LS&HC Horizons 2022 - Flipbook - Page 19
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
19
Digital Health and AI
Coverage and reimbursement challenges for digital health services
The development and use of digital therapeutics (DTx) has grown
exponentially in recent years, and the Covid-19 pandemic has accelerated
both interest in, and adoption of, these technologies by providers and
patients alike. DTx are used to treat a wide range of conditions, including
substance use disorders, pain, chronic conditions like diabetes, and mental
health diagnoses. However, regulatory agencies and payers continue to
struggle with how to regulate DTx, and whether and when to cover and
reimburse them.
DTx typically fall under FDA’s software-as-a-service medical device category,
but FDA’s approach continues to evolve. They also don’t neatly fall under any
Medicare or other payer benefit category, with some DTx companies seeking
to fit them into existing drug or device paradigms, and others likening them
more to durable medical equipment (DME). At the moment, most DTx
companies are negotiating with payers and pharmacy benefit managers
one at a time, and making the case that DTx can bridge gaps in access to
clinicians, and provide care that is both better and more convenient, or more
cost effective.
Legislation has been introduced in Congress that would expand Medicare
and Medicaid coverage to include prescription DTx meeting certain criteria.
In the meantime, new DTx services continue to be approved by FDA and
come to market, and DTx companies are collecting real-world data to
demonstrate their value to patients, clinicians and payers.
Brooke Bumpers
Counsel, Washington, D.C.
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