Recent changes concerning the COVID–19 Public Health Emergency (COVID–19 PHE) have raised questions about how it will affect telehealth practices going forward. As a result, the Drug Enforcement Administration (DEA) has released a temporary regulation to assist with this transition. The summary of this regulation is that, provided certain conditions are met, as long as a qualified practitioner has seen a patient via telemedicine (or in person) prior to November 12, 2023, they or their “covering practitioner” (as defined below) can continue to write controlled substance prescriptions to that person through November 11, 2024. Following that deadline, practitioners would be required to return to the previous regulations permitted by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (RHA) is an amendment to the Controlled Substances Act (CSA). Congress enacted the RHA in response to internet pharmacies selling controlled substances online. It is essentially a federal prohibition on internet pharmacies filling prescriptions for controlled substances based only on an online form, without ever having met with the patient.
Under the RHA, it is illegal to deliver, distribute, or dispense controlled substances via the internet (which includes telemedicine technologies) without a “valid prescription.”
The RHA defines a “valid prescription” as:
- A prescription issued for a legitimate medical purpose, and
- In the usual course of professional practice, and
- By a practitioner who has either:
- Conducted at least one “in-person medical evaluation” of the patient; or
- Is a covering practitioner
The RHA defines a “covering practitioner” as a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who:
- Has conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine within the previous 24 months; and
- Is temporarily unavailable to conduct the evaluation of the patient.
Under this regulation, so long as the practitioner has seen a patient at least once in person, their covering practitioner is able to provide a valid prescription as defined by the RHA so long as the above is followed. There is no federal requirement for yearly in-person/telemedicine visits in order for the primary practitioner to prescribe controlled substances.
While the RHA does not currently require subsequent in-person visits for primary practitioners following the initial in-person visit, though generally annual in-person visits are good practice. However, if the prescription is being issued by a “covering practitioner” as defined above, the patient should have been seen by the primary practitioner within the last 24 months, either in person or via telehealth. Even though no subsequent in-person visit is required under federal law, state law may vary and can require subsequent in-person visits. As an example, under NJ law NJSA 45:1-62(e), when prescribing Schedule II medications, after the initial in-person visit, subsequent in-person visits are required every three months (with an exception option for minors being prescribed Schedule II stimulants). Additionally, Some states may not allow the prescribing of controlled substances via telemedicine. If states do allow it, the federal requirement of the in-person visit prior to prescribing controlled substances must be followed, even if state law does not require it.
In response to the COVID–19 PHE on January 31, 2020, the DEA granted temporary exceptions to the Ryan Haight Act and DEA’s regulations under 21 U.S.C. 802(54)(D). This allowed the prescribing of controlled medications via telemedicine encounters, even when the prescribing practitioner had not conducted an in-person initial medical evaluation of the patient.
These telemedicine flexibilities permitted practitioners to prescribe controlled medications (schedule II–V) via audio-video telemedicine encounters, including schedule III–V narcotic controlled medications via audio-only telemedicine encounters, without requiring an in-person medical evaluation. This was allowed so long as the prescribing of these medications otherwise comply with the requirements outlined in DEA guidance documents, DEA regulations, and applicable Federal and State law.
Practitioners must comply with the following when issuing controlled substances via telemedicine:
- The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of the prescriber’s profession;
- The telemedicine communication is conducted using an audio-visual, real-time (synchronous), two-way interactive communication system; and
- The practitioner must also act in accordance with applicable Federal and State law.
Prescribers may issue the prescription in any manner allowed under DEA regulations and state law. This includes issuing the prescription for a Schedule II through V controlled substance electronically, calling in an emergency Schedule II prescription, or by calling in a Schedule III-V prescription to the patient’s pharmacy.
The temporary nature of the COVID–19 PHE exceptions to the Ryan Haight Act and DEA’s implementing regulations caused uncertainty for businesses and providers. Since these exceptions were based on the COVID–19 PHE, logically the expiration of that PHE would lead to the end of those exceptions. For providers and businesses that have been utilizing and relying on these exceptions over the last several years, this has surely caused some stress. Thankfully, an announcement has been made securing these exceptions for a time.
On March 1, 2023 the DEA, together with the HHS, drafted and presented two notices of proposed rulemakings (NPRMs) asking for comments on proposals to allow for prescribing of controlled medications pursuant to the practice of telemedicine in circumstances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. Those NPRMs resulted in 38,369 public comments, which are being closely reviewed as modifications are considered.
In the meantime, the DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a temporary rule to extend certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID–19 PHE, in order to avoid lapses in care for patients. This extension went into effect when the COVID–19 PHE expired last month.
On May 10, 2023, the DEA released a new regulation called the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” Like its name suggests, this regulation temporarily extends the full scope of the DEA’s COVID-19 waivers for prescribing controlled substances via telemedicine.
According to the DEA, the rule is designed to extend the COVID-19 telemedicine flexibilities in place to prevent lapses in care now that the COVID-19 PHE has expired. It is meant to ensure continuity of care under the current telehealth flexibilities in place as a result of the PHE. Additionally, it is meant to ensure the continuity of care for telemedicine relationships established via telemedicine during the PHE. The DEA has also stated this temporary regulation is intended to allow time to prepare for the transition from the PHE regulations, give the DEA time to properly examine the over 38,000 comments they received in response to the two NPRMs; and enable a through evaluation other ways to expand telemedicine while still maintaining consistency with public health and safety requirements.
This hints that the DEA is open to consider alternatives to prior regulations, such as publishing a Telemedicine Special Registration rule. A Telemedicine Special Registration rule is an excellent vehicle that will solve many of the concerns surrounding balancing access to care while limiting and identifying unscrupulous prescribing patterns and illegal diversion.
The COVID–19 PHE waivers, which went into place in March 2020, have been further extended until November 11, 2023. Additionally, for any practitioner-patient relationships created during the waiver period, the waivers will actually continue to apply for a year beyond the initial expiration, and will expire on November 11, 2024. Put another way, if a patient and practitioner establish a telemedicine relationship by November 11, 2023, the same flexibilities that governed the prescribing will continue to apply for a year, through November 11, 2024.
While this extension of COVID flexibilities is temporary, just like the COVID-19 PHE, it is still a win for those using the telemedicine COVID-19 waivers. According to the DEA, the goal of this temporary rule is to “ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards that DEA and/or SAMHSA promulgate in one or more final rules.”
This rule only temporarily extends the telemedicine flexibilities for patients seen prior to November 11, 2023, November 22, 2024 at most. We encourage businesses and providers utilizing telemedicine to stay focused on preparing their business for the expiration of the extension. While it is likely that the DEA will issue a new telemedicine final rule (based on the March proposed rule) prior to November 11, 2023, the road forward is still unclear. The best practice is to begin making shifts in your business practices to reflect the regulations required by current law until a final decision on the March proposed rule has been made. This would mean that initial first visits would have to be in-person.
*This blog post is for informational purposes only and does not constitute legal, financial, or medical advice or the forging of an attorney-client relationship. Please retain the services of an attorney licensed in your state to receive legal advice on how the law applies to your business.