CurrentASAMPolicy N/A

ASAM comments on SAMHSA proposed OTP rule (unsupervised use, telehealth, OTP services)

This document contains the American Society of Addiction Medicine's comments on SAMHSA's proposed rule revisions to 42 C.F.R. Part 8 affecting opioid treatment programs (OTPs), focusing on unsupervised use criteria, telehealth initiation, certification, and OTP service requirements. It is aimed at regulators, OTP medical directors, and clinicians involved in addiction treatment policy and operations.

Policy Summary

PayerASAM

PolicyASAM comments on SAMHSA proposed OTP rule (unsupervised use, telehealth, OTP services)

Policy CodePolicy N/A

Change TypeComments/Recommendations

Effective DateN/A

Next Review DateN/A

Key ActionAllow clinicians to use documented clinical judgment to permit unsupervised methadone dosing (including up to a 30-day supply after 31 days of treatment) and to exceed initial dosing thresholds when rationale is recorded in the patient's chart.

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POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7,000+ASAM members represented

remove time/abstinenceRemove time/abstinence

30 days30-day supply

audio-visual only for Schedule IITelehealth stance

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Interim treatment proposal

Coverage and Clinical Criteria

ASAM recommended coverage and operational criteria

ASAM recommends that the following modifications be adopted to expand access and allow clinical judgment:

Unsupervised use and take-home dosing: Remove time-in-treatment and toxicology/abstinence requirements from unsupervised use criteria; allow unsupervised use based on clinician judgment including at treatment entry; permit patients in methadone treatment from 31 days of treatment to access up to a 30-day supply of methadone for unsupervised use (in lieu of 28 days); and modify §8.12 to apply only to 'unsupervised use' and 'supply/doses of methadone for unsupervised use,' accounting for technologies that allow remote supervised dosing.see text

Document clinical rationale for extended supplies and ensure patient education on safe storage/transport

Telehealth initiation: Allow audio-visual telehealth for initial evaluation for Schedule II medications (methadone) and permit audio-only telehealth for Schedule III medications (buprenorphine); oppose audio-only evaluations for Schedule II medications except with clear definition of 'in the presence of a licensed practitioner.'N/A

Prefer audio-visual for Schedule II; clarify terms if audio-only considered

OTP admission and dosing: Eliminate the one-year duration requirement for OUD prior to OTP admission and remove the requirement for two documented unsuccessful treatment attempts for minors; permit clinical judgment to adjust initial methadone dosing above 40 mg when the practitioner documents specific rationale in the patient's record.Meets diagnostic criteria for moderate or severe OUD or is at high risk for recurrence/overdose

Document specific rationale when exceeding dosing guidance

OTP services and public health integration: Integrate harm reduction and recovery support services into OTP care plans; allow patient refusal of counseling without denying MOUD; allow split dosing for pregnant patients when clinically appropriate; include screening (e.g., HCV) and linkage to services as part of initial assessment and planning.N/A

Offer counseling but do not make it a condition of MOUD; require patient education and linkage to services

Certification and program structure: Support conditional one-year OTP certification for programs with non-immediate safety non-conformance; require accreditation applicants to include at least one licensed physician experienced in treating OUD with MOUD; allow medication units (including community pharmacies or mobile units) to provide OTP services if they comply with applicable security, recordkeeping, and certification requirements.Conditional certification requires achieving full accreditation within one year

Medication units may dispense or administer MOUD if staffed and operated consistent with law and Attorney General standards where applicable

ASAM recommends that the final rule explicitly state that the unsupervised use criteria in §8.12(i)(2) do not apply to buprenorphine and buprenorphine products. ASAM notes most buprenorphine is prescribed in office-based settings and that the 2023 CAA removed the DATA‑2000 x‑waiver and patient limits, supporting alignment of OTP buprenorphine treatment with other medical settings. This clarification would also be consistent with the existing exemption of buprenorphine from the dispensing restrictions in §8.12(i)(3)(i)–(iii).

ASAM recommends removing the phrase 'public or nonprofit, private' from the interim treatment provisions so interim treatment is not limited to specific ownership types. ASAM also suggests extending the interim treatment period (e.g., from the NPRM’s 180 days to 360 days) to align with conditional certification and temporary accreditation timelines and to maximize public health benefit.

