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Exemptions and Considerations for the Treatment of Opioid Use Disorder During the COVID-19 Emergency

On March 19 and 20, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) published new guidance for the care and treatment of mental and substance use disorders during the Coronavirus (COVID-19) outbreak. This guidance includes exemptions for providers working in opioid treatment programs (OTPs) relating to (i) the provision of methadone and buprenorphine to treat opioid use disorder and (ii) other factors that should be considered while managing treatment of alcohol or benzodiazepine withdrawal.

Specifically, OTPs are no longer required to perform an in-person evaluation (pursuant to 42 C.F.R. § 8.12(f)(2)) of any patients treated with buprenorphine if a program physician, primary care physician, or authorized healthcare professional under the supervision of a program physician determines that an adequate evaluation of the patient can be accomplished via telehealth. This exemption is exclusive to patients requiring treatment with buprenorphine and does not apply to new patients treated with methadone. For patients treated with methadone, an in-person evaluation is still required.

Treatment of OTP buprenorphine patients must occur in accordance with SAMHSA’s OTP guidance issued on March 16, 2020, which allows states to request blanket exceptions for all stable patients in an OTP to receive up to 28 days of take-home doses of the patient’s medication for opioid use disorder or up to 14 days of take-home medication for those patients who are less stable but who the OTP believes can safely handle this level of take-home medication.

OTPs may continue to treat existing patients with both buprenorphine and methadone via telehealth (including telephonically). Further, OTPs may dispense medication (both buprenorphine and methadone) under a blanket exemption based on telehealth evaluation (including telephone) using the following guidelines: (i) up to 28 doses for clinically stable patients or (ii) up to 14 doses for less clinically stable patients. Additionally, as outlined in a previous On the Subject, the DEA has eased restrictions on prescribing controlled substances via telehealth and has also loosened the delivery and administration requirements for methadone during the period of the national emergency.

In the event that a supervising physician can no longer oversee the administration or dispensing of medication-assisted treatment (MAT) medications, OTP mid-level providers may continue to dispense and administer such medications within an OTP, without the direct supervision of an OTP physician, if such mid-level practitioner is “licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense opioid drugs” pursuant to 42 C.F.R. § 8.12(h)(1).

Lastly, in the event that an OTP physician or medical director cannot perform his or her regulatory functions pursuant to 42 C.F.R. § 8.12, an OTP may request an exemption from the requirements of 42 C.F.R. § 8.12 in order to permit midlevel providers to perform those functions related to admitting patients, ordering unsupervised take home medication, or changing medication doses if such action is consistent with applicable state law and the midlevel provider’s scope of licensure.

These exemptions will continue for the period of the national emergency declared in response to the COVID-19 pandemic. It is also important to note that state laws may impact the practicality of these exemptions, particularly as states continue to make emergency proclamations and promulgate executive orders on a daily basis.

Other Considerations for Providers

SAMHSA has also provided several factors for providers to consider while managing treatment of alcohol or benzodiazepine withdrawal, particularly as access to care facilities becomes limited. Specifically, SAMHSA has recommended the use of intensive outpatient treatment services whenever possible, and that inpatient facilities should be preserved for patients for whom outpatient measures would not be adequate (e.g., patients diagnosed with life-threatening mental disorders, such as a severe depression, and exhibiting suicidal tendencies). SAMHSA has also encouraged the use of telehealth and/or telephonic services to evaluate and treat patients, including for consideration of the use of buprenorphine products to treat opioid use disorder. Lastly, SAMHSA advises providers to consider CDC guidance when admitting new patients, while managing current residents who may have been exposed to or who are infected with COVID-19, and when reviewing or revising visitor polices.

© 2020 McDermott Will & Emery

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About this Author

Karen Owen Gibbs, Health, Life sciences, Attorney, McDermott Will, Law Firm
Partner

Karen Owen Gibbs is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  She has extensive background in regulatory, compliance and policy issues in the health care and life sciences industries, including pharmacies (retail, mail and specialty), pharmaceutical and biologics manufacturers, pharmacy benefit management (PBM) companies, device manufacturers, durable medical equipment (DME) suppliers, hospitals, retail clinics and senior living facilities.   Karen also has substantial experience advising investors and lenders focused on those...

312-984-3652
Megan R. Rooney, Health Care Attorney, McDermott Will Emery Law firm
Partner

Megan R. Rooney is a partner in the law firm of McDermott Will & Emery LLP based in its Chicago office.  She focuses her practice on the representation of hospitals and health systems and other health industry providers and investors. She has experience in all aspects of healthcare transactions, including mergers, acquisitions, affiliations, joint ventures and system restructurings for hospitals and other health care providers. Megan also advises hospital and health system clients on regulatory compliance with licensure, accreditation and other state and federal regulatory matters.

312-984-6475
George Tzanetakos Healthcare Attorney Chicago
Associate

George Tzanetakos advises hospitals, health systems and other health industry clients on a variety of regulatory and transactional matters, including mergers, acquisitions, affiliations and joint ventures.

During law school, George served as a law clerk for the general counsel of a large Iowa health system, held a research assistantship at the University of Iowa Department of Health Management and Policy’s Rural Policy Research Institute, and was an intern for the United States Attorney’s Office for the Northern District of Iowa.

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