The continuation of the COVID-19 public health emergency (PHE) and consumer demand for digitally delivered healthcare not only necessitated the shift from in-person to virtual care, but also continued to drive interest, adoption, investment and transactions in digital health in 2021. Digital health funding in 2021 far surpassed 2020’s totals, with no signs of slowing down in 2022, and the potential permanence of some regulatory flexibilities beyond the PHE are charting a course for continued digital health growth in 2022 and beyond.
On December 27, 2020, the No Surprises Act was signed into law as part of the Consolidated Appropriations Act, 2021. In July and October 2021, respectively, the Department of Health and Human Services, the Department of Labor, the Department of the Treasury and the Office of Personnel Management (the Departments) issued two Interim Final Rules implementing core aspects of the No Surprises Act, including (1) prohibiting non-participating providers from balance billing individuals who receive services in participating facilities unless prior notice and consent is provided and obtained (referred to as Part I); and (2) requiring providers and facilities to provide good faith estimates (GFE) to uninsured (or self-pay) individuals of expected charges prior to their scheduled services (referred to as Part II, and together with Part I and the statute, the NSA).
Effective as of January 1, 2022, to the extent that an out-of-network telemedicine provider furnishes services to a patient at an in-network facility, the disclosure notice requirements and balance billing prohibitions under Part I apply. Additionally, to the extent that a telemedicine provider furnishes services to an uninsured (or self-pay) patient, the transparency requirements under Part II, including the requirement to provide a GFE, may apply. Notably, the NSA provides for steep penalties, including imposition of civil monetary penalties of up to $10,000 per violation. Additional information regarding a telemedicine provider’s compliance obligations under the NSA are outlined below.
In hopes that the COVID-19 public health emergency (PHE) will soon end, Congress and the administration are evaluating the telehealth expansions and flexibilities put in place to respond to the PHE. As a result, the future for telehealth stakeholders remains uncertain. This article outlines various changes in Medicare telehealth reimbursement policy in effect during the PHE and identifies what actions would be required to make these changes permanent.
Since the implementation of the PHE, there has been a significant uptick in the provision of telehealth services by Medicare, other public payers and commercial payers. In response to this increased utilization and outreach by stakeholders, Congress has actively explored ways to make some, or all, of the PHE flexibilities permanent.
During the PHE, telehealth providers have been able to receive reimbursement for a greater variety of telehealth services, leverage more types of healthcare providers, and treat patients in more locations than ever before. Telehealth providers have been energized by these changes and are voicing resistance to the prospect of losing these new reimbursement opportunities post-PHE.
The pathways to making telehealth flexibilities permanent, however, are neither simple nor clear. Reimbursement for telehealth services is governed by complex statutory, regulatory and subregulatory requirements at the state and federal level. At the federal level, the PHE-driven changes have come via both federal legislation and regulatory modifications. This article describes what steps would be necessary to make federal telehealth reimbursement policy changes permanent as the healthcare system recovers and rebuilds from the COVID-19 pandemic.
Washington (August 11, 2021) – McDermott Will & Emery partners Jennifer Geetter and Vernessa Pollard have been recognized within an Insider profile on the “9 behind-the-scenes players who can make or break your digital-health startup.” The pair discussed advising young companies on the regulatory hurdles they have to clear before tackling the healthcare market.
As part of the Firm’s industry-leading health practice, Jennifer advises digital health companies on the development, delivery and implementation of innovative healthcare solutions. Vernessa leads medical device and technology companies through US Food and Drug Administration (FDA) regulations to bring products to market.
Vernessa explored with Insider how more tech companies are spreading into healthcare. These companies need assistance discussing the FDA’s newest regulations, including machine learning oversights or health-data privacy rules. If businesses are not knowledgeable about their regulatory requirements, it can make or break their investments.
“We have a number of what we’d consider to be nontraditionally FDA regulated entities, such as the large tech companies and even hospitals and healthcare providers, that are entering this space because they’re developing new tools or technology that may trigger FDA requirements,” Vernessa noted.
