Overview

Accrediting Organizations (AOs) play a key role in determining whether health care providers and suppliers meet the Medicare health and safety requirements. CMS approves certain national AOs to evaluate compliance with Medicare conditions, allowing providers to participate in the Medicare program through participation with a CMS-approved AO.

Background

Medicare Participation Requirements

To participate in the Medicare program, health care providers and suppliers must comply with: 

• Applicable statutory requirements of the Social Security Act (the Act), and
• CMS’ regulations related to patient health and safety. 

According to Section 1864 of the Act,[DR1]  the State Survey Agencies (SAs) or other appropriate local agencies, under an agreement with the Secretary of the Department of Health and Human Services (the Secretary), survey health care providers and suppliers to assess their compliance with applicable Medicare conditions for the purpose of certification for participation in Medicare or Medicaid programs. 

Section 1865(a) of the Act allows most health care facilities to demonstrate their compliance with the Medicare conditions through accreditation by a CMS-approved AO program, instead of being surveyed by SAs for certification.  This is referred to as deemed status.  CMS grants deemed status when CMS-approved AOs: 

• Have accreditation standards that meet or exceed those of Medicare, and
• Demonstrate survey processes comparable to those of SAs. 

Note: AOs perform initial, re-accreditation, follow-up, and certain complaint surveys.

When a provider or supplier is accredited by a CMS-approved AO, CMS considers them to have met applicable Medicare requirements and conditions.

Accreditation vs. Deeming

While CMS often refers to “accreditation”, its formal authority applies to deeming. 

• Deeming authority is granted by CMS after a formal review of an AO’s standards and survey processes.
• Each AO may establish its own quality standards, which must meet or exceed Medicare’s requirements. 
• AOs may also offer accreditation activities outside of CMS deeming authority.

CMS-approved Deeming Programs

CMS currently recognizes two types of deeming programs: certified and non-certified. 

For many providers and suppliers seeking to participate in Medicare and Medicaid, there are two pathways to demonstrate compliance with federal health and safety standards:

1. Through agreements CMS makes with SAs that allow them to conduct facility surveys and certifications on CMS’ behalf. 
2. Accreditation by a national AO recognized by CMS to deem the facility as meeting CMS’ health and safety standards (this pathway is voluntary). 

Providers, who are able to be surveyed and certified by state surveyors on CMS’ behalf, are called Certified providers or suppliers (refer to Section 1864 of the Social Security Act for more information on certification). 

Therefore, AO programs with CMS approval to deem providers and suppliers as meeting our health and safety standards are called Certified CMS-Deemed Programs, which include:

• Ambulatory Surgical Centers (ASCs)
• Critical Access Hospitals (CAHs)
• End Stage Renal Disease (ESRD) Facilities
• Home Health Agencies (HHA)
• Hospice
• Hospitals (including Psychiatric Hospitals)
• Outpatient Physical Therapy (OPT)
• Rural Health Clinics (RHC)
• Clinical Laboratories (CLIA)[DR2] 

However, some providers and suppliers seeking to participate in CMS programs can only be surveyed by AOs because surveys by the state are not an option. CMS calls AO’s programs with CMS approval to deem providers and suppliers as meeting our requirements Non-Certified CMS-Deemed Programs, which include:

• Advanced Diagnostic Imaging (ADI)
• Diabetes Self-Management Training (DSMT)
• Home Infusion Therapy (HIT)

 General Note: With this update, we’re hyperlinking applicable downloads or resources in the page versus pointing users to a list of downloads.

Accrediting Organizations (AOs)

Overview

Accrediting Organizations (AOs) play a key role in determining whether health care providers and suppliers meet the Medicare health and safety requirements. CMS approves certain national AOs to evaluate compliance with Medicare conditions, allowing providers to participate in the Medicare program through participation with a CMS-approved AO.

Background

Medicare Participation Requirements

To participate in the Medicare program, health care providers and suppliers must comply with: 

• Applicable statutory requirements of the Social Security Act (the Act), and
• CMS’ regulations related to patient health and safety. 

According to Section 1864 of the Act, the State Survey Agencies (SAs) or other appropriate local agencies, under an agreement with the Secretary of the Department of Health and Human Services (the Secretary), survey health care providers and suppliers to assess their compliance with applicable Medicare conditions for the purpose of certification for participation in Medicare or Medicaid programs. 

Section 1865(a) of the Act allows most health care facilities to demonstrate their compliance with the Medicare conditions through accreditation by a CMS-approved AO program, instead of being surveyed by SAs for certification.  This is referred to as deemed status.  CMS grants deemed status when CMS-approved AOs: 

• Have accreditation standards that meet or exceed those of Medicare, and
• Demonstrate survey processes comparable to those of SAs. 

Note: AOs perform initial, re-accreditation, follow-up, and certain complaint surveys.

