On May 12, CMS released draft guidance outlining how the agency will implement negotiation under the Inflation Reduction Act's (IRA) Medicare Drug Price Negotiation Program (the "Program") for initial price applicability year (IPAY) 2028. The guidance also sets expectations for manufacturers and dispensing entities to effectuate negotiated Maximum Fair Prices (MFPs) in IPAY 2026, 2027, and 2028 and potentially renegotiate for IPAY 2028 the MFPs initially negotiated for IPAY 2026 or 2027. Comments are due by 11:59 PM Pacific Time on June 26.
The draft guidance is the Trump Administration's first opportunity to set policy and establish processes for the Program and, notably, does not make any fundamental alterations to Biden-era policy. President Trump's April 15 EO on drug pricing directed CMS to publish the IPAY 2028 guidance with the aim to "improve the transparency of the Medicare Drug Price Negotiation Program, prioritize the selection of prescription drugs with high costs to the Medicare program, and minimize any negative impacts of the maximum fair price on pharmaceutical innovation within the United States." However, most new concepts in the draft guidance along these lines—such as the submission of forward-looking data by manufacturers or new methodologies for developing the agency's opening offer—come as opportunities for comment rather than proposed new policies. (The agency could still implement such policies when it publishes the final guidance.) The draft guidance is also notable in that it sets policies for elements of the Program being implemented for the first time for IPAY 2028 per statute—namely renegotiation and MFP effectuation for Part B drugs.
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