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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 programs. In addition to writing regularly on matters related to his practice, Dale has spoken at numerous conferences around the world on the globalization of health care. Read Dale Van Demark's full bio.

Background: Issuing Florida’s Emergency Order

On March 16, 2020, Florida Surgeon General Dr. Scott Rivkees signed, stamped and finalized Emergency Order 20-002. In doing so, Florida joined what would become the vast majority of states in modifying licensure requirements for physicians in response to the Coronavirus (COVID-19) emergency.

The surgeon general’s order waived licensing requirements for out-of-state healthcare professionals, advanced life support professionals and basic life support professionals so that they could render services in Florida for the purposes of preparing for, responding to and mitigating any effect of COVID-19. In addition to waiving licensing requirements for in-person services, the order exempted out-of-state physicians, osteopathic physicians, physician assistants and advanced practice registered nurses from licensing requirements governing the provision of telehealth. The order also impacted emergency medical services training programs, physical examination requirements for physician certifications, prescription drug distribution and controlled substance prescription renewals (including medical marijuana). The order was to expire 30 days after signing—April 15, 2020.


Continue Reading Florida’s Extension of its COVID-19 Out-of-State Provider Waiver: A Sign of the Times

On April 2, 2020, the Federal Communications Commission (FCC) launched the $200 million Coronavirus (COVID-19) Telehealth Program contemplated in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Telehealth Program is distinguishable from the broader Connected Care Pilot Program, which will make an additional $100 million in federal universal service funds available for telehealth over the next three years.

Telehealth Program

Notwithstanding telehealth’s advantages, most low-income Americans are unable to utilize telehealth services due to their lack of consistent, broadband internet connection. Furthermore, some providers are limited in their ability to treat patients via telehealth due to the substantial financial and IT investment in developing connected care programs (e.g., purchase of remote patient monitoring devices, telehealth software platforms). The purpose of the Telehealth Program is to support healthcare providers in urban and rural areas, that are responding to the ongoing coronavirus pandemic by maximizing their provision of connected care services and devices. The Telehealth Program will help eligible healthcare providers purchase telecommunications services, information services and devices necessary to provide critical connected care services.

For purposes of the Telehealth Program and Connected Care Pilot Program, “connected care services” are defined as a subset of telehealth that uses broadband internet access service-enabled technologies to deliver care to patients at their mobile location or residence. Only internet-connected devices are covered, not unconnected devices that require the patient to communicate the results to their provider.

Funding will be awarded on a rolling basis until funds are exhausted or the coronavirus pandemic ends. To maximize the $200 million, the FCC anticipates limiting each applicant to $1 million in funding. Further, the FCC has indicated an interest in prioritizing funding to areas especially hard-hit by the coronavirus.

Eligible Healthcare Providers


Continue Reading $200 Million of Funding for COVID-19 Telehealth Program

The Centers for Medicare & Medicaid Services (CMS) continues to loosen the conditions for participation in Medicare, as well as specific reimbursement requirements, to ensure facilities and practitioners are able to practice at the top of their license and across state lines without jeopardizing Medicare reimbursement. Unfortunately, as demonstrated when CMS took similar actions over

On March 4, 2020, the House passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, a bipartisan bill to aid in COVID-19 preparedness and response. The bill includes, among other things, provisions that waive certain telehealth requirements during the COVID-19 public health emergency to ensure Medicare beneficiaries can receive telehealth services at home

As the number of confirmed COVID-19 cases in the United States grows, healthcare providers are stepping up their response planning. To combat the spread of COVID-19, the Centers for Disease Control and Prevention (CDC) urged healthcare systems and providers to deploy all of the resources necessary to ensure health system preparedness. The CDC recommended the

When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity can camouflage customer demand and its regulatory ecosystem adds layers of additional considerations.

Customer Demand and Digital Solutions

The convenience, competitive pricing, answers-at-your-fingertips responsiveness and hyper-personalization delivered by top technology brands and their integration into other industry sectors has created an expectation for digital health solutions that deliver the same experience.

In some instances, consumers are finding the solutions. For example, telemedicine is gaining momentum as consumers discover that digital interactions with high-quality providers are oftentimes more convenient and less expensive than face-to-face encounters. Other tools are providing access to prescriptions, better health condition management solutions, better information sharing enabling smoother transitions among care settings, and more efficiency in everything from hospital operations to scheduling appointments to identifying in-network care options.

When it comes to business strategy, however, digital health solutions need to recognize that consumer pressures are frequently at odds with existing incentives within care delivery systems and, perhaps legal and regulatory requirements. Accordingly, it is critical not just from a compliance perspective but also from a business strategy perspective to navigate the healthcare industry’s unique market and regulatory dynamics.

Balancing Demand with Reality

Continue Reading Digital Health Business Strategy: A Careful Balance

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

Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but in some cases from their own investors. While the regulatory framework for digital technology in health care and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success.

  1. Be accurate about quality.

Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product’s quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the product does not perform at the level described. As demonstrated in several recent public cases, an inaccurate statement of quality or efficacy can draw state and federal regulatory scrutiny, and carries consequences for selling your product in the marketplace and securing reimbursement.

Tech companies and non-traditional health industry players should take careful stock of the health sector’s unique requirements and liabilities in this area, as the risk is much higher in this arena than in other industries.


Continue Reading Three Tips for Tackling Risk in Digital Health

As previously noted in our Digital Health Mid-Year Review, 2018 has seen greater acceptance of telemedicine within the Medicare program. Both regulatory and statutory changes have expanded reimbursement opportunities and, consequentially, opportunities for the deployment of telemedicine technologies. As we noted then, however, improvement in the Medicare reimbursement environment for telemedicine services has been

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