January 29, 2023

Volume XIII, Number 29


January 27, 2023

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Potential Pitfalls of Telehealth Prescribing

As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled substances via telehealth is uncertain.  Although the American Telemedicine Association and other industry groups continue to advocate for changes to allow telehealth providers to prescribe controlled substances in certain circumstances, without further action by Congress or the Drug Enforcement Administration (DEA), telehealth providers who prescribe controlled substances will need to conduct an in-person examination of the patient once the PHE ends. 

Despite recent investigations into certain telehealth prescribing practices involving controlled substances, signs point to the DEA eventually making permanent changes to allow some controlled substances to be prescribed via telehealth.  For example, in 2018, Congress directed the DEA to create a telemedicine special registration program as part of the SUPPORT for Patients and Communities Act, and in recent months, several states have loosened their requirements for telehealth prescribing.  However, the PHE flexibility and anticipated changes do not fully address the risks involved for telehealth prescribers, which should be mitigated given the heightened scrutiny around prescribing controlled substances. Below are two key areas that telehealth prescribers should evaluate and address by implementing appropriate safeguards as necessary.

State Requirements for Prescribing

As any multi-state provider knows, getting a handle on different states’ regulatory requirements is a constant challenge.  The federal Controlled Substances Act and DEA regulations set the requirement of an in-person examination prior to issuing a prescription except in limited situations (including the current PHE) as a baseline for prescribing controlled substances via telehealth. However, several states have more stringent requirements.  For example, several states require in-person examinations prior to prescribing a controlled substance without any exceptions or with exceptions that are narrower than the DEA’s exceptions.  State laws around renewing and reissuing prescriptions also vary, and telehealth providers need to navigate how often an in-person or audio-visual visit needs to occur in order to renew a prescription.

Telehealth providers operating in multiple states should carefully consider all relevant state laws when developing protocols around prescribing controlled substances.  Providers can either adopt specific protocols for each individual state or, alternatively, adopt protocols that comply with the most stringent state requirements.  Regardless of the approach, protocols should allow individual clinicians to exercise their professional judgment while complying with all relevant state law.

In addition, telehealth providers should to the best of their ability monitor changes in law and regulation and update relevant protocols as necessary.

Standard of Care for Prescribing

Telehealth providers must also use their clinical judgment to ensure that the telehealth encounter is adequate to meet the standard of care for prescribing the controlled substance indicated.  In many circumstances, an audio-visual visit will enable the provider to gather adequate information to make a diagnosis and determine that a controlled substances is the appropriate treatment, but this may not always be the case.  Once a controlled substance is prescribed, the prescriber should also ensure that mechanisms for clinically appropriate follow-up are also in place. 

For telehealth providers focused on only one aspect of the patient’s care, it can be difficult to obtain a full picture of the patient’s health.  Telehealth providers and their pharmacy partners should adopt systems to ensure that systems are in place to combat over-prescribing and screen for medications that could have adverse effects when taken together.  Providers should also implement policies and procedures to ensure that clinicians can verify telehealth patients’ identities and confirm that patients have the capacity to consent to treatment. 

For individual providers who are licensed and providing telehealth services to patients in multiple states with different regulatory schemes, it is very challenging to stay on top of the various requirements.  Strong, clinically supported policies, procedures and protocols are key, but they should not be so prescriptive as to interfere with the providers’ individual clinical judgment.  Telehealth providers should adopt strong compliance programs to support clinical best practices, and any marketing materials should be developed by, or in close collaboration with, the clinical teams. 

There is no doubt that telehealth continues to play a huge role in increasing access to care, and there is no reason to believe that will change in the future.  As telehealth’s prevalence has increased, so too will enforcement efforts targeting telehealth providers, especially when controlled substances are involved. 

©1994-2023 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XII, Number 151

About this Author

Lara Compton Health Care Lawyer Mintz

Lara is a trusted advisor to clients ranging from traditional health care providers to disrupter digital health platforms as they navigate the practical and regulatory challenges of health care innovation. Her unique depth of knowledge across HIPAA privacy and other regulatory issues governing the use of data, state and federal fraud and abuse laws, business planning and operational issues has led colleagues to describe Lara as the “Swiss Army knife” of health care problem-solving.

Working at the intersection of health care and technology, Lara counsels telemedicine and other...

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

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...

Cassandra L. Paolillo, Health care lawyer, Mintz Levin Law Firm

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...