Press Releases

House Committee Advances Bipartisan Bill to Expedite CMS Coverage of Breakthrough Medtech

WASHINGTON – Today, the House Ways and Means Committee voted to pass the bipartisan H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act, during a markup meeting. The legislation, introduced by Representatives Brad Wenstrup (OH-02), Suzan DelBene (WA-01), Gus Bilirakis (FL-12), Tony Cárdenas (CA-29), Blake Moore (UT-01), Terri Sewell (AL-07), Brett Guthrie (KY-02), and Anna Eshoo (CA-16), would ensure FDA-designated breakthrough technologies are covered for four years by Medicare, and during this period CMS would be required to make permanent coverage determinations for the devices.
“This is a major step forward on a policy that will make a big difference in the lives of Medicare beneficiaries. But it is really important that all medical technologies, including diagnostic tests, are included. We look forward to working further with Congress to ensure breakthrough diagnostics, such as those that would detect cancer and other major diseases earlier, are in the final legislation that passes Congress. This would not only save lives—it would reduce costs to our health care system as well. Although during the markup a formal, public acknowledgement was made that the intent was to include diagnostics in the legislation, we will aggressively work with the committee to ensure the change is made before the legislation moves to the House floor. We know this legislation is also a priority for the Energy & Commerce Committee and look forward to progress there,” Scott Whitaker, AdvaMed President and CEO said.

 “As we continue to wait for CMS to finalize TCET, which was repealed 1,215 days ago, it is reassuring to see Congress step up and take action on behalf of Medicare beneficiaries. We thank Reps. Wenstrup and Del Bene and all the bill’s cosponsors for their leadership, and Chairman Smith and the Ways & Means Committee for today’s markup of this important legislation.”

Earlier this year, Whitaker sent a letter to CMS Administrator Chiquita Brooks-LaSure outlining the medtech industry’s disappointment in the lack of a finalized TCET rule. 

From the letter: “CMS’s delay in finalizing TCET is puzzling. The ability to establish a workable policy to ensure Medicare coverage of safe, effective, FDA-designated and market-authorized breakthrough devices should be easily within the agency’s grasp.   

“Medicare beneficiaries have waited long enough—too long—for coverage of breakthrough medical technologies to prevent, diagnose, and treat the chronic conditions from which they are suffering unnecessarily.”