U.S. telehealth regulations changing the landscape in 2023
2023 PRINDBRF 0040
By Amy Lerman, Esq., Epstein Becker & Green PC
Practitioner Insights Commentaries
January 24, 2023
(January 24, 2023) - Epstein Becker & Green PC attorney Amy Lerman discusses changes in telemental health access and coverage the past several years and what may lie ahead in 2023.
Our mental health is inseparable from our physical health and well-being. Yet, unlike for physical health conditions, treatment for mental health conditions has long been underfunded, underappreciated, and overly stigmatized.
While the COVID-19 pandemic certainly intensified the unmet needs for mental health services and made it more difficult for individuals to access mental health care services, this issue significantly predates and outscales the onset of the pandemic in early 2020.
According to a recent poll conducted by the Kaiser Family Foundation and CNN, approximately 90 percent of Americans believe there is a mental health crisis in the United States today.1 An estimated 1 in 5 adults are affected by mental illness, and of those nearly half do not receive the treatment they need.
In 2022, reports of a 25 percent increase in the global prevalence of anxiety and depression pushed the Biden administration to prioritize access to mental health services, including the $1.5 trillion Consolidated Appropriations Act of 2022 that extended Medicare coverage related to telehealth practices.2
Among the various barriers cited by KFF/CNN poll respondents, an insufficient supply of mental health providers was cited as one of the more significant contributing factors. In 2021, more than one-third of Americans (37 percent) lived in geographic areas with shortages of mental health professionals.3
Lending support to the mental health crisis are the many different companies delivering telehealth services. Experts have predicted that certain areas in health care, including mental health, have been riper for disruption by telehealth companies.4
A July 2021 report published by McKinsey & Company predicted that psychiatry has the highest penetration for telehealth usage, at 50 percent.5 A March 2022 study from the Kaiser Family Foundation reported that during the peak of the pandemic in March through August 2020, approximately 40 percent of mental health visits were performed via telehealth (compared to 11 percent of non–mental health visits).
And, while non–mental health visits performed via telehealth have more recently dropped to 5 percent, mental health visits performed via telehealth have continued to hold strong at 36 percent.6 Although a common perception is that reaching out for and receiving mental health care services carries a high degree of stigma, the access being provided by digital platforms has helped patients receive care discreetly and under circumstances where they feel comfortable.
As a result, stakeholders have worked to expand access to mental health care services through regulatory changes. The need for putting social distancing measures in place during the pandemic contributed to a sharp increase in the provision of telehealth services, as states promoted changes in regulations that served to widen access of counseling, therapy, prescribing, and other services via remote methods such as video and telephone.
The health care industry also has benefitted in recent years from ongoing innovation in, and continued efforts to expand access to, telehealth technologies in order to increase patient access to mental health providers, including psychiatrists, psychologists, counselors, therapists, and other trained professionals.
Yet, even with emphasis on improving access-to-care issues, throughout 2022 mental health care providers continued to grapple — in respect to in-person care and virtual care — with the same questions of access and coverage. These struggles have underscored the continued importance of supporting efforts at both the federal and state level to further ease certain significant regulatory barriers to entry for telemental health providers and companies.

Tracking state regulatory efforts in the EBG telemental health laws survey

In 2022, the telehealth industry saw federal and state governments continue to support regulatory flexibilities that were originally put into place during the height of the pandemic, many of which promoted increased use of telehealth, both as lessons learned and to help lawmakers and regulators decide which temporary changes should be made more permanent.
As state legislatures and Congress continue to tackle the mental health crisis through various regulatory efforts, Epstein Becker Green's 7th Annual Telemental Health Laws Survey (the "Survey") has tracked the continued expansion of regulations and other regulatory flexibilities provided by states with the purpose of promoting increased use of telemental health services.
The Survey's focus on behavioral health professions highlights the ongoing mental health crisis and an industry that is in dire need of qualified mental health resources. The 2022 updates to the Survey illustrate that there are significant opportunities for evolution in the telehealth industry and specifically within the telemental health industry. The Survey's complete findings are available for download via an app here.7

