Prescription digital therapeutics may finally become available to more patients – if Congress passes legislation to allow for Medicare coverage of the treatment tool.
The Access to Prescription Digital Therapeutics Act was re-introduced in March, sponsored by Senators Jeanne Shaheen (D-NH) and Shelley Moore Capito (R-WV) along with Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA). Patient advocates are hopeful this will be the year it passes as gaining Medicare coverage is often a first step toward broader access, including via private payers.
Clinicians can prescribe the software-based applications to help patients prevent or manage specific conditions ranging from mental health conditions and substance use disorder to diabetes and asthma. While prescription digital therapeutics are still relatively new, awareness and acceptance of them is expanding. Now, it’s time for coverage to do the same.
Not the Average Wellness App
The applications remotely capture and transmit data for clinician assessment in real-time. PDTs shouldn’t be confused with run-of-the-mill wellness applications that anyone can download at will. In contrast, prescription digital therapeutics are considered medical devices. They must be reviewed and approved by the Food and Drug Administration for use as part of a prescribed course of treatment.
The rigorous approval process involves clinical trials to prove safety and efficacy, similar to the process for prescription drugs. A growing number of prescription digital therapeutics have earned FDA approval and more are in the pipeline, despite the current lack of insurance coverage.
Battling the Mental Health Epidemic
Prescription digital therapeutics aren’t a replacement for in-person care or traditional medications, but they are a helpful patient-centered tool. Their use has already shown measurable success for a wide range of conditions, but their use in combatting the nation’s mental health epidemic might be the best example to date.
The mental health crisis peaked during the pandemic and hasn’t declined much since. The surge of patients continues to grow amidst a national shortage of qualified health care providers and a modest number of tolerable medications. The situation is dire, yet a handful of approved prescription digital therapeutics are helping clinicians provide timely, patient-centered care. Patients with chronic mental, behavioral and cognitive disorders including depression, chronic insomnia and attention deficit hyperactivity disorder can benefit from these devices as part of their treatment plan.
Like other innovations, prescription digital therapeutics have the potential to provide value to patients, providers and the health care system. But first, Medicare and other payers must allow for a path to clear, affordable access.