November 2, 2017
Authored and Edited by Bonnie Fletcher Price, Ph.D.; Thomas L. Irving
On November 2, 2017, Centers for Medicare and Medicaid Services (“CMS”) announced that it would finalize a policy to separately code and pay for biosimilar products under Medicare Part B.
Previously Medicare Part B paid for biosimilar products based on the average sales price of all biosimilar products within the same Healthcare Common Procedure Coding System code. This meant that biosimilar products with the same reference product were grouped together for purposes of calculating an average sales price and physicians were reimbursed the same amount under Part B for all such biosimilars.
Beginning in 2018, CMS will establish a unique code for each biosimilar product; and will calculate a payment rate specific to each individual biosimilar product. This policy change is intended to create a stronger marketplace, improve access to these drugs, and increase provider and patient choice and competition. In addition CMS believes that the change in policy will encourage innovation needed to bring more products to the market.
Notice of the policy can be found at: 82 Fed. Reg. 5,2976 (Nov. 15, 2017).
Biologic License Application (BLA), abbreviated biologic license application (aBLA), Biologics Price Competition and Innovation Act (BPCIA)
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