11/8/2024 – CMS Releases Physician Fee Schedule Final Rule for Calendar Year 2025 with Wins and Losses for Covered Entities

On Friday November 1, 2024, CMS published the Calendar Year 2025 Physician Fee Schedule Final Rule, which included implementation of several of the Medicare Part B and Part D drug pricing provisions in the Inflation Reduction Act (IRA). Among those IRA provisions were measures that Congress adopted to address the IRA’s intersection with the 340B program. Covered entities scored a victory because, under the Final Rule, manufacturers will not have access to 340B claims data which has been a longtime priority of covered entities. CMS also agreed with covered entity recommendations not to impose a point-of-sale claims identifier requirement on 340B Part D claims. On the other hand, covered entities will have to submit more specific data to the government on 340B Part D drugs and will continue to be subject to Part B claims identification requirements. And CMS declined to accept covered entities’ recommendation that it establish a neutral clearinghouse for avoiding duplicate discounts.

Part D: The IRA requires CMS to remove 340B units from Part D rebate calculations by January 2026. During the comment period for the proposed rule, commenters expressed concerns with CMS’s proposed estimation methodology, leading to CMS’s decision not to finalize this proposal.  CMS states that it is exploring the implementation of a claims data repository strategy as opposed to using an estimation methodology.

CMS solicited comments on how the data repository should function, how 340B units should be identified, and whether covered entities should be required to submit 340B claims data to the repository.  Commenters were largely in support of a three-month timeline following the end of a quarter year for submitting repository data, with additional time potentially available if new information surfaces.  CMS believes covered entities would need to provide, at a minimum, the date of service, dispensing pharmacy NPI, prescription or service reference number, and fill number. CMS also considered a point-of-sale 340B claims identifier requirement. In response to public comment, however, CMS decided not to finalize this proposal.

CMS states that it intends to consult with HRSA on developing covered entity guidance and education on these requirements and welcomes 340B stakeholder engagement regarding the data repository, data submission, and timing requirements.

Part B: Under Part B, CMS finalized its policy to remove separately payable billing units with the “TB” or “JG” modifiers.  Starting January 1, 2025, covered entities will be required to use only the “TB” modifier to identify separately billable Part B claims. CMS expects covered entities to use the correct modifiers and fix claims omitting any required modifiers.

CMS also states that it declines to provide claim-level data to manufacturers regarding the 340B Program because it does not find it necessary at this time and because there are no statutory requirements for the provision of such data. CMS further declined to adopt a clearinghouse model to identify and remove 340B units from Part B claims.