CMS finalizes Medicare drug negotiation rule, with up to 20 more drugs to be named by February 1
The rule, effective December 5, moves Medicare's price talks from guidance into regulation for prices starting in 2029 and targets what CMS calls a loophole.
By Government Desk · · 3 min read
What it means for you
- The rule sets no drug's price. It lays down how Medicare negotiates prices that start in 2029.
- CMS will name up to 20 more drugs by February 1, 2027, and the prices it agrees for them take effect on January 1, 2029.
- CMS's impact analysis gives no dollar estimate for the new policies and says only one, on certain combination drugs, would potentially have an impact on costs or savings.
- CMS says the public can send in data on the selected drugs until March 1, 2027, and that patient roundtables will follow in spring 2027.
The Centers for Medicare & Medicaid Services issued a final rule on November 5 that writes its drug price negotiation program into federal regulations for negotiated prices starting in 2029. The law let CMS run the rounds covering prices for 2026 through 2028 through guidance, and that authority is expiring. By February 1, 2027, CMS will name up to 20 more drugs for the fourth round.
The rule sets no drug's price. It takes effect on December 5, 2026, and applies to negotiations for 2029 onward and to Part D coverage beginning January 1, 2029. CMS proposed it on June 16, and the comment period closed on August 17.
| Round | Drugs | Prices take effect |
|---|---|---|
| First | 10, Part D | January 1, 2026 |
| Second | 15, Part D | January 1, 2027 |
| Third | 15, Part B and/or Part D, plus 1 for renegotiation | Beginning in 2028 |
| Fourth | Up to 20, Part B and/or Part D, plus any for renegotiation | January 1, 2029 |
What is new
Much of the rule restates existing policy; CMS's fact sheet repeatedly calls its provisions "consistent with statute and guidance" for the 2028 round. The main change concerns certain combination drugs. CMS says a manufacturer could avoid selection, or a negotiated price, by selling a new version of a drug with an added ingredient that lets it be given a different way. Under the final policy, when the same company holds the applications for both products, CMS will count the new version together with the older one.
The rule also applies a temporary price floor, required by law, for certain small biotech drugs in 2029 and 2030. And it codifies two Part D requirements: plans must include selected drugs that have a negotiated price on their formularies, and the prices plans pay pharmacies and other dispensers cannot exceed the negotiated price plus dispensing fees.
What it means for people with Medicare
In the announcement, CMS Administrator Mehmet Oz said the rule gives the agency tools to "achieve greater savings for taxpayers and beneficiaries." The rule's impact analysis puts no dollar figure on the new policies. Of those, it says only the combination-drug policy "would potentially have an impact," and calls the others "technical changes that would not result in additional costs or savings to the Negotiation Program." CMS writes that the combination-drug policy could cut both ways: a negotiated price may apply sooner to the newer product, but for a shorter time, because more products would leave the program once a generic or biosimilar is marketed. It says it cannot estimate the effect, but concludes that closing the gap and the possible short-term savings outweigh "uncertain and likely limited" long-term losses.
Prices now in force came from the first round, run under guidance, and our explainer on the first negotiated prices lists them. One practical question is left for later: how manufacturers must make the 2029 prices available. CMS says it intends to cover that in rulemaking in 2027, and to issue final guidance this fall on making the 2028 prices available.
Dates ahead
| Date | Step |
|---|---|
| November 30, 2026 | Deadline for CMS to publish agreed prices from the third round |
| December 5, 2026 | Final rule takes effect |
| February 1, 2027 | Deadline for CMS to publish the fourth-round drug list and any drugs for renegotiation |
| March 1, 2027 | Deadline for the public to submit data on selected drugs and possible alternatives |
| Spring 2027 | Patient roundtables and at least one clinical town hall |
| November 30, 2027 | Deadline for CMS to publish agreed fourth-round prices |
| January 1, 2029 | Fourth-round prices take effect |
CMS says it will share more about the public sessions later. Its program page has the file of selected drugs and negotiated prices.
Sources
- CMS Final Rule Strengthens Supports Lasting Drug Savings Centers for Medicare & Medicaid Services, November 5, 2026
- Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Final Rule (CMS-4215-F): fact sheet Centers for Medicare & Medicaid Services, November 5, 2026
- Final rule, FR Doc. 2026-22792 (public inspection copy) Office of the Federal Register
- Timeline: Medicare Drug Price Negotiation Program Final Rule (CMS-4215-F) Centers for Medicare & Medicaid Services
- Selected Drugs and Negotiated Prices Centers for Medicare & Medicaid Services
- Medicare Drug Price Negotiation Program: Final Guidance for Initial Price Applicability Year 2028 Centers for Medicare & Medicaid Services
Researched and drafted with AI assistance, then checked against the 6 sources above in a separate fact-check on November 5, 2026. Spotted an error? Tell us.