CMS posts guidance for drug negotiation program

CMS has issued initial guidance on key elements of the Medicare Drug Price Negotiation Program for 2026, the first year the negotiated prices will apply.

Negotiations will focus on key questions, including the selected drug's clinical benefit, if it fulfills an unmet medical need and how it affects Medicare beneficiaries.

The guidance details how CMS will use the program to effectively negotiate with drug companies for lower prices on certain high-cost drugs. The negotiation process aims to expand access to innovative treatments and lower costs of the drugs for individuals with Medicare as well as the agency itself. 

Medicare is the largest buyer of prescription drugs in the U.S., and those drugs account for more than one in four healthcare dollars the agency spends. If the drug negotiation program were implemented in 2018, it would have saved the government $26.5 billion — or 5 percent of estimated net Medicare drug spending — over a three-year period, according to a study published in JAMA Health Forum.

By Sept. 1, 2023, the agency will post the first 10 Medicare Part D drugs selected for the program, which will allow Medicare to negotiate how much it pays for certain medications. CMS will select for negotiation 15 more Part D drugs for 2027, 15 more Part B or Part D drugs for 2028, and 20 more Part B or Part D drugs for each year after that.

CMS is accepting comments until April 14 for a revised guidance that will be issued for the first year of negotiation this summer. 

"For far too long, millions of Americans have had to choose between their prescription drugs and other monthly expenses," HHS Secretary Xavier Becerra said in a March 15 news release. "Through the Medicare Drug Price Negotiation Program, we will make sure seniors get a fair price on Medicare's costliest prescription drugs, promote competition in the market, and ensure Medicare is strong for beneficiaries today and into the future."

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars