42 CFR Part 8 Final Rule - Frequently Asked Questions

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), published final revisions to the federal regulations (rules) that address opioid use disorder (OUD) treatment standards, as well as opioid treatment program (OTP) accreditation and certification standards. These standards are found in 42 CFR Part 8. This final rule is the first substantial update to the OTP treatment standards in over 20 years. These updates will expand access to care and improve Americans’ experiences as they seek treatment for substance use disorder (SUD). This is in direct response to the overdose crisis, and the final rule advances part of HHS’ Overdose Prevention Strategy.

The isolation, anxiety and reduced access to resources experienced by many during the COVID-19 pandemic exacerbated substance misuse and overdose deaths. Data from the Centers for Disease Control and Prevention (CDC)indicates that 111,964 Americans died from a drug overdose in the 12-month period ending in July 2023.¹ Treatment with medications for opioid use disorder (MOUD) significantly reduces opioid-related overdose mortality.² The rise in fentanyl use or exposure and overdose deaths necessitated changes to Part 8 to expand access to care. The Part 8 final rule removes stigmatizing or outdated language, supports a more patient-centered approach, and reduces barriers to receiving care. The final rule also makes flexibilities put forth during the COVID-19 public health emergency permanent and integrate telehealth technology and person-centered decision making.

The final rule draws on experience from the COVID-19 Public Health Emergency (PHE), as well as decades of research. ^3,4,5,6,7   The COVID-19 PHE necessitated changes to policy guidance and legal exemptions to protect the public’s health, promote social distancing and support patient and staff safety among OTPs. In March and April 2020, SAMHSA published flexibilities in the provision of take-home doses of methadone and the use of telehealth in initiating buprenorphine.⁸ A growing body of research has demonstrated that these flexibilities facilitate access to treatment and eliminate criteria that promote stigma and discourage people from accessing care in OTPs. A recent study showed that patients who received increased take-home doses allowed by these flexibilities saw positive impacts on their recovery, including being more likely to remain in treatment and less likely to use illicit opioids.⁹ In addition to making these flexibilities permanent, the final rule reflects an accreditation and treatment environment that has evolved since Part 8 went into effect in 2001.

The final rule makes the flexibilities SAMHSA issues in March and April 2020 permanent and supports take-home doses of methadone upon entry into treatment. The prior criteria for take-home doses were significantly revised, including prior requirements for lengthy periods in treatment before take-home doses can be considered and strict reliance on toxicology testing results. Now, based on the clinical judgment of the treating practitioner, patients may receive take-home doses upon entry into treatment. This recognizes the importance of the practitioner-patient relationship and is consistent with evidence-based treatment standards that include shared decision-making and individualized person-centered treatment.

The final rule also expands telehealth services for people seeking care from OTPs. It makes permanent the ability of OTPs to initiate buprenorphine via telehealth, both audio-visual and audio-only, and adds initiation of treatment with methadone through audio-visual telehealth platforms. Research and extensive feedback have demonstrated the safety and efficacy of the methadone take-home flexibility and the flexibility that supports initiation of buprenorphine via telehealth in OTPs.

The final rule promotes practitioner autonomy, removes stigmatizing or outdated language, supports a patient-centered approach, and reduces barriers to receiving care. These elements have been identified as being essential to promoting effective treatment in OTPs and reflect an OTP accreditation and treatment environment that has evolved over the past 20 years.

Accordingly, these final changes reflect evidence-based practice, language that aligns with current medical terminology, effective patient engagement, and promotion of a skilled and robust workforce providing services in OTPs. To this end, the definition of a qualifying practitioner has been expanded to include a practitioner who is appropriately licensed by the state to prescribe (including dispense) covered medications. Where state law allows, this includes nurse practitioners and physician assistants.

Admission criteria have been updated to remove significant barriers to entry, while also defining the scope and purpose of the ‘initial’ and ‘periodic’ medical examinations. The final rule also includes new definitions to expand access to evidence-based practices such as split dosing, telehealth, and harm reduction activities, and it promotes the chronic disease model of management. , Outdated terms such as “detoxification” have been revised to remove stigmatizing language.

The final rule allows for greater flexibility in creating plans of care that promote recovery activities such as employment, while also eliminating the barrier of frequent visits for individuals without access to reliable transportation. It also promotes the chronic disease model of management.

To expand access to care, SAMHSA updated the OTP admission criteria. It removed the requirement for one year of opioid addiction before admission to an OTP, in favor of consideration of a person’s problematic patterns of opioid use. It also removed the requirement that people under the age of 18 must have completed two unsuccessful episodes of treatment.

The final rule only impacts practitioners working in OTPs, and it allows practitioners within OTPs to order buprenorphine via telehealth, including via audio-only platforms. In OTPs, practitioners order treatment medications, and they are dispensed to the patient in person. This rule makes no changes to federal law governing prescribing practices. In accordance with Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill), which removed the federal requirement for practitioners to submit a Notice of Intent (and receive a DATA 2000 waiver) to prescribe medications, like buprenorphine, for the treatment of opioid use disorder (OUD), the final rule removes from Part 8 all content related to DATA 2000 waivers.

