On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the Medicare Prescription Drug Benefit (Part D) program and the Medicare Drug Price Negotiation Program (“Negotiation Program”).
Established by the Inflation Reduction Act, the Negotiation Program allows CMS to negotiate the Maximum Fair Price (“MFP”) for certain single-source brand-name Medicare Part B and Part D drugs with drug manufacturers (“Selected Drugs”). Manufacturers participating in the Negotiation Program are required to ensure pharmacies and other dispensing entities have access to the MFP either by (1) prospectively ensuring that the pharmacy acquires the drug at the MFP or (2) retrospectively reimbursing the pharmacy for any acquisition costs that exceed the MFP.
To facilitate this process, CMS designed the Medicare Transaction Facilitator (“MTF”) which includes two modules: the MTF Data Module (“Data Module”) and the MTF Payment Module (“Payment Module”). Under the Rule, Part D plans will include provisions in their network participation agreements to require pharmacies to enroll in the MTF Data Module.
Overview of Data Module
The Data Module is a data exchange designed to help manufacturers accelerate the payment process for retrospective refunds paid to pharmacies based on sales to MFP-eligible individuals, or those Part D enrolled individuals who are prescribed one of the ten negotiated drug products for CY 2026.
Specifically, the Data Module allows dispensing entities and manufacturers to do the following:
- Verify MFP-eligibility by exchanging claims-level data and payment information to confirm that a Selected Drug was dispensed to a Medicare Part D or Medicare Advantage Prescription Drug plan enrollee at a pharmacy, by a mail order service, or by another dispensing entity;
- Exchange banking information to allow dispensing entities to receive retrospective reimbursements from manufacturers;
- For dispensing entities:
- Submit disputes and complaints to resolve issues related to untimely refunds;
- Identify any cash flow concerns related to reliance on retrospective refunds.
Overview of Payment Module
Manufacturers and dispensing entities can also enroll in the optional Payment Module, which facilitates payment of the retrospective reimbursements. The Payment Module includes functionalities for both the transfer of funds and a credit/debit ledger system to manage claims revisions.
MTF Enrollment
MTF enrollment will begin in June after the Final Rule takes effect on June 3, 2025. Chain pharmacies can enroll through one centralized submission. Dispensing entities can continue to use Pharmacy Service Administrative Organizations (“PSAO”) to receive their MFP refunds. To do so, the dispensing entity must authorize the PSAO as the designated third-party support entity on the Dispensing Entity Enrollment Questionnaire and the PSAO must complete a Third-Party Support Entity Enrollment Questionnaire.
CMS will publish Technical Assistance once the June 2025 MTF enrollment period approaches. In the meantime, pharmacies and other dispensing entities can sign up to receive updates regarding the MTF here.
