APA’s Government, Policy, and Advocacy Update (October 2023)

As part of the Biden administration’s attempts to advance health equity, the U.S. Department of Health and Human Services (HHS) has drafted a framework to support and accelerate smoking cessation efforts. APA applauded the administration’s focus on smoking cessation but suggested that the framework’s broad scope may limit its overall impact. APA’s letter was addressed to Adm. Rachel Levine, M.D., HHS’s assistant secretary for health, and signed by APA CEO and Medical Director Saul Levin, M.D., M.P.A.

In the letter, APA offered additional details that HHS should consider adding to the framework, including the following:

APA urged the Centers for Medicare and Medicaid Services (CMS) to be cautious as it considers introducing a new Medicare coverage pathway to expedite access to medical technologies that the U.S. Food and Drug Administration (FDA) has designated as Breakthrough Devices. CMS’s proposed Transitional Coverage for Emerging Technologies pathway is voluntary, is meant to facilitate early access to new technologies, and allows manufacturers to identify and address evidence gaps in support of full Medicare coverage, according to a CMS fact sheet.

Yet the evidence required to demonstrate clinical benefits and effectiveness of Breakthrough Devices falls short of the clinical trial standards applied to other interventions, APA wrote in its letter to CMS Administrator Chiquita Brooks-LaSure. Several Breakthrough Devices are relevant to psychiatric care. “While we support innovative approaches to recovery and treatment, we urge CMS, in partnership with FDA and the clinical community, to maintain a rigorous standard of evidence to inform Medicare coverage determinations and ensure access to high-quality mental health and substance use disorder care.”

The FDA’s Center for Devices and Radiological Health sought public input in its effort to safely improve access to medical devices that patients can use outside of traditional clinical settings. In a letter, APA expressed its commitment to extending access to high-quality care through technology-enabled psychiatry, but urged the FDA to maintain a high standard of evidence on device safety and effectiveness before approving devices for at-home use. The letter, signed by Levin, was addressed to FDA Commissioner Robert Califf, M.D.

APA encouraged the FDA to consider at-home medical technology as analogous to over-the-counter pharmaceuticals and apply a similar threshold of risk, safety, and effectiveness. Device developers should be required to demonstrate that consumers can understand how to use the device safely without supervision from a health professional.

“When technologies are delivered without adequate scientific approval processes and without expert oversight, ineffective interventions can make it into the hands of patients,” APA’s letter stated. “These technologies are more appropriately considered an adjunctive to care, recommended by a clinician who is … familiar with the technology and can affirm that it does not create unique safety hazards to the patient.” ■