E-Prescribing Standards and Requirements

Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended Title XVIII of the Social Security Act (the Act) to establish the Voluntary Prescription Drug Benefit Program. Included in the provisions at section 1860D-4(e) of the Act is the requirement that prescriptions and certain other information for covered Part D drugs prescribed for Part D eligible individuals that are transmitted electronically comply with final uniform standards adopted by the Secretary under an electronic prescription drug program.

Part D sponsors who participate in the Part D program are required to support electronic prescribing. Providers that prescribe or dispense Part D drugs are required to comply with the standards when prescription information or certain other related information is electronically transmitted. Regulatory requirements are codified at 42 CFR 423.159 and 42 CFR 423.160.

Timeline of Adopted Standards for Electronic Prescribing

• 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 e-prescribing under Part D of the MMA. The foundation standards adopted were:
  • The National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version 5, Release 0 (version 5.0); for transactions between prescribers (who write prescriptions) and dispensers (who fill prescriptions) for new prescriptions; refill requests and responses; prescription change requests and responses; prescription cancellation, request and response; and related messaging and administrative transactions;
  • The Accredited Standards Committee X12N 270/271-Health Care Eligibility Benefit Inquiry and Response, Version 4010; for communicating eligibility and benefits information between prescribers and Part D sponsors; and
  • The NCPDP Telecommunication Standard Specification, Version 5, Release 1 (version 5.1); for communicating eligibility information between dispensers and Part D sponsors.
• 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).
• On November 27, 2007, CMS published the 2008 Physician Fee Schedule final rule with comment period (CMS-1385-FC) which eliminated the computer generated fax exemption from the NCPDP SCRIPT standard requirement for the communication of prescription or certain prescription related information between prescribers and dispensers beginning January 1, 2009. 
• On April 7, 2008, CMS published a final rule (CMS-0016-F and CMS-0018-F) adopting 3 additional standards known as the “initial standards” for use in electronic prescribing under Part D:
  • NCPDP Formulary and Benefit Standard Implementation Guide Version 1.0; to provide prescribers information about which drugs are covered by a Medicare Part D enrollee’s prescription drug plan;
  • NCPDP SCRIPT Standard Implementation Guide Version 8, Release 1 (version 8.1) for communication of prescription and prescription-related information, including medication history transactions (retiring NCPDP SCRIPT standard version 5.0); and
  • National Provider Identifier (NPI) as a standard identifier for health care providers for use in electronically transmitted prescription or prescription-related materials among the Medicare Part D sponsor, prescriber, and the dispenser.
• On November 19, 2008 CMS published the 2009 Physician Fee Schedule Payment Final Rule (CMS-1403-FC). In that final rule, CMS amended the previous computer generated fax exemption from the NCPDP SCRIPT standard requirement for the communication of prescription and prescription-related information and eliminated the exemption for the use of computer generated fax in all instances other than transient/temporary network transmission failures as of January 1, 2012.
• On January 16, 2009 CMS published a final rule (CMS-0009-F) updating the foundation standards to include:
  • The NCPDP Telecommunication Standard Specification, Version D, Release 0; for eligibility queries between dispensers and Part D sponsors; and
  • 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 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 standard version 10.6 standard effective November 1, 2013, and retired NCPDP SCRIPT standard version 8.1
  • Long Term Care exemption from using the NCPDP SCRIPT standard was lifted effective November 1, 2014
• On December 10, 2013 the CY 2014 Physician Fee Schedule final rule (CMS-1600-FC) adopted a newer version of the NCPDP Formulary and Benefit standard version 3.0 effective March 1, 2015 and retired NCPDP Formulary and Benefit version 1.0.
• On April 16, 2018 CMS published a final rule (CMS-4182-F) to adopt NCPDP SCRIPT standard version 2017071 and retire NCPDP SCRIPT standard version 10.6 for use in the Medicare Part D program effective January 1, 2020.
• On May 23, 2019, CMS published a final rule (CMS-4180-F) requiring that effective January 1, 2021, 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. CMS did not adopt a standard for RTBTs.
• 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 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 Physician Fee Schedule 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 sponsors 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 Part D sponsors implement a beneficiary real-time benefit tool (RTBT) by January 1, 2023 and permitted Part D sponsors to offer certain rewards and incentives for use of the RTBT. These requirements are codified at 42 CFR 423.128(d)(4)-(5).
• On November 19, 2021, CMS published the 2022 Physician Fee Schedule 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.
• On November 18, 2022, CMS published the 2023 Physician Fee Schedule final rule (CMS-1770-F) which updated the CMS EPCS program operational processes for determining the small-volume prescriber exemption and the source of the prescriber address to determine if a prescriber qualifies for an emergency or disaster exemption. CMS also discussed the timing of compliance actions.
• On November 16, 2023, CMS published the 2024 Physician Fee Schedule final rule (CMS-1784-F) which removed the exception to the EPCS requirement for prescriptions where the prescriber and dispensing pharmacy are the same legal entity. 
• On June 17, 2024, CMS published the Part D and Office of the National Coordinator for Health IT (ONC) final rule (CMS-4205-F2).  The finalized provisions modify the requirements related to e-prescribing standards throughout 42 CFR 423.160 as follows:
  • Following a transition period, requiring the NCPDP SCRIPT standard version 2023011, adopted by ONC 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 transactions) using electronic media for covered Part D drugs for Part D eligible individuals, beginning January 1, 2028.       
  • Following a transition period, requiring use of NCPDP Formulary and Benefit (F&B) standard version 60, adopted by ONC at 45 CFR 170.205(u), and retiring use of NCPDP F&B version 3.0 for transmitting formulary and benefit information between prescribers and Part D sponsors, beginning January 1, 2027.
  • Requiring the NCPDP Real-Time Prescription Benefit (RTPB) standard version 13, adopted by ONC at 45 CFR 170.205(c), as the standard for prescriber real-time benefit tools (RTBTs) supported by Part D sponsors beginning January 1, 2027; and
  • Revising current regulatory text to cross-reference the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations at 45 CFR 162.1202 for requirements related to standards for eligibility transactions.