Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

Dive Brief:

Medtech trade groups have voiced support for the Centers for Medicare and Medicaid Services’ plan to accelerate reimbursement of certain breakthrough devices.
In letters sent on the same day, AdvaMed and the Medical Device Manufacturers Association (MDMA) urged CMS to quickly finalize the program, while also naming changes they want the centers to make.
The trade groups recommended changes including the expansion of the CMS program to cover breakthrough diagnostics, products authorized in the previous three years and medical devices that are nearing approval.

Dive Insight:

In June, CMS released a draft version of the Transitional Coverage for Emerging Technologies (TCET) pathway for consultation. The path could fill a gap created by the repeal of the contentious Medicare Coverage for Innovative Medical Technologies plan and address industry calls to cut the gap between device approval and reimbursement.

AdvaMed and MDMA submitted feedback on the new proposal to CMS this week. If certain changes are made, MDMA said the pathway can be “a positive, incremental step” and urged CMS “to move forward quickly with its implementation.” AdvaMed expressed similar views, saying it “strongly supports the TCET program proposal” and urging CMS to finalize the notice as “quickly as possible” while incorporating its recommendations.

The trade groups made some of the same suggestions. Both groups want CMS to expand TCET to cover breakthrough in vitro diagnostics that are authorized by the Food and Drug Administration and products that are already on the market. AdvaMed proposed a “lookback provision” that extends TCET eligibility to breakthrough technologies that are authorized up to three years prior to the effective date. MDMA made a bolder pitch to allow “currently marketed devices,” or a lookback period “at a minimum.”

MDMA also called for CMS to see the pathway as the start, rather than the end, of work to support the coverage of breakthrough devices. While the trade group supports TCET, it also “strongly” believes that the notice fails to “leverage the full range of CMS coverage authorities to meaningfully accelerate beneficiary access and foster innovation.” MDMA wants the centers to create a new pathway “separate from [coverage with evidence development] for appropriate technologies.”

The request reflects fears that TCET lacks provisions for technologies that are reasonable and necessary but have limited context, meaning additional real-world data is needed to make a long-term national coverage policy. CMS delegates decisions on such devices to local Medicare Administrative Contractors, an approach that MDMA argues leads devices to “languish for years” as companies “struggle to navigate the opaque, inconsistent and undefined procedures.”

CMS stopped accepting feedback on the draft this week. The centers have also received broadly positive feedback from the American Academy of Neurology and the American Association of Tissue Banks.