42 CFR Part 8 Final Rule - Frequently Asked Questions

On February 2, 2024, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), published revisions to the federal regulations (rules) that address treatment of opioid use disorder (OUD) provided in opioid treatment programs (OTPs) as well as OTP certification and accreditation. These rules are found in 42 CFR part 8; the revisions are the first substantial update to the OTP treatment rules in more than 20 years. These updates will expand access to care and improve Americans’ experiences as they seek treatment for OUD. This is in direct response to the overdose crisis, and the revised 42 CFR part 8 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) indicated that 105,007, or nearly 76 percent of deaths in 2023 involved an opioid (including illicitly manufactured fentanyl, heroin, and prescription opioids). Treatment with medications for opioid use disorder (MOUD) significantly reduces opioid-related overdose mortality. The rise in fentanyl use or exposure and overdose deaths necessitated changes to 42 CFR part 8 to expand access to care. The changes removed stigmatizing or outdated language, supports a more patient-centered approach, and reduces barriers to receiving care. The rule also made flexibilities put forth during the COVID-19 public health emergency (PHE) permanent and integrated telehealth technology and patient-centered decision making.

42 CFR part 8 draws upon experience gained from the COVID-19 PHE, as well as decades of research. The 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. Research has demonstrated that these flexibilities facilitated access to treatment and eliminated criteria that promoted stigma and discouraged 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. In addition to making these flexibilities permanent, the rule reflects an accreditation and treatment environment that has evolved since 42 CFR part 8 initially went into effect in 2001.

42 CFR part 8 promotes practitioners' use of judgement, removes stigmatizing or outdated language, supports a patient-centered approach, and reduces barriers to receiving care. These elements have been identified as essential to promoting effective treatment in OTPs and reflect an OTP accreditation and treatment environment that has evolved over the previous 20 years.

Accordingly, the changes reflect evidence-based practice, language that aligns with current terminology, effective patient engagement, and promotion of a skilled and robust workforce providing services in OTPs. In addition, the definition of a qualifying practitioner has been expanded to include a practitioner who is appropriately licensed by the state to prescribe (including dispensing) covered medications. Where state law allows, this includes Physician Associates/Assistants and Nurse Practitioners.

Admission criteria have been updated to remove significant barriers to entry, while also defining the scope and purpose of the screening and physical examination process, removing the prior requirement for patients needing to meet one year of opioid dependency as a condition of admission, and providing greater flexibility for people under age 18 to access care in an OTP. 42 CFR part 8 also includes new definitions to expand access to evidence-based practices such as split dosing and telehealth, it promotes the chronic disease model of management, and the wording has been revised to remove stigmatizing language.

42 CFR part 8 provides flexibility in the provision of take-home medications, allowing 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 medication management.

Yes, the changes made the flexibilities SAMHSA issued in March and April 2020 permanent and support 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 patient-centered treatment.

To expand access to care, SAMHSA updated the OTP admission criteria. It removed the requirement for one year of opioid use before admission, 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 prior to admission into an OTP.

To enhance access to treatment for individuals with OUD, 42 CFR part 8 allows admission to an OTP upon completion of a screening examination that determines the need for treatment and an appropriate initial dose. Admission does not need to be delayed until a full physical examination can be completed. The screening examination can be completed in-person, via telehealth or based on an assessment performed by a non-OTP practitioner. The screening is used to diagnose OUD, gather relevant substance use information, medical and medication history, and identify any potential contraindications to initiating treatment with either buprenorphine or methadone.

For any telehealth encounter, the OTP must ensure that the platform used is secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA). For individuals seeking treatment with buprenorphine, the screening examination may be conducted using either audio-only or audio-visual platforms. For individuals seeking treatment with methadone, the screening exam should be conducted via an audio-visual platform. An audio-visual visit is recommended because methadone holds a higher risk of sedation than buprenorphine, especially if taken by someone who may already be experiencing drowsiness. Visual assessment allows practitioners to more easily identify signs of sedation, thereby promoting patient safety while still allowing for the use of telehealth.

