“TCET balances providing people with Medicare access to the latest medical innovations while ensuring these new technologies are appropriate and beneficial to the Medicare population based on data and available evidence,” CMS said. [Image courtesy of CMS]
The voluntary Centers for Medicare & Medicaid Services (CMS) program will expedite Medicare coverage for new medtech innovations that secure breakthrough device designation from the FDA before marketing authorization.
The new TCET pathway will increase the number of national coverage determinations (NCDs) that CMS will conduct per year, the agency said, “and supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population.”
CMS said it anticipates accepting up to five TCET candidates per year and hopes to finalize an NCD within six months of FDA marketing authorization. Transitional coverage is estimated to last five or more years, but “only as long as needed to facilitate the timely generation of evidence that can inform patient and clinician decision-making.”
CMS repealed a similar program, Medicare Coverage of Innovative Technology (MCIT), in 2021, citing concerns that it may have covered devices without adequate evidence.
“TCET balances providing people with Medicare access to the latest medical innovations while ensuring these new technologies are appropriate and beneficial to the Medicare population based on data and available evidence,” CMS said. “In addition, TCET promotes patient-centered care by supporting evidence development so that people with Medicare, their caregivers, and their doctors will have reliable information about the latest breakthrough technologies to make informed health care decisions. Finally, TCET gives device manufacturers what they have long asked for: a more efficient and transparent Medicare coverage review process that allows for enhanced communications between industry and CMS, clear evidence requirements, and defined timelines for final coverage actions.”
TCET eligibility and nominations
Beyond breakthrough designation, eligibility for the TCET program includes devices that are 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.
CMS said it will soon announce the factors it will use to prioritize TCET nominations, but until then will prioritize requests “based on the magnitude of the potential impact on the Medicare program and its beneficiaries and staffing resources.”
Device developers can nominate their devices for participation with a non-binding letter of intent approximately 18 to 24 months before anticipated FDA marketing authorization.
Submitting that non-binding letter of intent may avoid delays in TCET reviews, CMS said.
“When CMS is aware that manufacturers will likely pursue the TCET pathway for devices where appropriate clinical endpoints are uncertain, we may preemptively conduct a clinical endpoints’ review, and may convene a [Medicare Evidence Development and Coverage Advisory Committee, or MEDCAC] panel.”
Then, about 12 months prior to when the device company anticipates an FDA decision on a submission for authorization, they can submit a TCET pathway nomination.
CMS will review nominations on a quarterly basis. Nominations are due by Oct. 31, 2024 for the first quarterly review. Nominations for the following quarterly review cycles are due by Jan. 31, 2025, April 30, 2025, and July 31, 2025.
Interested manufacturers can notify CMS of their interest in TCET at the “Contact Us” link here.
TCET process evidence preview and development
If accepted into the TCET pathway, device developers will go through an evidence preview (EP) and come up with an evidence development plan (EDP).
CMS described the EP as a “focused literature review for a specific item or service [to] provide early feedback on the strengths and weaknesses of the available evidence, including any evidence gaps.” CMS intends for a contractor to conduct the EPs using standardized evidence grading, risk of bias assessment, and applicability assessment.
The EP “is intended to inform CMS and manufacturers about the best available coverage options for an item or service and offers greater efficiency, predictability, and transparency to manufacturers and CMS on the state of the evidence and any notable evidence gaps. … If an NCD is opened following the EP, 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.”
Then, an EDP will seek to fill any evidence gaps identified by the EP, and “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.”
“EDPs should incorporate interim reporting to ensure adequate progress and timely completion.” CMS said. “Interim reports should also disclose any meaningful changes to prespecified study protocols, which are essential to transparency.”
More TCET information is available from CMS here.
AdvaMed’s response
AdvaMed President and CEO Scott Whitaker said the final TCET plan “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.”
“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS,” he said in a news release. “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.”
