Authors:
Robert Baillieu, MD, MPH – Physician and Senior Advisor, The Center for Substance Abuse Treatment (CSAT), The Substance Abuse and Mental Health Services Administration (SAMHSA)
Yngvild Olsen, MD, MPH – Director, CSAT, SAMHSA
Patti Juliana, PhD – Division Director, The Division of Pharmacologic Therapies, CSAT, SAMHSA
Disclaimer:
The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by SAMHSA, HHS, or the U.S. Government. For more information, please visit: https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/42-cfr-part-8
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On February 2, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Department of Health and Human Services (HHS) published a significant revision to the federal regulations governing opioid treatment programs (OTPs) in 42 CFR part 8. This revised rule represents a major shift towards patient-centered care and harm reduction in the treatment of opioid use disorder (OUD). It empowers OTP staff and administrators to provide more accessible, flexible, and responsive care that is tailored to the unique needs and circumstances of each patient. The changes to 42 CFR part 8 have the potential to transform the OTP system and save countless lives amid the ongoing opioid overdose crisis.
Putting Patients First
The revised 42 CFR Part 8 rule emphasizes patient-centered care as a core principle of OUD treatment. It recognizes that every patient is unique and deserves a care plan that is individualized, respectful, and responsive to their specific goals and needs. The rule aims to enhance OTP environments in ways that are welcoming, non-stigmatizing, and conducive to long-term recovery.
One important way the revised rule promotes patient-centeredness is by giving OTPs much greater flexibility around take-home doses of methadone. Under the new regulations, patients can receive up to 7 take-home doses of methadone in the first 14 days of treatment, and a 28-day supply after just one month of demonstrated stability. This change represents a significant shift from the previous rules, which required patients to meet strict time-in-treatment requirements before being granted take-home privileges.
By allowing for more individualized decision-making around take-home doses, the revised rule empowers OTP practitioners to use their clinical judgment and knowledge of each patient to determine the most appropriate level of take-home access. This approach demonstrates respect for the patients, recognizes that patients who are doing well in treatment should not have to travel frequently to the OTP to access life-saving medication, and affirms that increased autonomy and flexibility can support long-term recovery.
The revised rule also takes important steps to remove barriers to OTP admission. It eliminates the requirement that patients have at least one year of opioid addiction history to qualify for methadone treatment, recognizing that this likely prevented many individuals from accessing care during the critical early stages of OUD or after a long period without MOUD. Instead, the revised rule aligns OTP admission criteria with the current scientific understanding of addiction, affirming that anyone with moderate-to-severe OUD or who is at high risk for recurrence or overdose should be eligible for services. This change reflects the urgency of the opioid crisis and the importance of rapid access to evidence-based treatment.
The revised rule eliminates the admissions requirement that patients less than 18 years old must have two unsuccessful attempts at withdrawal before being admitted to an OTP. This change is critically important because the rate of drug overdose deaths among youth aged 14-18 years increased by 20% between 2020 and 20211, and the overdose rate for 14-18 year-olds in 2022 was 5.2 deaths per 100,000, or an average of 22 adolescents each week, driven by fentanyl.2
Furthermore, the revised rule emphasizes that OTPs should adopt a compassionate, recovery-oriented approach to positive drug screens, acknowledging that occasional use can be a normal part of the recovery journey. Rather than viewing these instances as grounds for punishment, the rule encourages providers to see them as opportunities to adjust treatment plans and better meet patients’ needs. This shift from a punitive mindset to a more supportive, individualized approach to care has the potential to improve patient retention and overall treatment outcomes.
Incorporating Harm Reduction and Recovery Services
Harm reduction is an evidence-based, practical, and transformative approach that incorporates public health strategies, including prevention, risk reduction, and health promotion, to empower people who use drugs (PWUD) and their families with the choice to live healthier, self-directed, and purpose-filled lives. Harm reduction seeks to reduce the harmful impacts of stigma, mistreatment, and discrimination.3 The revised rule aligns with this approach by purposefully removing stigmatizing language and encouraging compassionate, responsive treatment. One example of a way in which the revised rule incorporates harm reduction is by emphasizing that refusal of counseling cannot preclude patients from receiving medication.
SAMHSA defines “recovery” as a process of change through which individuals improve their health and wellness, live self-directed lives, and strive to reach their full potential. The process of recovery may include clinical treatment, medications, faith-based approaches, peer support, family support, self-care, and other approaches. “Peer support” encompasses a range of activities and interactions between people who share similar experiences of having lived experience. By sharing their own lived experience and practical guidance, peer support workers help people to develop their own goals, create strategies for self-empowerment, and take concrete steps toward building fulfilling, self-determined lives for themselves.4 The revised rule encourages the integration of recovery services, including peer support, throughout the continuum of care, ensuring a holistic approach to treatment.
Counseling Requirements
Under the new rule, OTPs must provide adequate substance use disorder counseling to patients as clinically necessary, based on an individualized assessment of each patient’s needs and preferences. Counseling should be offered as a complementary service to MOUD, and OTPs are expected to employ or contract with qualified counselors to ensure that evidence-based behavioral health interventions are available and accessible to all patients who desire them.
To ensure that counseling services are patient-centered and responsive to individual needs, OTPs should adopt a stages-of-change approach, assessing each patient’s readiness to change and tailoring interventions accordingly. Counseling services should be trauma-informed, gender-responsive, and inclusive of diverse populations, and patients should be involved in treatment planning and goal setting.
