Providers must devote the resources to really understanding these laws and how to apply them to their business or services.Practice of Telemedicine Under the Ryan Haight Act The Act contains the following “practice of telemedicine” exceptions: (1) Treatment in a hospital or clinic. The practice of telemedicine is being conducted while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner: (i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d); or (ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f); (2) Treatment in the physical presence of a practitioner. The practice of telemedicine is being conducted while the patient is being treated by, and in the physical presence of, a practitioner acting in the usual course of professional practice, who is acting in accor

Certain of these practitioners are required by state law to be supervised by, or work in collaboration with, a DEA-registered physician when prescribing medications for the treatment of opioid use disorder.How to Claim the ExemptionTo claim an exemption, a practitioner must submit a notice of intent (NOI) to the Substance Abuse and Mental Health Services Administration (SAMHSA).2 The NOI must select a patient limit of 30, in which case the practitioner would not need to certify as to the training, counseling, or other ancillary services requirements listed at 21 U.S.C. § 823(g)(2)(B)(i)–(ii). However, the waiver only applies to practitioners treating patients who are located in the same states where the practitioner is licensed to treat patients, unless the practitioner is an employee of a contractor of the United States, acting within the scope of his or her employment/contract.SAMHSA reviews applications within 45 days of receipt.

21 U.S.C. § 802(21) (emphasis added).Second, the agency points to 21 U.S.C. § 823(f), which provides that the Administrator shall “register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” Id. § 823(f) (emphasis added).

take place within a “closed system” of distribution established by Congress. Under the framework of the CSA, and within the “closed system” created by the CSA, all legitimate handlers of controlled substances—manufacturers, distributors, physicians, pharmacies, and others—must be registered with the DEA (unless exempt) and maintain strict accounting for all controlled substance transactions. A controlled substance transaction under the framework of the CSA traditionally means that a controlled substance is manufactured by a DEA licensed manufacturer and distributed to a DEA registered and state-licensed pharmacy, which license and registration authorize the pharmacy to obtain and dispense controlled substances. In order to dispense a controlled substance within this closed and controlled system, amongst other requirements, the following must be adhered to:a pharmacy that dispenses a controlled substance (whether a Schedule II – V controlled substance) must be registered with the DEA (21 U.S.C.823(f) and 21 CFR 1301.11(a)) and must obtain a state pharmacy license (21 U.S.C. 823(f));a pharmacy that dispenses a controlled substance (whether a Schedule II – V controlled substance) must register as a new pharmacy and the DEA Form 224 must be completed (21 CFR 1301.13(e)(1)(iv));a pharmacy that dispenses a controlled substance (whether a Schedule II – V controlled substance) can only dispense a controlled substance that has been prescribed for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of 21 U.S.C. 829. The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled su

DEA, Press Release, DEA Proposes Process to Expand Marijuana Research in the United States (March 20, 2020).DEA anticipates approving applications for registration of three types of bulk marijuana manufacturers: manufacturers who grow marijuana for their own research or drug development; manufacturers who supply marijuana to other DEA registrants; and manufacturers who supply marijuana to support NIDA’s drug supply program.Id. at 16,295-96.The NPR explains that because marijuana is a schedule I controlled substance, registration applications to manufacture it are governed by 21 U.S.C. § 823(a). Controls to Enhance the Cultivation of Marijuana, at 16,293.

Id. While the policy change is to be applauded, the cynical among us might surmise that DEA loosened its marijuana growth policy to blunt criticism of its recent decision to deny the petitions to reschedule marijuana.Authority to Cultivate Marijuana Under the CSAThe federal Controlled Substances Act (“CSA”) requires all controlled substance manufacturers and distributors to apply for and obtain a DEA registration authorizing those activities, but the registrations must be consistent with the public interest and with U.S. obligations under the Single Convention. 21 U.S.C. §823(a)(1); Id. at 53,847. DEA cautions that while it intends to increase the number of registered marijuana cultivators for supplying researchers (assuming it receives qualified applicants), it must register only the number of bulk manufacturers necessary to “produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes.”

Currently, under the federal Controlled Substances Act (“CSA”), qualified practitioners can prescribe, administer or dispense buprenorphine products for the treatment of opioid use disorder in an office, community hospital, health department or correctional facility. 21 U.S.C. § 823(g)(2). To qualify, the practitioner must be a physician, hold a valid medical license and DEA registration, have the capacity to refer patients for counseling and other ancillary services, and have completed required training.

In addition, there is a nationwide shortage of psychiatrists and board certified substance abuse addiction specialists, coupled with the nation’s tragic opioid crisis, making telemedicine services an attractive resource. How the Proposed Bills Will Benefit Telemedicine Providers If adopted, the Improving Access to Remote Behavioral Health Treatment Act would expand the eligible “clinic” exception under the Ryan Haight Act, which currently states as follows:“Treatment in a hospital or clinic.The practice of telemedicine is being conducted while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located […]” The newly-eligible clinics under the draft bill would include community mental health centers and addiction treatment centers. This is an important step forward for patients and providers associated with those centers.

Final Order at 14,967 n.38 (citing cases). The Combining of 21 U.S.C. § 823(f)’s Factor 2 and Factor 4Of the five public interest factors that the Administrator must consider when determining whether to grant an application for DEA registration, Factor 2 looks to the “applicant’s experience in dispensing, or conducting research with respect to controlled substances,” and Factor 4 looks to the applicant’s “[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.” 21 U.S.C. § 823(f)(2), (4).

uding an audio-only telemedicine encounter that meets the standard of 42 CFR 410.78(a)(3), provided certain requirements and conditions are met. In addition to the requirements proposed under the Telemedicine Controlled Substance Proposed Rule (the expanded and amended definitions, the record keeping requirements and the prescribing requirements including supply limitations, as outlined above), the Telemedicine Buprenorphine Proposed Rule would amend 21 CFR §1306 to provide the following:The Telemedicine Buprenorphine Proposed Rule would clarify that buprenorphine may only be prescribed if “issued for maintenance or detoxification treatment” and not for any other purpose.The Telemedicine Buprenorphine Proposed Rule would add a new section 1306.34, setting forth the circumstances in which practitioners are authorized to use the expanded authorities to prescribe buprenorphine: A practitioner must obtain and maintain a DEA registration in the state where the practitioner is located. See 21 U.S.C. 823(g) and 21 CFR 1301.13(e)(l)(iv).A practitioner must be authorized by state law, or not otherwise prohibited by state law, from practicing telemedicine in the state in which the patient is located and the state in which the practitioner is located. This means, for example, that practitioners may not prescribe buprenorphine in states where state law prohibits the prescription of a controlled substance based solely on an audio-only evaluation.Prescription must comply with the provisions of the relevant Controlled Substances Act and DEA regulations that govern dispensing for maintenance and detoxification treatment.A practitioner must be technically capable of using audio and video equipment permitting two-way, real-time interactive communication with the patient at the time of the telemedicine encounter.All prescriptions issued based on a telemedicine encounter under the authority of the rule must be issued for a Schedule III, IV or V narcotic drug approved by the US Food and Drug Administr