E-Prescribing is a prescriber's ability to electronically send an accurate, error-free and understandable prescription directly to a pharmacy from the point-of-care and is an important element in improving the quality of patient care. The inclusion of electronic prescribing in the Medicare Modernization Act (MMA) of 2003 gave momentum to the movement, and the July 2006 Institute of Medicine report on the role of e-prescribing in reducing medication errors received widespread publicity, helping to build awareness of e-prescribing's role in enhancing patient safety. Adopting the standards to facilitate e-prescribing is one of the key action items in the Federal government’s plan to expedite the adoption of electronic medical records and build a national electronic health information infrastructure in the United States.
CMS requires Part D sponsors, prescribers, and dispensers to support electronic prescribing consistent with regulations at 42 CFR § 423.160.
CMS Invites Comments on E-Prescribing and Related Standards in Proposed Rule CMS-4201-P
The proposed rule “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications,” (87 FR 79452) published December 27, 2022, contains provisions related to e-prescribing standards at 42 CFR § 423.160, specifically:
- After a transition period, requiring the National Council for Prescription Drug Plans (NDPDP) SCRIPT standard version 2022011 proposed for adoption at 45 CFR 170.205(b), and retiring the current NCPDP SCRIPT standard version 2017071, as the e-prescribing standard for transmitting prescriptions and prescription-related information (including medication history and electronic prior authorization (ePA) transactions) using electronic media for covered Part D drugs for Part D eligible individuals;
- Requiring the NCPDP Real-Time Prescription Benefit (RTPB) standard version 12 proposed for adoption at 45 CFR 170.205(c) as the standard for prescriber real-time benefit tools (RTBTs) supported by Part D sponsors; and
- Revising current regulatory text referring to Health Insurance Portability and Accountability Act of 1996 (HIPAA) standards for eligibility transactions.
Comments are due by February 13, 2023. Submit comments at https://www.regulations.gov/document/CMS-2022-0191-0001
Electronic Prescribing for Controlled Substances (EPCS)
Electronic prescribing for controlled substances (EPCS) is the process of electronically transmitting prescriptions using an electronic format. Practitioners issuing electronic prescriptions for controlled substances must use a software application that meets all Drug Enforcement Administration (DEA) requirements. EPCS has many benefits such as improved patient safety and workflow efficiencies, fraud deterrence, adherence management, and reduced burden.
In October 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) was enacted into law to address the opioid crisis. Section 2003 of the SUPPORT Act generally mandates that Schedule II-V controlled substances under Medicare Part D prescription drug plans (Medicare Part D) be electronically prescribed. The CMS EPCS Program is separate from any state EPCS program requirements.
Section 2003 of the SUPPORT Act provides the Secretary with discretion on whether to grant waivers or exceptions to the EPCS requirement and gives the Secretary of the Department of Health and Human Services authority to enforce non-compliance with the requirement and to specify appropriate penalties for non-compliance through rulemaking. In November 2021, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year 2022 Physician Fee Schedule Final Rule, which implements phase 2 of Section 2003 of the SUPPORT Act. The final rule is available at: https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf.
NOTE: Consistent with Section 2003 of the SUPPORT Act, there is no requirement for Part D sponsors or pharmacists to verify that a prescriber has a waiver (or is otherwise exempt) from CMS EPCS requirements before covering or dispensing a Part D drug. The EPCS requirement does not affect the ability of the Part D plan to cover or the pharmacists' ability to continue to dispense covered Part D drugs from otherwise valid written, oral, or fax prescriptions that are consistent with laws and regulations.
Please Join CMS for a Webinar on the New EPCS Program
This inaugural webinar will provide an overview of the CMS Electronic Prescribing for Controlled Substances (EPCS) Program. In October 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) was enacted into law to address the opioid crisis. Section 2003 of the SUPPORT Act generally mandates that Schedule II-V controlled substances under Medicare Part D prescription drug plans (Medicare Part D) be electronically prescribed. Please join CMS in a discussion of this important upcoming program.
When: January 12, 2023, 1:00 - 2:00 PM ET
Register to attend:
After registering, you will receive a confirmation email containing information about joining the webinar.
Who should attend: All Schedule II-V controlled substances prescribers under Medicare Part D, staff and industry-wide stakeholders.
Questions: Please submit questions in advance, with the subject heading “EPCS Webinar Question” to EPCS@hsag.com On the call, we will answer as many of the questions received by noon as possible. We'll also post a subsequent summary document.
Important EPCS Program Milestones
- November 1, 2022 – Calendar Year 2023 Physician Fee Schedule Final Rule released
- January 1, 2023 – Compliance start date for 2023 measurement year
- January 12, 2023 - Introduction to the CMS EPCS Program Webinar (click to register)
- December 31, 2023 – Compliance end date for 2023 measurement year
- Summer 2024 – CMS analysis of Part D Prescription Claims Data for 2023 measurement year begins after Medicare Part D reconciliation period
- Summer/Fall 2024 – Notification of non-compliance sent and EPCS compliance available via an EPCS Dashboard
- Summer/Fall 2024 – EPCS waiver application period open for 2023 measurement year
- Late 2024 – Prescriber notification of waiver approval status for 2023 measurement year
2023 Measurement Year EPCS Program Overview
EPCS Program Prescribers
Prescribers who issue prescriptions for controlled substances to Medicare Part D beneficiaries.
EPCS Program Compliance Determination
The threshold is the percentage of prescription drug claims for Schedule II, III, IV, and V controlled substances under Medicare Part D that are electronically prescribed, after exceptions are applied, at the end of the calendar year. The threshold for compliance is 70%.
