CMS may add Part B drugs to negotiations under draft guidance

The Trump administration has issued new draft guidance for the third cycle of Medicare drug price negotiations.

The proposals seek to boost transparency in the program and put a focus on negotiating for the drugs that come at the highest cost to Medicare. The agency is also aiming to avoid negative impacts from the negotiated prices on U.S.-based pharmaceutical innovation, according to an announcement.

Under the guidance, drugs administered under Medicare Part B would be potentially included for the first time. The agency is looking for feedback in comments on how to manage access to the maximum fair price negotiated for Part B drugs.

The guidance also outlines that CMS may choose to renegotiate the price for certain drugs already set for 2026 or 2027.

“CMS is committed to ensuring that Americans with Medicare have access to affordable, lifesaving medications,” said Chris Klomp, director of the Center for Medicare. “This draft guidance is critical to creating a transparent, competitive, and fair prescription drug market that puts American patients first.”

“These efforts will ensure CMS negotiates the lowest maximum fair price for each selected drug for Medicare beneficiaries, strengthens Medicare for future generations, saves billions for American taxpayers, and preserves incentives for genuine innovation,” Klomp said in a statement.

CMS will announced the drugs included in the third round of negotiations by February 1, 2026. Negotiations for the first round wrapped up in August 2024, and the second cycle of negotiations, featuring 15 products, is currently ongoing.

Prices negotiated in the third cycle will go into effect on January 1, 2028. CMS said it will announced any drugs under consideration for renegotiation alongside the third wave, with those updated prices also taking effect in 2028.

Stakeholders can submit comments on the draft guidance through June 26.

Earlier Monday, the White House revived its controversial “most favored nation” policy through an executive order. The order aims to lower the price of prescription drugs by preventing drugmakers from charging more for drugs in the U.S. then they do in other countries.