hysical presence of a DEA-registered practitioner; 3) treatment by Indian Health Service or Tribal practitioners; 4) treatment during a public health emergency as declared by the Secretary of Health and Human Services; 5) treatment by a practitioner who has obtained a “special registration”; 6) treatment by Department of Veterans Affairs practitioners during a medical emergency; and 7) other circumstances specified by regulation. See 21 C.F.R. § 1300.04(i)(1)-(7).The proposed rule creates a new option under exception #7, a flexible catch-all exception (“The practice of telemedicine is being conducted under any other circumstances that the [DEA] Administrator and the Secretary of Health and Human Services have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.”). The requirements in the proposed rule apply to “telemedicine prescriptions” under 21 C.F.R. § 1306.31 conducted pursuant to 21 U.S.C. § 802(54)(G).3. What is the proposed rule intended to accomplish?According to the DEA’s statements, the proposed rule is designed to ensure that patients do not experience lapses in care, and to ensure continuity of care under the current telehealth flexibilities in place as a result of the COVID-PHE.The two new options introduced in the proposed rule are:A virtual first process where a practitioner can issue an initial prescription for a controlled substance without having conducted an in-person exam of the patient, but only if: 1) the medication is a non-narcotic Schedule III, IV, or V controlled substance (or buprenorphine for treatment of OUD); and 2) the prescribed amount does not exceed 30 days. This is called a “telemedicine prescription.” Before any additional prescribing can occur, the patient must undergo an in-person exam.A “qualified telemedicine referral” process where a patient has an initial in-person exam with a practitioner, who subsequently refers the patient to a second practiti

ce, sanctioning practitioners and pharmacies whose unethical and substandard prescribing practices violated the law.2. Is this rule issued pursuant to one of the “practice of telemedicine” exceptions under the Ryan Haight Act?Yes. The Ryan Haight Act contains seven “practice of telemedicine” exceptions to the in-person medical evaluation requirement. These are seven distinct categories Congress determined were appropriate to allow for telemedicine prescribing of controlled substances despite the practitioner never having examined the patient in person. The rule creates the temporary extension under exception #7, a flexible catch-all exception (“The practice of telemedicine is being conducted under any other circumstances that the [DEA] Administrator and the Secretary of Health and Human Services have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.”). The rule is issued pursuant to 21 U.S.C. § 802(54)(G) and amends 21 C.F.R. Part 1307 and 42 C.F.R. Part 12.3. What is this rule intended to accomplish?According to the DEA, the rule is designed to extend the COVID-19 telemedicine flexibilities in place to ensure patients do not experience lapses in care, and to ensure continuity of care under the current telehealth flexibilities in place as a result of the COVID-PHE. It is also intended to facilitate continuity of care for telemedicine relationships established via telemedicine during the COVID-19 PHE and address the urgent public health need for continued access to the initiation of buprenorphine as medication for opioid use disorder. Other stated purposes are:Allow patients, practitioners, pharmacists, service providers, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine;Enable DEA, jointly with SAMHSA, to thoroughly review and respond to the 38,369 comments they receive

h is also in a state of flux.Last July, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a Special Fraud Alert detailing high-risk activities conducted by telehealth providers and has, to date, indicted 31 telehealth providers alleging various health care fraud and abuse schemes.At the federal level, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the Controlled Substances Act that established controls on the remote prescribing of controlled substances. The Ryan Haight Act amendments established a general telehealth prescribing requirement that, in order for a controlled substance prescription to be valid, it must be issued for a legitimate medical purpose by a practitioner who is acting in the usual course of his/her professional practice and who has conducted at least one (1) in-person medical evaluation of the patient, unless a narrow exception applies. 18 U.S.C. § 829.Under 21 U.S.C. § 802(54), the “practice of telemedicine” means the remote practice of medicine in accordance with applicable federal and state laws, using an audio-visual, real-time, two-way interactive communication system, which practice is being conducted: (1) while the patient is being treated by, and physically located in, a DEA-registered hospital or clinic, and the remote prescribing practitioner is acting in the usual course of professional practice, in accordance with applicable state law, and is registered with the DEA in the State in which the patient is located; or (2) while the patient is being treated by, and in the physical presence of, a practitioner that is acting in the usual course of professional practice, in accordance with applicable state law, and is registered with the DEA in the State in which the patient is located. Additional, but narrower and less common scenarios also qualify as the “practice of telemedicine” as defined in 21 U.S.C. § 802(54), including circumstances designated by