When a provider or supplier is accredited by a CMS-approved AO, CMS considers them to have met applicable Medicare requirements and conditions.

Accreditation vs. Deeming

While CMS often refers to “accreditation”, its formal authority applies to deeming. 

• Deeming authority is granted by CMS after a formal review of an AO’s standards and survey processes.
• Each AO may establish its own quality standards, which must meet or exceed Medicare’s requirements. 
• AOs may also offer accreditation activities outside of CMS deeming authority.

CMS-approved Deeming Programs

CMS currently recognizes two types of deeming programs: certified and non-certified. 

For many providers and suppliers seeking to participate in Medicare and Medicaid, there are two pathways to demonstrate compliance with federal health and safety standards:

1. Through agreements CMS makes with SAs that allow them to conduct facility surveys and certifications on CMS’ behalf. 
2. Accreditation by a national AO recognized by CMS to deem the facility as meeting CMS’ health and safety standards (this pathway is voluntary). 

Providers, who are able to be surveyed and certified by state surveyors on CMS’ behalf, are called Certified providers or suppliers (refer to Section 1864 of the Social Security Act for more information on certification). 

Therefore, AO programs with CMS approval to deem providers and suppliers as meeting our health and safety standards are called Certified CMS-Deemed Programs, which include:

• Ambulatory Surgical Centers (ASCs)
• Critical Access Hospitals (CAHs)
• End Stage Renal Disease (ESRD) Facilities
• Home Health Agencies (HHA)
• Hospice
• Hospitals (including Psychiatric Hospitals)
• Outpatient Physical Therapy (OPT)
• Rural Health Clinics (RHC)
• Clinical Laboratories (CLIA)

However, some providers and suppliers seeking to participate in CMS programs can only be surveyed by AOs because surveys by the state are not an option. CMS calls AO’s programs with CMS approval to deem providers and suppliers as meeting our requirements Non-Certified CMS-Deemed Programs, which include:

• Advanced Diagnostic Imaging (ADI)
• Diabetes Self-Management Training (DSMT)
• Home Infusion Therapy (HIT)

How to Contact an Accrediting Organization (AO)

CMS-approved AOs evaluate whether health care providers and suppliers meet Medicare health and safety requirements. Below are the CMS-approved AOs: 

1. Accreditation Commission for Healthcare, Inc. (ACHC)
2. American Association for the Accreditation of Ambulatory Surgery Facilities (Quad A) 
3. Accreditation Association for Ambulatory Health Care (AAAHC)
4. Center for Improvement in Healthcare Quality (CIHQ)
5. Community Health Accreditation Partner (CHAP)
6. DNV Healthcare (DNV)
7. Joint Commission (JC)
8. National Dialysis Accreditation Commission (NDAC)
9. The Compliance Team (TCT)

How to File a Complaint with an AO

If you want to file a complaint with an AO, the links above will direct you to the organization’s website where you can find more information. 

If the complaint is about a Medicare-participating facility, you may also file a complaint with the State Survey Agency (SA), even if the facility is accredited by a CMS-approved AO and has deemed status.  

To receive CMS approval to become a national Accrediting Organization (AO) with deeming authority, an organization must submit an application and demonstrate that it meets all requirements per 42 CFR 488.1, 488.4, 488.5, and 488.8  for: 

• Initial AO recognition (CMS-approval), and
• Ongoing CMS review and approval.

A national AO, is an organization that: 

• Accredits health care provider entities under a specific program. 
• Has accredited providers or supplies under each program that are widely located geographically across the United States. 

For questions about the application process to become a national AO with CMS deeming authority, contact AO_Applications@cms.hhs.gov. 

Non-certified programs differ from certified programs primarily in the survey and certification process. While non-certified programs enroll in Medicare, they aren’t surveyed and certified by CMS through the traditional process. In these situations, State Survey Agencies (SAs) don’t conduct onsite surveys. Instead, onsite surveys are conducted by CMS-recognized Accrediting Organizations (AOs). 

CMS recognizes the AOs as having standards to ensure the health and safety of patients. Through oversight of these AOs, CMS ensures that these Medicare non-certified suppliers provide quality care. 

Advanced Diagnostic Imaging (ADI)

All suppliers who perform ADI services must be accredited by a CMS-approved AO to ensure imaging services meet federal safety and quality requirements.

Why is Accreditation Required?

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA),  which amended section 1834(e) of the Social Security Act (the Act), requires certain imaging suppliers to be accredited before they can receive Medicare payment for imaging services. Any supplier that performs the technical component of ADI must be accredited. This requirement doesn’t apply to hospitals or critical access hospitals.

Technical component means all non-physician work involved in producing the images, including administrative activities, personnel time, ADI equipment and facility use. 

