September 19, 2017
The Honorable Seema Verma
Centers for Medicare and Medicaid Services (CMS)
Room 445-G, Hubert H. Humphrey Building
200 Independence Ave, SW
Washington, DC 20201
RE: Revisions to Payment Policies under the Physician Fee Schedule (PFS) and Other Revisions to Part B for CY 2018 proposed July 13, 2017 (CMS-1676-P); allowing biosimilars that reference the same biologic to use unique billing codes
Dear Administrator Verma:
We appreciate the opportunity to provide a supplemental submission to our original comments on the proposed payment for biosimilar biological products under Section 1847A of the Social Security Act, included in the Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018 proposed rule (CMS-1676-P).
As discussed in our initial comments, the Biosimilars Council believes CMS should assign each non-interchangeable biosimilar a unique billing code and payment rate to ensure that the Medicare Part Be reimbursement framework creates an environment where biosimilars can not only compete amongst themselves, but also against the brand reference product. Over time, this biosimilar competition would significantly drive down the cost of the product, as well make the market more attractive to future entrants. More products increase patient access while lowering cost.
Therefore, we appreciate CMS’s request for “data to demonstrate how individual HCPCS codes could impact the biosimilar market” and “market analyses or research articles that provide data and insight into the current economics of the biosimilar marketplace.”
To that end, attached please find a report from The Moran Company (TMC) that analyzes the federal budgetary implications of our recommended change to the current CMS policy. The report indicates that if CMS were to require individual codes for biosimilars, the result could be $11.4 billion in savings to the federal government over the FY2018 to FY2027 budget window.
We believe this analysis provides a clear picture of the harm to patients and the nascent biosimilars industry caused by current policy and the important potential for separate codes to lower costs for patients and payors.
We appreciate the opportunity to provide this supplemental report, and look forward to working with CMS to expand patient access to biosimilar medicines. If you have any additional questions, please contact Christine Simmon, Executive Director of the Biosimilars Council, at (202) 249-
7100 or [email protected].
Executive Director, Biosimilars Council
Senior Vice President Policy & Strategic Alliances, AAM