Regulating medical devices can often be a delicate balancing act. On the one hand, you have to be absolutely scrupulous if you want to make sure that the devices are safe for patients to use. If the approval process is rushed, you can endanger the very people the devices are designed to help.
On the other hand, unnecessarily strict controls or lengthy approval times can be inherently dangerous. By delaying approval, you may be depriving patients of a life-changing or life-saving innovation.
It’s a common story and one that has come back to the fore with the decision to delay Medicare’s new Innovative Technologies (MCIT) coverage rule. The rule, which was originally scheduled to come into effect in March 2021, was later postponed to May and again to December – a move some have likened to “kicking the box in the road”.
The rule would have allowed Medicare beneficiaries to use “breakthrough” medical devices – innovative new technologies that have been cleared under the FDA’s Breakthrough Devices program. Critics have expressed concerns about the suitability of these devices for Medicare patients, who are often over 65 and living with disabilities.
“Ensure coverage for all breakthrough, market-cleared devices for any Medicare patient – with perhaps minimal or no evidence on the Medicare population and no requirement to develop evidence on the Medicare population. Medicare – could be problematic to ensure that these devices demonstrate value and don’t pose additional risks to Medicare beneficiaries, ”Health and Human Services (HHS) officials said.
Others, however, expressed deep frustration at the delay and argued that the MCIT could help alleviate health inequalities.
“I believe that MCIT has the potential to impact the lives of many patients, especially those living in rural areas,” said an cardiologist in the public comments. “The promise of MCIT is the promise that emerging technologies based on strong evidence can weld our healthcare fabric together. ”
What the rule is supposed to achieve
To put the debate in context: when bringing a new medical device to market, manufacturers must overcome a number of regulatory hurdles. For those who wish to market their devices in the United States, the first and most important is FDA approval.
While this is generally a fairly Byzantine process, the FDA launched its Breakthrough Devices program in 2016, with the goal of speeding up approvals in some cases. It can be used when the device meets an urgent need and patients do not have an equally good alternative.
As of March of this year, manufacturers can also apply for the FDA Safer Technology (STeP) program. This speeds up patient access to devices targeting less serious conditions.
While US manufacturers have welcomed these initiatives, they remain keenly aware that FDA approval is only one piece of the regulatory puzzle. Bringing their device to market is all well and good, but if manufacturers want the entire patient population to benefit, they must also get reimbursement approval from the Centers for Medicare & Medicaid Services (CMS). This will ensure access to 44 million Medicare beneficiaries (15% of the US population).
The new MCIT rule, which was proposed by CMS last year and finalized in January, would mean makers of breakthrough devices could receive a CMS refund on the same day they received marketing authorization for the FDA.
Medicare would cover its use nationwide for four years. If, at this point, device manufacturers had generated enough clinical data, they could apply for permanent coverage.
The ECRI Patient Safety Group has warned that the MCIT will remove the incentive for manufacturers to perform further safety testing. However, the four-year timeframe is supposed to provide exactly such an incentive.
“Typically, the MCIT path is intended to provide national rather than local Medicare coverage for qualifying medical devices,” says Thomas Miller, head of life sciences at Nixon Gwilt Law. “The path is primarily intended to smooth the existing New Technology Complementary Payment (NTAP) program, which is lengthy and can lead to long delays in coverage and adoption of innovative technologies. ”
Innovation versus regulation
The problem, Miller explains, is that authorization through the FDA’s breakthrough device process does not specifically mean that the device is safe or effective for Medicare patients. While the existing NTAP rule gives CMS its own opportunity to analyze the evidence, the MCIT rule does not provide this level of flexibility.
“This is a problem that could harm patients and cost the Medicare program untold amounts of money for potentially ineffective – albeit innovative – products,” he says.
On the other hand, the FDA review process is undoubtedly rigorous. Plus, doctors don’t have to use a revolutionary device, even if Medicare reimburses it – it just gives them additional options.
Writing in the public comment solicited by CMS, dozens of patients and physicians supported the rule, saying physicians should be empowered to analyze the evidence and make use decisions based on patients’ needs.
“It’s disheartening that I have to temper my expectations of any new, life-changing technology because it usually takes a decade for Medicare to pay for these products if I ever manage to cover them. ” wrote a 68 year old man living with multiple health problems.
Miller believes the current administration was right to delay the rule, giving it time to work on some of the potential impacts. That said, he thinks we’ll see him relaunched with a bit more clarity and a few more guarantees.
“I don’t think delaying the rule serves the public, and possibly innovators, more than advancing the current agenda,” he says.
In the meantime, he notices that the number of impacted technologies is actually quite low. To date, fewer than 400 devices have achieved breakthrough status from the FDA, and fewer receive the designation each year. The device in question must also fall under an existing Medicare coverage category, which many of these technologies do not.
“While the opportunities created by this rebate program are exciting for manufacturers looking to achieve strong market share at launch, the program is uniquely designed to provide access to products at the forefront of innovation,” says Miller. .
It remains to be seen whether the rule will actually go into effect in December, or whether there will be further delays. With strong opinions on both sides, the MCIT deadline is a classic example of the age-old struggle between innovation and regulation.