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.