It has been only a little over six months, and already 2018 has been a busy year for digital health, particularly in the area of Medicare reimbursement. The Centers for Medicare and Medicaid Services (CMS), Congress, the Medicare Payment Advisory Commission, and the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) have all contributed to make 2018 extraordinary.

This Special Report includes:

  • An up-to-date review of 2018 Medicare reimbursement highlights
  • A discussion of Congressional and CMS expansion of telehealth reimbursement
  • Notes of caution about the future of Medicare reimbursement

Read the Mid-Year Digital Health Report: Focus on Medicare.

Across the health care sector, telemedicine is naturally and strategically being integrated into health care delivery and treatment plans as targeted and efficient solutions to specific health issues by hospitals, medical groups and drug-to-consumer telemedicine companies.

Telemedicine is no longer viewed as a secondary option for care—it is a new standard of care that is both expected by patients and popular with providers. Consumers expect to see health care adapt—like many other industries already have—to fit within their daily lives and schedules. Whether it’s electronic check-in procedures or better automated systems, health care providers are beginning to treat their patients a little bit more like customers, and see telemedicine and patient engagement tools as a means of improving customer loyalty and engagement while reducing costs.

However, complex billing structure and payor and reimbursement issues can create significant hurdles for health care providers looking to advance telemedicine programs. Telemedicine billing requires special attention, and if not enough consideration is given on the front end of programs, organizations may be surprised to find that that something they thought was a billable service is, in fact, not.

The Bipartisan Budget Act, which provided for the reimbursement of the distance provider, significantly increased the telemedicine use cases that are approved under the Medicare reimbursement structure. However, because Congress will now pay for it, there is a new expectation that hospitals that do not have particular areas of expertise available on-site will investigate opportunities to incorporate a telehealth programs that ensure adequate patient care.

The standard of care continues to improve as patients have greater access to  nationwide physicians and  as new technology like telestroke and clinical decision support tools become more widely available. For example, a stroke neurologist in one New York can now diagnose a stroke patient in Florida, and then facilitate an emergency room physician to treat that stroke. Telestroke programs check off all of the right boxes: better quality care, better access to care, and overall lower cost of care.

As use cases like this continue to be integrated into health care delivery and familiarity builds around how telemedicine can be used effectively, expectations shift around the standard of care and new questions arise around the risks of integrating—or failing to integrate—telehealth programs. If the tools are available and easily accessible, and if there is a supportive reimbursement model, how much a part of the standard of care does telemedicine become and what is the risk of failing to embrace these tools? If hospitals choose not to implement telehealth programs, and then patients suffer harm as a result, for example a delayed diagnosis and treatment of a stroke, could that lead to increased medical malpractice suits or other types of liability?

In the newest episode of the Of Digital Interest podcast, McDermott Digital Health partners, Lisa Schmitz Mazur and Dale Van Demark, share their perspectives on these questions and the various barriers, risks and opportunities associated with the rise of telemedicine and other technological advancements in health care delivery. Access this episode at www.mwe.com/mcdermottdigitalhealth or subscribe to the podcast on iTunes, Pocket Casts or Soundcloud.

As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and investment among stakeholders or all sorts.

Health systems and other institutional providers are playing a more active investment role in the commercialization of biomedical, digital health, and other important health care discoveries in order to remain competitive, secure their positions as industry leaders and generate growth opportunities. This more active role also affords their internal innovators (e.g., physicians and scientists) to play a meaningful role in accelerating the commercialization of home-grown discoveries that may otherwise be left in “the valley of death” between government-funded basic research and later stage, industry-funded commercialization. Drug and medical device manufacturers, venture capital, private equity firms, large donors and other investors are injecting significant capital into fueling research, development and commercialization of health care technology innovation. On the one hand, health care systems and providers welcome such external co-investors who bring sophisticated expertise in product and market research, technology innovation, valuation and strategy capabilities, as well as access to networks of potential co-investors. For such external co-investors, on the other hand, joining forces with health care institutions affords much needed access to the expertise and thought leadership of clinicians, scientists and health technology innovation; a ready‑made proving ground and “anchor customer” for the product; and the halo effect of the health care provider around the co-investor’s clinical care and research reputation. The theory and the hope is that the combined capital and the different, but complementary, expertise, experience and perspectives of such co‑investors provides a formula for financially successful innovation that is transformative and not merely disruptive. Continue Reading Blazing New Trails in Health Care and Technology Innovation Ventures

Join McDermott next Wednesday for a live webinar on the unique considerations in developing and procuring AI solutions for digital health applications from the perspective of various stakeholders. We will discuss the legal issues and strategies surrounding:

  • Research and data mapping essential to the development and validation of AI technologies
  • Protecting and maintaining intellectual property rights in AI solutions
  • Technology development
  • Risk management and mitigation for various contractual arrangements, including contracts with customers, vendors and users

We will also focus on the trends in US law for AI solutions in the digital health space, and present actionable advice that will help you develop an effective strategy for developing and procuring AI solutions for digital health applications.

Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors
Wednesday, June 13, 2018 | 11:00 am CT | 12:00 pm ET
Register Here

 

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help solve challenging public health problems.

There is tremendous enthusiasm over the possibilities of leveraging this data for secondary use–i.e., a use of data that is distinct from the purpose for which it was originally collected. However, such secondary use is often subject to intersecting legal and regulatory regimes–including HIPAA, the Common Rule, and the Federal Food, Drug, and Cosmetic Act and its implementing regulations–that are not fully harmonized.  This lack of harmonization in requirements, coupled with the wide range of industry players involved–including regulators, academic medical centers, health systems, payers, technology companies, manufacturers and industry entities, research institutions, registries, and professional societies, to name a few– presents challenges that require careful planning and implementation. While regulators have recently taken significant steps to reconcile the differences among these laws and provide a path forward for harnessing the potential of big data, some specific requirements within these individual regulations continue to present challenges.

It is critical for academic medical centers and teaching hospitals, which stand at the intersection of government-funded research and industry-sponsored research, and are also paving the way in partnerships with non-traditional health care players—to understand the evolving legal framework and business and compliance imperatives behind the quest for digital health information.

During the AHLA Annual Meeting on Tuesday, June 26, McDermott partner Jiayan Chen will review trends and the value proposition relating to secondary use, with a particular focus on challenges presented by secondary use in the precision medicine and digital health context.  Along with co-presenter Leah Voigt, she will explore key regulatory and sub-regulatory developments relating to the secondary use of data under FDA regulations, the Common Rule, and HIPAA, and will also use case studies to explore, in a practical context, the challenges and ambiguities that remain when pursuing internal secondary use initiatives and external collaborations, including implementation and contracting tips, insights, and strategies.

Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data
AHLA Annual Meeting, Chicago, IL | June 26, 2018 | 9:45 – 10:45 am | Registration and program details.

McDermott’s Cocktail Reception during the AHLA Annual Meeting
The Art Institute of Chicago | June 26, 2018 | 6:00 – 8:00 pm
Following the programming on Tuesday, we invite you to join us for our annual cocktail reception at The Art Institute of Chicago. We look forward to an evening of networking, cocktails and private gallery tours with our colleagues, friends and fellow AHLA members. RSVP today!

Lack of a sufficient risk analysis continues to be one of the most commonly alleged violations in Office for Civil Rights (OCR) HIPAA enforcement actions, appearing in half of all OCR settlements announced in the last 12 months and in almost all of the $1 million-plus settlements during that time period. Significant confusion remains across the health care industry as to what actually constitutes a compliant risk analysis for purposes of the HIPAA Security Rule. On April 30, 2018 OCR issued guidance discussing the differences between a HIPAA Security Rule risk analysis and a HIPAA compliance “gap analysis.” Drawing from our experience reviewing clients’ historical risk analysis documents, helping clients to navigate OCR investigations and negotiating several recent HIPAA settlements with OCR, we elaborate on what constitutes a compliant HIPAA Security Rule risk analysis, discuss common risk analysis misunderstandings and pitfalls, and encourage covered entities and business associates to consider whether to conduct these reviews under attorney-client privilege.

Continue Reading.

As the telemedicine landscape continues to evolve and new capabilities come to bear, those working in the industry will face a diverse mix of legal and regulatory hurdles as stakeholders begin to leverage new avenues and options for care delivery. This evolution requires practitioners to understand the legal frameworks that will continue to change as regulators attempt to keep pace with evolving technology.

To help address the complexities of the telemedicine regulatory environment — and those across the digital health ecosystem at large — we partnered with the American Health Lawyers Association to release “The Law of Digital Health,” which details legal realities for digital health leaders and their advisors looking to bring new tools to market or expand their existing positions.

Unique Legal and Regulatory Considerations Applicable to Telemedicine

The “telemedicine sector” is undoubtedly complex and rife with nuance, beginning with how it is defined, which significantly varies among payers, regulators, accrediting bodies and providers. Adding to the intricacy are the variations in telemedicine regulation, depending on factors such as the patient’s location/geography and care setting, coverage and reimbursement or type of technology used. Despite these complexities, organizations are moving forward with their telemedicine initiatives and navigating these issues because of the great potential telemedicine has to expand access to care.  Continue Reading Telemedicine’s Complex Legal Landscape

Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA.

Visit www.mwe.com/lawofdigitalhealth to order this comprehensive legal and regulatory analysis, coupled with practical planning and implementation strategies. You can also download the Executive Summary and hear more about how Digital Health is quickly and dynamically changing the health care landscape.

Explore more!

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

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.

  1. 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.  Continue Reading Walking the Fine Line between the Delivery of Health Care Services and Information/Educational Support