The cited sections do not propose explicit coverage exclusions; instead, they discuss rulemaking principles and the evidentiary record underlying regulatory changes. ASAM highlights administrative‑law considerations such as the logical outgrowth doctrine

Provider Certification, Documentation, and Operational Requirements

Note
OTP Certification Requirement
Certification: An OTP must hold a current, valid certification from the Secretary to be determined qualified under 21 U.S.C. 823(gh) to dispense methadone for OUD. This includes programs that dispense methadone using appropriately licensed community pharmacists administering or dispensing (but not prescribing) methadone from the stock of one or more community pharmacies that comply with Attorney General standards for methadone security and recordkeeping or obtain necessary exceptions.
OTPs must be certified by the Secretary to be qualified under section 303(gh) of the Controlled Substances Act.
Community pharmacies dispensing from OTP stock must comply with Attorney General standards on security and records or obtain exceptions.

Note
Certification and Medication Units (Conditional Certification)
Conditional certification and medication units: The proposal creates a one-year temporary conditional OTP certification tied to a temporary one-year accreditation for programs addressing non-immediate, non-high-risk deficiencies; the OTP must obtain a standard three-year accreditation within one year. 'Medication units' are defined as geographically separate entities (brick-and-mortar or mobile) established as part of an OTP from which licensed OTP practitioners, OTP contractors, or community pharmacists may dispense or administer MOUD, collect drug-testing samples, or provide other OTP services, provided they comply with applicable law and have appropriate privacy and space.

Key Definitions and Terms

inv-17: Medication unit — definition and operational scope

DefinitionMedication unit: an entity established as part of, but geographically separate from, an OTP from which appropriate, licensed OTP practitioners, contractors working on behalf of the OTP, or community pharmacists dispense or administer MOUD, collect samples for drug testing or analysis, or provide other OTP services; may be brick-and-mortar or mobile.

Operational scopeMay provide any services that are provided in an OTP, assuming compliance with Federal, State, and local law and appropriate privacy/space.

Staffing requirementMedication units may operate using licensed OTP practitioners, contractors, or community pharmacists as specified in the proposed definition.

Relation to accreditation/certificationMedication units operate as part of a certified OTP and are encompassed by proposed updates to OTP certification (including temporary one-year conditional certification where applicable).

Formats allowedCan be a permanent brick-and-mortar location or a mobile unit providing OTP services.

Settings and Level-of-Care Considerations

Medication and Service Modalities

Methadone (MOUD)

Methadone treatment: Allow telehealth (audio-visual) for initial evaluation for methadone; oppose audio-only telehealth for Schedule II initiation; permit clinicians to individualize dosing including split dosing for pregnancy and to adjust initial dosing above 40 mg when documented; permit up to a 30-day unsupervised methadone supply after 31 days of treatment.clinical judgment documented

Document rationale when exceeding dosing thresholds and educate patients on safe storage/transport

Buprenorphine (MOUD)

Buprenorphine treatment: Clarify that unsupervised use criteria in §8.12(i)(2) do not apply to buprenorphine and buprenorphine products; support audio-only telehealth for initiation of buprenorphine (Schedule III) and align OTP buprenorphine practice with office-based prescribing.N/A

Reflect CAA 2023 removal of DATA 2000 waiver and align with office-based norms

Take-Home and Unsupervised Use Limits

inv-28: unsupervised methadone supply (recommended) — up to 30 days.

Recommended maximum supplyASAM recommends permitting up to a 30-day supply of methadone for unsupervised use starting from 31 days of treatment (in lieu of the NPRM's 28 days).

RationaleRecommendation aligns methadone prescribing practices with other Schedule II medications and supports patient engagement and retention in chronic disease care models.

Documentation expectationASAM notes clinical rationale should be documented and consistent with good faith efforts to ensure patients are not receiving services at another OTP.

Relation to scheduleThis recommended change adjusts the proposed unsupervised-use schedule in §8.12(i)(3)(i)-(iii) by increasing the post-31-day limit from 28 to 30 days.

Policy Summary

PayerASAM

PolicyASAM comments on SAMHSA proposed OTP rule (unsupervised use, telehealth, OTP services)

Policy CodePolicy N/A

Change TypeComments/Recommendations

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

One-year temporary/conditional certification permitted when linked to temporary accreditation addressing non-urgent nonconformances.
Medication units may provide any services offered in an OTP if compliant with Federal, State, and local law and adequate privacy/space requirements.
Accreditation applicants must include one licensed physician with experience treating OUD with MOUD.