lic health emergency declared on January 31, 2020, if authorized to dispense controlled substances by both the state in which a practitioner is registered with DEA and the state in which the dispensing occurs. Practitioners, in other words, must be registered with DEA in at least one state and have permission under state law to practice using controlled substances in the state where the dispensing occurs.Under the Controlled Substances Act (CSA), a prescription for a controlled substance issued by means of the Internet must generally be predicated on an in-person medical evaluation. See 21 U.S.C. § 829(e)(1). This requirement does not apply, however, when a practitioner is practicing telemedicine as defined by the CSA. The CSA’s definition of the practice of telemedicine includes multiple different categories of telemedicine. For several of these categories, the CSA specifically requires a practitioner to have a DEA registration in the state in which the patient is located. See, e.g., 21 U.S.C. § 802(54)(A), (B). But the practice of telemedicine during a public health emergency pursuant to 21 U.S.C. § 802(54)(D) does not include this requirement. On March 16, 2020, the Secretary of the United States Department of Health & Human Services, with concurrence of the Acting DEA Administrator, designated that the telemedicine allowance under section 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States.The March 31 letter extended waivers with respect to prescribing of buprenorphine. It stated, in relevant part:DEA notes that practitioners have further flexibility during the nationwide public health emergency to prescribe buprenorphine to new and existing patients with opioid use disorder (OUD) via telephone by otherwise authorized practitioners without requiring such practitioners to first conduct an examination of the patient in person or via telemedicine.On May 11, 2023, Foley received confirmation from the DEA’s Section Chief of its Diversion Regula

110-869. The Ryan Haight Act amendments were not designed with the current state of the industry in mind, and as such do not contemplate how the practice of telemedicine has developed and expanded in recent years to accommodate a range of physical and mental health treatments. Indeed, since the January 2020 declaration of the PHE, telemedicine has become a preferred method for many patients to access their health care providers, a significant example being increased access to mental health treatment.Exceptions to the in-person evaluation requirement have traditionally existed, but only in a narrow set of circumstances, such as when a practitioner is covering for another practitioner who has conducted an in-person examination of the patient within the previous two (2) years (i.e., a cross-coverage situation), or where a practitioner is engaged in the “practice of telemedicine,” e.g. because the patient was physically located in a DEA-registered hospital, clinic, or physician’s office. 21 U.S.C. § 802(54). The Ryan Haight Act authorized (and arguably directed) DEA to create a special registration process for prescribers of controlled substances via the internet. Since that time, however, despite attempts by members of Congress to petition DEA to initiate that rulemaking process, there was no meaningful movement. In 2018, Congress passed requirements under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, requiring DEA to create a special registration for opioid addiction treatment via telehealth by October 2019. This deadline came and went, also without meaningful action taken by DEA.Telemedicine Prescribing During the COVID-19 PHEDuring the COVID-19 PHE, among many other regulatory flexibilities, federal and state prescribing requirements were relaxed. The relaxing of such requirements made it easier for health care providers to prescribe both controlled and non-controlled substances to patients without ever c

