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Centers for Medicare & Medicaid ServicesAnnouncement: Inflation Reduction Act and Medicare.

June 4, 2024

 

*CMS Publishes a Revised Information Collection Request (ICR) for **Rebate Reduction Requests under Sections 11101 and 11102 of the Inflation Reduction Act*

The prescription drug law, known as the Inflation Reduction Act, requires drug companies that raise the prices of certain drugs covered under Part B and Part D faster than the rate of inflation to pay Medicare a rebate. As part of the revised guidance [ https://www.cms.gov/files/document/fact-sheet-medicare-prescription-drug-inflation-rebate-revised-guidance.pdf ] published in December 2023, CMS states a drug company that seeks a reduction of the rebate amount for a Part B or Part D rebatable biosimilar or Part D rebatable generic drug when there is a severe supply chain disruption or when a Part D rebatable generic drug is likely to be in shortage will be required to submit to CMS a request for a reduction along with supporting documentation. In February, CMS proposed an ICR, called the Rebate Reduction Requests, addressing information that must be submitted by a drug company in order to receive consideration for a rebate reduction under these policies, including the process steps for that submission.

A revised ICR for Rebate Reduction Requests under Sections 11101 and 11102 of the Inflation Reduction Act is now available. CMS invites public comments on the data and information the federal government will collect from manufacturers as part of a rebate reduction request for a Part B rebatable biosimilar biological product or generic Part D rebatable drug or biosimilar due to a severe supply chain disruption or for a generic Part D rebatable drug due to a likely shortage. The ICR is open for public input for 30 days. 

The revised ICR for Rebate Reduction Requests under Sections 11101 and 11102 of the Inflation Reduction Act can be found in the Federal Register [ https://www.federalregister.gov/documents/2024/06/03/2024-12122/agency-information-collection-activities-submission-for-omb-review-comment-request ]. The full text of the ICR can also be found at CMS’s PRA Listing website [ https://www.cms.gov/medicare/regulations-guidance/legislation/paperwork-reduction-act-1995/pra-listing/cms-10858 ]. Comments are due by *July 3, 2024*.

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