While the final notice of the Transitional Coverage for Emerging Technologies (TCET) Medicare payment pathway says much about in vitro diagnostic (IVD) products and diagnostic laboratory tests, the notice reinforces Medicare administrative contractors' (MACs) and Molecular Diagnostic Services (MolDx) Program roles in coverage determinations.
“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering," stated medtech industry advocate AdvaMed President and CEO Scott Whitaker in an email. "The exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection."
Proposed in June 2023, the voluntary TCET coverage pathway aims to accelerate Medicare coverage for certain "breakthrough" medical technologies. CMS posted its final procedural announced August 7, saying TCET will:
- Increase the number of national coverage determinations (NCDs) that CMS will conduct per year.
- Provide a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population.
- Accept up to five TCET candidates per year and, for technologies accepted into and continuing in the TCET pathway, finalize an NCD within six months after market authorization by the U.S. Food and Drug Administration (FDA).
Under the TCET pathway, CMS will coordinate with the FDA and manufacturers of breakthrough devices as those devices move through the FDA premarket review processes to ensure timely Medicare coverage decisions following any FDA market authorization,.
The TCET pathway also aims to coordinate benefit category determination, coding, and payment reviews and to allow any evidence gaps to be addressed through fit-for-purpose (FFP) studies, the notice stated. The anticipated result of the new coverage pathway would be faster access to technologies within a predictable coverage framework that generates clinical evidence for the Medicare population.
"We continue to believe that that the majority of coverage determinations for IVD products, including diagnostic laboratory tests, granted Breakthrough Designation should continue to be determined by the Medicare Administrative Contractors through existing pathways," the CMS said in its notice. "We acknowledge there may be instances where manufacturers and CMS agree that an NCD is appropriate for a diagnostic laboratory test. In those instances where manufacturers believe that additional evidence generation may be needed to satisfy the Medicare coverage standard, we encourage manufacturers to contact CMS to discuss options for their specific technology." Final guidance will be published August 12.
AdvaMed has been outspoken about TCET recommending that appropriate candidates for the payment pathway include diagnostic laboratory tests. Some tests granted breakthrough device designation (e.g., protein-based tests) can fall outside of the MolDx program, according to AdvaMed.
"While MolDx can and should remain an option for these FDA-approved tests and manufacturers, it should not be the only pathway available for novel breakthrough technologies," AdvaMed said in a letter last year. "The MolDx Program is not a national program and by definition would limit access to care in regions that do not participate in the program, as a result it should not be perceived as an adequate substitute for a national coverage option through the TCET program."
AdvaMed, which also advocates for the medical imaging industry, also recommended that TCET applications should not be limited; however, the final notice limits applications to five per year.
"The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS," Whitaker said.
AdvaMed also urged Congress to pass HR 1691, the Ensuring Access to Critical Breakthrough Products Act.
HR 1691, introduced by Reps. Brad Wenstrup (R-OH) and Suzan DelBene (D-WA), provides for Medicare coverage of medical devices that are approved under the FDA breakthrough devices program. HR 1691 would also allow designated medical breakthrough devices to be temporarily covered under Medicare during a four-year transitional period, with payment codes assigned within three months of FDA approval.
HR 1691 would go even further to establish a process that allows for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary. As of June 27, the bill continued to advance, passing the House Ways and Means Committee by a 36-5 vote.
This week's TCET guidance reminded medical device manufacturers that breakthrough devices provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions. The device must also 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 the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or device availability is in the best interest of patients.
While voluntary, TCET affects medical device, pharmaceutical, and biotechnology companies. TCET may also expand to other items and services, CMS said in the final notice. To support the industry's understanding, CMS said it will update information on its Guide for Medical Technology Companies and Other Interested Parties website.
