HHS Starts the Drug Price Negotiation Process

Earlier this week, HHS issued a press release announcing key dates for the first year of the Medicare drug price negotiation process. The Inflation Reduction Act provided Medicare with the authority to negotiate prices for a select number of prescription drugs. These negotiated prices will go into effect in 2026.

HHS and the Centers for Medicare and Medicaid Services have committed to providing the opportunity for stakeholders to be engaged in the negotiation process by providing the opportunity for public feedback collection.

According to CMS, they will be actively soliciting feedback on areas including:

Terms and conditions contained in the manufacturer agreement, including the manufacturer’s and Secretary’s responsibilities.
Approach for considering

the manufacturer-reported data elements and
evidence about alternative treatments.

Process for the offer and counteroffer exchange between the Secretary and manufacturers.
Content of an explanation for the maximum fair price.
Method for applying the maximum fair price across different dosage forms and strengths of a selected drug.
Dispute resolution process for specific issues that are not exempt from administrative and judicial review under section 1198.
Processes for compliance monitoring and imposition of civil monetary penalties for violations.

Additionally, CMS announced a number of key dates in 2023 and beyond.

Details of this process will be hammered out over the next several months as CMS is expected to issue guidance documents proposing the more specific details of this program.

Drug makers should follow this process closely and take the opportunity to become heard as CMS works out the specifics of a process that is expected to lower the costs of prescription drugs for Medicare beneficiars.

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