Brief introduction
In response to an escalating opioid crisis, SAMHSA has introduced revisions to the regulations guiding Opioid Treatment Programs (“OTP”; “OTPs”).1 This document gives an overview of the key changes significantly impacting providers and patients.
Background
The opioid crisis has escalated in recent years. Isolation and anxiety from the COVID-19 pandemic contributed to a spike in substance misuse and overdose deaths. Provisional CDC data indicated an alarming 109,940 overdose deaths between 2022-2023, driven largely by synthetic opioids, e.g., illicitly manufactured fentanyl.2
The number of OTPs has doubled since 2001 amidst rising fentanyl misuse, demonstrating the urgent need for accessible care.3 This is underscored by ‘treatment deserts’ in rural areas, the lack of access to Medications for Opioid Use Disorder (“MOUD”) for those at risk, and the disproportionate impact of the opioid crisis on minority communities, who experience higher overdose rates and lower access to treatment.4
Introduction to the changes
The following changes to OTPs have been designed to enhance practitioner autonomy, modernize treatment guidelines, and utilize technology, e.g. telehealth. These changes aim to make treatment more accessible, equitable and personalized. The final rule also promotes the principles of shared decision-making in all care plans; principles of harm reduction in treatment; removes outdated barriers to care; and aligns with current, evidence-based, best practices in management.
- Terminology changes
The final rule makes terminology changes to align with modern medical practices and reduce stigma in treating Opioid Use Disorder (“OUD”). The term ‘Medication-Assisted Treatment’ (“MAT”) has been updated to ‘Medications for Opioid Use Disorder’ (“MOUD”), and ‘Treatment Program’ is now referred to as ‘Opioid Treatment Program’. New definitions such as ‘Care Plan’, ‘Harm Reduction’, ‘Individualized Dose’, and ‘Telehealth’ have been added, while outdated terms like ‘Detoxification Treatment’ have been replaced with ‘Withdrawal Management’.
The terminology changes also broaden the definition of providers who can prescribe or order medications (depending on individual state regulations). This now encompasses physician assistants, nurse practitioners, and certified nurse midwives, improving access to care in underserved areas.
The definition of long-term care facilities has been broadened to include jails and prisons, expanding the waiver of OTP certification to ensure equitable access to treatment.
- Treatment changes
In the most significant raft of changes, the final rule to treatment protocols within OTPs is designed to improve access to care, patient satisfaction and engagement, and to encourage the use of clinical judgment by medical professionals.
- Admission Criteria changed/One-Year OUD requirement abolished.
These have been updated to remove references to the DSM-IV and the prerequisite of a one-year history of OUD. Patients can now be considered severe OUD by being in remission, or be at significant risk for recurrence or overdose. Documentation of admission decisions is now required for transparency.
The rule has also abolished the one-year OUD history requirement for specific populations, such as individuals recently released from incarceration, pregnant patients, and those previously in treatment.
- Admission of minors to OTP
The requirement for individuals under 18 to have two documented unsuccessful attempts at short-term withdrawal management drug-free treatment has been replaced with the option of obtaining consent from a parent, legal guardian, or responsible adult.
- Telehealth
SAMHSA’s final rule adapts to the digital age, allowing patient consent to be granted verbally or electronically, streamlining admission and the initiation of treatment. Recognizing the efficacy of telehealth—which has shown to be effective and safe for certain treatments—the rule permits the use of audio-only and audio-visual platforms, depending on the medication and the agreement between patient and provider.5
For Schedule III medications like Buprenorphine, and non-controlled medications such as Naltrexone, either platform can be used. In the case of Schedule II medications, including Methadone, audio-visual telehealth initiation is now accepted, acknowledging telehealth as a critical avenue for expanding access to care.
- Take-home or Unsupervised Methadone
The rules for unsupervised (take-home) methadone doses have been updated to reflect the flexibilities necessitated by the pandemic, allowing for increased take-home doses. The criteria allow up to 7 take-home doses in the first 14 days, 14 doses from day 15-30, and 28 doses from day 31 onward. This may contribute to greater levels of patient autonomy, improved outcomes and treatment retention, and reduced barriers to treatment.
- Methadone dosing
Regulations around the initial methadone dose have been adjusted, raising the permissible first-day dosage to 50mg with provisions for higher clinically justified doses. This is in recognition that higher initial and next-day doses are often clinically appropriate and necessary to prevent withdrawal and treatment attrition, especially for patients exposed to fentanyl, as well as for patients in the later stages of pregnancy.
- Interim treatment
To expand access to interim treatment and recognizing the need to bring individuals into treatment, the potential duration of interim treatment has been extended from 120 to 180 days. This includes new clarified eligibility criteria and the removal of the mandate for daily dose observation.
