This bill lengthens the amount of time for which drug products must have market approval in order for the products to qualify for negotiation under the Medicare Drug Price Negotiation Program.
The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation.
The bill modifies these provisions so as to require drug products to also have had at least 11 years of market approval in order to qualify for negotiation.
The bill's changes apply retroactively.