New Federal Rules Cannot Improve Methadone Delivery Without State Actions

The Substance Abuse and Mental Health Services Administration (SAMHSA) on Feb. 2 finalized new rules, effective in April, that permanently change federal requirements for opioid treatment programs (OTPs) for the first time since 2001. But states will also need to act to ensure that these changes can help make effective medication for opioid use disorder (OUD) more widely available.

OTPs are the only settings that can provide methadone, a critical medication for treating OUD. But many people don’t receive this lifesaving medication, in part because of inflexible federal and state rules.

SAMHSA’s new regulations represent a dramatic improvement from the previous regulatory approach. Among a host of changes intended to increase access to care and patient flexibility, they:

• Make COVID-19-related flexibilities permanent by allowing patients to receive up to 28 days of take-home methadone after one month in treatment. Before the national public health emergency, that amount was available only after two years of in-person treatment. The updated rules also emphasize that the decision to provide take-home doses should be based on individualized assessments conducted by an OTP medical provider.
• Remove counseling as a prerequisite for treatment.
• Allow people to start treatment faster, without first demonstrating a one-year history of OUD.
• Add harm reduction and recovery supports—such as distribution of overdose-reversing naloxone and use of peer recovery coaches—to the range of services that OTPs should provide.
• Allow more types of providers, such as nurse practitioners and physician assistants working in OTPs, to dispense methadone in accordance with state law.
• Permanently allow OTPs to provide services through telehealth, including starting people on buprenorphine, another effective medication for OUD, and developing treatment plans with methadone patients. However, these changes apply only to providers working in OTPs. Congress must act to make virtual access to buprenorphine permanent outside the OTP setting.
• Allow prisons and jails to provide methadone to patients with other health conditions if the facility is registered as a hospital or clinic with the Drug Enforcement Administration. Combined with recent policy changes that give state Medicaid agencies the option to pay for care prior to release, this policy change could expand access to medication for a group at high risk of overdose.
• Allow for-profit OTPs to provide interim treatment, in which patients are offered medication without other services because the provider does not have the capacity to offer comprehensive care to additional clients. Previously, only public and private nonprofit OTPs were permitted to provide such care. Now the 65% of OTPs that are for-profit can do the same.

The new federal regulations have the potential to transform OTP care with this update of the rules to align with decades of evidence on the safety and efficacy of methadone, including research on the impact of the pandemic-related flexibilities.

For example, take-home doses enable patients to take medication at home rather than traveling to an OTP sometimes daily. This additional flexibility would benefit rural patients, who can face average drives of 50 minutes to a facility, and communities of color, which are more likely to be served by OTPs than buprenorphine providers who have not been subject to such stringent federal requirements.

States must also act to increase methadone access

OTPs are also regulated at the state level, and without changes here, methadone access won’t improve. State policymakers need to review their regulations and make changes to align with the new evidence-based standards.

Research by Pew has found that, as of 2021, many states had rules that conflict with the new federal treatment guidelines for OTPs. For example:

• All states (except for Wyoming, which does not have any OTPs) allowed providers to terminate care for patients who don’t participate in ancillary services such as counseling.
• 23 states imposed a set counseling schedule—often tied to the ability to access take-home medication—rather than providing individualized care.
• 7 states did not allow medication to be taken home in the first 90 days. Other states allowed this practice but imposed other dose limits that wouldn’t allow OTPs to provide care in alignment with the new federal rules. For example, Massachusetts stated in 2021 rules that only one take-home dose per week was allowed in the first 90 days of treatment, and only after two months of daily dosing. The commonwealth changed this requirement in 2022, and the regulations now direct providers to comply with federal take-home rules.
• 10 states imposed additional take-home criteria beyond what was in the old federal rules, such as requirements that recipients be employed or enrolled in school.

While revisiting these rules, state policymakers should also change other regulations that limit access to care, such as burdensome staffing ratios that make it hard for OTPs to operate. Colorado removed such requirements, and four new OTPs opened across the state last year, with as many as nine more expected in 2024. State officials should make sure to engage current and former OTP patients when revising their rules to ensure that new regulations meet their needs. Resources are available to help with these engagements.

State Medicaid agencies will also need to review how they pay OTPs to ensure that payment policies support these new flexible rules. For example, New York’s Office of Addiction Services and Supports established new Medicaid billing codes for OTPs in 2020 to align with the temporary federal flexibilities at the beginning of the COVID-19 pandemic and has since made these payment changes permanent.

Most states acted to expand access to methadone through temporary means during the COVID 19 public health emergency. With that period now over, the federal government has taken permanent steps to improve methadone treatment. States now need to do the same.

Frances McGaffey works on Pew’s substance use prevention and treatment initiative.