Implementing this new approach to counseling may require OTPs to rethink their staffing models, training programs, and protocols for assessing and responding to patients’ behavioral health needs. However, the ultimate goal is to create a more patient-centered, flexible, and effective model of OUD treatment that recognizes the unique needs and preferences of each individual and supports long-term recovery.
Expanding Access with Telehealth and Mobile Services
The COVID-19 pandemic has accelerated the adoption of telehealth in OTPs, and the revised 42 CFR part 8 rule now incorporates these emergency flexibilities as permanent options for service delivery. Under the new rule, initial assessments for buprenorphine can be conducted via audio-only or video-based telehealth, as long as the OTP staff member determines that an adequate evaluation can be performed virtually. The use of telehealth in methadone inductions requires use of audio-visual telehealth. These changes have the potential to dramatically expand access to MOUD, particularly for patients in rural or underserved areas who may face significant barriers to accessing in-person care.
The revised rule also clarifies that mobile medication units can provide the full range of OTP services, including MOUD inductions and psychosocial supports. This means that OTPs can bring treatment directly to hard-to-reach populations, such as individuals living in homeless encampments, rural communities, or other areas with limited access to brick-and-mortar clinics. Mobile services can be a powerful tool for engaging marginalized populations and advancing health equity in the opioid crisis response.
To successfully implement these telehealth and mobile services, OTPs will need to invest in infrastructure, staff training, and workflow redesign. OTP administrators can support this process by allocating resources for secure videoconferencing software, mobile health equipment, and remote patient monitoring tools. Clinical staff may need additional training on how to conduct virtual assessments, provide telehealth-based counseling, and coordinate care across remote teams. By embracing these new models of service delivery, OTPs can expand their reach and positively impact in the communities they serve.
Expanding the Multidisciplinary Team
Providing comprehensive, patient-centered OUD care requires a multidisciplinary team approach. The revised 42 CFR part 8 rule expands the definition of an OTP practitioner to include, where state law allows, nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, in addition to physicians. This change recognizes the vital role that advanced practice providers can play in expanding access to MOUD and providing high-quality, team-based care. However, the Medical Director role remains the responsibility of a physician.
The revised rule also highlights the importance of involving a wide range of behavioral health professionals in OTP care, including counselors, social workers, and peer support specialists. These team members bring unique skills and perspectives that are essential for addressing the psychosocial aspects of addiction and supporting long-term recovery. By leveraging the expertise of all team members, OTPs can provide more holistic, individualized care that meets the full range of patients’ needs.
Building and sustaining a high-functioning multidisciplinary team requires a significant culture change. It involves shifting from siloed, hierarchical models of care to more collaborative, team-based approaches that include the patient. OTP administrators can support this process by investing in staff training and professional development, fostering open communication and teamwork, and creating organizational structures that value and reward collaboration. This may require rethinking traditional roles and responsibilities, as well as exploring new staffing models and reimbursement strategies that support team-based care.
Ultimately, the goal of the multidisciplinary team should be to provide the highest quality of patient-centered care possible. This means creating a culture of respect, inclusivity, and shared decision-making, where all team members feel valued and empowered to contribute their unique skills and perspectives. It means putting patients at the center of every decision and interaction, and working together to support their individual goals and needs. By embracing this team-based approach, OTPs can create a more supportive, effective, and sustainable model of care for patients with OUD.
Call to Action
The revised 42 CFR part 8 rule represents a once-in-a-generation opportunity to transform the OTP system and improve the lives of countless individuals affected by OUD. It provides the regulatory flexibility, evidence-based tools, and impetus to provide more patient-centered, accessible, and effective care. However, realizing the full potential of these changes will require concerted effort, visionary leadership, and a willingness to challenge the status quo from all levels of OTP staff and administration.
OTP leaders and staff must work together to implement the patient-centered principles and practices outlined in the revised rule. This will involve providing staff training on harm reduction, cultural competence, and trauma-informed care; developing new protocols and workflows to support take-home dosing and telehealth; and forging partnerships with healthcare providers and community organizations. It may require advocating for policy changes and funding streams that support more flexible, integrated models of care.
Importantly, OTPs must center the voices and needs of patients in all aspects of this transformation process. This means actively seeking out and incorporating patient feedback, involving patients in decision-making processes, and creating opportunities for patients to take on leadership roles within the organization. It means continuously evaluating and improving services based on patient outcomes and experiences, while also being willing to adapt and innovate in response to changing needs and circumstances.
Transforming the OTP system will not be easy, and there will undoubtedly be challenges and setbacks along the way. However, the stakes could not be higher. With alarmingly high overdose deaths, and the opioid overdose crisis persisting, OTPs have a moral and public health imperative to do everything in their power to expand access to evidence-based, patient-centered care. The revised rule provides a roadmap for this transformation, but it will take the collective efforts of all OTP staff and stakeholders to make it a reality.
1 Friedman, J., Godvin, M., Shover, C.L., Gone, J.P., Hansen, H., Schriger, D.L. (2022). Trends in Drug Overdose Deaths Among US Adolescents, January 2010 to June 2021. Journal of the American Medical Association, 327(14): 1398–1400. doi:10.1001/jama.2022.2847
2 Friedman, J, Scott, A, Hadland, E; The Overdose Crisis among U.S. Adolescents New England Journal of Medicine; V 390 N2; p 97-100; https://www.nejm.org/doi/full/10.1056/NEJMp2312084
3 https://www.samhsa.gov/sites/default/files/harm-reduction-framework.pdf
4 https://peerrecoverynow.org/wp-content/uploads/2023-OCT-02-prcoe-peer-specialist.pdf
