The 2018 Medicare Physician Fee Schedule Proposed Rule, issued by CMS on July 13, considers changing a contentious billing code policy affecting biosimilar products.
The 2018 Medicare Physician Fee Schedule Proposed Rule, issued by CMS on July 13, considers changing a contentious billing code policy affecting biosimilar products.
In its 2016 Physician Fee Schedule Final Rule, the body finalized a proposal that grouped payment for all biosimilar products referenced on a single originator product under common billing codes. However, in its Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for Calendar Year 2018, due to be published in the Federal Register on July 21, CMS indicates that it is reconsidering its policy.
CMS states that it reviewed a number of comments on its Part B billing code policy, which revealed that many stakeholders opposed a single payment amount for biosimilars that rely on the same reference product. These commenters believed that such a regulation would decrease incentives for biosimilar makers to develop products, which could in turn lead to market consolidation and increased costs for biosimilar treatments. Others were concerned that prescribers’ choices could be limited by the grouping, while still others said that they believed that pharmacovigilance activities could be negatively impacted by the policy.
CMS reports that many commenters suggested that the body determine a payment amount for each biosimilar or biologic treatment using individual Healthcare Common Procedure Coding System (HCPCS) codes, and suggested that this approach could create a cost savings of 10% to 15% on biosimilars in comparison to their reference products.
However, some commenters supported CMS’s proposed regulation and their view of its effect on competition, saying that the potential market for biosimilars is less risky than that of innovator biologics, and believed that separate payment for each biosimilar could result in both reduced competition among manufacturers and also higher prices for Medicare beneficiaries. Inside Health Policy reports that congressional Medicare advisors have recommended that CMS retain the policy, and that they have suggested that it could be used even more aggressively to group both reference and biosimilar products under the same codes.
Despite such support of the policy, CMS says that it “seeks to promote innovation, to provide more options to patients and physicians, and competition to drive prices down, recognizing that even though these two goals may be difficult to achieve concurrently, to delink them would be counterproductive.” CMS went on to say that “it is essential to take a measured approach that considers all options given the significant federal spending by Medicare on Part B drugs.” CMS says that it will seek comments regarding its payment policy as it continues to investigate alternatives to its current practice.
Biosimilars Forum hailed CMS’ decision to revisit the coding policy, saying that issuing unique HCPCS codes to each biosimilar product will help to ensure a robust and competitive marketplace for biosimilars, and that it could help spur innovation. “To ensure that the prescribed physician-administered biologics are given to patients, Medicare should allow a fair and predictable reimbursement to purchasers of biosimilars,” the nonprofit organization said in its July 14 statement.
CMS’ comment period on the entirety of its proposed rule will remain open until September 11, 2017.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.