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Trending in Telehealth: January 17 – 23, 2023

Trending in Telehealth is a new weekly series from the McDermott Digital Health team where we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate the delivery of virtual care.

Trending this week:

  • Provider Licensing
  • Telehealth Definitions
  • Telehealth Service Expansion

A closer look:

Finalized: 1

  • New Jersey finalized a seven-year extension to existing rules that were set to expire on January 15, 2023. These rules, in part, allow for flexibility for out of state speech pathologist and audiologists to obtain a license without an examination.

Proposed: 13

  • Maryland saw activity across a collection of nine proposed rules.
    • Comment periods closed on January 17, 2023, for five rules proposed in mid-December. These rules amend or create telehealth standards of practice for LCSWs, Behavior Analysts, Podiatrists, Optometrists, and Audiologists and Speech Pathologists.
    • On January 13 the state proposed rules that clarify standards of practice for telehealth providers in physical therapy and early intervention care for children settings.
    • The state proposed two additional rules expanding services provided via telehealth that would be covered under the Medical Assistance program. This includes expanding reimbursable physician’s services, and care provided in urgent care settings. Both proposed rules require that all telehealth services are compliant with general requirements for telehealth practice to be reimbursed.
  • The South Dakota House passed a bill that amends practice guidelines for speech pathologists, including clarifying telehealth standards. This bill goes to the state Senate for voting.
  • The Wyoming Senate has moved forward on two bills to adopt professional counseling compact and Psychology Interjurisdictional Compact (PsyPact) requirements. These bills both head to the South Dakota House.
  • Texas proposed rule changes related to the provision of prenatal care that expand the use of telehealth and differentiates between medical services provided through telehealth and non-health services.

Highlights for the Industry:

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Trending in Telehealth: January 9 – 16, 2023

Trending in Telehealth is a new weekly series from the McDermott Digital Health team where we track telehealth regulatory and legislative activity. Each week we will highlight developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate the delivery of virtual care.

Trending This Week:

  • Provider Licensing
  • Telehealth Definitions
  • Tele-behavioral health

A Closer Look:

Finalized: 2

  • Illinois enacted emergency changes to the Telehealth Act and other statutes that expand the ability of certain out-of-state providers to provide reproductive care via telehealth in the state.
  • Massachusetts’ Department of Medical Assistance finalized rules that amend definitions for diagnostic, case consult and treatment services (beginning on page 139), and establish requirements for licensed independent clinical social workers (LICSWs) to enroll as MassHealth providers and use of telehealth by LICSWs (beginning on page 309).
  • Oregon adopted a rule that clarifies that acupuncturists can provide telemedicine services.

Proposed: 6

  • Alaska proposed a rule that would amend the educational requirements for a professional counselor license, requiring that at least three of the hours are in telehealth. This is added alongside the existing professional ethics requirements and new additions of cultural competencies and suicidality.
  • Florida proposed updates to disciplinary rules for those licensed under the Florida Board of Osteopathic Medicine. The new rules include penalties for failing to identify to patients the type of license under which the practitioner is practicing, expanding the state’s existing rules imposing penalties related to care being provided through telehealth.
  • Texas proposed three rules relating to behavior analysts’ use of telehealth, as a result of a four-year rule review conducted by the Texas Department of Licensing & Regulation. These proposed rules establish requirements for behavior analysts’ use of telehealth in delivering care and align definitions with telehealth regulations for other providers. The public comment period for all three rules ends on February 5, 2023.
  • Wyoming proposed a rule that would modify standards of practice for occupational therapy. This includes clarification surrounding the requirement for occupational therapists and occupational therapist assistants to hold a Wyoming license to provide services to a patient in Wyoming, including treatment delivered through telehealth technologies, at the time of services. The public comment period ends March 5, 2023.

Highlights for the Industry:

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2021 Digital Health Year in Review


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.

Access the report.




Telemedicine Providers Take Note – The No Surprises Act Is Effective January 1, 2022

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);[1] 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).[2]

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.

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Staying Connected: An Update on Medicare Reimbursement for Telehealth Services After the PHE

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.

CLICK HERE TO ACCESS THE FULL REPORT.




McDermott Partners Recognized As Digital Health Power Players

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.




CMS Addresses Virtual Care Expansion in CY 2022 Medicare Physician Fee Schedule Proposal

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.

Read the full article here.




Access To Digital Health Applications And Digital Care Applications In Germany

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.

Read more in our latest edition of International News.




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.

  1. 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.
  2. 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.
  3. 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.

Click here for the full list of highlights.
Click here to view the full webinar.




Telehealth and Prescribing: What’s Permissible in Your State?

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?

Click here to access the map and download the full report. 




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