Regulators Call for the Revision of Part B Reimbursement Rules for Biosimilars

Published on: 

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.


In March 2015, Centers for Medicare & Medicaid Services (CMS) issued guidelines on biosimilar reimbursement, saying that it plans to create a separate code to distinguish a biosimilar from a reference biological, but that any distinguishing identifiers will “have no bearing on coding and payment.” At present, CMS’ plan via the 2016 Medicare Physician Fee Schedule proposed rule is to use one Healthcare Common Procedure Coding System (HCPCS) J-code for all biosimilars, a move which the Biosimilars Forum says will result in fewer treatment options for patients and providers.

Backed by 33 House members and led by Commerce Committee members Reps. Joe Barton (R, TX) and Anna Eshoo (D, CA), the Biosimilars Forum sent a letter to Acting Administrator of CMS, Andrew Slavitt, saying that the proposed rule would limit biosimilar options as a result of reduced investment in their development. Policies for biosimilars should not be crafted as are those for generic drugs, said a press release launched alongside the


to Slavitt, noting that there is a “multi-tiered system of biologics and biosimilars, with interchangeable and non-interchangeable biosimilars, and the potential for multiple different reference biologics within a therapy as well as the possibility that multiple biosimilars to a single reference product may not share all indications. Furthermore, consistent with the statute, an interchangeability determination only applies to a specific biosimilar and the reference product, and does not apply between or among multiple biosimilars approved to a single reference product.” The letter to Slavitt points to a provision in Section 1847A of the Social Security Act (SSA), which states that each biosimilar will have a unique HCPCS code. The language in the SSA act, according to the letter authors, “reflects congressional intent to encourage a vibrant biosimilars market” and the authors urge Slavitt to “enact a final payment rule that provides each biosimilar with a unique code.”

The accompanying press release also noted that, “issuing unique HCPCS codes to each individual biosimilar is essential to facilitate accurate attribution of adverse events,” although CMS has not opposed the assignment and use of distinguishing identifiers, which could be used to track adverse events, but would effectively be unrelated to a medication’s reimbursement.

It is unclear how a shared HCPC code for all biosimilars would affect pharmacovigilance activities if each biosimilar were to still have unique identifiers in their names. However, any naming or coding discrepencies could potentially cause electronic database problems. In 2014, The National Council for Prescription Drug Programs (NCPDP) protested the use of unique nonproprietary names for biosimilars, saying that, “unambiguous, interoperable, meaningful data exchange is jeopardized anytime standard operating procedures are violated in these naming and coding practices.” They argued that inconsistent nomenclature would impact how “data are pooled, sorted, and transferred” in pharmacy electronic databases.

Source: The Biosimilars Forum