Dr. Anand Shah is an oncologist and the former deputy commissioner at the FDA and the former chief medical officer at the Center for Medicare & Medicaid Innovation. He's also an advisor to Morgan Stanley.
Navigating public and commercial health insurance to get innovative medical products covered can be a never-ending cycle of bureaucracy.
Medical technologies deemed "safe and effective" by the Food and Drug Administration – the global gold standard for drug and device regulation – aren't always covered by the Centers for Medicare & Medicaid Services, which requires companies to meet the additional hurdle of proving their product is "reasonable and necessary."
Unlike drugs, which are typically covered by CMS immediately upon FDA approval, seniors can't access many FDA approved or cleared medical diagnostics and devices unless they can participate in a clinical study sanctioned by CMS. Those studies can take years — requiring additional data and a lengthy regulatory process to determine coverage criteria — and keep potentially lifesaving medical interventions from Medicare beneficiaries in the meantime.
A new policy that was set to take effect in mid-March would have allowed seniors and their doctors decide whether or not they need those devices, but it was put on hold along with other pending regulations when the Biden administration took office. The proposed Medicare Coverage of Innovative Technology policy, which was delayed until May 15 pending regulatory review, leverages existing FDA legal authority through the Breakthrough Devices Program to identify a limited number of promising medical technologies and offers those products a short period of guaranteed Medicare coverage — granted as early as the day of FDA authorization.
The proposed policy would be a crucial step forward for Medicare beneficiaries to make informed choices about their care.
As it stands, the FDA has approved, authorized or cleared at least 26 breakthrough diagnostics and devices. These medical products include in vitro diagnostics and imaging platforms to implants and portable devices, covering a range of ailments, including Ebola, traumatic brain injury, severe emphysema, and heart disease.
As an oncologist who helped develop this medical device policy while at CMS, I have cared for many patients who have been unable to access cutting-edge testing, such as next-generation DNA sequencing as part of a cancer workup because Medicare does not allow it. The same product can often be obtained by the patient through commercial insurance, which many forgo after aging into the Medicare program. As a last resort, the patient has no choice but to pay out of pocket.
Seniors deserve access to FDA-designated breakthrough medical devices – narrowly defined by Congress to include the most promising new technologies, like those that can treat life-threatening or irreversibly debilitating conditions – as soon as the FDA deems them safe and effective.
Importantly, the proposed rule maintains the same high standards required by both the FDA and CMS. It also maintains existing FDA post-market surveillance requirements. This policy closes the gap for patients who otherwise can't get access the latest FDA-authorized technologies while waiting for CMS coverage. Yet it still encourages researchers to continue to collect real-world evidence on health outcomes specific to Medicare beneficiaries.
Protections for patients are maintained as MCIT uses existing procedures to restrict access to new technologies if safety or efficacy concerns arise.
There is no downside to approving this policy change. Seniors will have more treatment options available to them, and medical technology innovators can work with CMS to carefully study these patients over four years, generate meaningful real-world evidence to prove a new device is "reasonable and necessary" and potentially secure a more permanent Medicare coverage decision.
This policy also encourages early investors to support innovation for the most pressing medical conditions as it creates a clear and predictable path — from investment to medical product development to regulatory review and then patient access.
If the federal government wants to incentivize investment for the development of transformative medical innovations, and expand choices for our seniors while encouraging rigorous evidence generation, MCIT provides a clear path forward. Too many lives depend on it.
Correction: This editorial was updated to correct the name of the agency that needs to approve the rule in the headline. It's CMS.