In an ongoing effort to enhance the efficiency, interoperability, and security of electronic health information systems, the Centers for Medicare & Medicaid Services (CMS) has issued the final rule CMS-4205-F2, “Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications”. This rule addresses the need for updated standards in the Medicare Prescription Drug Benefit Program (Part D) and Health Information Technology (HIT) to streamline electronic prescribing, patient out-of-pocket costs, electronic prior authorization, and information exchange processes. By implementing these changes, CMS aims to reduce administrative burdens, improve patient safety, and ensure more accurate and timely transmission of prescription-related information.

Key Problems Addressed by the Rule

1. Updating Outdated Standards: The rule modernizes the e-prescribing, e-prior authorization, formulary and benefit standards required under Part D to keep pace with industry advancements. This includes updating to newer versions of the NCPDP SCRIPT standard for e-prescribing, medication history, and electronic prior authorization, the NCPDP Formulary and Benefit (F&B) standard for exchanging formulary and benefit information, and newly naming the NCPDP Real-Time Prescription Benefit (RTPB) standard for real-time benefit tools.
2. Improving interoperability: By requiring the use of more current, standardized versions of e-prescribing transaction standards, the rule aims to enhance interoperability between the systems used by prescribers, pharmacies, payers, and intermediaries. This can help reduce barriers to efficient data exchange and streamline e-prescribing workflows.
3. Aligning with HIPAA standards: The rule addresses potential misalignment between Medicare Part D standards and HIPAA standards for eligibility transactions. By cross-referencing the HIPAA standards, the rule ensures that Part D requirements will automatically stay in sync with any future updates to HIPAA, reducing the need for separate rulemaking.
4. Enhancing real-time benefit tools: The rule requires Part D sponsors to use a specific NCPDP standard for prescriber real-time benefit tools, which can help prescribers access accurate, patient-specific cost and coverage information at the point of prescribing. This can support informed decision-making and help manage patient out-of-pocket costs.
5. Streamlining Federal requirements: By having ONC adopt the e-prescribing standards on behalf of HHS and CMS cross-referencing those standards, the rule creates a more unified, consistent approach to e-prescribing standards across Federal programs. This can help reduce regulatory complexity and potential misalignment between CMS and ONC rules.
6. Supporting patient safety and prescription accuracy: More advanced e-prescribing standards can help reduce medication errors, improve communication between prescribers and pharmacies, and support more accurate prescription data transmission.

Key Changes and Compliance Requirements

New Standards for Electronic Prescribing, Electronic Prior Authorization and Real-Time Prescription Benefit

• National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard:
  • Current Version: NCPDP SCRIPT standard version 2017071.
  • New Version: NCPDP SCRIPT standard version 2023011.
  • Transition Period: Entities can use either version until January 1, 2028.
  • Mandatory Use: From January 1, 2028, only NCPDP SCRIPT standard version 2023011 will be accepted.
• NCPDP Formulary and Benefit (F&B) Standard:
  • Current Version: NCPDP F&B standard version 3.0.
  • New Version: NCPDP F&B standard version 60.
  • Transition Period: Until January 1, 2027.
  • Mandatory Use: From January 1, 2027, only NCPDP F&B standard version 60 will be accepted.
• NCPDP Real-Time Prescription Benefit (RTPB) Standard:
  • Adopted Standard: NCPDP RTPB standard version 13.
  • Mandatory Use: By January 1, 2027.

Compliance and Enforcement

Stakeholders Required to Comply:

• Part D sponsors
• Prescribers
• Dispensers of covered Part D drugs for Part D eligible individuals

Exemptions:

There is no general requirement for Part D prescribers or dispensers to implement e-prescribing, except for mandatory electronic prescribing of Schedule II-V controlled substances that are Part D drugs, with a few exceptions to the EPCS requirement including when the prescriber:

• issues 100 or fewer controlled substance prescriptions for Part D drugs per calendar year
• is in an area affected by a natural disaster or emergency, or
• the prescriber has received a CMS-approved waiver due to circumstances beyond their control

Implications for Non-Part D Payers

While the standards adopted in this final rule are specifically required for Medicare Part D, they may have implications for non-Part D payers, prescribers, and dispensers, such as:

• Influence on industry standards: The standards adopted for Part D, given Medicare's significant market share, often become de facto industry standards. Many non-Part D payers, prescribers, and dispensers may choose to adopt these standards for consistency and interoperability, even if not legally required to do so.
• Alignment with state requirements: Some states have their own laws and regulations related to electronic prescribing, electronic prior authorization, real-time prescription benefit and formulary and benefit transactions. The adoption of newer versions of NCPDP standards for Part D may encourage states to update their own requirements to align with these standards or the state may not update their policies or have a requirement that is earlier than the compliance date found in this final rule. However, the final rule does not directly override or preempt state laws that are not specific to Part D.
• Prescriber and pharmacy workflow: Prescribers and pharmacies that serve both Part D and non-Part D patients may find it more efficient to use the same electronic prescribing workflows and standards for all patients, rather than maintaining separate processes.
• Encouragement of electronic transactions: The adoption of updated standards for electronic prescribing, electronic prior authorization, real-time prescription benefit and formulary and benefit in Part D, one can hope, will accelerate the general trend toward electronic transactions in the healthcare industry, including in non-Part D settings.

Penalties and Enforcement

While the final rule emphasizes compliance deadlines and standards, it does not explicitly outline penalties for non-compliance within the provided document. However, stakeholders should anticipate potential enforcement actions aligned with typical CMS regulatory practices and ensure timely adherence to avoid disruptions or sanctions.

Deadlines

• Effective Date: Regulations become effective 30 days after publication in the Federal Register.
• SCRIPT Standard Version 2017071 Expiration: December 31, 2027.
• Mandatory Use of SCRIPT Standard Version 2023011: January 1, 2028.
• Mandatory Use of F&B Standard Version 60: January 1, 2027.
• Mandatory Use of RTPB Standard Version 13: January 1, 2027.

The CMS final rule CMS-4205-F2 represents a significant update aimed at improving electronic prescribing, electronic prior authorization, transparency for patients related to their out-of-pocket costs and the interoperability of health information systems. To remain competitive and maintain smooth operations, stakeholders must prepare for these changes, ensuring compliance with new standards by the specified deadlines to avoid potential penalties.

For further details and to access the full text of the final rule, please visit federalregister.gov or govinfo.gov.

POCP experts are here to help your organization understand the implications of this new CMS final rule. We can assist you in revisiting your short- and long-term strategies, providing tailored recommendations to ensure seamless compliance and optimal operational efficiency. Reach out to us at today to navigate these regulatory changes with confidence.