DEA Extends Telemedicine Flexibilities for Prescribing of Managed Medicines

Up to date on Could 11, 2023

On Could 10, 2023, the Drug Enforcement Company (DEA) launched a brand new regulation – “Short-term Extension of COVID-19 Telemedicine Flexibilities for Prescription of Managed Medicines” – quickly extending the “full set” of DEA’s COVID-19 waivers for prescribing managed substances through telemedicine. These waivers, which have been in place since March 2020, at the moment are prolonged via November 11, 2023. As well as, for any practitioner-patient relationships created through the waiver interval, the waivers will proceed to use via November 11, 2024. Put one other manner, if a affected person and practitioner set up a telemedicine relationship by November 11, 2023, the identical flexibilities that ruled the prescribing will proceed to use via November 11, 2024.

Whereas that is only a non permanent extension of COVID flexibilities, it may be thought-about a win for sufferers and clinicians utilizing telemedicine. The credit score goes to the general public at giant for making their voices heard (loudly) via the submission of a record-breaking 38,369 public feedback to the proposed telemedicine rule. These public feedback have been a big cause for this extension. Our gratitude additionally goes out to the Administration and the management at DEA and Substance Abuse and Psychological Well being Companies Administration (SAMHSA) for listening to these voices. Lastly, a thanks to our shoppers and the stakeholder skilled associations, together with the American Telemedicine Affiliation (ATA), for his or her tireless advocacy in pursuit of affected person care.

Key Provisions Below the DEA’s Short-term Rule

1. What’s the Ryan Haight Act?

The statutory foundation for the DEA’s rule is the Ryan Haight On-line Pharmacy Client Safety Act of 2008 (Ryan Haight Act), which prohibits the distributing, meting out or supply of managed substances through the Web with out a legitimate prescription. It applies solely in restricted circumstances the place the practitioner needs to prescribe a managed substance through telemedicine and has by no means carried out an in-person medical examination of the affected person.

The Ryan Haight Act requires a practitioner to conduct at the very least one in-person medical analysis of the affected person earlier than prescribing a managed substance by the use of the “Web” (a broadly-defined time period that features telemedicine). As soon as the practitioner has carried out this in-person medical analysis, the Ryan Haight Act doesn’t set an expiration interval or requirement for subsequent annual exams. Failure to conduct this in-person medical analysis can represent a per se violation of the Managed Substances Act and end in civil and felony penalties.

The Ryan Haight Act was designed to fight the proliferation of so-called “rogue Web websites” that unlawfully allotted managed substances by the use of the Web, together with on-line pharmacies providing managed substances with out a legitimate doctor-patient relationship. But the broad language of the Ryan Haight Act applies not solely to pharmacies, but additionally to professional practitioners who prescribe managed substances through telemedicine. 

Within the years because it was enacted, the DEA has used the Ryan Haight Act to manage {the marketplace}, sanctioning practitioners and pharmacies whose unethical and substandard prescribing practices violated the legislation.

2. Is that this rule issued pursuant to one of many “observe of telemedicine” exceptions below the Ryan Haight Act?

Sure. The Ryan Haight Act comprises seven “observe of telemedicine” exceptions to the in-person medical analysis requirement. These are seven distinct classes Congress decided have been applicable to permit for telemedicine prescribing of managed substances regardless of the practitioner by no means having examined the affected person in individual. The rule creates the non permanent extension below exception #7, a versatile catch-all exception (“The observe of telemedicine is being carried out below every other circumstances that the [DEA] Administrator and the Secretary of Well being and Human Companies have collectively, by regulation, decided to be in keeping with efficient controls in opposition to diversion and in any other case in keeping with the general public well being and security.”). The rule is issued pursuant to 21 U.S.C. § 802(54)(G) and amends 21 C.F.R. Half 1307 and 42 C.F.R. Half 12. 

3. What is that this rule meant to perform?

In response to the DEA, the rule is designed to increase the COVID-19 telemedicine flexibilities in place to make sure sufferers don’t expertise lapses in care, and to make sure continuity of care below the present telehealth flexibilities in place on account of the COVID-PHE. It is usually meant to facilitate continuity of look after telemedicine relationships established through telemedicine through the COVID-19 PHE and handle the pressing public well being want for continued entry to the initiation of buprenorphine as medicine for opioid use dysfunction. Different acknowledged functions are:

• Enable sufferers, practitioners, pharmacists, service suppliers, and different stakeholders ample time to organize for the implementation of any future rules that apply to prescribing of managed medicines through telemedicine;

   

• Allow DEA, collectively with SAMHSA, to completely overview and reply to the 38,369 feedback they obtained in response to the 2 notices of proposed rulemaking; and

   

• Allow DEA, collectively with SAMHSA, to conduct an intensive analysis of regulatory alternate options so as to promulgate rules that the majority successfully increase entry to telemedicine encounters in a fashion that’s in keeping with public well being and security, whereas sustaining efficient controls in opposition to diversion.

