A new Final Rule1 was published on June 17, 2024, regarding health information technology (IT) changes and updates for Medicare Part D. The Office of the National Coordinator for Health Information Technology (ONC) is adopting specific standards: National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2023011, NCPDP Formulary and Benefit (F&B) standard version 60, and NCPDP Real-Time Prescription Benefit (RTPB) standard version 13. Attributed to the adoption of these standards, the Centers for Medicare and Medicaid Services (CMS) has finalized that these standards will be required for Medicare Part D plans. These standards serve to enhance the interoperability of prescribers, pharmacies, and payers (e.g., pharmacy benefit managers (PBMs), health plans, and processors).
NCPDP SCRIPT Standard Version 2023011
The NCPDP SCRIPT standard will be updated from the current version 2017071 to version 2023011. This standard is already a requirement for Medicare Part D plans. The NCPDP SCRIPT standard is "to facilitate the transfer of prescription data between pharmacies, prescribers, and payers."2 This standard enables patient specific transmissions such as new prescriptions, changes to prescriptions, renewal of prescriptions, cancelations or other modifications to the prescription, and prior authorizations.
The NCPDP SCRIPT standard version 2023011 is required for Part D plans to be implemented by January 1, 2028.
NCPDP Formulary and Benefit Standard Version 60
The current adopted standard for NCPDP F&B is standard version 3.0. The F&B standard provides similar capabilities to the SCRIPT standard, however, not at a patient specific level as described above. The F&B enables prescribers to access information about the formulary and benefit information such as the formulary status of a drug, formulary alternatives, coverage information (e.g., prior authorization, quantity limits, step therapy), cost-sharing, and pharmacy networks.
The NCPDP F&B standard version 60 is required for Part D plans to be implemented by January 1, 2027.
NCPDP Real-Time Prescription Benefit Standard Version 13
42 CFR § 423.160(b)(7) requires that Part D plans "implement one or more electronic real-time benefit tools (RTBT) that are capable of integrating with at least one prescriber's e-Prescribing (eRx) system or electronic health record (EHR) to provide complete, accurate, timely, clinically appropriate, patient-specific formulary and benefit information to the prescriber in real time for assessing coverage under the Part D plan." This was a requirement for plans by January 1, 2021, however, at that time there was no defined standard for plans to implement. Since this previous iteration of the Code of Federal Regulations, NCPDP has developed the NCPDP RTPB which provides requirements to meet this provision and was adopted in this final rule.
The NCPDP RTPB Standard version 13 will be required for plans to be implemented by January 1, 2027.
Action Items for Medicare Part D Plans
Operations and Healthcare IT
Often, relationships with technology vendors are established to administer these standards on the Part D plans' behalf. Alternatively, Part D plans could work with their PBM which administers these standards for the plan, or through a downstream technology vendor they contract with. There may also be intermediaries/switches or other participants involved with these data transmissions. With these changes, Part D operators will need to ensure that they have a thorough understanding of how these new standards will be deployed and transactions will be mapped for each new requirement. Processes that exist today may be different going forward, especially with the new adoption of NCPDP RTPB standard version 13.
There are a number of IT priorities facing health plans over the next several years. Health plans are likely to be faced with several conflicting priorities regarding IT implementations; notably the Interoperability and Prior Authorization Final Rule (CMS-0057-F). There are several provisions that will need to be met by January 1, 2026, and January 1, 2027, coinciding with these Medicare Part D requirements. (See Ankura's related article: Are you Paying Attention to Prior Authorization? Your Regulators Are.) Therefore, plans that offer Medicare Advantage Prescription Drug Plans (compared to Prescription Drug Plans) will encounter considerable project planning efforts and coordination across internal and external resources to ensure that deadlines are met and implemented in compliance with applicable standards.
Compliance
This final rule discusses the reorganization of language and removal of several of the historical references currently included in 42 CFR § 423.160. There are specific references that defer to the health IT initiatives, adopted by ONC, described in 45 CFR § 170 which were not present before. These changes will require an overhaul of current policies and procedures. Operations and IT resources will need to coordinate with compliance teams to discuss changes and methodologies that will be applied by the Part D plan (or the health plan) to ensure that internal and external processes are documented. Once these new policies and procedures are established, training and educational efforts will be necessary.
These standards require the transmission of data attributes across many disparate systems such as prescriber electronic medical records, PBMs, intermediaries/switches, and pharmacies. Accordingly, there is an important and complex oversight and monitoring component that involves a number of risks related to data integrity, data accuracy, and protected health information that will need to be developed. Depending on how your organization administers these services this may also involve First Tier, Downstream, or Related Entities (FDR). Constructing a robust oversight and monitoring program should consider elements such as:
- Data file accuracy reviews, such as:
- Formulary
- Alternative Products
- Utilization Management
- Benefit Coverage
- Pharmacy Networks
- Cost-sharing
- Data Security
- Dashboards
- e-Prescribing and e-Prior Authorizations
- Quantifying and trending transmissions and status of transactions that are "processed," "not processed," errors, or other applicable responses according to each standard.
- Complaints received from prescribers and pharmacies that are not only received by the plan but also by the FDR.
- Considering the new adoption of the NCPDP RTPB standard, plans should develop specific testing and auditing of the exchange of information for accuracy to ensure that patient information regarding coverage, benefits, pharmacy, and applicable formulary restrictions are correct.
Footnotes
1. Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications [CMS-4205-F2]. Effective July 17, 2024.
2. NCPDP SCRIPT Standard Implementation Guide. Version 2023011. May 2024. Page 12.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.