Drug Makers, Prescribers Urge CMS to Change Biosimilar Billing Policy

Last week, CMS closed its comment period on the 2018 Revisions to Payment Policies under the Physician Fee Schedule. Multiple stakeholder groups within the biosimilars industry submitted comments to CMS with respect to its policy on biosimilar reimbursement.

In 2016, CMS finalized a proposal to group payment for all biosimilar products referenced on a single originator biologic under common Healthcare Common Procedure Coding System (HCPCS) billing code. However, in its 2018 Proposed Rule, CMS sought comments from stakeholders about alternatives billing approaches for biosimilars.

In its comments to CMS, The Biosimilars Forum, a nonprofit organization with a membership comprising biosimilar developers including Amgen, Boehringer Ingelheim, Coherus BioSciences, and others, requested that CMS revise its policy, saying that each biosimilar should have its own HCPCS code for billing and payment. “It is imperative,” the group’s statement says, “that [the current] policy be reversed as soon as possible, and to take effect in [calendar year] 2018, in order to prevent lasting damage to the viability of this nascent biosimilars market.” Without a change to the billing procedure, the group said, biosimilar developers could introduce fewer products to the US marketplace, resulting in less competition and therefore higher costs of treatment. The letter notes that unique HCPCS codes for each product would also improve pharmacovigilance.

Additionally, the Association for Accsssible Medicines and the Biosimilars Council released a report, authored by The Moran Company, that found that, if CMS were to revise its reimbursement code policy, the federal government could save $11.4 billion on medicines over the next decade. “Shifting biosimilar reimbursement to unique codes increases patient access to more affordable, life-saving medicine and lowers prescription drug spending. This policy is critical to the development of a thriving biosimilars medicine market,” said Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at AAM. “This new report highlights the significant cost savings possible for both patients and [payers] if CMS implements this recommendation.”

The Pharmaceutical Research and Manufacturers of America (PhRMA), an organization representing biopharmaceutical companies, joined the other groups in urging CMS to revise its policy and to provide separate HCPCS codes for each biosimilar. Holly Campbell, deputy vice president of public affairs at PhRMA, told The Center for Biosimilars^® via email that “we oppose the current policy of blending coding and reimbursement for biosimilars that share the same reference product. We are encouraged to see the administration may be revisiting this policy. Revising the policy to allow for each biosimilar to have a distinct HCPCS code and reimbursement will promote appropriate clinical and safe use of these products, facilitate effective pharmacovigilence and help to ensure a robust competitive market.”

Prescribers, too, voiced support for a revised policy. The Biologics Prescribers Collaborative (BPC), an organization representing physicians who regularly prescribe biologic medicines, also weighed in. The BPC said that, in the absence of an FDA designation of interchangeability with the reference, each biosimilar product should have its own unique billing code. Biosimilars can only be similar to reference drugs, the BPC said, and assigning 1 reimbursement code “ignores the fundamental science”; a single code used for multiple treatments “seems to treat all biosimilars for a given reference product as interchangeable. Determinations of interchangeability must be made by FDA and based solely on scientific and medical considerations. Interchangeability requires a higher level of evidence than biosimilarity.”

BPC believes that blended reimbursement could encourage inappropriate non-medical switching in order to use the lowest-priced biosimilar at any given time, which could inappropriately limit choices, “especially where an individual patient’s immune reaction may differ between drugs.”