Dive Brief:

• Senior CMS officials on Monday elaborated on a proposed reimbursement pathway designed to speed coverage for medtech innovations, saying it will use the same definition of a breakthrough device as FDA and will also encompass diagnostics.
• The Medicare Coverage of Innovative Technologies (MCIT) pathway, which was laid out at the end of August, would enable coverage of any device designated by FDA as a breakthrough technology and will attempt to codify a clear definition of what is "reasonable and necessary" for making those determinations, said Tamara Syrek Jensen, director of CMS' coverage and analysis group, during a townhall webcast at AdvaMed's Virtual Medtech Conference.
• CMS is inviting public comments on the policy proposal through Nov. 2.

Dive Insight:

CMS' MCIT pathway, under review since March 2019 and supported by AdvaMed, comes after a push by the medical device industry for Medicare to cover new medical technologies for beneficiaries sooner after they come onto the market.

With the proposed rule, CMS would establish national Medicare coverage for designated breakthrough technologies for four years, beginning on the date of FDA approval or clearance. "We want to be streamlined from FDA to CMS," Syrek Jensen said.

At the end of the 4-year period, the device graduates to either case-by-case coverage, local coverage determination, or a national coverage determination. If seeking the latter, companies should initiate a conversation with CMS early enough during the MCIT pathway to avoid a gap when the four years are up, Syrek Jensen advised. The pathway is an opt-in program, rather than mandatory, so it requires outreach to CMS to participate.

Additionally, the agency's proposal to define "reasonable and necessary" to clarify coverage standards is based on factors found in Chapter 13 of the Medicare Program Integrity Manual that provides instructions for Medicare contractors. The definition considers whether an item or service is safe and effective, not experimental or investigational, and appropriate.

CMS is adding a new component that would allow the appropriateness criteria to be met if a commercial insurer already provides coverage. This is an important addition that the agency is particularly interested in getting feedback on from the public, Syrek Jensen said.

Don May, AdvaMed executive vice president for payment and healthcare delivery policy, said his group would be submitting comments on the proposed rule and would address the concept of incorporating commercial insurers, which could raise concerns.

Jason Bennett, acting director of CMS' technology coding and pricing group, said the agency has reorganized its staff to place a greater focus on technology innovations. CMS is seeing more complex products coming to market at a pace that is increasing year by year, he said.

A 6-month pilot program was formed with staff dedicated to working with companies in a liaison capacity, Bennett said. CMS is trying to determine what pathways companies are approaching and what regulatory or statutory hurdles they are encountering as the agency works to organize processes in a more efficient way, he said.

CMS has seen a big jump in the use of telehealth services during the COVID-19 pandemic with positive feedback, particularly in the behavioral and mental health space, said Carol Blackford, director of the agency's hospital and ambulatory policy group. Audio-only services have not been allowed under the telehealth benefit due to concerns about clinical limitations and integrity, she said.

The agency has estimated that the MCIT pathway, if finalized in its current form, could cost as much as $291.5 million in its first year.