Opioid treatment programs (OTPs) that dispense methadone got a fast and clear release from regulations due to the coronavirus/COVID-19 pandemic. The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued policies that give OTPs flexibility in take-homes. This limits the frequency of contact, contributing to the social distancing required to limit spread of the virus.
There is also an allowance for telemedicine inductions, waiving the physical examination requirement for new patients, but this is only for buprenorphine, not for methadone (see SAMHSA FAQ https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf).
Specifically, SAMHSA said:
- All states with declared states of emergency may request blanket exemption 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.
- In 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.
OTPs need to be ready with increased medication “to meet patient needs,” said SAMHSA.
Key to this new policy: the onus is on OTPs to make sure their patients are stable enough to be given more take-homes. If someone overdoses or diverts their medication to someone who overdoses, it is the OTP who is liable.
The American Association for the Treatment of Opioid Dependence (AATOD) issued guidance to help OTPs comply with new policies (see https://atforum.com/2020/03/aatod-releases-guidance-for-otps-on-coronavirus-covid-19/
COVID-19 is scaring everyone, and it’s commendable that the federal authorities—not only SAMHSA, but the Drug Enforcement Administration (DEA) as well—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,” Mark Parrino, MPH, president of AATOD, said. “All of this is against the backdrop of a frightened population, as governors, county executives, and mayors enter a phase of quasi-quarantining.”
Telemedicine and the DEA
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. 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).
The DEA requires that:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice.
- The telemedicine communication is conducted using an audiovisual, real-time, two-way interactive communication system.
- The practitioner is acting in accordance with applicable federal and state law.
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.”
SAMHSA has also implemented a “doorstep delivery” procedure in which OTPs are expected to send staff to deliver methadone to people’s homes. They would have to stand 6 feet away from the patient, and follow other rules. OTPs in general do not feel this is going to be an easy task, especially in places like New York City where there are so many patients and so many are expected to be sheltering in place.
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