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Telehealth and the Changing Regulatory Landscape: Opportunities and Challenges in the Digital Health Ecosystem

by Lisa Mazur | Mar 6, 2018 | General Interest, Mobile Apps, Telehealth

What if you didn’t have to take time out of your day to see a physician in person when you needed a prescription? What if a diagnosis could be delivered over video chat? What if your psychiatrist was available at the press of a button or swipe on your screen?

These options are fast becoming a reality, as telehealth (or telemedicine) continues to take hold in a health care system that is desperate for increased efficiency and higher quality outcomes. And while telehealth offers exciting new possibilities in terms of convenience and access for patients, it also poses new regulatory challenges for industry stakeholders still learning the new rules of the game in today’s digital health ecosystem.

The Chronic Care Act

One of the biggest drivers of change in the industry right now is the Chronic Care Act. Last month, as part of the House and Senate budget deal to fund the government through March 23, legislators included the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017, which will increase reimbursement for a lot of different telemedicine programs.

For example, if you went to a rural hospital and they didn’t have a stroke neurologist and you were having a stroke, you would have an ED doctor with no stroke specialty diagnosing you—not an ideal situation. With telemedicine, it’s now possible for rural doctors to consult with specialty doctors at renowned sites, which the government will fund thanks to the Chronic Care Act. (more…)

Walking the Fine Line between the Delivery of Health Care Services and Information/Educational Support

by Lisa Mazur | Feb 27, 2018 | Consumer Protection, General Interest, Mobile Apps, Telehealth

The explosion in digital health solutions that connect consumers with licensed health care providers (e.g., nurses, nutritionists, physicians) and laypersons who have certain informal training (e.g., wellness guide, lifestyle coach, outreach partner) has the potential to blur the lines between what constitutes the practice of a licensed health care profession and what does not (usually because the service is intended to be merely informational or educational). Why does it matter which side of the line a particular service falls on? If a service is one that is delivered by a licensed health care professional, there are various state laws and regulations that may govern the activity, and different potential causes of action that may apply in the event a consumer/patient is injured in the process.

If a digital health solution connects a consumer to an individual who is engaged in an activity that is normally performed by a licensed health care professional, state laws and regulations governing health care professionals likely apply.

As background, state professional boards regulate individuals who deliver health care services to the public (e.g., nursing, psychology, medicine, phlebotomy). What falls within the definition of a specific health care service can be very broad and varies state to state. (more…)

A Declaration without a Response: Senators Urge DEA to Enact Regulations on Opioid-Based Addiction Treatments Using Telemedicine

by McDermott Will & Emery and Lisa Mazur | Feb 16, 2018 | General Interest, Mobile Apps, Telehealth

This past fall, after months of speculation, President Trump declared the opioid crisis sweeping the United States a national public health emergency. Upon the president’s declaration, Acting Health and Human Services Secretary Eric D. Hargan made a formal declaration under Section 319 of the Public Health Service Act, making available an exception to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Haight Act) that would allow providers to prescribe controlled substances using telemedicine without first conducting an in-person visit. Currently, the Haight Act restricts the ability of a provider to prescribe controlled substances using telemedicine without first conducting an in-person examination, unless an exception applies. For a detailed discussion regarding the Haight Act and the restrictions on the use of telemedicine to prescribe controlled substances within the context of the treatment of opioid addiction and mental health generally, our latest article addresses the opioid crisis and access to mental and behavioral health providers.

The declaration of a public health emergency allows the US Drug Enforcement Agency (the DEA) to remove the restriction of prescribing controlled substances using telemedicine for the treatment of opioid addiction, but the DEA has not promulgated any rules or guidance on the subject. The lack of development has drawn the interest of Senators Claire McCaskill, Lisa Murkowski, and Dan Sullivan. The senators, in a January 30, 2018, letter to Robert Patterson, the acting administrator of the DEA, note that the restriction on the use of telemedicine from prescribing addiction treatment medications continues to have a harmful impact on rural Americans, citing specifically to Missouri, where 98 out of its 101 rural counties lack a licensed psychiatrist. In this letter, the senators call on Mr. Patterson to expedite the rulemaking process to create a special registration process to permit the prescription of opioid-based medication-assisted addiction therapies via telemedicine without first performing an in-person visit.

McDermott Will & Emery LLP will continue to monitor whether progress is made to develop this expedited rulemaking process and report updates on this blog.

Understanding the Implications of Federal Remote Prescribing Laws on Telemedicine’s Role in Behavioral Health Treatment

by McDermott Will & Emery and Lisa Mazur | Feb 14, 2018 | General Interest, Mobile Apps, Telehealth

The opioid epidemic is making the United States acutely aware of the horrors of substance abuse disorders and the limited means of treating the individuals suffering from addiction. Rural America is among the places hit hardest by opioid addiction while also having limited access to mental and behavioral health providers.

Telemedicine offers a viable solution to provider shortages, particularly with an eye toward mental health care professionals. Although telemedicine alone will not remedy the shortage of psychiatrists in the United States, the technology does possess the capability of greatly increasing access to them; however, a large driver of psychiatric care is provided through pharmaceutical treatments.

