Reimbursement Debate Over FDA Breakthrough Device Designation

“Gaining access to innovative, life-saving medical technology” is a phrase that can be heard from the mouths of many politicians when it comes to reforming the U.S. healthcare system. It’s a popular soundbite and it likely charts high with the general population. Sounds like a great idea in a political speech. But apparently, when it comes to real-world practice, it may not be as desirable.

My comments are made with regard to recent news that the proposed CMS rule that would provide a period of coverage to devices designated as “breakthrough” by the FDA is in jeopardy. In fact, as it is written, the proposed rule is likely finished.

The FDA’s Breakthrough Device Designation is granted to technologies that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” Upon such designation, it allows the device “priority access” to the agency in terms of its review (it is not an alternative to a 510k, PMA, or de novo). The designation is a “tag” that allows the device to move to the head of the review line within FDA.

The intended goal was to establish a way for medical devices that are innovative to have a faster route to the public so as to get more innovative products into the marketplace. Whether envisioned in this way or not, it was a reward for companies to produce innovative healthcare technologies.

In furthering this effort, it was proposed any technology designated as a breakthrough device would gain automatic CMS coverage for a period of time. Speeding up the FDA regulatory review process is not beneficial if companies have to ultimately wait around for a CMS decision on reimbursement coverage.

Upon initial glance, this rule sounds like a great idea. And honestly, I think the intent is just that—a great idea—but there are concerns.

A good number of devices have been granted the breakthrough designation since its rollout in 2018. While there is no official list from the agency (so giving an exact number is impossible), many companies are quick to publicize the achievement. From the sound of some of these devices, it is a wonder if they are truly a breakthrough. Was it “easier” to gain the status soon after rollout? Is the agency adjusting to the new rule and will begin to identify the truly breakthrough devices going forward? Perhaps a more clear definition of the term is needed.

Also, another fact that concerns me is a breakthrough device can be submitted for regulatory review using the 510k pathway. The 510(k) pathway requires a predicate device as part of its regulatory review. How can a truly innovative, “breakthrough” device have a predicate? I would be curious to hear the justification of that one. Again, one aspect of the rule that may require revisiting.

As far as the concern on the CMS side, the agency cites the lack of evidence or need for a clinical trial as issues. The requirements needed to qualify a device for entry into the breakthrough device program is less than what’s needed for that device’s approval. CMS also expressed concern that the device may not be deemed necessary or safe for Medicare’s patient population.

In addition, as the rule is currently written, should a device be approved and have been designated breakthrough, but later found to be dangerous or inappropriate for Medicare patient population, there’s no recourse to remove the automatic coverage.

On the other hand, supporters, including Advamed president and CEO Scott Whitaker, have expressed disappointment with the decision to eliminate the rule. Whitaker said in a statement, “It’s unfortunate for patients across the country that the Administration has decided to reject a rule to allow Medicare patients immediate access to breakthrough medical innovations. Any Medicare patient and their doctor who has exhausted all existing medical options should have immediate access to FDA-approved breakthrough medical technologies. That’s what this is all about. Doctors and patients should be trusted to make the right medical decision to treat a life-threatening condition. The federal government should incentivize access to these new breakthrough technologies. Repealing MCIT is the wrong decision for countless Medicare patients, and it’s the wrong decision for American medical innovation. Our goal in this country should be to spur and not inhibit innovation that will change patients’ lives. We will continue to make this important case with the Administration and Congress, and we are hopeful they will make the right decision.”

Hopefully, this rule isn’t completely eliminated and rather, the concerns are addressed and a rule that satisfies all parties is developed. Because ultimately, the U.S. healthcare system should have access to innovative medical devices for patients, and not just soundbites about it.  

Sean Fenske, Editor-in-Chief
[email protected]