graduation is an “F” level deficiency for food safety requirements (42 CFR §483.60(i) Tag F371), the RO has discretion to allow the facility to graduate from the SFF program. F371 deficiencies at a “G” level or greater will prevent the facility from graduating from the SFF program. • Authority for termination: Consistent with longstanding authority, the CMS ROs may use discretionary termination for SFFs (or any facility) if necessary to protect resident health and safety.

title: Fiscal Year (FY) 2017 Special Focus Facility (SFF) Program Update

memo_number: 17-19-NH

posting_date: Fri, 17 Feb 2017 12:00:00 -0500

summary: Memorandum Summary Revised on 03.10.17-***Revised to Reflect Minor Technical Updates to Tags Listed on Page 2 *** • Revised Regulations: On September 28, 2016, the Centers for Medicare & Medicaid Services (CMS) released revised requirements for participation under the Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities rule. Many of the regulations were re-designated and have new numbers. • Revisions to SOM Appendix PP: CMS has revised regulation text into the SOM Appendix PP to correct identified technical errors and correct the numerical order of tags. The revised version was released on February 10, 2017. The regulation text is effective November 28, 2016; the Interpretive Guidance has not been updated. Interpretive Guidance will be revised at a later date.

title: Revision to State Operations Manual (SOM) Appendix PP

memo_number: 17-18-ESRD

posting_date: Fri, 13 Jan 2017 12:00:00 -0500

summary: Memo revised 03.07.17-*** Reminder for State Agencies and Regional Offices *** • On December 14, 2016, an IFC concerning third party payment requirements for dialysis facilities was published in the Federal Register (81 Fed. Reg. 90211). An interim surveyor worksheet was then released to assist surveyors in evaluating compliance with the requirements of the IFC during ESRD surveys pending issuance of interpretive guidance. • Delayed Implementation Date: Pursuant to a Temporary Restraining Order (TRO) issued on January 12, 2017 temporarily enjoining implementation of the IFC pending further order of the court, use of the interim surveyor worksheet (as directed by S&C: 17-16-ESRD) and enforcement of the provisions in the IFC (amending 42 C.F.R. §§ 494.70 and 494.180) in ESRD surveys will cease until further notice.

title: Delayed Implementation of End Stage Renal Disease (ESRD) Interim Final Rule with Comment (IFC) – Third Party Payment

memo_number: 17-17-ALL

posting_date: Fri, 13 Jan 2017 12:00:00 -0500

summary: Recommendations for Providers and Suppliers for Cyber Security: The Centers for Medicare & Medicaid Services (CMS) is reminding providers and suppliers to keep current with best practices regarding mitigation of cyber security attacks. We have outlined resources to assist facilities in their reviews of their cyber security and IT programs.

title: Recommendations to Providers Regarding Cyber Security

memo_number: 17-15-LSC

posting_date: Fri, 16 Dec 2016 12:00:00 -0500

summary: • Fire Safety Requirements: The Centers for Medicare & Medicaid Services (CMS) has adopted the 2012 Life Safety Code (LSC) and the 2012 Health Care Facilities Code (HCFC) through regulation (see 81 FR 26872, 5/4/16), effective July 5, 2016.• FSES Edition to be Used To Meet Fire Safety Requirements: If the FSES is being used to demonstrate compliance with the fire safety requirements, the version of the FSES for Health Care Occupancies and Board and Care Occupancies found in the 2013 edition of the Guide on Alternative Approaches to Life Safety, NFPA 101A must be used. A facility that achieves a passing score on the 2013 edition of the FSES will be considered to meet the fire safety requirements for certification and recertification with the Medicare and Medicaid programs.• Survey Start Date: CMS began surveying for compliance with the 2012 LSC and HCFC on November 1, 2016. Facilities may now use the 2013 edition of the FSES.• Time Limited Waiver for Corrective Action: Long Term Care (LTC) facilities using the FSES may be granted a time limited waiver to correct certain deficiencies.

title: Use of the Fire Safety Evaluation System (FSES), National Fire Protection Association (NFPA) 101A, Guide on Alternative Approaches to Life Safety, 2013 Edition by Health Care Occupancies and Board and Care Occupancies

memo_number: 17-13-Transplant (EXPIRED)

posting_date: Mon, 18 Nov 2024 12:00:00 -0500

summary: EXPIRED AS OF 11/18/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-03-Transplant: Revisions to the State Operations Manual (SOM), Chapter 2- The Certification Process; SOM Appendix X, Guidance to Surveyors: Organ Transplant Programs; and SOM Chapter 9- Exhibits – Advance Copy for current guidance • Background: Certain Medicare-approved organ transplant center programs must maintain one-year patient and graft survival rates consistent with the Standard: Outcome requirements within the Transplant Center Conditions of Participation (CoP) at 42 CFR §482.82. The Centers for Medicare & Medicaid Services (CMS) uses risk-adjusted statistical reports, released semi-annually by the Scientific Registry of Transplant Recipients (SRTR), to measure and determine program compliance. • Enforcement of the Outcomes Requirement: Beginning with the January 2017 SRTR center-specific reports, CMS will identify those transplant programs who cross CMS’ thresholds for one-year patient and/or graft survival rates, in accordance with 42 CFR §482.82(c). Simultaneously, CMS will review more recent SRTR data to determine whether the program’s one year patient/graft survival rate is improving, static or declining. If the program is out of compliance upon the release of the next SRTR report and is not showing improvement in more recent data, CMS will consider the program to be non-compliant at a Condition level and may conduct an on-site survey to determine whether there are deficiencies with other requirements.

title: EXPIRED: Transplant Centers: Citation for Outcome Requirements

memo_number: 17-14-LSC

posting_date: Fri, 16 Dec 2016 12:00:00 -0500

summary: • Sprinkler Requirement for Long Term Care Facilities: On May 4, 2016, the Centers for Medicare & Medicaid Services (CMS) published the final rule Medicare and Medicaid Programs: Fire Safety Requirements for Certain Health Care Facilities (81 FR 26872). This regulation adopted the 2012 Life Safety Code (LSC), and the 2012 Health Care Facilities Code (HCFC). The 2012 LSC requires all existing and newly constructed health care facilities including long term care facilities to be equipped with a supervised automatic sprinkler system. This regulation requires compliance with the 2010 edition of National Fire Protection Association (NFPA) 13, Installation of Sprinkler Systems. • Sprinkler Installation Requirements for Attics containing Fire Retardant Treated Wood (FRTW): The use of FRTW is allowed to be installed in a facility in concealed or attic space without the installation of an automatic sprinkler system, provided that it meets certain conditions related to access, construction type, storage and fuel fired equipment. This is a change, because FRTW was not discussed clearly with regards to concealed spaces in the 2000 edition of the LSC or the 1999 edition of NFPA 13.

title: Clarification of Automatic Fire Sprinkler System Installation Requirements in Attic Spaces in Long-Term Care (LTC) Facilities

memo_number: 17-16-ESRD

posting_date: Fri, 16 Dec 2016 12:00:00 -0500

summary: • Publication: The Centers for Medicare & Medicaid Services (CMS) has published an IFR on third party payment requirements in the Federal Register on December 14, 2016. This rule implements new requirements for Medicare-certified dialysis facilities that make financial contributions to patients in order to support enrollment in individual market health plans either directly or indirectly through a parent organization or third party. • The IFR establishes new standards under the End Stage Renal Disease (ESRD) Conditions for Coverage (CfC) 42 CFR 494.70 Patient Rights (c) Standard: Right to be informed of health insurance options and 42 CFR 494.180 Governance (k) Standard: Disclosure of financial assistance to insurers. • The requirements of the IFR apply to any dialysis facility offering financial contributions in the form of premium assistance to support enrollment in individual market health plans. The requirements will be effective 30 days from the date of publication with the exception of one portion of 42 CFR 494.180(k) which may be delayed to July 1, 2017 if there is a potential for a coverage gap for the beneficiary. • A survey tool has been developed to assess compliance with the new standards pending completion of Interpretive Guidance.

title: Notice of Interim Final Rule (IFR) Third Party Payment and Information on Implementation Plan

memo_number: 17-12-NH

posting_date: Fri, 09 Dec 2016 12:00:00 -0500

summary: Enforcement Suspended Until and Unless Injunction is Lifted: The Centers for Medicare & Medicaid Services (CMS) will not enforce the new rule prohibiting skilled nursing facilities, nursing facilities and dually-certified facilities from using pre-dispute binding arbitration agreements while there is a court-ordered injunction in place prohibiting enforcement of this provision.

title: Long-Term Care (LTC) Regulation: Enforcement of Rule Prohibiting Use of Pre-Dispute Binding Arbitration Agreements is Suspended so Long as Court Ordered Injunction Remains in Effect

memo_number: 17-11- CLIA (EXPIRED)

posting_date: Thu, 12 Dec 2024 12:00:00 -0500

summary: Memorandum Summary: EXPIRED AS OF 12/6/24. FOR CURRENT GUIDANCE, REFER TO QSO-25-10-CLIA: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services Clinical Laboratory Improvement Amendments (CLIA) - Advanced Copy Revisions to Appendix C of the SOM: The entire document has been revised and updated to include comments and recommendations from: • Regional Office (RO) and State Agency (SA) surveyors, professional and accrediting organizations (AO); • Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC); • CMS Office of General Counsel (OGC); and • General Accounting Office (GAO) on reporting complaints. Deletion • D-tags (D2018, D6001, D6002 & 6077). It also includes: • New D-tags for surveyors; and • Board certification in dermatology by American Osteopathic Board of Dermatology is equivalent to board certification in dermatology by American Board of Dermatology (ABD)

title: EXPIRED: Advanced Copy –Revisions to State Operations Manual (SOM), Appendix C –Survey Procedures and Interpretive Guidelines for Laboratories and LaboratoryServices (Clinical Laboratory Improvement Amendments (CLIA))

memo_number: 17-10-CAHs

posting_date: Thu, 01 Dec 2016 12:00:00 -0500

summary: •Revisions were made to the regulation language for CAH Emergency Services standard in 2004 and 2006 but those revisions were not included in Appendix W of the State Operations Manual (SOM). •Corrections are being made at tag C-0207, standards §485.618(d)(1) through §485.618(d)(4), to reflect the current regulations.

title: Critical Access Hospital (CAH) Appendix W Revisions

memo_number: 17-09-ALL

posting_date: Fri, 18 Nov 2016 12:00:00 -0500

summary: • Project Overview: The Centers for Medicare & Medicaid Services (CMS) is in the second year of a three year pilot project to improve assessment of infection control and prevention regulations in Long Term Care (LTC) facilities, hospitals, and during transitions of care. All surveys during the pilot will be educational surveys (no citations will be issued) and will be conducted by a national contractor. • Second Year Activities: Using draft surveyor Infection Control Worksheets (ICWS) based on the new Long Term Care regulation as well as a revised hospital surveyor ICWS, 40 hospital surveys will be paired with surveys of LTC facilities, in order to provide an opportunity to assess infection prevention during transitions of care. In addition, CMS will pilot technical assistance opportunities for facilities in efforts to improve their infection control programs to meet these new regulations. The draft ICWSs are attached to provide transparency of CMS pilot expectations.

title: Infection Control Pilot: 2017 Update

memo_number: 17-08-NH

posting_date: Fri, 18 Nov 2016 12:00:00 -0500

summary: A web page to house general information on the reinvestment of State CMP funds is now available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/LTC-CMP-Reinvestment.html. This web page serves as a location to house pertinent information for entities interested in applying for State CMP funds, States and Regional Offices (ROs), and other stakeholders.

title: Civil Money Penalty (CMP) Reinvestment Resource Web Page

memo_number: 17-06-NH

posting_date: Fri, 04 Nov 2016 12:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) has completed the FY 2015 MDS Focused Surveys and is providing an overview of the results. • The FY 2015 MDS Focused Survey Summary outlines the background for the MDS Focused Surveys, the types of deficiencies and errors identified on these surveys, and provides technical resources for providers to help improve accuracy and help providers maintain compliance to enhance the safety and quality of care nursing home residents receive.

title: Fiscal Year (FY) 2015 Minimum Data Set (MDS) Focused Survey Summary

memo_number: 17-07-NH

posting_date: Wed, 09 Nov 2016 12:00:00 -0500

summary: • Revised Regulations: On September 28, 2016, the Centers for Medicare & Medicaid Services (CMS) released revised Requirements for Participation for Medicare and Medicaid-certified nursing facilities. Most regulations groups were re-designated and have new numbers. • Advance Copy - Revisions to SOM Appendix PP: CMS has incorporated revised regulation text into the SOM Appendix PP. The regulation text is effective November 28, 2016; the Interpretive Guidance has not been updated. Interpretive guidance will be revised at a later date. • Revised F-Tags: The current F-Tags have been revised to include the requirements and regulation text as is presented in the final rule.

title: Advance Copy - Revisions to State Operations Manual (SOM), Appendix PP-Revised Regulations and Tags

memo_number: 17-05-ALL

posting_date: Fri, 28 Oct 2016 12:00:00 -0400

summary: • Information for Implementation: The Centers for Medicare & Medicaid Services (CMS) Survey and Certification Group is providing general information regarding the implementation plans for the new Emergency Preparedness Rule. The information addresses the implementation date for providers and suppliers, the development of Interpretive Guidelines (IGs), surveyor training and resources available to assist in the implementation of this regulation. • Affects all 17 providers and suppliers: The regulation affects all 17 providers and suppliers and must be fully implemented by November 15, 2017.

title: Information on the Implementation Plans for the Emergency Preparedness Regulation

memo_number: 17-04-Transplant (EXPIRED)

posting_date: Mon, 18 Nov 2024 13:00:00 -0500

summary: EXPIRED AS OF 11/18/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-03-Transplant: Revisions to the State Operations Manual (SOM), Chapter 2- The Certification Process; SOM Appendix X, Guidance to Surveyors: Organ Transplant Programs; and SOM Chapter 9- Exhibits – Advance Copy for current guidance. • Citing Non-Compliance with Clinical Experience: Transplant programs are required per 42 CFR 482.80 (b) to generally perform 10 transplants within the past 12 months for initial certification with Medicare. Programs applying for initial Medicare certification that performed at least eight but less than 10 transplants in the previous 12 months should be cited at the Standard level. The program may still be certified with an acceptable plan of correction for clinical experience requirements if all Conditions of Participation (CoPs) are in compliance. • For re-approval: Programs are required per 42 CFR 482.82 (b) to perform an average of 10 transplants per year during the prior three years. Programs not meeting this average should be cited at the Standard level, and the program must submit an acceptable plan of correction. The program may be reapproved if all CoPs are in compliance. Voluntary program inactivity does not affect these evaluation periods.

title: EXPIRED: Transplant Centers: Clinical Experience Requirements

memo_number: 17-03-NH

posting_date: Mon, 24 Oct 2016 12:00:00 -0400

summary: • Need for Training: The Centers for Medicare & Medicaid Services (CMS) is developing an online training for Regional Offices (RO), State Survey Agencies (SA), providers and other stakeholders on the new Nursing Home Regulations. • Training Content and Availability: The online training will include information about Phase 1 of new Nursing Home Regulations, and will be available to all parties starting November 18, 2016. • Mandatory Requirement: All Long Term Care (LTC) surveyors are required to complete this training in order to be able to conduct any LTC surveys after November 28, 2016.

title: Save the Date: Training for Phase 1 Implementation of New Nursing Home Regulations

memo_number: 17-02-ESRD

posting_date: Fri, 21 Oct 2016 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) announces the release of the materials used for ESRD surveys that have been updated for FY 2017. • The FY 2017 DFR, Pre-survey DFR Extract files, and State profiles are available to authorized State Survey Agency (SA) personnel on the dialysisdata.org web site. • The ESRD Core Survey Data Worksheet and other ESRD Core Survey materials have been revised for FY 2017 to align with the FY 2017 DFR. • The FY 2017 survey materials for the ESRD Core Survey are available on the CMS ESRD Survey and Certification page of the CMS.gov web site at http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Dialysis.html

title: Release of the Fiscal Year (FY) 2017 Dialysis Facility Reports (DFR) and End Stage Renal Disease (ESRD) Core Survey Materials

memo_number: 16-42-NH

posting_date: Fri, 30 Sep 2016 12:00:00 -0400

summary: • Reform of LTC Requirements: On September 28, 2016 the Federal Register posted the notice of the final rule Reform of Requirements for Long-Term Care Facilities. The scheduled publication date is October 4, 2016. The regulation goes into effect on November 28, 2016. • LTC providers affected by this rule must comply and implement this regulations based on staggered effective dates, which is outlined in the final rule. Additional information will be provided in further guidance through release of the interpretive guidelines and future Survey & Certification policy memorandums.

title: Notification of Final Rule Published- Reform of Requirements for Long-Term Care (LTC) Facilities

memo_number: 16-40-NH/HHA/CLIA

posting_date: Thu, 08 Sep 2016 12:00:00 -0400

summary: • The Department of Health and Human Services (HHS) has published in the Federal Register on September 6, 2016 an IFR which adjusts for inflation CMP amounts authorized under the Social Security Act. (See Adjustment of Civil Monetary Penalties for Inflation) • The IFR establishes new section 45 CFR Part 102, which lists the new CMP amounts and ranges as adjusted by the IFR for affected regulations. The changes made by the IFR are effective on September 6, 2016. • The IFR addresses all applicable CMPs under the authority of HHS but we are highlighting only on those CMPs assessed for Skilled Nursing facilities (SNFs), Nursing Facilities (NFs), SNFs/NFs, Home Health Agencies (HHAs), and Clinical laboratories.

title: Notice of Interim Final Rule (IFR) Adjusting Civil Monetary Penalties (CMPs)

memo_number: 16-39-ALL

posting_date: Thu, 08 Sep 2016 12:00:00 -0400

summary: • SOM Section 2779A: The Centers for Medicare & Medicaid Services (CMS) has made revisions to this section in the SOM which provides guidance regarding the numbering system for CCNs for Medicare-participating providers and suppliers. The revision, specifically in Section 2779A1 for Medicare providers reflects the addition of new State Codes. • Additional State Codes: Due to a lack of available CCNs for some providers wishing to enroll or modify their current certification in Medicare, additional State codes are being added to the Automated Survey Processing Environment (ASPEN), the Accrediting Organization System for Storing User Recorded Experiences (ASSURE), as well as Medicare payment processing systems, effective October 1, 2016.

title: Certification Number (CCN) State Codes –State Operations Manual (SOM) Section 2779A Revisions

memo_number: 16-37-ALL

posting_date: Fri, 02 Sep 2016 12:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) worked collaboratively with the OCR to revise the OCR clearance process for new providers and Changes of Ownership (CHOW). • The new process requires that providers successfully submit electronically an attestation of compliance with the civil rights requirements to the OCR before the State Survey Agencies (SA) and Regional Offices (RO) may process requests for initial surveys or CHOWs. • Confirmation from OCR of successful submission of the attestation will meet the requirements for OCR clearance and eliminates the need for CMS ROs to issue provisional provider agreements. • OCR will begin receiving electronic attestations on September 1, 2016.

title: Office of Civil Rights (OCR) Clearance

memo_number: 16-38-ALL

posting_date: Thu, 08 Sep 2016 12:00:00 -0400

summary: Memorandum Summary • Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers: On September 8, 2016 the Federal Register posted the final rule Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. The regulation goes into effect on November 16, 2016. • Health care providers and suppliers affected by this rule must comply and implement all regulations one year after the effective date, on November 16, 2017.

title: Notification of Final Rule Published- Emergency Preparedness

memo_number: 16-36-HHA

posting_date: Fri, 26 Aug 2016 12:00:00 -0400

summary: • Effective July 29, 2016: The Centers for Medicare & Medicaid Services (CMS) extended the previous HHA moratoria to encompass the entire states of Illinois (IL), Florida (FL), Michigan (MI) and Texas (TX) for a period of six months. • Effective July 29, 2016: No initial HHA Medicare surveys may be conducted in the above States and all activities on initial certification actions in progress at the State Survey Agency (SA) or Regional Office (RO) as of that date must cease. Any prospective HHA provider that had an initial application still in progress on July 29, 2016 and received an enrollment denial notification from the Medicare Administrative Contractor (MAC) must reapply as a new applicant once the moratorium is lifted. • In conjunction with the extension of the moratoria, CMS will initiate a Provider Enrollment Moratoria Access Waiver Demonstration (PEWD) for HHAs in moratoria-designated geographic locations. These waivers will be evaluated by the Center for Program Integrity (CPI). Any waivers issued by CPI will be made on a case by case basis in response to access of care concerns. If a waiver is issued, CPI will notify the applicable SA and RO to confirm that a survey may be conducted within the moratorium area pursuant to the waiver. • SAs and ROs should refer all questions regarding the moratoria to the applicable MAC.

title: Extension and Expansion of the Provider Enrollment Home Health Agency (HHA) Moratoria

memo_number: 16-35-LSC

posting_date: Fri, 19 Aug 2016 12:00:00 -0400

summary: • Revisions to the SOM, Appendix I, Task 4: The Centers for Medicare & Medicaid Services (CMS) is reinstating guidance that was inadvertently removed to Life Safety Code (LSC) surveyors regarding the survey procedures for Task 4, Information Gathering, within Appendix I of the SOM. • Updating Appendix I with information regarding sharing of deficiency tags during Exit Conference: CMS is also updating Appendix I, Task 6 with more specific information regarding sharing specific regulatory references or tags during the exit conference. This information was previously outlined in and is consistent with Survey and Certification policy memorandum (S&C 16-11-ALL).

title: Revisions to the State Operations Manual (SOM), Appendix I

memo_number: 16-34-ICF/IID

posting_date: Fri, 12 Aug 2016 12:00:00 -0400

summary: Appendix J ? Interpretive Guidelines (IGs)/Exhibit 355: The Centers for Medicare & Medicaid Services (CMS) has revised the ICF/IID Interpretive Guidelines (IGs) and Exhibit 355 within the State Operations Manual (SOM) to remove all references to website links that are now inaccessible or may become so in the future.

title: Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) Appendix J and Exhibit 355: Removal of Website Links

memo_number: 16-33-NH

posting_date: Fri, 05 Aug 2016 12:00:00 -0400

summary: • Freedom from Abuse: Each resident has the right to be free from all types of abuse, including mental abuse. Mental abuse includes, but is not limited to, abuse that is facilitated or caused by nursing home staff taking or using photographs or recordings in any manner that would demean or humiliate a resident(s). • Facility and State Agency Responsibilities: This memorandum discusses the facility and State responsibilities related to the protection of residents. Specifically, at the time of the next standard survey for both the Traditional survey and QIS, the survey team will request and review facility policies and procedures that prohibit staff from taking, keeping and/or distributing photographs and recordings that demean or humiliate a resident(s).

title: Protecting Resident Privacy and Prohibiting Mental Abuse Related to Photographs and Audio/Video Recordings by Nursing Home Staff

memo_number: 16-31-NH

posting_date: Fri, 29 Jul 2016 12:00:00 -0400

summary: REVISED 07.29.16 to add temporary management under remedies for termination and correct the effective date. Revisions to the SOM are in yellow highlight. •Revisions to Chapter 7 of the State Operations Manual (SOM): This policy memorandum provides advanced guidance relating to revisions in SOM sections §7304 through 7304.3, 7306.1, 7308.3, 7400.5.1, 7400.6.2 and 7313.2 regarding policies on the Immediate Imposition of Federal Remedies (previously referred to as Opportunity to Correct or No Opportunity to Correct). Sections 7304.2.1 and 7304.2.2 are being deleted and incorporated into the revised sections noted above. •Civil Money Penalties (CMPs) for Immediate Jeopardy (IJ): The Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) must now immediately impose a CMP any time Immediate Jeopardy (IJ) is cited. •Immediate Imposition of Remedies Required: Irrespective of a state recommendation to impose or not impose a remedy, the CMS RO must immediately impose, without permitting a facility an opportunity to correct deficiencies, one or more federal remedies based on the seriousness of the deficiencies or when actual harm or Substandard Quality of Care (SQC) is identified as outlined in §7304.1.

title: Mandatory Immediate Imposition of Federal Remedies and Assessment Factors Used to Determine the Seriousness of Deficiencies for Nursing Homes

memo_number: 16-30-OPO/Transplant

posting_date: Fri, 08 Jul 2016 12:00:00 -0400

summary: On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2017 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System policy changes, quality provisions, and payment rates proposed rule (CMS-1656-P). The NPRM includes sections related to changes for OPOs and Transplant Centers. • To learn more about the proposed rule, please visit: https://www.federalregister.gov/public-inspection. CMS looks forward to feedback on the proposal and will accept comments until September 6, 2016.

title: Notice of Proposed Rulemaking (NPRM) for Organ Procurement Organizations (OPOs) and Transplant Centers

memo_number: 16-29-LSC

posting_date: Mon, 20 Jun 2016 12:00:00 -0400

summary: • The Centers for Medicare & Medicaid Services (CMS) has adopted by regulation the 2012 LSC and the 2012 HCFC. The regulation effective date is July 5, 2016. • CMS will begin surveying for compliance with the 2012 LSC and HCFC on November 1, 2016. • CMS will offer an online transitional training course for existing LSC surveyors to provide an update on the new requirements. The course will be available on September 2, 2016 via the CMS Surveyor Training Website. • CMS will update the ASPEN program (i.e., the information system which tracks surveys) and CMS Fire Safety Forms (2786) prior to the November 1, 2016 survey start date.

title: Adoption of the 2012 edition of the National Fire Protection Association (NFPA) 101 - Life Safety Code (LSC) and 2012 edition of the NFPA 99 - Health Care Facilities Code (HCFC)

memo_number: 16-28-NH

posting_date: Fri, 03 Jun 2016 12:00:00 -0400

summary: • Update Report: The Centers for Medicare & Medicaid Services (CMS) has released the second report that provides a brief overview of the National Partnership, summarizes activities following the release of Survey & Certification policy memorandum 14-19-NH, and outlines next steps. • The report describes the results of the Focused Dementia Care Surveys conducted in Fiscal Year (FY) 2015.

title: Update Report on the National Partnership to Improve Dementia Care in Nursing Homes

memo_number: 16-25-NH

posting_date: Fri, 20 May 2016 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) has posted a DRAFT version of the LTCF RAI 3.0 User’s Manual, Version 1.14 to the Nursing Home Quality Initiative web page so users can preview significant changes before they become effective October 1, 2016.

title: DRAFT Long-Term Care Facility (LTCF) Resident Assessment Instrument (RAI) 3.0 User’s Manual, Version 1.14, Release

memo_number: 16-27-NH

posting_date: Fri, 03 Jun 2016 12:00:00 -0400

summary: Posting of Nursing Home Enforcement Information: The Centers for Medicare & Medicaid (CMS) is posting information at http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationEnforcement/Nursing-Home-Enforcement.html which includes data on nursing home enforcement actions between 2006 and 2014. The contents of this letter supports activities or actions to improve patient or resident safety and increase quality and reliability of care for better outcomes.

title: Public Release of Nursing Home Enforcement Information Announcement

memo_number: 16-26-NH

posting_date: Fri, 20 May 2016 12:00:00 -0400

summary: Release of the Nursing Home Action Plan: The FY 2016 to 2017 Nursing Home Action Plan is posted on the CMS website at http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/NHs.html.

title: Fiscal Year (FY) 2016 to FY 2017 Nursing Home Action Plan

memo_number: 16-24-Hospitals (EXPIRED)

posting_date: Mon, 18 Nov 2024 13:00:00 -0500

summary: EXPIRED AS OF 11/18/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-03-Transplant: Revisions to the State Operations Manual (SOM), Chapter 2- The Certification Process; SOM Appendix X, Guidance to Surveyors: Organ Transplant Programs; and SOM Chapter 9- Exhibits – Advance Copy for current guidance. • Background on Organ Transplant Outcomes Standards: Medicare Conditions of Participation (CoPs) require that each solid organ transplant program maintain patient and graft survival rates that are within certain Centers for Medicare & Medicaid Services (CMS) tolerance limits. Specifically, when the total number of patient deaths or graft failures that occur within one year of transplant exceeds 150% of the risk-adjusted expected number (i.e., 1.5 times the expected number) for a 2.5-year period, and the result is both statistically significant (p<.05) and numerically meaningful (O – E >3), then the program is not in compliance with CMS requirements. • Revisions to Interpretive Guidelines: We are revising the CMS Survey & Certification interpretive guidelines to provide that such outcomes between 150% and 185% of the risk-adjusted expected number will generally constitute a “standard level” deficiency. A standard level deficiency requires improvement efforts but does not by itself put a program’s Medicare participation at risk. One-year post-transplant patient deaths or graft failures that exceed 185% of the expected number will generally be classified at the more serious “condition-level” if such a finding occurs in more than one (SRTR) report. • Reasoning: Since mid-2007 (the effective date of the CMS transplant regulations), national patient and graft survival rates have improved. Because individual programs are compared against the national risk-adjusted average, the national improvement has made the CMS outcomes standard increasingly stringent. We are concerned that transplant programs may avoid using certain available organs that they believe might adversely affect the program’s outcome statistics. We expect that this revised policy, by lessening such concerns and augmenting the policy with other efforts, will promote more effective use of available organs and help more waitlisted individuals to benefit from a transplant, while continuing to promote high rates of patient and graft survival.

title: EXPIRED: Solid Transplant Programs - Outcome Thresholds - Revised Guidelines

memo_number: 16-23-AO/ASCs

posting_date: Fri, 06 May 2016 12:00:00 -0400

summary: ? Announcement: The Centers for Medicare & Medicaid Services (CMS) announces its decision to recognize and approve IMQ?s accreditation program for ASCs seeking to participate in the Medicare program via deemed status.

title: Approval of The Institute for Medical Quality?s (IMQ?s) Ambulatory Surgical Center (ASC) Accreditation Program

memo_number: 16-22-LSC

posting_date: Fri, 06 May 2016 12:00:00 -0400

summary: • Fire Safety Requirements for Certain Health Care Facilities: On May 4, 2016, the Centers for Medicare & Medicaid Services (CMS) published a final rule titled “Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities,” which updates the fire safety requirements for health care providers and suppliers. This regulation requires certain providers and suppliers to meet the requirements of the 2012 edition of the Life Safety Code (LSC), National Fire Protection Association (NFPA) 101 and the 2012 edition of the Health Care Facilities Code, NFPA 99.

title: Notification of Final Rule Published: Adoption of 2012 Life Safety and Health Care Facilities Code

memo_number: 16-21-ALL

posting_date: Tue, 03 May 2016 12:00:00 -0400

summary: Revised 12.23.16-***Revised to remove the requirements for, and all references to, hospital specialty units to ensure that hospitals are able to meet the unique security needs for justice involved individuals receiving treatment *** Surveyor Guidance: The Centers for Medicare & Medicaid Services (CMS) are clarifying requirements for providing services to justice involved individuals in skilled nursing facilities (SNFs), nursing facilities (NFs), hospitals, psychiatric hospitals, critical access hospitals (CAHs), and intermediate care facilities for individuals with intellectual disabilities (ICFs/IID). Specifically, this guidance seeks to assure high quality care that is consistent with essential patient rights and safety for all individuals. • This policy memorandum replaces S&C: 16-21-ALL published May 03, 2016.

title: Updated Guidance to Surveyors on Federal Requirements for Providing Services to Justice Involved Individuals

memo_number: 16-19-ALL

posting_date: Fri, 08 Apr 2016 12:00:00 -0400

summary: REVISED 04.15.16: Revised to clarify questions regarding oversight • Information Only: The Centers for Medicare & Medicaid Services (CMS) is sharing this clarification with State and Federal Surveyors as information only. Surveyors will not be expected to determine compliance with Advanced Diagnostic Imaging (ADI) suppliers or hospital outpatient department requirements. Accrediting Organizations (AOs) will be evaluating compliance on a periodic basis. State Agency and Regional Office Staffs have no role to play in this process. • Clarifications: The CMS is providing compliance and payment clarifications based on stakeholder questions regarding National Electrical Manufacturers Association (NEMA) XR-29 Standard. • Frequently Asked Questions (FAQs): The FAQs attached with this policy memorandum aim to clarify stakeholder uncertainty and to include aspects of payment reductions if CT systems are found non-compliant.

title: Computed Tomography (CT) Compliance Clarifications under Section 218(a)(1) of the Protecting Access to Medicare Act (PAMA)- Information Only

memo_number: 16-20-CLIA

posting_date: Fri, 08 Apr 2016 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) is providing clarification regarding the policy on acceptable control materials, which includes: • Acceptable control materials: Acceptable control materials will now include on-board controls, i.e. ampules or cartridges containing the same QC material that would traditionally be considered as external QC. • Function checks and procedural controls: Instrument/electronic function checks and procedural controls do not fulfill the regulatory requirement for control materials. • Guidance for surveyors: The laboratory Director is responsible for the determination of what control materials to use in his/her laboratory. Surveyors will ensure that the laboratory is following its own established policies, specifically its QC procedures, in the context of the Outcome Oriented Survey Process.

title: Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories

memo_number: S&C-16-16-CLIA EXPIRED

posting_date: Tue, 16 Dec 2025 14:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Guidance for the Deployment of the Emergency Use Approval (EUA) Zika Virus Tests

memo_number: 16-09-ALL

posting_date: Fri, 11 Mar 2016 12:00:00 -0500

summary: • SOM Section 2779A: The Centers for Medicare & Medicaid Services (CMS) has made revisions to this section in the SOM which provides guidance regarding the numbering system for CCNs for Medicare-participating providers and suppliers. The revision, specifically in Section 2779A1 for Medicare providers reflects the addition of new State Codes. • Additional State Codes: Due to a lack of available CCNs for some providers wishing to enroll or modify their current certification in Medicare, additional State codes are being added to the Automated Survey Processing Environment (ASPEN), the Accrediting Organization System for Storing User Recorded Experiences (ASSURE), as well as Medicare payment processing systems, effective April 4, 2016.

title: Certification Number (CCN) State Codes –State Operations Manual (SOM) Section 2779A Revisions

memo_number: 16-17-NH

posting_date: Fri, 25 Mar 2016 12:00:00 -0400

summary: • Key Elements: The Centers for Medicare & Medicaid Services (CMS) provides a list of key elements for State website development for States to qualify for Federal funding. • Financing: The costs for development of the websites and operation are allowable expenses for reimbursement through a combination of Medicaid, Medicare survey and certification, and State-only funds under standard cost- allocation procedures. • Establishment of State Websites: Effective March 23, 2010, States must maintain consumer-oriented websites providing information regarding all skilled nursing facilities and nursing facilities within in their state. State websites are expected to be completed and be accessible to consumers as soon as possible, but not later than January 1, 2018.

title: Affordable Care Act Section 6103: Guidance for State Consumer Oriented Websites- Update to Survey and Certification Letter 11-41-NHs

memo_number: 16-14-NH

posting_date: Fri, 25 Mar 2016 12:00:00 -0400

summary: The 11th edition of the Centers for Medicare & Medicaid Services (CMS) Nursing Home Data Compendium contains figures and tables presenting data on all Medicareand Medicaid-certified nursing homes in the United States as well as the residents in these nursing homes. A series of graphs and maps highlights some of the most interesting data, while detailed data are available in accompanying tables. The data compendium is divided into three sections. Section 1 presents information on nursing home characteristics; Section 2 focuses on nursing home survey results; and Section 3 presents information on the demographic, functional and clinical characteristics of nursing home residents. • The data compendium presents five years of nursing home survey outcomes for the more than 15,000 nursing homes participating in Medicaid and Medicare, and four years of data on the more than 1.4 million residents who reside in nursing homes each day. • To access the compendium: https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/CertificationandComplianc/NHs.html

title: Release of 2015 Nursing Home Data Compendium

memo_number: 16-15-NH

posting_date: Fri, 25 Mar 2016 12:00:00 -0400

summary: • F329 Draft Revision: The Centers for Medicare & Medicaid Services (CMS) has revised guidance to surveyors in Appendix PP of the SOM under F329 to enhance ease of use for surveyors and to include language related to how unnecessary use of medications may cause psychosocial harm to residents. • Psychosocial Outcome Severity Guide: CMS has revised language in the Psychosocial Outcome Severity Guide in Appendix P of the SOM. • Revisions to Selected F tags: CMS has added language to selected F tags to emphasize the risk of psychosocial harm associated with noncompliance with specific regulations. • The regulatory language remains unchanged.

title: State Operations Manual (SOM) Surveyor Guidance Revisions Related to Psychosocial Harm in Nursing Homes

memo_number: 16-13-NH

posting_date: Fri, 18 Mar 2016 12:00:00 -0400

summary: Information about the requirement for LTC facilities to electronically submit staffing data through the PBJ: • We remind providers of the voluntary submission period ending June 30, 2016, and the mandatory submission period beginning July 1, 2016. • Restate instructions on how to register and where to find instructions to submit data. • Notify stakeholders of the posting of the revised and final PBJ policy manual and related information at: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html • Note, the Centers for Medicare & Medicaid Services (CMS) may use its enforcement authority for noncompliance with the requirement to submit data. The contents of this letter supports activities or actions to improve resident safety and increase quality and reliability of care for better outcomes.

