December 6, 2021

Volume XI, Number 340

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December 03, 2021

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Telemental Health Laws: Overview

Since 2016, Epstein Becker Green (EBG) has researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. We are pleased to release our latest and most comprehensive compilation of state telehealth laws, regulations, and policies within the mental/behavioral health practice disciplines.

2021: Another Year of Increased Recognition of Telehealth Benefits

It is well known that there is a shortage of behavioral health providers in the United States. Expanding telehealth technologies to increase patient access to psychiatrists, psychologists, counselors, therapists, and other behavioral health professionals has continued to gain attention and validation as the novel coronavirus disease (COVID-19) pandemic stretched into a second year.

For most of 2021, health care providers dealt with the implications of COVID-19 on their professional practices. While providers struggled to care for patients amid COVID-19 contagion concerns, federal and state regulatory efforts that began in 2020, and have continued throughout 2021, have significantly helped ease the path to greater provision of services via telehealth. Now that we are more than a year and a half into the pandemic, federal and state governments have continued to support flexibilities put into place during the height of the pandemic that have promoted increased use of telehealth, both as lessons learned and to help lawmakers and regulators decide which temporary changes should, perhaps, be made more permanent.

2021: Growing Focus on “Telefraud” and Enforcement

The sheer quantity of telehealth platforms to deliver health care services has been on the rise in recent years, but increased most dramatically in 2020 and 2021 as a result of pandemic-related policies. And, as within many areas of health care, with expansion and innovation comes a higher potential risk of enforcement activity. The U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) continues to build on their successful takedown of a $4.5 billion “telefraud” scheme related to opioid use in 2020, through continued, aggressive enforcement of telehealth schemes in 2021.

For example, in September 2021, DOJ announced criminal charges against nearly 150 defendants for their alleged participation in various health care fraud schemes that resulted in approximately $1.4 billion in alleged losses.[i] These charges targeted approximately $1.1 billion in fraud committed using telemedicine (the use of telecommunications technology to provide health care services remotely), $29 million in COVID-19 health care fraud, $133 million connected to substance abuse treatment facilities (or “sober homes”), and $160 million connected to other health care fraud and illegal opioid distribution schemes across the country. The more than $1.1 billion of allegedly false and fraudulent telemedicine claims was the result of defendants allegedly paying physicians and nurse practitioners to order unnecessary durable medical equipment, genetic and other diagnostic testing, and pain medications, either without any patient interaction or with only a brief telephonic conversation with patients they had never met or seen.

In May 2021, DOJ announced a coordinated law enforcement action against 14 telehealth executives, physicians, marketers, and health care business owners for their alleged fraudulent COVID-19-related Medicare claims resulting in over $143 million in false billing.[ii] In addition to the DOJ criminal charges, in May 2021, the Center for Program Integrity, within the Centers for Medicare & Medicaid Services (CMS), separately announced that it took adverse administrative actions against more than 50 medical providers for their involvement in health care fraud schemes relating to COVID-19 or abuse of CMS programs that were designed to encourage access to medical care during the pandemic.[iii] In the cases announced by both the DOJ and CMS, providers allegedly sought to exploit some of the telehealth waivers CMS put into place to expand access to care during the pandemic.

These enforcement actions should serve as a warning to the telehealth industry that there is a need not only to consider the law from a policy and operations perspective, but also to invest in a robust compliance infrastructure. The coordinated effort between the various federal agencies also highlights the increased scrutiny telehealth providers are facing as rapid expansion efforts due to COVID-19 shape industry standards.

At the state level, data compiled in September 2021 by the OIG illustrated that more than 20 states reported fraud, waste, and abuse as a “concern” with respect to use of telehealth to provide behavioral health services.[iv] Various states reported uncovering fraud schemes that are unique to telehealth, such as providers inappropriately billing state Medicaid programs for both delivering the telehealth service remotely and facilitating the telehealth service at the Medicaid enrollee’s location. Despite these concerns highlighted at the state level, OIG noted that, compared to the federal government, some states do not have adequate resources to conduct monitoring and oversight to detect fraud, waste, and abuse that is specific to telehealth.

2021 Trends: General Telemental/Telebehavioral Provisions Across the 50 States

Much of the state-level regulatory guidance on telemedicine/telehealth services focuses on provision of services by physicians, but other state professional boards have continued to actively develop comparable guidance for other types of mental/behavioral health professionals, such as psychologists, social workers, and counselors.

