Medicare Proposed Part B Payment Policy For 505(b)(2) Drugs Is Illegal, Biopharma Argues

 
• By Cathy Kelly
  
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BMS, Biogen and other urge CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program

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CMS Policy Seeks To Lower Medicare Part B Spending

The Centers for Medicare and Medicaid Services’ proposal to pay for Medicare Part B drugs approved through the section 505(b)(2) regulatory pathway at a lower rate applicable to multiple source drugs starting in 2021 exceeds the agency’s regulatory authority and will slow the development of innovative new drugs, biopharma companies and trade groups argue in recent comments to the agency.

Bristol Myers Squibb Company, Biogen, Inc., the Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization,

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