CMS Releases Draft Guidance on Manufacturer Implementation of 2028 Medicare Drug Price Negotiation Program

Key Takeaways

• The Centers for Medicare & Medicaid Services (CMS) has released draft guidance outlining how manufacturers would operationalize negotiated Maximum Fair Prices (MFPs) for Medicare Part B and Part D drugs beginning in 2028, with significant new policies focused on Part B implementation.
• The proposal introduces new operational requirements involving manufacturers, Medicare Advantage organizations, Part D plans, pharmacies, providers, and a Medicare Transaction Facilitator (MTF) designed to support claims processing, payment, and compliance.
• CMS is seeking stakeholder feedback on several operational issues—including payment methodologies, claims reporting, and administrative burden—before issuing final guidance later this year.

CMS has issued draft guidance detailing how manufacturers would operationalize negotiated MFPs for selected Medicare drugs beginning in 2028 under the Medicare Drug Price Negotiation Program. The guidance expands on policies already in place for Medicare Part D and introduces new operational processes for Medicare Part B drugs, marking another step in implementation of the Inflation Reduction Act's drug price negotiation provisions. CMS is accepting public comments through September 18, 2026, before issuing final guidance later this year.^1,2

While the draft does not change the statutory framework for negotiated pricing, it provides new direction on how manufacturers, Medicare Advantage organizations, Part D plans, pharmacies, physicians, hospitals, and other providers would exchange claims information and process payments necessary to ensure negotiated prices are made available to eligible Medicare beneficiaries.^1,2

Expanding Operational Framework to Medicare Part B

Much of the draft guidance focuses on extending MFP implementation beyond Part D to include drugs payable under Medicare Part B beginning in 2028.^1,2

CMS proposes expanding the MTF—the agency's operational platform for exchanging claims information and facilitating manufacturer payments—to support both Part D and Part B drugs. The agency states that, to the extent possible, it intends to align operational policies across both programs while accounting for important structural differences in claims processing and reimbursement.^1,2

Under the proposal, manufacturers would remain responsible for ensuring eligible providers ultimately receive access to the negotiated price, either by prospectively selling drugs at or below the negotiated MFP or retrospectively reimbursing providers for the difference between acquisition cost and the negotiated MFP.

CMS would continue requiring manufacturers to provide payment within 14 calendar days after verified claims data are transmitted through the MTF.²

New Operational Questions for Part B

Because Part B drugs are billed differently than Part D prescriptions, CMS identifies several operational challenges requiring stakeholder input.²

One issue involves identifying whether claims billed under shared Healthcare Common Procedure Coding System codes represent negotiated drugs or non-negotiated products. CMS outlines 3 potential approaches for addressing this issue:

• Creating new billing modifiers
• Requiring NDC reporting on Part B claims
• Assigning separate HCPCS codes to negotiated products

CMS requests comment on the administrative feasibility and operational burden of each option.

The agency also proposes several alternative methodologies for calculating standardized default refund amounts for Part B claims, including approaches based on Wholesale Acquisition Cost or Average Sales Price, and seeks feedback on which methodology would best approximate provider acquisition costs while minimizing administrative complexity.²

Medicare Transaction Facilitator Continues to Expand

CMS proposes making manufacturer participation in the MTF's data exchange mandatory while continuing to make participation in the payment module voluntary.²

Under the proposal, the MTF would do the following:

• Verify eligible claims
• Transmit claim-level data to manufacturers
• Facilitate payment processing
• Generate remittance information
• Support payment reconciliation
• Provide complaint and dispute resolution tools

CMS also proposes using the MTF to support Part B providers through integration with existing Medicare enrollment systems and by facilitating electronic payment workflows where possible.²

Compliance, Oversight, and Enforcement

The draft guidance also outlines CMS' proposed oversight framework.

Manufacturers would be required to submit detailed MFP Effectuation Plans describing how they intend to operationalize negotiated pricing, address provider cash-flow concerns, document payment methodologies, and maintain compliance with statutory requirements. CMS states it will monitor compliance through audits, data submitted through the MTF, and complaints filed by providers or other stakeholders.²

If CMS determines that a manufacturer failed to provide access to the negotiated price, the agency may issue a Notice of Potential Noncompliance and could ultimately impose civil monetary penalties authorized under the statute.²

Why It Matters for Managed Care

Although the draft guidance primarily addresses manufacturer implementation responsibilities, it also carries operational implications for Medicare Advantage organizations, Part D plan sponsors, pharmacies, health systems, physician practices, and other providers participating in the Medicare program.

The proposed policies seek to establish standardized processes for claims verification, payment reconciliation, and oversight while extending negotiated pricing to selected Part B drugs beginning in 2028. CMS is specifically requesting stakeholder feedback on administrative burden, operational feasibility, and payment workflows before finalizing the guidance, signaling that many implementation details remain under consideration.

References

1. Centers for Medicare & Medicaid Services. Manufacturer effectuation of the maximum fair price: draft guidance for 2028 Medicare drug price negotiation. July 16, 2026. Accessed July 17, 2026. https://www.cms.gov/newsroom/fact-sheets/manufacturer-effectuation-mfp-draft-guidance-2028-medicare-drug-price-negotiation.
2. Centers for Medicare & Medicaid Services. Draft guidance on manufacturer effectuation of the Maximum Fair Price in 2028 under the Medicare Drug Price Negotiation Program. July 16, 2026. Accessed July 17, 2026. https://www.cms.gov/files/document/ipay-2028-effectuation-draft-guidance-fact-sheet_2.pdf