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Dash to Digital Health? How the Regulatory Sprint to Coordinated Care Could Expand Access to Care

Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers’ ability to fully leverage remote patient monitoring and other telehealth tools. Many stakeholders are hoping that developments in the Regulatory Sprint to Coordinated Care will begin the rulemaking process to enable greater access to digital health and virtual care products.

The US Department of Health and Human Services (HHS) launched the Regulatory Sprint to Coordinated Care in 2018 with the goal of reducing regulatory burden and incentivizing coordinated care. As part of this initiative, the Centers for Medicare and Medicaid Services and other agencies are scrutinizing a variety of long-standing regulatory requirements and prohibitions to determine whether they unnecessarily hinder the innovative arrangements policy-makers are otherwise hoping to see develop. While regulations such as the civil monetary penalty prohibition on patient inducements have significant benefits for reducing fraud and abuse, they can also make it difficult for health systems to deploy digital tools that help patients track, monitor and share health data with their providers.

For example, Medicare reimbursement of digital health and virtual care products, while expanded in 2018, is still limited. This means that if a provider wants to use un-reimbursed technology, the provider must either charge the patient separately for the non-reimbursable service or provide the service to the patient for free. The former option is tricky—it can result in surprise charges for patients, and digital health services can be part of a care service plan and difficult to break out separately as a standalone billable service. As a result, many providers would prefer to offer virtual care services to the patient for free, but doing so immediately implicates the civil monetary penalties prohibition. Substantial time, effort and cost is required to evaluate the facts and circumstances, understand the available regulatory guidance and case law, and determine whether the provision of the service—which results in no increase in revenue—could result in governmental scrutiny

This is just one example of how certain long-standing regulations have become a barrier to broad adoption of digital health. If HHS chooses to update these regulations or issue additional guidance, the Regulatory Sprint to Coordinated Care could bring digital health technologies such as telehealth and virtual care products off the sidelines and into the race.

© 2019 McDermott Will & Emery

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About this Author

 Dale C. Van Denmark MWE Partner DC, Regulatory, Government & Lobbying Strategies  Health Care  Life Sciences
Partner

Dale C. Van Demark advises clients in the health industry on strategic transactions and the evolution of health care delivery models. He has extensive experience in health system affiliations and joint venture transactions. Dale also provides counseling on the development of technology in health care delivery, with a particular emphasis on telemedicine. Dale has been at the forefront of advising clients with respect to the globalization of the US health care industry. He advises US and non-US enterprises with respect to the formation of cross-border affiliations and international patient...

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Lisa Schmitz Mazur, Health Law Attorney, McDermott Will Law Firm
Partner

Lisa Schmitz Mazur is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  Lisa maintains a general health industry practice, focusing on the representation of hospitals and health systems and other health industry providers.

Lisa’s representation of hospitals and health systems includes providing guidance on not-for-profit corporate governance matters, tax-exemption issues, conflict of interest compliance and overall corporate compliance effectiveness.  In addition, Lisa regularly assists hospital and health system clients to develop and negotiate physician compensation programs, and prepare agreements with physicians and helps to guide governing boards and committees in the review and approval of such arrangements. 

Digital Health

Lisa advises a variety of healthcare providers and technology companies involved in “digital health” – the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the Internet and mobile devices – on the applicable legal and regulatory infrastructure, with a particular focus on telehealth, telemedicine, mobile health and consumer wellness programs. For example, Lisa has assisted numerous clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa assists her clients to identify and understand the relevant legal issues and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape.

In addition to writing extensively on matters related to her digital health practice, Lisa has spoken at numerous conferences on a variety of digital health topics. She is the co-editor of McDermott’s Of Digital Interest  blog, co-chairs the Interstate Collaboration in Healthcare Stakeholder Group and chairs the Illinois Telehealth Law Forum Program Planning Committee

Lisa also co-leads the Firm’s Digital Health affinity group, which brings together McDermott lawyers from within and outside the Health Industry Advisory Practice Group to develop thought leadership, share information and collaborate on best practices.

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