How UDI supports innovation and safety

When the Patient Protection and Affordable Care Act (ACA) was passed in 2010, many healthcare experts cautioned that access to coverage did not necessarily translate to access to care, due to a variety of factors, ranging from limited physician willingness to accept more Medicaid patients to individuals without transportation to go to the doctor or the ability to cover co-pays or high deductibles.

There is an analogous scenario in the world of medical devices. Just because the Food and Drug Administration (FDA) has approved a new device for sale does not necessarily mean insurers — public or private — have agreed to cover the costs (or even a portion) for its use. Lack of coverage can be a critical limiting factor that FDA Commissioner Scott Gottlieb says can have a detrimental impact on patients suffering from serious conditions that newly approved technologies are designed to treat. He adds that the delay between when the FDA approves a device and when payors cover it can take years, which could be just long enough to force smaller medical device companies out of business.

Last month, at the Medical Device Innovation Consortium (MDIC) annual public meeting, Commissioner Gottlieb announced expansion of a program to shorten the time from approval to coverage. In 2011, the FDA and the Centers for Medicare and Medicaid Services (CMS) first piloted the Parallel Review program, during which the two agencies are simultaneously considering clinical evidence for both approval and coverage decisions. Previously those steps were sequential, not concurrent. The program was expanded in 2016 to include both government and private payors, and last month, two new private insurers, CareFirst BlueCross BlueShield and United Health Group, were added to the list of participants.

Just because FDA and insurers have approved and agreed to cover a device does not always mean it is fully safe and effective. Commissioner Gottlieb noted at the meeting that you can never have absolute uncertainty as to a device’s safety and effectiveness, nor that you can know everything about a product’s performance as a result of pre-market trials. To help address this uncertainty, the Commissioner announced new draft guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” (Available at https://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM619220.pdf.)

Uncertain matters

Uncertainty is due to a variety of factors. One is that different patients can have different experiences with medical devices as a result of their own unique anatomy, genetics, lifestyles and co-morbidities. Further, unlike medication administration, many medical devices require significant training and expertise by surgeons and other clinicians.

Another driver of uncertainty is that clinical trials for medical devices often involve far fewer patients than for pharmaceuticals. In the case of implantable devices, it is not possible, practical nor ethical to conduct surgery on large numbers of patients. Between 100 and 200 patients are often considered adequate for many of the products that have undergone the FDA’s most stringent pathway, the Pre-Market Approval (PMA). That’s compared to thousands of patients who participate in the multiple stages of clinical trials for pharmaceuticals.

The regulatory pathway for medical devices is also far more flexible compared to drugs. Many medical devices on the market today are iterations of older devices. The original devices were approved using the PMA, but the iterations often go through a much less rigorous process known as supplement pathways, most of which do not require clinical data based on human testing. That’s not likely to change given that the U.S. FDA Modernization Act of 1997 requires the FDA to use the least burdensome approval pathway.

A UDI solution

Ultimately, one of the best ways to reduce uncertainty comes after a product has come to market, when its performance in routine clinical practice can be evaluated. This is why capturing unique device identifiers (UDIs) for medical products in electronic health records is so important. As Jeff Shuren, MD, JD, the FDA’s director of the Center for Devices and Radiological Health, told the attendees at the MDIC meeting, you have to know which technology was used when studying the associated outcomes. And it’s not just knowing which device was used but also the attributes of those devices, because a safety signal related to one device, e.g., one possibly related to a particular component or materials used, could indicate issues with other devices that use similar components or materials. The generation of real world evidence on device performance is a major focus of the FDA and MDIC, which is a public-private partnership spawned by FDA five years ago. Dr. Shuren also referenced the need for collaborative communities, specifically calling out the AHRMM Learning UDI Community as an example and adding that the FDA is currently recruiting for someone to work externally, with payors, providers, manufacturers and others (including patients) to promote science-based innovation and regulatory standards. As Commission Gottlieb added, innovation and safety must go hand in hand. And as far as I am concerned, so does UDI.