While all states require physicians and other health care professionals to hold a valid license to practice that has been issued by the state’s relevant professional board, a strong trend throughout 2021 has been the adoption by more states of various interstate compacts that allow specific providers to practice in states they are not licensed in as long as they hold a license in good standing in their home state. EBG’s 2021 Telemental Health Laws update highlights the number of states that have joined one or more of the professional licensure compacts. For example, 29 states plus the District of Columbia have joined the Interstate Medical Licensure Compact (for physicians),[v] 34 states have joined the Nurse Licensure Compact (for registered nurses and licensed practical nurses),[vi] and 26 states have joined the Psychology Interjurisdictional Compact (PSYPACT).[vii]

Another noteworthy trend highlighted in EBG’s 2021 Telemental Health Laws update relates to guidance on remote prescribing practices. Generally and gradually, a growing number of states have allowed licensed physicians to prescribe non-controlled substances via telehealth, and, over time, states have adjusted their guidance to permit physicians to do remote prescribing without requiring that the physician conduct a prior in-person examination, allowing instead for the necessary examination to occur via telehealth. The year 2021 has seen this trend continue to evolve in states, and for states to continue to adopt specific practice standards for remote prescribing.

Yet another issue highlighted in EBG’s 2021 Telemental Health Laws update was the noticeable uptick in states’ telehealth-specific data privacy/confidentiality laws. Roughly half of states have these laws, or other guidance, which are specific to the provision of telehealth services and generally extend above and beyond requiring health care providers merely to follow federal and state privacy/confidentiality requirements pertaining to medicine. In addition, 45 jurisdictions have established some type of informed consent requirements that must be followed before telehealth services are provided.[viii]

Telehealth and COVID-19: Increased Engagement

Prior to the start of the COVID-19 pandemic, upward trends in telehealth use were steady, but slow. However, circumstances surrounding the pandemic, along with supporting regulatory and policy changes, dramatically reduced barriers to telehealth access and have promoted telehealth as a way to deliver acute, chronic, primary, and specialty health care. This has resulted in noticeably increased engagement by patients. Below are some of the key events that have facilitated the recent upsurge in telehealth use.

Impacts at the Federal Level

  • In January 2020, HHS Secretary Alex Azar used his authority under the Public Health Service Act to declare a public health emergency (PHE) for the entire United States. Secretary Azar, and then HHS Secretary Xavier Becerra, renewed the PHE numerous times, most recently on October 15, 2021, in the “Renewal of Determination That A Public Health Emergency Exists.”

  • Whether federal telehealth policy changes are here to stay depends largely on what actions Congress and federal agencies take after the PHE ends, and as the United States transitions into a post-pandemic world.

  • As long as the PHE remains in place, many of the flexibilities CMS granted at the beginning of the pandemic have also remained in place. For example, the Section 1135 blanket waivers applicable to telehealth services are still in place. Moreover, pursuant to authority granted under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Congress broadened CMS’s waiver authority under Section 1135 of the Social Security Act, and the Secretary has authorized additional telehealth waivers. The waiver of these requirements expands the types of health care professionals who can furnish distant site telehealth services to include all those that are eligible to bill Medicare for their professional services. This allows health care professionals who were previously ineligible to furnish and bill for Medicare telehealth services to receive payment for Medicare telehealth services. CMS also waived its modality requirements and allows the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services.

  • It is still uncertain what CMS’s final policy for telehealth services will be when the PHE ends. As CMS continues to evaluate the inclusion of telehealth services that were temporarily added to the Medicare telehealth services list during the COVID-19 PHE, CMS finalized in the CY 2022 Final Physician Fee Schedule Rule, released in November 2021, that certain services added to the Medicare telehealth services list will remain on the list through December 31, 2023. CMS has said that this will allow it additional time to evaluate whether the services should be permanently added to the Medicare telehealth services list.

  • Significantly, the Drug Enforcement Agency (DEA) invoked its PHE exception under 42 U.S.C. § 247d (Section 319 of the Public Health Service Act), as set forth in 21 U.S.C. § 802(54)(D), to the federal Ryan Haight Act requirement to conduct an in-person examination before prescribing controlled substances via telemedicine. Accordingly, as of March 16, 2020, and continuing for as long as the Secretary’s designation of a PHE remains in effect (it was renewed again on October 15, 2021), DEA-registered practitioners throughout the United States have been permitted to prescribe all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:

  1. The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;

  2. The telemedicine communication is conducted using an audiovisual, real-time, two-way interactive communication system; and

  3. The practitioner is acting in accordance with applicable federal and state laws.

  • The Office for Civil Rights (OCR) within HHS, which is responsible for enforcing certain regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, has been exercising enforcement discretion during the PHE. Specifically, OCR has stated that it will not impose penalties for noncompliance with the regulatory requirements under the HIPAA rules against covered health care providers in connection with the good faith provision of telehealth services, regardless of whether the services are related to diagnosis and treatment of health conditions associated with COVID-19. A covered health care provider that wants to use audio or video communication technology to provide telehealth to patients during the PHE may use any non-public facing remote communication product that is available to communicate with patients.

