CMS Finalizes IPAY 2028 Drug Price Negotiation Guidance, Expands Program to Part B Drugs
核心洞察
CMS issued final guidance for the Inflation Reduction Act's Drug Price Negotiation Program (搜索) for IPAY 2028, marking the first time Part B drugs will be eligible for Medicare price negotiations alongside Part D drugs.
The guidance establishes a combined selection process where CMS will identify the top 50 highest-spend drugs under Part B and Part D, then select the 15 highest-ranked drugs based on combined expenditures for negotiation.
Key policy changes include maintaining distinct combinations of active ingredients as separate qualifying drugs, expanding biosimilar (搜索) delay provisions, and implementing new enforcement mechanisms with civil monetary penalties for non-compliance.
The Centers for Medicare & Medicaid Services (搜索) (CMS) has issued final guidance for the Inflation Reduction Act's Drug Price Negotiation Program (搜索) (DPNP (搜索)) for initial price applicability year (IPAY) 2028, marking a significant expansion that will include Part B drugs for the first time. The guidance, released on September 30, 2025, establishes comprehensive policies for Maximum Fair Price (搜索) (MFP (搜索)) effectuation across IPAYs 2026 through 2028.
Expansion to Part B Drugs Creates New Selection Framework
For IPAY 2028, CMS will implement a dual-track selection process that considers both Part B and Part D drugs. The agency will identify the 50 highest-spend drugs under Part B and the 50 highest-spend drugs under Part D, then combine total expenditures to rank and select the top 15 drugs for negotiation.
To calculate Part B expenditures, CMS will use both Medicare Fee-for-Service Part B claims and Medicare Advantage encounter data for dates of service between November 1, 2024, and October 31, 2025. The agency will calculate total allowed charges, which include beneficiary coinsurance and Medicare payments, while excluding expenditures bundled into payments for other services.
CMS acknowledged stakeholder concerns about methodological differences between Part B and Part D expenditure calculations. While Part B calculations reflect net drug costs, Part D calculations use "total gross covered prescription drug costs" that exclude rebates and price concessions, as defined in regulation at 42 C.F.R. § 423.308.
Fixed Combination Drug Policy Remains Unchanged
Despite proposing changes in draft guidance, CMS maintained its existing policy for fixed combination drugs (搜索). The agency will continue treating distinct combinations of active moieties or active ingredients as separate qualifying single source drugs (搜索) (QSSDs (搜索)) for IPAY 2028.
CMS had initially proposed an exception for fixed combination drugs (搜索) where one active ingredient "is not biologically active against the disease state(s) the drug is indicated for and thus does not result in a clinically meaningful difference." However, acknowledging the complexity of this issue, CMS indicated it needs additional time to develop objective policy criteria and stated its intent to address "program integrity" risks beginning in IPAY 2029.
Orphan Drug Exclusion Broadened
The final guidance aligns with recent statutory changes enacted by the Working Families Tax Cuts Act (P.L. 119-21), which broadened the orphan drug (搜索) exclusion beginning with IPAY 2028. The updated exclusion covers products designated for "one or more rare diseases (搜索) or conditions" and for which the product's only approved indications are for "one or more such rare diseases or conditions."
For products that lose eligibility for the orphan drug (搜索) exclusion, CMS will use the earlier of either the date of approval of a non-orphan indication or the date an orphan drug designation is withdrawn when identifying potential QSSDs (搜索).
Enhanced Biosimilar Delay Provisions
CMS expanded the circumstances that may satisfy the "high likelihood" standard for biosimilar (搜索) delay requests. The patent-related component may now be met if neither a court nor the Patent Trial and Appeal Board has adversely ruled against the biosimilar manufacturer's legal assertions and the manufacturer has specified a launch date that precedes the deadline and is not contingent on pending litigation outcomes.
For operational readiness, CMS specified that biosimilar (搜索) manufacturers may demonstrate preparedness with documents including "disclosures about capital investment, revenue expectations, and actions consistent with the normal course of business for marketing of a biosimilar biological product before February 1, 2028" and manufacturing schedules consistent with public statements.
Negotiation Timeline Compressed for IPAY 2028
CMS shortened the negotiation meeting period for IPAY 2028, allowing manufacturers only six weeks between CMS's rejection of their statutory written counteroffer and the deadline for negotiation meetings, compared to two months in previous years. All negotiation meetings must conclude by September 11, 2026, enabling CMS to send final offers by September 30 and giving manufacturers until October 31, 2026, to accept or reject final offers.
MFP Effectuation Framework Extended
While CMS finalized extending 2026 and 2027 MFP (搜索) effectuation policies to 2028 for Part D drugs, detailed policies for Part B drug effectuation remain pending. Beginning in 2028, manufacturers must provide access to MFPs for hospitals, physicians, and other suppliers regarding MFP-eligible individuals furnished or administered selected Part B drugs.
CMS plans to continue supporting Medicare Transaction Facilitator (搜索) (MTF (搜索)) operations through at least 2028, with potential expansion to support Part B drug effectuation. However, the agency indicated it will "monitor potential private sector alternative solutions for sharing verified data or for routing MFP (搜索) refund payments from manufacturers to dispensing entities."
Renegotiation Process Clarified
CMS finalized comprehensive renegotiation policies, identifying eligible drugs based on monopoly status changes, newly added indications, or material changes in statutory factors. For drugs seeking renegotiation eligibility due to newly added indications, the new indication must be added to FDA-approved labeling by November 30, 2025.
The agency defined "significant change" as "the likelihood that the new indication or material change would result in a renegotiated MFP (搜索) that represents a 15 percent or greater change relative to the current MFP" and whether such change would significantly impact the Medicare Program.
Enforcement Mechanisms Strengthened
The final guidance expanded substantive violations subject to civil monetary penalties, including failure to submit data requested by CMS, failure to provide renegotiation information, and failure to make MFPs available to eligible individuals and entities. Beginning in 2028, this extends to hospitals, physicians, and other providers for drugs selected for IPAY 2028 or with renegotiated MFPs.
Transition to Rulemaking
IPAY 2028 represents the final year CMS is statutorily required to implement the DPNP (搜索) via guidance. Future program modifications will require formal rulemaking processes, potentially providing greater stakeholder input opportunities and regulatory certainty.
CMS concurrently issued revised Information Collection Request forms for implementing small biotech exceptions, biosimilar (搜索) delay requests, and renegotiation processes, with comments due October 30, 2025. Additional ICR forms on negotiation data submissions and renegotiation are expected later this fall.