President’s message: Will COVID-19 have a lasting impact on opioid treatment program regulations?

The changes we have seen to the practice of addiction medicine due to the COVID-19 pandemic in the past few months have been unprecedented. Some federal and state regulations have been temporarily suspended in order to help stop the spread of COVID-19. People who are in treatment for substance use disorders (SUD) are in a somewhat unique situation in that treatment for SUD often involves regular visits to outpatient treatment centers, group therapy, repeated trips to the pharmacy, and/or daily visits to opioid treatment programs (OTPs) for medication dosing. The Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Agency (DEA) made several changes to regulations regarding the treatment of SUD during the pandemic, allowing people to receive SUD treatment in their homes via telehealth and make fewer trips to OTPs to receive health sustaining medication, a break from how SUD treatment has been provided in the United States for the past 45 years. I’d like to take this moment to focus on methadone treatment for opioid use disorder, reviewing the history of treatment of opioid use disorder (OUD), regulations surrounding OTPs, alternative provision of methadone treatment, and the recent loosening of regulations during the COVID-19 pandemic.

At the end of the 19^th century, it is estimated that 150,000 to 200,000 Americans were addicted to opioids. Laws enacted in the early 20^th century still impact practice today. The Harrison Narcotic Act of 1914 was an attempt to control manufacture, importation and exportation, sale, and distribution of opium, cocaine, and their respective salts. It required any person dealing with derivatives of opium and cocaine to register annually and pay an annual tax of $1. It made it illegal to sell or give away these drugs without a written order on a form issued by the commissioner of revenue. There was an exception made for people who possessed these substances prescribed in good faith by physicians, surgeons, and veterinarians in the course of professional practice. Several physicians and pharmacists were fined and incarcerated for prescribing and dispensing opioids in high quantities to treat OUD. ¹ By the early 1920s, morphine and heroin clinics which began operating in the 1910s were forced to close and individual physicians stopped treating OUD. ² It was not until the mid-1960s, when Dole and Nyswander ³ published their study of methadone for the treatment of heroin addiction, that physicians again started using an opioid to treat OUD. Following the publication of Dole and Nyswander’s research, several methadone clinics opened under Investigational New Drug (IND) applications from the Food and Drug Administration (FDA). By having an IND, clinics could investigate methadone as a treatment for OUD without sanction from the Bureau of Narcotics. From 1967 to 1970 the FDA liberally issued INDs and many criticisms of methadone were levied, including methadone causing “iatrogenic addiction,” diversion of methadone, children being poisoned by methadone, and methadone was replacing one drug for another. ⁴ Between 1970 and 1974, the FDA enacted methadone regulations and Congress passed laws including the Controlled Substances Act and Narcotic Addict Treatment Act. The regulations and laws created a system in which methadone could only be dispensed by licensed treatment programs, made eligibility for treatment contingent upon age and length of addiction to opioids, designated a maximum starting dose and a minimum amount of counseling, defined maintenance and detoxification treatment, specified criteria for take-home doses of methadone, and required annual DEA registration of practitioners. ⁴ These regulations and laws were criticized as being burdensome to the practice of medicine and were a departure from physicians being able to use their own clinical judgment, guided by FDA labeling of drugs, to make treatment decisions. Since 1974, some changes to the regulations have been made, including the length of time one needs to be dependent on opioids to be eligible for methadone treatment, acceptable forms of toxicology testing, and federal oversight of OTPs being transferred from the FDA to SAMHSA. Additionally, a change in response to another public health crisis, HIV/AIDS, allowed interim treatment for those on wait lists. This allowed clinics that had wait lists to provide methadone to individuals with OUD while they were waiting to be enrolled in comprehensive treatment to reduce the risk of transmission of HIV. Randomized studies of interim methadone treatment have found it is more effective in reducing illicit opioid use and facilitating entry to comprehensive methadone maintenance treatment than a wait list. ^{5 , 6}

Our current public health crisis, the COVID-19 pandemic, has resulted in a relaxation of OTP regulations regarding take-home doses of methadone. Normally, federal regulations allow for up to 1 month of take-home doses of methadone after two years of continuous treatment and meeting the eight take-home criteria. SAMHSA has issued a blanket waiver allowing OTPs to allow two and four week take-home doses of methadone if the OTP deems the patient to be stable, regardless of the usual take-home criteria. State regulations may be more restrictive, and during the time of COVID-19, states have also relaxed their regulations. Providing patients with an increased number of take-home doses of methadone decreases the number of trips an individual must make to an OTP, thereby reduces the potential number of times the individual may be exposed to COVID-19, including on public transportation or while waiting in line at the OTP. After more than 45 years of practicing under strict regulations, medical directors of OTPs are using their clinical judgment to make decisions regarding this one aspect of treatment. Patient outcomes and healthcare provider feedback could influence long-term changes that allow more flexibility for physicians and those in treatment.

There is evidence available showing the efficacy of methadone outside of a tightly regulated system. In the United Kingdom, Canada, and Australia, those with OUD are prescribed methadone by a general practitioner and dose or pick up their medication at local pharmacies. This practice has been shown to retain people in treatment and reduce harms from opioid and injection drug use. ^{7 , 8} Furthermore, there are data from the U.S. regarding experimental methadone medical maintenance (MMM) which was started in the mid-1980s through the FDA’s IND program. This program allowed individuals with OUD who were stable on methadone (i.e., in treatment for five years, no drug use or criminal activity for three years, and employed) to transfer their care to one of the experimental MMM programs. MMM continued to provide methadone treatment for individuals with OUD, but physicians were able to practice under fewer regulations and there were fewer requirements for those in treatment compared to an OTP. Twelve- to 15-year outcome studies of MMM show high retention in treatment, few problems with ongoing drug use, little to no diversion, and improved psychosocial outcomes. ^{9 , 10} Other researchers found that those in treatment at an OTP with shorter periods of clinical stability (i.e., six months to more than one year) also had positive outcomes with medical management. ^{11 – 13}

Prior to the COVID-19 pandemic, there were calls to change regulations regarding methadone treatment to make it more accessible considering the opioid epidemic. ⁷ Methadone has been repeatedly shown to retain people in treatment, improve clinical outcomes, and reduce overall morbidity and mortality secondary to opioid use. ⁷ There are data ^{9 – 13} showing that some individuals with OUD taking methadone are able to do so in a less restrictive environment, which would open up spots in OTPs for those who need a higher level of monitoring. With two overlapping public health crises, regulations regarding take-home doses of methadone have been loosened. It remains to be seen if this may be the impetus for some lasting changes in methadone treatment.

Julie Kmiec
American Osteopathic Academy of Addiction Medicine, Chicago, IL, USA
[email protected]