ASPS Weighs in on Coverage Pathway for Innovation
In August, CMS announced the Medicare Coverage of Innovative Technology (CMS-3372-P) proposed rule, which is designed to "provide Medicare beneficiaries access to the latest medical technology faster than ever." The policy was developed at the direction of President Trump via Executive Order on Protecting and Improving Medicare for Our Nation's Seniors (EO 13890).
ASPS recently joined fellow members of the Alliance of Specialty Medicine in commenting on the proposed rule and providing specific recommendations to CMS.
About the Medicare Coverage for Innovative Technology (MCIT) pathway
In response to the President's Executive Order 13890, CMS has proposed to establish a new Medicare coverage pathway for medical devices designated as breakthrough by the Food and Drug Administration (FDA), under which such devices would receive up to four years of Medicare coverage following the date of FDA market authorization.
ASPS and Alliance recommendations
Together with the Alliance of Specialty Medicine, ASPS supports the CMS MCIT proposal, with a few notable amendments and recommendations. The MCIT has the potential to promote innovation and enable the Medicare program to keep pace with the rapidly-evolving health technology landscape.
In its letter to CMS, the Alliance recommended the following:
- Finalize an expanded MCIT pathway that also includes innovative diagnostics, drugs, and biologics, in addition to FDA-designated breakthrough devices, allows for off-label use of products covered under MCIT, and provides coverage for up to 5 years;
- Align Medicare physician coverage and reimbursement policies with MCIT final policies to address potential gaps in coverage;
- Incentivize manufacturers to collect and regularly report data on outcomes based on the use of their products under the MCIT pathway; and
- Finalize the proposed definition of "reasonable and necessary," and clarify that the requirement for an item or service to be "safe and effective" does not necessitate FDA review, clearance, or authorization as a prerequisite for Medicare coverage.
Watch upcoming issues of Advocacy Matters and ASPS Government Affairs updates for developments on this issue and details of the final rule once it is released.