Compliance Corner—The End of the Public Health Emergency: What's Next for Telehealth?
- May 01, 2023
- Kathleen G. Healy , Robinson & Cole LLP
- Conor O. Duffy , Robinson & Cole LLP
COVID-19 has driven increased telehealth access and technology-based health care services. After grappling with the challenges imposed by the pandemic, health care organizations must now prepare for the upcoming end of the public health emergency (PHE). The COVID-19 national emergency and PHE were declared in early 2020. The PHE is scheduled to expire on May 11, 2023. This article highlights key legal and compliance issues affecting the future delivery and reimbursement of telehealth and technology-based services.
Congressional Extension of Telehealth Flexibilities
Following telehealth flexibilities passed by Congress in 2021 and 2022 in response to the COVID-19 pandemic, Congress extended certain statutory flexibilities as part of its Consolidated Appropriations Act of 2023.Federally Qualified Health Centers/Rural Health Clinics can serve as the distant site provider for non-behavioral/mental telehealth services; (2) Medicare patients can continue to receive services at any site, including their home; (3) continued coverage of audio-only telehealth services; (4) qualified occupational and physical therapists, speech pathologists, and audiologists can provide telehealth services; (5) delayed a provision requiring in-person visits with a physician every six months for the diagnosis, evaluation, and treatment of a mental health disorder; and (6) no geographic restrictions for an originating site for non-behavioral/mental telehealth services.These include the following waivers through December 31, 2024: (1)
In accordance with Congress’ actions, the Centers for Medicare & Medicaid Services (CMS) extended certain telehealth policies through at least December 31, 2023.Providers can bill for telehealth as if it were in-person and receive the same amount of reimbursement as in-person visits and provide telehealth services from their homes. Additionally, telehealth services added to the Medicare Telehealth Services List during the PHE will remain on the List at least through 2023.
Integral to the expansion of telehealth were corresponding flexibilities allowing for prescriptions of controlled substances based on a virtual treatment relationship. The Drug Enforcement Administration (DEA) affirmed in guidance that providers could prescribe controlled substances after conducting an evaluation of a patient via telehealth or in person.The federal Ryan Haight Act generally requires an in-person evaluation prior to a controlled substance prescription except in certain circumstances, including public health emergencies.
In March 2023, DEA issued proposed rules to extend certain tele-prescribing flexibilities relied upon by providers and patients during the pandemic under the Ryan Haight Act.DEA proposed allowing Schedule III-V controlled substances, and buprenorphine, to continue to be prescribed via telehealth in certain circumstances. DEA’s proposals have been the subject of extensive industry analysis on the basis that they do not go far enough to support telehealth prescribing that is essential to maintaining access to care, particularly for those patients relying on Schedule II controlled substances.
At the time of this writing, it remains to be seen whether DEA will finalize its proposals in their current form or whether industry pushback will expand the flexibilities for tele-prescribing. Regardless, practitioners who rely on tele-prescribing are likely to be the subject of ongoing scrutiny as DEA and other stakeholders assess the impact of these new flexibilities on both access to care and treatment, as well as on drug diversion and abusive prescribing practices.
The expansion of telehealth and corresponding waiver of or flexibility concerning licensure requirements during the PHE have been essential for treatment relationships and maintaining access to care. Remote virtual visits have been an essential infection control tool and have increased convenience for patients and providers. However, an ongoing challenge for providers is the patchwork of state laws concerning licensure and the practice of medicine or nursing via telehealth. Many of these laws and regulations were drafted prior to the era of telehealth. While good faith efforts during the pandemic to comply with state rules and to ensure continued delivery of medically necessary services for patients do not appear to have drawn widespread scrutiny from regulators, bad actors have been the subject of investigations and even prosecutions.
As we emerge from the pandemic the regulation of telehealth and licensure at the state level remains inconsistent, but there is growing support for state-level extension of telehealth flexibilities adopted during the pandemic. This is being accomplished in a number of ways, including growing support for interstate licensure compacts, as well as state-level legislation and regulations supporting telehealth modalities of care.
Increased Scrutiny at the Federal and State Level
Health care organizations should anticipate increased scrutiny and potential enforcement activity at the end of the PHE. For example, the Office for Civil Rights in the Department of Health and Human Services will no longer be exercising enforcement discretion for telehealth remote communications.The Federal Trade Commission will also seek enforcement under the Health Breach Notification Rule, which requires entities not covered by the Health Insurance Portability and Accountability Act to alert outside parties if there is a breach of individually identifiable electronic health information. The Department of Justice’s (DOJ’s) Health Care Fraud Unit is prioritizing investigations and prosecutions of fraudulent telemedicine schemes. Increased scrutiny can be expected for telehealth startups and telemental health prescribers, as evidenced by recent investigations and the Office of Inspector General (OIG) special fraud alert pertaining to arrangements with telemedicine companies, as well as the DOJ’s July 2022 announcement of coordinated action to combat telemedicine fraud.
Key Takeaways for Providers
- Develop policies for telehealth services for calendar year (CY) 2023 and be prepared to revise them for CY 2024 and as telehealth rules further evolve.
- Develop an annual telehealth training for telehealth providers and staff.
- Monitor OIG audit activity and reports, as well as DOJ investigations.
- Consider effective methods for blending in-person and virtual care delivery.
- Anticipate additional scrutiny from regulators and potential enforcement activity.
- Pay attention to forthcoming research regarding telemedicine patient outcomes as this may influence the standard of care and future legislation.
Kathleen Healy is a Partner at Robinson & Cole LLP. Kate advises health care entities on transactional and complex health care regulatory matters. She represents a wide range of clients, including hospital systems, behavioral health providers, physician groups, accountable care organizations, clinically integrated networks, data collaboratives and health plans. Kate is a member of the firm’s Health Law Group and the Health Care Industry and Data Privacy + Cybersecurity Teams. She can be reached at 617.557.5995 or [email protected].
Conor Duffy is a Partner at Robinson & Cole LLP. Conor regularly advises health systems, hospitals, physician groups, community providers, and other health care entities on a range of health care regulatory, corporate, and transactional matters. Conor is a member of the firm’s Health Law Group and Data Privacy + Cybersecurity Team, and also counsels clients on privacy and security matters related to health and personal information and data. He can be contacted at 860.275.8342 or [email protected].
*The authors wish to thank and acknowledge Paul Sevigny, Legal Intern at Robinson+Cole, for his invaluable assistance with this article.
1 Proclamation No. 9994, 85 Fed. Reg. 15337 (Mar. 13, 2020); Determination that a Public Health Emergency Exists (Jan. 31, 2020), https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx.
2 Statement of Administration Policy Regarding House Rules, Exec. Off. of the President, Off. of Mgmt. & Budget (Jan. 30, 2023).
3 Consolidated Appropriations Act, 2023, Pub. L. No. 117-328, 136 Stat. 4459.
7 88 Fed. Reg. 12875, 12890 (Mar. 1, 2023) (to be codified at 21 C.F.R. pts. 1300, 1304, 1306).
8 See Information for States,
10 16 C.F.R. § 318.3(a); see
11 Lisa H. Miller, Deputy Assistant Att’y Gen., U.S. Dep’t of Just., Remarks at University of Southern California Gould School of Law on Corporate Enforcement and Compliance (Feb. 16, 2023).
13 See Julia Shaver, The State of Telehealth Before and After the COVID-19 Pandemic, 49