DEA Controlled Substance Prescribing via Telehealth: Understanding In-Person Exam Waivers and Post-PHE Requirements

The ability for healthcare practitioners to prescribe controlled substances via telehealth has been a dynamic and often complex regulatory area, particularly following the COVID-19 Public Health Emergency (PHE). At the heart of this complexity lies the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 802(54)), which generally requires an in-person medical evaluation before a practitioner can prescribe controlled medications. However, the PHE introduced significant, albeit temporary, waivers to this rule.

The Ryan Haight Act: The Foundation

The Ryan Haight Act was enacted to combat the proliferation of rogue online pharmacies and prevent the unlawful distribution of controlled substances. A core tenet of this act is the requirement for a prior in-person medical evaluation before a controlled substance can be prescribed. Specifically, it states that a prescription for a controlled substance issued by means of the internet must be predicated on a medical evaluation of the patient that was conducted in the physical presence of the practitioner. The Act does provide for certain exceptions, such as when the patient is being treated in a hospital or clinic, or when the prescription is issued by a practitioner who is co-located with the patient and is acting as a covering practitioner for the patient's regular practitioner.

Key Provisions of the Ryan Haight Act:

• In-Person Exam Requirement: Generally mandates an in-person medical evaluation before prescribing controlled substances via the internet. (21 U.S.C. § 802(54)(A))
• Legitimate Medical Purpose: Emphasizes that any prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. (21 CFR § 1304.04(c))
• Exceptions: Outlines specific scenarios where the in-person exam is not required, such as patients in DEA-registered hospitals or clinics, or when the practitioner is covering for another. (21 U.S.C. § 802(54)(B))

The COVID-19 Public Health Emergency Waivers

During the COVID-19 PHE, which began in January 2020, the Drug Enforcement Administration (DEA), in conjunction with the Department of Health and Human Services (HHS), issued temporary waivers to the Ryan Haight Act's in-person examination requirement. These waivers allowed DEA-registered practitioners to prescribe Schedule II-V controlled medications to patients via telehealth without a prior in-person medical evaluation, provided certain conditions were met. The primary condition was that the prescription was issued for a legitimate medical purpose in the usual course of professional practice, and the practitioner was acting in good faith.

These waivers were instrumental in ensuring continuity of care during the pandemic, particularly for patients in rural areas or those with limited access to in-person care. They facilitated the expansion of telehealth services across various specialties, including mental health and pain management, where controlled substances are often a critical component of treatment plans.

Post-PHE Landscape and DEA's Proposed Rules

The COVID-19 PHE officially ended on May 11, 2023. This expiration meant that the broad waivers to the Ryan Haight Act were set to expire. Recognizing the significant impact this would have on patient access to care, the DEA issued a series of extensions and proposed new rules to establish a more permanent framework for telehealth prescribing of controlled substances.

Initial Proposed Rules (February 2023)

In February 2023, the DEA published two proposed rules: one for all controlled substances (Schedules II-V) and another specifically for buprenorphine for opioid use disorder (OUD). These rules aimed to create a pathway for telehealth prescribing while balancing patient access with diversion prevention. Key aspects of the initial proposals included:

• Schedule II Controlled Substances: Generally required an in-person medical evaluation for initial prescriptions of Schedule II controlled substances, with limited exceptions.
• Schedule III-V Controlled Substances: Allowed for an initial 30-day supply of Schedule III-V non-narcotic controlled substances and buprenorphine for OUD to be prescribed via telehealth without an in-person exam, provided certain conditions were met. Subsequent prescriptions would generally require an in-person evaluation.

PHE Expiration and Grace Periods

Upon the PHE's expiration on May 11, 2023, the DEA initially announced a telehealth prescribing grace period to allow patients to continue receiving care and practitioners to adjust their practices. This grace period extended the PHE flexibilities until November 11, 2023. For practitioner-patient relationships established on or before May 11, 2023, the full set of PHE flexibilities for prescribing controlled medications via telehealth remained in effect until November 11, 2023. For those relationships established after May 11, 2023, the flexibilities were more limited.

