The Affordable Care Act and the Inflation Reduction Act, as well as other ongoing healthcare legislative and regulatory reform measures, may have a material adverse effect on our business and results of operations.
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March 31, 2026
Nanobiotoix S.A.
Negative Outlook
Paris, France
51-200 employees
Additionally, in the United States, the Inflation Reduction Act of 2022 (IRA), enacted on August 16, 2022, includes several provisions to lower prescription drug costs for people with Medicare and reduce drug spending by the federal government. We cannot predict the ultimate content, timing or effect of any changes to the ACA, the IRA or other federal and state reform efforts, and there can be no assurance that any such health care reforms will not adversely affect our future business and financial results.
Disease Area: Oncology
Drug Type: Biologic
March 31, 2026
Revium Rx
Neutral Outlook
Herzliya, Israel
1-50 employees
As another example, the IRA, includes a number of changes intended to address rising prescription drug prices in Medicare Parts B and D. These changes include caps on Medicare Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer discount drug program (replacing the ACA Medicare Part D coverage gap discount program) and a drug price negotiation program for certain high spend Medicare Part B and D drugs (with the first list of drugs announced in 2023).
Disease Area: Neurological Diseases, Psychiatry
Drug Type: Small Molecule
March 31, 2026
Galmed Pharmaceuticals
Neutral Outlook
Tel Aviv, Israel
1-50 employees
The Inflation Reduction Act of 2022 contains significant reforms affecting the pricing of drugs and biologics paid by Medicare. The new requirements establish a timeline for certain drugs to negotiate with the federal government a “maximum fair price” for certain selected drugs.
Disease Area: Metabolic Diseases
Drug Type: Small Molecule
March 31, 2026
TAO Synergies
Neutral Outlook
New York, NY
1-50 employees
However, the IRA’s impact on the pharmaceutical industry in the United States remains uncertain, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S. Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program is unconstitutional for a variety of reasons, among other complaints. Those lawsuits are currently ongoing.
Disease Area: Multiple
Drug Type: Small Molecule
March 31, 2026
Fortress Biotech, Inc.
Neutral Outlook
Bay Harbor Islands, FL
1-50 employees
The Inflation Reduction Act of 2022 (the “IRA”) contains substantial drug pricing reforms, including the establishment of a drug price negotiation program within the U.S. Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation, and requires manufacturers to provide discounts on Part D drugs.
Disease Area: Multiple
Drug Type: Small Molecule
March 31, 2026
Tevogen Bio Holdings Inc
Neutral Outlook
Warren, NJ
51-200 employees
For example, the Inflation Reduction Act introduces several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs and a change in manufacturer liability under the program which could negatively affect the profitability of our product candidates. The IRA sunsets the current Part D coverage gap discount program starting in 2025 and replaces it with a new manufacturer discount program. Failure to pay a discount under this new program will be subject to a civil monetary penalty. In addition, the IRA established a Medicare Part B inflation rebate scheme effective January 2023 and a Medicare Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the price of a Part B or Part D drug increases faster than the pace of inflation.
Disease Area: Infectious Diseases, Oncology
Drug Type: Multiple
March 31, 2026
BioAtla Inc
Negative Outlook
San Diego, CA
51-200 employees
Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the biopharmaceutical industry and the pricing of prescription drug products.
Disease Area: Oncology
Drug Type: Biologic