title: Payroll-Based Journal (PBJ) - Implementation of required electronic submission of Staffing Data for Long Term Care (LTC) Facilities

memo_number: 16-11-ALL

posting_date: Fri, 11 Mar 2016 12:00:00 -0500

summary: Advance Guidance – Procedures for Conducting the Exit Conference: The Centers for Medicare & Medicaid Services (CMS) is clarifying guidance to surveyors regarding the procedures for conducting the exit conference in the review of compliance with Medicare or Medicaid Conditions of Participation, Conditions for Coverage, and Requirements for Participation. Review Exit Conference Procedures: Please review with surveyors the exit conference procedures for conducting the federal surveys to ensure consistency of this process across States.

title: Exit Conferences-Sharing Specific Regulatory References or Tags

memo_number: 16-12-ALL

posting_date: Fri, 11 Mar 2016 12:00:00 -0500

summary: • QIES Systems – Will be unavailable from March 16 through March 21, 2016. • Submission of Patient/Resident Assessments will not be possible during the downtime – Providers were notified in several email messages that the QIES system would be unavailable during the downtime. Providers were advised to plan their business needs around the downtime.

title: National Downtime of the Quality Improvement and Evaluation System (QIES)

memo_number: 16-10-Transplant

posting_date: Fri, 11 Mar 2016 12:00:00 -0500

summary: Revised May 3, 2016 - The attached Interpretive Guidelines for the Transplant CoPs at 42 CFR §§ 482.68 through 482.104 are temporarily ON HOLD pending additional revisions, clarifications and corrections.• Organ Transplant Interpretive Guidelines Update: Attached is an advance copy of the Interpretive Guidelines for the Transplant CoPs at 42 CFR §§ 482.68 through 482.104. CMS has now updated the Organ Transplant Interpretive Guidelines to incorporate previously-published changes, clarify certain areas, and address feedback received based on previously-released drafts. • New Appendix X: These Interpretive Guidelines supersede all previous versions and will be published in a new Appendix X of the State Operations Manual (SOM).

title: Advance Copy – Interpretive Guidelines for the Organ Transplant Conditions of Participation (CoPs) at 42 Code of Federal Regulations (CFR) §§ 482.68 through 482.104

memo_number: S&C-16-18-CLIA EXPIRED

posting_date: Wed, 26 Mar 2025 12:00:00 -0400

summary: EXPIRED AS OF DECEMBER 6, 2024. FOR CURRENT GUIDANCE REFER TO QSO-25-10-CLIA: Advanced Copy –Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services This policy memorandum supersedes S&C-10-07-CLIA “Consolidation of Personnel Policies for Individuals Directing or Performing Non-waived Tests under the Clinical Laboratory Improvement Amendments (CLIA).” · CLIA surveyors will now accept Primary Source Verification (PSV) as evidence of compliance with the personnel qualifications mandated in Subpart M of the Clinical CLIA Regulations. · If there are required elements in the personnel regulations that the PSV company does not verify, it is the laboratory director’s (LD) responsibility to ensure that these personnel qualifications are met by other means. · CLIA personnel regulations and the policy on mandatory citations are not changing. · Laboratories may choose to submit primary source verification for LD qualifications. · Bachelor’s and Associate’s degrees in nursing meet the requirement for earning a degree in a biological science for, respectively, high complexity testing personnel and moderate complexity testing personnel.

title: Expired Personnel Policies for Individuals Directing or Performing Non-waived Tests

memo_number: 16-08-CAH

posting_date: Fri, 12 Feb 2016 12:00:00 -0500

summary: REVISED 09.02.16:To Clarify Type of Hospital when Evaluating Distance Requirements CAH Recertification Checklist: In order to routinely re-evaluate the compliance of currently certified CAHs with the status and location requirements at 42 CFR 485.610, the Centers for Medicare & Medicaid Services (CMS) has revised the attached CAH Recertification Checklist: Rural and Distance or Necessary Provider Verification for use by the CMS Regional Office (RO) staff when processing CAH recertifications. The revised checklist includes: • Procedures on determining whether a CAH that was certified by CMS prior to January 1, 2006 had been designated by the State as a necessary provider. • Examples of documentary evidence to demonstrate necessary provider designation prior to January 1, 2006.

title: Critical Access Hospital (CAH) Recertification Checklist for Evaluation of Compliance with the Location and Distance Requirements

memo_number: 16-06-ALL

posting_date: Fri, 22 Jan 2016 12:00:00 -0500

summary: • Infection Control Courses: MLN has created infection control courses based on the Centers for Medicare & Medicaid Services (CMS) Ambulatory Surgery Center (ASC) surveyor online training course. • Continuing Education Credits: MLN courses can be accessed by surveyors to reinforce their infection control knowledge and receive continuing education credits.

title: Medicare Learning Network (MLN) Infection Control Courses

memo_number: 16-07-AO

posting_date: Fri, 29 Jan 2016 12:00:00 -0500

summary: Annual Report to Congress: The 2015 annual RTC details the review, validation, and oversight of the FY 2014 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program. • Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs. • Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results.

title: FY 2015 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

memo_number: 16-05-ALL

posting_date: Wed, 23 Dec 2015 12:00:00 -0500

summary: • Project Overview: The Centers for Medicare & Medicaid Services (CMS) has begun a three year pilot project to improve assessment of infection control and prevention regulations in nursing homes, hospitals, and during transitions of care. • Survey details: All surveys during the pilot will be educational surveys (no citations will be issued) and will be conducted by a national contractor. New surveyor tools and processes will be developed and tested, focusing on existing regulations as well as recommended practices (such as those for antibiotic stewardship and transitions of care). Ten pilot surveys to be conducted in Fiscal Year (FY) 2016 will occur in nursing homes. Surveys in FY17 and FY18 will be conducted in nursing homes and hospitals. • Project Outcomes: New surveyor infection control tools and survey processes that can be used to optimize assessment of new infection control regulations.

title: Infection Control Pilot Project

memo_number: 16-04-NH

posting_date: Fri, 27 Nov 2015 12:00:00 -0500

summary: Focused Dementia Care Survey Pilot: The Centers for Medicare & Medicaid Services (CMS) completed a pilot project in 2014 to examine the process for prescribing antipsychotic medications and assess compliance with other federal requirements related to dementia care practices in nursing homes. Additionally, it was initiated to gain new insights about surveyor knowledge and skills and ways that the current survey process may be streamlined to more efficiently and accurately identify and cite deficient practice. Expansion of Focused Dementia Care Survey Efforts: In 2015, the expansion project involved a more intensive, targeted effort to cite poor dementia care and the overutilization of antipsychotic medications, and broaden the opportunities for quality improvement among providers. Focused Dementia Care Survey Tools: In response to feedback from stakeholders and partners of the National Partnership to Improve Dementia Care in Nursing Homes, CMS is sharing the revised survey materials that were developed for the 2014 Focused Dementia Care Survey Pilot and 2015 expansion effort. The intent is that facilities would use these tools to assess their own practices in providing resident care.

title: Focused Dementia Care Survey Tools

memo_number: 16-03-ESRD

posting_date: Fri, 20 Nov 2015 12:00:00 -0500

summary: ESRD Core Survey Data Worksheet: The worksheet has been updated for FY 2016 with current clinical indicators and corresponding national thresholds for facility comparison. The Centers for Medicare & Medicaid Services (CMS) is providing the revised worksheet to ensure consistent administration of a standardized ESRD survey process and is requiring surveyor?s use of the ESRD Core Survey Data Worksheet for all recertification surveys of ESRD facilities.

title: Release of Fiscal Year (FY) 2016 End Stage Renal Disease (ESRD) Core Survey Data Worksheet

memo_number: 16-02-CLIA (EXPIRED)

posting_date: Thu, 12 Dec 2024 12:00:00 -0500

summary: Memorandum Summary: EXPIRED AS OF 12/6/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-10-CLIA: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services Clinical Laboratory Improvement Amendments (CLIA) - Advanced Copy The Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality Control Plan (IQCP) procedure in the revised SOM will supersede the IQCP procedure in S&C 13-54. • Revisions to Appendix C of the SOM: Revisions include the removal of Equivalent Quality Control (EQC) in the Interpretive Guidelines for §493.1256(d) and the insertion of IQCP in the Interpretive Guidelines for §493.1256(d) • Education & Transition Period: The IQCP Education and Transition Period will conclude on 12/31/2015. • Implementation of IQCP: The IQCP effective date will be 01/01/2016. • Guidance for surveyors after full implementation of IQCP: Surveyors will continue to follow established survey policies and protocols using the Outcome Oriented Survey Process. • Educational resources: Resources available on the CLIA Webpage at http://www.cms.gov/CLIA/

title: EXPIRED: Advanced Notification: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services

memo_number: 16-01-Hospital

posting_date: Fri, 30 Oct 2015 12:00:00 -0400

summary: Hospital Appendix A Updated: The Centers for Medicare & Medicaid Services (CMS) has updated the State Operations Manual (SOM) Appendix A with respect to both the hospital survey process and the interpretive guidelines for the pharmaceutical services Condition of Participation (CoP). The update includes the following features: • Pharmaceutical Services: Revisions were made to portions of the pharmaceutical services CoP to bring them into alignment with current accepted standards of practice. To improve clarity, the revised guidance addresses: accepted professional pharmacy principles, including United States Pharmacopeia (USP) standards; compounding of medications, particularly compounded sterile preparations (CSPs); determining beyond-use dates (BUDs); safe and appropriate storage and use of medications; and, policies and procedures related to high-alert medications and minimizing drug errors. • Additional Tag: We added a new standard-level tag to allow surveyors to cite to the regulatory language found in the condition stem statement at either the standard- or condition-level, as appropriate, in the Automated Survey Processing Environment (ASPEN). • Preparing CSPs Outside of the Pharmacy: We are updating our guidance for the nursing service regulatory requirements concerning medication administration to clarify that hospitals must ensure staff adherence to accepted standards of practice in those limited instances when CSPs may be prepared outside of the pharmacy.

title: Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications

memo_number: 15-51-HHA (EXPIRED)

posting_date: Fri, 05 Apr 2024 12:00:00 -0400

summary: EXPIRATION DATE 03/15/2024. State Operations Manual (SOM) Section 2185 ?HHA Change of Address?: HHAs must notify their respective MAC of a change of address and the notification timeframe in SOM Section 2185 has been revised from 30 days to 90 days to be consistent with the Provider Enrollment regulations at 42 CFR 424.516(e)(2).

title: EXPIRED: Home Health Agencies (HHAs): Change of Address ? Notification of the Medicare Administrative Contractor (MAC)

memo_number: 15-52-HHA (EXPIRED)

posting_date: Fri, 05 Apr 2024 12:00:00 -0400

summary: EXPIRATION DATE 03/15/2024. HHA Training Item Revised ? The Centers for Medicare & Medicaid Services (CMS) provides training on the use of the HHA Survey Protocols. The protocols provide guidance to assist surveyors in determining when a Condition-level deficiency may be considered. Previous trainings emphasized that the phrase ?consider citing the Condition? implied the surveyor ?should? cite the Condition. We have since revised our training in this area to indicate that surveyors may consider citing the Condition when indicated by the regulation but the phrase should not be taken as a prescriptive element of the guidance over surveyor judgment.

title: EXPIRED: Home Health Agency (HHA) Survey Protocol Training Item Revised

memo_number: 15-49-NH

posting_date: Fri, 07 Aug 2015 12:00:00 -0400

summary: • Publication of Medicare Program; Prospective Payment System (PPS) and Consolidated Billing for Skilled Nursing Facilities (SNF) for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data Collection: The final rule published on August 4, 2015 implements the new requirements regarding the submission of staffing data to the Centers for Medicare & Medicaid Services (CMS) based on payroll and other verifiable and auditable data. The full text document can be found at https://www.federalregister.gov/articles/2015/08/04/2015-18950/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities. • Mandatory Electronic Submission of Staffing Data: Effective July 1, 2016 long-term care facilities that participate in Medicare and Medicaid must electronically submit direct care staffing information (including information for agency and contract staff) based on payroll and other verifiable and auditable data in a uniform format to CMS. • Voluntary Electronic Submission of Staffing Data: Registration began August 4, 2015 for facilities to register for the voluntarily submission period which begins October 1, 2015.

title: Final Rule: SNF Medicare FY 2016 Payments, Quality Reporting, Value-Based Purchasing and Staffing Data Collection Requirements – Informational Only

memo_number: 15-50-NH

posting_date: Fri, 28 Aug 2015 12:00:00 -0400

summary: Revisions to the QIS Training Process – The Centers for Medicare & Medicaid Services (CMS) has revised the training procedures for State Survey Agencies (SA) and Regional Offices (ROs) utilizing the QIS to: • Eliminate the mock survey and replace it with a survey of record; • Eliminate the T3.5 process formerly called “The Trainer Instructor Training”; • Update the compliance process and associated tool used for evaluating surveyors; and, • Clarify the role of Certified Trainers. This revised QIS training protocol does not replace the structured training program each SA and RO is required to have as outlined in Exhibit 42 of the State Operations Manual (SOM).

title: Revised Quality Indicator Survey (QIS) Training Process and Clarification of Trainer Roles and Responsibilities

memo_number: 15-42-ALL

posting_date: Fri, 19 Jun 2015 12:00:00 -0400

summary: REVISED 08.28.15,“This guidance supersedes the previous guidance issued on June 19, 2015 and new to the memo is a Sample Request Letter attachment.” • Revision to Guidance – The Centers for Medicare & Medicaid Services (CMS) has revised this guidance to further clarify policies regarding SA release of data and documents to MFCUs. • Release of Information and Data to State MFCU: State Survey Agencies are reminded of the regulatory requirement to share Automated Survey Processing Environment (ASPEN) Complaint Tracking System (ACTS) data, Long-Term Care Minimum Data Set (MDS) data, and survey documents with their State MFCU upon receipt of a written request.

title: Guidance to State Survey Agencies (SA) Regarding Release of Information and Data to State Medicaid Fraud Control Units (MFCU)

memo_number: 15-46-NHs

posting_date: Fri, 17 Jul 2015 12:00:00 -0400

summary: • Publication of Proposed Rule for Long-Term Care Facilities: The Centers for Medicare & Medicaid Services (CMS) published a proposed rule (CMS-3260-P) on July 16, 2015 that would revise the requirements that long-term care facilities must meet in order to participate in the Medicare and Medicaid Programs. • Comment Period: Comments must be received no later than 5PM on September 14, 2015 to be assured consideration.

title: Publication of Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities; Proposed Rule (CMS-3260-P) – Informational Only

memo_number: 15-48-ICF/IID

posting_date: Fri, 17 Jul 2015 12:00:00 -0400

summary: Appendix J – Interpretive Guidelines (IGs): The Centers for Medicare & Medicaid Services (CMS) has revised the Interpretive Guidance for 42 CFR §483.430(d) (3) at Tag W187 within the State Operations Manual (SOM) Appendix J for ICF/IIDs to reflect erroneously omitted guidance language.

title: Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) Appendix J, Part II - Clarifications to the Interpretive Guidance at Tag W187 for §483.430(d)(3)

memo_number: 15-47-NH

posting_date: Fri, 17 Jul 2015 12:00:00 -0400

summary: • Medication-Related Adverse Events – Adverse events related to high risk medications can have devastating effects to nursing home residents. Proper management of high risk medications represents a serious challenge for nursing homes, and merits close attention by top management and staff throughout the facility. We are very concerned about the prevalence of adverse events involving such medications. • Focused Survey on Medication Safety Systems and Adverse Drug Event Trigger Tool - The Centers for Medicare & Medicaid Services (CMS) has begun pilot testing a Focused Survey on Medication Safety Systems to look at nursing home systems around high risk and problem-prone medications using an Adverse Drug Event Trigger Tool. The CMS is making the draft tool available to assist surveyors in investigating medication related adverse events and to nursing home providers as a risk management tool.

title: Medication-Related Adverse Events in Nursing Homes

memo_number: 15-45-CAH

posting_date: Fri, 26 Jun 2015 12:00:00 -0400

summary:  CAH Rural Status & Location/Distance Requirements:  Update of S&C 11-33-Hospital/CAH/RHC: This memorandum supersedes the portion of the guidance of policy memorandum S&C 11-33 which addresses metropolitan statistical areas (MSAs). That guidance is being updated to reflect the new CAH regulation at 42 CFR 485.610(b)(5). Under the new regulation, a Medicare-participating CAH that previously was located in a rural area, based on adoption by the Centers for Medicare & Medicaid Services (CMS) of the Office of Management and Budget’s (OMB) delineations of MSAs, may no longer be located in a rural area when CMS adopts the most recent OMB delineations. Such CAHs are permitted to retain their CAH status up to two years from the effective date of CMS’ latest adoption of the OMB delineations. During this grace period, the CAHs are expected either to reclassify as rural under one of the alternatives permitted at §485.610(b)(2), or to convert to a Medicare-participating hospital.  Minimum Distance to Other CAHs/Hospitals: The guidance found in Chapter 2 and Appendix W of the State Operations Manual (SOM) is being updated to specify that the proximity to each other of IHS/Tribal hospitals/CAHs and non-IHS/Tribal hospitals/CAHs is not considered when a CAH location determination is made.  CAHs Located on Islands: The guidance in Chapter 2 and Appendix W of the SOM is also being updated to reflect the location and distance requirements relative to CAHs located on islands.  Primary Roads: The criteria for a primary road have been refined with respect to numbered US highways. • Continued Compliance with CAH Location Requirements: All parties are being reminded that S&C-13-20, issued March 15, 2013, updated the interpretive guidelines for §485.610 and §485.610(c) to clarify that a CAH must meet the location and distance requirements not only at the time of initial conversion to CAH status, but at all times the facility participates as a CAH. The CAH’s compliance with these requirements must be reassessed at the time of each recertification.

title: Clarification of Critical Access Hospital (CAH) Rural Status, Location and Distance Requirements

memo_number: 15-44-ESRD

posting_date: Fri, 26 Jun 2015 12:00:00 -0400

summary:  Portable Reverse Osmosis Units that meet Association for the Advancement of Medical Instrumentation (AAMI) water quality standards, as incorporated by reference in the End Stage Renal Disease (ESRD) Condition for Coverage (CfC) at 42 CFR Section 494.40, may be used in outpatient dialysis facilities.  ESRD Surveyors should follow the ESRD Core Survey process in conjunction with this guidance for use of portable RO units and block carbon in outpatient dialysis facilities.

title: Use of Portable Reverse Osmosis (RO) Units and Block Carbon

memo_number: 15-43-ASC

posting_date: Fri, 26 Jun 2015 12:00:00 -0400

summary:  ASC Infection Control Surveyor Worksheet Revisions: The Centers for Medicare & Medicaid Services (CMS) has made minor revisions to the Infection Control Surveyor Worksheet, Exhibit 351 of the State Operations Manual (SOM) for assessing compliance with the Medicare ASC Infection Control Condition for Coverage (CfC).  Change: Revisions were made to bring the worksheet into alignment with current accepted standards of practice; reflect recently released guidance; and improve the clarity of certain questions. The worksheet is used by State and Federal surveyors on all survey activity in ASCs when assessing compliance with the infection control CfC.

title: Advanced Copy - Update to Ambulatory Surgical Center (ASC) Infection Control Surveyor Worksheet (ICSW)

memo_number: 15-41-ESRD

posting_date: Fri, 12 Jun 2015 12:00:00 -0400

summary: End Stage Renal Disease (ESRD) - Approval for Home Dialysis Modalities: The ESRD facility must have at least one patient on census who (and/or their caregiver) is in the process of being trained or has been trained by the facility interdisciplinary team (IDT) for each home dialysis service/modality for which it is applying.

title: Surveyor Guidance for Approval of Home Dialysis Modalities

memo_number: 15-38-Hospitals

posting_date: Fri, 15 May 2015 12:00:00 -0400

summary: Updated Guidance for Hospital Services: The Centers for Medicare & Medicaid Services (CMS) has updated the interpretive guidelines for the hospital Conditions of Participation (CoPs) for the below to reflect current accepted standards of practice: o Radiologic Services at 42 CFR 482.26, and o Nuclear Medicine Services at 42 CFR 482.53

title: Revised Hospital Radiologic and Nuclear Medicine Services Interpretive Guidelines—State Operations Manual (SOM) Appendix A

memo_number: 15-39-CLIA

posting_date: Fri, 15 May 2015 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) announces the release of Clinical Laboratory Improvement Amendment’s (CLIA) Workbook, co-authored with Centers for Disease Control and Prevention (CDC): IQCP, Individualized Quality Control Plan, Developing an IQCP, A Step-by-Step Guide.

title: Release of the Individualized Quality Control Plan (IQCP) Workbook

memo_number: 15-40-NH

posting_date: Fri, 22 May 2015 12:00:00 -0400

summary: • Nursing Home Survey Evaluation: For the past 10 years, the Centers for Medicare & Medicaid Services (CMS) and the States have used two standard survey processes that assess the quality of care and quality of life for nursing home residents. Enclosed is a review of both the traditional survey and QIS processes. • Survey Efficiency and Effectiveness: The CMS is continuing to make improvements to QIS to address the challenges, concerns and feedback we have received to optimize the effectiveness and efficiency of survey process.

title: Information Only - Review and Status of Nursing Home Survey: Summary of Traditional and Quality Indicator Survey (QIS) Findings and Issues

memo_number: 15-37-NH

posting_date: Fri, 01 May 2015 12:00:00 -0400

summary: Publication of Medicare Program; Prospective Payment System (PPS) and Consolidated Billing for Skilled Nursing Facilities (SNF) for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data Collection: A notice of proposed rule-making regarding the collection of staffing data in long-term care facilities was published on April 20, 2015. The proposed rule would implement the new requirements regarding the submission of staffing data to the Centers for Medicare & Medicaid Services (CMS) based on payroll and other verifiable and auditable data. A proposed rule “FY 2016 SNF PPS for Staffing Data Collection in Long-Term Care Facilities” was published on April 20, 2015. The document can be found at http://www.gpo.gov/fdsys/pkg/FR-2015-04-20/pdf/2015-08944.pdf. The public has until 5 p.m. on June 19, 2015 to comment on the proposed regulatory document.

title: Proposed Rule: SNF Medicare FY 2016 Payments, Quality Reporting, Value-Based Purchasing and Staffing Requirements – Informational Only

memo_number: 15-36-ALL

posting_date: Fri, 24 Apr 2015 12:00:00 -0400

summary: • File a New Appeal Using DAB E-File: Effective October 1, 2014, providers that disagree with actions imposed on their facility must file a hearing request electronically using the DAB’s E-Filing System (DAB E-File). • DAB E-File Filing Assistance: For assistance in submitting a request through the DAB E-File System, filers may call the Civil Remedies Division main telephone line at 202-565-9462. • DAB E-File Technical Assistance: For technical issues regarding the DAB E-File System, filers may contact E-File System Support at OSDABImmediateOffice@hhs.gov.

title: New Instructions for Providers Filing an Appeal with the Departmental Appeals Board (DAB)

memo_number: 15-32 Hospitals/CAHs/ASCs

posting_date: Fri, 03 Apr 2015 12:00:00 -0400

summary: • Situation: Recent newspaper articles, medical publications, and adverse event reports associate multidrug-resistant bacterial infections caused by CRE with patients who have undergone ERCP. Duodenoscopes used to perform ERCP are difficult to clean and disinfect, even when manufacturer reprocessing instructions are followed correctly, and have been implicated in these outbreaks. The U.S. Food and Drug Administration (FDA) has issued a Safety Communication warning, with related updates, that the design of duodenoscopes may impede effective cleaning. • Expectations for Reprocessing Duodenoscopes: Hospitals, critical access hospitals (CAHs), and ambulatory surgical centers (ASCs) are expected to meticulously follow the manufacturer’s instructions for reprocessing duodenoscopes, as well as adhere to the nationally recognized Multisociety consensus guidelines developed by multiple expert organizations and issued in 2011.

title: Alert Related to Outbreaks of Carbapenem-Resistant Enterobacteriaceae (CRE) during gastrointestinal endoscopy, particularly Endoscopic Retrograde Cholangiopancreatography (ERCP)

memo_number: 15-34-NH

posting_date: Fri, 03 Apr 2015 12:00:00 -0400

summary: • Funding Opportunity CMS-1K1-14-001: The Centers for Medicare & Medicaid Services (CMS) invited proposals for a grant opportunity to utilize Federal CMP Funds for the support and further expansion of the National Partnership to Improve Dementia Care in Nursing Homes. • Grant Award: The Eden Alternative, Inc. was deemed to be the most eligible applicant and has been awarded a grant, in the amount of $293,129.00 for their project entitled, “Creating a Culture of Person-Directed Dementia Care.” • National Partnership to Improve Dementia Care in Nursing Homes: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/National-Partnership-to-Improve-Dementia-Care-in-Nursing-Homes.html

title: Grant Award: Reinvestment of Federal Civil Money Penalty (CMP) Funds to Benefit Nursing Home Residents

memo_number: 15-35-NH

posting_date: Fri, 10 Apr 2015 12:00:00 -0400

summary: In this memorandum we notify States of the posting of technical specifications and related information for the electronic submission of staffing information based on payroll data. This information is posted at: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html

title: Implementation of Section 6106 of the Affordable Care Act - Collection of Staffing Data for Long Term Care Facilities

memo_number: 15-33-OPT

posting_date: Fri, 03 Apr 2015 12:00:00 -0400

summary: Guidance Updated: The Centers for Medicare & Medicaid Services (CMS) has added guidelines to the State Operations Manual (SOM) Chapter 2 to clarify certification requirements for providers of OPTs. • Off-Premises Activity: OPTs may only provide services at off-premises locations, such as ALFs/ILFs, on an intermittent basis when there is no ongoing or permanent presence of the OPT. • Two Person Duty Requirement: We are clarifying that a patient’s room, and by extension, common areas within an assisted living facility (ALF) or independent living facility (ILF) may be considered a patient’s residence and may be exempt from the OPT two-person duty requirement. • Extension Location Approval and Administration Requirement: Extension locations may be approved when they are located outside the immediate vicinity of the primary site.

title: Clarification of Requirements for Off-Premises Activities and Approval of Extension Locations for Providers of Outpatient Physical Therapy (OPT) and Speech-Language Pathology Services and Off-Premises Activities

memo_number: 15-31-NH

posting_date: Fri, 27 Mar 2015 12:00:00 -0400

summary: Final Report: Attached is a final report that outlines the basis for the Focused Dementia Care Survey Pilot, the process utilized, conclusions gathered based upon post-pilot data analysis, as well as next steps for the future. Expansion of Focused Dementia Care Survey Efforts: The CMS plans to expand upon the work of the focused survey pilot and has invited States to conduct such surveys in FY2015 on a voluntary basis. The expansion project will involve a more intensive, targeted effort to improve surveyor effectiveness in citing poor dementia care and the overutilization of antipsychotic medications, and broaden the opportunities for quality improvement among providers. Deficiency Implications: Deficient practices noted during the surveys will result in relevant citations. In the event that additional care concerns are identified during on-site reviews, those concerns will be investigated during the survey or will be referred to the SA as a complaint for further review.

title: 2014 Final Report & 2015 Expansion Project – Centers for Medicare & Medicaid Services (CMS) Focused Dementia Care Survey Pilot

memo_number: 15-29-ESRD

posting_date: Fri, 27 Feb 2015 12:00:00 -0500

summary: Reinforcement of Centers for Medicare & Medicaid Services (CMS) policy regarding contacting providers/suppliers prior to entry for survey: • Surveyors should contact the ESRD Networks for facility information after entering the ESRD facility building for survey purposes.

title: Contacting End Stage Renal Disease (ESRD) Networks for survey related facility information

memo_number: 15-28-CMHC

posting_date: Fri, 27 Feb 2015 12:00:00 -0500

summary: In response to the numerous questions received during the recent CMHC basic surveyor training courses, we have compiled a list of FAQs and responses. The FAQs are provided to promote greater surveyor consistency nationally and will be incorporated into Interpretive Guidance as indicated.

title: Community Mental Health Center (CMHC) Frequently Asked Questions (FAQs)

memo_number: 15-30-ALL

posting_date: Fri, 27 Feb 2015 12:00:00 -0500

summary: REVISED 05.08.15 to clarify that CHAP’s legal name should be used on all official documents and correspondence. • AO Name and Domain Changes – Det Norske Veritas Healthcare, Inc. (DNVHC’s) new legal name is DNV Healthcare USA, Inc. DNVHC’s new trade name is DNV GL - Healthcare. The new acronym is DNV GL. Please use the trade name and acronym on all official documents and correspondence. The domain name for all email addresses is @dnvgl.com and was effective January 5, 2015. • AO Name Change – The Community Health Accreditation Program (CHAP) continues to use the legal name Community Health Accreditation Program, but began to do business as the Community Health Accreditation Partner, effective January 1, 2015. Please use this name on all official documents and correspondence. The organization continues to use the acronym CHAP with a new logo and trade name.

title: Administrative Changes for Two Centers for Medicare & Medicaid Services (CMS) - Approved Accrediting Organizations (AOs) The

memo_number: 15-24-Hospitals

posting_date: Fri, 13 Feb 2015 12:00:00 -0500

summary: EMTALA & Ebola Requirements: • On November 21, 2014 the Centers for Medicare & Medicaid Services (CMS) Survey & Certification Group released SC 15-10-Hospitals concerning EMTALA Requirements and Implications Related to the EVD. • The CMS has received follow-up questions regarding EMTALA and Ebola and has produced a Q+A document in response.

title: Emergency Medical Treatment and Labor Act (EMTALA) and Ebola Virus Disease (EVD) – Questions and Answers (Q+A)

memo_number: 15-25-NH

posting_date: Fri, 13 Feb 2015 12:00:00 -0500

summary: FY2014 Pilot Surveys: In 2014, Centers for Medicare & Medicaid Services (CMS) and five volunteer States piloted a focused survey to assess MDS coding practices and its relationship to resident care in nursing homes.  A report on the findings from the pilot is attached. Nationwide Expansion: We subsequently announced that we would expand the MDS focused surveys to all States and include a review of nursing home staffing. This memo provides an update on the pilot and the status of the expansion of these surveys including:  Training for the next surveys will begin in early April 2015.  States will need to assign a minimum of three surveyors to be trained.  Training and surveys will be rolled out in two phases with Regions and States assigned to one of two groups.  Deficiencies identified during the surveys will result in relevant citations and enforcement actions.

title: MDS / Staffing Focused Surveys Update

memo_number: 15-26-NH

posting_date: Fri, 13 Feb 2015 12:00:00 -0500

summary: February 20, 2015 Improvements to Nursing Home Compare include: • Including Quality Measures (QMs) for nursing homes’ use of antipsychotic medication in residents without diagnoses of schizophrenia, Huntington’s disease, or Tourette syndrome in the Five Star calculations. One measure is for the new use of these medications in short-stay residents. A second measure reflects continued use of such medications in long-stay nursing home residents. • Raising the threshold for nursing homes to achieve a high rating on all measures publicly reported in the QM dimension on the website. • Updating expectations for State Survey Agencies to conduct specialized, onsite surveys of a sample of nursing homes across the U.S. that assess adequacy of resident assessments and the accuracy of information reported to CMS that is used in calculating quality measures used in the rating system.

title: Nursing Home Compare “3.0” - Five Star Quality Rating System - Expanded and Strengthened

memo_number: 15-27-Hospital, CAH & ASC

posting_date: Fri, 20 Feb 2015 12:00:00 -0500

summary: • Information on OR RH is provided for Ambulatory Surgical Centers (ASCs) & Supplemental Information for Hospitals & Critical Access Hospitals (CAHs) Using the Categorical Waiver of Life Safety Code (LSC) Anesthetizing Location RH Requirements • The Association for the Advancement of Medical Instrumentation (AAMI) coordinated the release on January 5, 2015 of a Joint Communication of multiple healthcare-related organizations on how a RH of <30% in ORs may affect the performance of some sterile supplies and electro-medical equipment. • S&C 13-25-LSC & ASC permits hospitals and CAHs to use a LSC categorical waiver to establish an RH level <35% in anesthetizing locations. Before electing or continuing to use this categorical waiver, hospitals and CAHs are expected to ensure that the humidity levels in their ORs are compatible with the manufacturers’ instructions for use (IFUs) for the supplies and equipment used in that setting. • ASCs do not require a categorical waiver in order to use a lower RH level in their ORs but also need to ensure they comply with the IFUs for their OR supplies and equipment.

title: Potential Adverse Impact of Lower Relative Humidity (RH) in Operating Rooms (ORs)

memo_number: 15-23-ICF/IID

posting_date: Fri, 30 Jan 2015 12:00:00 -0500

summary: • Use of audio surveillance devices in ICF/IID: To ensure that client’s rights are protected, the use of audio surveillance devices in the ICF/IID must be reviewed, approved and monitored by the Specially Constituted Committee (SCC) of the facility as constituted per 42 CFR 483.440(f)(3)(i-iii). • Informed Consent: If approved by the SCC, written informed consent must be obtained from every affected client or designated guardian prior to the implementation of audio surveillance devices. Audio surveillance devices may be used in common areas within the ICF/IID. • Prohibitions: Audio surveillance devices may never be used for any reason in areas where there are the highest expectations of privacy such as bathrooms, areas for private visitation or areas for private phone calls. Audio surveillance devices may not be used as a substitute for or supplement to adequate staffing or supervision protocols. The cost of the audio surveillance devices must be incurred by the facility and not the clients.

title: Use of Audio Surveillance Devices in Common Areas in Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)

memo_number: 15-22-Hospital/ASC/RHC/FQHC

posting_date: Fri, 30 Jan 2015 12:00:00 -0500

summary: • Guidance Updated: The Centers for Medicare & Medicaid Services (CMS) has updated its interpretive guidelines in the following State Operations Manual (SOM) Appendices to reflect recent amendments to the applicable Conditions of Participation (CoPs), Conditions for Coverage (CfCs) and Conditions for Certification: o Appendix A – Hospitals o Appendix T - Hospital Swing Beds o Appendix L – ASCs o Appendix G – RHCs and FQHCs We are also taking this opportunity to update and clarify some portions of the existing guidance. • Effective Dates: The revised regulations and their associated guidance were effective July 11, 2014, with the exception of the RHC change concerning the requirement to employ at least one Nurse Practitioner (NP) or Physician’s Assistant (PA); this latter change was effective July 1, 2014.

title: Revised Guidance Related to New & Revised Regulations for Hospitals, Ambulatory Surgical Centers (ASCs), Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

memo_number: 15-18-HHA

posting_date: Fri, 09 Jan 2015 12:00:00 -0500

summary: • On January 1, 2015, the Centers for Medicare & Medicaid Services (CMS) implemented the newest version of OASIS, OASIS-C1/ICD-9 and convert OASIS transmission to the ASAP system • Guidance to surveyors and Home Health Agencies (HHAs) – This memorandum outlines the changes to the OASIS transmission system and transition to the ASAP system, effective January 1, 2015. • CMS will publish a new OASIS Correction policy for OASIS.

title: Outcome and Assessment Information Set (OASIS) transition to the Automated Submission and Processing System (ASAP) and OASIS Correction policy

memo_number: 15-20-ICF/IID

posting_date: Fri, 16 Jan 2015 12:00:00 -0500

summary: Guidance Updated: The Centers for Medicare & Medicaid Services (CMS) has revised the ICF/IID SOM Appendix J – Interpretive Guidelines (IGs) to clarify the intent of the Conditions of Participation (CoPs) for ICF/IID as well as represent current standards of practice in the field. In addition, the probes and procedures have been removed from the IGs and placed into an Exhibit in the SOM.

title: Advance Copy of Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) State Operations Manual (SOM) Appendix J - Interpretive Guidelines and new Exhibit

memo_number: 15-19-CAH

posting_date: Fri, 16 Jan 2015 12:00:00 -0500

summary: The Centers for Medicare & Medicaid Services (CMS) CAH Conditions of Participation (CoPs) Changed in Two Final Rules: •CMS-3267-F was published on May 12, 2014 and portions related to CAHs became effective July 11, 2014. Among other provisions, this final rule revised the CAH Conditions of Participation (CoP) requirements related to the responsibilities of doctors of medicine (MDs) and doctors of osteopathy (DOs). •CMS-1599-F was published August 19, 2013 and became effective October 1, 2013. This final rule revised the CAH CoP requirements related to provision of inpatient acute care services. SOM Appendix W Updated: •We are updating the pertinent portions of the CAH interpretive guidelines, found in SOM Appendix W, to reflect these rule changes. •In addition, we are taking this opportunity to update the guidance for the portions of 42 CFR 485.635 addressing the following topics, in order to bring them into alignment with current accepted standards of practice: pharmacy services; infection prevention and control; dietary services; services under arrangement; nursing services; and rehabilitation services.

