The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule governing the use of medications for the treatment of opioid use disorder (OUD). In the rule, the first major update in 20 years, the agency made permanent some of the telehealth flexibilities that were put into place to respond to the COVID-19 pandemic and made a number of other changes similarly aimed at improving patient access to and reducing stigma of OUD treatment.

Additionally, with this rule, SAMHSA updated accreditation and certification requirements for opioid treatment programs (OTPs) as required by the Consolidated Appropriations Act, 2023 (CAA). The rule, which was printed in the Federal Register on February 2, 2024, takes effect April 2, 2024, and has a compliance date of October 2, 2024.

Permanent and Expanded Telehealth Flexibilities

One of the most noteworthy changes included in the final rule is the formal adoption (and expansion) of some of the telehealth flexibilities that were implemented during the COVID-19 pandemic to ensure patient access to treatment of OUD. Prior to the COVID-19 pandemic, each patient being admitted to an OTP was required to undergo an in-person physical examination by a program physician before beginning treatment with methadone or buprenorphine (a synthetic opioid used as an alternative to methadone to treat OUD).

During the COVID-19 pandemic, the Drug Enforcement Agency (DEA) and SAMHSA implemented flexibilities that enabled OTPs to admit patients for buprenorphine induction without conducting an in-person examination, if a program physician or qualified health care professional under the supervision of a program physician determined that adequate evaluation of the patient could be performed via telehealth. However, these flexibilities did not extend to admissions for methadone induction via telehealth/without an in-person evaluation.

In the final rule, SAMHSA amends the regulations to permanently allow OTPs to conduct initial admission evaluations for buprenorphine induction via telehealth, including audio-only or audio-visual technology. Importantly, the final rule also extends these flexibilities to OTP admissions for methadone treatment; however, the use of telehealth for such initial evaluations is limited to audio-visual telehealth technology.

It is important to note that these flexibilities relate to the initial screening evaluation, which is designed to determine that the patient meets the admission requirements and has no contraindications for treatment. This is an effort by SAMHSA to ensure that patients who need immediate care and do not have any contraindications can start their methadone or buprenorphine treatment right away. However, this does not mean that a full in-person examination does not ever have to take place during admissions efforts. In fact, under the final rule, such an examination must be completed within 14 calendar days of admission to the OTP. This examination can also be conducted by a non-OTP clinician under certain circumstances.

Take-Home Flexibilities

Generally, OTP patients have been required to make daily in-person visits to their OTPs for medication dispensing/administration. So-called “take home” doses were subject to narrowly defined limits, especially within the first year of treatment (e.g., historically, patients in the first 90 days of treatment have only been allowed a single “take-home” dose per week). During the COVID-19 pandemic, SAMHSA issued exemptions to allow state regulatory authorities to request more flexible take-home restrictions. Under these flexibilities, OTPs were permitted to provide up to 28 days of methadone for “stable” patients and 14 days for “less stable” patients.

Although these flexibilities were intended to reduce the risk of COVID-19 infection among OTP patients and providers, SAMHSA determined that the flexibilities also helped to promote individualized care, reduce stigma, and remove barriers to treatment access, without resulting in any meaningful increase in the medication diversion rates. Accordingly, in the final rule, SAMHSA has decided to formally adopt these flexibilities on a permanent basis with some additional specificity to remove the ambiguous (and potentially stigmatizing) “stable”/”less stable” terminology:

  • Days 0-14: Patients can receive up to 7 days of Take-Home Doses
  • Days 15-30: Patients can receive up to 14 days of Take-Home Doses
  • Days 31 and on: Patients can receive up to 28 days of Take-Home Doses

In all cases, the determination of the number of Take-Home doses a patient may receive (within the limits described above) is up to the OTP practitioner’s discretion. However, the determination must be based on criteria outlined in the regulation and documented in the patient’s clinical record.

Updated OTP Admission Criteria

Historically, SAMHSA regulations have required patients to meet certain admission criteria to receive treatment at an OTP. Specifically, patients had to have active opioid addiction for one-year prior to admission to an OTP. Additionally, minor patients had to have two documented unsuccessful attempts at short-term detoxification or drug-free treatment in a 12-month period before being admitted to an OTP.

The final rule replaces these requirements with a more subjective, individualized standard that requires a determination by a qualified health care professional that the patient: (i) meets the diagnostic criteria for active moderate to severe OUD, (ii) is in remission from OUD, or (iii) is at high risk for recurrence or overdose.

Reduction of Provider Restrictions

DATA Waiver Requirements

Previously, individual practitioners were required to obtain a waiver (known as the Drug Addiction Treatment Act or “DATA” Waiver) to prescribe certain Schedule III-V medications for the treatment of OUD, including buprenorphine. These requirements also imposed restrictions on the number of patients with OUD that an individual provider could treat (from 30-275 patients depending on certain conditions). The final rule implements provisions of the CAA that permanently eliminated these requirements, including the patient caps.

Scope of Practice Expansion

The SAMHSA OTP regulations have historically defined “Practitioner” to be limited to licensed physicians, which has substantially restricted other qualified practitioners from rendering care in an OTP. In an effort to establish greater staffing flexibilities in light of nationwide staffing shortages, the final rule expands this definition to include any provider who is appropriately licensed to dispense and/or prescribe approved medications. This will allow physician assistants and nurse practitioners to practice and prescribe methadone within an OTP (subject to any state restrictions/limitations on the scope of practice of such non-physician practitioners).

Other Changes

The final rule also includes other changes aimed at improving access to treatment, streamlining OTP operations, and reducing stigma. For example, the final rule:

  • Decouples medication access from receipt of counseling services;
  • Expands the period in which an individual waiting for admission to a comprehensive treatment program (e.g., inpatient/residential) can receive “interim treatment” with an OTP from 120 days to 180 days;
  • Incorporates “harm reduction” principles over abstinence-only (e.g., provision of fentanyl drug testing strips, HIV/STI testing);
  • Removes outdated terminology (e.g., detoxification) to reduce stigma and implements patient-centered language to acknowledge patient autonomy and involvement in care;
  • Changes the certification standards for OTPs to allow both the use of online or electronic forms during the accreditation process and also to facilitate information sharing between the third party accreditation services and SAMHSA; and
  • Incorporates a corrective action procedure for OTP certification processes to ensure continuity of operations when compliance issues arise, which allows OTPs 180 days to implement corrective action following receipt of a certification survey report from their respective accrediting organization.

Reed Smith will continue to follow developments related to OUD and treatment at OTPs. If you have any questions about this, please reach out to the authors of this post or to your health care lawyers at Reed Smith.