Breakthrough Medical Devices & MCIT: The Impact of Inaction

Jun 1, 2021

At PRIA Healthcare, our mission is to fight to get patients and providers access to the most innovative and effective medical treatments. The lag time between the development of a safe, effective new medical treatment, procedure, or device and the point when those new technologies are made available to the public at large is one of the most serious issues facing the healthcare industry today. Closing that gap would help untold numbers of people get much-needed care that will improve, or even save, their lives.

Understanding the Medicare Coverage of Innovative Technology (MCIT) Rule

One of the best ways to give patients access to new medtech devices and innovative treatment methods is with the passage of the Medicare Coverage of Innovative Technology (MCIT) rule, which would provide national Medicare coverage of breakthrough medical devices as early as the same day the devices receive Food and Drug Administration (FDA) market authorization, and lasting for four years.

As a new Medicare coverage pathway, MCIT would offer beneficiaries easy access to new, breakthrough medtech devices to help improve their health outcomes. MCIT would be beneficial for patients and medical device manufacturers alike:

  • Medicare patients with serious medical conditions would no longer have to fight to obtain access to proven innovative treatments.
  • Manufacturers would gain immediate market access to Medicare-covered patients, and would have four years to collect evidence to demonstrate that the breakthrough device is effective in improving the health of Medicare patients in preparation for wider market penetration.

Medical device manufacturers will be able to opt-in to MCIT and choose a start date for coverage any time from the date of FDA market authorization to two years from that date. Breakthrough medical devices authorized up to two years before MCIT goes into effect will also qualify for coverage, but coverage will extend for four years from the date of market authorization, not the date MCIT goes into effect, and claims will not be retroactively payable prior to the effective date of the rule.

To qualify as a “breakthrough device” under MCIT, the medical device must:

  1. Enable more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition
  2. Either use a “breakthrough technology” or offer a treatment option when no other cleared or approved alternatives exist

Medtech Devices Under the MCIT Rule

Currently, PRIA Healthcare is working with two such devices—the Optimizer from Impulse Dynamics and the BAROSTIM NEO from CVRx—both used to treat heart failure, a chronic condition that progresses quickly and requires intensive management to maintain quality of life and prevent death. According to the CDC, the mortality rate following hospitalization for patients with heart failure is 10.4% at 30 days, 22% at 1 year, and 42.3% at 5 years.

The Optimizer is an implantable device that senses the heart’s electrical activity and delivers therapy throughout the day to alleviate symptoms of heart failure such as fatigue, weakness, and shortness of breath. It is currently used in more than 5,000 patients with moderate to severe heart failure, however, only a small fraction of eligible patients receives the device because of coverage challenges.

The BAROSTIM NEO is a subcutaneous device designed to electrically activate the baroreflex, the body’s main cardiovascular reflex, signaling the brain to regulate cardiovascular function. The brain responds to BAROSTIM therapy by modulating efferent pathways to relax blood vessels, slow the heart rate, and reduce fluid in the body to help relieve congestion and swelling.

Under the MCIT rule, both these devices—and many more—could serve a large unmet need in the market and improve and prolong the lives of thousands more patients. Unfortunately, rather than moving quickly to finalize the rule, the administration has delayed approval of the rule to allow interested parties to provide comments. Based on those comments, the administration could decide to revise the rule or rescind it altogether.

This delay puts life-saving breakthrough medical devices out of the reach of Medicare patients who don’t have the time to wait for red tape to be untangled in order to get the care they need. Medicare patients deserve access to innovative treatments like these via a predictable and defined pathway. Providing access to the best technology available is a standard of care that everyone in the healthcare system should support.

To that end, PRIA Healthcare urges the current administration to expeditiously implement the MCIT final rule. Its implementation supports patients’ access to appropriate care, physicians’ decision-making, and the overall health of our healthcare system.


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