The Centers for Medicare & Medicaid Services (CMS) released a final procedural notice on Wednesday to expedite Medicare coverage of novel medical devices and get the devices to Medicare beneficiaries faster.
The House Ways and Means Committee passed legislation in June that significantly diverges from the final notice.
CMS proposed the Transitional Coverage for Emerging Technologies (TCET) pathway in June 2023. The Biden administration’s version of the rule differed significantly from the more expansive Medicare Coverage of Innovative Technology (MCIT) rule proposed by the Trump administration which would have covered devices that do not currently fall into a Medicare benefit category, like digital therapeutics.
FDA’s Breakthrough Device designation expedites the FDA review process for devices that are novel and could provide more effective treatment for severe conditions. The program has been operational for years, but many stakeholders criticized the time lapse between FDA market authorization and CMS coverage determinations. Some cited studies that said it takes CMS an average of over five years to make a coverage determination for a Breakthrough device.
“TCET gives device manufacturers what they have long asked for: a more efficient and transparent Medicare coverage review process,” CMS says in a press release. It touts that the final version of TCET includes increased pre-market engagement with CMS and allows evidence gaps to be filled with fit-for-purpose studies.
CMS says it worked with the Agency for Healthcare Quality and Research (AHRQ) to rework its evidence review process, in response to feedback from stakeholders which urged the agency to be more “agile and interactive.”
In its final procedural notice, CMS said it made several changes to the proposed rule including increasing transparency into the transitional coverage determination process and making some review decisions more expedient.
The new TCET procedure will allow manufacturers of medical devices to submit non-binding letters of intent 18-24 months before expected FDA marketing authorization. CMS may preemptively conduct a clinical endpoints review if clinical endpoints for a novel device are uncertain.
CMS says TCET devices can maintain their temporary national coverage decision status for an indefinite period of time until proper evidence is generated to determine its future coverage status. A summary of the rule says that CMS expects the TCET NCD to last for five or more years.
CMS will only review up to five devices per year to receive TCET status. Lawmakers and stakeholders pushed back on the limit in the proposed rule, saying the coverage pipeline is too small to make a big difference for Medicare beneficiaries.
However, CMS did update the frequency with which it will review TCET nominations to every quarter. Applications that are not selected will automatically be reviewed in the next quarter.
To increase transparency into the NCD process, CMS says it will make the process public on its website by posting the tracking sheet and dates of submission and review and allow for public comment. It will also create a TCET dashboard to show which devices have been accepted into the program.
CMS has not published final criteria for prioritizing devices selected for the transitional coverage program. A summary of the final procedural notice says CMS intends to release the criteria soon. In the meantime, it will rely on a 2013 guidance document and prioritize devices that will most impact Medicare.
As under the proposed TCET framework, CMS will not include in vitro diagnostic products in the TCET program.
President and CEO of the Advanced Medical Technology Association Scott Whitaker said in a statement that Congressional action is needed to grant CMS more resources for the program.
“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," Whitaker said. "The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS. And 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. While we appreciate that CMS has released the rule, we call on Congress to finish the job by passing HR 1691, the Ensuring Access to Critical Breakthrough Products Act. Too many patients in need of breakthrough diagnoses and treatments are counting on it.”