CMS closes the IPAY 2028 negotiation and renegotiation period of the Medicare Drug Price Negotiation Program (Social Security Act sections 1191 to 1198, added by the Inflation Reduction Act of 2022, Pub. L. 117-169) on November 1, 2026.
Eli Lilly, Novartis, Johnson & Johnson/Janssen, Bristol-Myers Squibb, Pfizer and Gilead Sciences, the manufacturers of the 15 Part B and Part D drugs CMS selected for IPAY 2028 plus Tradjenta (linagliptin) under the program's first renegotiation, must complete the negotiation with CMS before November 1, 2026: accept or counter the final maximum fair price offer (due September 30, 2026) and attend the remaining permitted meetings, or forfeit leverage over the maximum fair price CMS sets and publishes by November 30, 2026, effective January 1, 2028, with the IRC section 5000D excise tax backing the negotiation duty.
- Deadline : November 1, 2026, the IPAY 2028 negotiation and renegotiation period closes
- Who : Manufacturers of the 15 selected IPAY 2028 Part B and Part D drugs plus Tradjenta (linagliptin) for the program's first renegotiation
- What : Accept or counter CMS's final maximum fair price offer (due September 30, 2026) and attend the remaining permitted negotiation meetings
- Otherwise : CMS sets and publishes the maximum fair price by November 30, 2026, effective January 1, 2028; the IRC section 5000D excise tax backs the negotiation duty
- Official source : CMS IPAY 2028 Final Guidance Fact Sheet
What applies on November 1, 2026
November 1, 2026 is the statutory close of the IPAY 2028 negotiation and renegotiation period under SSA section 1191. CMS sent initial offers on June 1, 2026, manufacturers had until July 1, 2026 to accept or counter, and the final offer was due September 30, 2026. The November 1, 2026 close is the last window for a manufacturer to engage before CMS sets the price.
| Step | Date |
|---|---|
| CMS initial MFP offers sent | June 1, 2026 |
| Manufacturer accept or counter deadline | July 1, 2026 |
| CMS final MFP offer due | September 30, 2026 |
| Negotiation period closes | November 1, 2026 |
| CMS publishes negotiated MFPs | November 30, 2026 |
| MFPs take effect | January 1, 2028 |
CMS must publish its explanation of the IPAY 2028 prices by March 1, 2027.
Who is covered
The IPAY 2028 cohort, selected by CMS on January 27, 2026, comprises 15 drugs payable under Medicare Part B and covered under Part D: Anoro Ellipta, Biktarvy, Botox/Botox Cosmetic, Cimzia, Cosentyx, Entyvio, Erleada, Kisqali, Lenvima, Orencia, Rexulti, Trulicity, Verzenio, Xeljanz/Xeljanz XR and Xolair. Linagliptin (Tradjenta) is the first drug selected for renegotiation. IPAY 2028 is the first cycle to include physician-administered Part B drugs and the first to apply the ORPHAN Cures Act change (Section 71203 of Pub. L. 119-21, July 4, 2025), which broadened the orphan-drug exclusion and restarts the eligibility clock from a drug's first non-orphan approval.
The exposed manufacturers by US market exposure are Eli Lilly (Trulicity, Verzenio; co-promote Tradjenta), Novartis (Cosentyx, Kisqali; co-promote Xolair), Johnson & Johnson/Janssen (Erleada), Bristol-Myers Squibb (Orencia), Pfizer (Xeljanz/Xeljanz XR) and Gilead Sciences (Biktarvy). All 15 primary manufacturers plus the renegotiation drug's manufacturer signed CMS participation agreements by February 28, 2026.
What to do before November 1, 2026
- Accept or counter CMS's final maximum fair price offer, which was due on September 30, 2026, before the November 1, 2026 period close.
- Attend the remaining permitted negotiation meetings with CMS within the negotiation window.
- Confirm the negotiation data elements submitted on March 1, 2026 remain accurate for any counter-offer.
- Review the IPAY 2029 codification NPRM (CMS-4215-P, 91 FR 36236), comment period closing August 17, 2026, for IPAY 2029 changes.
- Brief government-affairs and pricing teams on the maximum fair price CMS will publish by November 30, 2026, effective January 1, 2028.
What happens otherwise
A manufacturer that does not complete the negotiation forfeits leverage over the maximum fair price CMS sets and publishes by November 30, 2026, effective January 1, 2028. The negotiation duty is backed by the IRC section 5000D excise tax, administered by the IRS and Treasury, on a manufacturer that fails to comply. Ongoing manufacturer litigation has not enjoined the program, and CMS has proceeded on schedule, so the November 1, 2026 close stands. Continuous per-jurisdiction monitoring surfaces each CMS guidance the moment it publishes.