Documentation Required
OTP Certification and Pharmacy Security
OTP certification and pharmacy security expectations: Programs dispensing via community pharmacies must ensure those pharmacies will comply with Attorney General standards for methadone security and record maintenance or will obtain necessary Attorney General exceptions. Community pharmacies dispensing from OTP stock are subject to security and recordkeeping expectations parallel to OTP requirements.
Community pharmacies must meet security and recordkeeping standards set by the Attorney General when dispensing OTP methadone stock.
Programs using pharmacy-dispensed OTP stock should document compliance or documented Attorney General exceptions.

Documentation Required
Documentation of Clinical Rationale for Dosing and Take-Homes
Documentation for dosing and take-homes: Clinical rationale must be documented when permitting unsupervised methadone doses (including extended take-home supplies beyond proposed schedules) and when initial dosing decisions exceed routine limits. Documentation should demonstrate good-faith efforts to ensure the patient is not receiving services at another OTP and include specific clinical rationale if higher-than-typical doses are required to suppress withdrawal.
Document clinical rationale for unsupervised use schedules consistent with efforts to verify exclusivity of OTP services.
Document specific clinical justification in the patient record if initial methadone dosing exceeds standard thresholds (e.g., >40 mg/day).

Documentation Required
Documentation of Individualized Dosing and Patient Surveys
Documentation of individualized dosing and patient surveys: OTPs should document individualized dosing decisions (including when initial dosing exceeds 40 mg) and are recommended to conduct annual patient experience surveys assessing OTP services and provision of methadone for unsupervised use. OTPs must maintain recordkeeping systems adequate to document and monitor patient care and survey results, with appropriate reporting and confidentiality safeguards.
Require documentation in the record that 40 mg did not adequately suppress withdrawal and that a higher dose was clinically indicated when dose >40 mg is given.
Programs should survey patients annually about OTP services and access to methadone for unsupervised use; survey methodology should draw on CAHPS/OAS resources.
OTPs must establish and maintain record systems to document care and survey/evaluate patient experiences.

Note
Admission Requirement Changes
Admission requirement changes: The proposal removes the requirement that a patient have at least one year of OUD before OTP admission and eliminates the requirement for two documented unsuccessful treatment attempts within one year for minors; admission may be based on meeting diagnostic criteria for moderate or severe OUD, active OUD or OUD in remission, or being at high risk for recurrence/overdose.
Elimination of one-year OUD duration requirement for OTP admission.
Removal of two failed-treatment attempt requirement for individuals under 18; parental consent requirements remain subject to state law.

Denial Risk
Risk from Unsupervised Use Criteria
Risk from unsupervised use criteria: ASAM supports removing time-in-treatment and abstinence-based toxicology requirements from unsupervised use criteria, recognizing that prior PHE flexibilities did not show meaningful increases in diversion and that increases in methadone-involved deaths were largely attributable to fentanyl. Patients should be educated on safe transport and storage of medication.
Do not use length of time in treatment or absence of substance use by toxicology as prerequisites for unsupervised take-homes.
Require patient education on safe transport and storage of methadone when permitting unsupervised doses.

Prior Authorization
Prior Authorization Not Addressed
Prior authorization and prior-authorization-like rules: The proposed rule and ASAM commentary do not establish or specify prior authorization requirements for OTP services or methadone dispensing; no formal PA rules are addressed in this section aside from documentation and certification expectations.
No explicit prior authorization program or PA triggers are defined in this portion of the proposal.
Providers should nonetheless maintain comprehensive documentation to support medical necessity and compliance with certification standards.

Note
Not Applicable Here — Legal/Regulatory Commentary
Not applicable / This portion does not define provider 'do' actions: Certain global legal and regulatory commentary (e.g., logical outgrowth doctrine and rulemaking standards) are informational and do not impose direct operational obligations on providers in this section; providers should note these as legal context but not as actionable clinical or billing requirements.
Legal/regulatory discussion on rulemaking and logical outgrowth is informational and not prescriptive of provider actions.
Providers should focus on certification, documentation, and operational requirements described elsewhere in this section rather than global legal commentary.

Compliance noteServices must comply with all applicable federal, state, and local law, and use units that provide appropriate privacy and adequate space.

inv-18: Unsupervised use vs take-home — recommendation that §8.12 apply only to 'unsupervised use' and acknowledge remote supervision tech.

