The Centers for Medicare and Medicaid Services (CMS) has proposed a new rule that would enable medical devices approved under the FDA's "breakthrough" designation to be covered by Medicare immediately, effectively eliminating delays in patient access.

The move would permit Medicare to cover eligible breakthrough devices the FDA has approved for use in 2019 and 2020, thereby allowing Medicare beneficiaries to use them for life-threatening illnesses and conditions, according to Policy and Medicine, a publication by Rockpointe Corporation.

“Too often, innovative devices are approved by the FDA but aren’t covered by Medicare until sufficient evidence has been collected,” said Patrick Hope, executive director of MITA, in a statement. “This creates a ‘Catch-22’ scenario in which, without adequate coverage or reimbursement, access to an FDA-approved treatment or therapy is limited to only those who can afford to pay out-of-pocket. This results in a reduced ability to collect the same data needed to support reimbursement.”

A breakthrough device must provide more effective treatment or diagnosis for either a life-threatening or irreversibly debilitating human disease or condition. It must also at least be designated a “breakthrough” technology, or offer a treatment option when no other cleared or approved alternatives exist, reports Policy and Medicine.

Qualifying devices would be covered nationally under Medicare Coverage of Innovative Technology (MCIT) for four years to demonstrate evidence of their value. During this time, private healthcare insurers called Medicare Administrative Contractors (MACs) would judge the reasonableness and necessity for using the technologies in specific claims. While a device is reasonable and necessary generally, it does not mean that it is reasonable and necessary in all circumstances, according to CMS.

After the four years are up, manufacturers can either seek local coverage determinations (LCD) or a national coverage determination (NCD) for qualifying devices. Those interested in pursuing an NCD are expected to submit a request for it during the third year of MCIT coverage. MCIT-covered devices would either receive an affirmative NCD, a negative NCD, or non-coverage; or MAC discretion through LCDs or claim-by-claim decisions.

Manufacturers of novel technologies would be able to opt into MCIT by notifying CMS of its intention to use the pathway. Those interested can do so by emailing CMS, which would then coordinate with the FDA and the manufacturer to start coverage once the breakthrough device is FDA market authorized. Manufacturers are still, however, responsible for obtaining the appropriate codes for their solutions.

“For new technologies, CMS coverage approval has been a chicken and egg issue,” said CMS Administrator Seema Verma in a statement. “Innovators had to prove their technologies were appropriate for seniors, but that was almost impossible since the technology was not yet covered by Medicare and thus, not widely used enough to demonstrate their suitability for Medicare beneficiaries. These efforts will ensure seniors get access to the latest technologies while lowering costs for innovators.

While ECRI acknowledges that the new pathway will enable quicker access to certain medical devices, it is concerned about the pathway's affect on safety. "This new approach offers no advantage for patient safety because it enables public access earlier to medical devices that have will likely have fewer safety data than one would expect from a full PMA pathway," said its director of health technology services, Diane Robertson.

Devices participating in the FDA’s Breakthrough Device Program would also be eligible for MCIT. Any MCIT-participating device would need to fit within a statutory Medicare benefit category. Following notification, CMS would coordinate with the FDA and manufacturer to work out details prior to the start of coverage.

In providing national Medicare coverage for four years, the MCIT rule is expected to streamline LCDs and promote equal access for seniors, while helping manufacturers focus on delivering their devices to patients and clinicians, according to Policy and Medicine.

CMS will post a list of breakthrough devices covered through MCIT and the duration of coverage on its website.

It is specifically asking for comments on whether MCIT should be extended to other categories, such as diagnostics, drugs, and biologics reviewed under expedited approaches, including Breakthrough Therapy or Priority Review. It also is seeking comments as to whether all diagnostics, drugs, and biologics should be MCIT-eligible. The proposed rule, however, addresses only devices, due to CMS believing there to be more uncertainty for devices than other items and services.

All comments must be submitted by November 2, 2020.