title: Revised State Operations Manual (SOM) Appendix W, Critical Access Hospitals (CAHs)

memo_number: 15-21-ESRD

posting_date: Fri, 16 Jan 2015 12:00:00 -0500

summary: The CMS Regional Offices (RO) assign CCNs. No other entity has the authority to assign a CCN. • CMS learned that ESRD Networks have issued numbers denoted as “Temporary CCNs” to non-certified ESRD facilities. These are not valid numbers. The temporary numbers were issued to enable the non-certified facilities to enter patient data into the CROWNWeb (CW) data collection system. • CMS instructed the Networks to discontinue issuing these numbers and discontinue entering data into CW using temporary CCNs.

title: Use of Invalid End Stage Renal Disease (ESRD) “Temporary” Centers for Medicare and Medicaid Services (CMS) Certification Numbers (CCN)

memo_number: 15-14-PRTF

posting_date: Fri, 19 Dec 2014 12:00:00 -0500

summary: • Guidance Updated: The Centers for Medicare & Medicaid Services (CMS) has a new State Operating Manual and interpretive guidelines in the following State Operations Manual (SOM) Appendices to reflect recent amendments to the applicable Conditions of Participation (CoPs): o Appendix N – PRTF • Effective Dates: The revised regulations and their associated guidance were effective July 11, 2014, with the exception of the RHC change concerning the requirement to employ at least one Nurse Practitioner (NP) or Physician’s Assistant (PA); this latter change was effective July 1, 2014.

title: Guidance Related to New State Operating Manual and Appendix N for Psychiatric Residential Treatment Facilities (PRTF)

memo_number: 15-17-CLIA (EXPIRED)

posting_date: Thu, 12 Dec 2024 12:00:00 -0500

summary: Memorandum Summary: EXPIRED AS OF 12/6/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-10-CLIA: Revisions to State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services Clinical Laboratory Improvement Amendments (CLIA) - Advanced Copy Revisions to Appendix C of the SOM: The entire document has been revised and updated to include comments and recommendations from: • Regional Office (RO)and State Agency(SA) surveyors, professional and accrediting organizations (AO); • Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC); • CMS Office of General Counsel (OGC); and • General Accounting Office (GAO) on reporting complaints. Deletion • Removal of Clinical Laboratory Standards Institute (CLSI) and CLSI standards and guidance documents. It also includes: • Patient Access regulatory changes and guidance on Patient Access to Test Reports; • Proficiency testing regulatory changes and definitions; • New D-tags for surveyors; and • New name for the American Board of Medical Genetics (ABMG)

title: EXPIRED: Advance Copy –Revisions to State Operations Manual (SOM), Appendix C –Survey Procedures and Interpretive Guidelines for Laboratories and LaboratoryServices (Clinical Laboratory Improvement Amendments (CLIA))

memo_number: 15-15-CLIA

posting_date: Fri, 19 Dec 2014 12:00:00 -0500

summary: This memorandum announces the release of CLIA Brochure #12, Considerations When Deciding to Develop an IQCP and Brochure #13, What is an IQCP? These brochures will available on the CLIA website.

title: Release of Clinical Laboratory Improvement Amendment’s (CLIA) Brochure #12, “Considerations When Deciding to Develop an IQCP” and Brochure #13, “What is an IQCP?”

memo_number: 15-13-ALL

posting_date: Fri, 12 Dec 2014 12:00:00 -0500

summary: • Clarification of “Spouse” & Related Terms: The Centers for Medicare and Medicaid Services (CMS) is clarifying that the terms “spouse”, “marriage,” “relative,” and “family,” as well as other terms that implicitly or explicitly implicate the spousal relationship, such as (but not limited to) “representative,” “support person,” “surrogate,” and “next-of-kin,” include all marriages lawful where entered into, including lawful same-sex marriages, regardless of the certified provider’s or supplier’s location or the jurisdiction in which the spouse lives. • Advance Copy: Interpretive Guidance for Appendices A, AA, M, W, PP, and Y: Attached is an advance copy of revisions to the State Operations Manual (SOM), Appendices A, AA, M, PP, W, and Y, incorporating this clarification.

title: Clarification of Terms Implicating the Spousal Relationship in Regulations and Guidance for Medicare- and Medicaid-certified Providers and Suppliers.

memo_number: 15-16-NH

posting_date: Fri, 19 Dec 2014 12:00:00 -0500

summary: • Civil Money Penalty Analytic Tool Case Submissions - The Centers for Medicare & Medicaid Services (CMS) is issuing the following guidance to notify States that CMS Regional Offices (ROs) are required to continue to use the CMP Analytic Tool and guidance in establishing CMPs, but are no longer required to submit Civil Money Penalty (CMP) Analytic Tool cases to the CMS Central Office. • Use of Civil Money Penalty Analytic Tool - On March 22, 2013, CMS issued guidance that all CMS ROs were required to use this guidance and CMP Analytic Tool as a guide to choose the appropriate type of CMP to be imposed and to calculate the baseline CMP amount, for all new enforcement cases when the CMS RO determines that a CMP is an appropriate enforcement remedy. • Enhanced Enforcement Consistency – CMS issued the CMP Analytic Tool and guidance to promote more consistent application of enforcement remedies for skilled nursing facilities (SNFs), nursing facilities (NFs), and dually-certified facilities (SNF/NFs) (collectively referred to as “nursing homes” or “facility(ies)”).

title: Civil Money Penalty (CMP) Analytic Tool and Submission of CMP Tool Cases

memo_number: 15-12-Hospital

posting_date: Wed, 26 Nov 2014 12:00:00 -0500

summary: • Three Hospital Surveyor Worksheets Finalized: The Centers for Medicare & Medicaid Services (CMS) has finalized surveyor worksheets for assessing compliance with three Medicare hospital Conditions of Participation (CoPs): Quality Assessment and Performance Improvement (QAPI), Infection Control, and Discharge Planning. The worksheets are used by State and Federal surveyors on all survey activity in hospitals when assessing compliance with any of these three CoPs. • Final Worksheets Made Public: Via this memorandum we are making the worksheets publicly available. The hospital industry is encouraged, but not required, to use the worksheets as part of their self-assessment tools to promote quality and patient safety.

title: Public Release of Three Hospital Surveyor Worksheets

memo_number: 15-09-RHC

posting_date: Fri, 14 Nov 2014 12:00:00 -0500

summary: RHC Eligibility Determinations: • The Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) Survey and Certification staff are responsible for making RHC applicant eligibility determinations related to the RHC rural location and shortage area criteria. Although State Survey Agencies (SAs) make preliminary assessments of eligibility when planning their survey schedule, the authority to make a determination may not be delegated to the SA or other non-CMS entities. The SA must not communicate a finding on the eligibility of the applicant’s location to the applicant. In making a determination, ROs rely upon publicly available information from the U.S. Census Bureau and the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA). o S&C-13-30, issued May 10, 2013, provided instructions to guide ROs on using the U.S. Census Bureau’s American Fact Finder with respect to rural location. This memo provides instructions on using HRSA’s Data Warehouse with respect to shortage areas, including when it is necessary to contact HRSA for additional information. Although the instructions are meant primarily for ROs making RHC location determinations, they may be of interest to others as well. • ROs must not provide any advance determinations on location eligibility, whether labeled preliminary or not, to any initial applicant seeking to enroll in Medicare as an RHC or to any existing RHC considering relocating. o A determination whether an initial applicant meets the rural and shortage area eligibility criteria may not be made by the RO before it receives a recommendation for enrollment approval by the Medicare Administrative Contractor (MAC), based on the MAC’s review of the applicant’s completed Form CMS-855A. The clinic must already be open and operating before the RO may make a determination. • Existing RHCs that relocate must submit a CMS-855A updating their location information to the appropriate MAC within 90 days after the relocation occurs. The RHC must also submit a Form CMS-29 reflecting its new location to the SA at the same time, and the SA then forwards it to the RO. After receiving notice of the relocation the RO will determine whether the RHC continues to meet the location requirements at the new location and will take action to terminate the RHC’s Medicare agreement if it does not. In addition, the RO has the discretion to require an on-site survey to confirm compliance with the other RHC Conditions for Certification at the new location.

title: Rural Health Clinic (RHC) Location Determination Guidance Updated

memo_number: 15-11-CLIA

posting_date: Fri, 21 Nov 2014 12:00:00 -0500

summary: March 13, 2015 - Temporarily Withdrawn and Reissued as Draft Only- For Comment Only, Draft Additions in RED • “Off-Label Use” of BGMS: Using a test outside of its Food and Drug Administration (FDA)-approved/-cleared intended use, limitations or precautions, as indicated in the manufacturer’s instructions, is considered “off-label use.” “Off-label use” applies whether the test is waived or non-waived and it means that the test is considered modified and therefore defaults to a high-complexity test under the Clinical Laboratory Improvement Amendments (CLIA) regulations. This will require all laboratories using the device for an “off label use” to meet all applicable CLIA high-complexity requirements. • Surveyors Will Document Off-Label Use: If any non-compliance is identified, a written statement of deficiencies (Form CMS-2567) will be issued and followed up using standard operating procedures and timeframes found in the applicable regulations and guidance documents. • Frequently Asked Questions (FAQs): Included with this memorandum are FAQs prepared by Centers for Medicare & Medicaid Services (CMS) and FAQs prepared by the FDA, respectively that provide responses to key questions.

title: Directions on the Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS)

memo_number: 15-10-Hospitals

posting_date: Mon, 24 Nov 2014 12:00:00 -0500

summary: • Ebola and EMTALA requirements: This Memorandum conveys information useful in responding to inquiries from hospitals concerning implications of Ebola for their compliance with EMTALA. • EMTALA Screening Obligation: Every hospital or critical access hospital (CAH) with a dedicated emergency department (ED) is required to conduct an appropriate medical screening examination (MSE) of all individuals who come to the ED, including individuals who are suspected of having been exposed to Ebola, and regardless of whether they arrive by ambulance or are walk-ins. Every ED is expected to have the capability to apply appropriate Ebola screening criteria when applicable, to immediately isolate individuals who meet the screening criteria to be a potential Ebola case, to contact their state or local public health officials to determine if Ebola testing is needed, and, when a decision to test is made, to provide treatment to the individual, using appropriate isolation precautions, until a determination is made whether the individual has Ebola. • EMTALA Stabilization, Transfer & Recipient Hospital Obligations: In the case of individuals who have Ebola, hospitals and CAHs are expected to consider current guidance of public health officials in determining whether they have the capability to provide appropriate isolation required for stabilizing treatment and/or to accept appropriate transfers. In the event of any EMTALA complaints alleging inappropriate transfers or refusal to accept appropriate transfers, CMS will take into consideration the public health guidance in effect at the time. • Centers for Disease Control and Prevention (CDC) Website: CMS strongly urges State Survey Agencies (SAs), hospitals and CAHs to monitor the CDC website at http://www.cdc.gov/vhf/ebola/ for the most current guidance and information concerning Ebola identification, treatment, and precautions to prevent the spread of the disease, as well as their State public health website.

title: Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Ebola Virus Disease (Ebola)

memo_number: S&C-15-08-CLIA EXPIRED

posting_date: Tue, 16 Dec 2025 14:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Information for Clinical Laboratories Concerning Possible Ebola Virus Disease

memo_number: 15-06-NH

posting_date: Fri, 31 Oct 2014 12:00:00 -0400

summary: MDS / Staffing Focused Surveys: In mid-2014, the Centers for Medicare & Medicaid Services (CMS) piloted a short-term focused survey to assess Minimum Data Set, Version 3.0 (MDS 3.0) coding practices and its relationship to resident care in nursing homes in five states. CMS will expand these surveys in 2015 to be conducted nationwide. Reported Staffing: The scope of some or all of the focused surveys will also be expanded to include an assessment of the staffing levels of nursing facilities. This assessment will aim to verify the data self-reported by the nursing home, and identify changes in staffing levels throughout the year.

title: Nationwide Expansion of Minimum Data Set (MDS) Focused Survey Background

memo_number: S&C-15-07-CLIA EXPIRED

posting_date: Fri, 12 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Effect on Microbiology Laboratories Due to the Removal of References to the Clinical Laboratory Standards Institute (CLSI) and to CLSI Documents

memo_number: 15-04-ALL

posting_date: Fri, 24 Oct 2014 12:00:00 -0400

summary: • Grantee States may apply for a fifth year no-cost grant extension. The grant period of 36 months may be extended, up to five years (60 months), as applicable. • Grantee States may apply for the full award amount allowed under section 6201 of the Affordable Care Act. Grantee States that did not receive the full amount may apply for the remaining amount, up to $3 million, as applicable. • Interested States may still apply for an award. The Centers for Medicare & Medicaid Services (CMS) is accepting applications on a flow basis. Applications are acted upon every 30 days.

title: National Background Check Program (NBCP) Grant Award Updates

memo_number: 15-02-Hospitals/CAHs

posting_date: Fri, 10 Oct 2014 12:00:00 -0400

summary: • Screening for Possible Ebola Virus Disease: the U.S. Centers for Disease Control and Prevention (CDC) have issued a Health Advisory Alert on Evaluating Patients for Possible Ebola Virus Disease. The CDC has also issued additional guidance, including a checklist and algorithm for patients being evaluated for Ebola Virus Disease in the United States, as well as a hospital preparedness checklist. Links to these documents are provided. • Hospitals and CAHs are strongly urged to review and fully adopt and implement this guidance.

title: Information for Hospitals and Critical Access Hospitals (CAHs) Concerning Possible Ebola Virus Disease

memo_number: S&C-15-05-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Tests Subject to Clinical Laboratory Improvement Amendments (CLIA) Edits Downloadable File on the CLIA Internet Page - Informational Only

memo_number: 15-03 Hospitals

posting_date: Fri, 10 Oct 2014 12:00:00 -0400

summary: Memo updated on January 9, 2015 and changes to the memo are indicated in red font color. • New LTCH Moratorium: A new statutory moratorium prohibits, with certain exceptions, the establishment of new LTCHs or new LTCH satellites of existing LTCHs. Additionally, the moratorium prohibits, with no exceptions, an increase in the number of an LTCH’s certified beds. The moratorium is effective April 1, 2014 to September 30, 2017. • LTCH Determinations: Centers for Medicare & Medicaid Services (CMS) Regional Offices (ROs) will determine whether a hospital seeking to convert to LTCH status, or an LTCH seeking to add a satellite, qualifies for an exception to the moratorium.

title: Implementing the New Moratorium on Establishment of New Long-Term Care Hospitals (LTCH) or New LTCH Satellites, or Increases in LTCH Beds

memo_number: 15-01-Hospice

posting_date: Fri, 03 Oct 2014 12:00:00 -0400

summary: • Extraordinary Circumstances due to Nursing Shortage: The period of time has been extended for hospices to qualify for an “extraordinary circumstance” exemption when they believe that the nursing shortage has affected their ability to directly hire sufficient numbers of nurses. • Extension: The effective date of this policy continues through September 30, 2016.

title: Impact of Nursing Shortage on Hospice Care

memo_number: 14-46-LSC

posting_date: Fri, 26 Sep 2014 12:00:00 -0400

summary: • Categorical Waiver: CMS has determined that the 2000 edition of the National Fire Protection Association (NFPA) 101® Life Safety Code (LSC) contains provisions on the use of power strips in health care facilities that may result in unreasonable hardship for providers or suppliers. Further, an adequate alternative level of protection may be achieved by compliance with the 2012 edition of the LSC, which has extended allowances on the use of power strips in patient care areas. o CMS is permitting a categorical waiver to allow for the use of power strips in existing and new health care facility patient care areas, if the provider/supplier is in compliance with all applicable 2012 LSC power strip requirements and with all other 2000 LSC electrical system and equipment provisions. o Resident rooms in long-term care or other residential care facilities that do not use line-operated electrical appliances for diagnostic, therapeutic, or monitoring purposes are not subject to the more restrictive NFPA 99 requirements regarding the use of power strips in patient care areas/rooms. Resident rooms using line-operated patient-care-related electrical equipment in the patient care vicinity must comply with the NFPA 99 power strip requirement and may elect to utilize this categorical waiver. • Individual waiver applications are not required: Providers and suppliers are expected to have written documentation that they have elected to use the waiver. A provider or supplier must notify the LSC survey team at the entrance conference that it has elected the use the waiver permitted under this guidance and that it meets the applicable waiver requirements. The survey team will review the information and confirm the facility meets the conditions for the waiver.

title: Categorical Waiver for Power Strips Use in Patient Care Areas Various

memo_number: 14-45-Hospital

posting_date: Mon, 15 Sep 2014 12:00:00 -0400

summary: • Guidance Updated: The Centers for Medicare & Medicaid Services (CMS) has updated its Hospital interpretive guidelines in State Operations Manual (SOM) Appendix A to reflect recent amendments to the Governing Body and Medical Staff Conditions of Participation (CoPs) as well as to make technical corrections, and clarify and update selected portions of the guidance. • Effective Dates: The revised regulations were effective July 11, 2014.

title: Revised Guidance Related to New & Revised Hospital Governing Body and Medical Staff Regulations

memo_number: 14-44-Hospital/CAH/ASC

posting_date: Fri, 29 Aug 2014 12:00:00 -0400

summary: • Change in Terminology: “Flash” Sterilization vs. IUSS: Nationally recognized organizations with expertise in infection prevention and control and instrument sterilization processes, and other professional organizations recommend abandoning the use of the term “flash” sterilization, which is now considered outmoded, and replacing it with the term “IUSS.” • Update of S&C Memorandum 09-55 Regarding Standards for Immediate Use Sterilization in Surgical Settings: This memo reiterates and updates information regarding nationally recognized infection prevention and control guidelines and professionally acceptable standards of practice with respect to immediate use sterilization and supersedes S&C Memorandum 09-55.

title: Change in Terminology and Update of Survey and Certification (S&C) Memorandum 09-55 Regarding Immediate Use Steam Sterilization (IUSS) in Surgical Settings

memo_number: 14-43-NH

posting_date: Mon, 25 Aug 2014 12:00:00 -0400

summary: Completion of Minimum Data Set (MDS) 3.0 Discharge Assessments for Transfer from Medicare- and/or Medicaid-Certified Beds to Non-Certified Beds: The Centers for Medicare & Medicaid Services (CMS) is reinforcing the requirement for MDS 3.0 Discharge assessments to be completed when a resident transfers from a Medicare- and/or Medicaid-certified bed to a non-certified bed. Discharge assessments are required assessments and are critical to ensuring the accuracy of Quality Measures (QMs) and in aiding in resident care planning for discharge from the certified facility.

title: Completion of Minimum Data Set (MDS) 3.0 Discharge Assessments for Resident Transfers from a Medicare- and/or Medicaid-Certified Bed to a Non-Certified Bed

memo_number: 14-42-NH

posting_date: Fri, 22 Aug 2014 12:00:00 -0400

summary: 07.17.15- Revised to update the Training Tool website link • Release of Training Materials: The Centers for Medicare & Medicaid Services (CMS) announce the release of a free learning tool on Building Respect for LGBT Older Adults. • Program Content and Design: The learning tool addresses the needs and rights of older LGBT adults in long term care (LTC) and is presented in six online training modules. • Target Audience: The learning tool is intended for LTC providers.

title: Release of Learning Tool on Building Respect for Lesbian, Gay, Bisexual, Transgender (LGBT) Older Adults

memo_number: 14-41-CAH

posting_date: Fri, 08 Aug 2014 12:00:00 -0400

summary: • In accordance with 42 CFR 485.623(b)(1), CAHs are required to maintain all essential mechanical, electrical and patient-care equipment in safe operating condition. o A CAH may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment, unless: • Other Federal or state law, or CAH Conditions of Participation (CoPs) require adherence to manufacturer’s recommendations and/or set specific requirements. For example, the National Fire Protection Association (NFPA) Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 485.623(d) have some provisions pertinent to equipment maintenance, and compliance with these requirements is assessed on Federal surveys; or • The equipment is imaging/radiologic equipment or a medical laser device; or • New equipment without a sufficient amount of maintenance history has been acquired. • CAHs electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish. • CAHs must be able to demonstrate that qualified personnel, whether employees or contractors, are making the decisions to place equipment in the AEM program, performing the risk-based assessments, establishing the alternate equipment maintenance requirements, managing the AEM program, and performing the maintenance in strict accordance with the AEM policies and procedures.

title: Critical Access Hospital (CAH) Equipment Maintenance Requirements

memo_number: 14-39-AO/RHCs

posting_date: Fri, 25 Jul 2014 12:00:00 -0400

summary: Announcement: The Centers for Medicare & Medicaid Services (CMS) announces its decision to recognize and approve TCT?s Medicare RHC accreditation program for RHCs seeking to participate in the Medicare program via deemed status.

title: Approval of The Compliance Team?s (TCT?s) Rural Health Clinic (RHC) Accreditation Program

memo_number: 14-40-HHA

posting_date: Fri, 25 Jul 2014 12:00:00 -0400

summary: • Centers for Medicare & Medicaid Services announces changes to OASIS-C1 implementation: • Upcoming Webinar: The Survey and Certification Group (SCG) is sponsoring a webinar entitled “OASIS-C1/ICD9” on September 3, 2014, 2:00-3:30 pm EST. • SCG Presenter: Patricia Sevast, RN, Nurse Consultant, along with Linda Krulish, PT, MHS, COS-C, President, OASIS Answers, Inc., and Deborah Chisholm, RN, BSN, CPHQ, COS-C, Director of Educational Programs, OASIS Answers, Inc., will present a discussion of the new OASIS-C1 data set to be implemented January 1, 2015. • Target Audience: This webinar is intended for all State Survey Agencies and Regional Office staff, as well as Home Health Agency (HHA) providers.

title: Outcome and Assessment Information Set (OASIS)-C1/International Classification of Diseases (ICD)-9 Webinar: September 3, 2014

memo_number: 14-37-NH

posting_date: Thu, 03 Jul 2014 12:00:00 -0400

summary: • Revisions to Appendix PP of the SOM: We have revised the Interpretive Guidelines and, where appropriate, Investigative Protocols for the following F Tags to incorporate Survey & Certification (S&C) policy memos issued from October 2003 through May 2014. Specifically, the guidelines have been updated for the following F Tags: F161 - Assurance of Financial Security F202 - Documentation for Transfer and Discharge F208 - Admission Policy F221 - Physical Restraints F278 - Accuracy of Assessment/Coordination/Certification/Penalty for Falsification F281 - Services Provided Meet Professional Standards of Quality F286 - Maintaining 15 Months of Resident Assessments (Use) F332 - Medication Errors/Free of Medication Errors of 5% or Greater F333 - Medication Errors/Residents are Free of Significant Medication Errors F371 – Sanitary Conditions F387 - Frequency of Physician Visits/Timeliness of Visits F388 - Personal Visits by the Physician F390 - Physician Delegation of Tasks in SNFs/Performance of Physician Tasks in NFs F425 - Pharmacy Services F428 - Drug Regimen Review F431 - Service Consultation/Labeling of Drugs and Biologicals/Storage of Drugs and Biologicals F441 - Infection Control F492 - Compliance with Federal, State and local laws and Professional Standards F514 - Clinical Records F516 - Resident Identifiable Information/Safeguard against loss, destruction, or unauthorized use • Revisions to SOM Chapter 4: Section 4132.1E Waiver of Program Prohibition has been revised to incorporate information consistent with CFR 483.151(c)(1). Section 4542.2 State Agency (SA) Expenses for Training of SA Personnel has been revised to include Association of Health Facility Survey Agencies (AHFSA) to the list of annual meetings.

title: Advance Guidance - Revisions to State Operations Manual (SOM), Appendix PP- Guidance to Surveyors for Long-Term Care (LTC) Facilities and Chapter 4

memo_number: 14-38-OPT

posting_date: Thu, 03 Jul 2014 12:00:00 -0400

summary: • SOM Appendix E – The interpretive guidance for OPTs is revised to clarify the fire safety requirements. Surveyors should review the revised Appendix to view the requirements in their entirety. • Rehabilitation Agencies – Fire Safety Requirements: Rehabilitation Agencies are required to have an automatic extinguishing system or an enclosure with a 1-hour fire resistance rating in hazardous areas as well as fire extinguishers, a fire alarm system, and a fire evacuation plan. • Air Horns as a Fire Alarm System: Air horns will not serve in place of a fire alarm system for Rehabilitation Agencies. • Certification/Recertification: Rehabilitation Agencies cannot be certified or recertified and extension locations cannot be approved if they do not meet the minimum fire protection requirements.

title: Rehabilitation Agencies: Fire Alarm Systems, SOM Appendix E Revision - Advance Copy

memo_number: 14-31-Hospitals/CAHs

posting_date: Fri, 16 May 2014 12:00:00 -0400

summary: Surveying Hospitals & CAHs with EHRs: EHRs are increasingly common in hospitals and CAHs and pose new challenges to the survey process. The Centers for Medicare & Medicaid Services (CMS) wishes to advise hospitals and CAHs that State Survey Agency (SA) surveyors may be requesting that experienced hospital/CAH EHR users with appropriate system permissions be assigned as “navigators” to assist surveyors with medical record information retrieval for survey tasks requiring detailed medical record review. Providing such assistance is analogous to the traditional expectation for paper-based records that hospitals and CAHs retrieve closed paper medical records requested by surveyors, and hospitals/CAHs are expected to provide the necessary assistance to enable surveyors to review EHRs.

title: Provision of Electronic Health Record (EHR) “Navigators” during Hospital and Critical Access Hospital (CAH) Surveys

memo_number: 14-36-All

posting_date: Fri, 30 May 2014 12:00:00 -0400

summary: REVISED 10.28.16 ***Additional Information has been added to Breaches to Be Referred. This policy memorandum supersedes policy memorandum S&C: 14-36-ALL**** • Infection Control Breaches Warranting Referral to Public Health Authorities: If State Survey Agencies (SAs) or Accrediting Organizations (AOs) identify any of the breaches of generally accepted infection control standards listed in this memorandum, they should refer them to appropriate State authorities for public health assessment and management. • Identification of Public Health Contact: SAs should consult with their State’s Healthcare Associated Infections (HAI) Prevention Coordinator or State Epidemiologist on the preferred referral process. Since AOs operate in multiple States, they do not have to confer with State public health officials to set up referral processes, but are expected to refer identified breaches to the appropriate State public health contact identified at: http://www.cdc.gov/HAI/state-based/index.html.

title: Infection Control Breaches Which Warrant Referral to Public Health Authorities

memo_number: 14-29-LSC

posting_date: Fri, 16 May 2014 12:00:00 -0400

summary: • Sprinkler Requirement: On August 13, 2008, the Centers for Medicare and Medicaid Services (CMS) published a final rule entitled “Medicare and Medicaid Programs: Fire Safety Requirements for Long Term Care Facilities, Automatic Sprinkler Systems.” This regulation required all long term care facilities to be equipped with a supervised automatic sprinkler system by August 13, 2013. • Limited Extensions: On May 12, 2014, CMS also published a final rule (CMS-3267-F) to permit a very limited extension of the automatic sprinkler due date for a facility that is building a replacement facility or undergoing major modifications to unsprinklered living areas. • Procedures to Request Time Extension: Attached are the procedures to apply for approval of a request for an extension of time by a qualifying long term care facility that has not met the August 13, 2013 deadline for the installation of a complete automatic sprinkler system throughout the facility.

title: Information for Applications to Extend the Due Date for the Installation of Automatic Sprinkler Systems in Existing Nursing Homes

memo_number: 14-35-ALL

posting_date: Tue, 20 May 2014 12:00:00 -0400

summary: Triaging and Referring Complaints: • A “Non-IJ High” category for prioritizing complaint allegations has been added to Section 5075 of the State Operations Manual (SOM) for non-long term care (non-LTC). It applies to all substantial allegations of noncompliance (except for immediate jeopardy (IJ) allegations), and requires a SA complaint investigation. • All complainants whose complaints concerning deemed providers/suppliers are prioritized below non-IJ High must be referred to the applicable accrediting organization(s) (AOs).

title: Update of State Operations Manual (SOM) Chapter 5, Triaging Complaints & Referral of Complainants to Accrediting Organizations

memo_number: 14-26- Hospitals

posting_date: Fri, 09 May 2014 12:00:00 -0400

summary: New LTCH Moratorium: A new statutory moratorium prohibits, with certain exceptions outlined in a proposed rule, the establishment of new LTCHs or new LTCH satellites of existing LTCHs. Additionally, the moratorium prohibits, with no exceptions, an increase in the number of an LTCH’s certified beds. The moratorium is effective April 1, 2014 to September 30, 2017. • Determinations for Exceptions Must Await Further Guidance: Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) staff must defer making determinations on whether a proposed new LTCH or LTCH satellite meets any exceptions to the moratorium until the implementation of those exceptio

title: Long-term Care Hospital (LTCH) Moratorium – Preliminary Instructions

memo_number: 14-32-Transplant

posting_date: Fri, 16 May 2014 12:00:00 -0400

summary: Publication of NPRM: CMS-1607-P was published on May 15, 2014. The proposed rule updates the Inpatient Prospective Payment System (IPPS) for hospitals. The NPRM also includes program updates for certain other acute care providers. This S&C memorandum summarizes only the proposals related to solid organ transplant programs. Transplant Mitigating Factors Process: Current regulations permit a transplant program to apply for consideration of mitigating factors that, if approved, would permit the program to continue to participate in Medicare despite not fully meeting CMS requirements for patient or graft survival. This proposed rule would clarify the mitigating factors process, increase transparency, and explicitly recognize CMS willingness to consider program improvements and the use of innovative practices as part of the mitigating factors process.

title: The CMS Mitigating Factors Process for Solid Organ Transplant Programs – Notice of Proposed Rule-Making (NPRM) - Informational Only

memo_number: 14-33-ALL

posting_date: Tue, 20 May 2014 12:00:00 -0400

summary: • Publication of Final Rule: CMS-3267-F was published on May 12, 2014. In this final rule we implement reforms in Medicare regulations that the Centers for Medicare & Medicaid Services (CMS) has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). • Effective Date: These regulations are effective on July 11, 2014, with the exception of amendments to 42 CFR Part 483 related to nursing home sprinklers, which are effective May 12, 2014.

title: Final Rule - Promoting Program Efficiency, Transparency, and Burden Reduction; Part II - Informational Only

memo_number: 14-34-NH

posting_date: Tue, 20 May 2014 12:00:00 -0400

summary: • Guidance for Nursing Homes: Skilled nursing and nursing facilities should use pasteurized shell eggs or liquid pasteurized eggs to eliminate the risk of residents contracting Salmonella Enteritidis (SE). The use of pasteurized eggs allows for resident preference for soft-cooked, undercooked or sunny-side up eggs while maintaining food safety. In accordance with the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) standards, skilled nursing and nursing facilities should not prepare nor serve soft-cooked, undercooked or sunny-side up eggs from unpasteurized eggs. • Guidance for Surveyors: Signed health release agreements between the resident (or the resident’s representative) and the facility that acknowledges the resident’s acceptance of the risk of eating undercooked unpasteurized eggs are not permitted. Pasteurized eggs are commercially available and allow the safe consumption of eggs. If the facility prepares or serves unpasteurized or undercooked eggs which are not cooked until both the yolk and white are completely firm, surveyors should consider citing deficiencies at F371. Determination of the appropriate scope and severity shall be based upon the actual or potential negative resident outcomes in accordance with guidance given at F371. We are revising F371 to clarify this section; a revised F371 is attached.

title: Advance Copy of Revised F371; Interpretive guidance and Procedures for Sanitary Conditions, Preparation of Eggs in Nursing Homes

memo_number: 14-30- NH

posting_date: Fri, 16 May 2014 12:00:00 -0400

summary: • Grant Solicitation for the Reinvestment of Civil Money Penalty (CMP) Funds to Benefit Nursing Home Residents: As part of the 2010 Affordable Care Act, the Centers for Medicare & Medicaid Services (CMS) is soliciting proposals for a grant opportunity in which Federal CMP Funds will be utilized to support and further expand the National Partnership to Improve Dementia Care in Nursing Homes. • Funds: A total of $500,000 for FY2014-2015 will be available for a three year period of performance. Funding will be awarded in 12 month budget periods. • Terms: Further information about this new initiative may be accessed at http://www.grants.gov.

title: Grant Solicitation for the Reinvestment of Federal Civil Money Penalty (CMP) Funds to Benefit Nursing Home Residents

memo_number: 14-27-Hospital-CAH/DPU

posting_date: Fri, 09 May 2014 12:00:00 -0400

summary: • Hospital Restraint/Seclusion Deaths to be Reported Using Form CMS-10455: Hospitals must use Form CMS-10455 to report those deaths associated with restraint and/or seclusion that are required by 42 CFR §482.13(g) to be reported directly to their Centers for Medicare & Medicaid Services (CMS) Regional Office (RO). This requirement also applies to rehabilitation or psychiatric distinct part units (DPUs) in Critical Access Hospitals (CAHs). • RO to Provide Submission Instructions: CMS ROs must provide hospitals with instructions for submitting the form to the RO by fax and/or e-mail, based on RO preference.

title: Hospital Restraint/Seclusion Deaths to be Reported Using the Centers for Medicare and Medicaid Services (CMS) Form CMS-10455, Report of a Hospital Death Associated with Restraint or Seclusion

memo_number: 14-28-NH

posting_date: Fri, 09 May 2014 12:00:00 -0400

summary: Publication of Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2015 – Nursing Home Civil Monetary Penalties: A notice of proposed rule-making (NPRM) regarding Nursing Home Civil Monetary Penalties was published Tuesday, May 6, 2014. The proposed rule provides clarification of statutory requirements under Section 6111 of the Affordable Care Act regarding the approval and use of Civil Money Penalties (CMPs) imposed by The Centers for Medicare & Medicaid Services (CMS) against nursing facilities.

title: Publication of Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2015 – Nursing Home Civil Monetary Penalties - Informational Only

memo_number: S&C-14-25-NH EXPIRED

posting_date: Tue, 02 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Advance Copy – Single Use Device Reprocessing under Tag F441, Revisions to Interpretive Guidance in Appendix PP, State Operations Manual (SOM) on Infection Control EXPIRED

memo_number: 14-23-CLIA

posting_date: Fri, 02 May 2014 12:00:00 -0400

summary: • Publication of Final Rule: CMS-1443-FC published on May 2, 2014. The effective date for the Changes to Clinical Laboratory Improvement Amendments (CLIA) of 1988; Enforcement Actions for Proficiency Testing Referral provisions is July 1, 2014. • Effect of Changes: The changes provide the Secretary with discretion as to which sanctions may be applied to cases of intentional PT referral.

title: Publication of Final Rule CLIA ‘TEST ACT” for Proficiency Testing (PT) Referral - Informational Only

memo_number: 14-24-ALL

posting_date: Fri, 02 May 2014 12:00:00 -0400

summary: Medicare Agreement Effective Date: Section 2008D is being revised to conform more clearly to the governing regulation at 42 CFR 489.13. (See also SC-11-04 and SC-13-60). Survey Process after Denial of Initial Application: Section 2005 has been revised to reflect the following: an applicant who is denied certification by the Centers for Medicare & Medicaid Services (CMS), based on a finding of substantial noncompliance from the initial survey, may reapply for certification. However, the applicant may submit no more than two reapplications for certification in connection with one enrollment application, and no more than six months may elapse between the date of the CMS Regional Office’s (RO’s) first denial and the RO’s receipt of the second reapplication. Applicants who reapply for certification must undergo a subsequent survey. •Hospital Initial Applicant - at State Survey Agency (SA) or accrediting organization (AO) discretion, the subsequent survey may be focused survey. This same approach may also be used for initial Critical Access Hospital (CAH) conversion surveys. •Applicants subject to the Life Safety Code (LSC) – if the applicant was in substantial compliance with the LSC on the initial survey, at SA or AO discretion compliance with the LSC does not have to be reassessed. The RO retains the authority in the above types of cases to require another full survey and should promptly notify the SA or AO if it intends to require a full survey. For all other cases a survey subsequent to a reapplication for certification must always be a full survey. Medicaid-Only Hospitals are not required to enroll in Medicare but must meet Medicare participation requirements: Most hospitals choose to participate in both the Medicare and Medicaid programs, but a small number participate in Medicaid only. Various SOM sections, including Sections 2053, 2777, 2779, 3005 and 3008 have been revised to update provisions concerning Medicaid. New procedures for handling a Medicaid-only hospital include: •SA role in determining if the hospital meets Medicare requirements; •Assigning Medicaid-only CMS Certification numbers (CCNs) within the classification system, including in the Automated Survey Process Environment (ASPEN). •The role of State Medicaid Agencies (SMAs) and ROs. Multiple provisions of the SOM related to accreditation have been clarified.

title: State Operations Manual (SOM) Chapters 1, 2 & 3 Selected Updates: Medicare Effective Date Determination for Initial Applicants; Survey & Certification Process for Initial Medicare Applicants; Medicaid-only Hospitals; & Deemed Providers/Suppliers

memo_number: 14-20-NH

posting_date: Fri, 18 Apr 2014 12:00:00 -0400

summary: • Revised total SFF Slots: Effective April 2014, we have adjusted the number of designated slots and candidates so States can resume selecting and replacing nursing homes for SFF designation. • Adjustment to Number of Slots: Pursuant to the FY2013 budget sequestration, we reduced the number of SFF slots. We are now re-building the program by a gradual increase in the number of SFF slots from its reduced base. Later, we will also introduce additional methods to address persistently poor quality in nursing homes. • Phase in period: States may have the option to start selecting SFFs immediately or phase in the total to meet the required number by July 2014. • Continuation of Program Changes: As outlined previously the Centers for Medicare & Medicaid Services (CMS) Regions and States will continue with the Programmatic and Operational Adjustment by conducting the 18 month “last chance” onsite survey and reviewing the progress of all facilities that have been on the SFF list for more than 12 months.

title: Fiscal Year (FY) 2014 Post Sequester Adjustment for Special Focus Facility (SFF) Nursing Homes

memo_number: 14-22-NH

posting_date: Fri, 18 Apr 2014 12:00:00 -0400

summary: Focused Nursing Home Surveys Under Development: The Centers for Medicare & Medicaid Services (CMS) is currently developing two distinct focused survey processes to assess dementia care and Minimum Data Set, Version 3.0 (MDS 3.0) coding practices in nursing homes. CMS is planning to pilot these survey types beginning in 2014. The intent of the dementia care focused survey is to document dementia care practices in nursing homes. The intent of the MDS focused survey is to document MDS 3.0 coding practices and associated care planning in facilities. Training: CMS will provide training for those States participating in the focused reviews via webinar. This training will be mandatory for those State Survey Agency (SA) staff conducting reviews as well as one manager or trainer within the SA. Enforcement Implications: Deficient practices noted during the survey will result in relevant citations.

title: Focused Minimum Data Set (MDS) and Dementia Care Surveys

memo_number: 14-21- LSC

posting_date: Fri, 18 Apr 2014 12:00:00 -0400

summary: Publication of NPRM for Fire Safety Requirements: The Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would amend the current fire safety standards for Medicare- and Medicaid-participating providers and suppliers. This proposed rule would adopt the 2012 edition of the Life Safety Code (LSC), National Fire Protection Association, (NFPA) 101. Comments may be accepted until 5 pm EST June 16, 2014.

title: Publication of Notice of Proposed Rulemaking (NPRM) for Fire Safety Requirements – Informational Only

memo_number: 14-19-NH

posting_date: Fri, 11 Apr 2014 12:00:00 -0400

summary: Report – The Centers for Medicare & Medicaid Services (CMS) has released an interim report that discusses the history of the National Partnership to Improve Dementia Care, summarizes activities to date, provides reasons for early progress and outlines next steps for future Partnership efforts.

title: Interim report on the CMS National Partnership to Improve Dementia Care in Nursing Homes: Q4 2011 – Q1 2014

memo_number: 14-18-NH

posting_date: Fri, 28 Mar 2014 12:00:00 -0400

summary: ****Document updated and posted on 4/2/14 and contains updates made to the SOM effective 12-13-13 and corrects formatting issues in the previous version.**** • Advance Copy of Chapter 7: Chapter 7 of the State Operations Manual (SOM) has been revised to incorporate the following provisions of Section 6111 of the Patient Protection and Affordable Care Act (the Affordable Care Act): • Independent IDR: An independent informal dispute resolution process (independent IDR) will be available when a civil money penalty (CMP) is imposed. • Escrow: After an independent IDR, CMP funds will be collected and placed in escrow pending completion of any formal appeal. • 50 Percent Reduction: A CMP may be reduced by 50 percent in certain cases of prompt correction for self-reported non-compliance. • Use of CMP Funds: A portion of the CMP attributable to Medicare may be used for programs for the protection or benefit of nursing home residents. • Reminder of Survey Process Timeframes: We are also highlighting specific timeframes associated with the survey process and emphasizing the importance of meeting these timeframes.

title: Advance Copy: Update of State Operations Manual (SOM) Chapter 7 and Survey Process Timeframe Reminder

memo_number: 14-17-HHA

posting_date: Fri, 21 Mar 2014 12:00:00 -0400

summary: 04.18.14 Update-The webinar is postponed due to the Centers for Medicare & Medicaid Services (CMS) examining the implications of the ICD-10 provision in the recently enacted Protecting Access to Medicare Act of 2014 and will provide guidance to providers and other stakeholders soon on the implementation of OASIS-C1. • Upcoming Webinar: The Survey and Certification Group (SCG) is sponsoring a webinar entitled “OASIS-C1” on April 30, 2014, 2:00-3:30 pm EST is postponed until further notice. • SCG Presenter: Patricia Sevast, RN, Nurse Consultant, along with Linda Krulish, PT, MHS, COS-C, President, OASIS Answers, Inc., and Deborah Chisholm, RN, BSN, CPHQ, COS-C, Director of Educational Programs, OASIS Answers, Inc., will present a discussion of the new OASIS-C1 data set to be implemented October 1, 2014. • Target Audience: This webinar is intended for all State Survey Agencies and Regional Office staff, as well as Home Health Agency (HHA) providers.

title: Outcome and Assessment Information Set (OASIS)-C1 Webinar: April 30, 2014

memo_number: 14-12-ALL

posting_date: Fri, 28 Feb 2014 12:00:00 -0500

summary: Revised Emergency Preparedness Checklist: The Centers for Medicare & Medicaid Services (CMS) is alerting healthcare facilities that we have revised current emergency preparedness checklist information for health care facility planning. These updates provide more detailed guidance about patient/resident tracking, supplies and collaboration.

title: Survey and Certification Emergency Preparedness Initiative: S&C Emergency Preparedness Checklist Revision

memo_number: 14-16-OPO

posting_date: Fri, 14 Mar 2014 12:00:00 -0400

summary: This memorandum communicates an advanced copy of the Interpretive Guidance and associated revisions to Chapters 2 and 3 of the State Operations Manual (SOM) for the OPO Conditions for Coverage.

title: Interpretive Guidance for the Survey Process of the Organ Procurement Organization (OPO) Conditions for Coverage, published May 31, 2006, in the Federal Register – Interim Final

memo_number: 14-14-HHA (EXPIRED)

posting_date: Mon, 01 Apr 2024 12:00:00 -0400

summary: EXPIRATION DATE 03/15/2024. • Appendix B – Guidance to Surveyors: Home Health Agencies – Recent establishment of survey and enforcement regulations as well as changes to other HHA policies have necessitated revisions to previously published survey guidance. • HHA Survey and Enforcement regulations – The final rule on available alternative sanctions for HHAs with condition-level deficiencies was published in 2012. Among other things, this rule allows for the imposition of civil money penalties (CMP), directed in-service training, directed plan of correction, suspension of payment, and temporary management. The Centers for Medicare & Medicaid Services (CMS) has developed a new SOM chapter 9 to guide State Agencies (SAs) and Regional Offices (ROs) on imposing these sanctions, as well as on the procedures regarding an informal dispute resolution process (IDR). Office of Strategic Operation and Regulatory Affairs (OSORA) has determined that the Chapter 9 designation is already in use. This chapter has been renumbered as Chapter 10. • SOM, Chapter 2, Certification, Sections 2180-2202.19 – Survey protocols, HHA enforcement regulations, changes to Outcome and Assessment Information Set (OASIS) data transmission and other policy changes have resulted in the need to update the HHA sections of Chapter 2. An error in section 2202.10 has resulted in 2 corrections.

title: EXPIRED: Home Health Agency (HHA) State Operations Manual (SOM) revisions:Appendix B, HHA Enforcement Guidance and revisions to Chapter 2,Certification Process

memo_number: 14-15-Hospital

posting_date: Fri, 14 Mar 2014 12:00:00 -0400

summary: • Medication Administration: We are updating our guidance for the hospital medication administration requirements to: • Make clear that the medication administration requirements under the nursing services condition of participation (CoP) are related to only some components of the overall hospital medication process, but that hospitals are expected, through this and the related requirements under the pharmaceutical services and quality assessment/performance improvement CoPs, to take a comprehensive approach to the medication process. • Update our guidance for IV medications and blood transfusions in general; and • Reflect the need for patient risk assessment and appropriate monitoring during and after medication administration, particularly for post-operative patients receiving IV opioid medications, in order to prevent adverse events. • Immediate Post-operative Care: Clarification is also being made to the guidance for the surgical services CoP requirement for hospitals to have adequate provisions for immediate post-operative care, to emphasize the need for post-operative monitoring of patients receiving IV opioid medications, regardless of where they are in the hospital.

title: Requirements for Hospital Medication Administration, Particularly Intravenous (IV) Medications and Post-Operative Care of Patients Receiving IV Opioids

memo_number: 14-13-NH

posting_date: Fri, 07 Mar 2014 12:00:00 -0500

summary: • Purpose: To make State Survey Agency Directors and Stakeholders aware of the release of comments on the LTCCC Work Group report. • National Background Check Program (NBCP) Long Term Care Criminal Convictions Work Group: We convened a workgroup in response to the Office of Inspector General’s (OIG) recommendation to the Centers for Medicare & Medicaid Services (CMS) that we develop standards to define direct patient access, as well as convictions that should disqualify individuals from direct access employment with LTC facilities and providers, the conviction types that should be considered for mitigation or rehabilitation, and the time period for which each conviction should disqualify individuals from employment. • Public Comments: Public comment was accepted until September 16, 2013.

title: For Information Only: Public Comments on the Report of the National Background Check Program (NBCP) Long-Term Care Criminal Convictions (LTCCC) Work Group

memo_number: 14-11-CLIA

posting_date: Fri, 07 Feb 2014 12:00:00 -0500

summary: • Goal: To support the commitment of the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and the Office of Civil Rights (OCR) that patients should have access to their personal health information, including access to their laboratory test reports. • Notice of Final Rule: CMS-2319-F was published in the Federal Register on February 6, 2014. • CLIA regulations: The regulations at §493.1291(f) have been revised by replacing the phrase “individual responsible” with “persons responsible.” A new regulation has been added at §493.1291(l) to specify that, upon a request by a patient (or the patient’s personal representative), the laboratory may provide patients, their personal representatives, and those persons specified under 45 CFR 164.524(c)(3)(ii), as applicable, with access to completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient. • HIPAA Privacy Rule: The rule was amended at 45 CFR §164.524 to remove the exceptions that relate to CLIA and affect an individual’s right of access. This change preempts any contrary provisions of State law.

title: Publication of Final Rule “Clinical Laboratory Improvement Amendments (CLIA) Program and Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule; Patients’ Access to Test Reports”

memo_number: 14-10-HHA

posting_date: Tue, 04 Feb 2014 12:00:00 -0500

summary: Moratoria – The Centers for Medicare & Medicaid Services (CMS) announced new moratoria on Home Health Agency (HHA) enrollment in four geographic areas and an extension of the existing moratoria in two geographic areas, effective January 30, 2014. Effective January 30, 2014, CMS will halt the enrollment of new HHA providers and HHA branch locations in the metropolitan areas of Fort Lauderdale, FL, Detroit, MI, Dallas, TX and Houston TX, and extend the existing moratoria in Miami, FL and Chicago, IL. • Length of Moratoria - The moratoria will be in place for six months. Federal regulations allow CMS to lift the moratoria as necessary or to extend the moratoria for six month periods by notifying the public. • HHA Application Status – Prospective HHA applications within the affected areas which were not approved prior to January 30, 2014 will be denied by the Medicare Administrative Contractor (MAC). Approved means that by 12:00 AM January 30, 2014 the initial certification survey was completed; the second MAC review was completed; the CMS Regional Office (RO) sent the tie-in notice to the MAC; the MAC performed a site visit and the MAC decided to switch the HHA’s Provider Enrollment Chain Organization System (PECOS) record to an “approved” status. • State Survey Agency (SA)/Regional Office (RO) Review – As of 12:00 AM on January 30, 2014, the SAs and ROs must cease all review of any initial HHA applications pending within the SA or RO for prospective providers in the affected zip codes of the moratoria. In addition, the SAs/ROs may not review any application for an HHA branch location within the affected zip codes throughout the duration of the moratoria.

title: Moratoria on Home Health Agency (HHA) Enrollment- Phase 2 - Metropolitan Areas of Fort Lauderdale, Detroit, Dallas and Houston and Extension of Moratoria on Metropolitan Areas of Miami and Chicago

memo_number: 14-09-Emergency Preparedness

posting_date: Fri, 03 Jan 2014 12:00:00 -0500

summary: Publication of NPRM for Emergency Preparedness: This proposed rule would establish national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It would also ensure that these providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations.

title: Publication of NPRM for Emergency Preparedness – Informational Only

memo_number: 14-06-Hospitals /CAHs

posting_date: Fri, 13 Dec 2013 12:00:00 -0500

summary: • EMTALA & Payor Requirements: Some proposed or existing payment policies of third party payors of hospital services have generated confusion among providers about their EMTALA obligations. The Centers for Medicare & Medicaid Services (CMS) is clarifying for Medicare-participating hospitals and critical access hospitals (CAH) that they are required to comply with EMTALA, regardless of any conflicting requirements of third-party payors, including when those payors are State Medicaid programs. • Certain Hospital Collection Practices May Also Conflict with EMTALA: It is not acceptable for a hospital or CAH to request immediate payment, by cash or other methods, for services provided to an individual who is protected under EMTALA prior to the receipt of such services. A hospital may only request on-the-spot payment after it has conducted an appropriate medical screening examination (MSE) and, if applicable, stabilized an individual’s emergency medical condition (EMC) or admitted the individual. Hospital patients are further protected under the patient’s rights Condition of Participation at 42 CFR 482.13(c)(3), which protects patients from abuse or harassment. • Provisions of the Affordable Care Act May Mitigate Future Problems: The Affordable Care Act contains provisions requiring certain insurance issuers to cover emergency services, including stabilization, without preauthorization.

title: Emergency Medical Treatment and Labor Act (EMTALA) Requirements & Conflicting Payor Requirements or Collection Practices

memo_number: 14-08-Transplant Programs

posting_date: Fri, 20 Dec 2013 12:00:00 -0500

summary: REVISED 04.11.14 “Revised to extend the prospective termination date for all §482.96 Condition: Quality Assessment and Performance Improvement (QAPI), to 210 days”. New to this version is new language in red on page 2 and an updated attachment. • F-QAPI Surveys: In July-August 2013, the Centers for Medicare & Medicaid Services (CMS) conducted a pilot of the new transplant F-QAPI survey, and will now proceed with full implementation of this survey, including the issuance of citations. • Purpose: The transplant F-QAPI survey provides CMS an opportunity for a more comprehensive assessment of compliance with the Transplant Program QAPI Condition of Participation (CoP) at §482.96. Additionally, the survey team may provide tools and information that programs can use to improve the effectiveness of their QAPI program. • UPDATE: The timeframe for prospective termination due to a QAPI condition-level deficiency will be 210 days regardless of the survey type (re-approval, complaint or F-QAPI).

title: QAPI Condition-Level Deficiency in Transplant Re-approval, Complaint and Focused Quality Assessment and Performance Improvement (F-QAPI) Surveys for Organ Transplant Programs – Informational Only

memo_number: 14-07-Hospital

posting_date: Fri, 20 Dec 2013 12:00:00 -0500

summary: • S&C 12-07-Hospital Superceded: We are updating previously provided guidance to clarify: o Hospital facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality. o A hospital may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel, unless: • Other Federal or state law; or hospital Conditions of Participation (CoPs) require adherence to manufacturer’s recommendations and/or set specific requirements. For example, all imaging/radiologic equipment must be maintained per manufacturer’s recommendations; or • The equipment is a medical laser device; or • New equipment without a sufficient amount of maintenance history has been acquired. • Hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish.

title: Hospital Equipment Maintenance Requirements

memo_number: 14-02-ALL

posting_date: Tue, 01 Oct 2013 12:00:00 -0400

summary: Pursuant to the federal government shutdown, we are doing our utmost to: • Protect Medicare and Medicaid beneficiaries against immediate dangers to life and health, and • Prevent providers and suppliers from experiencing harm that would threaten their ability to provide healthcare services that are vital to Medicare and Medicaid beneficiaries. In this memorandum we identify functions that (a) are not affected by a shutdown, (b) essential functions that are to be continued in the event of a shutdown, and (c) other functions that are directly affected and therefore should not be operational during a shutdown.

title: Contingency Plans – State Survey & Certification Activities in the Event of Federal Government Shutdown

memo_number: S&C-14-05-CLIA EXPIRED

posting_date: Fri, 12 Dec 2025 12:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Use of Direct for the Secure Transmission of Laboratory Test Results

memo_number: 14-01-NH

posting_date: Fri, 18 Oct 2013 12:00:00 -0400

summary: REVISED 01.23.15 ***Revised to include information on CPR certification and Appendix PP draft guidance revisions at F155*** • Revisions to Guidance - The Centers for Medicare & Medicaid Services (CMS) have revised the guidance to surveyors in Appendix PP under F155 to clarify a facility’s obligation to provide CPR. • Initiation of CPR - Prior to the arrival of emergency medical services (EMS), nursing homes must provide basic life support, including initiation of CPR, to a resident who experiences cardiac arrest (cessation of respirations and/or pulse) in accordance with that resident’s advance directives or in the absence of advance directives or a Do Not Resuscitate (DNR) order. CPR-certified staff must be available at all times. • Facility CPR Policy - Some nursing homes have implemented facility-wide no CPR policies. Facilities must not establish and implement facility-wide no CPR policies. • Surveyor Implications - Surveyors should ascertain that facility policies related to emergency response require staff to initiate CPR as appropriate and that records do not reflect instances where CPR was not initiated by staff even though the resident requested CPR or had not formulated advance directives. • CPR Certification - Staff must maintain current CPR certification for healthcare providers through CPR training that includes hands-on practice and in-person skills assessment. Online-only certification is not acceptable.

title: Cardiopulmonary Resuscitation (CPR) in Nursing Homes

memo_number: 14-04-ALL

posting_date: Fri, 25 Oct 2013 12:00:00 -0400

summary: On October 16, 2013 Congress enacted Public Law 113-46, providing for a continuing appropriation until January 15, 2014, with retroactive authority back to October 1, 2013. Attached are responses to questions we received from States and providers with regard to the manner in which survey & certification activities should accommodate the effects of the federal government shutdown that occurred from October 1, 2013 through October 16, 2013.

title: Questions + Answers for State Recovery after the Federal Government Shutdown

memo_number: 14-03-NH/LSC

posting_date: Fri, 25 Oct 2013 12:00:00 -0400

summary: • Citations at F Tag 454 no longer apply: The regulations at §483.70(a) are covered by the Life Safety Code (LSC) requirements and all citations under these regulations should be made under the appropriate LSC K Tags. • Systems Changes: The Centers for Medicare & Medicaid Services (CMS), has deleted F Tag 454 from our Automated Survey Processing Environment (ASPEN) system.

title: Citations at F Tag 454 – 42 CFR §483.70 Physical Environment, §483.70(a) Life Safety from Fire

memo_number: 13-58-LSC

posting_date: Fri, 30 Aug 2013 12:00:00 -0400

summary: • Several Categorical LSC Waivers Permitted: The Centers for Medicare & Medicaid Services (CMS) has identified several areas of the 2000 edition of the LSC and 1999 edition of NFPA 99 that may result in unreasonable hardship on a large number of certified providers/suppliers and for which there are alternative approaches that provide an equal level of protection. This memorandum specifies the provisions that are available for waiver, including the conditions for the alternative approaches. • Providers and Suppliers Must Elect to Use the Waiver: Individual waiver applications are not required, but providers and suppliers are expected to have written documentation that they have elected to use a waiver and must notify the survey team at the entrance conference for any survey assessing LSC compliance that it has elected the use of a waiver permitted under this guidance and that it meets the applicable waiver requirements. The survey team will review the information and confirm they are meeting the circumstances for the waiver.

title: 2000 Edition National Fire Protection Association (NFPA) 101® Life Safety Code (LSC) Waivers

memo_number: 13-60-ALL

posting_date: Fri, 06 Sep 2013 12:00:00 -0400

summary: • The Centers for Medicare & Medicare Services (CMS) Encourages New Owners of a Provider/Supplier to Accept Automatic Assignment of the Seller’s Medicare Agreement: o 42 CFR 489.18(c) provides for automatic assignment of the current Medicare agreement to a new owner. However, new owners have the option to reject automatic assignment, resulting in termination of the prior Medicare agreement in accordance with 42 CFR 489.52. o If the new owner rejects assignment, the facility must be treated as an initial applicant if it seeks to participate in Medicare. Like all initial applicants the facility will experience a period (of uncertain duration) with no Medicare payments. This policy also applies in the case of hospitals that acquire another hospital, reject assignment, and make the acquired hospital a provider-based campus. • State Survey Agency (SA) & Accreditation Organization (AO) Surveys Must Be Unannounced: o All surveys conducted for Medicare certification purposes must be unannounced in accordance with Section 2700A of the State Operations Manual (SOM). o If an initial survey of an applicant that acquired a provider/supplier but rejected assignment is conducted shortly after the acquisition date, it raises significant doubts that the survey was unannounced. At a minimum, the appearance is created that the SA or AO collaborated with the new owner on the timing of the survey. o CMS may refuse to accept a survey for certification purposes if the survey timing creates reasonable doubt that the survey was unannounced. • SAs Must Prioritize Initial Surveys in Accordance with CMS Workload Priorities: o Unless the CMS Regional Office (RO) directs the SA to conduct an initial certification survey as soon as possible, SAs must not conduct initial surveys unless they are able to complete their higher priority workload. For initial applicants that have an accreditation option, initial certification surveys are the lowest SA priority. o When an SA conducts an initial certification survey of an applicant that acquired a provider/supplier but rejected assignment, the RO must review the facts of the case carefully to determine whether the SA deviated from CMS workload priorities as well as the SA’s typical practice for initial applicants. Such deviation may raise reasonable doubt that the survey was unannounced. • Determination of the Medicare Agreement Effective Date: ROs determine the effective date of each Medicare provider agreement or supplier approval in accordance with 42 CFR 489.13. While the effective date can be the last day of an initial Medicare survey conducted by the SA or AO as part of the certification process, this is not always the case. SAs and AOs must not speculate to prospective providers/suppliers on what the likely effective date will be. • Non-Long Term Care Survey Procedures When An Initial Survey Finds Substantial Noncompliance: We are reiterating the existing policy and process to be followed when an initial certification survey of a non-long term care applicant results in condition-level deficiency citations.

title: Acquisitions of Providers/Suppliers with Rejection of Automatic Assignment of the Medicare Provider Agreement: Implications for Timing of Surveys and Participation Effective Date

memo_number: 13-57-NH

posting_date: Fri, 30 Aug 2013 12:00:00 -0400

summary: Applicability of CMP, Escrow, IIDR: CMPs imposed pursuant to all standard or complaint surveys that begin on or after October 1, 2013, that initiate an enforcement action in which a CMP is imposed where the highest level of deficiency is less than a “G” level, will be subject to collection and escrow in accordance with 42 C.F.R. §488.431. CMPs based on surveys in which a deficiency is cited for actual harm or immediate jeopardy (“G” or higher) are already subject to escrow. Net Effect: Previously, CMS phased in the escrow requirement by limiting it to CMPs imposed for actual harm or immediate jeopardy. Effective October 1, 2013 every CMP imposed for a deficiency in a nursing home will be subject to escrow and the nursing home may request an independent informal dispute resolution.

title: Escrow and Independent Informal Dispute Resolution (Independent IDR) Process for Nursing Homes – Applicable to All Civil Money Penalties (CMPs)

memo_number: S&C-13-59-CLIA EXPIRED

posting_date: Fri, 12 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Release of Clinical Laboratory Improvement Amendment’s (CLIA) Brochure #11, CLIA Individualized Quality Control Plan Introduction

memo_number: 13-56-NH

posting_date: Fri, 23 Aug 2013 12:00:00 -0400

summary: MDS 3.0 Discharge Assessments: The Centers for Medicare & Medicaid Services (CMS) is clarifying steps to take to address Minimum Data Set (MDS) 3.0 discharge assessments that have not been completed and/or submitted as required under 42 CFR §483.20(g) and 42 CFR §483.20(f)(1). The memo is intended to help surveyors understand both (a) what nursing homes should do to address inactive residents remaining on their resident roster due to incomplete and/or unsubmitted discharge assessments and (b) how nursing homes can ensure compliance with discharge assessment requirements. Action by September 30, 2013: We are providing this information in order to promote nursing home completion of discharge assessments for inactive residents by September 30, 2013.

title: Minimum Data Set (MDS) 3.0 Discharge Assessments that Have Not Been Completed and/or Submitted

memo_number: S&C 13-54-CLIA EXPIRED

posting_date: Fri, 12 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Individualized Quality Control Plan (IQCP): A New Quality Control (QC) Option

memo_number: 13-55-LSC

posting_date: Fri, 16 Aug 2013 12:00:00 -0400

summary: November 15, 2013 Revision •Automatic Sprinkler Required in All Nursing Homes: All nursing homes must be fully sprinklered as of August 13, 2013 in order to participate in Medicare or Medicaid. •End of Five-Year Phase-In to August 13, 2013: The sprinkler requirement was published on August 13, 2008 in a final rule entitled Medicare and Medicaid Programs: Fire Safety Requirements for Long Term Care Facilities, Automatic Sprinkler Systems. The regulation provided a five-year advance timeframe to achieve full sprinkler status by August 13, 2013. •Survey Process: While CMS is not requiring any special surveys focused on the sprinkler requirement, a life-safety code (LSC) inspection is part of each facility’s recertification survey. As these surveys occur during the year, facilities that are not fully sprinklered on or after August 13, 2013 will be cited for a deficiency. •No Extensions: CMS does not have authority to allow extensions of the timeframe. CMS did issue a proposed rule on February 7, 2013 that would permit CMS to grant a time-limited extension of the due date for a facility that is building a replacement or undergoing major modification. At present, a final rule has not been promulgated. In reviewing the plans of correction for such facilities, we will take note of any facility that is in this circumstance. In the absence of a final rule, however, a deficiency will still be issued if the facility is not in compliance with the regulation in force at the time of the survey. •Attachments: Four attachments provide useful information. Attachment Three provides answers to technical questions we have received, and Attachment Four specifies actions that a nursing home may take to substantially lower exposure to fire risks while a sprinkler system is being installed.

title: Enforcement Actions - Installation of Automatic Sprinkler Systems in Nursing Homes - August 13, 2013 Deadline

memo_number: 13-51-Transplant Programs

posting_date: Fri, 02 Aug 2013 12:00:00 -0400

summary: • Pilot F-QAPI Surveys: The Centers for Medicare & Medicaid Services (CMS) developed the F-QAPI survey to enhance assessment of the Transplant Program Quality Assessment and Performance Improvement (QAPI) Condition of Participation (CoP). • Purpose: These initial F-QAPI surveys will pilot-test stand-alone surveys focused on QAPI. We will use the pilot to determine the extent to which a more in-depth review of QAPI may (a) improve surveyor ability to identify weaknesses in a QAPI program, (b) enable surveyors to offer improved feedback to hospitals, (c) provide tools that hospitals may use for internal risk assessment, and (d) offer CMS an option for a more focused survey for some transplant hospitals in lieu of more frequent, full, onsite surveys. • Educational Approach: During the pilot-test phase, F-QAPI surveys will be educational. They will assess the risks that a transplant program’s QAPI may not be in compliance with CMS requirements, but will not involve the issuance of deficiency citations. And CMS will learn more about the manner in which QAPI elements relate to program outcomes.

title: Pilot-Test: Focused Quality Assessment and Performance Improvement (F-QAPI) Surveys for Organ Transplant Programs – Informational Only

memo_number: 13-50-NH

posting_date: Fri, 02 Aug 2013 12:00:00 -0400

summary: • Background: Any individual serving as the administrator of a skilled nursing facility (SNF), nursing facility (NF) or dually participating facility (SNF/NF) must provide written notification of an impending closure of a facility including the plan for relocation of residents at least 60 days prior to the impending closure. New regulations have been added at 42 CFR §§483.75(r) and (s) as well as amendments made to §§483.12(a)(8) and 489.52(a)(2) to reflect this requirement. • SOM Appendix PP: The Centers for Medicare & Medicaid Services (CMS) is providing advanced guidance regarding the federal requirements for Notification of Facility Closure.

title: Notification of Facility Closure: Revisions to Tags F203 and F204 and Issuance of New Tags F523 and F524 in the State Operations Manual (SOM), Appendix PP

memo_number: 13-52-AO

posting_date: Fri, 09 Aug 2013 12:00:00 -0400

summary: Announcement: The Centers for Medicare & Medicaid Services (CMS) announces its decision to recognize and approve CIHQ’s Medicare hospital accreditation program for hospitals seeking to participate in the Medicare program via deemed status. Note that CIHQ’s approved program does not apply to psychiatric hospitals or critical access hospitals (CAHs), which are different provider types for which there are separate accreditation programs.

title: Approval of the Center for Improvement in Healthcare Quality’s (CIHQ) Hospital Accreditation Program

memo_number: 13-53-HHA

posting_date: Fri, 09 Aug 2013 12:00:00 -0400

summary: • Temporary Moratorium – On July 31, 2013 the Centers for Medicare & Medicaid Services (CMS) announced a temporary moratorium on Home Health Agency (HHA) enrollment in two geographic areas. Effective July 30, 2013, CMS will halt the enrollment of new HHA providers and HHA branch locations in the metropolitan areas of Miami, FL and Chicago, IL. • Length of Moratorium - The moratorium will be in place for six months. Federal regulations allow CMS to lift the moratorium as necessary or to extend the moratorium for six month periods by notifying the public. • HHA Application Status – Prospective HHA applications within the affected areas which were not approved prior to July 30, 2013 will be denied by the Medicare Administrative Contractor (MAC). Approved means that by 12:00 AM July 30, 2013 the initial certification survey was completed; the second MAC review was completed; the CMS Regional Office (RO) sent the tie-in notice to the MAC; the MAC performed a site visit and the MAC decided to switch the HHA’s Provider Enrollment Chain Organization System (PECOS) record to an “approved” status. • State Survey Agency (SA)/Regional Office (RO) Review – As of 12:00 AM on July 30, 2013, the SAs and ROs must cease all review of any initial HHA applications pending within the SA or RO for prospective providers in the affected zip codes of the moratorium. In addition, the SAs/ROs may not review any application for an HHA branch location within the affected zip codes throughout the duration of the moratorium.

title: Temporary Moratorium on Home Health Agency (HHA) Enrollment-Metropolitan Areas of Miami and Chicago

summary: This memorandum is intended to provide guidance related to the following: • STAR 3.6 (STAR “Lite”) release scheduled to occur with the ASPEN 10.1.5 upgrade. • State Survey Agency actions to ensure an efficient transition to STAR 3.6 for current surveyor STAR users.

title: Surveyor Technical Assistant for Renal Disease (STAR) automated End Stage Renal Disease (ESRD) survey program upgrade release to coordinate with the ESRD Core Survey process roll-out Purpose

memo_number: 13-48-OPO

posting_date: Fri, 26 Jul 2013 12:00:00 -0400

summary: • OPO Hospital Agreements: Hospital regulations at 42CFR 482.45 (a)(1) require that all hospitals have written agreements in place with their OPO to notify them of an imminent death or of a death which has occurred. OPO regulations at §486.322 (a) require that OPOs have a written agreement in place with 95 percent of all participating Medicare and Medicaid hospitals and Critical Access Hospitals that have both a ventilator and an operating room. Historically, OPOs have not initiated agreements with hospitals without a ventilator and an operating room as donor maintenance cannot be accomplished in that setting. • OPO Agreements with Hospitals That Do Not Have a Ventilator and Operating Room: While OPOs are not required to initiate agreements with hospitals that do not have a ventilator and an operating room, they are required at §486.303 (g) to enter into an agreement with any hospital that requests an agreement with them pursuant to the hospital regulations. However, for hospitals that do not have a ventilator and operating room, the agreement may be limited to notification of the OPO by the hospital of imminent death and/or death which has occurred in the facility.

title: Organ Procurement Organizations (OPO) Agreements with Hospitals

memo_number: 13-46-ALL

posting_date: Fri, 12 Jul 2013 12:00:00 -0400

summary: This memo supersedes S&C: 09-57. •Office for Civil Rights Clearance Process – A health care provider that applies for participation in the Medicare Part A program must receive a civil rights clearance from OCR, as set forth in 42 CFR 480.10(b). •Initial Enrollment or CHOW- State Survey Agencies (SAs) are to include the OCR Civil Rights Certification Information Request Packet (Civil Rights Packet) with their initial enrollment package that is sent to a potential provider or to a provider undergoing a CHOW. •Civil Rights Packet may be submitted on line- SAs must now also offer the potential provider the option to answer all questions and submit the entire civil rights clearance package on line at https://ocrportal.hhs.gov/ocr/pgportal/. • Online Application Submission Start Date- This change will be effective July 15, 2013.

title: Office for Civil Rights (OCR) Clearance Process– Changes to State Survey Agency Responsibilities in Obtaining Information for Civil Rights Clearances for Initial Certifications and Changes of Ownership (CHOWs)

memo_number: 13-47-LSC/ESRD

posting_date: Fri, 12 Jul 2013 12:00:00 -0400

summary: •Limited LSC Applicability to ESRD Facilities: Effective July 16, 2012, compliance by certified ESRD facilities with the applicable requirements of the 2000 edition of the National Fire Protection Association (NFPA) Life Safety Code 101 is limited to those ESRD facilities that are located adjacent to high hazardous occupancies and those facilities that do not exit to the outside at grade level from the patient treatment area. •Retained Compliance by ESRD Facilities: All ESRD facilities are still required to comply with State and local fire codes and other safety standards required by 42 CFR Part 494 Conditions for Coverage (CfC) for ESRD facilities. •Attestation by ESRD Facilities for Exemption: ESRD providers may submit an attestation to claim an exemption to the NFPA LSC requirements if they are not located adjacent to high hazard occupancies and they do provide exits at grade level from the patient treatment area level.

title: Compliance with the Life Safety Code (LSC) in End Stage Renal Disease (ESRD) Facilities

memo_number: 13-45-PRTF

posting_date: Wed, 03 Jul 2013 12:00:00 -0400

summary: • Provision of the Psych Under 21 Benefit: The benefit can only be provided in: • A Medicare or Medicaid-certified psychiatric hospital; • A general hospital with an inpatient psychiatric program accredited by a national accreditation organization (AO) whose hospital accreditation program has been approved by the Centers for Medicare & Medicaid Services (CMS); or • A PRTF that is Medicaid-certified. • Ongoing issue: States that choose to send children out-of-State to receive the Psych Under 21 Benefit must ensure that these patients receive services in facilities that are Medicaid-certified. Currently, there are instances where children are being transferred out of their home State to receive these services in facilities that are not certified as PRTFs. This is occurring in situations where the Medicaid State Plan for the receiving State does not include PRTF services. • State Survey Agency Activity: If the transferring State Medicaid Agency (SMA) wishes to enter into a PRTF agreement with a facility located outside its State, they must make arrangements for the survey of the facility for compliance with applicable regulations. They may make these arrangements with any State Survey Agency (SA). The SA that performs the survey assumes the responsibility for entering the associated data into ASPEN and ensures that re-certification surveys occur at five (5) year intervals.

title: Provision of Inpatient Psychiatric Services to Individuals Under the Age of 21(Psych Under 21 Benefit) in Out-of-State Psychiatric Residential Treatment Facilities (PRTFs)

memo_number: 13-42-NH

posting_date: Fri, 28 Jun 2013 12:00:00 -0400

summary: •Interpretive Guidelines: This memorandum reviews current interpretive guidelines for F-Tag 172, reiterating resident rights surrounding access and visitation. •Facility Obligations: LTC facilities must ensure that all individuals seeking to visit a resident be given full and equal visitation privileges, consistent with resident preference and within reasonable restrictions that safeguard residents.

title: Reminder: Access and Visitation Rights in Long Term Care (LTC) Facilities

memo_number: 13-43-NH

posting_date: Fri, 28 Jun 2013 12:00:00 -0400

summary: • Redirecting website traffic to the data.medicare.gov website – In July 2013 all users of the Nursing Home Compare website that wish to download the nursing home data will be redirected to the data.medicare.gov website (https://data.medicare.gov/). • New data layouts and additional nursing home data available for viewing and download on the data.medicare.gov website –In July 2013, we will be restructuring some of the nursing home data currently available for download. We will also be adding additional information that is not currently posted on the Nursing Home Compare website.

