On June 22, CMS issued a notice regarding the Transitional Coverage for Emerging Technologies (TCET) program (link) along with a fact sheet (link).

This notice outlines a proposed pathway to allow for transitional coverage of certain innovative products that have FDA-designated Breakthrough Device status. CMS intends to create a mechanism for coverage that supports additional evidence generation in the Medicare beneficiary population. The TCET pathway CMS proposes would follow current National Coverage Determination (NCD) and coverage with evidence development (CED) processes.

There is a 60-day public comment period on this notice (comments due August 21), after which CMS will respond to comments through a final notice.

CMS is proposing to establish a voluntary alternative coverage pathway for certain FDA-designated Breakthrough Devices that are determined to be within a Medicare benefit category, not already the subject of an existing Medicare National Coverage Determination (NCD) or otherwise excluded from coverage.

General Principles for TCET

The TCET program is voluntary, and manufacturers of eligible FDA-designated Breakthrough Devices may self-nominate to participate. Manufacturers may withdraw from the pathway until CMS posts an NCD tracking sheet. CMS does not intend to publicly disclose the manufacturers who request coverage under TCET until the NCD tracking sheet is posted.
CMS may conduct an early evidence review prior to FDA marketing authorization and discuss the best available coverage pathway based on strength of the evidence.
CMS may also initiate discussions with manufacturers about evidence gaps and studies that may be needed to be completed to support coverage prior to FDA marketing authorization.
If CMS determines that coverage with evidence development (CED) is the most appropriate coverage pathway, the agency will work to ensure CED requirements are not duplicative of FDA post-market requirements.
Under the TCET pathway, coverage under CED will be time-limited to facilitate timely evidence generation and support a Medicare coverage determination.

TCET Pathway

Premarket
Manufacturers should submit nominations to CMS approximately 12 months prior to anticipated FDA decision on a submission.
CMS may request additional information from the manufacturer and will make a preliminary decision to accept or decline a nomination within 30 business days.
CMS will offer an initial meeting with the manufacturer to discuss the TCET nomination.
CMS will meet with their counterparts at FDA to learn more about the technology in the nomination.
CMS will initiate a benefit category review.
Following CMS’ review of the nomination, CMS will notify the manufacturer whether the product is an appropriate candidate for the TCET pathway.
CMS will initiate an Evidence Preview, which is a systemic literature review that provides early feedback on the strengths and weaknesses of the evidence.
This will be conducted by a third-party contractor and expected to take 12 weeks.
The Evidence Preview will be shared with the manufacturer, AHRQ, and FDA to obtain their feedback.
A meeting with CMS, the manufacturer, and representatives from AHRQ and FDA will take place to discuss the Evidence Preview, the TCET pathway or other available coverage pathways.
If manufacturers decide to pursue national coverage through the TCET pathway, they would need to submit a formal NCD letter requesting that CMS open a TCET NCD analysis.
Manufacturers who decide to discontinue with the TCET pathway would not see a publicly posted tracking sheet or any public notification that an Evidence Preview was conducted.
If there are evidence gaps identified in the Evidence Preview, the manufacturer should submit an evidence development plan (EDP) to CMS as soon as possible after FDA market authorization.
The EDP should be submitted to CMS at the same time as the formal NCD request cover letter.
CMS is partnering with AHRQ to determine how to allow for greater flexibility in CED by allowing fit-for-purpose (FFP) evidence study designs that meet CMS requirements.
CMS and AHRQ will review the EDP within 30 business days, share written feedback with the manufacturer on the EDP and schedule a meeting.
CMS and the manufacturer will have 60 business days after the meeting to make any adjustments to the EDP.
Non-proprietary elements of EDPs will be made publicly available on the CMS website upon posting of the proposed TCET NCD.
Should a manufacturer’s EDP not meet CMS and AHRQ’s established standards, CMS may withdraw participation from the TCET pathway. CMS notes they expect this will be a rare occurrence.
Coverage under TCET
If a device that is accepted into the TCET pathway receives FDA marketing authorization, CMS will initiate the NCD process.
CMS and AHRQ aim to have a finalized Evidence Development Plan no later than 90 business days after market authorization.
CMS proposes the following timeline for a TCET NCD:
CMS posts TCET NCD tracking sheet
30-day public comment period
Issue proposed TCET NCD and EDP within 6 months
30-day public comment period
Issue a final TCET NCD within 90 days after the proposed TCET NCD
CMS encourages stakeholder groups like specialty societies and patient advocacy groups to publicly post specific feedback on conditions of coverage and the existing evidence base on their website within 90 days of CMS opening an NCD and notifying the agency of their recommendations.
CMS proposes that the duration of coverage under TCET would be based on the review dates specified in the EDP plus additional time for manufacturers to analyze their study data, draft manuscripts, and submit for peer review. In general, CMS expects transitional coverage to last for 3 to 5 years.
Transition to post-TCET coverage
CMS proposes to contract with a third-party organization to conduct an evidence review within 6 months of the review date specified in an EDP. After the contractor has conducted a systematic literature review, CMS will assess whether the evidence meets the “reasonable and necessary” standard and applicable practice guidelines and consensus statements.
CMS proposes to open an NCD reconsideration by posting a proposed decision with one of the following outcomes:
NCD without CED
NCD with continued CED
Non-coverage NCD
Deferral to local Medicare Administrative Contractor (MAC) discretion for coverage
After the proposed decision is issued, there would be a 30-day comment period after which CMS will finalize the NCD reconsideration within 60 days.

Additional Considerations

CMS notes that they anticipate accepting up to 5 TCET candidates annually due to resource constraints and will prioritize medical devices that have the potential to benefit the greatest number of Medicare beneficiaries.
CMS intends to work with FDA to consider updates to the Parallel Review program.
CMS proposes that devices similar to Breakthrough Devices would be subject to the same coverage standards under a TCET NCD, as is the case with current NCDs which are applicable class-wide.

Public Comment Requests

CMS seeks public comments on the following topics in the notice:

Coverage of Similar Devices
CMS is seeking public comment on whether similar devices to Breakthrough Devices should be addressed in a separate NCD or if similar devices should be subject to the same coverage conditions as Breakthrough Devices, including the requirement to propose an EDP.
Guidance Documents
CMS published several new guidance documents:
Coverage with Evidence Development (link)
CMS National Coverage Analysis Evidence Review (link)
Clinical Endpoints Guidance: Knee Osteoarthritis (link)
Evidence Preview
CMS is seeking public comment on sharing Evidence Previews with the MACs, even if manufacturers withdraw from the TCET pathway following the completion of an Evidence Preview. For those that withdraw, there will be no publicly posted tracking sheet or notification that an Evidence Preview was completed. However, CMS believes it would be beneficial for patients and the Medicare program as a whole to share the Evidence Preview with the MACs to aid them in any decision making.

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