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INFLATION REBATES IN MEDICARE
INFLATION REBATES IN MEDICARE
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.
RULEMAKING FOR THE INFLATION REBATE PROGRAM
CMS issued final rulemaking for the Medicare Prescription Drug Inflation Rebate
Program on November 1, 2024. The final rule is published in the Federal
Register. Prior to issuing the final rule, CMS issued the proposed rule on July
10, 2024 for public comment and the 60-day comment period closed on September 9,
2024.
Fact Sheet: Medicare Prescription Drug Inflation Rebate Program Final Rule
(PDF)
CY 2025 Physician Fee Schedule and Quality Payment Program Final Rule
GUIDANCE FOR THE INFLATION REBATE PROGRAM
Fact Sheet: Medicare Prescription Drug Inflation Rebate Program Revised Guidance
(PDF) (December 14, 2023)
Fact Sheet: Medicare Prescription Drug Inflation Rebate Program Initial Guidance
(PDF) (February 9, 2023)
MEDICARE PART B GUIDANCE
Medicare Part B Inflation Rebate Program Revised Guidance (PDF) (December 14,
2023)
Revised Part B Inflation Rebate Guidance: 340B Modifier (PDF) (December 14,
2023)
Medicare Part B Inflation Rebate Program Initial Guidance (PDF) (February 9,
2023)
Part B Inflation Rebate Guidance: 340B Modifier (PDF) (December 20, 2022)
MEDICARE PART D GUIDANCE
Medicare Part D Inflation Rebate Program Revised Guidance (PDF) (December 14,
2023)
Medicare Part D Inflation Rebate Program Initial Guidance (PDF) (February 9,
2023)
PUBLIC COMMENTS ON INITIAL REBATE GUIDANCE
Public Comments: Medicare Inflation Rebate Program Initial Guidance (ZIP)
(submitted by March 11, 2023)
REBATE REDUCTION REQUESTS
Frequently Asked Questions: Rebate Reductions under the Medicare Prescription
Drug Inflation Rebate Program (PDF) (July 22, 2024)
INSTRUCTIONS TO SUBMIT A REBATE REDUCTION REQUEST
To request a rebate reduction when a drug company believes there is a severe
supply chain disruption of a Part B or Part D rebatable biosimilar or generic
Part D rebatable drug or a likely shortage of a generic Part D rebatable drug,
the drug company should first email IRARebateandNegotiation@cms.hhs.gov to
indicate its intention to submit a request for a reduction in the rebate amount
and specify whether the request is for a severe supply chain disruption or
likely shortage. CMS will then provide the drug company with the relevant
request form(s) and access to a Box folder, or alternative submission process
approved by CMS, specific to the drug company’s request to allow for secure
submission of the materials relating to the rebate reduction request.
INFORMATION COLLECTION REQUEST (ICR)
The Rebate Reduction Requests under Sections 11101 and 11102 of the Inflation
Reduction Act ICR is available for viewing on OMB’s website. Click “all” to see
full details.
ACCESS TO THE INFLATION REBATE PORTAL
CMS expects to to provide detailed instructions for how to gain access to the
upcoming inflation rebates portal very soon.
To get access to the portal when it is live, first an individual will need to be
listed as a contact in the CMS Health Plan Management System (HPMS). If a
manufacturer of drugs covered under Part B does not currently have HPMS access,
they should follow the instructions in the September 13, 2024 HPMS memo to
request a P Number to gain access to HPMS:
https://www.cms.gov/about-cms/information-systems/hpms/hpms-memos-archive-weekly.
COINSURANCE ADJUSTMENT FOR PART B REBATABLE DRUGS
Beginning April 1, 2023, people with Medicare started to see lower out-of-pocket
costs for certain Part B drugs and biologicals with prices that have increased
faster than the rate of inflation. For these drugs and biologicals, the
beneficiary coinsurance is 20 percent of the inflation-adjusted payment amount,
which is less than what the beneficiary would pay in coinsurance otherwise.
Fact Sheet: Part B Rebatable Drug Coinsurance Reduction (PDF) (March 2, 2023)
QUARTERLY UPDATES TO PART B COINSURANCE ADJUSTMENT
2024 Reduced Coinsurance for Certain Part B Rebatable Drugs
Reduced Coinsurance for Certain Part B Rebatable Drugs (October 1 - December 31,
2024) (PDF)
Reduced Coinsurance for Certain Part B Rebatable Drugs (July 1 - September 30,
2024) (PDF)
Reduced Coinsurance for Certain Part B Rebatable Drugs (April 1 - June 30, 2024)
(PDF)
Reduced Coinsurance for Certain Part B Rebatable Drugs (January 1 - March 31,
2024) (PDF)
2023 Reduced Coinsurance for Certain Part B Rebatable Drugs
Reduced Coinsurance for Certain Part B Rebatable Drugs (October 1 - December 31,
2023) (PDF)
Reduced Coinsurance for Certain Part B Rebatable Drugs (July 1 - September 30,
2023) (PDF)
Reduced Coinsurance for Certain Part B Rebatable Drugs (April 1 - June 30, 2023)
(PDF)
Page Last Modified:
11/01/2024 04:30 PM
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