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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
August 12, 2015.
The Biosimilars Forum has written to the Acting Administrator of CMS, Andrew Slavitt, saying that the proposed rule - via the 2016 Medicare Physician Fee Schedule - to use one Healthcare Common Procedure Coding System (HCPCS) J-code for all biosimilars will result in fewer treatment options for patients and providers.
Policies for biosimilars should not be crafted like those for generic drugs, said a Forum press release, launched alongside the
to Slavitt. The letter 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's authors, “reflects congressional intent to encourage a vibrant biosimilars market” and they urge Slavitt to “enact a final payment rule that provides each biosimilar with a unique code.”
The Biosimilars Forum 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.
For more information, see http://www.pharmtech.com/regulators-call-revision-part-b-reimbursement-rules-biosimilars-0