House Members Urge Medicare and Medicaid to Reimburse Biosimilars on Individual Basis
A bipartisan group of 33 House lawmakers is challenging the Centers for Medicare & Medicaid Services’ plan to lump all biosimilars of the same reference product into a single payment code, arguing that each product deserves a unique code.
In a letter sent to CMS Acting Administrator Andrew Slavitt, the lawmakers take issue with a section of the agency’s proposed rule on the 2016 Medicare physician fee schedule, which would reimburse like-referenced biosimilars according to the same Healthcare Common Procedure Coding System code based on a single average sales price under Medicare Part B.
The concern is that the proposal treats biosimilars as generic drugs, which differ fundamentally from biosimilars in development, manufacture and chemical makeup, the lawmakers say. They note that the Social Security Act specifically states that calculations for reimbursing biosimilars must be made separately, so that each product has its own unique payment rate and unique HCPCS code.
“This reflects congressional intent to encourage a vibrant biosimilars market,” the letter says.
GPhA’s Biosimilars Council has raised similar concerns to CMS, saying the proposed reimbursement rule would discourage innovation and reduce incentives for investment. In order to provide patients access to a wider array of affordable treatments, the system must provide adequate incentives.
Having a distinct code for each biosimilar is also critical to a robust pharmacovigilance infrastructure, BIO says, noting the ability to distinguish between products is necessary to accurately attribute postmarket safety surveillance and outcomes research.
CMS could not be reached for comment by press time. Read the letter at www.fdanews.com/8-15-HouseLetter.pdf. — Jonathon Shacat