The COVID-19 pandemic is likely to have profound impacts on people with opioid use disorder (OUD) and other drug use disorders. Generally, opioid agonist therapies such as methadone and buprenorphine require patients to gather in large groups and attend frequent in-person visits with prescribers. Public health interventions designed to mitigate the spread of COVID-19 can severely impact the ability of patients with OUD to access opioid agonist therapy and to use drugs safely.
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 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.
Opioid Treatment Programs
Specifically, OTPs are no longer required to perform an in-person evaluation 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 can be performed through telemedicine. This exemption applies only to those patients requiring buprenorphine treatment. For patients treated with methadone, an in-person evaluation is still required.
Treatment of buprenorphine patients must occur in accordance with SAMHSA’s OTP guidance, 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 OUD, or up to 14 days of take-home medication for patients who are less stable if the OTP believes they can safely handle this level of take-home medication.
OTPs may continue to treat existing patients with both buprenorphine and methadone via telemedicine, including telephonically. Further, OTPs may dispense both buprenorphine and methadone under a blanket exemption based on telemedicine using the following guidelines: (i) up to 28 doses for clinically stable patients, or (ii) up to 14 doses for less clinically stable patients.
In the event that a supervising physician can no longer oversee the administration or dispensing of these medications, mid-level providers may continue to dispense and administer such medications within an OTP, without the direct supervision of an OTP physician. However, such mid-level practitioner must be “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 federal requirements. This exemption would 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.
SAMHSA provided several factors for providers to consider while managing treatment of alcohol or benzodiazepine withdrawal. Because of the substantial risk of coronavirus spread with the congregation of individuals in a limited space, such as in an inpatient or residential facility, SAMHSA advised that outpatient treatment options be used to the greatest extent possible.
Specifically, SAMHSA recommended that inpatient facilities be reserved for patients for whom outpatient measures would not be adequate (e.g., patients diagnosed with severe depression and/or exhibiting suicidal tendencies). SAMHSA also encouraged the use of telehealth and/or telephonic services to evaluate and treat patients. These resources can be used for initial evaluations, including evaluations for consideration of the use of buprenorphine products to treat opioid use disorders. Further, these resources can be used to implement individual or group therapies, such as evidence-based interventions including cognitive behavioral therapy for mental and/or substance use disorders. For those with substance use disorders, inpatient/residential treatment has not been shown to be superior to intensive outpatient treatment. Finally, SAMHSA advises providers to consider Centers for Disease Control and Prevention guidance when admitting new patients, while managing current residents who may have been exposed to or are infected with COVID-19, and when reviewing or revising visitor policies.
In this time of national crisis, it is important that federal and state health officials continue to consider aggressive action to ensure that people with OUD are able to access life-saving medications. McGuireWoods has a dedicated team of experienced lawyers who will continue to monitor state and federal responses to COVID-19. Please contact the authors of this alert with any questions and for additional guidance.
In a series of video alerts, McGuireWoods’ healthcare lawyers address issues providers face and overcoming COVID-19 challenges.