by Amanda Conschafter, blog editor
A bipartisan group of 20 United States senators have a message for the Centers for Medicare and Medicaid Services: Wait to finalize reimbursement coding policy for biosimilars. In a letter to CMS Acting Administrator Andrew Slavitt, the bipartisan group of senators explained that CMS should delay determining billing codes, or J-Codes, for biosimilars until the FDA “has completed regulations for these drugs” and the biosimilar market is “safe and stable.”
CMS’ 2016 Medicare Physician Fee Schedule proposed rule suggested that the agency would treat biosimilar coding as it had generic versions of conventional medications. The proposed rule ignored subtle differences – and their effect on patient safety – between biosimilars and reference biologics. That raised concerns among physicians, patients and advocacy groups. As U.S. Senators explained in their letter to Administrator Slavitt, “reimbursement for biosimilar drugs may be important for tracking usage of these drugs for purposes of patient safety and research, medical innovation and increasing patient access to biosimilar treatments.”
The Alliance for Patient access raised similar concerns in an August 28 letter to CMS. “In the case of an adverse event,” AfPA noted, “it is critical that the patient, physician, and healthcare system can immediately identify the exact product the patient received. By providing that each FDA approved biologic and biosimilar has its own unique J-Code, CMS will ensure the ability to completely track and trace each individual product thereby allowing the patient’s physician to access…data regarding the product the patient actually received.”
Though the FDA approved the first U.S. biosimilar earlier this year, the agency has been slow to offer long awaited guidance about several key regulatory issues, including naming, prescribing information and extrapolating indications from the biologic to the follow-on biosimilar. Lack of clarity on these core issues could undermine confidence in the new drugs, despite their potential for patients and the health care system at large. Thus, the U.S. senators encouraged CMS in their letter to wait for the biosimilar market to “stand up and continue to develop” before addressing how these medications will be assigned billing codes.