Abstract
Opioid treatment programs (OTPs) that dispense methadone got a fast and clear reprieve from federal authorities last week in the face of COVID‐19. The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued policies that give OTPs flexibility in take‐homes, limiting the frequency of face‐to‐face contact and opportunities for transmission of COVID‐19. There is also greater flexibility for office‐based opioid treatment (OBOT) with buprenorphine.
Opioid treatment programs (OTPs) that dispense methadone got a fast and clear reprieve from federal authorities last week in the face of COVID‐19. The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued policies that give OTPs flexibility in take‐homes, limiting the frequency of face‐to‐face contact and opportunities for transmission of COVID‐19. There is also greater flexibility for office‐based opioid treatment (OBOT) with buprenorphine.
Specifically, SAMHSA said March 16 that all states with declared states of emergency may request blanket exemption (from SAMHSA) for all stable patients to receive 28 days of take‐home doses of methadone. In addition, the state may request up to 14 days of take‐homes for “patients who are less stable but who the OTP believes can safely handle” the take‐homes.
For states without a declared emergency, each individual OTP may request a blanket exemption for its clinic for up to 28 days for stable patients and up to 15 days for less stable patients. The requests don't have to be on a per‐patient basis, and programs and states should use their clinical judgment and procedures to identify stable patients.
Make sure that enough medication is on hand, SAMHSA urges. An increased supply will accompany these requests. “Therefore, OTPs and states must ensure that there is enough medication ordered and on hand to meet patient needs,” said SAMHSA.
The American Association for the Treatment of Opioid Dependence (AATOD), the membership association of OTPs, is also working on draft field recommendations in dealing with COVID‐19, which incorporate SAMHSA's recommendations in addition to those of the Office of National Drug Control Policy (ONDCP) of the White House. ADAW obtained this document, which is awaiting a coordinated response by the State Opioid Treatment Authorities (SOTAs), after which AATOD will release it.
Many states have OTP regulations that are stricter than those of the federal government, and the point of the revisions is to make it easier, not harder, to get take‐homes and minimize possible contagion via human contact. So it's vital that the states work with the federal government, and that's what happened here, AATOD President Mark Parrino told ADAW last week. “I do believe that SAMHSA's coordination with SOTAs and our guidance is extremely helpful,” he said. “The fact that they are working on blanket take‐home guidance with the states and providers is demonstrating increasing and necessary flexibility.”
COVID‐19 is scaring everyone, and it's commendable that the federal authorities responded so quickly to the needs of the OTP population, so often ignored. “The DEA is also demonstrating greater flexibility in dealing with OTP policy,” Parrino said. “All of this is against the backdrop of a frightened population as governors, county executives and mayors enter a phase of quasi‐quarantining.”
Patients maintained on methadone and buprenorphine need daily medication or they will go into withdrawal. With methadone, many patients need to go into the clinic on a daily or almost‐daily basis due to federal (and, mostly, state) regulations. “People are getting understandably rattled as greater restrictions are imposed and as freedom of movement is increasingly limited,” said Parrino.
But the greatest number of complaints appears to be that the bars are closed, said Parrino. These complaints are from local officials in New York, he said.
As for the SAMHSA take‐home changes, Zachary Talbott, chief clinical officer of ReVida Recovery Centers, president of the National Alliance for Medication Assisted Recovery, and president of the Alcohol and Drug Abuse Certification Board of Georgia, said they are “progressive.”
DEA and telemedicine
The DEA is also allowing for increased use of telemedicine and the internet in particular for office‐based opioid treatment and buprenorphine, as well as for OTPs (which dispense buprenorphine and other medications as well as methadone — only OTPs can dispense methadone for opioid use disorder). The sticking point has been the initial evaluation, which had to be done face to face — until now. “While a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in‐person medical evaluation (21 U.S.C. 829(e)), the Controlled Substances Act contains certain exceptions to this requirement,” the DEA states. “One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency under 42 U.S.C. 247d (section 319 of the Public Health Service Act), as set forth in 21 U.S.C. 802(54)(D). Secretary Azar declared such a public health emergency with regard to COVID‐19 on January 31, 2020 (https://www.hhs.gov/about/news/2020/01/31/secretary-azar-declares-public-health-emergency-us-2019-novel-coronavirus.html). For as long as the Secretary's designation of a public health emergency remains in effect, DEA‐registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in‐person medical evaluation, provided all of the following conditions are met:
The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.
The telemedicine communication is conducted using an audio‐visual, real‐time, two‐way interactive communication system.
The practitioner is acting in accordance with applicable Federal and State law.”
Note that if “the prescribing practitioner has previously conducted an in‐person medical evaluation of the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the patient via telemedicine, or any other means, regardless of whether a public health emergency has been declared by the Secretary of Health and Human Services, so long as the prescription is issued for a legitimate medical purpose and the practitioner is acting in the usual course of his/her professional practice,” the DEA wrote, adding however, that “for the prescription to be valid, the practitioner must comply with any applicable State laws.”
Confidentiality
However, there may be some concerns going forward about confidentiality, already at risk as the federal government pushes to overhaul 42 CFR Part 2 and Congress considers eliminating it. The Department of Health and Human Services said on March 17 that it would waive potential Health Insurance Portability and Accountability Act penalties “for good faith use of telehealth” during the COVID‐19 crisis. “Enforcement discretion” is only for telehealth and not for in‐person treatment; however, in‐person treatment for anything is taking a back seat to COVID‐19.
As ADAW was going to press, SAMHSA issued a new directive eliminating 42 CFR Part 2 confidentiality restrictions on SUD telehealth in the case of a medical emergency (https://www.samhsa.gov/sites/default/files/covid-19-42-cfr-part-2-guidance-03192020.pdf). More on this, and on how to define “stable,” next week.
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