HHS Outlines Timeline to Negotiate Medicare Drug Prices

The Biden administration Wednesday outlined how it plans to engage with stakeholders and other steps it will take as it begins to implement Medicare drug pricing negotiations as stipulated in the Inflation Reduction Act, which passed last year.

Between now and January 1, 2026, when prices on the 10 drugs with the largest share of Medicare spending are expected to drop, HHS will issue a raft of guidance and comment periods, starting this winter.

The first round starts with a 60-day comment period to identify which small biotech drugs should be excluded from the first few years of negotiated prices.

In the spring, CMS said it will release how it plans to collect data for decision making and what should be considered when negotiating the top fair price, as well as information that should be included in the counteroffer process with drug manufacturers.

The government will use the time frame of June 1, 2022, to May 31, 2023, to collect data on Medicare Part D total spending to determine which drugs to target for the first year of price reductions in 2026, with the announcement of the 10 drugs coming on September 1.

Drug makers will have until October 1 to sign agreements to participate in the negotiation process, followed by the submission of company-specific data they want CMS to consider by the following day.

As announced Wednesday, the process would then continue to unfold in 2024:

• February 1: CMS starts the negotiating process with the first offer of a maximum fair price.
• March 2: Pharma companies accept the offer or propose a counteroffer.
• August 1: Negotiation period ends.
• September 1: CMS will publish the maximum fair prices for the drugs selected for 2026.

An additional 15 Part D drugs will be selected for 2027, followed by another 15 Part B or Part D drugs for 2028, and 20 more Part B or Part D drugs for each year that follows.

Also Wednesday, administration officials touted the almost-final results of signups for health insurance under the Affordable Care Act, saying that a record of nearly 16 million individuals have enrolled. The open enrollment period ends this Sunday, January 15.

Just over 3 million people are new enrollees, officials said. Overall, this year saw a 13% increase in enrollment over last year.