CMS Issues Rulemaking Supported in 2016 #SubHealth Hearing


WASHINGTON, DC – The Centers for Medicare & Medicaid Services (CMS) yesterday issued their finalized 2018 Quality Payment Program and Physician Fee Schedule.

According to CMS’ announcement, “As part of the President’s priority to reduce drug costs for Americans, CMS is taking an important step in the Physician Fee Schedule to modernize the Medicare payment system through innovation in the biopharmaceutical market. Beginning in 2018, CMS will update payment for biosimilars, which are lower-cost alternatives to certain types of drugs known as ‘biologicals.’”

The announcement is welcome news following a February 2016 #SubHealth hearing that examined biosimilars and the controversial coding and payment rules proposed by CMS. The underlying theme was that biosimilars are inherently different than single molecule generic drugs and their complexity must be recognized in both coding and payment.

The hearing provided an opportunity to get an update on the regulation and approval of biosimilars from the Food and Drug Administration (FDA) as well as an update on the reimbursement policy recently outlined by CMS.

Members raised concerns that the unique qualities of biosimilars were not properly considered by CMS, and that the existing payment policy could negatively impact future biosimilars entering the market or ultimately limit beneficiary access and program savings.

Then-Chairman Emeritus Joe Barton (R-TX) asked Sean Cavanaugh, then-Deputy Administrator and Director of the Center of Medicare, CMS, if the agency would revisit how these drugs are priced. Mr. Cavanaugh responded saying CMS would monitor the market and that rulemaking could be possible down the line.

This announcement is welcome news for patients, paving the way for more affordable medications and boosting competition in the marketplace.


Health (115th Congress)