Changes Would Make Permanent COVID-Timed Medication Flexibilities, and Update Decades-Old Definitions and Standards for Opioid Treatment Programs at a time when fewer than 1 out 10 Americans can access treatment for substance use disorder
The U.S. Department of Health and Human Services (HHS), through its Substance Abuse and Mental Health Services Administration (SAMHSA), is proposing to expand access to treatment for opioid use disorder (OUD) at a time when more than 107,000 Americans lost their lives to an overdose last year. The proposal would update the federal regulations that oversee OUD treatment standards as part of HHS’ Overdose Prevention Strategy that supports President Biden’s National Drug Control Strategy – a whole-of-government approach to beat the overdose epidemic. Specifically, the proposed rule change would allow Americans to access the treatment by allowing take home doses of methadone and the use of telehealth in initiating buprenorphine at opioid treatment programs (OTPs).
In its Notice of Proposed Rulemaking (NPRM) to update 42 CFR Part 8, SAMHSA is proposing to improve Americans’ access to and experiences with OUD treatment, in particular through OTPs. The proposed changes reflect the widespread desire by many stakeholders for SAMHSA to provide greater autonomy to OTP practitioners, positively support recovery, and continue flexibilities that were extended at the start of the nation’s COVID-19 public health emergency.
“These proposed updates would address longstanding barriers treatment in regulations – most of which have not been revised in more than 20 years,” said Miriam E. Delphin-Rittmon, the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “I am committed to moving these forward as quickly as possible because we have heard from both providers and patients how urgent the need is for treatment.”
According to Centers for Disease Control and Prevention (CDC) data, more than 107,000 Americans died from drug overdoses in 2021, an increase of more than 15 percent from 2020. These updates could help reduce overdose deaths.
SAMHSA proposes to update Part 8 by removing stigmatizing or outdated language; supporting a more patient-centered approach; and reducing barriers to receiving care. For example, in March and April 2020, SAMHSA published flexibilities for the provision of take-home doses of methadone and for the use of telehealth in initiating buprenorphine in OTPs. Patients deemed stable by physicians have been able to take home up to 28 days’ worth of methadone doses; other patients – again, so determined by their physicians – received up to a 14-day supply. A recent study showed that patients who received increased take-home doses after federal flexibilities were enacted during COVID-19 saw positive impacts on their recovery, including being more likely to remain in treatment and less likely to use illicit opioids.1
These flexibilities represented the first substantial change to OTP treatment standards in more than 20 years. Under the NPRM for Part 8, SAMHSA proposes to make these flexibilities permanent.
SAMHSA’s proposed changes also would update standards to reflect an OTP accreditation and treatment environment that has evolved since Part 8 went into effect in 2001. Accordingly, SAMHSA proposes updates that reflect evidence-based practice, language that aligns with current medical terminology, effective patient engagement approaches, and the workforce providing services in OTPs, including:
- expanding the definition of an OTP treatment practitioner to include any provider who is appropriately licensed to dispense and/or prescribe approved medications. The current Part 8 rule defines a practitioner as being: “a physician who is appropriately licensed by the State to dispense covered medications and who possesses a waiver under 21 U.S.C.823(g)(2).” During the COVID-19 public health emergency, this has been formally expanded to align with broader definitions of a practitioner (nurse practitioners, physician assistants, etc.), and OTPs reported that this change was essential in supporting workflow and access;
- adding evidence-based delivery models of care such as split dosing, telehealth and harm reduction activities;
- removing such outdated terms as “detoxification”;
- updating criteria for provision of take-home doses of methadone;
- strengthening the patient-practitioner relationship through promotion of shared and evidence-based decision-making;
- allowing for early access to take-home doses of methadone for all patients, to promote flexibility in creation of plans of care that facilitate such everyday needs as employment, while also affording people with unstable access to reliable transportation the opportunity to also receive treatment; likewise, promoting mobile medication units to expand an OTP’s geographic reach; and
- reviewing OTP accreditation standards.
To facilitate expansion of access to care, SAMHSA proposes to update OTP admission criteria in Part 8. This includes removal of the one-year requirement for opioid addiction before admission to an OTP, in favor of considering a person’s problematic patterns of opioid use. In conjunction with updated standards that include extended take-home doses of methadone and access to telehealth, these changes are likely to expand access while also improving retention in treatment. The NPRM also proposes to eliminate the requirement that practitioners who have a waiver to prescribe buprenorphine for up to 275 patients provide reports to SAMHSA on an annual basis.
The NPRM also promotes the chronic disease model of management, while removing barriers to providing individualized care. “Removing these barriers promotes patient trust and reduces the need for individuals to attend an OTP each day to receive treatment services,” said Assistant Secretary Delphin-Rittmon. “In this way, the proposed changes to Part 8 are focused on the individual and their treatment environment.”
The proposal, on display with the Federal Register, is viewable at https://public-inspection.federalregister.gov/2022-27193.pdf (PDF | 626 KB). Public comment on the proposed regulatory changes may be made until February 14, 2023.