The Public Health Emergency Ended May 11, 2023: Are the COVID-Era Prescribing Exceptions in Effect?

At the beginning of COVID-19, telemedicine rules were softened on the state and federal level.  In a previous blog post, we discussed the Medicare and Ryan Haight Act rules during the COVID-19 Public Health Emergency (“PHE”).   The PHE was lifted on May 11, 2023, and there is no final rule modifying the Ryan Haight Act, so that leaves the question:

Do we go back to the strict Pre-Covid-19 telemedicine rules? 

This post intends to answer that question.  If you have questions about telemedicine rules or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

• Pre-COVID-19 Federal Prescribing Rules

Under the federal Ryan Haight Act, prescribing controlled substances generally requires that the Practitioner/prescriber conduct at least one in-person medical evaluation of the patient.  21 U.S.C. Sect. 829(e) (“Controlled substances dispensed by means of the Internet”).    This is still the law on the books, but, as you’ll see below, there are still COVID-era exceptions in place as well as proposed rules to modify this law (nothing is final yet so it’s important to know the current law). The Ryan Haight Act states:

1. No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.][1] may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.
2. As used in this subsection:

(A) The term “valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by-

(i) A practitioner who has conducted at least 1 in-person medical evaluation of the patient; or

(ii) A covering practitioner.

(B) (i) The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals. (ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course or professional practice.

(C) The term “covering practitioner” means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who-

(i) Has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and

(ii) Is temporarily unavailable to conduct the evaluation of the patient.

• COVID-Era Flexibility to the Rule

One exception to the general rule requiring an in-person medical evaluation is when the Secretary of HHS declares a PHE under 42 U.S.C. 247d.  21 C.F.R. § 1300.04(i)(4).  The exception provides flexibility to the rules as follows:

DEA-registered practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:

• • The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
  • The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and
  • The practitioner is acting in accordance with applicable Federal and State laws.

See DEA Diversion Program FAQ.

• Post-COVID-Era: Shor-Term Flexibility Extension

The PHE ended last month (May 11, 2023).  Prior to it ending, however, the DEA extended these COVID-era exceptions to avoid lapses in care for patients.  The extension is to allow the DEA to review the over 38,000 comments to the March 1, 2023 telemedicine rules proposed by the DEA and HHS, which will likely take the place of the Pre-COVID-19 rules (but nothing is final yet).

The extension took effect on May 11, 2023 and extends the COVID-era flexibilities for six-months.  The temporary extension states as follows:

The full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will remain in place through November 11, 2023.

Additionally, . . . . if a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until November 11, 2024.

As is clear from the above, medical practices must be thoughtful before offering healthcare telemedicine visits.  If you have questions about telemedicine rules or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

 

*Disclaimer: Thoughts shared here do not constitute legal advice and are only up-to-date to the date posted (posts are not updated unless otherwise indicated).