  Be aware: This remaining function (conduct a “thorough analysis of regulatory alternate options”) doubtlessly hints the DEA is open to contemplate one other various, comparable to publishing a Telemedicine Particular Registration rule. A Telemedicine Particular Registration rule is a superb automobile to resolve for most of the considerations about balancing entry to care whereas limiting and figuring out unscrupulous prescribing patterns and unlawful diversion.

4. What time interval does this rule cowl?

The rule extends the COVID-19 PHE DEA telemedicine flexibilities via November 11, 2023. For any practitioner-patient relationships established through telemedicine encounters on or earlier than that date, the rule additionally extends the COVID-19 PHE telemedicine flexibilities via November 11, 2024.

• The total set of telemedicine flexibilities relating to prescription of managed medicines as have been in place through the COVID-19 PHE will stay in place via November 11, 2023.

   

• For practitioner-patient telemedicine relationships established on or earlier than November 11, 2023, the total set of telemedicine flexibilities relating to prescription of managed medicines as have been in place through the COVID-19 PHE will proceed to be permitted through a one-year grace interval via November 11, 2024. In different phrases, if a affected person and a practitioner have established a telemedicine relationship on or earlier than November 11, 2023, the identical telemedicine flexibilities which have ruled the connection to that time are permitted till November 11, 2024.

5. Which DEA waivers are prolonged below this rule?

DEA stated it’s extending the “full set” of telemedicine flexibilities relating to the prescription of managed medicines, referencing the 2 DEA letters that licensed telemedicine waivers.

• A March 25, 2020 “Pricey Registrant” letter signed by William T. McDermott, DEA’s then-Assistant Administrator, Diversion Management Division.
• A March 31, 2020 “Pricey Registrant” letter signed by Thomas W. Prevoznik DEA’s then-Deputy Assistant Administrator, Diversion Management Division.

The March 25 letter addressed two waiver exceptions: one associated to DEA registrations in particular person states; and one associated to the in-person analysis requirement. It acknowledged, in related half:

• DEA-registered practitioners are usually not required to acquire extra registration(s) with DEA within the extra state(s) the place the meting out (together with prescribing and administering) happens, at some point of the general public well being emergency declared on January 31, 2020, if licensed to dispense managed substances by each the state wherein a practitioner is registered with DEA and the state wherein the meting out happens. Practitioners, in different phrases, should be registered with DEA in at the very least one state and have permission below state legislation to observe utilizing managed substances within the state the place the meting out happens.

   

• Below the Managed Substances Act (CSA), a prescription for a managed substance issued by the use of the Web should typically be predicated on an in-person medical analysis. See 21 U.S.C. § 829(e)(1). This requirement doesn’t apply, nonetheless, when a practitioner is working towards telemedicine as outlined by the CSA. The CSA’s definition of the observe of telemedicine consists of a number of completely different classes of telemedicine. For a number of of those classes, the CSA particularly requires a practitioner to have a DEA registration within the state wherein the affected person is situated. See, e.g., 21 U.S.C. § 802(54)(A), (B). However the observe of telemedicine throughout a public well being emergency pursuant to 21 U.S.C. § 802(54)(D) doesn’t embrace this requirement. On March 16, 2020, the Secretary of america Division of Well being & Human Companies, with concurrence of the Appearing DEA Administrator, designated that the telemedicine allowance below part 802(54)(D) applies to all schedule II-V managed substances in all areas of america.

The March 31 letter prolonged waivers with respect to prescribing of buprenorphine. It acknowledged, in related half:

• DEA notes that practitioners have additional flexibility through the nationwide public well being emergency to prescribe buprenorphine to new and present sufferers with opioid use dysfunction (OUD) through phone by in any other case licensed practitioners with out requiring such practitioners to first conduct an examination of the affected person in individual or through telemedicine.

