December 6, 2022

Volume XII, Number 340

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December 06, 2022

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December 05, 2022

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Telehealth Update: Assessing PHE Flexibilities, Pending Legislation Entering Fall 2022

As we covered in a prior Telehealth Update, many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (the PHE).  While permanent changes in many states have expanded the types of providers who can provide telehealth services and loosened requirements for establishing provider-patient relationships exclusively via telehealth, the telehealth flexibilities connected to the PHE have also played a large role in expanding access to care.  Specifically, the PHE telehealth flexibilities have allowed for greater reimbursement of telehealth services under Medicare, and crucially for many providers, allowed for the prescription of controlled substances without an in-person visit.  The temporary nature of the PHE telehealth flexibilities has also caused a lot of uncertainty and confusion among telehealth providers. 

We review below the current state of the PHE flexibilities around Medicare reimbursement and prescription of controlled substances, examine pending legislation that, if passed, would bring greater certainty to patients and providers, and discuss what we know about the status of a possible PHE extension as we move into the third Fall of the pandemic.

Current State of PHE Telehealth Flexibilities

At the beginning of the PHE, the Centers for Medicare and Medicaid Services announced several waivers related to Medicare coverage of telehealth services.  These waivers, outlined below, were initially intended to expire at the end of the PHE, but in March, as part of the Consolidated Appropriations Act, 2022, Congress extended these flexibilities for a period of 151 days, or about 5 months, after the expiration of the PHE.  The Medicare waivers include: 

  • Originating Site: Allows Medicare beneficiaries to receive telehealth services from any geographic location, including their home.

  • Expansion of Eligible Practitioners: Allows physical therapists, occupational therapists, speech therapists, and audiologists to provide telehealth services to Medicare beneficiaries.

  • Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs): Allows FQHCs and RHCs to continue providing telehealth services.

  • In-Person Requirement for Mental Health: Waives the requirement for mental health providers to see patients in person prior to providing behavioral health services via telehealth.

  • Audio-Only: Allows Medicare coverage of audio-only services when appropriate. 

Other significant PHE telehealth flexibilities involve the prescription of controlled substances via telehealth.Under the Controlled Substances Act (CSA) and its implementing regulations, providers may not prescribe controlled substances without first conducting an in-person examination of the patient, unless an exception applies.One such exception allows providers to satisfy the in-person examination requirement via a synchronous, audio-visual telehealth interaction during a public health emergency, as determined by the Secretary of the Department of Health and Human Services (HHS).In response to the PHE, the Drug Enforcement Administration (DEA) adopted policies to allow DEA-registered practitioners to prescribe controlled substances without having to interact in-person with their patients.In March 2020, the DEA also issued guidance waiving the requirement for separate registration requirements in each state where a provider prescribes.Pursuant to this guidance, for the duration of the PHE, providers with a DEA registration in one state have been able to prescribe controlled substances in other states where they are licensed or otherwise authorized to practice with prescriptive authority, without having to obtain multiple DEA registrations.Together, these DEA flexibilities have allowed telehealth providers to significantly expand the scope and geographic reach of their practices.For underserved patients, and especially in the area of mental health, this expansion has provided patientsaccess to much needed care.However, without further action by Congress or the DEA, both of these flexibilities will expire upon the expiration of the PHE.

Pending Legislation

At the end of July 2022, the Advancing Telehealth Beyond COVID-19 Act of 2021 passed the House and was sent to the Senate.  This bill, if passed, would extend most of the Medicare telehealth flexibilities outlined above through December 31, 2024 if the PHE ends before that date.  The waiver related to in-person evaluations requirements for mental health and telehealth services would be extended through January 1, 2025 or the first day after the PHE ends, whichever is later. 

As previously covered in a Telehealth Update earlier in 2022, the Telehealth Extension and Evaluation Act, which was introduced to the Senate in February, would extend the Medicare flexibilities and the flexibilities under the CSA for two years following the end of the PHE.  This bill has not progressed since being introduced. 

The American Telemedicine Association and other industry groups have indicated strong support for both of these bills. 

What Comes Next? 

On July 15, 2022, HHS Secretary Xavier Becerra renewed the PHE for an additional 90 days, as authorized under the Public Health Service Act.  While there was some conjecture that this might be the last renewal, and that the PHE would permanently end in mid-October, signs are now pointing to at least one more renewal, through January 2023.  As previously discussed, in January 2021, then-Acting HHS Secretary Norris Cochran issued a letter to state governors, which indicated that HHS will provide states with 60 days’ notice of the termination of the PHE.  Because we are now within 60 days of the end of the current extension, it is likely that the PHE will be extended again.

Telehealth providers who have been preparing for the end of the PHE for months or even years are likely relieved about the possible additional extension, but Congress will need to act in order to bring greater certainty to telehealth providers and their patients who have made the practice of telehealth an integral part of the health care delivery system.

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XII, Number 244
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About this Author

Ellen L. Janos, Health care attorney, mintz levin law firm,Digital Health PBMs & Pharmacies Hospitals & Health Systems Post-Acute & Long-Term Care Retail & Urgent Care Physician Organizations
Member

Ellen utilizes her in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Ellen often comments on developments in telehealth, HIPAA, and the corporate practice of medicine. As an assistant attorney general for the Commonwealth of Massachusetts, Ellen represented state...

617-348-1662
Cassandra L. Paolillo, Health care lawyer, Mintz Levin Law Firm
Associate

Cassie’s practice primarily involves advising health care clients on transactional and regulatory matters, including mergers and acquisitions, regulatory compliance, and general contracting.

Throughout her career, Cassie has worked with providers, payors, and individual patients, so she understands the unique challenges facing clients in the ever-changing health care landscape.

Prior to joining Mintz, Cassie worked as in-house counsel at a national senior living company. There she advised the business on matters related to state and federal health care regulations, physician...

617-348-1828
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