DEA Unveils Lengthy-Overdue Particular Registration for Telemedicine in Proposed Rule

Within the remaining days of the Biden administration, the Drug Enforcement Administration (DEA) launched a proposed rule that might enable practitioners with a Particular Registration to prescribe Schedule III-V, and in restricted circumstances Schedule II, managed substances by way of telemedicine.

Practitioners with a Particular Registration would nonetheless must receive a DEA registration in every state the place they prescribe or dispense managed substances. Nevertheless, the proposed rule establishes a restricted, cheaper State Telemedicine Registration as a substitute for the standard DEA registration. The proposed rule imposes a number of obligations on practitioners with Particular Registrations after they prescribe managed substances by way of telemedicine. Of notice, practitioners would must be positioned in the identical state because the affected person on the time of the encounter when issuing a Schedule II managed substance prescription, and the common month-to-month variety of Schedule II managed substances prescribed by way of telemedicine would must be restricted to lower than 50% of the practitioner’s whole Schedule II prescriptions (together with each telemedicine prescriptions and non-telemedicine prescriptions).

If finalized, the Particular Registration course of would supply an alternate pathway for practitioners to prescribe managed substances by way of telemedicine if the DEA telemedicine prescribing flexibilities presently in place by way of December 31, 2025, expire. We offer a abstract of a few of the key provisions of the proposed rule under.

Definitions

The proposed rule introduces a number of new definitions, a few of which embrace:

• Clinician practitioner — a person practitioner who offers direct affected person care or assesses, diagnoses, or treats medical circumstances.
• Platform practitioner — a lined on-line telemedicine platform that dispenses managed substances by advantage of its central involvement as an middleman within the distant prescribing of managed substances by a person practitioner. Platform practitioners are topic to the necessities imposed upon non-pharmacist practitioners underneath the Managed Substances Act, 21 U.S.C. Sections 801-904, and its rules.
• Lined on-line telemedicine platform — an entity that facilitates connections between sufferers and clinician practitioners, by way of an audio-video telecommunications system, for the prognosis and remedy of sufferers that will consequence within the prescription of managed substances, however is just not a hospital, clinic, native in-person medical apply, or insurance coverage supplier, and meets a number of of the next standards:
  • The entity explicitly promotes or advertises the prescribing of managed substances by way of the platform;
  • The entity has monetary pursuits, whether or not direct incentives or in any other case, tied to the quantity or sorts of managed substance prescriptions issued by way of the platform, together with however not restricted to, possession curiosity in pharmacies used to fill sufferers’ prescriptions, or rebates from these pharmacies;
  • The entity exerts management or affect on scientific decision-making processes or prescribing associated to managed substances, together with, however not restricted to: prescribing pointers or protocols for clinician practitioners employed or contracted by the platform; consideration of clinician practitioner prescribing charges within the entity’s hiring, retention, or compensation selections; imposing express or de facto prescribing quotas; directing sufferers to most well-liked pharmacies; and/or
  • The entity has management or custody of the prescriptions or medical information of sufferers who’re prescribed managed substances by way of the platform.

Particular Registrations

Classes and Eligibility

The proposed rule establishes the next classes of Particular Registrations and eligibility necessities:

• Telemedicine Prescribing Registration: This registration would enable clinician practitioners to prescribe Schedule III-V managed substances.
  • Clinician practitioners would wish to show a professional want for the registration.
  • Physicians, nurse practitioners, physicians, and different mid-level practitioners outlined underneath 21 C.F.R. § 1300.01 (“mid-level practitioners”) would have a professional must prescribe Schedule III-V managed substances in the event that they anticipate to deal with sufferers for whom in-person exams can be burdensome.
    • Examples embrace sufferers who expertise extreme climate circumstances, reside in distant or distant areas, or have communicable illnesses.
• Superior Telemedicine Prescribing Registration: This registration would enable sure specialised clinician practitioners to prescribe Schedule II-V managed substances.
  • Specialised clinician practitioners would wish to show a professional want for the registration and justify the extra authorization to prescribe Schedule II drugs. These practitioners would wish to offer data demonstrating their specialised coaching on their Particular Registration software.
  • Specialised physicians and board-certified mid-level practitioners would have a professional must prescribe Schedule II-V managed substances when treating weak affected person populations. This contains people who face important obstacles to accessing care and who are suffering from debilitating or terminal sicknesses.
  • Solely specialised physicians and board-certified mid-level practitioners within the following restricted circumstances or apply specialties are eligible:
    • Psychiatrists;
    • Hospice care physicians;
    • Palliative care physicians;
    • Practitioners rendering remedy at long-term care services;
    • Pediatricians;
    • Neurologists; and
    • Mid-level practitioners and physicians from different specialties who’re board licensed within the remedy of psychiatric or psychological issues, hospice care, palliative care, pediatric care, or neurological issues unrelated to the remedy and administration of ache.
• Telemedicine Platform Registration: This registration would enable lined on-line telemedicine platforms to dispense Schedule II-V managed substances by way of a clinician practitioner who holds a Telemedicine Prescribing Registration or Superior Telemedicine Prescribing Registration (i.e., a platform practitioner).
  • Lined on-line telemedicine platforms would wish to show a professional want for the registration.
  • Lined on-line telemedicine platforms, of their capability as platform practitioners, would have a professional must dispense Schedule II-V managed substances after they:
    • Count on to offer needed companies that join sufferers with clinician practitioners by way of telemedicine for the prognosis, remedy, and prescription of managed substances;
    • Adjust to federal and state rules;
    • Oversee the clinician practitioner’s prescribing practices; and
    • Implement safeguards to prioritize affected person security and forestall diversion, abuse, or misuse of managed substances.
  • Platform practitioners would wish to attest to their professional want on their Particular Registration software.

