In 2001, the Food and Drug Administration transferred regulation of methadone treatment programs for opioid use disorder (nowadays called Opioid Treatment Programs or OTPs) to the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration. DEA and SAMHSA work together to establish and enforce criteria for treating people with substance use disorder and the regulations that govern how health care practitioners prescribe and administer opioids as medication assisted treatment (MAT) for opioid use disorder. The rules govern the dose and number of drugs clinicians prescribe and even dictate if and when patients may be given medication to take home.
For several years, the DEA and SAMHSA have allowed practitioners to prescribe the Schedule III opioid buprenorphine to patients they see in their offices or clinics as take‐home medication for opioid use disorder, provided they take an 8‑hour course and go through a burdensome application process to receive a waiver on the federal narcotics prescribing license they receive from the DEA (a so‐called “X‑waiver,” because the letter ”X” is appended to the license number). The DEA limits how many patients such practitioners can treat at any given time and, until recently, only gave these waivers to physicians.
The DEA and SAMHSA apply different regulations to using methadone to treat opioid use disorder. For example, practitioners may only administer methadone at DEA/SAMHSA‐approved OTPs, and regulators have required people with opioid use disorder to have been addicted to opioids for at least one year before qualifying for admission to a program. The programs must include counseling sessions and social services. Patients must show up every day and ingest the methadone in front of clinic staff to prove they are not injecting it or selling it on the street. The regulations have allowed some patients to take a small amount of methadone home with them, but only after clearing several hurdles and with many strings attached.
During the COVID public health emergency, SAMHSA relaxed several regulations so people with substance use disorder could access these medications while minimizing the risk of contracting the virus. For example, SAMHSA allowed OTPs to give a 28‐day supply of take‐home methadone to “stable” patients and a 14‐day supply to “less stable” patients. The agency permitted OTPs to operate vans that can go out to the patients where they live. To deal with pandemic‐related OTP staffing problems, SAMHSA allowed people to receive “interim treatment” from OTPs (daily methadone but without the counseling and other services typically offered by OTPs) for up to 180 days. SAMHSA allowed certain OTP follow‐up visits to use telemedicine and permitted community practitioners prescribing buprenorphine under the X‑waiver to perform initial evaluations of new patients via telemedicine. SAMHSA also expanded the categories of health care practitioners it permits to prescribe buprenorphine, including physician assistants, nurse practitioners, certified nurse anesthetists, and nurse midwives.
After numerous reports that the relaxed regulations did not result in misuse or diversion of methadone into the black market, SAMHSA decided to extend the relaxed rules until one year after the President officially declared the public health emergency over.
On December 16, 2022, SAMHSA published a Notice of Proposed Rulemaking (NPRM) and solicited comments. In the notice, SAMHSA stated it had extended the COVID‐related relaxation of standard regulations to provide time so the agency could issue a proposal to permanently change the rules. The NPRM would make all the emergency measures permanent. The agency expressed a serious commitment to destigmatizing people with substance use disorder and, consequently, proposed changing many of the terms that policymakers have used when discussing the overdose crisis and substance use disorder. For example, the agency offers to replace the term “medication assisted treatment” with “medication for opioid use disorder” (MOUD).
I submitted my comment to the agency. In it, I argued that the relaxed rules were a step in the right direction, but that I and many others have long argued that health care practitioners—especially primary care providers interested in treating substance use disorder—should be allowed to prescribe take‐home methadone to treat their patients with substance use disorder as they have been doing for over 50 years in the U.K., Canada, and Australia. I also pointed out that the omnibus bill passed by Congress on December 23 and signed by President Biden on December 29 contained the Mainstreaming Addiction Treatment Act, which ended the X‑waiver required to prescribe buprenorphine, expanded the categories of providers who may dispense buprenorphine, and permitted telemedicine. Therefore, the Mainstreaming Addiction Treatment Act might have rendered many of SAMHSA’s proposed changes to the rules concerning buprenorphine moot.
I commended the agency for committing to destigmatizing people with substance use disorder. However, I argued that the agency perpetuates the stigma attached to substance use disorder by maintaining a unique set of rules that govern how clinicians may give care and treatment to people with substance use disorder apart from how they would treat other patients. Changing the words policymakers use is nice. But “action speaks louder than words.” In the penultimate paragraph of my comments, I wrote:
The only way to completely destigmatize people with substance use disorder, and thus facilitate their access to care and improve the likelihood of recovery, is to remove the regulations and restrictions unique to opioid treatment programs. This includes rules affecting the use of telemedicine technology. Licensed health care practitioners should be able to prescribe opioid agonists such as methadone, as well as the partial agonist buprenorphine, to people with substance use disorder the same way the government allows them to prescribe beta blockers to treat hypertension and insulin to treat diabetes. In short, if the Substance Abuse and Mental Health Services Administration seriously wants to destigmatize people with substance use disorder, it can start by destigmatizing how they receive treatment.
You can read my entire comment here.
