Congress Should Give CMS Authority to Cover Prescription Digital Treatments

Smartphones, social networks and internet applications help us communicate with family, friends and colleagues, but they can do so much more to improve our lives. Advances in technology and connectivity offer new methods for monitoring and accessing information about our health and well-being.  

In a speech at the Medical Device Manufacturers Association annual meeting, Centers for Medicare and Medicaid Services Administrator Seema Verma announced that CMS is working on a strategy to help Medicare beneficiaries benefit from new technologies more quickly. The new “comprehensive strategy” aims to foster innovation and improve patient access to transformative medical technologies.

While the details of this plan are still being articulated, it seems that one of the more obvious new technologies — digital health tools, particularly mobile medical applications — may have been overlooked, despite the Food and Drug Administration’s specific focus in recent years on digital health, including mobile medical apps. These tools could be an even more powerful asset in helping patients if they were included in the CMS strategy.

The FDA has a Digital Health Innovation Action Plan to “reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products” such as mobile health, health information technology, wearable devices, telehealth, telemedicine and personalized medicine. Increasingly, the FDA is clearing mobile medical apps that may only be prescribed by a clinician that stand on their own or as an adjunctive treatment for specific illnesses or injuries, but Medicare has not identified a way to pay for them.

For example, the FDA recently permitted marketing of the first mobile medical application to help increase the amount of time a patient participates in an outpatient treatment program for individuals with opioid use disorder. Yet there is no way to use Medicare funds to cover this prescription digital treatment.

Many of the mobile medical applications that have been cleared by the FDA are coupled with another device for which Medicare has already established coverage, coding and payment policies — such as glucose testing systems for people with diabetes or dialysis machines for people with kidney failure.

For other devices classified in the same category as mobile medical applications (Class II), Medicare pays for them either as durable medical equipment (like a power wheelchair or continuous glucose meter), under their own payment system (like the ESRD prospective payment system for dialysis treatments), or as part of the clinician’s associated service (use of an electrosurgical cutting and coagulation device is included in the payment for the associated surgery).

It is great news that the FDA is clearing medical mobile apps that treat illnesses and injuries, but because Medicare does not have a way to pay for them, they remain out of reach for many people. Broadening Medicare’s emphasis on new technology to include coverage, coding and payment for mobile medical applications that have been cleared by the FDA, and using its Innovation Center and other programs to promote them, can make new technology more accessible to people with Medicare and ultimately deliver better health outcomes for patients. 

CMS and the administration should also call on Congress to legislate the authority for CMS to cover FDA-cleared mobile medical apps used to diagnose or treat illnesses or injuries under the Medicare program, unless CMS can find a way within its own authority to add them as a benefit under the Medicare program. 


Jim Scott served as a senior legislative adviser at the Centers for Medicare and Medicaid Services during the George W. Bush administration and is the president and CEO of Applied Policy, a health policy and reimbursement consultancy in Alexandria, Virginia.

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