Biosimilars Forum says CMS coding issues could discourage US biosimilar adoption

By Zachary Brennan

- Last updated on GMT

Biosimilars Forum says CMS coding issues could discourage US biosimilar adoption

Related tags Reference product Centers for medicare and medicaid services

If each biosimilar to a reference product doesn’t get a different HCPCS (Healthcare Common Procedure Coding System) code, providers “may not be confident that they they will receive appropriate payment,” Juliana Reed, President of the Biosimilars Forum, told

The newly created, industry-led Biosimilars Forum is seeking to raise new awareness around issues related to the biosimilars industry, and member companies include all of the leading biosimilar developers, such as Hospira, Amgen, Pfizer and Samsung.

The latest issue for the group centers on Medicare Part B coding and payment policy suggestions for CMS (Centers for Medicare and Medicaid Services).

We believe the statute supports each biosimilar, including subsequent biosimilars of the same reference product, be reimbursed based on their own ASP (Average Sales Price) and receive a unique J-code​, [which is part of the HCPCS code set​],” the Forum said in its comments.

In addition, if multiple biosimilars to the same reference product “shared the same HCPCS code, MACs [Medicare Administrative Contractors] would not be able to write coverage policies that limit use of each particular biosimilar to certain indications​,” the Forum said. “MACs and other payers would find it extremely difficult to write coverage policies describing when use of a particular biosimilar is clinically appropriate.​”

The comments come as CMS said last month that Part B payments for newly-approved biosimilars will be 106% of the manufacturer’s wholesale acquisition cost, for the product, and then once the ASP is available, the payment will be 100% of the biosimilar’s ASP plus 6% of the ASP of the reference product. The 6% add-on is recognized as payment for a physician’s resource costs and overhead.

The formula, mandated by the Affordable Care Act, was designed to reduce or eliminate the financial incentive to prescribe the biologic with the higher ASP, typically the reference product, according to Covington and Burling lawyers writing in the National Law Review​.

Reed also told us that the statute “does not require CMS to combine ASPs for multiple biosimilars of the same reference product.  The Biosimilars Forum strongly believes that a scenario for payment that blends biosimilars into the same payment group/ASP would be very detrimental to the adoption of biosimilars. Such a decision would not foster a sustainable or vibrant biosimilar market​.”

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