Biosimilars Council Supplemental Comments on the CY 2018 Physician Fee Schedule

Tuesday September 19, 2017

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].


Christine Simmon
Executive Director, Biosimilars Council
Senior Vice President Policy & Strategic Alliances, AAM

Download PDF

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at

Stay Informed

Subscribe for Updates

Receive our monthly Biosimilars Bulletin and other important updates on biosimilars in the U.S.


Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:



October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.