Jennifer explained that it’s not always clear if decade old FDA laws apply, so she advises her clients to prioritize building trust with patients through an emphasis of privacy and cybersecurity protection.
“There’s something about the intimacy of the standard doctor-patient relationship when you’re sitting across the room from your doctor that breeds trust,” Jennifer said. “When you’re in a digital healthcare system with distance, you don’t necessarily have that.”
McDermott Will & Emery is the nation’s leading health law firm. The Health Industry Advisory group is the only health practice to receive top national rankings from U.S. News – Best Lawyers “Best Law Firms,” Chambers USA, The Legal 500 US and Law360. The practice was also recognized by Chambers as “Health Team of the Year” in 2010, 2013, 2017 and 2019. McDermott has also held the top spot in PitchBook’s League Tables as the most active firm for healthcare private equity since 2017.
On July 23, 2021, the Centers for Medicare & Medicaid Services (CMS) published its annual proposed changes to the Medicare Physician Fee Schedule (MPFS), which include several key telehealth and other virtual care-related proposals. The proposals address long-standing restrictions that have historically limited the use of telehealth and virtual care, including geographic and originating site restrictions, and limitations on audio-only care, as well as coverage extensions for some services added during the COVID-19 public health emergency.
These proposals include:
- The implementation of the Consolidated Appropriations Act, 2021 (CAA) in-person visit requirement for mental health services that either do not meet Medicare’s typical geographic restrictions or occur when the originating site is the patient’s home, regardless of geography
- The ability for certain mental health services to be delivered via audio-only communications when patients are located in their homes (however, in these cases, the provider would also be required to comply with the in-person visit requirement described above)
- The extension of coverage of the services temporarily added to the Medicare telehealth services list (Category 3 services) through the end of CY 2023 to allow more time for evaluation, and the rejection of proposed new, permanent Medicare telehealth services
- The permanent adoption of HCPCS Code G2252 for extended virtual check-ins, which was established on an interim basis in the CY 2021 MPFS.
On 20 January 2021, the German Federal Cabinet approved the draft law on the digital modernization of healthcare and nursing care. The draft has been criticized for not taking into account lessons learned from the implementation of the 2019 digital health applications law.
The legally enforceable right of patients insured in the Germany statutory healthcare system (SHI) to be able to access digital health applications (DiGAs) was included in the German SHI code (SGB V) at the end of 2019.
DiGAs are low-risk medical devices (risk class I and IIa) that are primarily based on digital technologies and support the detection, monitoring, treatment, or alleviation of diseases, injuries, or disabilities. Under the SGB V, DiGAs have to be approved by the German Federal Institute for Drugs and Medical Devices (BfArM) and included in the DiGA List before doctors can prescribe them to their patients on an individual basis and at the SHI’s expense. Among the DiGAs listed by BfArM since the first listing in October 2020, are those that support patients with light depression, insomnia, obesity, or tinnitus.
Top Takeaways | Cybersecurity & Insurance Coverage in the Age of Telehealth: Understanding and Mitigating Your Risk
With more frequent and more severe ransomware attacks against health care platforms and vendors and the increasing use of telemedicine, it is critical to understand how to proactively defend your organization using robust legal, regulatory and cyber-coverage strategies. In this webinar, McDermott partners Dale Van Demark and Edward Zacharias joined Brett Buchanan of Marsh & McLennan Agency and Larry Hansard of Gallagher USA to explore the intersection of telemedicine and cybersecurity. Our panelists offered attendees a road map for navigating this rapidly changing space, including practical strategies for shoring up their defenses and addressing potential risks to their businesses.
- Providers engaging in telemedicine should consider three critical areas of insurance coverage: medical professional liability, technology errors and omissions, and cyber/privacy liability. “Several carriers have packaged these three important coverages into a one-policy format, referred to as a virtual health program,” Hansard said.