If an audio-visual examination is not available to the patient, an audio-only telehealth screening can be used for methadone initiation only when the patient is physically present with a licensed practitioner who is registered to prescribe (and dispense) controlled medications. In this circumstance, the in-person practitioner may confirm relevant physical signs and symptoms of OUD. The OTP practitioner then reviews the screening findings and orders treatment medications, as indicated. 

In all instances, the screening must be conducted by a licensed Medical Doctor (MD)/Doctor of Osteopathic Medicine (DO), Physician Associate/Assistant (PA), or Nurse Practitioner (NP). Regardless of whether the telehealth screening visit is conducted via audio-visual or audio-only telehealth, the purpose is of the screening examination is the same to establish a diagnosis of OUD or determine the appropriateness for OTP admission, identify contraindications to medication, establish an initial dose and identify any additional substance use disorders (SUD), medical, psychiatric or social issues that may need to be addressed in the comprehensive examination. Practitioners should use clinical judgement to determine which telehealth modality allows for a safe and effective screening.

A full physical examination must be conducted within 14 days of admission. This ensures a comprehensive assessment of the patient’s health allows for any necessary medication adjustments and supports development of an individualized care plan. While some components of the full physical examination can be completed through telehealth, others require an in-person examination by a licensed MD/DO, PA, or NP, such as listening to heart and lungs, examining the nose and oral cavity, and abdominal palpation and collection of blood and toxicology samples. Because patients must attend the OTP in-person to receive medication, the in-person components of the full exam can be scheduled to occur within the first 14 days of treatment.

Non-OTP practitioners may support the OTP admissions processes by conducting an assessment that can be used for screening purposes or by conducting a full examination that can be utilized in support of the OTP practitioner’s full physical examination. For screening purposes, a non-OTPS practitioner’s assessment completed within 7 days prior to admission can be transmitted to the OTP, with the patient’s consent. The OTP practitioner may then review, verify, and incorporate the findings into the patient’s OTP medical record to support the screening and admission decision.

If the patient had or has a full physical examination by a non-OTP practitioner within 14 days of admission, the results of this examination may be shared with the OTP and incorporated into the patient’s treatment records when reviewed, verified, and documented by an OTP practitioner. Use of a non-OTP practitioner’s examination helps ensure timely access to treatment while maintaining clinical oversight and continuity of care within the OTP.

The revised 42 CFR part 8 specifies that OTPs are required to provide clinically appropriate, trauma-informed, and culturally responsive SUD counseling tailored to each patient’s clinical needs, values and wishes. Counseling within OTPs is an important component of comprehensive care for OUD; it should be patient-centered, evidence-based, and provided with the combination and frequency of services tailored to each individual patient’s treatment and recovery goals, as they evolve and change over time. Relapse prevention skills, cognitive-behavioral techniques and Motivational Interviewing are some types of counseling that are utilized to support treatment and recovery. Other issues that can be addressed include vocational and educational counseling, infectious disease prevention and pre-/post-counseling (e.g., HIV, sexually transmitted infection (STI), viral hepatitis, etc.). Ultimately, counseling should be based on an individualized assessment and the patient’s care plan created through shared decision-making between the patient and the clinical team.

While it is expected that counseling be available at the OTP, counseling services can also be arranged by the OTP on behalf of a patient by a referral to a community-based organization with which the OTP has developed agreements. Importantly, if a patient is not interested in participating in counseling, their refusal does not preclude them from receiving MOUD. The benefits of counseling services should consistently be shared with patients as part of their ongoing OTP treatment services.

There are several SAMHSA technical assistance resources that are helpful as OTPs work to develop policies and procedures to incorporate quality counseling services within their program. For instance, SAMHSA’s Advisory: Using Motivational Interviewing in Substance Use Disorder Treatment would be helpful for OTP counselors in working with patients who may be ambivalent about participating in counseling services.

It is important to clarify that “Medications for Opioid Use Disorder (MOUD)” and “Medication-Assisted Treatment (MAT)” are not synonymous terms. MAT has been used to describe the combination of medications, typically for OUD, and counseling and other behavioral interventions. However, the term “MAT” has been criticized as implying that the medications are not as important as counseling or the other services in treating OUD, that medications are inferior to counseling, and that counseling is the core treatment for OUD. While perhaps unintentional, this term has been seen as further stigmatizing medications such as methadone and buprenorphine. Substance use disorder is a chronic disease and like with other chronic diseases, medications can be an integral part of treatment, not ancillary.

