Biden Administration Releases Revised Guidance For Medicare Drug Price Negotiation Amid Industry Lawsuits

The Centers for Medicare and Medicaid Services released revised guidance on using its authority with pharmaceutical manufacturers in the Medicare Drug Negotiation Program to expand benefits, lower drug costs, keep prescription drug premiums stable, and improve the strength of the Medicare program.

This year, Medicare will start negotiating directly with drug manufacturers to reduce the price of covered, high-cost prescription drugs. 

CMS will announce the first ten drugs selected for negotiation by September 1. 

Also Read: Pharmaceutical Lobbying Group Challenges Biden Administration Over Medicare Price Negotiations.

The first round of negotiations will occur between 2023 and 2024. The prices that are negotiated will be effective starting in 2026.

In the negotiations, CMS will consider the selected drug's clinical benefit, the extent to which it fulfills an unmet medical need, and its impact on people who rely on Medicare, among other considerations, such as costs associated with research and development and production and distribution for selected drugs.

Before March 1, 2025, as part of its public explanation of the maximum fair prices, CMS "will make public a narrative explanation" of the negotiation process and the agreed-upon maximum fair price.

"However, if a drug company chooses to disclose information prior to the publication of the explanation of the maximum fair price, then CMS may decide to make early disclosures about the negotiation process as well," CMS said in a fact sheet.

HHS today also announced that President Biden's cap on insulin costs at $35 per month will go into effect for people who get their insulin through Medicare Part B and Medicare Advantage with the use of a traditional pump starting July 1, 2023.

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