title: Changes to the Nursing Home Compare Website Data that is Available for Download on the Medicare.gov Website (Effective July 2013)

memo_number: 13-44-NH

posting_date: Fri, 28 Jun 2013 12:00:00 -0400

summary: Public release of the Five-Star Quality Rating System Three-Year Report – We will be posting on the Five-Star Quality Rating System page of the CMS.gov website the results of an analysis that examined trends in the first three years of the Five-Star Quality Rating System. We expect the report to be available on June 28, 2013. The report will be available under the downloads section of the web page available here: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/FSQRS.html.

title: Public Release of the Five-Star Quality Rating System Three-Year Report

memo_number: 13-41-NH

posting_date: Fri, 21 Jun 2013 12:00:00 -0400

summary: • Notice: The Centers for Medicare & Medicaid Services (CMS) is revising the ninth solicitation for the National Background Check Program (NBCP) for any States or U.S. Territories that were unable to meet the previous deadline for submitting their applications under the previous solicitation. • Application Deadline: Applications will be accepted on a flow basis and acted on every 30 days.

title: Notice –Revision to the Ninth Opportunity National Background Check Program Funding

memo_number: 13-40-ESRD

posting_date: Fri, 21 Jun 2013 12:00:00 -0400

summary: • Clarification of CMS Policy on Home Dialysis Only Facilities: In 2012 a statement was erroneously added to Form CMS-3427 requiring that ESRD Home Dialysis Only facilities must provide both HHD and PD support and training services in order to be Medicare certified. In fact, these facilities may provide either HHD or PD or both. • Associated ASPEN Revisions: A revision to form CMS-3427 allowing HHD or PD or both modalities will be incorporated at the next ASPEN release scheduled for July, 2013.

title: End Stage Renal Disease (ESRD) Home Dialysis Only Facilities Offering Home Hemodialysis (HHD), Home Peritoneal Dialysis (PD), or Both HHD and PD Modalities

memo_number: S&C-13-39-CLIA EXPIRED

posting_date: Thu, 11 Dec 2025 14:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Guidance Regarding the Deployment of the Emergency Use Approval (EUA) Bird Flu Test (H7N9) to State Public Health Laboratories (PHLs) by the Centers for Disease Control and Prevention (CDC)

memo_number: 13-37-NH

posting_date: Fri, 07 Jun 2013 12:00:00 -0400

summary: • Rollout of QAPI Materials: The Centers for Medicare & Medicaid Services (CMS) is making the following set of introductory materials available on the CMS QAPI website: o QAPI at a Glance – a guide for understanding and implementing QAPI in nursing homes o QAPI Tools – process tools, within QAPI at a Glance, to help providers establish a foundation in QAPI o QAPI News Brief – newsletter describing basic principles of QAPI o Video – Nursing Home QAPI – What’s in it for you? - introduces QAPI, its value to residents, their families and caregivers, and what is in it for nursing homes that embrace QAPI • Nursing Home Quality Improvement Questionnaire: Analysis is nearly complete on wave one of the Nursing Home Quality Improvement Questionnaire; results will be released on QAPI Website later this summer. • QAPI Website: A new webpage to house QAPI training materials, tools and resources has been created on the CMS website. • Next Steps: CMS will expand its QAPI efforts by developing resources for consumers.

title: Rollout of Quality Assurance and Performance Improvement (QAPI) Materials for Nursing Homes

memo_number: 13-38-CAH/EMTALA

posting_date: Fri, 07 Jun 2013 12:00:00 -0400

summary: • The Center for Medicare & Medicaid Services (CMS) Welcomes use of Telemedicine by CAHs: Telemedicine has great potential to expand availability of specialty care services, including emergency medicine services, to rural populations. However, misconceptions about CAH CoP and EMTALA requirements may cause unnecessary concerns about, or create barriers to, using telemedicine. • The CAH Emergency Services CoP does not Require a Physician to Appear On-site Whenever an Individual Comes to the Emergency Department (ED): • Under 42 CFR 485.618(d), a doctor of medicine (MD), a doctor of osteopathy (DO), a physician assistant (PA), a nurse practitioner (NP), or a clinical nurse specialist (CNS), with training or experience in emergency care, must be immediately available by telephone or radio, and available on-site within 30 minutes (60 minutes for CAHs in frontier areas that meet certain conditions). Under the CAH CoPs an MD or DO is not required to be available in addition to a non-physician practitioner. • Under the CoP at §485.618(e), an MD or DO must be immediately available by telephone or radio contact on a 24-hours a day basis to receive emergency calls, provide information on treatment of emergency patients, and refer patients. This requirement can be met by the use of a telemedicine MD/DO as well as by an MD/DO who practices on-site at the CAH. • EMTALA is Not a Barrier to Using Telemedicine to Extend CAH Emergency Services: • If using telemedicine for emergency and other services, a CAH is not required to include the telemedicine physicians on its physician on-call list mandated under the EMTALA regulations at 42 CFR 489.20(r)(2) and §489.24(j), nor would it be advisable for a CAH to do so. • The CAH is required under EMTALA to have an on-call list reasonably related to the services it offers, composed of physician(s) who practice on-site at the CAH. This does not mean that physicians who practice on site must be on-call and available to appear in person at all times. Nor does it mean that an on-call physician must be called to appear on-site in every case involving an emergency medical condition.

title: Critical Access Hospital (CAH) Emergency Services and Telemedicine: Implications for Emergency Services Condition of Participation (CoPs) and Emergency Medical Treatment and Labor Act (EMTALA) On-Call Compliance

memo_number: 13-36-NH

posting_date: Fri, 07 Jun 2013 12:00:00 -0400

summary: Revisions to Appendix P of the State Operations Manual (SOM): Changes have been made to the Sub-Task 5E - Medication Pass Observation Task in the Traditional Survey. o The number of observations required to calculate the facility medication error rate is revised to a minimum of 25 medication administration opportunities. A minimum number is specified because it is acceptable to include more than 25 observations in a medication observation to capture multiple routes, times, and caregivers. o This revision eliminates the current requirement to extend the medication pass for another 20-25 opportunities if errors are detected in the first 20-25 observations. o Form CMS–20056 (2/2013), Medication Administration Observation will be used; this form replaces Form CMS-677, Medication Pass Worksheet. o This change matches the Quality Indicator Survey (QIS) Medication Administration Observation protocol, thus standardizing the medication error rate calculation for both the Traditional and QIS surveys.

title: Advance Copy– Changes for Sub-Task 5E, Medication Pass Observation Protocol for Long Term Care (LTC) Facilities

memo_number: 13-34-ALL

posting_date: Fri, 24 May 2013 12:00:00 -0400

summary: • Release of Training Materials: The Survey and Certification Group (SCG) is providing the third and final training program on the care of persons with dementia and unnecessary antipsychotic medication use. The first two programs were made available in January 2013; the third program will be released after May 31, 2013. • Program Content and Design: The third program is a video-streaming that discusses how to cite severity. The first program provides survey basics related to care of persons with dementia and unnecessary medications. The second program is an interactive self-study with video clips that walks through portions of an actual nursing home survey. • Target Audience: These three programs are mandatory for all State and Regional Office surveyors and optional for other interested personnel. Surveyors have until August 31, 2013 to view the final training. The deadline to view the first two programs was April 30, 2013.

title: Release of Mandatory Surveyor Training Program on Care of Persons with Dementia and Unnecessary Antipsychotic Medication Use – Release of Third Video

memo_number: 13-35-NH

posting_date: Fri, 24 May 2013 12:00:00 -0400

summary: • Guidance – This memo conveys clarification to Appendices P and PP related to nursing home residents with dementia and unnecessary drug use.• Training - Mandatory surveyor trainings are available online at https://qsep.cms.gov.

title: Advanced Copy: Dementia Care in Nursing Homes: Clarification to Appendix P State Operations Manual (SOM) and Appendix PP in the SOM for F309 – Quality of Care and F329 – Unnecessary Drugs

memo_number: 13-33-FQHC

posting_date: Fri, 17 May 2013 12:00:00 -0400

summary: Updated Guidance on FQHC Medicare Enrollment Requirements & Effective Date: • Various portions of Section 2826 of the SOM are being revised to streamline the process for initial issuance of a Medicare FQHC participation agreement. Revisions: o Reduce the number of documents the Medicare Administrative Contractor (MAC) must forward to the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) along with the MAC letter recommending approval; o Clarify that it is the responsibility of the FQHC to understand whether or not it requires a Clinical Laboratory Improvement Act (CLIA) certificate when it attests to its compliance with FQHC regulatory requirements; the RO does not make a separate determination on this. o Clarify that the effective date of the Medicare FQHC agreement is the date on which the MAC determined that the FQHC application was complete. • Exhibit 177 is being revised to include instructions to the applicant and add space for the applicant’s address and a “doing business as” name, if applicable. • Exhibit 179 is being revised to track the changes in Section 2826.

title: Federally Qualified Health Center (FQHC) Medicare Enrollment Guidance Updated

memo_number: 13-31-HHA

posting_date: Fri, 17 May 2013 12:00:00 -0400

summary: • Office of Management and Budget (OMB) Circular A-87: OMB Circular A-87 articulates basic principles for determining the allowability of costs in the administration of certain federal programs. One principle is that costs should be allocated between cost centers in accordance with relative benefits received. • Benefiting Programs: Medicare, Medicaid, and States all benefit when surveys are conducted to assure compliance with basic public expectations for quality of care and safety through the federal survey process. • HHA Surveys: Costs for HHA surveys must be allocated among the benefiting cost centers in accordance with the relative benefits received. • Fiscal Year 2014 Centers for Medicare & Medicaid Services (CMS) Reviews: We will work with States to review the FY2014 State survey budgets to ensure that the HHA survey amounts reflect the appropriate allocation of costs across Medicare, Medicaid, and State-only sources.

title: Cost Allocations for Surveys of Home Health Agencies (HHAs)

memo_number: 13-32- HOSPITAL

posting_date: Fri, 17 May 2013 12:00:00 -0400

summary: Discharge Planning Guidance Revised: SOM Hospital Appendix A has been revised to update the guidance for the discharge planning Condition of Participation (CoP). • Advisory Boxes: Included in the updated interpretive guidelines are “blue boxes,” to display advisory practices to promote better patient outcomes. The information found in these advisory boxes is not required for hospital compliance but only resurce information or references for process improvement. • Automated Survey Processing Environment (ASPEN) Tags: ASPEN Tags for discharge planning CoPs have been reorganized. A number of tags were eliminated. These changes were made in 2012. CMS

title: Revision to State Operations Manual (SOM), Hospital Appendix A - Interpretive Guidelines for 42 CFR 482.43, Discharge Planning

memo_number: 13-30-Hospital/RHC

posting_date: Fri, 10 May 2013 12:00:00 -0400

summary: • American FactFinder now includes 2010 Census Bureau Data on Urban/Rural Location: • A hospital seeking swing bed approval or a clinic seeking RHC certification must be located outside an “urbanized area,” as indicated by the Census Bureau. • Instructions are provided on how to access the Census Bureau Data for specific addresses

title: Utilizing the US Bureau of the Census’ (Census Bureau) American FactFinder 2010 Census Data for Rural Area Location Determinations - Hospital Swing Beds & Rural Health Clinics (RHC)

memo_number: 13-29-Transplant

posting_date: Fri, 10 May 2013 12:00:00 -0400

summary: • Delay in Outcomes Information –The release of the January 2013 SRTR PSRs has been delayed while CMS works with the Social Security Administration (SSA) and the Health Resources and Services Administration (HRSA) to address changes to the availability of the Social Security Master Death File (SSMDF) data, which is used in calculating the PSR reports. Medicare regulations require that CMS use the most recent SRTR report for determining compliance with Medicare outcome requirements. As such, the July 2012 SRTR PSRs will be used to determine compliance until further notice. • Programs with Condition-level deficiencies may apply for mitigating factors (MF) to avoid termination - Transplant programs that were not in compliance according to the July 2012 SRTR PSRs, may apply for consideration of MF prior to their prospective Medicare termination date. As part of the MF process, we examine the most recent data available to us and the transplant program, including data that may not yet be published in the PSRs.

title: Delayed Publication of Scientific Registry for Transplant Recipients (SRTR) Program Specific Reports (PSR) and Implications for Centers for Medicare & Medicaid Services (CMS) Transplant Program Oversight

memo_number: 13-28- ICF/IID-QIDP

posting_date: Fri, 03 May 2013 12:00:00 -0400

summary: •Rosa’s Law: The enactment of Rosa’s Law on October 5, 2010 changed all references to “mental retardation” in Federal law to “intellectual disability” and changed all references to a “mentally retarded individual” to “an individual with an intellectual disability.” These changes were codified in regulation by the Centers for Medicare & Medicaid Services (CMS) on May 16, 2012. •Revised Nomenclature for Qualified Mental Retardation Professional (QMRP): Pursuant to these regulatory changes, previous nomenclature for a QMRP, as referenced at 42 CFR 483.430(a), is changed to Qualified Intellectual Disabilities Professional (QIDP).

title: Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) –Nomenclature Change (Qualified Intellectual Disabilities Professional (QIDP)

memo_number: 13-27-Deemed Providers/Suppliers & Hospitals

posting_date: Mon, 22 Apr 2013 12:00:00 -0400

summary: Post-Complaint Survey Procedure - Deemed Providers/Suppliers: • A full survey of a deemed provider/supplier after a complaint survey with condition-level findings will be made on a selective rather than an automatic basis. • All survey reports and related correspondence must be shared promptly with a deemed provider/supplier’s accrediting organization (AO). Hospital Restraint/Seclusion Death Reporting: This section is being moved, to reflect the fact that the procedures therein apply to all hospitals, not just deemed hospitals. We are also streamlining the procedure for making disclosures to State Protection and Advocacy (P&A) agencies, to reduce burden.

title: Update of State Operations Manual (SOM) Chapter 5, Complaint Investigation

memo_number: 13-24-NH

posting_date: Fri, 12 Apr 2013 12:00:00 -0400

summary: The National Background Check Program Purpose: To provide grants to States to implement background checks on prospective direct patient access employees in the LTC field. • Role of The Office of Inspector General (OIG): Tasked by statute with evaluating the NBCP and has recommended that the Centers for Medicare & Medicaid Services (CMS) develop standards in defining direct patient access and identifying convictions that disqualify an individual from nursing facility employment. • NBCP LTC Criminal Convictions Work Group: Made up of grantee State Agency representatives and other interested state officials and has prepared options in response. • Request of Stakeholders: To review the Work Group’s options and provide CMS comments.

title: Report of the National Background Check Program (NBCP) Long-Term Care (LTC) Criminal Convictions Work Group

memo_number: 13-26-CAH

posting_date: Mon, 22 Apr 2013 12:00:00 -0400

summary: • Rural Location: The Centers for Medicare & Medicaid Services (CMS) is updating Chapter 2 and Appendix W of the State Operations Manual (SOM) to reflect the guidance issued in SC-11-33, July 15, 2011. • Mountainous Terrain Criteria for Distance From Hospitals/\Other CAHs: A CAH is eligible, based on location in mountainous terrain, to use the shorter minimum distance from a hospital/other CAH standard if over 15 miles of the roads on the travel route(s) from the CAH to any hospital or another CAH: • Are located in a mountain range; and • Have either of the following characteristics: • Consists of extensive sections of roads with steep grades (i.e., greater than 5 percent), continuous abrupt and frequent changes in elevation or direction, or any combination of horizontal and vertical alignment that causes heavy vehicles to operate at crawl speeds for significant distances or at frequent intervals; or • The roads on the travel route are considered by the State Transportation or Highway agency to be located in mountainous terrain based on significantly more complicated than usual construction techniques required to achieve compatibility between the road alignment and surrounding rugged terrain. • A letter from the State Transportation or Highway agency specific to the travel route(s) in question is required to support the claim of mountainous terrain.

title: Clarification of the Critical Access Hospital (CAH) Criteria for Rural Location and Mountainous Terrain Distance Standard

memo_number: 13-25-LSC & ASC

posting_date: Mon, 22 Apr 2013 12:00:00 -0400

summary: • RH of ≥20 Percent Permitted in Anesthetizing Locations: The Centers for Medicare & Medicaid Services (CMS) is issuing a categorical LSC waiver permitting new and existing ventilation systems supplying hospital and critical access hospital (CAH) anesthetizing locations to operate with a RH of ≥20 percent, instead of ≥35 percent. We are also recommending that RH not exceed 60 percent in these locations. • This Waiver Does Not Apply: • When more stringent RH control levels are required by State or local laws and regulations; or • Where reduction in RH would negatively affect ventilation system performance. • Hospitals & CAHs Must Elect to Use the Categorical Waiver: • Individual waiver applications are not required, but facilities are expected to have written documentation that they have elected to use the waiver. • At the entrance conference for any survey assessing LSC compliance, a facility that has elected to use this waiver must notify the survey team. • Ongoing Requirements: • Facilities must monitor RH in anesthetizing locations and take corrective actions when needed to ensure RH remains at or above 20 percent. • ASCs: ASCs are not subject to all of the same LSC requirements as hospitals, but are required, consistent with 42 CFR 416.44(a)(1), to maintain RH in operating rooms in accordance with nationally accepted guidelines. • State Operations Manual (SOM) Appendices A, I, L & W are being updated accordingly.

title: Relative Humidity (RH): Waiver of Life Safety Code (LSC) Anesthetizing Location Requirements; Discussion of Ambulatory Surgical Center (ASC) Operating Room Requirements

memo_number: 13-23-ALL

posting_date: Fri, 05 Apr 2013 12:00:00 -0400

summary: • Sequester: Across-the-board federal budget reductions as required by the Balanced Budget and Emergency Deficit Control Act, as amended, popularly known as “sequestration,” took effect March 1, 2013. • Priority: Our priority is in maintaining public protections. State survey agency (SA) functions are central to that priority. • Action: In this memorandum we describe adjustments we are making that affect State operations and that are intended to accommodate sequestration.

title: FY2013 Sequestration Adjustments for Survey & Certification (S&C)

memo_number: 13-22-NH

posting_date: Fri, 05 Apr 2013 12:00:00 -0400

summary: • LSC Survey Focus: In FY2013 and FY2014 we undertake the dual challenge of (a) responding to resource limitations, and (b) enforcing the August 13, 2013 requirement that all nursing homes be fully sprinklered. The fire safety record of nursing homes has improved due to the installation of automatic sprinkler systems, and should continue to improve as more nursing homes complete full installation of sprinkler systems. • Efficiency and Effectiveness: Increasing survey efficiency will enable CMS and States to best maintain public protections while meeting these challenges. • State Option: We will permit States - at State option - to implement a Short Form Fire Safety Survey for a limited number of specified facilities that have demonstrated superior compliance with life safety code requirements and are fully sprinklered. • Training: States using the Short Form life safety code survey process must ensure that surveyors participate in a prior special training event.

title: Life Safety Code (LSC) Short Form Survey for Nursing Homes – Limited Option

memo_number: 13-19-HOSPITALS

posting_date: Fri, 15 Mar 2013 12:00:00 -0400

summary: Hospitals are Required to Track Adverse Events: The Condition of Participation (CoP) for Quality Assessment and Performance Improvement (QAPI) at 42 CFR 482.21(a)(2) requires hospitals to track adverse patient events. However, several recent reports completed by the Department of Health and Human Services Office of the Inspector General (OIG) indicated that hospitals fail to identify most adverse events. Use of the Common Formats May Help Hospitals Improve Tracking. The OIG suggested staff failure to understand what events need to be reported to the hospital’s QAPI program contributes to the problems with internal tracking systems. The OIG recommended that the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS) could help hospitals improve their ability to track adverse patient safety events by disseminating information on AHRQ’s Common Formats. The Common Formats define a systematic process for reporting adverse events, near misses, and unsafe conditions, and allow a hospital to report harm from all causes. Hospital use of the AHRQ Common Formats is voluntary, but a hospital that uses them and is adept at the analysis that they permit will be in a better position to meet the CMS QAPI requirements. Common Formats version 1.2 can be accessed at www.psoppc.org Surveyors Should be Familiar with the Common Formats: Surveyors may increasingly encounter use of the Common Formats in hospital QAPI programs. We encourage all surveyors to develop a general understanding of this tool, and become knowledgeable regarding how providers may access the relevant information about Common Formats.

title: AHRQ Common Formats - Information for Hospitals and State Survey Agencies (SAs) - Comprehensive Patient Safety Reporting Using AHRQ Common Formats

memo_number: 13-20-Acute Care

posting_date: Fri, 15 Mar 2013 12:00:00 -0400

summary: • Various Burden Reduction Regulations Adopted: • On October 24, 2011, the Centers for Medicare & Medicaid Services (CMS) published a final rule revising the ASC Patient Rights regulation at 42 CFR 416.50, effective December 23, 2011 (76 FR 65886). • On November 30, 2011, CMS published the Hospital Outpatient Prospective Payment System rule, effective January 1, 2012 (76 FR 74122). The rule included revisions to 42 CFR 489.20(w), governing required notice to patients by hospitals and CAHs that do not have an doctor of medicine (MD) or doctor of osteopathy (DO) present in the hospital or CAH at all times. • On May 16, 2012, CMS published two final rules (77 FR 29002 & 77 FR 29034) which included provisions: • For Hospitals: Revisions of the Conditions of Participation (CoPs) concerning governing body, patient’s rights, medical staff, nursing services, medical records, pharmaceutical services, infection control, outpatient services and transplant center organ recovery and receipt. • For CAHs: Revisions of the CoPs concerning definitions, personnel qualifications, physical plant and environment, and surgical services. • For ASCs: Revision of the Condition for Coverage (CfC) for environment. • State Operations Manual (SOM) Revisions: Appendices A (hospitals), W (CAHs) and L (ASCs) are revised to reflect these final rules, except that transplant center guidance will be updated separately. In addition, we are taking this opportunity to make minor technical corrections to Appendix L. • Automated Survey Processing Environment (ASPEN) Changes: ASPEN regulatory text and tags have been updated for hospitals and CAHs. ASC updates will be made in ASPEN at a later date. Some tags have been renumbered, consolidated or deleted. A crosswalk from the old to the new tags is provided.

title: Guidance for Hospitals, Critical Access Hospitals (CAHs) and Ambulatory Surgical Centers (ASCs) Related to Various Rules Reducing Provider/Supplier Burden

memo_number: 13-21-ALL

posting_date: Fri, 22 Mar 2013 12:00:00 -0400

summary: Survey Findings Posted on http://www.cms.gov: In July 2012, the Centers for Medicare & Medicaid Services (CMS) began posting redacted Statements of Deficiencies (CMS-2567s) for skilled nursing facilities and nursing facilities on Nursing Home Compare. In March 2013, CMS began posting CMS-2567s for short-term acute care hospitals and critical access hospitals (CAHs) for surveys based on complaint investigations. This memorandum describes the contents and location of those files. • Other Web-based Tools Based on These Data: At least two additional websites, provided by private parties (ProPublica and the Association for Health Care Journalists), publish information based on the CMS-2567 data. These websites are independent of CMS. CMS does not endorse or sponsor any particular private party application. • Plans of Correction (POC): The posted CMS data do not contain any POC information. State Survey Agencies (SAs) and CMS Regional Offices (RO) may see an increase in requests for both the CMS-2567 and any associated POCs. • Question & Answers: We plan to issue an update to this memorandum that will include an attachment of frequently asked questions in order to provide answers to other queries that may arise.

title: Access to Statements of Deficiencies (CMS-2567) on the Web for Skilled Nursing Facilities, Nursing Facilities, Hospitals,& Critical Access Hospitals

memo_number: 13-15-NH

posting_date: Fri, 08 Mar 2013 12:00:00 -0500

summary: This memorandum replaces Survey and Certification memorandum S&C-04-08 dated November 13, 2003, which discusses physician delegation of tasks in SNFs and NFs. Guidance revision: This memo provides clarification of Federal guidance related to physician delegation of certain tasks in SNFs and NFs to non-physician practitioners (NPPs; formerly “physician extenders”) such as nurse practitioners, physician assistants, or clinical nurse specialists Implements Section 3108 of the Affordable Care Act (ACA): Implements section 3108 of the Affordable Care Act, which adds physician assistants to the list of practitioners that can perform Skilled Nursing Facility (SNF) level of care certifications and re-certifications. Co-signing of orders: Clarifies policy on co-signing orders in SNFs and NFs.

title: Physician Delegation of Tasks in Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)

memo_number: 13-14-ALL

posting_date: Fri, 08 Mar 2013 12:00:00 -0500

summary: Luer Misconnections continue to result in adverse events and deaths – Luer connectors easily link many medical components, accessories, and delivery systems. Clinicians, in any type of provider or supplier setting, can mistakenly connect the wrong devices and deliver substances through the wrong route. Despite numerous alerts and warnings, a patient’s blood pressure tubing was recently misconnected to an intravenous (IV) line in an ambulatory surgery center (ASC) resulting in a patient death. • Adverse Event Complaint Investigation: During a complaint investigation for an adverse event involving delivery of an incorrect substance or utilization of an incorrect delivery route, surveyors must be alert to whether the event involved misconnection of a Luer device. If so, surveyors must determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse event. • Facility Reporting to Food & Drug Administration (FDA): Surveyors should encourage health care facilities to report problems with Luer misconnections to the FDA, even if no adverse event occurred.

title: Luer Misconnection Adverse Events

memo_number: 13-13-NH

posting_date: Fri, 01 Mar 2013 12:00:00 -0500

summary: New Dining Practice Standards: An interdisciplinary task force, sponsored by the Pioneer Network and the Rothschild Foundation, has released new dining practice recommendations for nursing home residents. • Expanding Diet Options for Older Individuals: Research has indicated that many older individuals may not need to be limited to very restrictive diets, pureed foods, and thickened liquids even though they may have many chronic conditions. Conversely, restricting food choices can result in loss of appetite and eventual weight loss. • Surveyor Training Video: The Centers for Medicare & Medicaid Services (CMS) is providing a new 24-minute video training product to all survey agencies with information on new dining standards of practice and therapeutic diets. This video, which is an introduction to the New Dining Practice Standards, was developed by several national professional organizations.

title: Information Only: New Dining Standards of Practice Resources are Available Now

memo_number: 13-17-NH

posting_date: Fri, 08 Mar 2013 12:00:00 -0500

summary: This memorandum replaces a previous version of S&C: 12-46-NH dated September 27, 2012. Revisions: Additional revisions have been made to Surveyor Guidance at F tag 322 in Appendix PP of the State Operations Manual (SOM) and the associated training slides since the release of S&C 12-46 on September 27, 2012. The revisions include: o Revision of the Regulatory Language format. o Additional clarification regarding the Centers for Medicare and Medicaid Services (CMS) expanded definition of “Naso-Gastric tubes.” o Updating the Power Point training slides. • Advance Copy Interpretive Guidelines: Revised advance copy of surveyor guidance is included in this memorandum. • Power Points: The revised Power Point training material with speaker notes is provided.

title: F tag 322—Naso-Gastric Tubes - Revised Advance Copy

memo_number: 13-18-ESRD

posting_date: Fri, 08 Mar 2013 12:00:00 -0500

summary: This Memo Updates and Supersedes SC13-01-ESRD. Roll Out of the ESRD Core Survey Training: Roll-out of the new ESRD Core Survey process began on November 28, 2012. • FY 2013 Training: Core training is mandatory for all ESRD surveyors. Training spots for FY 2013 are in high demand so prioritize attendance, and register surveyors in the Total Learning Management System (LMS) as soon as possible. As much as possible, we seek to train “teams” of State ESRD surveyors instead of waiting to train States as a whole. • Core ESRD Surveys versus traditional ESRD Surveys: States may simultaneously have a team(s) of ESRD surveyors doing ESRD Core Surveys and a team(s) doing traditional ESRD surveys. CMS will continue to support both survey processes until all ESRD surveyors are trained in the ESRD Core Survey process. • Designating ESRD Core Surveys in Automated Survey Processing Environment (ASPEN): ESRD surveyors must designate their ESRD Core surveys in ASPEN. • Surveyor Technical Assistant for Renal Disease (STAR) Updates: CMS will continue to support STAR 3.4 for the ESRD surveyors who are doing the traditional ESRD surveys. We are currently revising STAR for use with the ESRD Core Survey process. • Implementation Support: As a supplement to traditional support for survey decisions through the State Agencies and Regional Offices, a specialized mailbox will provide additional support: ESRDCoreSurvey@cms.hhs.gov.

title: Revised Roll-Out of the New End Stage Renal Disease (ESRD) Core Survey Process

memo_number: 13-16-NH

posting_date: Fri, 08 Mar 2013 12:00:00 -0500

summary: This memorandum replaces a previous version of S&C: 12-47-NH dated September 27, 2012. Revisions: Additional revisions have been made to Surveyor Guidance at F tag 155 in Appendix PP of the State Operations Manual (SOM) and the associated training slides since the release of S&C 12-47 on September 27, 2012. The revisions include: o Removal of the term “right to accept” when referring to medical and surgical treatment. o Addition of guidance specific to experimental research. o Clarification that §483.10(b)(8) applies only to adult residents and not all residents regardless of age. o Addition of definition for “Investigational or experimental drugs.” o Updating the Investigative Protocol. o Updating the Power Point training slides. • Advance Copy Interpretive Guidelines: Revised advance copy of surveyor guidance is included in this memorandum. • Power Points: The revised Power Point training material with speaker notes is provided.

title: F tag 155-- Advance Directives- Revised Advance Copy

memo_number: 13-12- NH

posting_date: Fri, 01 Mar 2013 12:00:00 -0500

summary: • Notice: The Centers for Medicare & Medicaid Services (CMS) will release a ninth solicitation for the National Background Check Program (NBCP) for any States or U.S. Territories that were unable to meet the previous deadline for submitting their applications under the previous solicitation. • Application Deadline: Applications will be due on May 31, 2013.

title: Notice -Ninth Opportunity National Background Check Program Funding

memo_number: S&C 13-09-NH EXPIRED

posting_date: Tue, 02 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Clarification of Interpretive Guidance at F Tag 441-Laundry and Infection Control EXPIRED

memo_number: 13-11- ICF/IID

posting_date: Fri, 08 Feb 2013 12:00:00 -0500

summary: The Burden Reduction Rule I removed the time limited agreement for certification of ICF/IID’s – The regulation at §442.15 was changed to provide that provider agreements for ICF/IID’s would remain in effect as long as the facility remains in compliance with the Conditions Of Participation (COP’s). Regulations at §442.109 through §442.111 are also changed to reflect this change. • The rule was published May 16, 2012 – Beginning on that date, ICF/IID’s are no longer subject to time-limited agreements. However, they are to be surveyed for re-certification an average of every 12 months and at least once every 15 months. • If during a survey the survey agency finds a facility does not meet the standards for participation the facility may remain certified if the survey agency makes two determinations – The facility may maintain its certification if the survey agency finds Immediate Jeopardy doesn’t exist, and if the facility provides an acceptable plan of correction. • An ICF/IID may be decertified under procedures outlined in Section 3012 of the State Operations Manual. More specifically, a facility may be decertified if an immediate jeopardy finding remains unabated after 23 days or if it fails to regain compliance with conditions of participation after 90 days.

title: Intermediate Care Facilities for the Intellectually Disabled (ICF/IID) No Longer Certified Under Time-Limited Agreements

memo_number: 13-10-Transplant

posting_date: Fri, 01 Feb 2013 12:00:00 -0500

summary: Development of Transplant Policy Crosswalk - CMS, the Health Resources and Services Administration (HRSA) and the OPTN Contractor, the United Network for Organ Sharing (UNOS), have collaboratively developed a document that compares OPTN policy and CMS requirements and identifies areas of overlap. The crosswalk summarizes how CMS and OPTN conduct their oversight activities and what surveyors review during their onsite visits. • Ongoing Efforts to Address Survey Process and Overlap - This Crosswalk is the first step in reviewing the two sets of oversight activities to identify potential policy changes and/or to improve the efficiencies in the survey process. • Background Information: The material in this memorandum is largely informational in nature, designed to assist surveyors in better understanding OPTN requirements and the manner in which CMS and OPTN requirements mesh.

title: Crosswalk Guide to the Organ Procurement and Transplant Network (OPTN) and the Centers for Medicare & Medicaid Services (CMS) Oversight of Organ Transplant Programs

memo_number: 13-08--Hospitals

posting_date: Fri, 25 Jan 2013 12:00:00 -0500

summary: LTCH Moratorium Expired: The statutory LTCH moratorium expired as of December 29, 2012. The LTCH moratorium prevented, with certain exceptions, the establishment of new LTCHs, increasing existing LTCHs’ number of certified beds, or the establishment of a satellite by an existing LTCH.

title: Expiration of the Long-Term Care Hospital (LTCH) Moratorium

memo_number: 13-05-NH

posting_date: Fri, 14 Dec 2012 12:00:00 -0500

summary: Preview of Nursing Home QAPI materials: The Centers for Medicare & Medicaid Services (CMS) will make a core set of introductory materials available on the CMS QAPI website by February 2013. Prior to that release, CMS is making QAPI at a Glance available in draft form for advance previewing by Quality Improvement Organizations (QIOs), State Survey Agencies, and Regional Offices; • QAPI at a Glance: QAPI at a Glance is a step-by-step guide that provides tools and resources to help nursing homes establish a foundation for QAPI; • ACA Provision: Section 6102(c) of the Affordable Care Act directs the Secretary to provide technical assistance and promulgate regulations for each nursing home to implement a QAPI system, and permits the Secretary to sequence these actions so the technical assistance is available prior to the regulations.

title: Preview of Nursing Home Quality Assurance & Performance Improvement (QAPI) Guide – QAPI at a Glance

memo_number: S&C-13-07-CLIA EXPIRED

posting_date: Thu, 11 Dec 2025 14:00:00 -0500

summary: Please check the downloads section for the most current version of the memo.

title: EXPIRED: Release of CLIA Brochure #10, What Do I Need to Do to Assess Personnel Competency?

memo_number: 13-06 - NH

posting_date: Fri, 14 Dec 2012 12:00:00 -0500

summary: Notice: The Centers for Medicare & Medicaid Services (CMS) will release an eighth solicitation for the National Background Check Program (NBCP) for any States or U.S. Territories that were unable to meet the previous deadline for submitting their applications under the previous solicitation. • Application Deadline: Applications will be due on January 31, 2013.

title: Notice - Eighth Opportunity National Background Check Program Funding

memo_number: 13-04-IRF

posting_date: Fri, 30 Nov 2012 12:00:00 -0500

summary: • Certification Form Processing: The Centers for Medicare & Medicaid Services (CMS) is revising the process for the Regional Offices (RO) and State Agency (SA) review of the Forms CMS 437A and 437B (Rehabilitation Criteria Worksheets for Rehabilitation Hospitals or Rehabilitation Units in acute care hospitals and the Certification/Attestation Statement State Operations Manual (SOM) Exhibit 127). • Revised Time Frame: Effective November 1, 2012, the IRFs will be reviewed once every three years (consistent with the interval for other hospital surveys). • Work Load Implications: A decrease in SA and RO workload is expected. Implementation will be phased in so that on the effective date, SAs will review the documentation for the excluded status for one third of the IRFs in their State each year.• Revised Time Frame: Effective November 1, 2012, the IRFs will be reviewed once every three years (consistent with the interval for other hospital surveys). • Work Load Implications: A decrease in SA and RO workload is expected. Implementation will be phased in so that on the effective date, SAs will review the documentation for the excluded status for one third of the IRFs in their State each year.

title: Collection of Information from Inpatient Rehabilitation Facilities (IRFs)

memo_number: 13-03-Hospital

posting_date: Fri, 09 Nov 2012 12:00:00 -0500

summary: Patient Safety Initiative: The Centers for Medicare & Medicaid Services (CMS) is continuing to test revised surveyor worksheets for assessing compliance with three hospital Conditions of Participation (CoPs): Quality Assessment and Performance Improvement (QAPI), Infection Control, and Discharge Planning. We are focusing on compliance with these CoPs as a means to reduce hospital-acquired conditions (HACs), including healthcare associated infections (HAIs), and preventable readmissions. • Draft Worksheets Made Public: Via this memorandum we are making the revised draft worksheets publicly available. As was the case previously, there may be additional revisions to the worksheets at the end of FY 2013.