MOUD has emerged as a term to describe the three classes or categories of medications approved by the Food and Drug Administration (FDA) for the treatment of OUD, namely methadone, buprenorphine, and naltrexone. These medications reduce or eliminate withdrawal symptoms from other opioids, curb cravings, and stabilize patients so they can engage more effectively in other treatment services which results in reduced opioid use and overdose. While some people with OUD may be able to stabilize on a medication alone, for many people with moderate to severe OUD, achieving remission and recovery will involve the incorporation of a wide range of services that address the multifaceted needs of individuals with OUD alongside the use of MOUD. These services are then described as being combined with or provided along with MOUD.

42 CFR part 8 significantly enhances OTP practitioners’ use of clinical judgement by shifting from specific rigid, rules-based decision-making to a more flexible, patient-centered care approach. This shift emphasizes the importance of individualized care plans driven by the practitioner’s professional judgment and understanding of each patient’s unique needs and circumstances. It gives practitioners the freedom and responsibility to make clinical decisions based on their expertise and training. The use of clinical judgement requires that the practitioner document the basis for their decision in the patient’s record. In all cases, the medical director remains accountable for ensuring comprehensive and cohesive care by OTP practitioners and other medical and clinical staff.

Measuring and monitoring practitioner decision-making within OTPs is essential to ensure that healthcare providers are effectively using their professional judgment to deliver high-quality, individualized care. The process of monitoring involves multiple strategies that collectively provide a comprehensive understanding of how practitioners make clinical decisions and the impact the decisions have on patient outcomes. Reviewing decision-making documented in patient records, frequency and quality of patient care plans (in terms of relevance to the patients’ needs), tracking patient outcomes, gathering practitioner feedback, conducting peer reviews, ensuring ongoing training, maintaining regulatory compliance, and collecting patient feedback all contribute to a comprehensive understanding of the effectiveness of the practitioners’ clinical decision-making.

SAMHSA recognizes SUD as a chronic medical disorder requiring ongoing care - not a moral failure deserving punishment. Individuals with other chronic diseases, such as hypertension, continue to receive medication even in the face of uncontrolled blood pressure. Stigma impedes individuals’ access to and continued participation in SUD care. Evidence shows that a supportive, patient-centered approach is most effective for managing substance use disorders and restoring healthy functioning. The revised 42 CFR part 8 offers low-barrier options for accessing MOUD while ensuring access to comprehensive care. These regulatory changes allow people to stay in care and work on their recovery under medical supervision and engagement with a clinical team, while empowering people to reach their own goals through incremental change.

While 42 CFR part 8 changes provide flexibility in how medication might be provided to patients receiving treatment for OUD, analysis of data on fatal overdoses demonstrates the COVID-19 PHE take-home flexibility did not lead to more deaths involving methadone. In addition, it has been determined that diversion of methadone and buprenorphine were low among patients receiving take-home doses under the COVID-19 PHE flexibility. 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. 42 CFR part 8 revisions do not remove guardrails around the provision of take-home doses, maintain safeguards to prevent diversion, and align with current evidence and experience gained during the past 4 years.

Studies show that flexible access to MOUD saves lives and supports recovery. With appropriate practitioner clinical judgment, guidance, and monitoring, diversion risks are low while MOUD treatment benefits are high, i.e., preventing overdoses, reducing transmission of infections, and enabling patients to rebuild healthy, productive lives.

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.

Safeguards remain in place to ensure medications are only provided to those with a clinical need. OTP screening and assessments must support a diagnosis of opioid use disorder by a licensed practitioner as part of the admission process, with ongoing monitoring and evaluation. The change reflects that early intervention can prevent progression to a severe disorder.