2022 momentum

In 2022, the telehealth industry and, specifically, mental health professionals working in the industry, benefitted from continued regulatory updates in many states that were intended to promote greater flexibility and access to telehealth technology for use by psychiatrists and other mental health professionals such as psychologists, social workers, and counselors. Measures of increased accessibility in 2022 have included:
Broader coverage under state Medicaid programs. While all state Medicaid programs provide coverage and reimbursement for some telehealth services, a key development seen throughout 2022 was certain state Medicaid programs making permanent the temporary COVID-19 flexibilities in coverage and reimbursement, expanding the coverage of telehealth services more broadly than ever before. State Medicaid programs expanded the categories and types of telehealth services for which they will provide coverage, and some state programs took the significant step of extending coverage for certain services that are supplied through audio-only modalities. Providers of mental health services via telehealth have benefitted from these expansions in coverage.
Increased opportunities for interstate practice. In 2022, states continued to evolve in terms of regulating how professionals can fulfill professional licensure requirements which traditionally have been controlled by the individual states. Certain states have addressed the issue by offering limited use, special telemedicine licenses that will allow practitioners to provide telehealth services to patients in the state under certain parameters. Greater state participation in various professional compacts also has helped facilitate cross-state practice activities. Irrespective of federal and state policies, compacts have become a major force behind increased momentum for telehealth among various types of providers, including those providing mental health services.
Notably, as of the fall of 2022:
•Thirty-seven (37) states, the District of Columbia, and the territory of Guam have joined the Interstate Medical Licensure Compact (for physicians) ("IMLC").8
•Thirty-seven (37) states, the U.S. Virgin Islands, and Guam have joined the Nurse Licensure Compact (for registered nurses and licensed practical nurses) ("NLC").9
•Twenty-six (26) states have joined the Psychology Interjurisdictional Compact ("PSYPACT").10
•The Advanced Practice Registered Nurse Compact, which goes into effect once seven jurisdictions have enacted the legislation, continues to gain steam.
•Seventeen (17) states have enacted the Counseling Compact, and the Counseling Compact Commission hopes to begin accepting applications in late 2023 or early 2024.11
Greater flexibilities for remote prescribing. States also continued throughout 2022 to clarify and refine requirements under which physicians and certain other professionals may engage compliantly in remote prescribing practices, often by eliminating the requirement that a provider conduct a prior in-person examination and allowing instead for the necessary examination to occur via telehealth.
While remote prescribing issues have gained greater clarity at the state level, uncertainty remains as to efforts at the federal level to make changes to similar requirements under the federal Controlled Substances Act ("CSA").
As background, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was enacted in October 2008 and amended the CSA by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet.12
One such amendment was adding the requirement of an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the internet, except in the case of practitioners engaged in the "practice of telemedicine" — however, the definition of the "practice of telemedicine" includes seven (7) distinct categories which describe circumstances in which the prescribing practitioner may be unable to satisfy the Act's in-person medical evaluation requirement yet, nonetheless, has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of the practitioner's professional practice.
One of the 7 categories is "a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. § 831(h)]."13
The Ryan Haight Act contemplated that DEA had to issue regulations in order to effectuate this special registration provision. DEA has long proposed to amend the CSA to permit such a special registration, but to date no meaningful actions have been fully taken.14 DEA has, in response to the January 2020 declaration of a public health emergency ("PHE"), utilized a temporary waiver that has allowed providers to remotely prescribed controlled substances provided certain conditions are met.15
When enacting this temporary waiver, DEA was clear that the agency was only doing so "for as long as the Secretary's designation of a public health emergency remains in effect." The current PHE is set to expire on April 11, 2023, and, until closer to that date, it will be unclear whether the Biden Administration will renew it.16

