5 reasons to be concerned over proposed Medicare rule on biosimilar coding

A Medicare reimbursement policy proposing that multiple biosimilars have the same pricing J-code for Medicare reimbursement purposes could ultimately result in fewer treatment options, according to a group representing the industry.

Related: New forum expands access to biosimilars

As currently proposed in the 2016 Medicare Physician Fee Schedule rule, multiple biosimilars for the same reference product would be grouped and issued the same J-code for Medicare reimbursement purposes.

The Biosimilars Forum supported House Energy and Commerce Committee members Reps. Joe Barton (R-Texas) and Anna Eshoo (D-Calf.), as well as a delegation of 33 House members, for sending a

letter

to Andrew Slavitt, acting administrator for the Centers for Medicare & Medicaid Services (CMS), regarding the provisions relating to biosimilar reimbursement in the CMS's 2016 Medicare Physician Fee Schedule proposed rule.

Related:5 reasons to keep biosimilar names the same

“The ACA [Affordable Care Act] created a clear methodology for the payment amount for the first biosimilar with respect to a given reference product-CMS is to pay the sum of the ASP of the biosimilar and 6% of the ASP of the reference product,” according to Michael Werner, Biosimilars Forum policy advisor.

“Every biosimilar should have its own unique J code and its own reimbursement. Per ACA and FDA guidance, biosimilars products are unique from each other as biosimilars and unique from the reference product,” Werner says. “If implemented, this proposal could result in fewer biosimilars being introduced in the United States and ultimately in fewer treatment options for healthcare professionals and patients, as potential biosimilars manufacturers will not be able to plan and invest in biosimilar development programs when the potential marketplace the CMS proposed does not align with ACA or the FDA guidance on biosimilars.”

 

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