Particular Registration numbers can be formatted distinctly, permitting pharmacists to simply differentiate between practitioners with a Particular Registration and people with a conventional DEA registration.

Utility Necessities

Within the proposed rule, the DEA outlines a number of Particular Registration software necessities. Notably, candidates would wish to offer a bodily tackle as their registered location, and platform practitioners would wish to reveal all employment relationships, contractual relationships, {and professional} affiliations with any clinician practitioner with a Particular Registration and on-line pharmacy.

State Telemedicine Registration

Along with a Particular Registration, clinician practitioners and platform practitioners, until exempt, would nonetheless must receive a DEA registration in every state by which they intend to prescribe or dispense managed substances to sufferers by way of telemedicine. Nevertheless, in lieu of the standard DEA registration, the proposed rule establishes a restricted State Telemedicine Registration, which might be cheaper for clinician practitioners. The proposed charge is $50 for clinician practitioners, reflecting a big discount from the price of a conventional DEA registration, and $888 for platform practitioners, which matches the price of a conventional DEA registration. Much like Particular Registrations, State Telemedicine Registration numbers can be formatted distinctly, permitting pharmacists to simply differentiate between practitioners with a State Telemedicine Registration and people with a conventional DEA registration.

Necessities of the Proposed Rule

Telehealth Modality

Much like the remaining rule concerning telemedicine prescribing of buprenorphine, practitioners can be permitted to prescribe Schedule III-V managed substances authorized by the U.S. Meals & Drug Administration to deal with opioid use dysfunction by way of telemedicine (presently restricted to buprenorphine) by way of an audio-only go to. (See our dialogue on the DEA’s remaining buprenorphine rule right here.) Audio-only visits would solely be permitted if the practitioner has the potential to make use of audio-video, however the affected person is both unable to make use of video or doesn’t consent to it. Nevertheless, not like the ultimate buprenorphine rule, remedy would must be initiated by way of an audio-video go to, and the practitioner would wish to have performed a minimum of one medical examination of the affected person by way of audio-video. Prescriptions not assembly the factors described above would solely be capable of be issued by way of an audio-video go to.

Schedule II Managed Substances

Practitioners would solely be permitted to prescribe Schedule II managed substances by way of telemedicine if they’re bodily positioned in the identical state because the affected person on the time of the encounter when the prescription is issued. Moreover, the variety of Schedule II managed substances prescribed by way of telemedicine, averaged month-to-month, can be restricted to lower than 50% of the practitioner’s whole Schedule II prescriptions (together with each telemedicine prescriptions and non-telemedicine prescriptions).

PDMP Verify

Efficient instantly, if the proposed rule is finalized, practitioners with a Particular Registration would wish to test the affected person’s managed substance prescription information in Prescription Drug Monitoring Applications (PDMPs) of sure jurisdictions earlier than issuing a prescription for managed substances by way of telemedicine. The practitioner would wish to evaluate the PDMPs for any managed substance prescriptions issued to the affected person throughout the final yr, or, if lower than a yr is obtainable, for the whole out there interval. The related jurisdictions embrace:

• The state the place the affected person is positioned;
• The state the place the practitioner is positioned; and
• Any U.S. jurisdiction with PDMP reciprocity agreements with both of the states above.

