On August 7, 2024, CMS released the final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway (link) and accompanying fact sheet (link).

Highlights include:

CMS will limit the TCET pathway to certain eligible FDA-designated Breakthrough Devices, because the agency believes this is the area with the most immediate need.
Appropriate candidates for the TCET pathway would include those devices that are certain FDA-designated Breakthrough Devices, determined to be within a Medicare benefit category, not already the subject of an existing Medicare NCD, and not otherwise excluded from coverage through law or regulation.
As the TCET pathway develops and proves successful, CMS may consider expanding its application to other items and services, contingent on sufficient available resources.
CMS expects the majority of coverage determinations for Breakthrough-designated diagnostic laboratory tests will continue to be made by Medicare Administrative Contractors; however, CMS notes there may be instances where manufacturers and CMS agree that an NCD is appropriate for a diagnostic laboratory test.
CMS intends to review TCET pathway nominations quarterly, which will allow the agency to review eligible devices and coordinate with manufacturers and FDA as needed.
TCET Process allows for exit opportunities, but with increasing burden to the applicant as the process advances.
Results of TCET are likely an NCD with CED, the process is intended to determine the nature of the CED study.

TCET Pathway Overview

The TCET pathway uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain FDA-designated Breakthrough Devices. TCET is voluntary for manufacturers.
Pre-Market (FDA & CMS Review): The following steps outline the TCET process before a device receives FDA authorization.
Nonbinding letter of intent
Nomination
CMS review and feedback
CMS benefit category review
Evidence preview (EP) review
EP meeting
Once the device receives FDA authorization, CMS and AHRQ review and approve the Evidence Development Plan (EDP).
Standard NCD processes and timelines will continue to apply, and following a 30-day public comment period, CMS will have 60 days to finalize the NCD reconsideration.
During the transitional coverage period (as specified in the EDP), the manufacturer provides intermittent EDP progress updates until the CED stops.
During the transition to post TCET coverage:
Evidence development stops and manufacturer publishes results
CMS (re)reviews evidence
NDC reconsideration

Nominations

The appropriate timeframe for manufacturers to submit TCET pathway nominations is approximately 12 months prior to the anticipated FDA decision on a submission as determined by the manufacturer.
Manufacturers of certain FDA-designated Breakthrough Devices may self-nominate to participate in the TCET pathway.
CMS incorporates an opportunity for manufacturers to submit a non-binding letter of intent to nominate a potentially eligible device approximately 18 to 24 months before they anticipate FDA market authorization.
CMS notes that submission of a non-binding letter of intent may avoid delays in TCET reviews.
When CMS is aware that manufacturers will likely pursue the TCET pathway for devices where appropriate clinical endpoints are uncertain, they may preemptively conduct a clinical endpoints review and may convene a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
TCET nominations will be reviewed quarterly.
If a nomination is not accepted into the pathway in one quarterly review cycle, it may be considered again in the following quarterly review cycle.
Manufacturers will not need to resubmit a nomination for it to be considered in a subsequent quarter.
CMS clarifies that nominations for devices that are already FDA market authorized or those anticipated to receive an FDA decision on market authorization within 6 months of nomination will not be accepted for TCET because TCET relies on extensive pre-market engagement to expedite coverage reviews.
CMS notes that if the timelines for this pre-market engagement are shortened, it is unlikely that an NCD will be finalized within six months of FDA market authorization. An NCD can also be pursued outside of TCET or MAC discretion.

Evidence Preview (EP)

CMS’ proposal introduced the Evidence Preview (EP) concept, which is a focused literature review that would provide early feedback on the strengths and weaknesses of the available evidence, including any evidence gaps, for a specific item or service.
In this final notice, CMS clarifies that the evidence review contractor’s role is to support the Coverage and Analysis Group (CAG) staff by conducting a rapid systematic literature review and summarizing the evidence based on a modified Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology.
The contractor’s role is to support and accelerate CMS reviews, but CMS will perform extensive quality assurance on contracted reviews, independently complete substantial portions of the EP, and determine coverage policy.
If an NCD is opened, an evidence summary, including a disclosure of which contractor completed the review, will be posted with the tracking sheet on the CMS website for public comment.
CMS will publicly post an evidence summary for devices that are withdrawn from the TCET pathway without an evidence gap assessment. CMS changed their position and has decided to share the full EP with the Medicare Administrative Contractors (MACs) if a manufacturer withdraws from the TCET pathway.

