AATOD Calls for OTP Reforms, Including Relaxing Rules

The American Association for the Treatment of Opioid Dependence (AATOD) is recommending that federal regulators relax rules regarding methadone treatment by opioid treatment programs (OTPs). Only OTPs, certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), are allowed to dispense methadone for the treatment of opioid use disorders (OUDs). The rules include strict criteria for “take-homes” (medication that the patient can take home instead of coming into the clinic for), limitations on telehealth especially for new patients, limitations on interim treatment, and more. With COVID-19, SAMHSA quickly relaxed some rules to provide for fewer in-person interactions (more lenient take-homes) to reduce virus transmission.

The paper focuses on the importance of expanding, not getting rid of, OTPs, as a way to make methadone more widely accessible.


  • SAMHSA should consider a change in take-home requirements based on the “real-world” experience during COVID-19.
  • SAMHSA should make it possible for OTPs to admit new patients to treatment with methadone via telehealth.
  • States need to better align their policies on oversight with changes in federal oversight.
  • Reimbursement via state Medicaid programs as well as federal Medicare programs need to be aligned with federal and state oversight requirements.
  • SAMHSA should continue to monitor how states use funds to ensure the expansion of mobile vans connected to OTPs wherever they are needed to expand access to care to treat opioid use disorder.
  • SAMHSA should remove two primary barriers in expanding access to interim maintenance treatment by removing the restriction for for-profit entities and by allowing patients to have take-home medication during the period of interim maintenance.
  • Satellite medication units should work in conjunction with licensed OTPs, and SAMHSA should coordinate this effort with the DEA and State Opioid Treatment Authorities. “We believe SAMHSA needs to amend the existing regulatory guidance to OTPs from 2015 and clearly define what services can be provided in satellite medication units,” states the policy paper.
  • Federal and state authorities develop additional and creative/innovative options to treat patients. Such innovations include deliveries to home bound patients during times of crisis in addition to working with an expanded number of partners in mental health and residential settings.
  • SAMHSA should encourage states to widen flexibilities in regard to staffing ratios so OTPs can balance the needs of patients with both their level of risk and the availability of various workforce components (i.e., physicians, physician extenders, nurses and counselors/therapists) “in a way that, while not always ideal, allows for the provision of adequate care under various environmental conditions.”
  • Patient admission criteria should be reviewed. Current regulations require this: “A person under 18 years of age is required to have had two documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period to be eligible for maintenance treatment.” These provisions should be eliminated, according to AATOD.
  • SAMHSA should work with the approved accreditation entities with regard to how such entities are interpreting SAMHSA regulations and guidelines.
  • Pharmacies should not be allowed to dispense methadone through physician prescribing.
  • SAMHSA should work with other agencies within the Department of Health and Human Services, the Office of National Drug Control Policy, and other federal agencies, which have the ability to create loan forgiveness opportunities so that individuals in the health profession are given the opportunity to work in OTPs to fulfil their obligations in receiving student loans.

In releasing the paper September 30, AATOD president Mark Parrino called especially for expanding the use of mobile methadone and expanding the use of satellite medication units and telemedicine units. All of these services would be connected to brick and mortar OTPs. The paper was approved by the AATOD board of directors for national distribution, said Mr. Parrino.

“It is our hope that this paper provides guidance to our colleagues in the coming months as we continue to respond to the needs of patients against the backdrop of increasing opioid related mortality,” he said. “The underlying premise of the paper is to expand access to the treatment of opioid use disorder without compromising the integrity of care offered to patients in need of treatment.”

There are more than 1,200 OTPs throughout the United States, and over 600 OTPs in the World Federation for the Treatment of Opioid Dependence (WFTOD), which represents substance use treatment programs in Europe and works cooperatively with other treatment centers throughout the world. Together with the World Federation, AATOD works with the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) in disseminating policies and practices to treat opioid use disorder. AATOD, founded in 1984, produced the first Treatment Improvement Protocol (TIP) for SAMHSA in cooperation with the American Society of Addiction Medication (ASAM) and released by SAMHSA in 1993. AATOD worked with the Drug Enforcement Administration (DEA) to produce the first Best Practice Guideline, published by the DEA in 2000.

Recent history

Beginning in March 2020, and under emergency exemption policies promulgated by SAMHSA in collaboration with the State Opioid Treatment Authorities (SOTAs), OTPs were approved to provide more take-home medications to patients. Many of the OTPs in the United States also suspended toxicology screenings to protect the safety of the staff and patients. However, more toxicology reports were found to be positive with heroin and fentanyl once OTPs reinitiated testing. Few reports of methadone related overdoses were attributable to patients consuming take-home medication prematurely, which “opened the door to rethinking how take-home medication can be implemented with greater flexibility in treating clinically stable and unstable patients,” according to the paper. “SAMHSA also needs to make clearer distinctions with regard to clinically unstable patients if there is any attempt to reevaluate the existing regulatory criteria for dispensing take-home medications. We believe SAMHSA’s OTP regulatory oversight policies should be cautiously reevaluated and based on evidence and clinical practice. Clearly, OTPs need to have greater flexibility to make ongoing care less burdensome for the patient.”

Expanding the footprint of OTPs throughout the United States, especially in suburban and rural areas, is a key focus of AATOD. But in order for this to happen state regulations need to be aligned with federal regulations. Just because the federal government says two weeks of take-homes can be given to less than stable patients, for example, doesn’t mean the states have changed their regulations, which limit take-homes to one day, for example.

Pressuring SAMHSA to pressure the states is one way for this to happen. States have as much interest as the federal government in keeping COVID-19 transmission down and in reducing opioid overdoses and use disorders.

Another rule in some states – not from the federal government – is that OTPs use pharmacists to administer and/or dispense medication. “In an environment of shortages in pharmacists, such regulations are burdensome and significantly add to the cost of treatment,” the paper states. “No one has provided any evidence to support how pharmacists offer superior care in the OTP setting when compared to nursing or clinical personnel.”

Some states require patient-to-staff ratios without any rationale, some of the strict siting requirements, and some have census capacity limits which are not based on occupancy.

Finally, SAMHSA does not allow funds distributed by State Alcohol and Drug Abuse Authorities to go to for-profit entities. This is a problem, the paper stated, because about 60% of OTPs are for-profit. Regardless of ownership status, OTPs will benefit from opportunities to expand, the paper noted. SAMHSA has already begun to take steps in this direction by stating that SAMHSA funds to purchase mobile methadone vans can be used by both nonprofit and for-profit OTPs. “The use of mobile vans is particularly vital to serving patients in rural areas as well as prisons and 7 jails where research shows a large majority of the patients with OUD exist,” the paper noted.

For the full paper, go to https://files.constantcontact.com/55b56c59001/4146153a-c8b7-4bc6-9495-8a03360fd0a2.pdf

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