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Legal Insights and Perspectives for the Healthcare Industry

Telehealth is a highly regulated field and legal issues can vary across payers, across states, and even across countries. Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In China, the Chinese government has been actively promoting internet-based medicine, even before the COVID-19 pandemic accelerated the need for telehealth services.

In July 2018, the National Health Committee and the State Administration of Traditional Chinese Medicine jointly issued the three fundamental rules that formed the basic legal framework of China’s internet-based medicine. According to the rules, internet-based medicine in mainland China is classified into three categories: internet-based diagnosis, internet hospitals, and telemedicine services. The Chinese government continues to adjust regulations on internet-based medicine as there are still many issues that have not yet been addressed under the existing legal framework.

Read the full LawFlash >>

We are pleased to announce that Morgan Lewis partners Nancy Yamaguchi and Janice Logan are organizing and participating in the US-Japan Healthcare Connections’ MedTech Emerging Growth Companies 2020 Virtual Roadshow. This year’s virtual conference, to be held in the United States October 12-14, 2020, will introduce more than 20 emerging US medical technology companies to a broad audience around the globe.

The conference will provide thematically grouped presentations and virtual networking, giving attendees a unique insight into the latest developments in medical technology.

We are honored to be a founding partner of the US-Japan Healthcare Connection – Conference Organizer.

Visit the conference website for more information and to register >>

We are pleased to announce that we are participating in three upcoming digital health events.

Michele Buenafe, FDA partner and leader of our digital health initiative, will speak at two upcoming FDLI conferences focused on the Food and Drug Administration’s (FDA's) regulation of digital health and developments in digital health regulation before and beyond the coronavirus (COVID-19) pandemic, including significant enforcement discretion policies and exemptions FDA has implemented over the last six months.

On our next Fast Break webinar, Jake Harper will discuss updates in telehealth, a topic that has been top of mind for so many healthcare companies amid the COVID-19 pandemic. Register for Fast Break now.

Don’t forget you can check out all of our latest healthcare events and publications on Our Thinking on Healthcare.

US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years. The order contains four specific directives:

  1. The US Department of Health and Human Services (HHS) must create a new 1115A model to test payment mechanisms related to rural healthcare providers.
  2. HHS, the Federal Communications Commission, and the US Department of Agriculture must develop a strategy to improve rural health care through developing healthcare-related infrastructure.
  3. HHS must issue a report regarding existing and planned policy initiatives that enhance various rural healthcare quality metrics, including identifying “regulatory burdens that limit the availability of clinical professionals.”
  4. HHS must propose regulation that would extend the measures taken during the PHE beyond its current duration as to both “the additional telehealth services offered to Medicare beneficiaries” and “the services, reporting, staffing, and supervision flexibilities offered to Medicare providers in rural areas.”

We are celebrating our 10th year of Technology May-rathon, our annual webinar series focusing on current technology issues, trends, and developments. This year, we have a full schedule of webinars with discussions on privacy and big data, global commerce, fintech, the coronavirus (COVID-19) pandemic, and more. Be sure to register for the many healthcare webinars our lawyers will be presenting on:

And don’t forget to visit our 2020 Technology May-rathon page for our full list of programs!

As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the coronavirus (COVID-19) crisis. We noted that the Office of Inspector General (OIG) and the Office for Civil Rights (OCR) at HHS simultaneously issued policy statements with respect to their exercise of enforcement discretion regarding, respectively, telehealth-related copay waivers and HIPAA violations. These coordinated policy announcements represent a concerted effort by federal government agencies to broaden telehealth flexibility to immediately promote and expand the use of technology to help Medicare beneficiaries follow guidance from the CDC, including practicing social distancing, thereby enabling vulnerable beneficiaries and beneficiaries with mild symptoms to access the care they need from their homes. Not only will this help protect Medicare beneficiaries who are particularly vulnerable to COVID-19 infection, it presumably will help deter the spread of the virus and ease the burden on already over-stressed emergency departments, doctor’s offices, and other healthcare facilities.

Healthcare industry lawyers Eric Knickrehm and Jake Harper recently authored a LawFlash analyzing medical licensure waivers issued in connection with the coronavirus (COVID-19) emergency that permit healthcare professionals to receive federal healthcare program reimbursement for telehealth services in states where they do not hold a license.

Noting that such waivers are limited in scope to conditions of participation and payment for federal healthcare programs such as Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), Knickrehm cautions that “these waivers alone do not waive the requirement for physicians and other healthcare providers to maintain licensure in states where they are practicing a licensed profession, including via telehealth.” Waivers by state medical boards to implement emergency changes to licensure requirements are also addressed.

Read the full LawFLash.

CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the coronavirus (COVID-19) crisis. Telehealth and other healthcare stakeholders have been waiting for these program instructions to be released to determine how CMS will fully implement the Medicare telehealth waiver.

Traditionally, under the Medicare program, professional telehealth services are restricted by statute to originating site locations (defined generally as healthcare facilities and physician offices) that are located in rural areas or outside of Metropolitan Statistical Areas (MSAs). Medicare beneficiaries generally would not be allowed to receive telehealth services in their home. CPRSAA waived both of these requirements, enabling Medicare beneficiaries across the country (regardless of urban or rural location) to receive telehealth services, including in their home, from a doctor in a remote location directly through their smart phone or computer.

As part of emergency funding to combat the threat of the 2019 Novel Coronavirus (COVID-19), last week Congress waived many of the telehealth restrictions for Medicare services in certain situations. This monumental change could—depending on how it is implemented—radically alter how telehealth is performed in connection with the government’s most ubiquitous healthcare program. In a win for telehealth advocates, Congress waived the originating site and geographic limitations for coverage of Medicare telehealth services, which heretofore have prevented most commercial forms of telehealth from reaching Medicare beneficiaries. Specifically, Congress allowed the secretary of HHS to waive the originating site and geographic restrictions in Social Security Act § 1834(m) in “emergency areas.” However, only practitioners (or their group practice partners) who have seen a particular patient and billed Medicare for such service within a three-year period are eligible to take advantage of this waiver. In other words, only a practitioner’s established patients who have received Medicare services in the past (and who are in a designated emergency area) are eligible for this program.

Partner Reece Hirsch recently attended and spoke at the 2020 Health Datapalooza held in Washington, DC. This year, Health Datapalooza was co-located with the National Health Policy Conference, providing attendees with an opportunity to participate in both events and hear the latest developments in digital health and health policy innovation.