The currently-prevailing interpretation is that this newly-released rule extends the waivers in each the March 25 letter (registration and in-person examination) and March 31 letter (buprenorphine), collectively constituting the “full set” of telemedicine flexibilities. Foley has reached out to DEA for affirmation that the registration necessities are being prolonged and can replace this weblog once we obtain a response.

6. What’s the definition of “telemedicine relationship established through COVID-19 telemedicine prescribing flexibilities”?

Below the rule, “telemedicine relationship established through COVID-19 telemedicine prescribing flexibilities” means:

1. The practitioner has not carried out an in-person medical analysis of the affected person; and

    

2. The practitioner has prescribed a number of managed substances to the affected person through the interval Could 12, 2023 via November 11, 2023 and the next situations are met:
   1. The prescription is issued for a professional medical function by a practitioner appearing within the traditional course {of professional} observe;
   2. The prescription is issued pursuant to a communication between a practitioner and a affected person utilizing an interactive telecommunications system referred to in 42 C.F.R. § 410.78(a)(3);
   3. The practitioner is:
      1. Approved below their registration below 21 C.F.R. § 1301.13(e)(1)(iv) to prescribe the fundamental class of managed substance specified on the prescription; or
      2. Exempt from acquiring a registration to dispense managed substances below 21 U.S.C. § 822(d); and
   4. The prescription is in keeping with all different necessities of 21 C.F.R. Half 1306.

On Could 11, 2023, Foley obtained affirmation from the DEA’s Part Chief of its Diversion Regulatory Draft and Coverage Help Part (Scott Brinks) that the registration coverage outlined within the March 25, 2020 letter is being prolonged.  Thus, the coverage on single-state DEA registrations in place through the PHE will proceed through the length of the flexibilities as outlined within the non permanent rule.

7. Does this rule shed any mild on how DEA views telemedicine and telemedicine corporations typically?

Sure. Within the rule, DEA acknowledged “SAMHSA and DEA strongly assist insurance policies that promote entry to efficient and protected therapy for opioid use dysfunction, together with via telemedicine platforms, and making certain continued entry to obligatory managed medicines previous the COVID-PHE.” DEA additionally harassed:

Whereas sure telemedicine corporations could have interaction in problematic habits, many telemedicine corporations are engaged in good religion, patient-centered prescribing practices. DEA appears ahead to working with them – and future corporations on this area – to additional improve affected person entry to wanted medicines when telemedicine prescriptions are applicable and issued within the traditional course {of professional} observe following bona fide medical evaluations.

Regardless of the bullishness severally, DEA stays involved about “problematic prescribing practices” and needs to “disincentivize the creation of telemedicine corporations which will search to have interaction in problematic prescribing practices.” Within the meantime, DEA acknowledged it’s actively investigating sure telemedicine corporations DEA believes could have engaged in problematic prescribing practices.

8. What comes subsequent after this rule?

In response to DEA, the “aim of this non permanent rule is to make sure a clean transition for sufferers and practitioners which have come to depend on the supply of telemedicine for managed medicine prescriptions, in addition to permitting ample time for suppliers to come back into compliance with any new requirements or safeguards that DEA and/or SAMHSA promulgate in a number of remaining guidelines.”

DEA stated it plans to difficulty “a number of remaining guidelines … primarily based on the 2 proposed guidelines printed on March 1, 2023”. DEA anticipates such remaining rule(s) will “lengthen[] sure telemedicine flexibilities on a everlasting foundation” to allow “the observe of telemedicine below circumstances which can be in keeping with public well being and security, whereas sustaining efficient controls in opposition to diversion.” 

Conclusion

This rule solely non permanent extends the telemedicine flexibilities for sufferers seen previous to November 11, 2023. Telemedicine corporations should stay centered on preparation for care after this date. Primarily based on the timeframe of the extension, it’s possible the DEA will difficulty a brand new telemedicine remaining rule (primarily based on the March proposed rule) previous to November 11, 2023. We are going to proceed to observe for updates.

Need to Be taught Extra?

We’d wish to thank Jennifer Walsh, Director of Public Affairs for her contribution to this weblog submit.

Foley is right here that will help you handle the short- and long-term impacts within the wake of regulatory modifications. For extra data on telemedicine, telehealth, digital care, distant affected person monitoring, digital well being, and different well being improvements, together with the group, publications, and consultant expertise, go to Foley’s Telemedicine & Digital Well being Business Staff or our Well being Care Apply Group.