On November 2, 2021, The Centers for Medicare & Medicaid Services (CMS) issued their Final Rule on reporting Average Sales Price (ASP) for items, services, supplies and products that are reimbursable as drugs or biologics under a variety of Medicare Part B provisions. This Final Rule requires manufacturers to report pricing information for a wide variety of non-drug or biological products reimbursed under Medicare Part B. Fidia Pharma USA Inc (Fidia) has the distinction of bringing Hyalgan®, the first hyaluronic acid-based viscosupplementation to the US market. This product, as well Fidia’s 2-injection Hymovis® and 3-injection Triluron®, are medical devices reimbursed under the Medicare Part B program.
The Consolidated Appropriations Act was signed into law on December 27, 2020. The Act requires manufacturers without a Medicaid drug rebate agreement to report ASP and other pricing information to CMS for calendar quarters that begin on January 1, 2022. This mandatory requirement applies to all items, services, supplies, and products that are payable under Medicare Part B provisions as a drug or biologic. This represents a change from the previous reimbursement methodology that was based on Wholesale Acquisition Cost (WAC). Physician reimbursement will now be calculated based on the reported ASP for the product. Fidia anticipates that each Medicare Administrative Contractor (MAC) will adapt ASP conversion in Q3 2022, and we are committed to working compliantly with our customers to ensure a smooth transition to this reimbursement model.
Fidia has a dedicated reimbursement team to work with our customers to address questions on ordering and reimbursement of our three viscosupplementation products for Osteoarthritis (OA) knee pain: Hymovis®, Triluron® and Hyalgan® (hyperlink to individual sites). For questions about the Medicare reimbursement methodology, please contact your local Medicare Administrative Contractor (MAC) or consult the CMS website. To discuss your specific situation, including ordering and submission prior to the reimbursement change, please contact firstname.lastname@example.org, your Fidia sales representative, or call 844-307-7223.
We will continue to monitor any legislative developments and policy mandates that impact patient access to our viscosupplementation products and provide updates on this page, as well as to our valued customers through our sales team.
To read a letter to healthcare providers from Fidia Pharma USA Inc. President Antonio Marielli, click here.