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After the Inflation Reduction Act was enacted earlier this month, the main question from providers who administer Part B drugs in-office was: which Part B drugs will be subject to a “maximum fair price” (MFP)?
Most projections in various articles simply list Part B’s highest expenditure drugs, but the MFP mechanism has certain requirements before a drug can be included, and these requirements go beyond merely looking at expenditures. For example, to be subject to an MFP, a drug must be single-source, which means that it cannot have a generic or biosimilar on the market. Additionally, a biologic must have been on the market for eleven years before MFP negotiations could begin, and thirteen years before an MFP could actually be applied to it. These limiting factors – plus the fact that Medicare will rely on expenditure data from future years – mean that lists of Part B drugs eligible for the MFP mechanism are, at this time, more akin to informed predictions than actual fact.
That said, Part B providers will have plenty of notice with regard to which drugs will be included. The MFP negotiation process between a company and Medicare would officially begin two years before MFP applicability, and the list of drugs under negotiation would be made public by the Department of Health and Human Services. That means rheumatologists and other Part B providers should have clarity as to exactly which Part B medications are under negotiation by 2026 – two years before any MFP in Part B would take effect in 2028.
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