Legal Insights and Perspectives for the Healthcare Industry

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.

Several lawyers from our healthcare industry team recently attended HLTH in Las Vegas. HLTH provided a showcase for innovative ideas, platforms, and programs embracing the concept of “patient-centered care.”

This year’s event offered particular focus on innovations addressing the social determinants of care, elements of daily life that create barriers to receiving health services. As one executive of a large hospital system mentioned, they were reframing the institution’s vision around “health” and not “healthcare.” From programs in states partnering with ride-share apps to ensure Medicaid beneficiaries made their appointments, to highly integrated medical record and patient communication platforms designed to meet patients in their own space, there were numerous examples of business opportunities and legal challenges.

The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software. In a recent LawFlash, Morgan Lewis partner Michele Buenafe details key takeaways from the revised guidance, which is a significant departure from the 2017 draft.

Read the LawFlash >

We invite you to join us in Houston on September 12 for our Second Cup of Coffee breakfast series covering the latest legal developments in digital health and healthcare innovation. In Siri Goes to Medical School – The Rise of AI in Healthcare, partners Susan Feigin Harris, Michele Buenafe, and Andrew Ray will discuss what is happening in the world of artificial intelligence and healthcare, including recent developments, legal trends, and FDA regulatory hurdles.

If you are interested in registering, please contact Stefani Cornwall. Space is limited—reserve your spot now!

Could a new FDA regulatory approach for postmarket changes to artificial intelligence (AI)/machine learning (ML)–based software devices be in our future? A recent discussion paper offers important insight into the FDA’s thinking on reducing postmarket burdens for FDA cleared or approved AI/ML technologies. Given that the FDA has yet to develop clear guidance on when AI/ML technologies are subject to regulation, could the FDA’s proposal to address postmarket changes for these technologies be putting the cart before the horse?

Read the full LawFlash for more in-depth analysis on FDA’s discussion paper.

Did you catch our most recent edition of Fast Break? If not, we had an awesome extended session with Michele Buenafe on May 16 that was also part of our annual Technology May-rathon series. Michele described how the FDA is treating various types of software and hardware that may have healthcare functions as well as certain clinical decision support systems. Michele discussed some of the new and innovative ways that the FDA is trying to regulate—perhaps with a lighter hand—various AI and software systems that have historically had challenges with FDA oversight.