CMS readies changes for 2nd round of drug price negotiation program

 The Centers for Medicare & Medicaid Services (CMS) rolled out guidance Oct. 2 as stakeholders prep for the second round of the drug price negotiation program.

Made possible through the Inflation Reduction Act, the federal government has praised the program, saying it drastically lowers the cost of lifesaving drugs.

The negotiation period for the first round of 10 drugs ended in August, with the new prices set to go into effect Jan. 1, 2026. The feds anticipate the first round of negotiations will save people $1.5 billion in out-of-pocket costs in 2026.

CMS will announce the next round, this time selecting 15 drugs, by Feb. 1. Those prices will be effective starting Jan. 1, 2027.

To build on the program, CMS will work with a Medicare Transaction Facilitator to ensure Medicare beneficiaries and pharmacies have access to maximum fair prices. Drug manufacturer participation is voluntary.

The agency will host monthly technical calls for pharmacies, as already done for Part D plans and drug companies. CMS will also hold 15 patient-focused roundtables and one town hall meeting to receive clinical feedback regarding the selected drugs, according to a news release.

“We are continuing to implement the prescription drug law thoughtfully, prioritizing engagement with all interested parties, and ensuring the process is as transparent and inclusive as possible,” said Meena Seshamani, M.D., Ph.D., deputy administrator for CMS, in a statement. “As we approach the second cycle of negotiations, we continue to focus on ensuring people with Medicare prescription drug coverage have access to the innovative cures and therapies they need at prices they can afford.”

The CMS guidance instructs drug companies, health plans, pharmacies and mail-order services how they must adhere to price requirements starting in 2026 using the Medicare Transaction Facilitator.

Last year’s negotiation process between drug companies and the government will remain similar. However, CMS is allowing additional offers and counteroffers if CMS rejects the manufacturer’s first counteroffer.

“CMS believes these revisions to the negotiation process provide further opportunities for productive exchanges between CMS and participating drug companies throughout the negotiation period,” a fact sheet (PDF) said.

Pharma companies, incensed by the government's ability to negotiate drugs, have taken the feds to court in a number of lawsuits. Those efforts have been largely unsuccessful so far.

https://www.fiercehealthcare.com/payers/cms-readies-changes-second-round-drug-price-negotiation-program