clinic.B. The patient is being treated by and in the physical presence of another practitioner.C. The patient is being treated by a provider employed by the Indian Health Services.D. The treatment is occurring during a PHE declared by the secretary of the US Department of Health and Human Services (HHS) involving locations and controlled substances designated by the Secretary and the US Attorney General.E. The patient is being treated by a practitioner who holds a special registration, requirements for which are set forth at 21 U.S.C. § 831(h).F. There is a medical emergency and the patient is being treated by an employee of the Veterans Health administration (provided that certain additional requirements are met).G. The patient is being treated under other circumstances as set forth in regulation as determined jointly by the HHS Secretary and the US Attorney General to be consistent with effective controls against diversion and otherwise consistent with the public health and safety (21 U.S.C. § 802(54)).The controlled substance prescribing flexibilities invoked in January 2020 in response to the COVID-19 PHE under subparagraph D were set to end with the termination of the PHE on May 11, 2023. Providers and others have long been awaiting the development of the “special registration” process described in subparagraph E, which would require the DEA to establish the circumstances and procedures under which a special registration could be issued under the Ryan Haight Act. In the 14 years since the act’s passage, the DEA has failed to implement such a process, even though Congress imposed a deadline of October 2019 in the 2018 SUPPORT for Patients and Communities Act for the promulgation of final regulations. In the proposed rules, the DEA opted not to implement the registration process and instead invoked its authority under subparagraph G.Summary of the RulesTelemedicine Prescribing of Controlled Substances Without Prior In-Person EvaluationThe Telemedicine Controlled Substance Proposed

The Second Circuit (Walker, Carney, and Koeltl) issued a decision vacating a 10-year sentence of imprisonment for conspiracy to distribute and possess with intent to distribute marihuana. The Court held that, contrary to the district court’s finding, a prior conviction for the attempted sale of a controlled substance in the fifth degree, in violation of N.Y. Penal Law (NYPL) §220.31, was not a conviction for a “felony drug offense,” as defined by 21 U.S.C. §802(44). The case, United States of America v. Jeremy L. Thompson, 18-2545-cr, clarifies that courts must use the “categorical approach” when identifying predicate felony drug offenses, and that the Second Circuit will not expand §802(44)’s reach beyond its enumerated classes of drugs.

Section 54-5705, which required a provider to establish a provider-patient relationship by using two-way audio and visual interaction, is completely suspended, while 54-5707, which regulates prescribing, is partially suspended.PrescribingIn accordance with the Proclamation, providers may, during the Pandemic, issue prescription drug orders using telehealth services within the scope of the provider’s license to the extent that the prescribing complies with federal laws and health and human services guidance related to COVID-19. Generally, under 54-5707, the provider may not prescribe controlled substance unless prescribed in compliance with 21 US.C. § 802(54)(A), which requires that the patient be treated and physically located within a DEA-registered hospital or clinic and that the patient be treated by a DEA-registered practitioner. The Proclamation suspended the limitations imposed by 21 U.S.C. § 802(54)(A), and, in connection with the HHS enactment of a “public health emergency” per 21 U.S.C. § 802(54)(D), prescribing controlled substances by a DEA-registered health care provider via telemedicine to a patient who is at home is permitted as long as all other state and federal controlled substance prescribing laws are followed.

Mellouli v. Lynch, USSC No. 1034, 2015 WL 2464047 (June 1, 2015), reversingMellouli v. Holder, 719 F.3d 995 (8th Cir. 2013); Scotusblog page (including links to briefs and commentary)Resolving a split between federal circuit courts of appeal, the Supreme Court holds that the statute providing for deportation based on a violation of a state drug crime “relating to a controlled substance” is limited to “controlled substance” listed in the federal controlled substances schedule under 21 U.S.C. § 802. Thus, the Eighth Circuit was wrong to hold that any drug offense triggers the removal statute, without regard to the appearance of the drug on a § 802 schedule.

The argumentsMr. Mellouli argues before the Court that Descamps and Moncrieffe require a categorical analysis for determining whether his offense was a removable controlled substance offense under the INA, and that the plain language of the INA dictates that the offense relate to a substance that is listed in federal controlled substance schedules pursuant to 21 U.S.C. § 802, part of the federal Controlled Substances Act (CSA). Because the Kansas schedule of controlled substances under which he was convicted is broader than the federal schedule and the record of conviction submitted by the government in his case did not specify the substance he was accused of holding in his sock, Mr. Mellouli argues that the government has failed to prove that he was necessarily convicted of an offense relating to a federally controlled substance.