Industry Urges Medicare Rethink On 505(b)(2) Policy
Medicare Proposed Part B Payment Policy For 505(b)(2) Drugs Is Illegal, Biopharma Argues
Teva, Sun and the AAM are among those urging the 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.
You may also be interested in...
Sun Pharma and its US Taro subsidiary have added to criticism over a recent CMS policy proposal that would see Medicare Part B drugs approved under the US hybrid 505(b)(2) pathway reimbursed at a lower rate applicable to multiple source products.
It’s not quite the rebate rule, but final reg aims for ‘a reduction in the use of rebates and other price concessions’ driven by the transparency requirement and broad definitions. PCMA warns that ‘mandating an increased level of disclosure for this information could result in higher prescription drug prices for consumers.’
Part of a broad rule that also aims to fix a coverage gap for COVID-19 vaccines, the payment policy differs from NTAP in that manufacturers of COVID therapies won’t have to formally apply and the add-on payments will not take the cost of the COVID products into account.