As it’s planned, CMS would assign all biosimilars of a single reference product one HCPCS (Healthcare Common Procedure Coding System) code “based on the weighted average of their average sales price under Medicare Part B,” according to the legislators.
But such an approach “treats biosimilars as if they are generic drugs,” according to the bipartisan letter, which include Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA). The letter echoes comments made previously by the industry-led Biosimilars Forum, which has said the CMS proposal could discourage the use of biosimilars.
The House contingency also says that the Social Security Act “states that the calculation for reimbursing biosimilars shall be made separately, such that each biosimilar will have its own unique payment rate and unique HCPCS code.”
The Biosimilars Forum also claims that lawmakers who passed the Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a “multi-tiered system of biologics and biosimilars,” with interchangeable and non-interchangeable ones and the potential for multiple different reference biologics “as well as the possibility that multiple biosimilars to a single reference product may not share all indications.
“This CMS proposal may lead to confusion in each of these areas, and dramatically reduce the investment in the development of biosimilars and thereby reduce treatment options available to patients,” the forum says.
Michael Werner, Biosimilars Forum policy advisor, added: “We are pleased that this issue has quickly attracted the interest of Congress and applaud the House members who are working to correct the proposed regulation to reflect the BPCIA’s biosimilar payment and coding requirements…We urge CMS to revise its proposed rule for Part B to better reflect the law and to support this new industry by giving each biosimilar of the same reference product its own, unique Medicare claims code and payment amount.”