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The Trump Administration is an Ally in Digital Health Progress

Rene Quashie, VP, Policy and Regulatory Affairs, Digital Health, Consumer Technology Association

The Trump Administration’s approach to digital health regulation has successfully balanced patient protection and healthcare innovation. The administration has  made good on its promises to strip away anachronistic regulations holding back innovation and investment, and digital health is no exception. Indeed, that regulatory approach is helping promising innovations in health care technology better address critical issues such as clinician shortages, patient access and increasing health care costs.

Here are a few examples: 

Medicare Coverage for Remote Patient Monitoring

Effective this year, the Centers for Medicare and Medicaid Services (CMS) provide a separate unbundled payment for remote patient monitoring (RPM)—allowing physicians and other qualified health professional to be reimbursed for time spent collecting and interpreting health data generated by a patient remotely.

Starting in 2019, Medicare will expand its RPM coverage to provide separate payment for three more remote monitoring codes, including payment for set-up of the equipment, and training of patients. In the home health context, the cost of remote patient monitoring will be included as an allowable administrative cost starting next year.

Other Medicare Virtual Care Coverage

Starting in 2019, Medicare will provide a separate payment to practitioners for brief check-ins with patients via telephone or other telecommunications device to decide whether an office visit or other service is needed. Medicare will also provide payment to Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) for communication technology-based and remote evaluation services that are furnished by an RHC or FQHC practitioner when there is no associated billable visit.  

HHS Patient-Centered Initiatives

The Department of Health and Human Services has implemented initiatives including  MyHealthEData and Blue Button 2.0 to promote greater interoperability and a patient-centered approach empowering beneficiaries to make more informed decisions about their health.

FCC Broadband-Enabled Healthcare Program

The Federal Communications Commission (FCC) has several initiatives underway to better promote use of broadband-enabled healthcare. Among them, the FCC has boosted funding for its Rural Health Care Program, and sought public comment on its proposed Connected Care Pilot Program which promotes virtual care to low-income rural Americans.

In recent public comments, FCC Chairman Ajit Pai discussed the agency’s work regarding telehealth and highlighted programs such as the Connect America Fund, which has awarded $1.5 billion to help bring fixed broadband to 700,000 unserved homes and businesses; and the agency’s plan to invest up to $4.5 billion over the next decade through its Mobility Fund to deploy 4G LTE service to rural Americans who do not have it today.

FDA Precertification Pilot

The Food and Drug Administration (FDA) is in the process of initiating a first-in-kind digital health software precertification pilot program emphasizing firm/organization review rather than product review. Because the FDA views software as different from conventional medical devices given that software is updated frequently, it has concluded that “[a]n agile regulatory paradigm is necessary to accommodate the faster rate of development and potential for innovation in software-based products."
The precertification model is part of a broader Digital Health Innovation Action Plan that lays out FDA’s vision for facilitating digital health innovation while protecting the public health. 

These are just a few examples. All in all, this has a been a banner year for digital health and medicine. To be sure, there is much work to be done, even with some of the programs referenced above. But 2018 has seen greater acceptance and coverage of digital health solutions, and the federal agencies have played a key role.