During methadone initiation, patients may need more frequent OTP visits as the dose is being adjusted to minimize the risk of adverse effects and to confirm that the treatment is effectively addressing opioid withdrawal and craving. Under the revised 42 CFR part 8, OTP practitioners have the flexibility to determine whether a patient may safely receive some take-home doses upon admission into treatment, based on the clinical judgment of the treating practitioner rather than rigid rules. This approach prioritizes patient safety while supporting patient-centered care, the practitioner-patient relationship and modern standards used for other health conditions treated with controlled medications. The revisions also allow for care plans that support recovery and stability, such as maintaining employment, while reducing unnecessary barriers like frequent visits for patients who lack reliable transportation.

The decision to provide take-home doses rests with the treating practitioner and their clinical judgement. The revised 42 CFR part 8 supports patient-centered care, shared decision-making, and practitioners’ autonomy. In this way, practitioners can balance 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.

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. Medication follows an initial screening appointment with the OTP practitioner who orders the medication to be dispensed after having determined the nature, diagnosis, and severity of the person’s OUD, any accompanying opioid withdrawal, and any contraindications to starting methadone. Additionally, the practitioner must ensure that the individual properly understands the safe use 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.

42 CFR part 8 defines mobile medication units as extensions of OTPs. These units enhance access to treatment by delivering essential services directly to underserved or hard-to-reach populations. These rules allow any activity performed by an OTP to be carried out in a mobile medication unit when appropriate space and privacy considerations are met. Mobile medication units can provide convenient, flexible, and immediate access to a range of medication, medical, and behavioral health services. This approach helps reduce logistical, geographic, and socio-economic barriers to treatment, making timely and appropriate care available to more individuals. OTPs interested in applying for a mobile medication unit should use the SAMHSA OTP Extranet.

An exemption is a waiver from any part of 42 CFR part 8. Exception requests are the type of exemptions related to take-home doses. Generally, these are requests that are therapeutically necessary but fall outside what is permitted in 42 CFR § 8.12(i) Unsupervised or ‘‘take-home’’ medication doses.

The revised 42 CFR part 8 provides greater flexibility, however OTPs are required to submit a patient exception in instances where take-homes would not meet regulatory requirements, such as when the patient does not have the required length of time in treatment or in instances of a designated-other picking up medication on behalf of a patient who is unable to come into the clinic themselves or when medication may be delivered to a third party, such as a nursing home or jail in which chain of custody documentation is indicated. Additionally, exception requests can be submitted on SMA-168 through the SAMHSA OTP Extranet when a patient admission may not comply with the time in treatment outlined in 42 CFR part 8.

An OTP needs to secure the approval from their State Opioid Treatment Authority (SOTA) when seeking to do interim treatment. Interim treatment means that on a temporary basis, an OTP can provide a patient with MOUD without providing comprehensive OUD treatment services but needs to ensure that comprehensive OUD treatment begins within 180 days post-admission. The SOTA reviews the OTP's plan for interim treatment and approves the plan, and then the OTP submits this request, along with the SOTA approval, to SAMHSA’s Center for Substance Abuse Treatment’s (CSAT) Division of Pharmacologic Therapies at DPT@samhsa.hhs.gov for its approval.

The revised 42 CFR part 8 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 Notice of Proposed Rulemaking (NPRM), SAMHSA further clarified the responsibilities of the accrediting bodies and time frames for OTP responses to survey results.

States may have or may promulgate regulations that are more restrictive than the federal regulation, but they cannot diminish the federal regulation. 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.

No. The revised 42 CFR part 8 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 outside of OTPs. In accordance with Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill), the federal requirement for practitioners to submit a Notice of Intent (and receive a DATA 2000 waiver or X-waiver) to prescribe medications, such as buprenorphine, for the treatment of OUD was removed. This requirement content was also removed from 42 CFR part 8.

No. These suggested changes are outside SAMHSA’s regulatory purview, and this rule does not allow for methadone to be prescribed outside of an OTP for the treatment of OUD. However, 42 CFR part 8 does allow for the establishment of an OTP medication unit in a pharmacy, should the state and pharmacy space allow for one.

SAMHSA published the 2024 Federal Guidelines for Opioid Treatment Programs, as an update to the 2015 version of the Guidelines, which provide comprehensive details on implementation and regulatory considerations pertaining to the revised 42 CFR part 8 regulations. Download the 2024 Federal Guidelines for Opioid Treatment Programs.