Subsequent Extension and Current Status

In October 2023, the DEA, in conjunction with HHS, announced a further extension of the full telehealth flexibilities for prescribing controlled substances. For relationships established on or before November 11, 2023, the PHE flexibilities remain in effect until December 31, 2024. This extension was granted to allow the DEA more time to review the over 38,000 public comments received on its proposed rules and to potentially finalize a new, more enduring regulatory framework.

Current Rules for Telehealth Prescribing of Controlled Substances:

As of late 2023 and extending into 2024, the following applies:

1. Patient-Practitioner Relationship Established On or Before November 11, 2023: If a practitioner-patient relationship was established on or before November 11, 2023, through a telehealth encounter, the practitioner may continue to prescribe controlled medications to that patient via telehealth, even if an in-person medical evaluation has not occurred. This flexibility is extended until December 31, 2024.
2. Patient-Practitioner Relationship Established After November 11, 2023: For new patient-practitioner relationships established after November 11, 2023, the Ryan Haight Act's in-person examination requirement generally applies, unless one of the statutory exceptions is met. This means, typically, an in-person evaluation is required before prescribing controlled substances.

The Future of Telehealth Prescribing: What to Expect

The DEA's goal is to finalize a new set of rules that balances patient access to care with the prevention of diversion and abuse. The significant number of public comments indicates a strong desire from both patients and providers for continued telehealth flexibilities. It is anticipated that the final rules may include some form of ongoing telehealth prescribing for certain controlled substances, potentially with safeguards such as:

• Initial in-person or qualifying telehealth evaluation: A requirement for a comprehensive initial evaluation, which might include a limited telehealth assessment followed by a referral for an in-person exam within a certain timeframe.
• Limits on initial prescription quantities: Restrictions on the amount or duration of the first prescription issued via telehealth.
• Specific requirements for Schedule II vs. Schedule III-V: Differentiated rules based on the schedule of the controlled substance.
• State law compliance: Continued emphasis that federal rules are a floor, and state laws (which can be more restrictive) must also be followed.

Compliance Implications for Healthcare Businesses

Healthcare businesses, including telehealth platforms, medspas, dental practices, and chiropractic offices, must remain vigilant and ensure their prescribing practices for controlled substances comply with the current DEA regulations and any forthcoming final rules. Key considerations include:

• Documentation: Meticulous documentation of all patient encounters, medical evaluations, and prescribing decisions, especially when utilizing telehealth.
• State Law Adherence: Always verify and comply with state-specific laws and medical board regulations regarding telehealth and controlled substance prescribing, as these can be more stringent than federal requirements.
• Practitioner Training: Ensure all prescribing practitioners are fully aware of and trained on the current DEA regulations, including the nuances of the Ryan Haight Act and any applicable waivers or grace periods.
• Technology and Security: Utilize secure, HIPAA-compliant telehealth platforms and electronic prescribing systems that meet DEA requirements for controlled substances (EPCS).
• Ongoing Monitoring: Continuously monitor DEA announcements and federal register publications for updates on the final rules for telehealth prescribing of controlled substances.

Conclusion

The regulatory environment for telehealth prescribing of controlled substances is in a state of transition. While the COVID-19 PHE waivers provided unprecedented flexibility, the DEA is working towards a more permanent framework. Healthcare businesses must understand the foundational Ryan Haight Act, the temporary extensions post-PHE, and actively prepare for the implementation of new, finalized rules. Proactive compliance and a commitment to patient safety will be crucial for navigating this evolving landscape successfully.

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Source: Drug Enforcement Administration (DEA) Diversion Control Division

URL: https://www.deadiversion.usdoj.gov/pubs/docs/telemed_qa.htm

URL for Proposed Rules & Extensions: https://www.deadiversion.usdoj.gov/telemedicine/