The Centers for Medicare & Medicaid Services has delivered its final policy for the Transitional Coverage for Emerging Technologies (TCET) program, which incorporates existing coverage mechanisms. However, the Advanced Medical Technology Association (AdvaMed) stated that the policy suffers from several deficiencies and called on Congress to pass legislation that would fix the gaps in the TCET program.

The TCET program will use the national coverage determination (NCD) process to provide coverage for devices that have been granted access to the FDA’s breakthrough devices program.  Although in vitro diagnostics (IVDs) are not specifically excluded, CMS stated that it believes that Medicare administrative contractors (MACs) should continue to manage coverage policy work for these tests, including those that are in FDA review under the breakthrough devices program.

CMS expects to admit no more than five applications to the TCET program each year, a limit that is reflective of the agency’s limited resources. While the draft policy indicated that CMS would respond to TCET applications within 30 days of receipt of the application, the final policy clarifies that the agency will review applications only on a quarterly basis. This schedule will allow CMS to prioritize the applications and provide a more level playing field for applicants in terms of the date of the FDA marketing authorization for the device.

Manufacturers may provide CMS with a non-binding letter of intent to self-nominate up to 24 months before the anticipated date of FDA approval or clearance, although the full nomination for inclusion in TCET can be filed only within 12 months of the expected FDA marketing authorization date. However, the program is not open to devices that are already on the market or are within six months of the FDA clearance/approval date. This exclusion of eligibility is due to the extensive premarket engagement required for a timely coverage decision on the device.

Manufacturers will be required to file an evidence development plan for any devices that are accepted into the TCET program, and CMS will use the coverage with evidence development (CED) process to provide the evidence for a final coverage policy. The agency stated that it may convene an advisory committee meeting if there are questions about the appropriateness of the endpoints proposed for the CED study. The study may run five years or longer if necessary, at which point the agency will determine the next steps for the device. This may include a completed NCD with or without CED requirements, or a non-coverage determination.

Another possible outcome is a rescission of the coverage analysis, which would leave the manufacturer with the option of applying to MACs for coverage within each MAC’s jurisdiction. An alternative device may be granted access to an existing TCET coverage analysis, but CMS provided little information as to how a similar device would be defined for the purposes of the TCET program.

Congress may pass legislation that would provide CMS with an expanded statutory authority for a coverage policy specific to FDA breakthrough devices, which would include IVDs. The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 was passed by the House Ways and Means Committee in June, but the bill, H.R. 1691, has seen little movement outside of the Ways and Means Committee. The health subcommittee of the House Energy and Commerce Committee marked up H.R. 1691 and several other bills in November 2023, but the full committee has yet to act on the bill.

AdvaMed President and CEO Scott Whitaker said the final TCET notice offers a “stronger, more robust policy” for breakthrough devices, but added that the policy “doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering.” Whitaker said the yearly limit on TCET devices demonstrates the need for more resources at CMS, adding that the exclusion of IVDs “is disappointing” considering that IVDs may not only save lives, but may also curtail health care spending. He called on Congress to pass H.R. 1691, stating that “too many patients in need of breakthrough diagnoses and treatments are counting on it.”

AdvaMed Statement on Final TCET Notice