Innovation is a popular buzzword in the digital health space. Before the latest gizmo is rushed to market, work is done to make sure it is safe and effective and that its use will not add to burdens being added to physician practices.
“The AMA is working to ensure that new technologies become assets to physicians and solutions that improve patient care,” said Susan Wilson, vice president of health solutions sales and marketing at the AMA.
“We believe that the physician's perspective is a key ingredient to realizing the potential of health care innovation,” she added. “We facilitate collaborations across the health-care ecosystem to ensure that the physician perspective is represented in the design, implementation and evaluation of new health care technologies and digitally enabled care.”
Wilson spoke during an AMA webinar examining the key role the Food and Drug Administration (FDA) plays in medical device regulation, and how the FDA’s work precedes and intersects with the Current Procedural Terminology (CPT®) code set. (The webinar is available on demand. Registration is required.)
The code set plays an important role in fostering innovation, Wilson explained.
“We curate, maintain and distribute the Current Procedural Terminology code set—or the language of medicine—that provides the foundation for communication in many critical areas of care, including innovation, research, interoperability and health equity,” she said.
FDA seeks early input on devices
For its part, the FDA also is encouraging earlier input on medical technology, according to Douglas E. Kelly, MD, chief scientist and deputy director of the FDA Center for Devices and Radiological Health. He outlined the FDA’s device-approval process and highlighted the importance of physician input.
“The Food and Drug Administration does not tell physicians how to practice medicine—we listen to physicians when we determine whether or not a device is safe or effective for a given indication,” Dr. Kelly said. “We also use advisory committees when technologies are new, and we're trying to understand what the larger community thinks about it—especially the medical community.”
The FDA relies on input from 50 committees and panels to obtain expert advice on scientific, technical and policy matters.
Among those cited by Dr. Kelly were the FDA’s Payer Communication Task Force, Medical Device Innovation Consortium and the Total Product Lifecycle Advisory Program, which he helped start with the aim of helping innovators avoid “late-stage failures” after receiving FDA approval.
These failures could happen because patient-advocacy groups didn’t like “the endpoints that the company chose” or had a different risk-benefit analysis, or physician professional societies were looking for different evidence to assess a device’s usefulness or needed guidance on what coding was needed.
“It's much better to know what these issues are in the beginning of medical device development, then later on,” Dr. Kelly said. “The hope is that, by incorporating stakeholder input at the beginning of the process, you can come up with a much more holistic evidence-generation strategy.
“Ultimately, we feel like you may end up with a larger study, but much less risk and a much more transparent and faster time to commercialization and profitability—all to the service of patients,” he added.
In addition to the FDA’s historical role of protecting consumers from unsafe products, the agency is also looking to “catalyze innovation” and facilitate “timely patient access to safe and effective medical devices,” Dr. Kelly said.
Developers of digital health tools can now use the CPT Smart App to submit applications for new codes or revisions. The app also has online training materials that give instructions and insights into the CPT Editorial Panel process.
The CPT® 2024 Professional Edition and CPT® Changes 2024: An Insider’s View are available from the AMA Storefront on Amazon.