  • Most recently, in October 2021, the OIG published a study conducted on the flexibilities that HHS has granted to telehealth providers during the PHE. The purpose of the OIG study was to provide data to policymakers as they consider how to implement changes to coverage and payment parameters for telehealth services under the Medicare program on a more permanent basis. For example, during the PHE, HHS has been exercising its discretion to not enforce requirements for established practitioner-patient relationships prior to the provision of telehealth services. After reviewing Medicare claims data for telehealth services provided between March 2020 and December 2020, the OIG found that 84 percent of beneficiaries received telehealth services only from providers with whom they had an established relationship. OIG intends for Congress and HHS to use this data to inform decisions about which services to allow to be delivered via telehealth on a more permanent basis and to what extent Medicare should require that beneficiaries have a relationship with their providers prior to receiving certain telehealth services. The OIG’s study data also will inform state regulators as they continue to examine telehealth utilization and concerns about telehealth being vulnerable to fraud, waste, and abuse.

Impacts at the State Level

  • In response to COVID-19, every state granted some type of flexibility to its laws and rules to increase access to telehealth in 2020. Many states made these temporary changes through executive orders or emergency declarations issued by the states’ governor. State agencies, such as a state’s Department of Health, and state professional licensing boards, such as a state’s Board of Medicine, further granted additional flexibilities.

  • Presently, as we look toward the end of 2021, many states have revoked their states of emergency and, with that, the temporary changes to state telehealth laws and rules. However, EBG’s 2021 Telemental Health Laws update highlights how certain states have now taken action to make their temporary changes more permanent, by enacting legislation or issuing rules at the state professional board level. While the legislative process in the individual states can take time, these are interesting developments to track.

  • A trend that has persisted since EBG’s 2019 update is continued changes to state laws and other guidance related to non-physician and non-nurse health care professionals. Although these types of changes may be due in part to COVID-19, they may also be a reflection of states recognizing that telehealth is here to stay, and that mental/behavioral health professionals need guidance from state professional boards in order to provide high-quality telehealth care to their patients.

Conclusion

Interest in, and acceptance of, telehealth services continues to grow. More than ever before, federal and state legislators are under pressure to codify the flexibilities granted in response to the COVID-19 pandemic that increased access to telehealth services. Meanwhile, increased use of telehealth has put a much greater focus on the potential for fraudulent behavior and the need for enforcement activity. Telehealth providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on telehealth opportunities while at the same time making investments in compliance infrastructures in order to operate in accordance with applicable laws.

ENDNOTES

[i] U.S. Department of Justice, National Health Care Fraud Enforcement Action Results in Charges Involving over $1.4 Billion in Alleged Losses (Sept. 17, 2021), available at https://www.justice.gov/opa/pr/national-health-care-fraud-enforcement-ac....

[ii] U.S. Department of Justice, DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19 (May 26, 2021), available at https://www.justice.gov/opa/pr/doj-announces-coordinated-law-enforcement....

[iii] U.S. Department of Justice, DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19 (May 26, 2021), available at https://www.justice.gov/opa/pr/doj-announces-coordinated-law-enforcement....

[iv] U.S. Department of Health and Human Services, Office of Inspector, Data Brief OEI-02-19-00401 (Sept. 2021), available at https://oig.hhs.gov/oei/reports/OEI-02-19-00401.pdf.

[v] Interstate Medical Licensure Compact, available at https://www.imlcc.org/.

[vi] National Council of State Boards of Nursing, Nurse Licensure Compact, available at https://www.ncsbn.org/nurse-licensure-compact.htm.

[vii] The Psychology Interjurisdictional Compact, available at https://psypact.site-ym.com/page/About.

[viii] Center for Connected Health Policy (CCHP), Policy Trend Maps, available at https://www.cchpca.org/policy-trends/.

©2021 Epstein Becker & Green, P.C. All rights reserved.National Law Review, Volume XI, Number 322
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About this Author

AMY F LERMAN regulatory transactional health care lawyer Epstein Becker Law firm
Member

AMY F. LERMAN is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. Ms. Lerman focuses her practice on a variety of regulatory and transactional health care matters, including corporate compliance, durable medical equipment, Medicare program integrity auditing and monitoring, and telehealth/telemedicine. She represents a variety of health care providers and organizations, as well as investors and other financial institutions that invest in or support the health care industry.

Ms. Lerman:

...
202-861-1832
Francesca R. Ozinal, Epstein Becker, Due Diligence Lawyer, Policy Compliance Attorney
Associate

 

FRANCESCA R. OZINAL is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. She will be focusing her practice on such areas as legislation and policy developments, compliance, and due diligence.

During law school, Ms. Ozinal was the Executive Editor of the Administrative Law Review and received academic excellence awards for Health Law and Healthcare Fraud and Abuse. She also served as a judicial intern for the Honorable Russell F. Canan at the D.C....

202-861-1862
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