The Controlled Substances Act (CSA) in the United States imposes stringent regulations governing the prescribing, dispensing, and usage of narcotic drugs, especially those utilized for maintenance or detoxification treatment. However, preceding the COVID-19 pandemic, the CSA included specific provisions permitting these practices under tightly controlled circumstances. Oversight for these controls fell under the purview of two agencies: the Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA).

During the COVID-19 Public Health Emergency (PHE), the DEA temporarily eased regulations concerning substance use disorder (SUD) treatment to ensure uninterrupted patient care during lockdowns and social distancing. This included relaxing restrictions on patient-prescriber interactions and expanding the use of telemedicine for SUD medication prescriptions. SAMHSA also waived certain requirements, such as patient limits for providers and the need for a DEA-X number, to improve access to buprenorphine treatment.

Despite the end of the PHE in May 2023, the positive outcomes during this period sparked interest in making these changes permanent. Recently, on February 1, 2024, the Health and Human Services (HHS) issued a Final Rule titled “Medications for the Treatment of Opioid Use Disorder,” which overhauled the accreditation and certification process for Opioid Treatment Programs (OTPs). This rule formally implemented the Drug Addiction Treatment Act (DATA) Waiver for buprenorphine, expanded telemedicine prescribing, and introduced flexibility in methadone treatment by allowing select patients to receive unsupervised doses for at-home consumption.

This shift in federal policy has far-reaching implications, affecting prescribers, telehealth companies and pharmacies engaged in substance abuse treatment and medication dispensing and counseling. Effective April 2, 2024, these changes will require states to align with federal policy. While all states can impose stricter controlled substance laws, some already do. It is crucial to note that exemptions only apply in states that align with federal changes. Aligning state policies with federal regulations may require specific legislation or regulations.

Healthcare providers, including physicians, psychiatrists, psychologists, and other professionals offering substance abuse treatment, are urged to closely scrutinize the recent final rule issued by SAMHSA and preceding state rules. Understanding the implications of these rules for telehealth services linked to opioid treatment is crucial, encompassing changes in regulations and reimbursement policies that may affect their practice. Simultaneously, healthcare organizations such as hospitals, clinics, and substance abuse treatment centers need to ensure that their telehealth initiatives comply. This may necessitate adjustments to telehealth policies, procedures, and technological infrastructure to align with the regulatory standards set forth by SAMHSA. Moreover, health IT companies, encompassing telehealth platforms, electronic health record (EHR) vendors, and other health information technology (IT) entities facilitating telehealth services, must thoroughly review the final rule to verify that their offerings uphold compliance with SAMHSA regulations.

Payers, comprising private health insurers and government entities like Medicare and Medicaid, must grasp the implications of the final rule on coverage and reimbursement for telehealth services related to opioid treatment. Consequently, they may need to revise their policies to accommodate the changes dictated by the new regulatory framework.

In navigating the complex landscape of laws governing prescribing-controlled substances like those used to treat substance use disorders, organizations can rely on Point-of-Care Partners (POCP) for comprehensive support. With our subject matter expertise and extensive resources, POCP offers daily tracking and analysis of policies, providing updates through our Regulatory Resource Center subscription solutions. By using our deep understanding of the legal landscape and continuous monitoring of changes, organizations can stay informed and compliant.

Partnering with POCP ensures access to up-to-date information and interpretation of complex laws, enabling the delivery of quality care to individuals in need of substance use disorder treatment. Stay compliant and informed with POCP as your trusted partner in navigating changing DEA rules. Reach out to me at kim.boyd@pocp.com if you’d like more information about how our subscription solutions can support your organization or if you have specific questions about how these changes may impact your company or your solutions.