Originally published on WLF’s Forbes.com contributor page on April 29, 2021.

In 2016 the U.S. Congress passed, and President Barack Obama signed, the 21st Century Cures Act. Section 3501 of the law granted the Food and Drug Administration (FDA) authority to designate certain medical devices as “breakthrough.” The program, FDA Commissioner Scott Gottlieb explained in a report to Congress, “is intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”

FDA approval is but one hurdle in the regulatory obstacle course medical-device manufacturers must navigate. Device makers must also obtain reimbursement approval from the Centers for Medicare & Medicaid Services (CMS) for use of their products by Medicare beneficiaries. That approval has proven especially difficult for breakthrough device makers. As CMS itself acknowledged, “[W]ith the current Medicare coverage options, we have had challenges keeping national Medicare coverage on pace with these innovations.” In August 2020, CMS proposed a rule, “Medicare Coverage of Innovative Technology” (MCIT), that would allow breakthrough device makers to choose participation in a program under which CMS would provide reimbursement for their products as soon as the same day as FDA market authorization.

CMS published the final rule on January 14, 2021 and set March 15, 2021 as its effective date. But just three days before the rule was to take effect, CMS slammed on the breaks.

On March 12 the agency posted a pre-publication version of an Interim Final Rule with Comment Period, delaying the implementation date by 60 days (until May 15). CMS sought additional feedback from the public on several issues, including operational challenges, the volume of devices that have received the FDA’s breakthrough designation to date, and Medicare’s ability to assess the benefits of the technologies for Medicare beneficiaries.

The future of MCIT is now rather uncertain, and uncertainty is the last thing that Medicare patients and their doctors, as well as medical-device innovators and their investors, need.

MCIT Increases Patient Choice

Under MCIT, Medicare would nationally cover the use of a device that earned breakthrough status and fits into an existing Medicare benefit category for 4 years. CMS imposed the time limit as an incentive for device makers to develop any necessary clinical data that would support permanent coverage at the conclusion of the four years. That’s not good enough, however, for MCIT’s opponents, some of whom have alleged that concurrent FDA approval and Medicare coverage of breakthrough devices rush products onto the market that have been insufficiently studied and could cause patient harm.

Consider, however, that device makers must produce substantial analytical and clinical studies to satisfy FDA’s rigorous review standards. If those studies, or FDA’s review process, reveal side effects or other risks, FDA requires identification of those risks on product labels. If other risks become apparent through clinical adoption of a breakthrough device, FDA has the authority to require further label changes.

Those voicing safety concerns as justification for withdrawing MCIT fail to appreciate that CMS coverage merely provides physicians and their patients with a choice. Medicare patients with debilitating conditions, such as heart failure, diabetes, and kidney disease who may not have viable alternative treatment options, should be given the opportunity to choose a breakthrough device in consultation with their doctor. Numerous comments filed in response to CMS’s March 12 notice implore the agency to implement MCIT and give consumers that very choice.

A 67-year old stroke survivor writes that “this rule could dramatically improve the health and wellbeing of stroke survivors everywhere.” He explains that many of his fellow survivors are scraping by financially and can’t afford the “breakthrough devices and modalities that could offer more improvement and independence” out of pocket. Another stroke survivor urged MCIT implementation because it offers “hope for a better future post-stroke by making breakthrough devices for stroke survivors accessible and affordable.”

A physician who treats Medicare beneficiaries with Chronic Obstructive Pulmonary Disorder notes how “Novel, device-based interventions in COPD may provide critical options for patients with long-standing, unmet medical needs.”

The Director of Arrhythmia Services with ProMedica Heart Institute comments on how “new technology is impacting outcomes and mortality in patients on a regular basis” in the field of clinical cardiac electrophysiology. He acknowledges critics concerns, but pointedly adds, “it should be duly noted that practicing physicians like myself do not take the decision to offer a patient a surgical procedure lightly.”

A cardiologist in Maine also appreciates the need for caution with new devices, but “trust[s] the FDA to be the gold standard for assessing safety,” and adds, “the decision to prescribe a breakthrough product rests with me as the primary provider of services.”

Considerable Nationwide Coverage Benefits

The four years of national reimbursement coverage MCIT offers cuts considerable red tape and, as trade group AdvaMed’s comments stress, can “improve [a] long-standing issue of regional coverage inconsistencies” and “help address the impact of health inequities and social disparities in health.” The aforementioned cardiologist from Maine adds some on-the-ground flavor to this point:

“I believe that MCIT has the potential to impact the lives of many patients, particularly those living in rural areas. As a physician practicing in the state of Maine, the most rural state east of the Mississippi, I have a keen appreciation of the needs of patients living in rural areas. These individuals need access to new, life-saving devices, similar to what they would receive at institutions such as Johns Hopkins and the University of Pennsylvania where I trained. Given the lack of trained people to administer legacy services, and the large gap in services available in rural versus urban centers, the promise of MCIT is the promise that emerging technologies built on strong evidence can suture our healthcare fabric together.”

Finally, in its comment supporting MCIT implementation, the American Diabetes Association explained:

“People with diabetes, a disproportionate number of whom are socioeconomically disadvantaged, are faced with barriers that include uneven access to diabetes management devices and other breakthrough technologies like insulin pump therapies and artificial pancreases. These FDA-approved technologies have been demonstrated to improve glucose control, which is known to reduce the long-term complications of diabetes, kidney failure, blindness, and amputations.”

As of 2016 33% of all Medicare beneficiaries had diabetes, more than 40% of which are Black or Hispanic, the group added.

Delays Chill Innovation and Investment

The uncertainty and delay that accompanies CMS’s consideration, post FDA-approval, of Medicare coverage chills device-company risk taking and investors’ financial commitments. A physician who also develops medical technologies commented that “Many innovators refer to this period where safe and effective technologies are not accessible to patients as the ‘valley of death.’” The Minnesota Medical Device Alliance’s comment stressed “These delays can result in investor fatigue which signals to the capital market that investment may be more effectively deployed to making non-medical device ‘widgets.’”


WLF joins join the stakeholders mentioned here—the patients, doctors, clinicians, professional associations, and innovators—in urging CMS to finalize MCIT on May 15. The rule significantly advances the goals set out in the 21st Century Cures Act adopted with widespread bipartisan support. It also will help achieve the type of national health equity the current administration pursues, provide American companies and investors with market-based incentives, and provide doctors and patients with more treatment choices.