Op-Ed: Medicare must adhere to the OK rule to give seniors access to FDA-approved medical devices
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Dr. Anand Shah is an oncologist and former FDA Deputy Commissioner and former Chief Medical Officer of the Center for Medicare & Medicaid Innovation. He is also an advisor to Morgan Stanley.
Navigating public and commercial health insurance to cover innovative medical products can be an endless cycle of bureaucracy.
Medical technologies classified as “Safe and Effective” by the Food and Drug Administration – the global gold standard for regulating drugs and devices – are not always covered by the Centers for Medicare & Medicaid Services. Product is “Sensible and Necessary”.
Unlike drugs, which are typically covered by CMS immediately after FDA approval, seniors can only access many FDA cleared or approved medical diagnoses and devices if they can participate in a CMS approved clinical trial . These studies can take years – additional data and a lengthy regulatory process to determine coverage criteria – and in the meantime sustain potentially life-saving medical interventions from Medicare beneficiaries.
A new policy, due to go into effect in mid-March, would have allowed seniors and their doctors to decide whether or not they needed these devices. However, it was put on hold, along with other pending regulations, when the Biden Administration took office. The proposed Medicare Innovative Technologies Coverage Policy, postponed until May 15 for regulatory review, leverages existing FDA legal expertise under the Breakthrough Devices program to identify a limited number of promising medical technologies, and offers these products a short Medicare warranty. granted on the day of FDA approval.
The proposed policy would be a critical step forward for Medicare beneficiaries to make informed decisions about their care.
Currently, the FDA has approved, authorized, or cleared at least 26 breakthrough diagnoses and devices. These medical products include in vitro diagnostic and imaging platforms for implants and wearable devices that cover a range of diseases, including Ebola, traumatic brain injury, severe emphysema, and heart disease.
As an oncologist who helped develop this medical device policy at CMS, I have looked after many patients who have not had access to state-of-the-art tests such as next-generation DNA sequencing as part of a cancer screening because Medicare does not allow them. The same product can often be obtained by the patient through a commercial insurance policy, which many do not get under the Medicare program after aging. As a last resort, the patient has no choice but to pay out of pocket.
Seniors deserve access to FDA-named breakthrough medical devices – narrowly defined by Congress to include the most promising new technologies, such as those that can treat life-threatening or irreversibly debilitating conditions – once the FDA deems them safe and effective.
It is important that the proposed rule maintain the same high standards required by both the FDA and the CMS. In addition, the existing FDA requirements for post-market surveillance will be maintained. This policy bridges the void for patients who would otherwise not have access to the latest FDA authorized technology while waiting for CMS coverage. Still, it encourages researchers to continue collecting real-world evidence of health outcomes that are specific to Medicare beneficiaries.
Patient protection is maintained as MCIT uses existing procedures to limit access to new technology when safety or efficacy concerns arise.
There is no disadvantage in approving this policy change. Seniors will have more treatment options, and medical technology innovators can work with CMS to carefully examine these patients over a four-year period, generating meaningful real-world evidence to prove that a new device is “sensible and necessary.” “Is Medicare Coverage Decision, and potentially offers more permanent security.
This policy also encourages early investors to support innovation for the most pressing medical conditions, as it creates a clear and predictable path – from investing to developing medical products, to regulatory review and subsequent patient access.
If the federal government wants to incentivize investment in developing transformative medical innovations and expand choices for our seniors while promoting rigorous evidence generation, MCIT offers a clear way forward. Too many lives depend on it.
Correction: This editorial has been updated to correct the name of the agency that needs to approve the rule in the headline. It’s CMS.