Updates to rules for Opioid Treatment Programs: The 42 CFR Part 8 Final Rule Table of Changes
The following table summarizes some key changes to 42 CFR part 8. This table does not discuss all changes. To review all of the changes to 42 CFR part 8, interested parties are encouraged to view the final rule.
For questions regarding implementation of the final rule, please contact SAMHSA’s Division of Pharmacologic Therapies at 240-276-2700 or DPT@samhsa.hhs.gov or your State Opioid Treatment Authorities.
| Provision | What Changed? | Why Has This Changed? |
|---|---|---|
| Title and Terminology | The title of the rule has been updated to “Medications for the Treatment of Opioid Use Disorder.” The final rule replaces outdated terms such as “detoxification” and adds new definitions. | Aligns with current evidence-based practices and terminology to promote patient-centered treatment activities. |
| Admissions | The final rule eliminates the 1-year opioid addiction history requirement and promotes priority treatment for pregnant individuals. It also removes the requirement for two documented instances of unsuccessful treatment for people under age 18. Allows consent to be obtained electronically. In addition, medication access is no longer contingent on receipt of counseling. The final rule also allows screening examinations to be performed by practitioners external to the OTP under certain conditions. | Removes unnecessary barriers to medication access by focusing on individual patient needs. Adds protections for vulnerable groups. |
| Treatment Standards | The final rule adds patient-provider “shared decision making” considerations to all care plans and incorporates harm reduction principles into treatment. | Recognizes the need to meet patients where they are with their opioid and other substance use disorders, and help patients make positive change, reducing harm along the way. |
| Take-Home Doses | The final rule updates criteria for consideration of take-home doses of methadone and allows patients to receive take-home doses from the first week of treatment under certain conditions. Safeguards like diversion control procedures remain. | Makes permanent the COVID-19 flexibilities which demonstrated that wider access to methadone improves outcomes, without increasing rates of diversion, when paired with individualized, clinical judgment, safeguards, and patient education. |
| Telehealth | The final rule allows screening patients for initiation of buprenorphine via audio-only or audio-visual telehealth technology if certain providers determine that an adequate evaluation of the patient can, or has been, completed via telehealth. The final rule also allows for screening patients for the initiation of methadone via audio-visual telehealth under certain conditions. | Telehealth is an evidence-based practice that has been shown to be safe and effective. Its use expands access to care and promotes activities known to support recovery such as employment. |
| Interim Treatment | Interim Treatment is now allowed at any qualifying OTP and the time frame for Interim Treatment was expanded from 120 to 180 days. Requires prioritization of moving patients from interim into comprehensive treatment. State approval for use of interim treatment is still required. | Expands access to treatment. |
| Accreditation Body Oversight | The responsibilities of Accrediting Bodies are clarified in terms of reporting time frames, follow-up on OTP implementation of corrective measures and communications with SAMHSA. | Improves monitoring to uphold quality standards at OTPs. |
| OTP Compliance and Accreditation | The final rule sets forth time frames and follow-up of OTPs on corrective measures. The time for OTPs to take corrective action is extended to 180 days following receipt of the survey report. Removes an expired type of accreditation, clarifies the category of “provisional” certification and authorizes “conditional” certification. | Allows continuity of operations if compliance issues arise while restoring full standards. |
| Scope of Practice Expansion | Allows nurse practitioners and physician assistants to order MOUD for dispensing at the OTP if consistent with state law. The final rule also clarifies medication unit rules and defines the range of services that they may offer. | Establishes flexibility for practitioner staffing to improve access, especially in underserved areas. Clarifies the scope of medication units that can reach new areas. |
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