Scope recommendationASAM recommends that §8.12 apply only to 'unsupervised use' and that SAMHSA make global changes to replace inconsistent uses of 'take home' with 'unsupervised use' where appropriate.

Technology acknowledgementASAM urges the rule to explicitly acknowledge newer technologies that permit remotely supervised 'take home' dosing, distinguishing these from true unsupervised use.

Terminology rationale'Unsupervised use' is the statutory term (21 U.S.C. 823(h)); inconsistent terminology in the NPRM risks regulatory confusion.

Clinical implicationDistinguishing remotely supervised dosing from unsupervised use supports allowing supervised 'take home' models without triggering unsupervised-use restrictions.

inv-19: Interim treatment — NPRM contemplates extension; ASAM comments on length and scope.

DefinitionInterim treatment: a time-limited provision of methadone where comprehensive services may not be readily available; proposed to permit interim treatment when comprehensive services are not readily available rather than limited to public or nonprofit programs.

NPRM contemplationSAMHSA's NPRM contemplates changing the interim treatment period from 120 to 180 days.

ASAM recommendation on lengthASAM recommends extending the interim treatment period to 360 days, citing workforce and access constraints that are unlikely to be resolved within 180 days.

Scope changeASAM supports removing ownership-type limits (e.g., 'public or nonprofit') so interim treatment is not restricted by program ownership status.

inv-20: Long-term care facility (proposed) — NPRM proposed exemptions; ASAM recommends explicit inclusions/exclusions.

NPRM proposalThe NPRM proposes defining 'long-term care facilities' to allow certain facility types to forgo OTP certification when treating admitted patients whose primary medical condition is not OUD.

ASAM recommendation — include confined settingsASAM recommends explicitly including local jails and state and federal prisons in the definition of 'long-term care facilities' so these institutions are not precluded from providing methadone treatment to residents who require medically necessary care.

DEA registration noteASAM requests the final rule clarify that facilities registered with the DEA as a 'hospital/clinic' do not need separate registration under 21 U.S.C. 823(h) to treat OUD with methadone for admitted patients.

Examples to includeASAM suggests listing extended acute care facilities; rehabilitation centers; skilled nursing facilities; permanent supportive housing; assisted living facilities; chronic care hospitals; and correctional facilities (jails/prisons).

inv-21: logical outgrowth doctrine — legal doctrine summary relevant to rule changes.

Doctrine summaryLogical outgrowth doctrine: an agency's final rule must be a logical outgrowth of its proposed rule; courts assess whether the final rule was within a range of foreseeable alternatives to the public.

Judicial standardThe inquiry is fact-specific; courts may still affirm a final rule that is not a logical outgrowth if any divergence constitutes harmless error requiring the challenger to show prejudicial harm under APA §706.

Practical implicationRegulators should ensure proposed rule language and comment opportunities adequately signal foreseeable alternatives to avoid litigation risk under the doctrine.

Medications for opioid use disorder (MOUD), including methadone and buprenorphine, reduce illicit opioid use and overdose risk and improve retention and broader health and social outcomes. ASAM’s recommendations in this docket are framed to expand access to these effective treatments by reducing unnecessary structural barriers while preserving clinical judgment and patient safety.

Methadone/MOUD

Methadone dosing and formulation: Permit OTP practitioners to individualize methadone formulation (e.g., tablets/diskettes) and to adjust initial dosing above 40 mg when documented in the record; require documentation that 40 mg did not adequately suppress withdrawal when higher dosing is provided.documented clinical rationale

Amend §8.12(h)(3)(i) to allow formulations that reduce parenteral misuse

Community pharmacy dispensing: Recommend permitting pharmacists to dispense methadone for OUD from community pharmacy stock if the community pharmacy complies with Attorney General standards for methadone security and recordkeeping or obtains necessary exceptions, and the OTP remains certified under applicable law.pharmacy meets security/recordkeeping standards or obtains exceptions

OTP must hold current, valid certification from the Secretary

Methadone treatment (OTP-related)

Evidence and programmatic context: Cited studies analyze methadone-involved overdose deaths before and after federal policy changes and note limitations and potential confounders; ASAM uses these studies to support cautious expansion of take-home and telehealth flexibilities with appropriate safeguards.N/A

Consider study limitations and contextual factors (e.g., fentanyl co-involvement) when interpreting outcomes