The final rule also formalized the expectation that crisis services and information for ancillary services be made available to those in interim treatment. It also sets out the requirement for a formal continued treatment plan for patients after their interim treatment phase is over.
- Drug testing strips
SAMHSA has amended regulations to permit the use of non-FDA-approved drug-checking test strips for patients who wish to test their supply for adulteration where this is permitted by law. FDA-approved strips however must be used when conducting random drug testing on patient samples such as urine or saliva.
- Pregnancy testing
The final rule acknowledges that pregnancy testing is often necessary for appropriate clinical care but clarifies that pregnancy testing should be requested only when clinically appropriate, and that refusal of such testing should not preclude access to treatment.
- Accreditation changes
Recent updates to the accreditation and certification oversight for Opioid Treatment Programs (OTPs) enhance quality and accountability. Now, Accreditation Bodies must include experienced physicians in OUD treatment on survey teams and enforce specific training policies.
The role of AI/AN communities and tribes has been recognized, allowing them to seek approval as Accreditation Bodies, reflecting a move towards culturally sensitive practices. SAMHSA has also tightened supervision guidelines and certification processes, including electronic submissions and the addition of a “Conditional Certification” category, ensuring continuous high-standard care and addressing compliance comprehensively.
- What these changes mean for patients
These changes mark a shift towards expanding access, flexibility, and patient empowerment. Tailoring care to individual needs, the updated rules dismantle the one-size-fits-all approach towards a shared decision-making model, where patients and care teams collaborate in developing a treatment plan.
This extends to medication management, where dosages and access to take-home doses are adapted to individuals. Additionally, the changes expand the cadre of professionals authorized to provide care, integrating nurse practitioners and physician assistants into the fold. This, along with the embracement of telehealth and mobile medication units, brings treatment closer to those in need, particularly in underserved areas.
Furthermore, the updates embrace harm reduction philosophies, moving away from inflexible criteria for take-home methadone doses towards considering each patient’s safety and specific situation. These comprehensive changes are underpinned by respect for patient autonomy and the idea that recovery is a personal and non-linear journey while upholding safety and accountability. Ultimately, these changes aim to create a compassionate environment that meets patients where they are.
- What the changes mean for OTPs
SAMHSA’s updated CFR 42, effective April 2, requires OTPs to recalibrate policies in preparation for the October 2 compliance date. The modifications champion clinically driven decisions on patient admission, medication dosing, and methadone distribution. While this is a step away from former constraints it does not signal a relaxation of standards. A discerning application is essential to avoid a blanket liberalization that could lead to administrative overstretch and unintended/unwanted treatment outcomes.
Previously medical directors have historically exercised discretion within the old framework and state authorities have generally supported requests for exceptions or special consideration in the context of OUD treatment. It’s crucial to note, however, that these newly established freedoms do not equate to a de-restriction of regulation nor imply a one-size-fits-all approach.
Concerning patient safety and trust, these new changes warrant responsible interpretation to prevent misapplication. It is critical to guard against administrative misinterpretation that could see these changes as a universal fit for all treatment scenarios, potentially causing undue patient stress and challenging the therapeutic integrity of OTP programs
A failure to do so risks misinformation among healthcare providers and undue distress for patients, potentially disrupting the relationship between patients and program staff. While individualized care stands at the forefront, medical directors must continue upholding sensible, safety-oriented standards in medication management. Amidst these updates, the role of shared decision-making becomes paramount, reinforcing the partnership between patients and providers to tailor care that respects each individual’s journey
While we champion individualized care, we must also maintain a commitment to safety and best practices that align with common-sense industry standards, ensuring that our adjustments are both responsible and responsive.
Your engagement and insights are valuable as we navigate these updates. We invite you to join the conversation by providing any feedback on our blog.
References
3. Opioid Treatment Program Directory [Internet]. SAHMSA. 2024 [cited 4/26/2024]. Available from: https://dpt2.samhsa.gov/treatment/directory.aspx.
4. Kariisa M, Davis NL, Kumar S, Seth P, Mattson CL, Chowdhury F, et al. Vital Signs: Drug Overdose Deaths, by Selected Sociodemographic and Social Determinants of Health Characteristics – 25 States and the District of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep. 2022;71(29):940-7.
5. Tanz LJ, Jones CM, Davis NL, Compton WM, Baldwin GT, Han B, et al. Trends and Characteristics of Buprenorphine-Involved Overdose Deaths Prior to and During the COVID-19 Pandemic. JAMA Network Open. 2023;6(1):e2251856-e.