The ability for providers to prescribe pharmaceuticals, particularly controlled substances, to patients the provider has not seen in person is limited by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Haight Act). The relevance of the Haight Act, a law that went into effect almost nine years ago, has been revitalized, but the opioid epidemic and advances in psychiatric treatment are now demonstrating the law requires clarification through amendment to improve access to pharmaceutical treatments and, in turn, increase access to mental health care.

Bipartisan Budget Act of 2018 Includes Significant Changes in Medicare, Other Federal Health Programs

by Karen S. Sealander and Lisa Mazur | Feb 12, 2018 | General Interest, Mobile Apps, Telehealth

On February 9, 2018 after a brief shutdown, Congress passed and President Trump signed the Bipartisan Budget Act of 2018, a two-year budget agreement that includes funding for the operation of the federal government until March 23, 2018. The law includes significant health care policy changes impacting Medicare, Medicaid and other federal health agencies. In addition to raising federal spending caps enacted in the Budget Control Act of 2011, this legislation includes additional spending for health care priorities. Here we break down some of the changes affecting telehealth.

Expanded Access to Telehealth Stroke Services

The new law expands, beginning in 2019, the ability of patients presenting with stroke symptoms at hospitals or mobile stroke units to receive a timely telehealth consultation with a neurologist in order to determine the best course of treatment. The provision eliminates the current geographic restriction that limits originating sites to rural areas, meaning distant site providers delivering telestroke services could receive a professional fee for delivering the consultation to patients located anywhere in the United States, provided that the other Medicare telehealth coverage requirements are satisfied (e.g., type of provider, type of technology). (more…)

On the Digital Health Frontier: Developments Driving Industry Change in 2018

by Jiayan Chen and Lisa Mazur | Jan 25, 2018 | Big Data, Consumer Protection, Cybersecurity, Data breach, Data Privacy, Mobile Apps, Telehealth

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake.

What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018. (more…)

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by Jiayan Chen, Lisa Mazur, Michael W. Ryan, Scott Weinstein, Vernessa T. Pollard, McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark and Jennifer S. Geetter | Jan 12, 2018 | Advertising & Marketing, Big Data, Cloud, Consumer Protection, Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, Mobile Apps, Telehealth

Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.

We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.

Read the full Special Report.

Surviving Disruption: A Roadmap for Health Care Governance

by McDermott Will & Emery and Michael W. Peregrine | Dec 14, 2017 | Big Data, Consumer Protection, Data Privacy, Ecommerce, General Interest, Mobile Apps, Telehealth

Disruption of traditional health care is inevitable and poses a central challenge for health care governance. While the size and complexity of the health care industry have slowed the process of business disruption, its high costs and lack of convenience make it highly vulnerable to innovative, nontraditional competitors.

To make sure boards are well-prepared to address this challenge, McDermott Will & Emery and Kaufman Hall have partnered on a new thought leadership series designed to help you identify the signs of disruption, learn how to prepare your organization, and understand the implications for health care governance.

Get critical insights on how to spot, prepare for and manage disruption in your organization now:

Listen to Surviving Disruption Podcast, Episode 1: The Signs of Disruption.
Download Is Your Organization Disruption Ready? Questions to Assess Preparedness.
View our Top 5 Business Disruption Considerations for Corporate Governance infographic.
Watch our Behind the Scenes: The Making of the Surviving Disruption Podcast Series video.

Subscribe to the Surviving Disruption podcast on iTunes, SoundCloud and Pocket Casts, and keep an eye on the Resource Center for Episode 2: The Path Through Disruption and Episode 3: A Governance Foundation, being released on December 27 and January 10.

Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018

by McDermott Will & Emery and Lisa Mazur | Dec 7, 2017 | Big Data, Mobile Apps, Telehealth

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program Final Rule published on November 15, 2017 (the Final Rule). Among many other developments, the Final Rule expands allowable telehealth reimbursement under the calendar year (CY) 2018 Physician Fee Schedule, List of Medicare Telehealth Services (list) and permits virtual sessions in certain circumstances under the Medicare Diabetes Prevention Program Expanded Model (MDPP, or the Program). The regulations are effective January 1, 2018.

“New” and “Add-On” Telehealth Services Slated for Reimbursement

CMS evaluates requests for the addition of telehealth services on the basis of two categories: (1) services that are similar to services already on the list and (2) services that are not similar to services already on the list. An evaluation of a category (2) service requires CMS to assess, based on the submission of evidence, whether the use of a telecommunications system to furnish the service “produces demonstrated clinical benefit to the patient.” (more…)

ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria

by Scott Weinstein | Nov 6, 2017 | Big Data, Consumer Protection, Cybersecurity, Mobile Apps, Telehealth

In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health record (EHR) technology (CEHRT). Going forward, ONC will allow health developers to self-declare their products’ conformance with 30 of the 55 certification criteria.

ONC will also exercise discretion and not enforce the requirement that certification bodies conduct randomized surveillance of two percent of the health IT certifications they issue.

Read “ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria.”