Biosimilars Council Comments on the CY 2018 Physician Fee Schedule

Monday September 11, 2017

Revisions to Payment Policies under the Physician Fee Schedule (PFS) and Other Revisionsto 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 invitation to provide comments on the proposed payment for biosimilarbiological products under Section 1847A of the Social Security Act, included in the Revisions toPayment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018proposed rule (CMS-1676-P). The Biosimilars Council, a division of the Association forAccessible Medicines (AAM), works to ensure a positive environment for patient access tobiosimilar medicines. The Biosimilars Council is the leading source for information about thesafety and efficacy of these more affordable alternatives to costly brand biologic medicines.

In January 2016, the Centers for Medicare and Medicaid Services (CMS) first proposedassigning a single Healthcare Common Procedure Coding System (HCPCS) billing code and Average Sales Price (ASP) calculation for biosimilars that reference a common innovatorbiologic under Medicare Part B. As the biosimilar market has begun to develop, CMS is nowseeking for future consideration, “new or updated information on the effects of the currentbiosimilar payment policy that is based on experience with the United States marketplace… particularly market analyses or research articles that provide data and insight into the current economics of the biosimilar marketplace.” CMS is also seeking “data to demonstrate how individual HCPCS codes could impact the biosimilar market, including innovation, the number of biosimilar products introduced to the market, patient access, and drug spending.”

The Biosimilars Council is looking forward to working with CMS to make sure Medicare beneficiaries have access to therapeutically-appropriate, lower-cost alternatives to many expensive biologic medicines available today, and that this market can be developed in a fair and sustainable manner.

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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 www.accesiblemeds.org.

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