On October 6, 2023, the Drug Enforcement Administration (DEA) launched a second non permanent rule extending the COVID-19 Telemedicine Flexibilities for Prescription of Managed Drugs. This second extension, issued shortly after DEA’s listening session on a possible new Telemedicine Particular Registration, provides practitioners and sufferers certainty of the DEA necessities for telemedicine prescribing by way of the top of 2024.
With out this Second Momentary Rule, COVID-19 telemedicine flexibilities would expire on November 11, 2023, with respect to practitioner-patient relationships established after that date (as described in our earlier weblog publish). This Second Momentary Rule – entitled “Second Momentary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Managed Drugs” – continues the non permanent extension of 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 by way of December 31, 2024.
Key Provisions Beneath the DEA’s Second Momentary Rule
1. Which DEA waivers are prolonged beneath this rule?
DEA mentioned it’s once more extending the “full set” of telemedicine flexibilities relating to the prescription of managed medicines, referencing the 2 DEA letters that approved 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 will not be required to acquire extra registration(s) with DEA within the extra state(s) the place the shelling out (together with prescribing and administering) happens, at some stage in the general public well being emergency declared on January 31, 2020, if approved to dispense managed substances by each the state wherein a practitioner is registered with DEA and the state wherein the shelling out happens. Practitioners, in different phrases, should be registered with DEA in no less than one state and have permission beneath state legislation to follow utilizing managed substances within the state the place the shelling out happens.
- Beneath the Managed Substances Act (CSA), a prescription for a managed substance issued via the Web should usually be predicated on an in-person medical analysis. See 21 U.S.C. § 829(e)(1). This requirement doesn’t apply, nevertheless, when a practitioner is practising telemedicine as outlined by the CSA. The CSA’s definition of the follow of telemedicine contains a number of totally 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 follow 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 Providers, with concurrence of the Appearing DEA Administrator, designated that the telemedicine allowance beneath 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 approved practitioners with out requiring such practitioners to first conduct an examination of the affected person in individual or through telemedicine.
On Might 11, 2023, Foley obtained affirmation from the DEA’s Part Chief of its Diversion Regulatory Draft and Coverage Assist Part (Scott Brinks) that the registration coverage outlined within the March 25, 2020 letter is being prolonged. Thus, the PHE coverage on single-state DEA registrations will proceed through the length of the flexibilities as outlined within the Might 10th Momentary Rule and prolonged on this Second Momentary Rule as effectively.
2. What time interval does this Second Momentary Rule cowl?
The Second Momentary Rule extends the COVID-19 PHE DEA telemedicine flexibilities by way of December 31, 2024. As acknowledged within the Second Momentary Rule, the DEA has eliminated the excellence between new and beforehand seen sufferers outlined within the preliminary extension:
- This extension authorizes all DEA-registered practitioners to prescribe schedule II-V managed medicines through telemedicine by way of December 31, 2024, whether or not or not the affected person and practitioner established a telemedicine relationship on or earlier than November 11, 2023. In different phrases, the grace interval supplied within the First Momentary Rule is successfully subsumed by this Second Momentary Rule, which continues the extension of the present flexibilities for all practitioner-patient relationships – not simply these established on or earlier than November 11, 2023 – till the top of 2024.
3. Does this rule shed any mild on when DEA might problem new proposed guidelines on this subject?
Sure. Within the Second Momentary Rule, DEA acknowledged:
- DEA is working to promulgate new requirements or safeguards by the autumn of 2024.
If that estimated timeframe is correct, and a brand new substantive proposed rule is issued in fall of 2024, that isn’t a lot time earlier than this second extension expires. It virtually appears sure {that a} third extension can be essential. Time will inform.
Conclusion
This Second Momentary Rule lengthens the runway for telemedicine corporations planning for modifications till the top of 2024. Whereas each anticipated and essential, it stays to be seen what DEA’s proposal will seem like in 2024 and whether or not it is going to embrace a particular telemedicine registration. Keep tuned. We are going to proceed to observe for updates.
Wish to Be taught Extra?
Foley is right here that will help you tackle the short- and long-term impacts within the wake of regulatory modifications. For extra info on telemedicine, telehealth, digital care, distant affected person monitoring, digital well being, and different well being improvements, together with the crew, publications, and consultant expertise, go to Foley’s Telemedicine & Digital Well being Business Crew or our Well being Care Apply Group.
