Billing Code Proposal Raises Patient Safety Concerns

by Amanda Conschafter, blog editor

J-Codes, the billing codes used for medical therapies and procedures, could impact how well physicians and health care systems can monitor patient responses to biological medicines as more biosimilars enter the U.S. market. So explained the Alliance for Patient Access earlier this month in a letter to the Centers for Medicare and Medicaid Services.

At its core, the issue is one of pharmacovigilance. When patients respond adversely to a biological medicine – an allergic reaction, for instance, or an immune response – physicians and the health care system need to quickly and accurately determine which medication the patient was taking. But recovering that basic detail can prove difficult if biosimilars and their biologic reference products carry the same J-Code.

Nevertheless, CMS’ recently proposed rule approaches biosimilar coding as it would with conventional medications and their generic counterparts. The strategy ignores subtle differencesbetween biologics and biosimilars, as well as the challenges of potential immune responses from patients taking biological medications. If implemented, the proposed rule could unnecessarily complicate the process of tracking patients’ medication regimens and monitoring for safety.

As the Alliance for Patient Access explained, “When establishing billing codes for biosimilar therapies…CMS should adopt a rule…premised on the fact that biosimilars are not generic medications. Accordingly each non-interchangeable biosimilar must be assigned a separate reimbursement code from that of the referenced product and from each other.” AfPA further noted, “For prescribers to have confidence in biosimilars and for patients to realize their benefits, it is necessary that federal and state policy be transparent and science based.”


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