New Final Rule on Medications for the Treatment of Opioid Use Disorder

On April 4, 2024, a final rule published on February 2, 2024 (the Final Rule) went into effect that concerns medication for the treatment of opioid use disorder. The Final Rule, published by the Substance Abuse and Mental Health Services Administration (SAMHSA) in concert with the Department of Health and Human Services (HHS), makes changes to the existing regulations concerning opioid treatment programs (OTPs) at 42 C.F.R. Part 8. The compliance date for the Final Rule is October 2, 2024.

The Final Rule updates accreditation and certification standards to codify the use of online/electronic forms and to reflect a modern treatment environment. It also promotes practitioner autonomy and individualized care by making more flexible the criteria for unsupervised doses of methadone for patients in OTPs. Based on the clinical judgment of the treating provider, patients may be eligible for unsupervised, take-home doses of methadone upon entry into treatment, which provides greater flexibility in creating plans of care that promote recovery activities such as employment or education and eliminates a significant barrier for individuals without access to reliable transportation.

The Final Rule also makes permanent flexibilities put forth during the COVID-19 public health emergency. Due to the increasing need to reach remote and underserved communities, HHS and SAMHSA permit the initiation of buprenorphine at an OTP if the appropriate provider determines that an adequate evaluation of the patient can be, or was, accomplished via audio-only or audio-visual telehealth technology. Treatment of a patient by methadone via audio-visual telehealth may also be permitted under the changes if the appropriate provider determines an adequate evaluation can be accomplished.

The full text of the Final Rule, 89 FR 7528, can be accessed here.

Final Rule on Substance Use Disorder Confidentiality

On April 16, 2024, a final rule, which was published by HHS, SAMHSA, and the Office for Civil Rights (OCR) on February 16, 2024, becomes effective and modifies the regulations governing the Confidentiality of Substance Use Disorder (SUD) Patient Records at 42 C.F.R. Part 2. The final rule makes certain modifications to increase alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to improve workability and decrease burden on programs, covered entities, and business associates. The compliance date is February 16, 2026.

The final rule modifies rules on patient consent by allowing a single consent for all future uses and disclosures for treatment, payment, and healthcare operations, and by allowing HIPAA covered entities and business associates that receive records under this consent to re-disclose the records in accordance with the HIPAA regulations. The final rule also permits the disclosure of records without patient consent to public health authorities, provided that the records are de-identified according to the standards established in the HIPAA Privacy Rule. However, these records cannot be used in civil, criminal, administrative, and legislative proceedings against patients without specific consent or a court order, which is more stringent than the HIPAA standard. Additionally, the rules require a separate patient consent for the use and disclosure of SUD counseling notes.

The final rule also creates a safe harbor that places a limit on civil or criminal liability for investigative agencies that act with reasonable diligence to determine whether a provider is subject to the regulation before making a demand for records in the course of an investigation. The safe harbor requires investigative agencies to take certain steps in the event they discover they received applicable records without having first obtained the requisite court order. Other major changes to the rule include modifications regarding penalties, notification of breaches, and patient notice requirements to better align with HIPAA.

The full text of the Final Rule, 89 FR 12472, can be accessed here.

Rural Opioid Treatment and Recovery Initiative

On March 6, 2024, HHS published a press release announcing the Biden-Harris administration’s launch of a nearly $50 million initiative to support opioid treatment and recovery services in rural communities. Through HHS’ Health Resources and Services Administration (HRSA), the Rural Opioid Treatment and Recovery Initiative will support rural areas in responding to the opioid crisis; expand the rural substance use treatment workforce; support key populations such as adolescents, young adults, and individuals with justice involvement; and respond to rural communities’ needs. Applications will be accepted through May 6, 2024, and can be submitted online here.

Applicants for the grant are able to integrate supportive services, such as food access, housing support, employment training and opportunities, and other social determinants of health into their proposals. Funding may support transportation to facilitate access to treatment and recovery appointments or to expand the rural substance use disorder workforce, including clinical providers and peer support professionals. Average awards are expected to be up to $750,000 per year over four years.

The HHS press release announcing the grant can be accessed here.

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