- A medical professional liability program should include incident reporting, punitive damages, and sexual abuse and molestation. The latter may seem surprising in a telemedicine context, but is important given reports of inappropriate patient behavior during telemedicine encounters, Hansard said.
- New telehealth technologies, such as AI chatbots for patient intake, create new and more complex bodily injury exposures, Buchanan said. “Working with an insurance underwriter that understands these nuances is absolutely key,” he said. In addition to bodily injury, coverage should include technology errors and omissions, cyber liability and general liability.
Telehealth’s state-by-state regulatory patchwork means that healthcare providers must navigate a variety of regulations that govern which types of care can be provided by virtual means, and even what modalities can be used in different care settings.
Our new interactive map explores the standards and requirements that physicians and nurse practitioners must follow when prescribing non-controlled substances or ordering tests via a telemedicine encounter in all 50 states and the District of Columbia. Key issues addressed in the survey include:
- In what states are asynchronous solutions permitted?
- What are state rules governing prescriptions when a physician-patient relationship does not exist prior to the telehealth encounter?
- What are state rules on prescribing via audio-visual encounters or audio-only encounters?
- Under what state regulations can a questionnaire be sufficient to create a physician-patient or advance practice registered nurse-patient relationship?
Private equity deal volume hit a low in the first half of 2020 as the pandemic slowed the US and global economies. But toward the end of the year, deals began picking back up, particularly in the digital health space.
COVID-19 forced healthcare providers to shift from in-person to virtual care, and technology was the vehicle to make that switch possible. Investors noticed, and more deals focused on companies specializing in telehealth, remote patient monitoring and other technology platforms that facilitate communication among specialists.
Expect this trend to continue in 2021, and keep these three factors in mind when evaluating the digital health landscape.
Easing of Laws and Regulations Surrounding Telehealth and Digital Health
Both telehealth and digital health are highly regulated, as every state has laws and regulations that govern how care is provided virtually and how those services are billed. In response to the pandemic, we’ve seen flexibility with these laws and regulations, and the Biden administration has signaled that it might make some flexibilities permanent.
Investment opportunities will likely increase as a result of the Biden administration’s willingness to lower some of the longstanding barriers to coverage and payment for virtual services, including telehealth, remote patient monitoring and other related services. That’s a positive sign for firms looking at healthcare through the lens of a technology solution.
Reallocation of Resources Due to Vaccine Rollout
Since the onset of the pandemic, labs have conducted a huge volume of testing and have had to ramp up personnel and other resources. Plus, the vast majority of COVID-19 tests must be ordered by a physician or nurse, further straining available resources.
While testing will likely continue in some capacity for a long time, the number of tests will presumably decline steadily as more people are vaccinated. That means capacity will open up, both for healthcare providers who were ordering the tests and for lab companies that were performing them. As a result, firms should begin asking themselves:
- Where are there opportunities to shift focus and resources previously devoted to testing?
- What other conditions lend themselves to at-home testing?
- Where can companies shift efforts that were previously focused on reviewing orders?
Addressing Mental Health and the Other Epidemic
COVID-19 obviously emerged as the foremost health emergency of the past year. But it’s important to remember that the United States is still in the midst of an opioid addiction epidemic.
On top of that, COVID-19 has been hard on many people’s mental health. In response, many employers have made mental health a higher priority, and that trend is likely to continue, even as employees return to the workplace. In 2021, investors are likely to continue to emphasize digital health tools and service offerings that are focused on mindfulness and behavior health.
To learn more from Lisa and other thought leaders about the healthcare investing landscape heading into 2021, you can view a recording of The Deal’s webinar here.
In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through telehealth and clarified the scope of liability protections provided by the PREP Act. In particular, the declaration is important to telehealth providers because it appears to preempt, under certain circumstances, state laws that have limited cross-border practice of medicine using telehealth. Healthcare providers should take note that the licensure exception and any immunity protections are limited to healthcare providers who are ordering or administering a Covered Countermeasure and there is no indication of intent to expand beyond these focused measures.