Three years after the efficient date, earlier than issuing a prescription for managed substances by way of telemedicine, practitioners with a Particular Registration would wish to test the PDMPs of all U.S. jurisdictions for managed substance prescriptions issued to the affected person throughout the final yr, or, if lower than a yr is obtainable, for the whole out there interval. If there isn’t a means to carry out this nationwide PDMP test, the practitioner would proceed performing the PDMP checks as described above. We notice that there’s presently no nationwide PDMP database in operation.

Further Necessities and Commentary

The proposed rule additionally:

• Units forth sure recordkeeping, affected person identification verification, reporting, prescription, and e-prescribing necessities for these with Particular Registrations;
• Notes that practitioners with Particular Registrations would must be positioned throughout the U.S. when issuing a prescription by way of telemedicine and would wish to nonetheless adjust to any relevant state necessities and restrictions concerning prescribing managed substances;
• Emphasizes that when an in-person medical examination has been performed, the practitioner and affected person would now not be thought-about to be engaged within the apply of telemedicine, and the necessities of the proposed rule wouldn’t apply; and
• Establishes reporting necessities for pharmacies filling Particular Registration prescriptions.

A Transient Historical past

The rule stems from the Ryan Haight Act, which amended the Managed Substances Act to limit practitioners from prescribing managed substances until the practitioner conducts an in-person examination of the affected person. The Managed Substances Act additionally requires practitioners receive a separate DEA registration in every state the place their sufferers are positioned. The Ryan Haight Act (at 21 U.S.C. § 802(54)) outlines seven exceptions underneath which practitioners might prescribe managed substances by way of telemedicine with out an in-person examination, one in every of which entails practitioners who’ve obtained a particular registration. Congress anticipated the DEA to problem the particular registration rule shortly after the Ryan Haight Act was signed into legislation in 2008. After years of DEA failing to take action, Congress and the White Home signed the SUPPORT Act of 2018, a federal legislation that mandated DEA promulgate the particular registration rule by October 2019. 

Throughout the COVID-19 Public Well being Emergency (PHE), the DEA issued letters on March 25, 2020, and March 31, 2020, granting non permanent exceptions to the Ryan Haight Act and its implementing guidelines that enabled DEA-registered practitioners to prescribe managed substances with out an in-person examination and with a DEA registration in just one state. In March 2023, two months earlier than the tip of the PHE, the DEA proposed a rule on telemedicine prescribing of managed substances, however the rule didn’t embrace a particular registration framework and was not favorably-viewed. In response, the DEA shortly rescinded the proposed rule and prolonged the COVID-era flexibilities in Might 2023 and once more in October 2023. In June 2024, the DEA submitted a particular registration rule for Workplace of Administration and Finances clearance that was so unworkable for stakeholders that it was not printed. As an alternative, the flexibilities had been additional prolonged in November 2024, and at the moment are set to run out on December 31, 2025. (For extra particulars, see our earlier discussions on the DEA’s proposed guidelines for telemedicine prescribing of managed substances and the first, second, and third non permanent guidelines extending COVID-era flexibilities.)

Make Your Voice Heard

The DEA is soliciting feedback till 11:59 p.m. ET March 18, 2025. Stakeholders might submit feedback electronically right here or by way of common or specific mail to the next tackle:

Drug Enforcement Administration
Attn: DEA Federal Register Consultant/DPW
8701 Morrissette Drive, Springfield, VA 22152

All correspondence, together with attachments, should embrace a reference to “Docket No. DEA-407”.

Moreover, these with considerations concerning the proposed rule can share their suggestions by contacting their native Congressperson or the White Home.

What Comes Subsequent

With the widespread frustration that met the March 2023 and June 2024 variations of this rule, there’s little likelihood that the proposed rule will probably be finalized near its present type. A key level of rivalry for stakeholders within the proposed rule is the nationwide PDMP test requirement, which is seen as overly burdensome given the absence of a nationwide PDMP database — a burden the DEA continues to underestimate. Nevertheless, the way forward for the Particular Registration is unclear because of the change in administration and doubtlessly altering priorities and approaches.

President Trump’s first spherical of govt orders included a regulatory freeze. Nevertheless, the Regulatory Freeze Pending Evaluation Government Order doesn’t have an effect on the proposed rule. To affect the route of the proposed rule, ATA Motion has urged President Trump to prioritize the quick withdrawal of it. If the proposed rule undergoes one other set of revisions and spherical of notice-and-comment rulemaking, it’s unlikely that practitioners could have entry to a particular registration in 2025. With out a particular registration course of this yr, one other extension of the DEA telemedicine flexibilities will probably be essential. We are going to proceed to carefully monitor any developments concerning the particular registration course of.

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 Workforce.