The final rule only applies to practitioners working in OTPs, and it allows OTP practitioners, subject to certain conditions, to order treatment medications after a telehealth visit. All practitioners must follow DEA rules that regulate prescribing of Schedule III controlled medications using telehealth (Schedule II controlled medications cannot be prescribed for the treatment of opioid use disorder at this time).

The proposed rule removed a category of accreditation that expired in 2003, clarified the use of the “provisional” category of accreditation and authorized “conditional” accreditation. It also codified the use of electronic/online forms and clarified SAMHSA’s expectations of the accrediting bodies. In response to public comments to the NPRM, SAMHSA further clarified the responsibilities of the accrediting bodies and time frames for OTP responses to survey results.

While the final changes provide flexibility in how medication might be provided to patients receiving treatment for OUD in OTPs, analysis of data on fatal overdoses from January 2019 to August 2021, published in JAMA Psychiatry, demonstrate that the COVID-19 PHE take-home flexibility did not lead to more deaths involving methadone.¹⁰ Further to this, a recent survey found that diversion of methadone and buprenorphine is low among patients receiving take-home doses under the COVID-19 PHE flexibility.^11,12 Analysis of the data indicates that the actual level of misuse, diversion or harm from methadone is more likely to occur when it is prescribed for pain as opposed to OUD, and that the rate of diversion is lower than that of oxycodone or hydrocodone.¹³ Additionally, the final rule does not remove guardrails around the provision of take-home doses. Instead, they are updated to align with current evidence and experience gained during the past 4 years.

These changes are also supported by principles underlying the care of patients in other specialty areas of medicine and settings where controlled medications are used. The flexibilities provided during the COVID-19 PHE were met with widespread support among patients, OTPs, and state authorities. For example, patients reported that increased take-home doses left them feeling more respected and trusted as responsible individuals. In a meeting with state authorities, it was reported that the flexibilities were appreciated by patients and OTPs alike, with no significant change in rates of diversion.

The decision to provide take-home doses rests with the treating practitioner and their use of clinical judgement. The final rule supports person-centered, shared decision-making and practitioners’ autonomy. In this way, practitioners can base their decision on knowledge of the individual, their medical issues, the stability of their home life and social connections with taking unsupervised doses of methadone and risk profile. This is in line with evidence-based models of chronic disease management found across different health conditions. However, these new changes do not supersede State rules and regulations in which the OTP is licensed.

Under the revised rules, a patient starting MOUD may need to be seen more frequently at the OTP as the dose is being increased to safeguard against the dose causing undue or adverse effects and to ensure that the person’s OUD is responding as anticipated. It also means that patients may safely receive some take-home doses upon admission into treatment. Basing those decisions on clinical judgment of the treating practitioner rather than rigid rules, recognizes the importance of the practitioner-patient relationship and is consistent with modern standards of care for other health conditions treated with controlled medications. The rules also allow for greater flexibility in creating plans of care that promote recovery activities such as employment, while eliminating the barrier of frequent visits for individuals without access to reliable transportation.

No. Methadone is dispensed at the OTP, and so the first dose of methadone, at a minimum, would be provided under direct supervision. This ensures patient safety, that the medication is tolerated, and that the patient has connected with other members of the treatment team. This follows an initial screening appointment with the OTP practitioner who orders the medication to be dispensed after having established the nature, diagnosis, and severity of the person’s opioid use disorder, any accompanying opioid withdrawal, and any contraindications to starting methadone. Additionally, the practitioner must ensure that the individual properly understands the safety aspects of methadone, including safe transportation and storage of any take-home doses, how the dose will safely be increased, and other precautions the person can take as they start treatment (e.g., having naloxone on hand). These activities altogether are unlikely to occur in a 15-minute encounter.

No, this is not possible. The final rule does, however, allow for the use of audio-visual telehealth for a new patient who will be treated by the OTP with methadone if a program practitioner determines and documents that an adequate evaluation of the patient has been, or can be accomplished via an audio-visual telehealth platform. The final rule does not permit use of audio-only telehealth because methadone, in comparison with buprenorphine, holds a higher risk of sedation, especially if taken by someone who already is experiencing some drowsiness. Mild drowsiness is easier to identify through an audio-visual telehealth platform than an audio-only interaction. This promotes patient safety, while also allowing for the use of telehealth technology.

States may have or may promulgate regulations that are more restrictive than the final rule. However, changes to 42 CFR part 8 were created in an evidence-based manner and are designed to be delivered as a suite of interventions. These interventions support engagement in treatment, and activities, such as employment, that are associated with recovery. The final changes also support practitioner and patient engagement in care. This is not only an important way to keep people in treatment, but it also fosters a dynamic and person-centered workforce.

These changes are outside SAMHSA’s regulatory purview, and this rule does not allow for methadone prescribing outside of an OTP for the purpose of treatment of OUD.

The effective date is 60 days after publication of the Final Rule, and the compliance date is 6 months after the effective date. Entities subject to the final rule have until the compliance date to achieve compliance with this rule.

The final rule can be found in the Federal Register. Over the next several months, SAMHSA will be holding webinars and other convenings to review the changes and releasing updated guidance which will update the 2015 Federal Guidelines for Opioid Treatment Programs and describe implementation and regulatory issues pertaining to the final rule.