Press Releases

In Letter, AdvaMed CEO Calls on CMS to Release Final Breakthrough Technology Coverage Rule, Calling Delay “Puzzling”

Whitaker: “We are left with no other conclusion than that the agency is simply unwilling to implement this bipartisan policy”

WASHINGTON – Today, Scott Whitaker, President and CEO of AdvaMed, the Medtech Association, sent a letter to CMS Administrator Chiquita Brooks-LaSure outlining industry disappointment in the lack of a finalized rule for Transitional Coverage for Emerging Technology. It has been 1,082 days since CMS first “suspended” the rule and promised a replacement policy.

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. Eighty-one medical technologies both authorized and designated as “breakthrough” by FDA have been effectively denied by CMS to Medicare beneficiaries for years through CMS inaction. Beneficiaries are right to ask: Why, if FDA has declared a medical technology safe, effective, and the kind of breakthrough they might need, Medicare denies them access to these breakthrough technologies for years?   

  “On behalf of the entire medical technology industry, I urge you to release a final notice as soon as possible. We remain as available to continue advising on all technical and policy matters that will help CMS accomplish this milestone as we have been since CMS repealed this bipartisan policy for seniors nearly three years ago. We also continue to work with congressional allies who understand the value of this policy. Whether through CMS regulation or congressional action, it is time to get the job done.”

According to the final rule establishing Medicare Coverage for Innovative Technology, the repealed coverage pathway preceding TCET, “The FDA’s Breakthrough Devices Program is not for all new medical devices; rather, it is only for those that the FDA determines meet the standards for breakthrough device designation. In accordance with section 3051 of the 21st Century Cures Act (21 U.S.C. 360e–3), the Breakthrough Devices Program is for medical devices and device-led combination products that meet two criteria. The first criterion is that the device provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The second criterion is that the device must satisfy one of the following elements: It represents a breakthrough technology; no approved or cleared alternatives exist; it offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute; or device availability is in the best interest of patients (for more information see 21 U.S.C. 360e–3(b)(2)). These criteria make breakthrough designated devices unique among all other medical devices.

Read the full letter here.