Federal agencies have substantial authority to increase access to methadone


Methadone, a Food and Drug Administration-approved treatment for opioid use disorder (OUD), can reduce illicit opioid use and prevent overdose deaths, which have reached record number last year. More than 400,000 people in the United States received methadone as part of their addiction treatment in 2019, and many more could benefit from this lifesaving drug – an estimated 1.6 million people had a OUD the same year. But federal regulations limit the availability of methadone at a time when there is a great need to increase access to this effective treatment.

Today, methadone for OUD can only be dispensed in licensed opioid treatment programs (OTPs), which are specialized health care facilities with different criteria than other medical practices. The practitioners who work there must also meet strict federal and state requirements. Also, under current rules, people on methadone often have to go to the CNP almost daily to receive their dose. The sometimes long journeys can then interfere with patients’ ability to work and live their lives.

To improve access to OUD treatment, the Biden administration must consider ways to remove restrictions without relying on legislative action by Congress. A new report from the George Washington University (GWU) Regulatory Studies Center, released August 11 and funded by The Pew Charitable Trusts, finds that regulatory barriers to methadone access can be removed or changed by executive agencies , particularly the Substance Abuse and Mental Health Services Administration (SAMHSA) and Drug Enforcement Administration.

What could change

SAMHSA and DEA currently have restrictions and regulations in place that can and should be changed to expand access to methadone.

First, SAMHSA now requires OTPs to meet restrictions to obtain and maintain DEA certification in order to operate as narcotics treatment programs. Many of these rules could impede access to methadone; for example, patients must be addicted to an opioid for at least one year prior to admission, drug tests must be performed for each patient, ancillary services such as counseling must be offered, and patients who do not not meet specified criteria for management (e.g., duration of full maintenance treatment) should make near-daily visits to the facility to receive treatment. Studies have shown that such policies can reduce adherence and hinder access to treatment.

SAMHSA has the legal authority to remove or modify these restrictions through advice or the rulemaking process, according to the GWU study. The latter would require the building of an administrative record to support the changes, including the evidence supporting them, and consultation with the United States Attorney General. Issuing guidance would be a faster and less cumbersome process. The agency used this approach to ease restrictions during the COVID-19 public health emergency, but those changes would be less permanent than through rulemaking and subject to the discretion of agency officials.

Second, DEA regulations include a binding requirement that methadone for OUD can only be dispensed to an OTP and cannot be prescribed for pickup at a pharmacy. Since the number of pharmacies far exceeds the number of PTAs, the dispensing of methadone in pharmacies could significantly increase access to treatment.

The DEA could change that without further authorization from Congress because the agency’s regulations on methadone distribution are more restrictive than current law, according to the report.

Third, the DEA could move methadone from a Schedule II controlled substance to Schedule III, which would allow health care practitioners to prescribe or dispense the drug for OUD without special DEA registration. or SAMHSA. This DEA action would align methadone with other drugs used to treat the disease, such as buprenorphine. Specialized training and certification are still required to prescribe this medication. If methadone were a Schedule III controlled substance, practitioners who have already obtained a waiver to treat patients with buprenorphine would also be allowed to prescribe methadone. Such a change could encourage more suppliers to obtain a waiver.

To do this, the DEA would need to work with the federal Department of Health and Human Services (HHS) to create an administrative record to support such a move. This would involve a “scientific and medical evaluation” of the substance by the FDA and planning recommendations from the HHS Assistant Secretary for Health to the DEA.

Finally, the DEA and SAMHSA could eliminate or streamline other lower-level barriers that collectively may play a role in making it difficult and costly for OTPs to operate, thereby reducing access to methadone. These include:

  1. The DEA requirement that each practitioner, hospital, or retail pharmacy that prescribes or dispenses a controlled substance must be registered with the agency and obtain separate registration as a “narcotics treatment program.” Stand-alone opioid treatment programs are the only health care facilities that must separately register with the DEA as narcotic treatment programs.
  2. SAMHSA’s cumbersome certification and accreditation process for OTPs. The Agency’s authorization for a facility to operate as an OTP expires or must be renewed after a maximum of three years. Program applications should include a variety of information, including a “description of the organizational structure” of the OTP and their sources of funding. Following this process, SAMHSA must complete a consultation with the relevant state agency that oversees OTPs.
  3. Extensive DEA security checks for controlled substances. Programs must store methadone in a locked steel cabinet or safe per DEA specifications, and depending on the weight of the cabinet and the amount of methadone, must be bolted or cemented to the floor and have an alarm system. Filers must also notify the DEA of the theft and “significant loss” of methadone. There are specific criteria for determining whether a loss is significant, including the amount lost, whether the loss can be attributed to specific people or activities, and loss trends over time and local trends. Only a licensed practitioner or authorized person can sign an invoice for controlled substances the program receives, and patients must wait in an area separate from the narcotics storage area.
  4. The DEA’s requirement that registrants maintain detailed methadone inventories and records as well as a dispensing log that tracks the amount of medication dispensed or administered to a patient. OTPs authorized to use a computer for data storage must have a DEA pre-approved system and always produce signed hard copies of each day’s distribution log.

These may not be the biggest hurdles identified by experts and public health advocates, but appropriate updates and changes could help increase the supply of providers available to care for patients as the country faces a growing opioid crisis. All OTP policies must serve the public interest and not unnecessarily impede access to treatment.

The GWU report identifies opportunities for SAMHSA and DEA to update their policies regarding the dispensing of methadone. This would be an important step forward in improving the treatment landscape for patients with OUD.

Sheri Doyle manages The Pew Charitable Trusts Drug Prevention and Treatment Initiative.


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