title: Patient Safety Initiative FY 2013 Pilot Phase – Revised Draft Surveyor Worksheets

memo_number: 13-01-ESRD

posting_date: Fri, 02 Nov 2012 12:00:00 -0400

summary: Core Survey Pilot: ESRD surveyors in 11 states completed more than 100 surveys during the pilot phase of the new ESRD Core Survey during July through September 2012. The Core-trained surveyors in the pilot States may continue to use the Core Survey process. • New Process Results: Initial data analysis shows continued effectiveness while reducing survey time. • Training Plan: National training on the new ESRD Core Survey process starts November 28, 2012: o The 3-day ESRD Core Conversion Survey Course is for experienced ESRD surveyors. o The 4-day ESRD Basic Technical Core Course is for new ESRD surveyors. • State Procedures: All ESRD surveyors need to designate their surveys as either “Traditional” or “Core” in Automated Survey Processing Environment (ASPEN). • STAR Update Schedule: Updates to the ESRD computer-based survey, Surveyor Technical Assistant for Renal (STAR), will be in two phases: o STAR Lite will highlight Core elements and will be available summer 2013. o STAR Brite will be a total conversion to the Core survey process and will be available at a later date. • Implementation Support: In addition to traditional support for survey decisions through the State Agencies and Regional Offices, a specialized mailbox will provide additional support: ESRDCoreSurvey@cms.hhs.gov.

title: The Roll-Out of the New End Stage Renal Disease (ESRD) Core Survey Process

memo_number: 13-02-NH

posting_date: Fri, 02 Nov 2012 12:00:00 -0400

summary: We are providing clarification on three specific topics related to medication errors and pharmacy services: • Medication Errors: Potential medication errors related to medication administration via feeding tube and administration timing for metered dose inhalers and proton pump inhibitors and survey implications. • Medication Administration Practices: The practice of “borrowing” medications and issues related to diversion, control, reconciliation and disposal of medications, including fentanyl patches. • Medication Regimen Reviews for Stays under 30 days and/or Changes in Condition: The need for pharmacist medication regimen reviews when a resident experiences a change in condition and/or for residents admitted for less than 30 days.

title: Nursing Homes - Clarification of Guidance related to Medication Errors and Pharmacy Services

memo_number: 12-47- NH

posting_date: Thu, 27 Sep 2012 12:00:00 -0400

summary: Revisions: Revisions have been made to Surveyor Guidance at F tag 155 in Appendix PP of the SOM, to include resident’s rights to: o Establish Advance Directives; and o Accept or decline treatments. • Advance Copy Interpretive Guidelines: Advance copy of surveyor guidance revision is included in this memorandum. • Power Points: Power Point Training material with speaker notes for Centers for Medicare & Medicaid Services (CMS) Regional Offices (ROs) and State Survey Agencies (SAs) to be used to train surveyors on this revision to F tag 155 in the SOM are provided.

title: F tag 155-- Advance Directives- Advance Copy

memo_number: 12-45-NH

posting_date: Thu, 27 Sep 2012 12:00:00 -0400

summary: Revisions to Appendix P of the SOM: Survey Protocols for LTC Facilities have been revised for the Traditional Survey process Tasks 1-5C to reflect changes for the: - Minimum Data Set (MDS) 3.0; - New Quality Measures (QM) Reports; - Revised CMS forms 672 and 802, 802S and 802P; and - Sampling and reviewing residents receiving psychopharmacological medications, specifically antipsychotic medications. • Revisions to Chapter 9 of the SOM: Various Exhibits including survey forms have been revised to accommodate changes for MDS 3.0 and the new QM Reports; and • New QM Reports: Available for use in the Traditional Survey Process.

title: Advance Copy of Interim Guidance - Revisions to State Operations Manual (SOM), Appendix P-Traditional Survey Protocol for Long-Term Care (LTC) Facilities and Chapter 9/Exhibits including Survey Forms 672, 802, 802S and 802P

memo_number: 12-48-NH

posting_date: Thu, 27 Sep 2012 12:00:00 -0400

summary: Revisions: Revisions have been made to Guidance to Surveyors at F tag 309 in Appendix PP of SOM. • Power Points: Power Point training material with speaker notes for Centers for Medicare & Medicaid Services (CMS) Regional Offices (ROs) and State Survey Agencies (SAs) to be used to train surveyors on this revision are provided.

title: F tag 309—Quality of Care- Advance Copy

memo_number: 12-46-NH

posting_date: Thu, 27 Sep 2012 12:00:00 -0400

summary: • Revision to F tag 322: Revisions have been made to Guidance to Surveyors at F tag 322 in Appendix PP of SOM concerning Feeding Tubes. • Collapsed F tag 321: F tag 321 is deleted and the regulatory language and guidance moved to F tag 322. • Training: Power Point training material with speaker notes for Centers for Medicare & Medicaid Services (CMS) Regional Offices (ROs) and State Survey Agencies (SAs) to be used to train surveyors on this revision to F tag 322 in the SOM are provided.

title: F tag 322—Feeding Tubes-Advance Copy

memo_number: 12-43-Hospice

posting_date: Fri, 14 Sep 2012 12:00:00 -0400

summary: •Extraordinary Circumstances due to Nursing Shortage: The period of time has been extended for hospices to qualify for an “extraordinary circumstance” exemption when they believe that the nursing shortage has affected their ability to directly hire sufficient numbers of nurses. •Extension: The effective date of this policy has been extended from September 30, 2012 to September 30, 2014.

title: Impact of Nursing Shortage on Hospice Care

memo_number: 12-44-NH

posting_date: Fri, 14 Sep 2012 12:00:00 -0400

summary: The Affordable Care Act: Section 6121 requires the Centers for Medicare & Medicaid Services (CMS) to ensure that nurse aides receive regular training on how to care for residents with dementia and on preventing abuse. CMS created this training program to address the requirement for annual nurse aide training on these important topics. • Course Content: The Hand in Hand training materials consist of an orientation guide and six one-hour video-based modules, each of which has a DVD and an accompanying instructor guide. Though Hand in Hand is targeted to nurse aides, it may be valuable to all nursing home caregivers, administrative staff and surveyors.

title: “Hand in Hand: A Training Series for Nursing Homes,” on Person-Centered Care of Persons with Dementia and Prevention of Abuse

memo_number: 12-42-NH

posting_date: Fri, 24 Aug 2012 12:00:00 -0400

summary: The memo was revised on August 31, 2012 to include additional stakeholders. •Partnership to Improve Dementia Care in Nursing Homes - In 2012, Centers for Medicare & Medicaid Services (CMS) launched the Partnership to Improve Dementia Care in Nursing Homes to promote comprehensive dementia care and therapeutic interventions for nursing home residents with dementia-related behaviors. •Stakeholder Letters - Stakeholders are sending letters to support the Partnership to Improve Dementia Care in Nursing Homes. •Please Share - Please share information about these documents as you communicate with facilities in your State and in other appropriate communication media (such as State website).

title: Request to Convey Information: Partnership to Improve Dementia Care in Nursing Homes

memo_number: 12-41-ESRD

posting_date: Fri, 27 Jul 2012 12:00:00 -0400

summary: •The S&C QAEE Initiative #1, the ESRD Core Survey process began a three-month Pilot Test phase on July 1, 2012. •For 3 months (July through September 2012), 11 States will Pilot Test the new ESRD Core Survey process. •Following the Pilot Test phase and subsequent updating of Core Survey Process and Materials, the ESRD Core Survey process will be implemented nationally in FY 2013. •A sample of draft Core Survey materials are attached for your information.

title: Pilot Surveys Begin for the Survey & Certification (S&C) Quality Assurance Efficiency & Effectiveness (QAEE) Initiative #1: The End Stage Renal Disease (ESRD) Core Survey Process

memo_number: 12-40 - NH

posting_date: Fri, 13 Jul 2012 12:00:00 -0400

summary: •Notice: The Centers for Medicare & Medicaid Services (CMS) will release a seventh solicitation for the National Background Check Program (NBCP) for any States or U.S. Territories that were unable to meet the previous deadline for submitting their applications under the previous solicitation. •Application Deadline: Applications will be due on October 30, 2012.

title: Notice - Seventh Opportunity National Background Check Program Funding

memo_number: 12-39-NH

posting_date: Fri, 06 Jul 2012 12:00:00 -0400

summary: Nursing Home Action Plan: The 2012 Nursing Home Action Plan will be posted on the CMS website at http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/NHs.html.

title: 2012 Centers for Medicare & Medicaid Services (CMS) Nursing Home Action Plan

memo_number: 12-38-NH

posting_date: Fri, 29 Jun 2012 12:00:00 -0400

summary: Quality Assurance and Performance Improvement (QAPI) Activities: Section 6102(c) of the Affordable Care Act mandates the Centers for Medicare & Medicaid Services (CMS) to establish standards and provide technical assistance to nursing homes on the development of best practices relating to QAPI. The CMS put forth several initiatives to implement these provisions that include: •Refinement of QAPI Tools and Resources: Ongoing development of QAPI tools and resources that nursing homes may use to design and implement an effective QAPI program. •Launch of a QAPI Demonstration: Demonstration project in 17 nursing homes in 4 States to test tools and resources and provide technical assistance to nursing homes in QAPI implementation. •Rollout of QAPI materials: CMS will release materials later this calendar year that will support nursing homes in QAPI implementation. •Draft of the QAPI Regulation: CMS is in the process of drafting a new QAPI regulation. •Launch of the Nursing Home Quality Improvement Questionnaire: The CMS has launched a nursing home quality improvement questionnaire using an independent contractor. The data collection period is from June 25 through September 28, 2012.

title: Quality Assurance and Performance Improvement (QAPI) in Nursing Homes- Activities Related to QAPI Implementation

memo_number: 12-35-ALL

posting_date: Fri, 15 Jun 2012 12:00:00 -0400

summary: •Under certain conditions, it is permissible to repackage single-dose vials or single use vials (collectively referred to in this memorandum as “SDVs”) into smaller doses, each intended for a single patient: The United States Pharmacopeia (USP) has established standards for compounding which, to the extent such practices are also subject to regulation by the Food and Drug Administration (FDA), may also be recognized and enforced under §§501 and 502 of the Federal Food, Drug and Cosmetics Act (FDCA). These USP compounding standards include USP General Chapter 797, Pharmaceutical Compounding - Sterile Preparations (“USP <797>”). Under USP <797>, healthcare facilities may repackage SDVs into smaller doses, each intended for use with one patient. Among other things, these standards currently require that: •The facility doing the repackaging must use qualified, trained personnel to do so, under International Organization for Standardization (ISO) Class 5 air quality conditions within an ISO Class 7 buffer area. All entries into a SDV for purposes of repackaging under these conditions must be completed within 6 hours of the initial needle puncture. •All repackaged doses prepared under these conditions must be assigned and labeled with a beyond use date (BUD), based on an appropriate determination of contamination risk level in accordance with USP <797>, by the licensed healthcare professional supervising the repackaging process. •Administering drugs from one SDV to multiple patients without adhering to USP <797> standards is not acceptable under CMS infection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the Centers for Disease Control and Prevention (CDC), ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately. •Deficiency Citation Policy: Healthcare facilities that do not adhere to USP <797> standards but reuse SDVs for multiple patients must be cited for deficiencies under the applicable infection control standards for each type of provider/supplier. On the other hand, healthcare facilities that utilize appropriately stored medications, derived from repackaged SDVs and prepared in accordance with USP <797> must not be cited solely on the basis of this practice.

title: Safe Use of Single Dose/Single Use Medications to Prevent Healthcare-associated Infections

memo_number: 12-37-NH

posting_date: Fri, 22 Jun 2012 12:00:00 -0400

summary: •Nursing Home Compare: The Centers for Medicare & Medicaid Services (CMS) will launch a re-designed Nursing Home Compare website on July 19, 2012. •New Information: Website will add new MDS 3.0 quality measures, detailed inspection reports (CMS 2567s), nursing home ownership information, and additional staffing data.

title: Redesign Updates to the Nursing Home Compare Website

memo_number: 12-36-HOSPITAL

posting_date: Fri, 15 Jun 2012 12:00:00 -0400

summary: Revised Hospital Regulations Effective July 16, 2012: The Centers for Medicare & Medicaid Services (CMS) has adopted a number of changes to the hospital CoPs and is in the process of developing interpretive guidelines to assist surveyors in assessing compliance under the revised regulations. Due to the number and complexity of the revisions, this guidance may not be published for all of the affected requirements by July 16th, the effective date of the final regulations. Hospital Governing Body and Medical Staff: In the case of the new requirement for a hospital’s governing body to include a member of the medical staff under §482.12, CMS is presently reconsidering this policy in light of the numerous comments that have been received since publication of the final rule. Therefore, •Surveyors should not attempt to assess compliance with this new requirement or cite deficiencies related to this specific requirement without receiving instructions from CMS. •Accrediting organizations with CMS-approved hospital accreditation programs are not expected to revise their standards or survey processes related to this particular requirement until we have addressed the issue completely.

title: Revised Hospital Conditions of Participation (CoPs) – Governing

memo_number: 12-34-NH

posting_date: Fri, 01 Jun 2012 12:00:00 -0400

summary: Revised Guidance for Tag F492: Current guidance in Appendix PP of the SOM for Tag F 492, 42 CFR §483.75(b) and (c) States that this tag should be cited only when the authority having jurisdiction has both made a determination of noncompliance and has taken a final adverse action as a result. There has been confusion as to whether this requirement may be cited when a facility simply does not meet a State regulation. This memorandum clarifies and revises the Centers for Medicare & Medicaid Services (CMS) guidance to Surveyors in Appendix PP of the SOM regarding citations under Tag F492.

title: Clarification and revisions to Interpretive Guidance at F Tag 492, as Part of Appendix PP, State Operations Manual (SOM) for Long Term Care (LTC) Facilities

memo_number: 12-30-ALL

posting_date: Fri, 18 May 2012 12:00:00 -0400

summary: Insulin Pen devices: The Centers for Medicare & Medicaid Services (CMS) has recently received reports of use of insulin pens for more than one patient, with at least one 2011 episode resulting in the need for post-exposure patient notification. These reports indicate that some healthcare personnel do not adhere to safe practices and may be unaware of the risks these unsafe practices pose to patients. Insulin pens are meant for use by a single patient only. Each patient/resident must have his/her own. Sharing of insulin pens is essentially the same as sharing needles or syringes, and must be cited, consistent with the applicable provider/supplier specific survey guidance, in the same manner as re-use of needles or syringes.

title: Use of Insulin Pens in Health Care Facilities

memo_number: 12-33-AO

posting_date: Fri, 25 May 2012 12:00:00 -0400

summary: Accreditation Organization (AO) Deeming Approval for RHCs: • The Centers for Medicare & Medicaid Services (CMS) has recognized AAAASF as a national AO with an approved accreditation program for RHCs seeking to participate in the Medicare or Medicaid programs. • This approval provides RHCs with an accreditation option which previously did not exist.

title: Approval of the American Association for Accreditation of Ambulatory Surgery Facilities’ (AAAASFs’) Rural Health Clinic (RHC) Accreditation Program

memo_number: 12-31-HAI

posting_date: Fri, 18 May 2012 12:00:00 -0400

summary: •Notification: The Centers for Medicare & Medicaid Services (CMS) will conduct a Healthcare Associated Infections (HAI) Prevention Program Environmental Scan of State Survey Agency Training Coordinators and State HAI Coordinators. •State Selection: All states except those already contacted during pilot •Effective Date: The environmental scan will begin in May 2012.

title: Environmental Scan of State Survey Agency Training Coordinators and Healthcare Associated Infections (HAI) Coordinators Nursing Home HAI Prevention programs

memo_number: 12-32-Hospital

posting_date: Fri, 18 May 2012 12:00:00 -0400

summary: •Patient Safety Initiative: The Centers for Medicare & Medicaid Services (CMS) is testing three revised surveyor worksheets for assessing compliance with three hospital Conditions of Participation (CoPs): Quality Assessment and Performance Improvement (QAPI), Infection Control, and Discharge Planning. We are focusing on compliance with these CoPs as a means to reduce hospital-acquired conditions (HACs), including healthcare associated infections (HAIs), and preventable readmissions. •Draft Worksheets Made Public: Via this memorandum we are making these revised draft worksheets publicly available. We emphasize there may be additional revisions based on information gathered during the pilot test phase, which will end sometime in FY 2013.

title: Patient Safety Initiative Pilot Phase – Revised Draft Surveyor Worksheets

memo_number: S&C: 12-28-CLIA EXPIRED 2025-12-04

posting_date: Tue, 09 Dec 2025 16:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Process Change for Histocompatibility Laboratories

memo_number: 12-29-ALL

posting_date: Fri, 11 May 2012 12:00:00 -0400

summary: •Final Rule: The final rules CMS-9070-F and CMS-3244-F are on display and will publish on May 16, 2012. The rules will be effective July 16, 2012. •Overview: The final rules increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care, or that divert providing high quality patient care.•Background: In Executive Order 13563, “Improving Regulations and Regulatory Review”, the President directed each executive agency to establish a plan for ongoing retrospective review of existing significant regulations, to identify those rules that can be eliminated as obsolete, unnecessary, burdensome, or counterproductive or that can be modified to be more effective, efficient, flexible, and streamlined.

title: Publication of Two Final Rules “Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction CMS-9070-F” and “Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation CMS-3244-F”

memo_number: 12-27-Hospital/RHC

posting_date: Fri, 20 Apr 2012 12:00:00 -0400

summary: Additional guidance is provided on determining rural location for hospital swing bed & Rural Health Clinic (RHC) eligibility: •A hospital seeking swing bed status or a clinic seeking RHC certification must be located outside an area delineated as “urbanized” by the Census Bureau. •The Census Bureau has transitioned to a NEW American FactFinder. Detailed instructions and screenshots are provided on utilizing the NEW American FactFinder when making rural determination. •NEW American FactFinder will not use 2010 census data to determine whether a specific address is located in an urbanized area or urban cluster until the fall of CY 2012. However, if an applicant has obtained a written communication from the Census Bureau that a specific address is either non-urbanized or in an urban cluster, the RO must accept that information in making a rural determination. This applies even if the written communication contradicts the American FactFinder data.

title: Utilizing the US Bureau of the Census’ (Census Bureau) American FactFinder Database when making a Rural Area Location Determination

memo_number: 12-26-HHA

posting_date: Fri, 06 Apr 2012 12:00:00 -0400

summary: • Survey Activity Required as a Result of the Deactivation of the Medicare Billing Privilege: CMS-1560-F amended the regulation at 42 CFR 424.540(b)(3) to require that, upon deactivation of a Home Health Agency’s (HHA) billing privileges, a survey to validate compliance with the Conditions of Participation (CoPs) must be performed before billing privileges can be reactivated. These surveys will be considered re-certification surveys and will be scheduled as a Tier IV priority.

title: Home Health Survey and Certification Activities Related to Program Safeguards: Deactivation

memo_number: 12-25-NH

posting_date: Fri, 30 Mar 2012 12:00:00 -0400

summary: The updated MDS 3.0 Manual(v1.08)and Item Subset (v.1.10.4)are posted for April 1, 2012 implementation. RAI Manual (v1.08) Errata – An errata document for the MDS 3.0 RAI Manual (v1.08) is posted and contains the replacement pages and describes and corrects seven issues present in the manual.

title: Revisions to the Minimum Data Set (MDS) 3.0 Resident Assessment Instrument (RAI) Manual and Item Subsets

memo_number: 12-24-ASC

posting_date: Fri, 30 Mar 2012 12:00:00 -0400

summary: Revised ASC patient rights regulation was effective December 23, 2011. Revisions include the removal of the requirement to provide notice of patient rights and disclosure of physician financial interest or ownership in advance of the date of the procedure. Appendix L of the State Operations Manual (SOM) will be revised accordingly.

title: Revisions to Ambulatory Surgical Center (ASC) Patient Rights Regulation

memo_number: S&C-12-22-NH EXPIRED

posting_date: Tue, 02 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Healthcare Associated Infections (HAI) Prevention Program Environmental Scan of State Survey Agency EXPIRED

memo_number: 12-19-Transplant

posting_date: Fri, 09 Mar 2012 12:00:00 -0500

summary: Living Donors Served by a Different Program. This letter addresses Medicare requirements for transplant programs and surveyor activities in which some or all of the services for a living donor are provided by a program other than the transplant program of the organ recipient. These can be ongoing arrangements between two hospitals or can be episodic arrangements as part of a single donation or multi-organ exchange. Responsibility of Recipient Transplant Program. The organ recipients transplant program must have evidence of a written agreement or contract with the living donor organ program and is responsible for ensuring that certain minimum quality standards are met for each donor organ it receives. Finalizes Interim Guidance, S&C 11-40-Transplant. This memorandum replaces the interim guidance that was previously released September 30, 2011.

title: Living Donor Services Occurring in Transplant Programs Other than that of the Organ Recipient: Requirements and Surveyor Guidance

memo_number: 12-21-LSC

posting_date: Fri, 09 Mar 2012 12:00:00 -0500

summary: Updates to Previous Instructions. This letter addresses updates to the Centers for Medicare & Medicaid Services policy regarding Capacity of the Means of Egress, Cooking Facilities, Heating, Ventilating, and Air Conditioning, and Furnishings, Mattresses, and Decorations.

title: Instructions Concerning Waivers of Specific Requirements of the 2012 Edition of the National Fire

memo_number: 12-23-ALL

posting_date: Fri, 16 Mar 2012 12:00:00 -0400

summary: On Thursday March 15, 2012 the Centers for Medicare & Medicaid Services (CMS) announced the Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents, a new effort designed to improve care for people living in nursing facilities who are enrolled in Medicare and Medicaid.

title: INFORMATION: Reducing Avoidable Hospitalizations among Nursing Facility Residents; State Survey

memo_number: 12-20-CLIA

posting_date: Fri, 09 Mar 2012 12:00:00 -0500

summary: The Centers for Medicare & Medicaid Services (CMS) is incorporating into the Interpretive Guidelines (IG), based on 42 CFR 493.1250, key concepts and graphics from Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol-23 (EP-23), Laboratory Quality Control Based on Risk Management, as alternative Clinical Laboratory Improvement Amendment (CLIA) Quality Control (QC) policy.

title: Implementing the Individualized Quality Control Plan (IQCP) for Clinical Laboratory Improvement Amen

memo_number: 12-18-Hospitals

posting_date: Fri, 02 Mar 2012 12:00:00 -0500

summary: Guidance concerning the protection of patient privacy and medical record information is clarified. This guidance is consistent with the standards under the Federal Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.Guidance concerning permitted incidental uses and disclosures is clarified and includes reasonable safeguards that must be in place to ensure patient privacy.Tags A-0441, A-0442 and A-0443 have been combined. It will take time for this guidance to be incorporated into a future ASPEN release. Prior to this conversion citations should be made only to Tag A-0441.

title: Hospital Patient Privacy and Medical Record Confidentiality

memo_number: 11-35-NH

posting_date: Fri, 12 Aug 2011 12:00:00 -0400

summary: August 11, 2017- Due to changes in federal requirements related to long-term care training components, the Centers for Medicare & Medicaid Services can no longer confirm that the trainings listed in this memo meet the training mandate for nurse aides in the topics of dementia care and the prevention of abuse. Therefore, this memo has been removed from the Survey & Certification -General Information website.

title: Mandate of Section 6121 of the Affordable Care Act for Nurse Aide Training in Nursing Homes

memo_number: 10-23-NH

posting_date: Mon, 12 Jul 2010 12:00:00 -0400

summary: A notice of proposed rule-making (NPRM), Independent IDR, Escrow, 50 Percent Reduction.

title: Publication of Proposed Rule Civil Money Penalties for Nursing Homes CMS-2435-P

memo_number: 12-11-NH

posting_date: Fri, 09 Dec 2011 12:00:00 -0500

summary: The Centers for Medicare & Medicaid Services (CMS) released a fifth solicitation for the National Background Check Program (NBCP) for any States or U.S. Territories that were unable to meet the previous deadline for submitting their applications under the previous solicitation.Applications are due February 28, 2012.

title: Notice - Fifth Opportunity National Background Check Program Funding

memo_number: 09-27

posting_date: Fri, 13 Mar 2009 12:00:00 -0400

summary: This memorandum provides updated guidance regarding the temporary mid-level staffing waiver for RHCs. This memo supersedes SC-09-14 issued November 21, 2008. This update will reduce burdens on existing RHCs resulting from the 1998 policy.

title: Updated Interim Guidance Regarding the Temporary Mid-Level Staffing Waiver for RHCs

memo_number: 09-07

posting_date: Fri, 17 Oct 2008 12:00:00 -0400

summary: This letter announces the introduction of the CLIA Laboratory Demographics Look-up link on the CMS CLIA Web site. The CLIA Laboratories Demographic Look-up link leads to demographic information about CLIA certified laboratories.

title: New Web Feature: Laboratories Demographic Look-Up

memo_number: 09-09

posting_date: Fri, 24 Oct 2008 12:00:00 -0400

summary: Attached is an advance copy of changes to Chapters 2 and 3 of the SOM and the Survey Protocol which will be included in Appendix X of the SOM.

title: Advance Copy - Organ Transplant Program State Operations Manual (SOM) and Survey Protocol

memo_number: 10-30-ESRD

posting_date: Fri, 10 Sep 2010 12:00:00 -0400

summary: ESRD Surveyor Web sites: The End Stage Renal Disease (ESRD) Program has four key Web sites to help keep State agencies informed about survey and certification data, information, and operations related to the various program areas.

title: End Stage Renal Disease (ESRD) Program Keeping Informed about Survey

memo_number: 10-13-AO

posting_date: Fri, 02 Apr 2010 12:00:00 -0400

summary: This memorandum announces CMS' decision to approve ACHC for recognition as a national accreditation program for hospices seeking to participate in the Medicare or Medicaid programs.

title: Approval of Deeming Authority of the Accreditation Commission for Health Care (ACHC) for Hospices

memo_number: 09-34

posting_date: Thu, 30 Apr 2009 12:00:00 -0400

summary: This memorandum reiterates current law and regulations and also guidance contained in Chapters 3 and 7 of the CMS State Operations Manual SOM that involve the release of the survey findings as reflected in the Statements of Deficiencies, commonly referred to as the 2567. Procedures for release of the Form CMS-2567 have not changed with the publication of 73 FR 53148, dated September 15, 2008 that amended 45 CFR Part 2 entitled "Testimony by Employees and the Production of Documents in Proceedings Where the United States Is Not a Party." More detailed information concerning the impact of this regulation will follow in the near future.

title: Release of Form CMS-2567 (Statement of Deficiencies) by State Survey Agencies (SAs)

memo_number: 10-16-Transplant

posting_date: Fri, 16 Apr 2010 12:00:00 -0400

summary: This letter addresses the CMS review and enforcement activities for transplant programs that are Medicare-approved under the CoPs, but no longer meet Medicare's patient and/or graft survival outcome requirements.

title: Outcome Deficiencies in Medicare-Certified Transplant Program: Procedures for Citation

memo_number: 10-33-NH

posting_date: Fri, 24 Sep 2010 12:00:00 -0400

summary: Guidance to Surveyors, Effective Date of the Revisions to Appendix PP of the SOM, Training Materials.

title: Advance Copy: Revisions to Appendix PP, State OpeGuidance to Surveyors for Long Term Care Facilities

memo_number: 09-38

posting_date: Fri, 15 May 2009 12:00:00 -0400

summary: The Recovery Act provides for a one-time cash benefit of $250 to certain eligible individuals who receive a Social Security benefit, Railroad Retirement pension, Veterans Administration disability pension, and Supplemental Security Income (SSI). The payments will begin in May of 2009 and be distributed by check or electronic transfer to eligible beneficiaries by June 4, 2009. Many residents in nursing homes will be eligible for this cash benefit (although some who receive SSI benefits at a reduced rate may not be eligible).

title: One-Time Cash Benefit to Nursing Home Residents

memo_number: 11-39-ALL

posting_date: Fri, 16 Sep 2011 12:00:00 -0400

summary: This memorandum provides updated guidance for the handling of subpoenas duces tecum and other written requests that seek disclosure of records in the possession of the State Survey Agency (SA) as a result of the SA's implementation of its Agreement with the Secretary, Health and Human Services under section 1864 of the Social Security Act (section 1864 Agreement).

title: Guidance for State Survey Agencies Responding to Requests for Survey Documents

memo_number: 08-09

posting_date: Fri, 11 Jan 2008 12:00:00 -0500

summary: When a nursing home (facility) receives food services from an off-site location, the surveyor must assess whether the facility is compliant with 42 C.F.R. 483.35(i) which states: a facility must procure food from sources approved or considered satisfactory by Federal, State, or local authorities.

title: Surveying Facilities that Receive Food Prepared by Off-Site Kitchens

memo_number: 11-40-Transplant

posting_date: Fri, 30 Sep 2011 12:00:00 -0400

summary: This letter addresses Medicare requirements for transplant programs and surveyor activities in which some or all of the services for a living donor are provided by a program other than the transplant program of the organ recipient. These can be ongoing arrangements between two hospitals or can be episodic arrangements as part of a single donation or multi-organ exchange.

title: Living Donor Services Occurring in Transplant Programs Other than that of the Organ Recipient

memo_number: 08-10

posting_date: Fri, 18 Jan 2008 12:00:00 -0500

summary: CMS has been asked to clarify the use of the Interpretive Guidance to Surveyors for Long Term Care Facilities in reviewing for compliance with the regulatory requirements for nursing homes. Surveyors must cite all deficiencies based on a violation of statutory and/or regulatory requirements.

title: Use of Interpretive Guidance by Surveyors for Long Term Care Facilities

memo_number: 09-46

posting_date: Wed, 24 Jun 2009 12:00:00 -0400

summary: Announces the release of the Evaluation of the Quality Indicator Survey (QIS)and the posting of the Executive Summary on the CMS Web site. Outlines Action Plan for future QIS Evaluation Initiatives.

title: Release of Report Evaluation of the Quality Indicator Survey (QIS)

memo_number: 08-11

posting_date: Fri, 08 Feb 2008 12:00:00 -0500

summary: CMS has approved the American Osteopathic Association (AOA) for recognition as a national accreditation program for CAHs. This recognition includes CAH distinct part units. The final notice of approval for AOA's deeming authority was published in the Federal Register November 23, 2007 (72 FR 65738) and was effective December 28, 2007. CAH distinct part units will now have a deemed accreditation option. States may continue to treat CAH distinct part surveys as a Tier 3 priority.

title: Accreditation Option for Critical Access Hospital (CAH) Distinct Part Units

memo_number: 12-04-NH

posting_date: Thu, 10 Nov 2011 12:00:00 -0500

summary: This memo reviews current interpretive guidelines for F323 reemphasizing adequate supervision of all residents.

title: Alert: Smoking Safety in Long Term Care Facilities

memo_number: 09-49

posting_date: Fri, 07 Aug 2009 12:00:00 -0400

summary: This memorandum amends the guidance contained in S&C-08-03, issued on November 5, 2007, concerning the workload priority for initial surveys of CAH DPUs. CAH DPU initial survey priority is changed from Tier 3 to Tier 4, effective October 1, 2009.

title: Initial Surveys of CAH Distinct Part Units (DPUs) Changed to Tier 4 Priority Status

memo_number: 12-05-Hospital

posting_date: Fri, 18 Nov 2011 12:00:00 -0500

summary: Revised memo updated 12/02/11.SOM Appendix A guidance concerning medication administration in hospitals is being updated to reflect current standards of practice related to timeliness of medications. Hospitals are expected to establish policies and procedures for the timing of medication administration that appropriately balance patient safety with the need for flexibility in work processes. Incorporate policy regarding standing orders from S&C-09-10.

title: Updated Guidance on Medication Administration, Hospital Appendix A of the State Operations Manual

memo_number: 12-12-ALL

posting_date: Fri, 09 Dec 2011 12:00:00 -0500

summary: Since 2001 there has been a 21.4% increase in the overall number of Medicare-certified providers to be surveyed. Among all types of facilities, the numbers of home health agencies (HHAs), ambulatory surgical centers (ASCs), and dialysis facilities (ESRD) have grown the fastest (increasing by 69.3%, 60.8%, and 37.3% respectively, between 2001 and 2010). New and expanded responsibilities have further increased the S&C workload. For example, due to improved Centers for Medicare & Medicaid Services (CMS) quality of care and safety expectations for dialysis facilities, average hours per ESRD survey recently increased by 37%. The fiscal year 2012 has already begun, and we expect it will still take some time before the full Congress acts on legislation to fund the FY2012 Centers for Medicare & Medicaid budget. However, early indications are that the budget level for Medicare survey & certification (S&C) will most likely be 10%-12% less than the level requested by the President. Therefore, we believe it is prudent to prepare now for a lower FY2012 funding level than previously expected. Fortunately, CMS and States have worked to develop a variety of methods to increase efficiency and effectiveness. While these efforts may not entirely address the difference between the requested and likely budget levels, they will mitigate negative effects. Additional efforts will be necessary, and expectations for FY2012 funding will need to be adjusted.

title: Prudent Action for the FY 2012 Medicare Survey & Certification (S&C) Budget

memo_number: 09-54

posting_date: Fri, 14 Aug 2009 12:00:00 -0400

summary: We made changes to surveyor guidance for Infection Control in Appendix PP of the SOM. The changes will provide clarification to nursing home surveyors when determining compliance with the regulatory requirements for infection control. The regulatory language will remain unchanged.

title: Issuance of Revisions to Interpretive Guidance at F Tag 441, as Part of Appendix PP, SOM

memo_number: 12-17-Hospitals

posting_date: Fri, 17 Feb 2012 12:00:00 -0500

summary: Outpatient services in hospitals may be ordered (and patients may be referred for hospital outpatient services) by a practitioner who is responsible for the care of the patient; licensed in, or holds a license recognized in the jurisdiction where he/she sees the patient; acting within his/her scope of practice under State law; and authorized by the medical staff to order the applicable outpatient services under a written hospital policy that is approved by the governing body. This includes both practitioners who are on the hospital medical staff and who hold medical staff privileges that include ordering the services, as well as other practitioners who are not on the hospital medical staff, but who satisfy the hospital's policies for ordering applicable outpatient services and for referring patients for hospital outpatient services.

title: Referring Practitioners Ordering Outpatient Services in Hospitals

memo_number: 09-12

posting_date: Fri, 07 Nov 2008 12:00:00 -0500

summary: SandC-08-23, issued May 30, 2008, updated Section 5140 of the SOM, concerning handling of hospital reports of deaths associated with the use of restraint or seclusion. Sections 5140.3 and 5140.4 are being revised further to streamline the process for disclosing restraint/seclusion death report data to Protection and Advocacy organizations (P and As). New Exhibits are added to facilitate the implementation of Data Use Agreements with P and As.

title: SOM Chapter 5 Update - Release of Person-Identifiable Data Related to Restraint/Seclusion Deaths

memo_number: 10-31-Hospice

posting_date: Fri, 17 Sep 2010 12:00:00 -0400

summary: This memorandum extends the period of time for hospice agencies to qualify for an "extraordinary circumstance" exemption when they believe that the nursing shortage has affected their ability to directly hire sufficient numbers of nurses. This policy exemption was first outlined in S&C-02-44.

title: Impact of Nursing Shortage on Hospice Care

memo_number: 08-19

posting_date: Fri, 09 May 2008 12:00:00 -0400

summary: The FDA has issued recalls for medications that have the potential for serious adverse reactions in patients/residents. It is important that all health care providers are aware of this information regarding recalled products.

title: Alert: Food and Drug Administration (FDA) Heparin Recall For All Provider Types

memo_number: 08-22

posting_date: Fri, 30 May 2008 12:00:00 -0400

summary: Effective immediately, HHAs and hospices may not accept physicians' rubber stamp signatures for their clinical record documentation. This memo updates S and C-04-35, published July 8, 2004

title: Signature Stamps for Home Health Agencies and Hospices

memo_number: 08-06

posting_date: Fri, 07 Dec 2007 12:00:00 -0500

summary: The Centers for Medicare & Medicaid Services (CMS) has conducted a comprehensive review of the Exhibits to the State Operations Manual (SOM). As a result, a number of Exhibits have been added, deleted, or revised.

title: Revisions to State Operations Manual (SOM) Exhibits

memo_number: 10-32-NH

posting_date: Fri, 17 Sep 2010 12:00:00 -0400

summary: The number of SFF slots for each State are adjusted to reflect the current population of nursing homes in each State and a ten percent increase in SFF slots nationally. New Computation of the Candidate List effective in the Fall 2010, the candidate list will be adjusted so that each SFF slot will have 5 candidates from which States may recommend selection.

title: Special Focus Facilities (SFF) Procedures

memo_number: 08-25

posting_date: Fri, 13 Jun 2008 12:00:00 -0400

summary: Attached is an advance copy of the Organ Transplant Interpretive Guidelines. These Interpretive Guidelines will also be published in a new Appendix X of the State Operations Manual.

title: Advance Copy - Organ Transplant Program Interpretive Guidelines

memo_number: S&C-09-35 EXPIRED

posting_date: Thu, 04 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Clinical Laboratory Improvement Amendments (CLIA) -- Impact of A/H1N1 Swine Flu on CLIA Operations

memo_number: 11-12-NH

posting_date: Fri, 11 Mar 2011 12:00:00 -0500

summary: The purpose of this letter is to explain the relationship between civil money penalty funds collected from nursing homes that have been out of compliance with Federal requirements, and programs designed to provide alternatives to nursing homes, such as the Money Follows the Person Rebalancing (MFP) Demonstration grant program.

