CMS issues final rule codifying the Medicare Drug Price Negotiation Program for 2029 and later (CMS-4215-F)
Published November 8, 2026 · Coverage November 1–7, 2026, Pacific · Lower priority
On November 5, 2026, CMS issued a final rule that codifies the Medicare Drug Price Negotiation Program for initial price applicability year 2029 and later, replacing the program-instruction approach used for 2026 through 2028. The rule is effective December 5, 2026, and was published in the Federal Register on November 9. CMS says it will select up to 20 Part D and/or Part B drugs for each initial price applicability year from 2029, and it finalized a policy to group certain fixed combination products (for example, a drug plus hyaluronidase that enables a new route of administration) with the same holder's original product when identifying qualifying single source drugs. CMS states it intends to release final guidance in fall 2026 on manufacturer effectuation of the maximum fair price (MFP) in 2028, including for drugs payable under Part B.
Background
The Inflation Reduction Act of 2022 established the Negotiation Program to negotiate maximum fair prices for certain high expenditure, single source drugs and biological products. CMS says this rule builds upon policies established for the first three cycles of negotiations.
Who this affects
Drug manufacturers and Part D sponsors directly; hospitals and health systems that bill Part B drugs or dispense Part D drugs are indirectly affected through later maximum fair price (MFP) effectuation requirements, which this rule does not set for 2028.
Why it matters
Inference: the fact sheet read for this entry describes no new duty on hospitals; the full rule and its other Part D provisions were not checked. The operational item for hospitals is the separate 2028 MFP effectuation guidance CMS says is coming in fall 2026, which will cover Part B drugs and will matter to pharmacy, revenue cycle and 340B teams. The fixed-combination policy may bring subcutaneous co-formulations of selected Part B drugs within negotiated pricing in later years.
Recommended action
- Pharmacy and Revenue Cycle: watch for the CMS 2028 MFP effectuation guidance (stated for fall 2026) and assess Part B drug billing and acquisition effects when it issues.
Scope and timing
- Authority status
- Final
- Responsible owner
- Pharmacy
- Publication date
- 2026-11-09 (Federal Register, 91 FR 72176); CMS issued the rule 2026-11-05
- Effective date
- 2026-12-05
- Other dates
- MFP effectuation guidance for 2028 stated as intended for fall 2026 (no date)
Not established
The 215-page rule text (91 FR 72176-72390) was not retained or read; facts rest on the CMS fact sheet and the Federal Register application programming interface (API) record. Part D benefit provisions beyond the Negotiation Program were not checked in the rule text.
Sources
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