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Medicare Payment Demo Would Put Often-Prescribed Cancer Drugs ‘Underwater’

 
• By Cathy Kelly

Community oncology practices and hospitals strongly object to CMS’ plan for testing different reimbursement formula Part B drugs, which is expected to particularly impact treatments for cancer, arthritis and eye disease.

Nearly 50 of the most frequently-prescribed oncology or treatment-related drugs would be ‘underwater’ – or reimbursed at less than acquisition cost – under the payment rate in the Medicare demonstration project recently proposed by the Centers for Medicare and Medicaid Services, according to the Community Oncology Alliance.

In May 9 comments to CMS, the oncology provider organization takes issue with the agency’s claim that the proposed payment approach would help ensure that prescribing decisions are based on the value of treatments and

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More from United States

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

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US FDA Advisory Committee Misperceptions Abound … At HHS

 
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US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
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Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

More from North America

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.