Breakthrough Device Designation Reimbursement, Round 2

If we expect healthcare to improve, new technologies need to be developed and brought to market. The age of 510(k) “me too” products must be curbed in favor of dynamic products that speed diagnosis and/or treatment with less invasive solutions. (Sure, that’s an oversimplification but I think you get the idea.) In order for that to happen, however, companies must have a reason to do so. And let’s be real; that reason needs to be financial.
 
Helping patients and treating disease is a noble effort and one employees of these companies can be proud of. In fact, it’s just that initiative many HR professionals point to as a factor to leverage when seeking talent. The medical device manufacturing industry is putting forth an effort to battle disease, improve care, and enhance procedures.
 
As I mentioned, however, this mission is also a business and companies can’t run on “feel good initiatives.” Absolutely worthwhile and something to be proud of, but simply put: they don’t pay the bills. Therefore, it’s important to ensure devices that exceed the current standard of care are reimbursed for doing so. As many innovative solutions originate at startup companies, getting paid for fresh ideas is critical to a firm’s survival. These organizations likely don’t have the resources to remain viable while waiting on a decision from CMS regarding how much the reimbursement for a device should be.
 
As such, several years after the Breakthrough Device Designation (BDD) initiative was put forth, it was proposed to be coupled with a reimbursement component that granted four years of guaranteed CMS coverage. This new program would provide a financial incentive for firms to “go above and beyond” the current standard of care with a new device. Not only would a BDD indication from the agency propel the company’s product to the front of the line for its review journey, but it would also ensure the device would be paid for once on the market. The company would still need to secure a long-term reimbursement solution from CMS, but this rule would enable the device to be granted a grace period during which this could be resolved.
 
Unfortunately, not everyone was on board with this proposed addendum, of sorts. In late 2021, CMS repealed the “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” final rule. Some of CMS’ reasons for concern were covered in my October 2021 Editor’s Letter “Reimbursement Debate Over FDA Breakthrough Device Designation” but suffice to say, it was not going to go forward with the proposed plan. The organization said it would explore other means to ensure innovative BDD technologies would be reimbursed, but alas, almost a year and a half later and we’ve still gotten nothing.
 
Recognizing this significant need and perhaps frustrated by the delay in any sort of progress at CMS regarding the issue, a bipartisan bill has been proposed to essentially restore the four-year reimbursement period tied to the BDD program. The bill, titled “Ensuring Patient Access to Critical Breakthrough Products Act of 2023,” would force the hand of CMS to pay for BDD devices as the MCIT rule would have done.
 
“Seniors should not be forced to wait years for cutting-edge, safe, and effective treatments that could change or even save their lives,” Suzan DelBene (D-WA) declared in a statement. “Guaranteeing Medicare coverage of breakthrough medical devices would encourage future innovation and investment in next-generation medical technologies while improving the quality of life for millions of seniors. We can’t let the coverage approval process be a barrier to life-saving treatments or care.”
 
“Seniors should be able to access the most innovative care and breakthrough devices as soon as we know these are deemed safe and effective by the FDA. They should not have to wait years for a Medicare coverage decision on life-saving treatments,” added Brad Wenstrup (R-OH). “With this legislation, millions of seniors could live longer, healthier lives, and companies that develop these innovative treatments would be supported in their investment in medical technologies and devices.”
 
Mark Leahey, president and CEO of the Medical Device Manufacturers Association, echoed the representatives’ sentiments in a formal statement: “Medical technology innovation is only beneficial when patients and physicians have access to it, and MDMA thanks this broad, bipartisan coalition of leaders in the House of Representatives for introducing legislation that seeks to speed access to safe and effective cures and therapies for Medicare beneficiaries.”

Now, we can only hope the rest of the federal government agrees and this bill is signed into law to ensure companies not only have a moral reason for developing innovative devices, but a financial one as well.