Expansion of Buprenorphine Treatment via Telemedicine Encounter

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1306</CFR> <DEPDOC>[Docket No. DEA-948]</DEPDOC> <RIN>RIN 1117-AB78</RIN> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 12</CFR> <SUBJECT>Expansion of Buprenorphine Treatment via Telemedicine Encounter</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice; Substance Abuse and Mental Health Services Administration, Department of Health and Human Services. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Drug Enforcement Administration and the Department of Health and Human Services are amending their regulations to expand the circumstances under which practitioners registered by the Drug Enforcement Administration are authorized to prescribe schedule III-V controlled substances approved by the Food and Drug Administration for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. Under these new regulations, after a practitioner reviews the patient's prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, the practitioner may prescribe an initial six-month supply of such medications (split amongst several prescriptions totaling six calendar months) through audio-only means. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. The <E T="03">Ryan Haight Online Pharmacy Consumer Protection Act of 2008</E> generally requires an in-person medical evaluation prior to issuance of a controlled substance prescription. However, this regulation falls under one of the exceptions found within the <E T="03">Ryan Haight Act.</E> Additionally, this regulation does not affect practitioner-patient relationships in cases where an in-person medical evaluation has previously occurred. The purpose of this regulation is to prevent lapses of care by continuing some of the telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective February 18, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Heather E. Achbach, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-3882. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> This final rule falls under the last category of telemedicine under the <E T="03">Ryan Haight Act,</E> Public Law 110-425, 122 Stat. 4820 (2008), which authorizes the practice of telemedicine in specified circumstances when no in-person medical evaluation has occurred. The Administrator of the Drug Enforcement Administration (DEA) (pursuant to delegation by the Attorney General)  <SU>1</SU> <FTREF/> and the Substance Abuse and Mental Health Services Administration (on behalf of the Secretary of Health and Human Services (HHS) jointly issue this regulation and have each determined that this regulation is consistent with effective controls against diversion and with the public health and safety as required under 21 U.S.C. 802(54)(G). <FTNT> <SU>1</SU>  The Attorney General has delegated this authority to the Administrator of DEA under 28 CFR 0.100. </FTNT> In March 2023, DEA published a notice of proposed rulemaking (NPRM) titled <E T="03">Expansion of Induction of Buprenorphine via Telemedicine Encounter.</E> <SU>2</SU> <FTREF/> DEA and HHS are now finalizing the rule, with several modifications to the proposed provisions to address concerns brought forth by commenters. Under this final rule, a DEA-registered practitioner, prior to issuing a prescription via telemedicine for a schedule III-V controlled substance approved by the Food and Drug Administration (FDA) for use in the treatment of opioid use disorder (OUD), <SU>3</SU> <FTREF/> must review the prescription drug monitoring program (PDMP) data of the state in which the patient is located when the telemedicine encounter occurs, and the pharmacist must verify the identity of the patient  <SU>4</SU> <FTREF/> prior to filling the prescription. The practitioner is authorized to prescribe up to an initial six-month supply (split amongst several prescriptions totaling six calendar months); additional prescriptions may be issued under other forms of telemedicine as authorized by the Controlled Substances Act (CSA) or after an in-person medical evaluation is conducted. <FTNT> <SU>2</SU>  88 FR 12890 (Mar. 1, 2023). </FTNT> <FTNT> <SU>3</SU>  Treatment of OUD means the use of effective FDA-approved medications including methadone, buprenorphine, and naltrexone to treat opioid use disorder. See NIDA. 2021, December 2. Overview. <E T="03">https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/overview.</E> Last accessed on January 8, 2025. </FTNT> <FTNT> <SU>4</SU>  DEA understands there are situations where the patient (for whom the prescription was written) may not be the individual picking up the prescription at the pharmacy. In these situations, DEA defers to the definition of “ultimate user” as found in 21 U.S.C. 802(27). As such, this regulation authorizes the pharmacist to verify the identity of the patient by accepting identification from any individual who falls under the definition of “ultimate user” prior to filling a prescription. </FTNT> This final rule pertains to practitioners prescribing controlled substances to patients for the treatment of OUD in circumstances where the prescribing practitioner has not conducted an in-person medical evaluation of the patient prior to the issuance of the prescription. Therefore, it is important to emphasize that the limitations set forth in this final rule, and those associated with the “practice of telemedicine” as defined in 21 U.S.C. 802(54) generally, do not apply to practitioner-patient relationships in which there has already been a prior in-person medical evaluation of the patient by the prescribing practitioner. <HD SOURCE="HD1">II. Legal Authority and Background</HD> DEA implements and enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the CSA, and the Controlled Substances Import and Export Act, (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 through 1399. These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes. As mandated by the CSA, DEA establishes and maintains a closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822. <SU>5</SU> <FTREF/> The CSA further authorizes the Attorney General (and the Administrator of DEA by delegation through 28 CFR part 0) to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA. <SU>6</SU> <FTREF/> <FTNT> <SU>5</SU>  “Dispense” in the context of this rulemaking means to deliver a controlled substance to an ultimate user, which includes the prescribing of a controlled substance. 21 U.S.C 802(10). </FTNT> <FTNT> <SU>6</SU>  21 U.S.C. 871(b), 958(f). </FTNT> <HD SOURCE="HD2">The Ryan Haight Act</HD> The <E T="03">Ryan Haight Online Pharmacy Consumer Protection Act of 2008</E> ( <E T="03">Ryan Haight Act</E> ) amended the CSA, in part, by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet. The <E T="03">Ryan Haight Act</E> generally requires that a practitioner conduct an in-person medical evaluation before issuing a prescription to a patient. This requirement is set forth in 21 U.S.C. 829(e), which provides that “[n]o controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be . . . dispensed by means of the internet without a valid prescription.”  <SU>7</SU> <FTREF/> A “valid prescription” is defined as “a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by . . . a practitioner who has conducted at least 1 in-person medical evaluation of the patient.”  <SU>8</SU> <FTREF/> Section 829(e) further provides an exception to the in-person medical evaluation when a practitioner is “engaged in practice of telemedicine.”  <SU>9</SU> <FTREF/> The practice of telemedicine is defined as “the practice of medicine in accordance with applicable Federal and state laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system  <SU>10</SU> <FTREF/> referred to in section 1395m(m) of Title 42.”  <SU>11</SU> <FTREF/> <FTNT> <SU>7</SU>  21 U.S.C. 829(e)(1). </FTNT> <FTNT> <SU>8</SU>   <E T="03">Id.</E> 829(e)(2)(A)(i). </FTNT> <FTNT> <SU>9</SU>   <E T="03">Id.</E> 829(e)(3)(A). </FTNT> <FTNT> <SU>10</SU>  42 U.S.C. 1395m(m) references, but does n ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 153k characters. 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