Modifies the current law “non-interference” clause to require the HHS Secretary to negotiate drug price with manufacturers for some drugs covered under Medicare Part B and Part D.

Which drugs qualify for negotiation? The Secretary selects drugs to be negotiated from the 50 “negotiation-eligible” drugs with the highest total Medicare Part D spending and the 50 “negotiation-eligible” drugs with the highest total Medicare Part B spending.

Which drugs are excluded from negotiation? “Negotiation eligible drugs” include brand-name drugs or biologics and exclude the following drugs:

  • Drugs that have a generic or biosimilar available
  • Drugs less than 9 years (for small-molecule drugs) or 13 years (for biological products) from their FDA-approval or licensure date
  • Certain “small biotech drugs” (from 2026 to 2028)
  • Drugs that account for Medicare spending of less than $200 million in 2021
  • Drugs with an orphan designation as the only FDA-approved indication

How many drugs will have negotiated prices? Limits the total number of drugs to be negotiated to 10 Part D drugs in 2026, 15 Part D drugs in 2027, 15 Part D and Part B drugs in 2028, and 20 Part D and Part B drugs in 2029 and later years.

Have any questions regarding this notice? Don’t hesitate to contact your Total Benefit Solutions Medicare health insurance specialists today at (215)355-2121.