E-prescribing enables a prescriber 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.
E-Prescribing and Related Standards in Final Rule CMS-4205-F2
The final rule, “Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications,” (89 FR 51238) finalized proposals related to standards for electronic prescribing from the proposed rule “Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications,” (88 FR 78476) published November 15, 2023. The finalized provisions modify the requirements related to e-prescribing standards throughout42 CFR 423.160 as follows:
- Requiring the NDPDP SCRIPT standard version 2023011, adopted by the Office of the National Coordinator for Health IT (ONC) at45 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. A transition period begins July 17, 2024, the effective date of the final rule, during which either version of the NCPDP SCRIPT standard may be used. The transition period will end on January 1, 2028, which is the date that NCPDP SCRIPT standard version 2017071 will expire for the purposes of U.S. Department of Health and Human Services (HHS) use. Beginning January 1, 2028, entities must exclusively use NCPDP SCRIPT standard version 2023011 for Part D e-prescribing.
- 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. During a transition period beginning on July 17, 2024, the effective date of the final rule, and ending January 1, 2027, entities are permitted to use either NCPDP F&B version 3.0 or NCPDP F&B standard version 60. Beginning January 1, 2027, entities must comply with a standard adopted by ONC only. Therefore, as of January 1, 2027, entities will be required to exclusively use NCPDP F&B standard version 60 for the electronic transmission of formulary and benefits information for Part D e-prescribing;
- Requiring the NCPDP Real-Time Prescription Benefit (RTPB) standard version 13, adopted by ONC at45 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. This revision does not alter existing requirements but will ensure that Part D regulations align with potential future updates to standards required under HIPAA regulations.
The final rule also made multiple technical changes to the regulation text throughout § 423.160 by removing references to requirements and incorporations by reference that are no longer applicable, re-organizing existing requirements, and a technical correction.
The effective date of the final rule is July 17, 2024.