title: Relationship Between Civil Money Penalty Funds Paid by Nursing Homes and the Money Follows the Perso

memo_number: 08-23

posting_date: Fri, 30 May 2008 12:00:00 -0400

summary: Section 5140 of Publication 100-07, the SOM, concerning deaths in Hospitals associated with the use of restraint or seclusion, has been revised to correspond to the regulatory requirements at 42 CFR 482.13(g) and to reflect operational procedures implemented since the revised regulation took effect in January, 2007. An advance copy of the revised SOM section 5140 is attached. The final version will be released as a Publications Manual transmittal later this year and may differ slightly from this advance copy.

title: SOM Chapter 5/Release of Person-Identifiable Data Related to Restraint/Seclusion Deaths to PA and As

memo_number: 09-11

posting_date: Fri, 07 Nov 2008 12:00:00 -0500

summary: This report evaluates the efforts to reduce the use of physical restraints after Congressional Passage of the 1987 Nursing Home Reform Act. Because of the hard work of practitioners, providers, advocates, and government agencies, the percentage of nursing home residents physically restrained daily substantially declined from 21.1 percent in 1991 to less than 5.0 percent in 2007.

title: Release of Report - Freedom from Unnecessary Physical Restraints: Two Decades of National Progress

memo_number: 09-36

posting_date: Wed, 06 May 2009 12:00:00 -0400

summary: To assist surveyors to observe signs of the H1N1 flu virus infection, and proper facility etiquette, a guidance document has been developed in collaboration with CDC. To assist in reporting any impact to State survey activities and providers that have been affected by the H1N1virus infection to the CMS Regional Office, a tracking tool has also been developed.

title: H1N1 Flu State Survey Agency Guidance and Provider Tracking Tools

memo_number: 08-26

posting_date: Fri, 13 Jun 2008 12:00:00 -0400

summary: The Medicare, Medicaid, and SCHIP Extension Act (MMSEA) (Pub. L. 110-173), enacted December 29, 2007, establishes a three-year moratorium on the designation of new long-term care hospitals (LTCH) or satellites, and on an increase of beds in an LTCH. The statute creates certain limited exceptions to the moratorium. The Centers for Medicare and Medicaid Services adopted an Interim Final Rule with Comments on May 22, 2008 (73 FR 29699) to implement the LTCH moratorium provisions of the MMSEA. CMS Regional Offices will determine whether a facility qualifies for an exception to the moratorium.

title: Moratorium on Classification of Long-Term Care Hospitals

memo_number: 10-14-ALL

posting_date: Fri, 02 Apr 2010 12:00:00 -0400

summary: On December 3, 2009 the FDA issued a Notice and Recommendations regarding the SS1. In this notice, the FDA reported that modifications by the manufacturer to the SS1 system have not been approved or cleared. For that reason, the FDA has not determined whether the SS1 is safe or effective for its labeled claims. The FDA has urged health care facilities to find acceptable alternatives to the SS1 to meet their sterilization and disinfection needs.

title: Guidance to Surveyors Regarding the STERIS SYSTEM 1 Sterile Processing System (SS1)

memo_number: 08-21

posting_date: Fri, 16 May 2008 12:00:00 -0400

summary: For your information, we are providing an updated, 2008 version of the brochure that provides a brief description of the QIS and an overview of the QIS training process.

title: Updated Brochure Describing the Quality Indicator Survey (QIS)

memo_number: 08-20

posting_date: Fri, 16 May 2008 12:00:00 -0400

summary: Recently the State of Nevada and federal epidemiologists identified a cluster of hepatitis C infections where the infected individuals all had procedures in the same ASC. Subsequent survey of that ASC identified unsafe injection practices. The Centers for Disease Control and Prevention (CDC) has developed pertinent information on safe injection practices. State Agencies (SAs) should disseminate this information to certified ASCs in their States, and should also ensure that all surveyors who conduct ASC surveys are familiar with this material.

title: Safe Injection Practices in Ambulatory Surgical Centers (ASCs)

memo_number: 09-01

posting_date: Fri, 03 Oct 2008 12:00:00 -0400

summary: Attached is an advance copy of the ESRD Interpretive Guidance. This Interpretive Guidance will also be published in an updated Appendix H of the State Operations Manual (SOM).

title: Advance Copy ESRD Program Interpretive Guidance Version 1.1

memo_number: 09-02

posting_date: Fri, 03 Oct 2008 12:00:00 -0400

summary: This memorandum announces the CMS decision to approve Det Norske Veritas Healthcare, Inc. (DNV Healthcare) for recognition as a national accreditation program for hospitals seeking to participate in the Medicare program.

title: Approval of Deeming Authority of Det Norske Veritas Healthcare, Inc. for Hospitals

memo_number: 09-30

posting_date: Fri, 27 Mar 2009 12:00:00 -0400

summary: Several States in the Midwest have been seriously impacted during this year's active flooding season. Citizens in North Dakota, South Dakota, and Minnesota are currently facing difficult circumstances as they respond to the flooding. The President has declared a national emergency in specified counties in the State of North Dakota and Minnesota. Charles Johnson, the Acting Secretary of the U.S. Department of Health and Human Services, has also declared a public health emergency in the North Dakota and Minnesota geographic areas covered by the President's declaration. CMS may waive or modify, to the extent necessary, certain requirements, or timetables if providers, acting in good faith to provide needed forms are services, are unable to comply with the requirements as a results of the effects of the disaster.

title: Survey and Certification Issues Related to North Dakota and Minnesota Flooding

memo_number: 09-32

posting_date: Fri, 17 Apr 2009 12:00:00 -0400

summary: The American Recovery and Reinvestment Act (ARRA), enacted on February 17, 2009, expands the exceptions to the three-year moratorium on LTCH or LTCH satellites previously enacted in the Medicare, Medicaid, and SCHIP Extension Act (MMSEA) (Pub. L. 110-173). The new exception permits an increase in the number of beds in an existing LTCH or LTCH satellite when the bed increase was authorized under a Certificate of Need (CON) issued within a specified timeframe. CMS is amending the guidance issued in S&C-08-26 to reflect this statutory change. CMS Regional Offices will determine whether a facility qualifies for the new exception to the moratorium.

title: Expansion of Moratorium Exception on Classification of Long Term Care Hospitals or Satellites

memo_number: 11-05-LSC

posting_date: Fri, 18 Feb 2011 12:00:00 -0500

summary: Hospital/CAH LSC Occupancy Classification: Hospital and CAH component facilities may be classified as new or existing Health Care, Ambulatory Health Care, Business, or other occupancies, as allowed by provisions of the LSC.

title: Hospital and Critical Access Hospital (CAH) Facility Life Safety Code (LSC) Occupancy Classification

memo_number: 09-33

posting_date: Tue, 28 Apr 2009 12:00:00 -0400

summary: Human cases of swine influenza A (H1N1) virus infection have been identified in several States in the United States, as well as internationally. Charles Johnson, the Acting Secretary of the U.S. Department of Health and Human Services, as a consequence of confirmed cases of swine influenza A (swH1N1) in California, Texas, Kansas, and New York, declared that a public health emergency exists nationwide. In emergencies where certain conditions precedent have been met, the Secretary of the Department of Health and Human Services may invoke his or her waiver authority under Section 1135 of the Social Security Act and delegate to CMS the authority to waive or modify certain survey and certification requirements. At this time the Secretary has not invoked the 1135 authority.

title: Survey and Certification Issues Related to Swine Flu Outbreak

memo_number: 10-22-ALL

posting_date: Mon, 12 Jul 2010 12:00:00 -0400

summary: Release of Records and Posting 2567s on State Website, Paper & Electronic Record Retention, Provides cross-references and links to establish CMS electronic file management and other guidance for use by SAs, Guidance Only Applies to State paper and electronic records and does not include ASPEN data.

title: Questions Related to State Agency (SA) Records Management Policy for Paper and Electronic Formats

memo_number: 12-08-NH

posting_date: Fri, 02 Dec 2011 12:00:00 -0500

summary: This memorandum replaces Survey and Certification memorandum S&C: 12-02-NH dated October 14, 2011, which discusses Federal requirements for the Independent IDR process for nursing homes. Please disregard the October 14, 2011 version.This memorandum provides interim advanced guidance regarding the Federal requirements for the Independent IDR process for nursing homes.

title: Federal Requirements for the Independent Informal Dispute Resolution (Independent IDR) Process for

memo_number: S&C-09-06-CLIA EXPIRED

posting_date: Tue, 09 Dec 2025 16:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Revised CLIA Policy on Quality Control for Commercially Available Microbial Identification Systems

memo_number: 09-58

posting_date: Fri, 18 Sep 2009 12:00:00 -0400

summary: The attached advance copy of the hospice sections of Chapter Two of the SOM includes revised interpretive guidance related to the revised Hospice CoPs that were effective December 2, 2008.

title: Advance Copy - Hospice State Operations Manual (SOM) Sections 2080-2089

memo_number: 12-15-HHA (EXPIRED)

posting_date: Mon, 01 Apr 2024 11:00:00 -0400

summary: EXPIRATION DATE 03/15/2024. Revised HHA Initial Certification Process: This memorandum revises the current process for initial certification of prospective HHAs. An additional step is added to accommodate a second review of enrollment criteria performed by the Regional Home Health Intermediary (RHHI) or Medicare Administrative Contractor (MAC). The Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) will hold the issuance of a CMS certification number (CCN) and provider agreement until the RHHI/MAC has re-reviewed certain Medicare enrollment requirements (e.g., site visit verification, capitalization requirements and Medicare exclusion) following the initial survey. Only upon recommendation from the RHHI/MAC that the prospective HHA continues to remain in compliance with the enrollment requirements will the RO proceed with completing initial certification of the HHA.

title: EXPIRED: Revised Initial Certification Process for Home Health Agencies

memo_number: 10-28-NH EXPIRED

posting_date: Tue, 02 Sep 2025 16:00:00 -0400

summary: Please check the downloads section for the latest version of the memo.

title: Point of Care Devices and Infection Control in Nursing Homes EXPIRED

memo_number: S&C-10-11-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Cautions Regarding the Release/Use of the Name of the Laboratory Director and Employer Identification Number (EIN) listed in the Clinical Laboratory Improvement Amendments (CLIA) Data System

memo_number: 08-34

posting_date: Fri, 05 Sep 2008 12:00:00 -0400

summary: CMS has adopted the 2000 edition of the National Fire Protection Association's (NFPA) Life Safety Code (LSC) as part of the Medicare health and safety standards for certified providers and suppliers. It is permissible to use a State fire and safety code (State Code) in lieu of the NFPA 2000 LSC, if CMS finds that the State Code is imposed by State law and that it adequately protects residents or patients. There are also financial implications for State Survey Agencies (SAs).

title: Compliance With State Fire and Safety Code in Lieu of Life Safety Code

memo_number: 11-32- Hospital/CAH

posting_date: Fri, 15 Jul 2011 12:00:00 -0400

summary: On May 5, 2011, the Centers for Medicare & Medicaid Services (CMS) published a final rule (76 FR 25550), effective July 5, 2011, governing the agreements under which a hospital or CAH may provide telemedicine services to its patients.

title: Telemedicine Services in Hospitals and Critical Access Hospitals

memo_number: 12-14-HHA

posting_date: Fri, 23 Dec 2011 12:00:00 -0500

summary: The Home Health Prospective Payment System (PPS) final rule, Centers for Medicare & Medicaid Services (CMS) 1510-F, amended the regulations for home health agency (HHA) certification. HHAs that undergo a change in majority ownership within three years of initial Medicare enrollment or within three years of a previous change in majority ownership must enroll in the Medicare program as a new HHA, and obtain a new State survey or deemed status accreditation. This is necessary to ensure that newly-sold HHAs are in compliance with the Conditions of Participation (CoPs). This rule also provides four allowable exceptions to the 36-month ownership provisions.

title: Home Health Survey and Certification Activities Related to Program

memo_number: 10-01-ALL

posting_date: Fri, 02 Oct 2009 12:00:00 -0400

summary: This memorandum provides guidance for the handling of subpoenas duces tecum that seek disclosure of records in the possession of the State Survey Agency (SA) as a result of the SA's implementation of its Agreement with the Secretary, Health and Human Services under Section 1864 of the Social Security Act (1864 Agreement). Guidance contained herein is based upon 45 C.F.R. Part 2, as amended by 73 FR 53148, dated September 15, 2008. It is effective immediately and supersedes previous instructions related to subpoenas for records treated as Freedom of Information requests.

title: State Survey Agency Treatment of Subpoenas Duces Tecum for Federal and Joint Federal/State Documents

memo_number: 11-30-NH

posting_date: Fri, 17 Jun 2011 12:00:00 -0400

summary: 01.20.12- Memo revised to include updated versions of the Questions and Answers and Appendix One documents. In order to promote timely application of the protections offered by section 1150B of the Act for LTC facility residents, we are explaining now the current obligations of LTC facilities to comply with the law as it is plainly written, without any delay that might be occasioned by waiting for any administrative rule-making process that might further clarify application of the law.

title: Reporting Reasonable Suspicion of a Crime in a Long-Term Care Facility

memo_number: S&C-09-28 EXPIRED

posting_date: Thu, 04 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Publication of Proposed Regulations for Gynecologic Cytology Proficiency Testing (PT) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)

memo_number: 08-36

posting_date: Fri, 12 Sep 2008 12:00:00 -0400

summary: Mike Leavitt, the Health and Human Services Secretary, has declared a public health emergency in affected counties in Texas which invokes time-limited statutory authority under section 1135(b) of the Social Security Act (SSA) to permit CMS and its agents to waive or modify certain requirements, or modify certain deadlines and timetables for the performance of required activities.

title: Survey and Certification Issues Related to Hurricane Ike

memo_number: 09-05

posting_date: Fri, 10 Oct 2008 12:00:00 -0400

summary: This memorandum provides specific details on the scoring methodology used to identify those nursing homes that become candidates for the SFF initiative by virtue of their more serious history of severe and persistent quality of care problems. We explain the method for scoring nursing home deficiency findings and survey results. The SFF methodology produces a score for identifying those facilities that merit closer survey attention through the SFF initiative.

title: Special Focus Facility (SFF) Program Survey Scoring Methodology

memo_number: 10-26-LSC

posting_date: Tue, 27 Jul 2010 12:00:00 -0400

summary: Self-evacuation during an emergency, full evacuation drills, and exceptions to full evacuation drills.

title: 42CFR 483.470(i)(2)(i) Evacuation Drills for IMentally Retarded (ICFs/MR) Certified

memo_number: 10-02-ALL

posting_date: Fri, 16 Oct 2009 12:00:00 -0400

summary: This memo provides information that CMS will work with the SAs, on a case-by-case basis, to adjust work schedules, and other survey and certification actions if State emergency response authorities determine that they must deploy surveyors to administer vaccinations and the State has determined no alternative strategies are available.

title: H1N1 Flu Vaccinations or Other Emergency Activities

memo_number: 10-29-ALL

posting_date: Fri, 10 Sep 2010 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) is providing advance notice that we will release a second solicitation for the National Background Check Program for any States or U.S. Territories that were unable to meet the previous deadline for submitting their applications for the previous solicitation.

title: Advance Notice - Second Opportunity National Background Check Program Funding

memo_number: 11-10-Hospitals

posting_date: Fri, 14 Jan 2011 12:00:00 -0500

summary: Revisions to Recently Updated Interpretive Guidelines for Anesthesia Services.

title: Revised Hospital Anesthesia Services Interpretive Guidelines - State Operations Manual Appendix

memo_number: 09-08

posting_date: Fri, 17 Oct 2008 12:00:00 -0400

summary: CMS has developed a comprehensive set of frequently asked questions and responses related to the impact of a provider/supplier's accreditation status on various survey and certification activities. Although much of this guidance may be found in various sections of the State Operations Manual or in previous Survey and Certification policy memoranda, the FAQs make this information available in one document.

title: Accreditation and its Impact on Various Survey and Certification Scenarios

memo_number: 09-29

posting_date: Fri, 27 Mar 2009 12:00:00 -0400

summary: The FDA and CDC have received reports of deaths of elderly nursing home residents who had underlying health conditions and had consumed recalled food products containing peanuts contaminated by Salmonella. The FDA is issuing a warning to nursing home and other long-term care facility administrators, owners, and food managers to ensure they are aware of the dangers of their residents eating recalled food products, and urging them to check their institutional supply of peanut butter and other products containing peanut ingredients for food items that may be affected by the recent voluntary recalls.

title: FDA Warning to Nursing Homes Regarding Recalled Food Products Containing Peanuts

memo_number: 12-06- Hospitals/CAHs

posting_date: Fri, 02 Dec 2011 12:00:00 -0500

summary: Exhibit 286, the Hospital/CAH Database Worksheet, has been updated to add or refine some fields. Instructions for completing the Worksheet have also been updated, and have been added to the SOM. The ASPEN system has also been updated to correspond to the revised Worksheet.

title: Instructions for Completing Exhibit 286, Hospital/Critical Access Hospital (CAH) Database Worksheet

memo_number: 09-51

posting_date: Fri, 14 Aug 2009 12:00:00 -0400

summary: We are clarifying the ASC interpretive guidelines to indicate that an ASC and an Independent Diagnostic Testing Facility (IDTF) may not share space, even when temporally separated.

title: Clarification of Ambulatory Surgical Center (ASC) Interpretive Guidelines

memo_number: S&C-09-23 EXPIRED

posting_date: Thu, 04 Dec 2025 12:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Clarification of Policies and Procedures for the Certification of Entities with One Certificate for Multiple Sites Under the Clinical Laboratory Improvement Amendments (CLIA)

memo_number: 11-34-ICF/MR

posting_date: Fri, 29 Jul 2011 12:00:00 -0400

summary: To ensure that client's rights are protected, the use of video cameras in the ICF/MR must be reviewed, approved and monitored by the Specially Constituted Committee of the facility as constituted per 42 CFR 483.440(f)(3)(i-iii).

title: The Use of Video Cameras in Common Areas in Intermediate Care Facilities for

memo_number: S&C-10-24-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: COLA Pathology Withdrawal – Transition Procedures under the Clinical Laboratory Improvement Amendments (CLIA)

memo_number: 10-25-Hospitals

posting_date: Tue, 27 Jul 2010 12:00:00 -0400

summary: LTCH Moratorium Extended and No Changes to Administration of Moratorium.

title: Extension of Long-Term Care Hospital (LTCH) Moratorium

memo_number: 09-04

posting_date: Fri, 03 Oct 2008 12:00:00 -0400

summary: The purpose of this memorandum is to notify States and regional offices of the publication on August 13, 2008, in the Federal Register (73 FR 47075), of a final rule entitled "Medicare and Medicaid Programs; Fire Safety Requirements for Long Term Care Facilities, Automatic Sprinkler Systems" with an effective date of October 14, 2008. A copy of the regulation is attached.

title: Adoption of New Fire Safety Requirements for LTC, Mandatory Sprinkler Installation Requirement

memo_number: 11-11-HHA (EXPIRED)

posting_date: Fri, 11 Feb 2011 12:00:00 -0500

summary: EXPIRATION DATE 3/15/24. The Centers for Medicare & Medicaid Services is issuing revisions to the existing Home Health Agency survey process. New State Operations Manual Appendix B is provided.

title: EXPIRED: Revised Home Health Survey Protocols

memo_number: 09-31

posting_date: Fri, 10 Apr 2009 12:00:00 -0400

summary: Revisions have been made to Guidance to Surveyors at several Tags in Appendix PP of SOM concerning Quality of Life and Environment. Tag F255 (closets) is deleted and regulatory language and Guidance moved to F461. A training document with speaker notes for CMS Regional Offices ROs and State Survey Agencies to use to train surveyors in this revision to the SOM is included in this memorandum. Power point slides will be issued to ROs and SAs under a separate communication.

title: Issuance of Revisions to Interpretive Guidance at Several Tags, as Part of Appendix PP, SOM

memo_number: 09-25

posting_date: Fri, 13 Feb 2009 12:00:00 -0500

summary: 1. Revision to Physician-owned Hospital Disclosure Requirements. 42 CFR 489.3 and 489.20(u) and (v) were amended, effective October 1, 2008, to: Expand the definition of physician-owned hospital to include a participating hospital in which a physician or immediate family member of a physician has an ownership interest in the hospital; Require hospitals/CAHs to provide a list of physician owners at the time a patient requests it; Require hospitals/CAHs to make disclosure at the time of referral a condition of medical staff membership for referring physician owners; and Exempt from the disclosure requirements hospitals whose physician owners do not refer patients. 2. Clarification of Termination Basis. 42 CFR 489.53 was also amended as of October 1, 2008, to clarify that CMS may terminate the provider agreement of hospitals or CAHs that fail to make required disclosures, including disclosures when a hospital does not have a physician on site 24/7.

title: Enforcement of Amended Requirements for Certain Hospital and CAH Disclosures To Patients

memo_number: 12-10-Hospital/CAH

posting_date: Fri, 09 Dec 2011 12:00:00 -0500

summary: The Affordable Care Act prohibits the referral of Medicare beneficiaries by physician owners or investors to new PoHs or to existing PoHs that have expanded their facility capacity beyond their baseline (as described below). An exceptions process allows some PoHs, which meet specific criteria, to expand after the baseline date.The statutory prohibition applies to physician owner referral and hospital billing activity. It does not prohibit licensure by the States or Medicare certification by the Centers for Medicare & Medicaid Services (CMS) of new or expanded PoHs.

title: Affordable Care Act and Implications for Certification of Physician-owned Hospitals

memo_number: 10-27-NH

posting_date: Fri, 30 Jul 2010 12:00:00 -0400

summary: The purpose of this memorandum is to advise you of the temporary revision to the Traditional Survey Process in Appendix P of the State Operations Manual (SOM). The Centers for Medicare & Medicaid Services (CMS) will release the MDS 3.0 version on October 1, 2010. As a result, there will be an inability to run the QM/QI Reports which are used offsite to assist the surveyors in selecting their Phase 1 resident sample. The survey tasks have been revised so that nursing home survey teams can select the Phase 1 survey sample without the benefit of the QM/QI Reports. This temporary revision to Traditional Survey Process Tasks 1-5C will be implemented October 1, 2010 only for those nursing home surveys in which the traditional survey process is being used. An advance copy of the revised Tasks is attached.

title: Advance Copy - Description of Temporary Changes to Appendix P, State Operations Manual (SOM),

memo_number: 08-33

posting_date: Tue, 02 Sep 2008 12:00:00 -0400

summary: The President has declared a national emergency in specified counties in the States of Louisiana, Texas, Mississippi, and Alabama. In addition, Mike Leavitt, the Secretary of the U.S. Department of Health and Human Services, has declared a public health emergency in specified counties in these same States. CMS may waive or modify, to the extent necessary, certain requirements, or timetables if providers, acting in good faith to provide needed forms are services, are unable to comply with the requirements as a results of the effects of the disaster.

title: Survey and Certification Issues Related to Hurricane Gustav

memo_number: 12-13-NH

posting_date: Fri, 16 Dec 2011 12:00:00 -0500

summary: Update Supersedes S&C: 11-42-NH.Centers for Medicare & Medicaid Services (CMS) Beginning January 1, 2012, States must obtain prior approval from CMS for the use of federally imposed CMP funds. Effective January 1, 2012 CMS approval is required for any new project, new grantee, or new use of federally imposed CMP funds, as well as for any previously State-approved use or project that is planned or approved for a period that will endure more than 36 months from December 31, 2011. Current State-approved CMP projects or uses that a State has in effect prior to January 1, 2012 do not require retrospective CMS approval so long as the project, grantee, use or purpose is not planned to endure for a period of more than 36 months from December 31, 2011. If the period of performance is planned or approved for a period of more than 36 months, then the project must receive CMS approval.

title: Use of Federally Imposed Civil Money Penalty (CMP) Funds by States

memo_number: 08-16

posting_date: Fri, 04 Apr 2008 12:00:00 -0400

summary: A CAH may maintain beds used solely for outpatient observation services without counting these beds toward the statutory CAH maximum of 25 inpatient beds. However, State Survey Agencies (SAs) must examine CAH provision of outpatient observation services carefully to assure they are consistent with the statutory limit of 25 inpatient beds that have an annual average length of stay that does not exceed 96 hours per patient. An advance copy of revised portions of the State Operations Manual (SOM) CAH Appendix W, addressing the assessment of observation bed services in CAHs, is attached to this memorandum.

title: Provision of Observation Services in Critical Access Hospitals (CAHs)

memo_number: 09-57

posting_date: Fri, 11 Sep 2009 12:00:00 -0400

summary: The purpose of this letter is to remind State survey agencies of their role in the Office for Civil Rights (OCR) clearance process.

title: Obtaining Civil Rights Clearances for Initial Certifications and CHOWs- Please see new update to this memo-S&C:13-46-ALL, dated July 12, 2013.

memo_number: 11-09-AO-CAHs

posting_date: Fri, 14 Jan 2011 12:00:00 -0500

summary: Accreditation Organization Deeming Approval for Critical Access Hospitals -The Centers for Medicare and Medicaid Services (CMS) has approved DNVHC as a national accreditation program for CAHs seeking to participate in the Medicare or Medicaid programs.

title: Approval of Deeming Authority of Det Norske Veritas Healthcare (DNVHC) for Critical Access Hospitals

memo_number: 09-10

posting_date: Fri, 24 Oct 2008 12:00:00 -0400

summary: We are clarifying a portion of S&C-08-12 and S&C-08-18, issued on February 8 and April 11, 2008 respectively, regarding use of standing orders in hospitals. The use of standing orders must be documented as an order in the patient's medical record and signed by the practitioner responsible for the care of the patient, but the timing of such documentation should not be a barrier to effective emergency response, timely and necessary care, or other patient safety advances.

title: Standing Orders in Hospitals Revisions to SandC Memoranda

memo_number: 09-26

posting_date: Fri, 06 Mar 2009 12:00:00 -0500

summary: The Fiscal Year (FY) 2009 IPPS final rule included EMTALA revisions, effective October 1, 2008. The regulatory provisions have been revised and reorganized. Key changes include introduction of a shared community call (CCP) plan option and elimination of ambiguous language concerning on-call list criteria. Technical corrections were made to track the statutory language. A hospital with specialized capabilities is not required under EMTALA to accept the transfer of a hospital inpatient who presented to the admitting hospital under EMTALA. The Interpretative Guidelines in the State Operations Manual Appendix V that correspond to these changes are attached.

title: Inpatient Prospective Payment System (IPPS) 2009 Final Rule Revisions to EMTALA Regulations

memo_number: 09-53

posting_date: Fri, 14 Aug 2009 12:00:00 -0400

summary: The Department of Health and Human Services (HHS) and CMS are committed to the goal that by 2014, most Americans will have access to health care providers who use EHRs. CMS recognizes the importance of the use of EHRs and their benefits to better patient/resident care and reduced costs.

title: Surveying Facilities That Use Electronic Health Records (EHR)

memo_number: 11-29-Transplant

posting_date: Fri, 27 May 2011 12:00:00 -0400

summary: This memorandum provides clarification of CMS guidance to the CMS Regional Offices (ROs), State Survey Agencies (SAs), and the CMS contractor involved in the survey and certification activities of organ transplant programs related to the verification of blood type (ABO) and other vital data per CoP, Organ Recovery and Receipt (42 CFR 482.92).

title: Verification of Recipient and Donor Blood Type and Other Vital Data

memo_number: 12-16-ALL

posting_date: Fri, 23 Dec 2011 12:00:00 -0500

summary: Revocation of a provider's billing privileges in the Medicare program automatically results in termination of the associated provider agreement, according to regulations at 42 CFR 424.535(b), for all provider types. This memo outlines the responsibilities of the Regional Office (RO) when the Medicare Administrative Contractor/Fiscal Intermediary issues a notice of revocation to a provider.

title: Survey and Certification Responsibilities Related to Provider Enrollment Revocations

memo_number: 11-06-ASC

posting_date: Fri, 17 Dec 2010 12:00:00 -0500

summary: Numerous questions have come to our attention concerning the ASC H&P requirement. We have revised our interpretive guidelines to provide the following clarifications of these issues. An advance copy is attached. The final version will be released at a later date and may differ slightly from this advance copy.

title: Clarifications to the Ambulatory Surgical Center (ASC) Interpretive Guidelines - Comprehensive Medic

memo_number: 10-21-NH

posting_date: Fri, 28 May 2010 12:00:00 -0400

summary: As part of the new 2010 Affordable Care Act, the Centers for Medicare and Medicaid Services (CMS) will soon release to all States and U.S. Territories a solicitation to apply for Federal funds for a multi-year national background check program for several long term care facilities and providers.

title: Advance Notice - Upcoming Solicitation - National Background Check Program for Direct Patient Access

memo_number: 08-32

posting_date: Fri, 15 Aug 2008 12:00:00 -0400

summary: The 9th Scope of Work for QIOs directs each QIO to provide technical assistance to a SFF nursing home in each State in each of the three years of the contract. If you have suggestions with regard to which SFFs you believe are most in need and most appropriate for technical assistance, please communicate those ideas to your QIO as soon as possible (preferably by August 22, 2008).

title: State Selection of SFFs for Technical Assistance by QIOs - New 9th Scope of Work Item

memo_number: 11-08-CLIA

posting_date: Thu, 13 Jan 2011 12:00:00 -0500

summary: This memorandum provides guidance on the applicability of CLIA regulations to testing associated with blood, cells/tissue, and organs for transfusion, implantation, infusion, or transplantation.

title: Clinical Laboratory Improvement Amendments of 1988 (CLIA)

memo_number: 08-17

posting_date: Fri, 04 Apr 2008 12:00:00 -0400

summary: This memorandum provides guidelines for determining the level of non-compliance when deficiencies are cited under the clinical experience (volume) requirements or the survival outcome requirements in organ transplant programs. Organ transplant programs that are surveyed for the first time under the new transplant regulations and receive Condition-level deficiencies in the areas of clinical experience (volume) or outcomes will be given a specific timeframe to come into compliance with the Condition before Medicare approval is terminated.

title: Transplant Surveys: Guidance for Citing Condition and Standard-Level Deficiencies

memo_number: 11-07-LSC

posting_date: Fri, 17 Dec 2010 12:00:00 -0500

summary: The purpose of this memorandum is to clarify the Centers for Medicare & Medicaid Services (CMS) policy regarding existing interior finish and the requirements for documenting flame spread rating of existing interior finish materials.

title: Interior Finish Documentation Requirements for Multiple Providers -Hospitals, Ambulatory Surgical Ce

memo_number: 12-07-Hospital

posting_date: Fri, 02 Dec 2011 12:00:00 -0500

summary: Section 482.41(c)(2) requires that hospital facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This memorandum updates the guidance in Appendix A of the State Operations Manual related to hospital facility and medical equipment maintenance.

title: Clarification of Hospital Equipment Maintenance Requirements

memo_number: S&C-12-03-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: Initial Plans and Policy Implementation for Clinical and Laboratory Standards Institute (CLSI)

memo_number: 09-55

posting_date: Fri, 04 Sep 2009 12:00:00 -0400

summary: State survey agencies using the new survey process in FY 2009, including completing the Infection Control Surveyor Worksheet, have experienced challenges in evaluating use of flash sterilization by ASCs. Attachment 1 clarifies what this term means, and how to distinguish appropriate from inappropriate use of flash sterilization.

title: Flash Sterilization Clarification - FY 2010 Ambulatory Surgical Center (ASC) Surveys

memo_number: 08-35

posting_date: Fri, 05 Sep 2008 12:00:00 -0400

summary: This memorandum provides additional guidance regarding the circumstances when laboratories performing drug or alcohol screening and/or testing must be CLIA certified, and should be considered an addendum to the attached February 05, 1993 memorandum Guidance on the Applicability of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to Substance Abuse Testing. We are restating our ongoing policy that laboratories performing drug or alcohol screening and/or testing followed by individual treatment must be CLIA-certified. Facilities found to be performing such testing without CLIA certification are in violation of CLIA.

title: Drug or Alcohol Screening/Testing and CLIA Certification

memo_number: 08-37

posting_date: Fri, 19 Sep 2008 12:00:00 -0400

summary: This memorandum extends the period of time for hospice agencies to qualify for an extraordinary circumstance exemption when they believe that the nursing shortage has affected their ability to directly hire sufficient numbers of nurses. This policy exemption was first outlined in S&C-02-44 and again in S&C-05-02 and 06-28. The effective date of this policy has been extended from September 30, 2008 to September 30, 2010.

title: Impact of Nursing Shortage on Hospice

memo_number: 09-52

posting_date: Fri, 14 Aug 2009 12:00:00 -0400

summary: The attached fact sheet clarifies options that are permissible under EMTALA and should reassure the provider community and public health officials that there is existing flexibility under EMTALA.

title: EMTALA Requirements and Options for Hospitals in a Disaster

memo_number: 08-18

posting_date: Fri, 11 Apr 2008 12:00:00 -0400

summary: The on-line SOM Hospital Appendix A requires revision to reflect changes in regulatory text adopted through rulemaking by CMS, established interpretive guidance issued via previous Survey and Certification memoranda, new interpretive guidance for the patients' rights rule at 42 CFR 482.13(e), (f) and (g), governing hospital use of restraint and seclusion, some minor technical corrections, and revision of the Tag numbers to correspond to Tag numbers currently found in ASPEN and also to make further refinements that will be captured in the next ASPEN release.

title: Restraint/Seclusion Interpretive Guidelines & Updated SOM Appendix A

memo_number: 09-24

posting_date: Wed, 11 Feb 2009 12:00:00 -0500

summary: In this memorandum, we describe the procedures we are implementing for the LSC provisions of the new ESRD Conditions for Coverage. While major portions of the ESRD regulation became effective on October 14, 2008, the LSC component became effective on February 9, 2009. The ESRD regulation provides certain exceptions to the LSC provisions, including sprinkler systems, Essential Electrical Systems, and fire drills. The regulation also provides for specific LSC waivers based upon an "unreasonable hardship."

title: Implementation of the Life Safety Code Component for the New ESRD Conditions for Coverage

memo_number: 09-48

posting_date: Fri, 31 Jul 2009 12:00:00 -0400

summary: This memorandum further defines and clarifies the CMS policies for attendance at the CLIA Basic Training scheduled for November 16 through 20, 2009 in Baltimore.

title: CLIA Policy on November 2009 CLIA Basic Training

memo_number: 08-15

posting_date: Fri, 21 Mar 2008 12:00:00 -0400

summary: The attached advance copy of the Emergency Medical Treatment and Labor Act (EMTALA) Appendix V to Publication 100-07, the State Operations Manual (SOM) incorporates guidance provided in Survey and Certification memoranda issued since the last SOM update. The revised Appendix V also contains some technical corrections. The Tag numbers contained in the Appendix also have been revised, to correspond to the Tag numbers reflected in the December, 2007 ASPEN release.

title: Revised State Operations Manual Appendix V - EMTALA

memo_number: 12-09-CLIA

posting_date: Fri, 02 Dec 2011 12:00:00 -0500

summary: Additional clarification and guidance is given for certifying laboratories under the various regulatory multiple sites exceptions. There are scenarios with guidance for all areas of the three regulatory exceptions for each type of certificate. State laws must be considered and when certificates that meet a multi-site exception cross State/Regional lines, the corresponding regional offices must coordinate oversight.

title: Certificate and Regulatory Multiple Site Exceptions under CLIA

memo_number: 09-03

posting_date: Fri, 03 Oct 2008 12:00:00 -0400

summary: Section 506 of the MMA requires hospitals and critical access hospitals (CAHs) to accept Medicare-like rates when providing care to individuals who are beneficiaries of Indian Health Service (IHS), Tribal health, and urban Indian health programs. 42 CFR 489.29 implements the statutory requirement.

title: Enforcement of Section 506, MMA, Acceptance of Medicare-like Rates

memo_number: 09-50

posting_date: Fri, 07 Aug 2009 12:00:00 -0400

summary: This memorandum provides States with a QIS implementation priority order for remaining States not currently implementing the QIS. Offers guidance to support States' preparation for QIS implementation.

title: Priority Order of Quality Indicator Survey (QIS) National Implementation in States

memo_number: 08-14

posting_date: Fri, 21 Mar 2008 12:00:00 -0400

summary: Attached are Federal minimum standards for training surveyors and trainers in the QIS. These standards are intended to assure effective and consistent QIS implementation for the training of State and Federal surveyors and their trainers in the Federal QIS process.

title: Federal Minimum Qualification Standards for LTC Registered QIS Surveyors

memo_number: 10-18-LSC

posting_date: Fri, 14 May 2010 12:00:00 -0400

summary: This memorandum updates and revises information first conveyed in Survey and Certification letter 04-41, issued on August 12, 2004 by CMS, which provided guidance on corridor width requirements associated with the installation of wall-mounted computer touch screens in health care facilities.