EPCS Program Exceptions
- Prescriptions for controlled substances issued when the prescriber and dispensing pharmacy are the same entity.
- Prescribers who issue 100 or fewer qualifying Medicare Part D controlled substance prescriptions per calendar year.
- Prescribers who CMS determines are in the geographic area of an emergency or disaster as declared by a Federal, State, or local government entity.
- Prescribers who have received a CMS-approved waiver because the prescriber is unable to conduct electronic prescribing of controlled substances due to circumstances beyond the prescriber's control.
Compliance actions for prescriptions for beneficiaries in a long-term care (LTC) facility will begin January 1, 2025.
Prescribers may request a waiver when circumstances beyond their control prevented them from electronically prescribing controlled substances. The waiver application period for the 2023 EPCS measurement year will open in calendar year 2024.
For the 2023 EPCS measurement year, CMS will enforce compliance by sending notification of non-compliance to prescribers violating the EPCS mandate.
CMS encourages you to subscribe to the EPCS listserv (Click to subscribe) to stay up to date on the EPCS Program.
See Downloads and Related Links below for additional resources.
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E-Prescribing Standards Timeline
- On November 7, 2005, CMS published the first set of adopted standards known as the foundation standards (CMS-0011-F). The foundation standards became effective on January 1, 2006. These standards apply to all electronic prescribing done under Part D of the MMA.
- MMA required CMS to implement pilot projects to test additional standards. These additional standards were pilot tested in 2006.
- On June 23, 2006 CMS published an interim final rule with comment to adopt NCPDP SCRIPT Standard version 8.1 on a voluntary basis to be used for e-prescribing.
- The results of the pilot test were announced in a report to Congress in April 2007 and were the basis for an NPRM proposing additional standards that was published on November 16, 2007 (CMS-0016-P).
- The final e-prescribing rule was published at the Federal Register on April 7, 2008 (CMS-0016-F and CMS-0018-F). In this final rule CMS adopted 3 additional standards for use in e-prescribing under Part D.
- On January 16, 2009 CMS published a final rule (CMS-0009-F), In this reg the Medicare Part D e-Prescribing foundation standards were updated to include:
- The National Council for Prescription Drug Programs Telecommunication Standard Specification, Version D, Release 0 for eligibility queries between dispensers and Part D sponsors.
- The Accredited Standards Committee X12N 270/271-Health Care Eligibility Benefit Inquiry and Response, Version 5010; For eligibility and benefits queries and responses between prescribers and Part D sponsors.
- While CMS-0009-F updated the HIPAA eligibility transaction standards at 45 CFR § 162.1202, conforming amendments to 42 CFR § 423.160(b)(3) reflecting the updated standards were made in CMS-9070-F published May 16, 2012.
- On November 19, 2008 CMS Published the 2009 Physician Fee Schedule Payment Final Rule (CMS-1403-FC). In that payment reg CMS lifted the exemption to the Computer Generated Fax (CGF) exemption. CMS listed a date of January 1, 2012 for the elimination of the CGF exemption.
- On July 01, 2010 CMS published an interim final rule with comment (CMS-0023-IFC) to adopt NCPDP SCRIPT Standard version 10.6 on a voluntary basis to be used for e-prescribing.
- On November 16, 2012, the CY 2013 Physician Fee Schedule final rule (CMS-1590-FC) adopted the NCPDP SCRIPT Version 10.6 standard effective (10/1/13)
o Retired Version 8.1
o Lifted the Long Term Care Exemption (effective 10/1/14)
- On December 10, 2013 the CY 2014 Physician Fee Schedule final rule (CMS-1600-FC) adopted a newer version of the NCPDP Formulary and Benefits 3.0 transaction effective 2/28/15 and it also retires NCPDP Formulary and Benefits version 1.0 on 3/1/15.
- On April 16, 2018 CMS published a final rule (CMS-4182-F) to adopt a new NCPDP SCRIPT Standard Version 2017071 and retirement of current NCPDP SCRIPT Version 10.6 for use in the Medicare Prescription Drug Benefit (Part D) program effective January 1, 2020.
- On May 23, 2019, CMS published a final rule (CMS-4180-F) requiring that Part D plans adopt one or more real time benefit tools (RTBTs) capable of giving prescribers clinically appropriate patient-specific real-time formulary and benefit information. This mandate is effective January 1, 2021.
- On August 4, 2020, CMS published a Request for Information (RFI) for Electronic Prescribing of Controlled Substances (EPCS) in Medicare Part D (CMS-3394-NC). The RFI sought input from stakeholders around implementation of Section 2003 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) which generally requires that prescriptions for controlled substances covered under a Medicare Part D prescription drug plan be transmitted by a health care practitioner electronically.
- On December 28, 2020, CMS published the 2021 PFS final rule (CMS-1734-F), which requires that prescribers use the NCPDP SCRIPT standard version 2017071 for EPCS transmissions.
- On December 31, 2020, CMS published the Electronic Prior Authorization for Medicare Part D final rule (CMS-4189-F). This rule allows Part D plans to use the NCPDP SCRIPT standard version 2017071 for electronic prior authorization transactions beginning January 1, 2021, and requires use of this standard for these transactions beginning January 1, 2022.
- On January 19, 2021, CMS published the Part C and D final rule (CMS-4190-F2) requiring that plans implement a beneficiary real-time benefit tool (RTBT) by January 1, 2023.
- On November 19, 2021, CMS published the 2022 PFS final rule (CMS-1751-F) which delayed the compliance deadline for EPCS to no earlier than January 1, 2023 and no earlier than January 1, 2025 for LTC prescriptions for controlled substances, specified a 70% threshold for compliance, and established exceptions to the EPCS requirement.