42 CFR Part 8 Final Rule - Frequently Asked Questions

To enhance accessibility for individuals seeking treatment for opioid use disorder (OUD), the revised Part 8 rule allows for admission to an OTP upon completion of a screening examination that would determine the need for treatment, identify any contraindications to MOUD, and establish an appropriate first dose of medication. Admission no longer needs to wait until a full physical examination can be completed. A screening examination can be completed, either in-person, through use of telehealth (subject to the practitioner’s medical judgment), or through use of a non-OTP practitioner’s assessment to make the diagnosis of an opioid use disorder, gather relevant substance use and health information, medical and medication history, and identify any potential contraindications to either buprenorphine or methadone to begin treatment.

For any telehealth visit, the OTP must ensure that the platform is secure and HIPAA-compliant. For individuals requesting treatment with buprenorphine, the screening visit can be done via audio-only and audio-visual telehealth platforms. For individuals requesting treatment with methadone, the screening visit by telehealth can only be done using an audio-visual platform. In all instances, the screening examination is conducted by an appropriately licensed practitioner, such as a Medical Doctor (MD)/Doctor of Osteopathic Medicine (DO), Physician Associate (PA), or Nurse Practitioner (NP).

A non-OTP practitioners’ examination can be used to expedite the screening process, if the exam was performed within seven days prior to the individual’s admission to the OTP. With proper patient consent, the non-OTP practitioner’s examination findings can be transmitted to the OTP, where the examination can be reviewed, verified, and integrated by the OTP practitioner into the patient’s records.

Within 14 days of admission, a full physical examination must be conducted. This ensures a complete assessment of the patient’s health and allows for any necessary adjustments to the medication type or dose, and development of a more refined treatment plan. A full physical examination completed by a non-OTP practitioner can also be utilized with the patient's consent, shared with the OTP and reviewed, verified, and documented accurate and thorough by the OTP practitioner.

While some elements of the full physical examination can be completed through telehealth, other elements of the exam require an appropriately licensed practitioner (such as an MD/DO, NP, or PA) to see the individual in-person (e.g. to conduct an examination of the nose and mouth, auscultate lungs and heart, and palpate the abdomen). Blood and urine samples can also then be provided in person. Because the individual will have to visit the OTP to receive their medication, the in-person components of the full exam can be scheduled to occur within the first 14 days of treatment.

The rule specifies that counseling within opioid treatment programs (OTPs) is an important component of comprehensive care for individuals with opioid use disorder (OUD). OTPs are required to provide clinically appropriate substance use disorder counseling tailored to each patient's clinical needs, values and preferences. Counseling must be delivered by qualified program clinicians who possess the appropriate education, training, or experience to provide such services. These clinicians engage with patients to develop suitable care plans and continuously monitor and update patient progress. Importantly, if a patient refuses to participate in counseling, this refusal does not preclude them from receiving medications for opioid use disorder (MOUD).

The new rule significantly enhances OTP practitioner’s use of clinical judgement and discretion within opioid treatment programs (OTPs) by shifting from specific rigid, rules-based decision-making to a more flexible, person-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 judgement requires that the practitioner explain the basis for their decision in the patient’s record. And in all cases, the medical director remains accountable for ensuring the provision of comprehensive and cohesive care by OTP practitioners and other medical and clinical staff.

Measuring and monitoring practitioner decision-making within opioid treatment programs (OTPs) is essential to ensure that healthcare providers are effectively using their professional judgment to deliver high-quality, individualized care. The processes of monitoring involve 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 a how practitioners’ decision- making.

The rule defines mobile medical units as crucial extensions of OTPs. These units enhance accessibility by delivering essential services directly to underserved or hard-to-reach populations. By doing so, they ensure individuals with OUD receive the treatment and support they need. The revised Part 8 rule allows any activity performed by an OTP to be carried out in a mobile unit provided that appropriate space and privacy considerations are met, and assuming compliance with other applicable state and federal requirements. With this change, mobile medical units now 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, making timely and appropriate care available to more individuals.

It is important to clarify that MOUD and MAT are not synonymous terms. The term “Medication-Assisted Treatment (MAT)” has been historically used to describe the combination of medications, typically for OUD, and counseling and other behavioral interventions. However, this term has been criticized by many given its implication that the medications are not as important as counseling or the other services in treating OUD, that medications are inferior to counseling, and that it is the counseling that is the true treatment for OUD¹. While perhaps unintentional, this term has been seen as furthering stigma underlying medications like methadone and buprenorphine².

Language has evolved to describe the current components of treatment of OUD more clearly and accurately. In that, the term “medications for opioid use disorder (MOUD)” has emerged as a catch-all term to describe the three classes or categories of medications approved by the Food and Drug Administration for the treatment of OUD, namely as 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.

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. These services are then described as being combined with or provided along with MOUD.