What’s an ADI procedure?

Section 1834 of Social Security Act defines ADI as:

• Magnetic Resonance Imaging (MRI) 
• Computed Tomography (CT) 
• Nuclear medicine imaging, such as Positron Emission Tomography (PET).  

The following are not considered ADI procedures: 

• X-ray
• ultrasound
• fluoroscopy procedures 
• diagnostic and screening mammography  
  Note: Diagnostic and screening mammography are regulated by the U.S. Food and Drug Administration (FDA).   

Who can enroll as an ADI supplier?

Under Sections 1861(d) and 1834(e)(1)(A) of the Social Security Act, an ADI supplier provides the technical component of diagnostic ADI services for which payment is made under the (physician) fee schedule established under Section 1848(b). An ADI supplier must be accredited by a CMS-approved ADI AO and can include: 

• Physicians or other practitioners
• Independent Diagnostic Testing Facilities (IDTF)
• Other facilities  

ADI accreditation procedures are set forth at 42 CFR 414.68.  For questions about the accreditation process, email the ADI Accreditation Mailbox at: ADIAccreditation@cms.hhs.gov.

For enrollment related questions, reach out to your CMS Medicare Administrative Contractor.

CMS-Approved ADI Accrediting Organizations 

CMS approved the following national AOs for ADI services: 

• American College of Radiology (ACR)
• Intersocietal Accreditation Commission (IAC)
• Joint Commission (JC) 
• RadSite

Diabetes Self-Management Training (DSMT) 

Diabetes Self-Management Training (DSMT) helps people with diabetes learn the skills they need to manage their condition and follow their treatment plan. Medicare covers DSMT services when certain requirements are met.

CMS Authority and Coverage

Section 1861(qq) of the Social Security Act defines Medicare outpatient coverage of DSMT services, which: 

• Include educational and training services provided to an individual with diabetes by a certified provider. 
• Are given in an outpatient setting. 
• Are ordered by the physician managing the individual’s diabetes as part of a comprehensive care plan.
• Are provided by an individual or entity who meets CMS quality standards.

DSMT Approved Entity

CMS may recognize an individual, physician, or entity accredited by an approved organization as meeting one of the sets of quality standards described in § 410.144 and approved by CMS under § 410.141(e) to furnish training.

Why is Accreditation Required?

Accreditation is required under Final rule (65 FR 83130), which implemented Section 4105(a) of the Balanced Budget Act (BBA) of 1997 that includes provisions to address coverage, payment, quality standards, and accreditation requirements for DSMT.

DSMT Accreditation Standards

CMS regulations 42 CFR 410.144 require DSMT AOs to use one of the following quality standards: 

• CMS quality standards
• The National Standards for Diabetes Self-Management Education and Support Programs standards, or
• Other standards developed by a national organization, submitted to CMS, and approved as meeting or exceeding CMS quality standards.

CMS-Approved DSMT Accrediting Organizations

CMS approved the following national AOs to accredit entities that provide DSMT services: 

• American Diabetes Association® (ADA) 
• Association of Diabetes Care & Education Specialists (ADCES) 

DSMT  accreditation procedures are outlined in 42 CFR 410.142.  For questions about the accreditation process, email the DSMT Accreditation Mailbox at: DSMTaccreditation@cms.hhs.gov.

Home Infusion Therapy (HIT)

Home Infusion Therapy (HIT) involves the intravenous or subcutaneous administration of drugs or biologicals to an individual at home.  HIT typically includes:

• Medications/drugs (e.g. antivirals or immune globulin) 
• Equipment (e.g. a pump)
• Supplies (e.g. tubing and catheters)

Providing HIT often requires coordination among multiple parties, including patients, physicians, hospital discharge planners, health plans, home infusion pharmacies, and, if applicable, home health agencies. Learn more about Home Infusion Therapy. 

CMS Authority and Coverage

Section 1861(iii) of the Social Security Act defines the requirements that HIT suppliers must meet to participate in Medicare. These requirements are outlined in 42 CFR 486 Subpart I. 

CMS-Approved HIT Accrediting Organizations

CMS approved the following national AOs for HIT:

• Accreditation Commission for Health Care, Inc. (ACHC) 
• Community Health Accreditation Partner (CHAP)    
• National Association of Boards of Pharmacy (NABP)  
• The Compliance Team (TCT)   
• Joint Commission (JC)   
• URAC

HIT Approved Supplier

A qualified HIT supplier must be accredited by a Medicare-approved AO and is required to enroll in Medicare as a Part B supplier. 

A HIT supplier is not required to enroll as a Durable Medical Equipment (DME) supplier. However, a DME supplier or Home Health Agency should consider enrolling as a HIT supplier if they intend to provide home infusion therapy services beyond what is covered under the DME benefit or Home Health benefit, respectively.