title: Revision of SC-04-41, Corridor Width ands Corridor Mounted Computer Touch Screens in Facilities

memo_number: 12-02-NH

posting_date: Fri, 14 Oct 2011 12:00:00 -0400

summary: State survey agencies (SAs) must have in place a functioning Independent IDR process with specific elements by no later than January 1, 2012. The Independent IDR process must be offered to nursing homes for deficiencies that lead to the imposition of a civil money penalty (CMP) and for which notice has been provided to the nursing home that the CMP will be collected and placed in escrow. : States must submit, by no later than November 30, 2011, a process for Independent IDR to the appropriate Centers for Medicare and Medicaid Services (CMS) Regional Office (RO) for approval. Standard cost allocation methods for long term care surveys apply to the costs of the Independent IDR process, although the initial set-up and initial training expenses were eligible for one-time funds in FY2011. States should submit a FY2012 estimated budget plan for costs associated with this process.

title: Federal Requirements for the Independent Informal Dispute Resolution (Independent IDR) Process for N

memo_number: 11-25-PSYCH

posting_date: Fri, 29 Apr 2011 12:00:00 -0400

summary: Provides clarification for the complete neurological examination with guidance, and testing intellectual functioning, memory functioning and orientation with guidance.

title: Clarification of 482.61(b (3): Requirements for a Screening Neurological

memo_number: 09-44

posting_date: Fri, 19 Jun 2009 12:00:00 -0400

summary: The purpose of this memorandum is to clarify that States may direct collected CMP funds to entities other than nursing homes as long as funds are used in accordance with statutory intent; share innovative practices that States may want to consider when making decisions about how CMP funds can be directed and used to improve the quality of care and life for nursing home residents; and announce CMS will consider reporting CMP amounts that have been returned to each State.

title: Use of Civil Money Penalty (CMP) Funds by States and Reporting of CMP Funds Returned to the State

memo_number: 11-31-NH

posting_date: Fri, 01 Jul 2011 12:00:00 -0400

summary: The purpose of this memorandum is to describe changes that the Centers for Medicare & Medicaid Services (CMS) has made to the MDS 3.0 assessment modification and formatting policies, as well as changes to the Nursing Home Compare website (http://www.medicare.gov/NHCompare) as a result of MDS 3.0 implementation.

title: Changes to the Minimum Data Set Version 3.0 (MDS 3.0) Assessment Modification

memo_number: 09-56

posting_date: Fri, 04 Sep 2009 12:00:00 -0400

summary: In order to promote common understandings and consistency of standards and expectations regarding the new ESRD CfCs, we are distributing a series of FAQs that are related to those CfCs. The first of this series of Questions and Answers (Wave One) is attached to this memorandum

title: Frequently Asked Questions (FAQs) Related to the New ESRD Conditions for Coverage

memo_number: 11-23-NH

posting_date: Fri, 22 Apr 2011 12:00:00 -0400

summary: The CMS has issued a third multi-year National Background Check Program for Patient Protection solicitation for Federal matching grants to all States and the U.S. Territories that did not submit proposals during the first two solicitations. States that applied during the first two solicitations but did not receive the full award amount may apply for the remaining amount allowed under the provisions of the law at section 6201 of the Affordable Care Act. The Federal matching funds and State funds will be used by States to perform criminal background checks for direct patient access employees of long term care facilities and providers. CMS has received applications from 19 States that were able to meet the frame for submitting a proposal under the first two proposals.

title: Notice - Third Opportunity National Background

memo_number: 11-37-NH

posting_date: Fri, 21 Oct 2011 12:00:00 -0400

summary: UPDATE 10.01.12: On September 27,2012, S&C: 12-46-NH: F tag 322—Feeding Tubes-Advance Copy replaced S&C memo 11-37. Please see S&C: 12-46-NH for the updated guidance.

title: Issuance of Revisions to Interpretive Guidance at F tag 322, as Part of Appendix PP, State Operations Manual (SOM)

memo_number: 11-26-AO

posting_date: Fri, 06 May 2011 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services has approved the Joint Commission as a national accreditation program for psychiatric hospitals seeking to participate in the Medicare or Medicaid programs. This approval provides psychiatric hospitals with an accreditation option which previously did not exist.

title: Approval of Deeming Authority of the Joint Commission for Psychiatric

memo_number: 11-04 -ALL

posting_date: Fri, 26 Nov 2010 12:00:00 -0500

summary: The final FY 2011 IPPS rule was published on August 16, 2010 (75 FR 50042) and was effective on October 1, 2010. Several provisions in the rule directly affect areas of survey and certification responsibility. There were also changes in the Medicaid rules that are of interest because of their connection to the Hospital CoPs as well as Centers for Medicare & Medicaid Services (CMS)-approved national hospital accreditation programs.

title: FY 2011 Inpatient Prospective Payment System (IPPS) Rule Changes Affecting Survey and Certification

memo_number: 08-08

posting_date: Fri, 11 Jan 2008 12:00:00 -0500

summary: Growth in the demand for hospital emergency services has resulted in a number of hospitals seeking to expand their emergency department (ED) services to off-site locations. Provider-based off-site hospital EDs are permitted, and must demonstrate compliance with the hospital Conditions of Participation (CoPs). They must also be in compliance with the provider-based regulations at 42 CFR 413.65. In rare cases, new providers are seeking certification as a hospital specializing in the provision of emergency services. Such providers have the burden of proof to demonstrate that they meet the statutory definition of a hospital for Medicare purposes, and their applications require detailed, case-specific analysis. Regional Offices are to consult with CMS Central Office survey and certification staff before processing such applications.

title: Requirements for Provider-based Off-campus Emergency Departments

memo_number: 11-28-Hospitals

posting_date: Fri, 13 May 2011 12:00:00 -0400

summary: CMS is clarifying our guidance related to training requirements for personnel administering blood transfusions and intravenous (IV) medications, and to the requirement for immediate reporting of drug administration errors, adverse drug events, and incompatibilities. Attached is an advance copy of the SOM Appendix A reflecting these updates. The final version of Appendix A will be issued at a later date, and may reflect some changes from this advance copy.

title: State Operations Manual (SOM) Hospital Appendix A Update

memo_number: 09-21

posting_date: Fri, 16 Jan 2009 12:00:00 -0500

summary: On November 19, 2008, the Centers for Medicare & Medicaid Services (CMS) published revisions and updates to payment policies as well as conditions of participation (CoPs) under the Physician Fee Schedule. These changes affected several CoPs and conditions for coverage (CfCs)listed in this memo.

title: 2009 Physician Fee Schedule Changes Affecting the Survey & Certification of Rehabilitation Programs

memo_number: S&C-10-12-CLIA EXPIRED

posting_date: Thu, 04 Dec 2025 13:00:00 -0500

summary: Please check the downloads section for the latest version of the memo.

title: EXPIRED: CLIA – Issuance of Revised Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services in Appendix C of the State Operations Manual to Facilitate the Electronic Exchange of Laboratory Information

memo_number: 08-30

posting_date: Fri, 01 Aug 2008 12:00:00 -0400

summary: On November 27, 2007, CMS published revisions to payment policies under the Physician Fee Schedule. These changes affected the certain CMS Conditions of Participation.

title: 2008 Physician Fee Schedule Changes Affecting Survey & Certification

memo_number: 08-29

posting_date: Fri, 01 Aug 2008 12:00:00 -0400

summary: Sections 2002, 2003A, 2005, and 2825-2826 of the SOM are being revised to update general Medicare enrollment information, as well as the process for enrolling FQHCs in Medicare, and for handling complaints about FQHCs. A new Exhibit 179, Information on Medicare Participation, FQHCs, is introduced and is to be made available by Regional Offices (ROs) or State Agencies (SAs) to potential FQHC applicants.

title: Revision of Publication 100-07, State Operations Manual (SOM) - FQHCs

memo_number: 09-22

posting_date: Fri, 23 Jan 2009 12:00:00 -0500

summary: Revised guidance for long-term care surveyors at F309, Quality of Care, including a new general investigative protocol and new pain management guidance and investigative protocol will be effective March 31, 2009; The advance copy of this guidance and training materials are to be used to train all surveyors who survey nursing homes by the implementation date; Removed hospice and dialysis survey protocol language from Appendix P and inserted into F309; Removed weight loss investigative protocol from Appendix P due to the June 2008 issuance of F325 investigative protocol; Deleted guidance requiring paper copy storage of Minimum Data Set in homes with electronic records at Tag F286, 483.20(d), Use; and Removed demand billing survey process at Appendix P, Part VII and inserted new procedure at Task 5C.

title: Revised Quality of Care Guidance at F309, including Pain Management as Part of Appendix PP SOM

memo_number: 10-10-CAH

posting_date: Thu, 31 Dec 2009 12:00:00 -0500

summary: On July 31, 2009, the Centers for Medicare & Medicaid Services (CMS) issued the final FY 2010 Inpatient Prospective Payment System (IPPS) rule, effective October 1, 2009. The final rule included two changes affecting CAHs.

title: Critical Access Hospital (CAH) Regulatory Changes

memo_number: 08-13

posting_date: Fri, 07 Mar 2008 12:00:00 -0500

summary: Congress's appropriation of part of the increase in Medicare Survey and Certification funds requested in the President's proposed FY 2008 budget permits us to raise initial surveys of RHCs and SNFs to Tier 3 priority from Tier 4. For initial surveys assigned Tier 3 priority status, States may prioritize the initial surveys within Tier 3. We encourage States to offer a high Tier 3 status for initial surveys of dialysis facilities given the unique reliance on Medicare on the part of end stage renal disease patients.

title: Initial Surveys of RHCs and SNFs - Raised to Tier 3 Priority

memo_number: 11-22-NH

posting_date: Fri, 08 Apr 2011 12:00:00 -0400

summary: The purpose of this memorandum is to advise you of initiatives that CMS is undertaking to implement mandates of Section 6102 (c) of the Affordable Care Act related to Quality Assurance and Performance Improvement.

title: QAPI Initiatives related to Section 6102 (c)

memo_number: 08-28

posting_date: Fri, 20 Jun 2008 12:00:00 -0400

summary: Revised guidance for long-term care surveyors regarding Nutrition and Sanitary Conditions (Tags F325 and F371) will be effective September 1, 2008. An advance copy of this guidance and training slides are attached. A comprehensive training guide has been sent to State and regional office training coordinators under separate cover to assure that all surveyors who survey nursing homes are trained in the revised guidance by the implementation date.

title: Issuance of Revised Nutrition and Sanitary Conditions as Part of Appendix PP, SOM

memo_number: 09-45

posting_date: Fri, 19 Jun 2009 12:00:00 -0400

summary: The Secretary has determined the Public Health Emergency no longer exists in North Dakota and Minnesota, and the 1135 waiver authority is ending concurrently with the termination of the public health emergency.

title: North Dakota and Minnesota Flooding Public Health Emergency and 1135 Waiver Termination

memo_number: 11-27-AO

posting_date: Fri, 06 May 2011 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services has approved American Association for Accreditation of Ambulatory Surgery Facilities, Inc. as a national accreditation program for providers of outpatient physical therapy and speech-language pathology services seeking to participate in the Medicare or Medicaid programs. Providers of outpatient physical therapy and speech-language pathology services now have an accreditation option where previously none existed.

title: Approval of Deeming Authority of the American Association for Accreditation of Ambulatory Surgery

memo_number: 10-08-ESRD

posting_date: Fri, 20 Nov 2009 12:00:00 -0500

summary: LSC surveys are being phased into the ESRD survey program in two phases. Phase I includes the implementation of initial surveys for new facilities, relocation surveys for existing facilities which move to a new location, and complaint surveys that include allegations related to LSC requirements. LSC surveys for existing ESRD facilities will be implemented following the development of Interpretive Guidance specific to those surveys, an ESRD LSC Survey Protocol, and a specific Training Module for ESRD LSC.

title: Phasing Implementation of Life Safety Code Surveys in ESRD Facilities for CY 2010

memo_number: 08-31

posting_date: Fri, 08 Aug 2008 12:00:00 -0400

summary: We invite staff of State agencies, members of the renal community, and our Federal colleagues to provide additional input to CMS' revision of the surveyor Interpretive Guidance by way of comment to the attached draft Interpretive Guidance for the new ESRD regulation. The attached document includes the regulatory language that was published as a Final Rule for the ESRD Program in the Federal Register on April 15, 2008, as well as regulatory text that was incorporated by reference in that Final Rule.

title: Draft Interpretive Guidance for the Survey Process of the New ESRD Conditions for Coverage

memo_number: 09-41

posting_date: Fri, 05 Jun 2009 12:00:00 -0400

summary: This memorandum reiterates current policy that all surveys must be unannounced for all providers and suppliers, except for standard surveys of Clinical Laboratory Improvement Amendments (CLIA) laboratories and other limited exceptions. This includes standard surveys, complaint surveys and onsite revisit surveys.

title: Policy Regarding Unannounced Surveys

memo_number: 09-47

posting_date: Fri, 10 Jul 2009 12:00:00 -0400

summary: The regulations at 42 CFR 483.420(a)(4) state that clients in the ICFMR must be allowed to manage their financial affairs and be taught to do so to the extent of their capabilities. The determination as to the appropriateness of a formal money management program for an ICFMR client is based upon the results of a comprehensive functional assessment and a consensus by the interdisciplinary team.

title: ICFMR Clarification of Protection of Client's Rights

memo_number: 10-09-Hospital

posting_date: Fri, 11 Dec 2009 12:00:00 -0500

summary: CMS is clarifying the interpretive guidelines concerning the provision of anesthesia services in a hospital.

title: Revised Hospital Anesthesia Services Interpretive Guidelines SOM Appendix A

memo_number: 09-19

posting_date: Fri, 02 Jan 2009 12:00:00 -0500

summary: Attached is an advance copy of the Hospice Interpretive Guidance. This Interpretive Guidance will also be published in an updated Appendix M of the State Operations Manual (SOM).

title: Advance Copy Hospice Program Interpretive Guidance Version 1.1

memo_number: 11-19-CLIA

posting_date: Fri, 08 Apr 2011 12:00:00 -0400

summary: Notification that CMS has withdrawn the Cytology Proficiency Testing NPRM. The majority of recommendations made by the cytopathology and cytotechnology experts and the Clinical Laboratory Improvement Advisory Committee (CLIAC) will be implemented through revised interpretive guidance and administrative policy. Cytology laboratories must continue to meet the existing regulations at 42 CFR 493.855 by enrolling and successfully participating in a CMS-approved cytology PT program for the annual testing of the subject individuals. CMS will continue to monitor cytology PT performance and to collaborate with the cytology community on all cytological quality initiatives.

title: Notification of Withdrawal of CMS 2252-P -Cytology

memo_number: 11-13-ESRD

posting_date: Fri, 18 Mar 2011 12:00:00 -0400

summary: CMS wants to promote common understandings about the regulatory process and the specific rules that guide the CMS S&C process. In order to promote consistency of standards and expectations regarding the ESRD CfCs, we actively support our ESRD email mailbox for questions and comments and periodically refresh our compendium of FAQs on our CMS S&C Web site.

title: End Stage Renal Disease (ESRD) Update of

memo_number: 08-12

posting_date: Fri, 08 Feb 2008 12:00:00 -0500

summary: The attached interpretive guidelines correspond to the regulatory changes published November 27, 2006 amending Hospital Conditions of Participation pertaining to requirements for history and physical examinations; authentication of verbal orders; securing medications; and post-anesthesia evaluations. The Tag numbers have been revised to correspond to the Tag numbers reflected in the December, 2007 ASPEN release. State survey agencies should not use the temporary Tag numbers identified in the S&C letter of February 23, 2007 (S&C-07-13). The interpretive guidelines also include newly-adopted additional changes that were incorporated into the Calendar Year 2008 Outpatient Prospective Payment System (OPPS) regulation. They are effective January 1, 2008.

title: Revised Interpretive Guidelines for Hospital Conditions of Participation

memo_number: 11-01-NH

posting_date: Fri, 15 Oct 2010 12:00:00 -0400

summary: Attached is the revised Chapter 7 of the State Operations Manual. This instruction is now posted to the Centers for Medicare & Medicaid (CMS) Web.

title: Copy of Chapter 7 - Survey and Enforcement Processes for Skilled Nursing Facilities and Nursing Faci

memo_number: 09-39

posting_date: Fri, 29 May 2009 12:00:00 -0400

summary: This memorandum clarifies that 1) The language at 42 CFR 483.35(i), Tag F 371 'Procure food from sources approved or considered satisfactory by Federal, State or local authorities' is intended solely for the foods procured by the facility. A revision has been made to the interpretive guidelines at F371 to further clarify this intent; 2) Foods accepted by residents from visitors, family, friends, or other guests are not subject to the regulatory requirement at F 371; and 3) Residents have the right to choose to accept food from visitors, family, friends, or other guests according to their rights to make choices at 483.15, F 242, Self Determination and Participation.

title: Nursing Home Requirements for Food Procurement, Self Determination, and Participation

memo_number: 11-24-ALL

posting_date: Fri, 22 Apr 2011 12:00:00 -0400

summary: On April 12, 2011 Secretary Kathleen Sebelius and CMS Administrator Donald Berwick announced the Partnership for Patients: Better Care, Lower Costs, a new public-private partnership that will help improve the quality, safety and affordability of health care for all Americans. The Partnership for Patients brings together leaders of major hospitals, employers, health plans, physicians, nurses, and patient advocates along with State and Federal governments in a shared effort to make hospital care safer, more reliable, and less costly. The Partnership will help save 60,000 lives by stopping millions of preventable injuries and complications in patient care over the next three years and has the potential to save up to $35 billion, including up to $10 billion for Medicare. Over the next ten years, it could reduce costs to Medicare by about $50 billion and result in billions more in Medicaid savings.

title: New Initiative: Partnership for Patients: Better Care,

memo_number: 11-03-CLIA

posting_date: Fri, 29 Oct 2010 12:00:00 -0400

summary: To facilitate preparedness in the event of a chemical terrorism act, all designated CT PHL's will request and obtain a CLIA certificate at their projected highest level of testing, regardless if testing human samples presently.

title: Survey and Certification of Chemical Toxicity Public Health Laboratories (CT PHL's) under the

memo_number: 10-20-ASC

posting_date: Fri, 21 May 2010 12:00:00 -0400

summary: This memorandum clarifies CMS requirements for ASC waiting areas, including the prohibition on the sharing of waiting areas with other entities.

title: Ambulatory Surgical Center (ASC) Waiting Area Separation Requirements

memo_number: 10-19-NHQIS

posting_date: Fri, 21 May 2010 12:00:00 -0400

summary: The purpose of this memo is to announce that information about the QCLIs used in the Quality Indicator Survey (QIS) process is publically accessible on the QTSO Web site.

title: Posting of Quality of Care and Quality of Life Indicators

memo_number: 09-20

posting_date: Fri, 09 Jan 2009 12:00:00 -0500

summary: This memorandum reviews a Skilled Nursing Facility (SNF) provider's obligations to issue Medicare beneficiary liability notices, a Medicare beneficiary's rights related to standard claim and expedited appeals; and the surveyor's responsibility to determine compliance with Medicare notice and billing requirements for determinations of non-coverage. The SNF provider must inform the beneficiary of potential liability for payment for non-covered services when limitation of liability applies. The SNF must provide a written notice to the Medicare beneficiary explaining his/her right to file an expedited appeal upon termination of all Medicare covered services. Appendix P of the SOM, Survey Protocol for Long Term Care Facilities, Part VII will be deleted. The information in this memo will be moved to Sub-Task 5C and a new section on Liability Notices and Beneficiary Appeal Rights will be created. This memo does not apply to beneficiaries with Medicare Advantage.

title: S and C Issues Related to Liability Notices and Beneficiary Appeal Rights in Nursing Homes

memo_number: 09-42

posting_date: Fri, 05 Jun 2009 12:00:00 -0400

summary: On June 30, 2009, the Department of Health and Human Services plans to gather its key partners in the Action Plan to Prevent Healthcare Associated Infections to provide updates on the initiative and engage in a dialogue about potential next steps. The Recovery Act HAI initiatives, including the ASC HAI initiative, are distinct from, but consistent with the goals, objectives, and recommendations in the HHS Action Plan. We are sharing with you the information HHS provided to us so that you can, in turn, provide it to interested individuals in your areas and other organizations, as appropriate. The June 30th meeting is in Washington, DC. Future meetings may take place in Seattle, Denver, and Chicago.

title: June 30, 2009 Healthcare Associated Infections Professional Stakeholder Meeting

memo_number: 10-15-NH

posting_date: Fri, 16 Apr 2010 12:00:00 -0400

summary: Beginning on April 16, 2010 nursing homes that are Special Focus Facility (SFF) candidates will receive notification of that fact on the monthly provider preview that they receive on the CASPER reporting page.

title: Change to the 5 Star Monthly Provider Preview

memo_number: 09-14

posting_date: Fri, 21 Nov 2008 12:00:00 -0500

summary: The regulations at 42 CFR Part 405, Subpart X, Section 2401 and 42 CFR Part 491, Subpart A, governing RHC and FQHC participation in Medicare, have undergone major changes in recent years and are now proposed for further changes. This memorandum provides an overview of previous changes and clarifies the current RHC and FQHC regulatory requirements.

title: Interim Guidance Regarding the Survey and Certification of RHCs and FQHCs

memo_number: 09-40

posting_date: Fri, 29 May 2009 12:00:00 -0400

summary: The American Recovery and Reinvestment Act of 2009 (Recovery Act) provides for a one-time cash benefit of 250.00 to certain eligible individuals who receive a Social Security benefit, Railroad Retirement Pension, Veteran's Administration disability pension and Supplemental Security Income (SSI). Many ICF/MR clients may be eligible for this one-time cash benefit. The money is for the client's personal use and must not be used to pay for facility services.

title: One-time Cash Benefit to ICF/MR Clients

memo_number: 11-18-NH

posting_date: Fri, 01 Apr 2011 12:00:00 -0400

summary: The Interim Final Rule with comment Notification of Facility Closure was published in the Federal Register on Friday, February 18, 2011; the public has 60 days to comment on the interim final rule. The Patient Protection and Affordable Care Act under section 1128I (h) mandates specific procedures in the event of a SNF or (NF) closure. These procedures help protect the resident, the resident's family, and visitors because they require the facility to provide an organized plan that allows the resident, family, and visitors to make the necessary adjustments within a reasonable time frame.

title: Final Rule for Skilled Nursing Facilities (SNF) and Nursing Facilities (NF)

memo_number: 11-36-Hospital/CAH

posting_date: Wed, 07 Sep 2011 12:00:00 -0400

summary: On April 15, 2010 the President issued a memorandum to the Secretary of Health and Human Services(copy enclosed) directing the initiation of rulemaking to ensure that hospitals respect the right of patients to have and designate visitors. The memorandum also directs the Secretary to issue guidance that clarifies existing regulatory requirements at 42 CFR 482.13, governing the right of a patient's representatives to make informed decisions concerning the patient's care, and 42 CFR 489.102(a), concerning advance directives, such as durable powers of attorney and health care proxies. This Survey & Certification Memorandum provides the clarifications of existing regulations and policy guidance concerning new regulations that fulfill the expectations of the President's memorandum.

title: Hospital Patients' Rights to Delegate Decisions to Representatives

memo_number: 09-17

posting_date: Fri, 05 Dec 2008 12:00:00 -0500

summary: The purpose of this memorandum is to give the State Survey Agencies (SAs) advance notice of the Five Star Quality Rating System being added to the Nursing Home Compare Web site. States will receive a preview of their provider's Five-Star rating on December 15, 2008. Providers will have access to their individual Five-Star rating beginning December 16, 2008.

title: Launching of Five Star Rating System on the Nursing Home Compare Website

memo_number: 11-21-ASC

posting_date: Fri, 08 Apr 2011 12:00:00 -0400

summary: ASCs may not limit surveyor ability to observe patient care and surveyors are not required to sign documents or provide proof of vaccinations in order to observe a surgical procedure, and obtain the consent of the operating physician prior to observing a surgical procedure. Surveyors will obtain patient's consent and conduct themselves in a manner that protects patient safety and that does not interfere with the operating physician or procedure.

title: Clarifications to the ASC Interpretive Guidelines

memo_number: 09-16

posting_date: Wed, 26 Nov 2008 12:00:00 -0500

summary: Sections 2003A and 2826 of the SOM are being revised to clarify the effective date for FQHC supplier agreements and to update information on the Medicare Administrative Contractor (MAC) and legacy Fiscal Intermediary (FI) assignments for tribal and Urban Indian FQHCs.

title: Additional Revision of SOM - Federally Qualified Health Centers (FQHCs)

memo_number: 09-13

posting_date: Fri, 21 Nov 2008 12:00:00 -0500

summary: The new ESRD Conditions for Coverage provide clearer and better provisions for patient safety and improved quality of care. While the overall effective date was October 14, 2008, the rule recognized that not all facilities may be in a position to fully meet all new or revised requirements of the Conditions for Coverage on that date. Therefore, the rule specifies separate effective dates for certain Conditions and provides that some facilities may request a waiver for certain other requirements. In this memorandum we describe the procedures we are implementing for requesting a waiver or time-limited extension of the time needed to phase-in the program improvements needed to achieve full compliance.

title: Waivers and Phase-In Time Extensions for the Implementation of the New ESRD Conditions for Coverage

memo_number: 08-27

posting_date: Tue, 17 Jun 2008 12:00:00 -0400

summary: Several States in the Midwest have been seriously affected by tornados, severe thunderstorms, and flooding. The citizens of Indiana and Iowa have especially faced extraordinary circumstances in coping with extensive flooding and damage, which has also affected many health care facilities and hundreds of patients and residents. The President has declared a national emergency in specified counties of Indiana and Iowa, and Mike Leavitt, the Secretary of the U.S. Department of Health and Human Services, has also declared a public health emergency in the specified Indiana and Iowa counties. CMS may waive or modify, to the extent necessary, certain requirements or timetables, if providers, acting in good faith to provide needed services, are unable to comply with the requirements as a result of the effects of the disaster.

title: Survey and Certification Issues Related to Iowa and Indiana Flooding Disasters

memo_number: 09-15

posting_date: Fri, 21 Nov 2008 12:00:00 -0500

summary: CMS published a final rule in the November 27, 2007 Federal Register (72 Fed. Reg. 66934) amending 42 CFR Part 485 Subpart F, adding a new standard at 485.610(e), governing a CAH's location relative to other hospitals or CAHs with respect to co-location and off-campus provider-based arrangements. These amendments became effective January 1, 2008.

title: New CAH requirements under 42 CFR 485.610(e) related to CAH Co-location and provider-based locations

memo_number: 11-20-ALL

posting_date: Fri, 08 Apr 2011 12:00:00 -0400

summary: This memo was not issued and there will be no download.

title: Contingency Plans - State Survey & Certification

memo_number: 09-43

posting_date: Fri, 12 Jun 2009 12:00:00 -0400

summary: CMS and States will improve quality assurance of ASCs during FY 2009 and FY 2010 by implementing a new survey process to promote better infection control practices. Approximately 10 million is available to States for this purpose over the course of the two years. By June 30, 2009, we request that States volunteering for implementation in 2009 submit key information to CMS. Recovery Act funds may not be used to support work already required by CMS.

title: Recovery Act Ambulatory Surgical Center Healthcare Associated Infection Prevention Initiative

memo_number: 09-18

posting_date: Fri, 19 Dec 2008 12:00:00 -0500

summary: The Five Star Nursing Home Rating System was launched on December 18, 2008. The star rating system will give a more user friendly way for consumers to compare nursing homes within a State. We are providing a comprehensive set of questions and answers concerning the Five Star Rating System.

title: The Five Star Nursing Home Rating System Questions and Answers

memo_number: 11-41-NHs

posting_date: Fri, 30 Sep 2011 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services provides a list of key elements for State website development for States to qualify for Federal funding. The costs for development of the websites and operation are allowable expenses for reimbursement through a combination of Medicaid, Medicare survey and certification, and State-only funds under standard cost- allocation procedures.

title: Affordable Care Act Section 6103: Guidance for State Consumer Oriented Websites

memo_number: 11-38-NH

posting_date: Wed, 07 Sep 2011 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) have received inquiries from nursing homes and State survey agencies asking if Federal law permits nursing homes to have produce gardens and use the foods harvested on the menu for any portion of the resident population. Residents can benefit from having a variety of fresh foods for their consumption, as long as the dangers of food-borne illness are mitigated to the greatest extent possible through the facility. The facility should be following safe food handling practices once foods are harvested and brought to the kitchen for preparation.

title: Compliance with Food Procurement Requirements for Nursing Homes with Gardens

memo_number: 10-05-EMTALA

posting_date: Tue, 06 Oct 2009 12:00:00 -0400

summary: The Fiscal Year (FY) 2010 Inpatient Prospective Payment System (IPPS) Final Rule included technical revisions concerning the non-applicability of EMTALA sanctions under Section 1135(b)(3) of the Social Security Act (the Act). During a public health emergency, waivers under section 1135(b)(3) can provide exceptions to penalties for the otherwise impermissible redirection or relocation of individuals for a medical screening examination (MSE) and for inappropriate transfers. In this memorandum we describe the waiver process for these EMTALA-specific waivers.

title: EMTALA Regulation Changes and H1N1 Pandemic Flu and EMTALA Waivers

memo_number: 11-42-NH

posting_date: Fri, 30 Sep 2011 12:00:00 -0400

summary: States must obtain CMS approval for the use of any CMP funds through either categorical or prior approvals.

title: Use of Civil Money Penalty (CMP) Funds by States

memo_number: 11-02-NH

posting_date: Fri, 29 Oct 2010 12:00:00 -0400

summary: Guidance to Surveyors- This memorandum outlines the handling of LTC facility citations at F287 regarding MDS submissions as a result of an issue with the Centers for Medicare & Medicaid Services (CMS) MDS 3.0 ASAP system.

title: Impact of Submission Issues with the Minimum Submission and Processing (ASAP) System on the Long

memo_number: 12-01-Hospital

posting_date: Fri, 14 Oct 2011 12:00:00 -0400

summary: The Centers for Medicare & Medicaid Services (CMS) is testing three new surveyor worksheets for assessing compliance with three hospital Conditions of Participation. Discharge Planning, Infection Control, and Quality Assessment and Performance Improvement. A separate document containing instructions for the Infection Control worksheet is also included. We are focusing on compliance with these CoPs as a means to reduce healthcare-acquired conditions and hospital readmissions. Via this memorandum we are making these draft worksheets publicly available. We emphasize that we expect to revise these worksheets over the course of FY 2012 and that they will not be made a formal part of the federal hospital survey process before FY 2013.

title: Survey & Certification Focus on Patient Safety and Quality - Draft Surveyor Worksheets

memo_number: 10-17-ESRD

posting_date: Fri, 23 Apr 2010 12:00:00 -0400

summary: The new ESRD Conditions for Coverage, published on April 15, 2008, require that PCTs who have been employed since October 14, 2008, must be certified by either a CMS-approved State or National dialysis technician certification program by April 15, 2010. PCTs hired after October 14, 2008, must be certified within 18 months of their date of hire. Any surveys of ESRD facilities conducted after April 15, 2010, must include review of the certification of PCTs.

title: ESRD Program Survey Guidance on Patient Care Dialysis Technicians Certification

memo_number: S&C-10-07-CLIA EXPIRED

posting_date: Wed, 26 Mar 2025 11:00:00 -0400

summary: EXPIRED AS OF JANUARY 17, 2025. FOR CURRENT GUIDANCE REFER TO QSO-25-10-CLIA: SOM, Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services –Presently CLIA-related personnel policies and procedures are dispersed throughout the regulations, State Operations Manual (SOM), Interpretive Guidelines, training presentations and in other less formal venues. This memo attempts to consolidate and clarify them for the surveyor’s use and understanding.

title: EXPIRED: Consolidation of Personnel Policies for Individuals Directing or  Performing Non- waived Tests under the Clinical Laboratory Improvement Amendments (CLIA)

memo_number: 11-33-Hospital/CAH/RHC

posting_date: Fri, 15 Jul 2011 12:00:00 -0400

summary: Guidance is provided on determining rural location for CAHs, hospital swing beds & RHCs for a facility seeking CAH designation must be located outside a Metropolitan Statistical Area (MSA) or be treated as rural, and a hospital seeking swing bed status or a clinic seeking RHC certification must be located outside an area delineated as "urbanized" by the US Bureau of the Census (Census Bureau).

title: Clarification of Rural Eligibility Status for Hospital Swing Beds, Critical Access Hospitals

memo_number: 10-06-ALL

posting_date: Fri, 06 Nov 2009 12:00:00 -0500

summary: Secretary Sebelius exercised her waiver authority under section 1135 of the Social Security Act, effective October 23, 2009. The Secretary has delegated to the Centers for Medicare & Medicaid Services (CMS) the determination for a waiver for each case justified by necessity and extent (other than for the Health Insurance Portability and Accountability Act [HIPAA] waivers permitted under section 1135). H1N1 Tracking Tool for State Agency (SA) Staffing: Attachment 1 contains a tracking tool to assist States in reporting any H1N1 influenza impact to their survey and certification activities.

title: Presidential Emergency Declaration and HHS Section 1135 Waiver Authorization

memo_number: 09-37

posting_date: Fri, 15 May 2009 12:00:00 -0400

summary: New ASC Conditions for Coverage (CfCs) take effect on May 18, 2009. SOM Appendix L has been revised: Part 1, Survey Protocol has been added. The Interpretive Guidelines have been extensively updated to reflect the new and revised CfCs, as well as to provide more detailed guidance for existing CfCs. Feedback on this guidance is welcome; as needed, further refinements will be made in the future. ASPEN Tags for ASC surveys have been revised and renumbered. ASPEN surveyor kits with the new tags and regulatory text will be available shortly after May 18th.

title: State Operations Manual (SOM) Appendix L, Ambulatory Surgical Centers (ASC) Comprehensive Revision

memo_number: 11-17-NH

posting_date: Fri, 18 Mar 2011 12:00:00 -0400

summary: The purpose of this memorandum is to describe changes that the Centers for Medicare & Medicaid Services (CMS) will make to the Nursing Home Compare website http://www.medicare.gov/ on April 23, 2011 and on July 21, 2011. CMS is soliciting comments about these website changes. CMS will be evaluating the website in a systematic way, including seeking comments from stakeholders and visitors to the site. Based on these evaluations, CMS will continually making revisions to the website in the future.

title: April and July 2011 Changes to Nursing Home Compare

memo_number: 11-14-ICF/MR

posting_date: Fri, 18 Mar 2011 12:00:00 -0400

summary: It has been the expectation of ICF/MR surveyors pursuant to previous Centers for Medicare & Medicaid Services interpretations of 483.460(k)(4), that every client residing in an ICF/MR must participate at some level in a formal, self-administration program for medications.

title: Clarification of Self-Administration of Medications

memo_number: 11-15-ICF/MR

posting_date: Fri, 18 Mar 2011 12:00:00 -0400

summary: Section 42 CFR 483.420(d)(2)of the ICFs/MR regulations addresses the obligation of the facility staff to report allegations of mistreatment, neglect or abuse, and injuries of unknown source immediately to the administrator of the facility or to other officials in accordance with State law through established procedures. Both State and Federal surveyors have requested further clarification regarding the parameters surrounding what constitutes "injuries of unknown source", the definition of "immediate" and to whom such allegations/injuries must be reported.

title: Clarification of Reporting Mistreatment, Neglect and

memo_number: 10-04-LSC

posting_date: Fri, 30 Oct 2009 12:00:00 -0400

summary: This memorandum permits hospitals to apply the NFPA 6-year testing interval for fire and smoke dampers in hospital heating and ventilating systems, so long as the hospital's testing system conforms to the testing requirements under the 2007 edition of NFPA 80 and NFPA 105. Hospitals may operate under the damper testing cycle of the NFPA 2007 edition without special application to CMS.

title: Waiver to Allow Hospitals to Use the NFPA 6-Year Damper Testing Interval

memo_number: 11-16-NH

posting_date: Fri, 18 Mar 2011 12:00:00 -0400

summary: The final rule "Civil Money Penalties for Nursing Homes" was published in the Federal Register on March 18, 2011.

title: Publication of Final Rule Civil Money Penalties for Nursing Homes

memo_number: 10-03-ESRD

posting_date: Fri, 30 Oct 2009 12:00:00 -0400

summary: The new ESRD Conditions for Coverage require that dialysis patient care technicians (PCTs) who have been employed since October 14, 2008, must be certified by either a State or a National PCT certification program by April 15, 2010. PCTs hired after October 14, 2008 must be certified within 18 months of their date of hire.

title: Approval of State and National Certification Programs for Dialysis Technicians Under New ESRD CFCs