Following finalization of the EP, if a manufacturer decides to continue pursuing coverage under the TCET pathway, they may initiate the NCD request. The manufacturer must submit a formal NCD letter to CMS expressing desire for CMS to initiate a national coverage analysis.

Evidence Development Plans (EDPs)

Manufacturers may produce EDPs to address any evidence gaps identified in the EP.
EDPs may include traditional clinical study designs and/or fit-for-purpose study designs, including those that rely on secondary use of real-world data, consistent with applicable CMS guidance documents.
The development of an EDP will include CMS-AHRQ collaboration to evaluate the EDP to ensure it meets established standards of scientific integrity and relevance to the Medicare population.
CMS will engage with the manufacturer to provide feedback and discuss any recommended refinements.
Non-proprietary elements of the CMS and AHRQ-approved EDP will be made publicly available on the CMS website when a proposed NCD is posted.
The EDP process will include CMS engagement with the manufacturer to provide feedback and discuss any recommended refinements.
Elements of the EDP, specifically the non-proprietary information, would be made publicly available on the CMS website when a proposed NCD is posted.
A forthcoming fit-for-purpose (FFP) guidance will provide information on study designs and analysis methods that are FFP.
CMS expects TCET coverage with evidence development (CED) studies to be registered and listed on clinicaltrials.gov.
A summary of the EDPs and the anticipated CED NCD reconsideration window will be posted on the CMS website.

Coverage of Similar Devices

CMS has not defined “similar devices” in the final notice.
If the similarity of two or more devices is uncertain, CMS will consult with FDA and the manufacturer(s), as appropriate, when determining whether a device could be considered individually or as part of a class of similar devices for coverage purposes.
CMS clarifies NCDs are limited to particular items or services but note that some NCDs apply to products for the same indication. In these instances, CMS will follow the existing NCD process detailed in section 1862(l) of the Act.
Any follow-on devices in the TCET pathway will not count toward CMS’ annual limit.

Other Notable Provisions

A Breakthrough Device must fall into an existing benefit category to be included under TCET.
Devices subject to an existing NCD are not eligible for the TCET pathway.
CMS intends to release proposed prioritization factors for TCET nominations soon. For now, CMS will prioritize TCET candidates based on language from Federal Register notice 78 FR 48164 (link), which states CMS will review NCD requests according to the magnitude of the potential impact to the Medicare program, its staffing resources, and beneficiaries.
Information on TCET devices will be added to the NCD Dashboard, including the number of devices in the TCET pathway, the date of nomination, the date of acceptance, and the date the NCD process was initiated.

Collection of Information Requirements

CMS anticipates receiving approximately eight nominations for the TCET pathway per year.
CMS does not anticipate the TCET pathway will accept more than five candidates per year.
CMS will provide an updated analysis if they receive a higher number of respondents than anticipated.
CMS notes in addition to the TCET NCDs, they intend to continue issuing their typical number of non-TCET NCDs.

ADVI Angle

TCET is an important new coverage pathway for technologies for which an NCD is appropriate. A thorough review of the technology’s evidence base should be conducted to understand potential CED requirements, prior to participation.
TCET is only a coverage pathway. While CMS acknowledges the importance of coding and payment, they are not built into TCET. Potential applicants must consider coding for reporting the technology under CED, payment for the physician/qualified healthcare professional and the facility and ensure that both are adequate prior to engaging in TCET.

Summary of other NCD Documents from CMS

Coverage with Evidence Development (link)
Revised guidance from CMS on the CED process
CMS National Coverage Analysis Evidence Review (link)
A framework for manufacturers to aid in transparent and predictable evidence development
Clinical Endpoints Guidance: Knee Osteoarthritis (link)
A summary of CMS’ current thinking on knee osteoarthritis health outcomes. This document is not reflective of any current technologies being evaluated and is not a national coverage analysis or NCD.

ADVI will continue monitoring developments and the next steps. This is a delayed release. ADVI Instant content is distributed in real-time for retainer clients. Get in touch to learn more about how we can support your commercialization, market access, and policy needs.