Looking ahead in 2023

As the telehealth and telemental health industries continue to expand, federal and state legislators have important decisions to make about which of the flexibilities granted in response to the COVID-19 pandemic should become permanent.
In 2023 it will remain critical for telehealth and specifically telemental health services providers to monitor developments in federal and state laws, regulations, and policies while making investments in compliance. Enforcement data provides a useful starting point for setting regulatory compliance priorities. Some key areas where providers should focus are:
Making compliance an essential, rather than optional, element of ongoing operations. In 2022, the telehealth industry saw greater scrutiny from state and federal lawmakers and regulators, through efforts at both levels to address the increased risk of fraudulent schemes. Agencies including the U.S. Department of Justice ("DOJ") and the U.S. Department of Health and Human Services' Office of Inspector General ("HHS-OIG") have continued to build on previous activities in this area.17
As a result, telehealth providers and companies are, for many reasons, on notice regarding a variety of compliance considerations, including, but not limited to, professional licensure requirements, scope of practice, technology considerations, prescribing activity, HIPAA compliance, and patient consent. State and in many cases federal laws in each of these areas, and others, continue to evolve.
Constructing and operationalizing a compliance infrastructure that can manage the necessary operational effects of these changes (e.g., policies and procedures, education and training, investigation and resolution functions) is no longer a "nice to have" but, rather, a "must have" for all telehealth providers and companies, regardless of their size.
Maintaining consistency and quality control over coding and billing for telehealth services. The OIG's September 2022 Data Brief on program integrity risk in Medicare telehealth billing provided an extremely useful roadmap for the industry with respect to billing and coding priorities. In 2023, stakeholders must continue to look closely at their internal coding, billing, auditing, and monitoring practices, all of which serve as important checks and balances to ensure compliant behavior.
Continuing to advocate for greater accessibility, coverage, and reimbursement of telehealth services. Although the increased use of telehealth has represented increased accessibility for many patients, equity challenges still remain.
While payors generally have dramatically improved coverage for telehealth services, these changes have not been equal across the board and do not account for remaining populations who are uninsured. There are certain conditions for which access to telehealth-based services remains inaccessible, often because the individuals dealing with these conditions may not be able to receive services via telehealth. In addition, many patients do not have access to the types of technology needed to participate in telehealth services.
These equity challenges underscore the importance of continuing to advocate for greater coverage of telehealth services with all payors, and for covering audio-only options for people who do not have access to smartphones, videoconferencing services, and/or Wi-Fi. Providers of mental health services can be among the strongest advocates for these types of changes, having had the most direct contact and experience with the patients who face these equity challenges.
Continued improvements to provider reimbursement rates for telehealth services also will go a long way toward promoting the cost effectiveness of the services. Telehealth services are less likely to be perceived as cost effective by users if their costs are on par with in-person visits.
Likewise, the currently popular model of charging users for individual virtual interactions (e.g., per phone call, per portal message, per videoconferencing session) using a fee-for-service model makes it less likely the technology will be perceived by payors as cost-effective. Yet, if reimbursement rates for telehealth services are too low, providers could decide to stop delivering these types of services.
Higher reimbursement rates also could lead to increases in out-of-pocket spending for beneficiaries. Providers and payors should continue in 2023 to collaborate on developing cost effective models for the delivery of telehealth services.
Notes
1 See KFF/CNN Mental Health in America Survey (Oct. 5, 2022), available at http://bit.ly/3Xa2e1f; see also The Advisory Board, Daily Briefing, The U.S.' Growing Mental Health Crisis, In 6 Charts (Oct. 7, 2022), available at http://bit.ly/3COs9Dr.
2 World Health Organization, COVID-19 Pandemic Triggers 25% Increase in Prevalence of Anxiety and Depression Worldwide (Mar. 2, 2022), available at http://bit.ly/3CNSpxT; U.S. Department of Health & Human Services, Telehealth Policy Changes After the COVID-19 Public Health Emergency (last updated Nov. 23, 2022), available at http://bit.ly/3H2HFOr.
3 Julia Harris et al., Bipartisan Policy Center, The Future of Telehealth After COVID-19: New Opportunities and Challenges (Oct. 11, 2022), available at http://bit.ly/3ZCq5YQ.
4 Gabriel Perna, Health Evolution, Telehealth's Mixed 2021 Leads to Questions About 2022 and Beyond (Jan. 5, 2022), available at http://bit.ly/3QGSA3S.
5 McKinsey & Company, Telehealth: A Quarter-Trillion Dollar Post-COVID-19 Reality? (July 9, 2021), available at http://bit.ly/3ZCSPkv.
6 Justin Lo et al., Kaiser Family Foundation, Issue Brief, Telehealth Has Played an Outsized Role Meeting Mental Health Needs During the COVD-19 Pandemic (Mar. 15, 2022), available at http://bit.ly/3XmGIWU.
7 http://bit.ly/3iJxcy2
8 For more information about the IMLC, see http://bit.ly/3XahiMi.
9 For more information about the NLC, see http://bit.ly/3H3CgXz.
10 For more information about PSYPACT, see https://bit.ly/3IJIsFt.
11 For more information about the Counseling Compact, see http://bit.ly/3IJ63Gl.
14 See Office of Management and Budget, Office of Information and Regulatory Affairs, Pending EO 12866 Regulatory Review (Mar. 17, 2022), available at http://bit.ly/3WbkbeD.
15 See U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Division, COVID-19 Information Page (refer to "Telemedicine" section on page) (last viewed Jan. 4, 2023), available at http://bit.ly/3QHPzAi.
16 See U.S. Department of Health and Human Services, Administration for Strategic Preparedness & Response, Renewal of Determination That a Public Health Emergency Exists (Jan. 11, 2023), available at http://bit.ly/3w4Mzo6. The Biden Administration has indicated they will give states sixty (60) days' notice prior to the termination or expiration of the PHE to begin winding down the flexibilities that have been available during the COVID-19 pandemic (e.g., Medicaid eligibility expansion).
17 U.S. Department of Justice, Press Release, Justice Department Charges Dozens for $1.2 Billion in Health Care Fraud (July 20, 2022), available at http://bit.ly/3Xh23RW; U.S. Department of Health and Human Services, Office of Inspector General, Special Fraud Alert: OIG Alerts Practitioners to Exercise Caution When Entering Into Arrangements with Purported Telemedicine Companies (July 20, 2022), available at https://bit.ly/3GIwF7J; U.S. Department of Health and Human Services, Office of Inspector General, Data Brief, Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks (OEI-02-20-00720) (Sept. 2022), available at https://bit.ly/3QDD1d2.
By Amy Lerman, Esq., Epstein Becker & Green PC
Amy Lerman is a member of Epstein Becker & Green PC's health care and life sciences practice. She is based in the firm's Washington, D.C., office, where she focuses on regulatory and transactional health care matters, including telehealth and telemedicine. She can be contacted at [email protected].
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