On April 27, 2021, the federal Department of Health and Human Services (HHS) announced new practice guidelines for providers to prescribe buprenorphine, a medication used to treat opioid use disorder (OUD). These guidelines create an exemption from longstanding federal training requirements for providers, including physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. The regulations also exempt providers from a requirement to certify their ability to provide counseling services.

Removing these requirements may help states to increase OUD treatment capacity – particularly among primary care providers – at a time when opioid-related overdose fatalities continue to surge. Under the new guidelines, providers may now prescribe buprenorphine to up to 30 patients without completing an 8-hour (for physicians) or 24-hour (for all other providers) training to receive a waiver from the federal Drug Enforcement Agency (DEA). Previously, only providers who had this waiver were able to prescribe buprenorphine for OUD.

The training requirement has long been viewed by some providers and policymakers as a barrier to building OUD treatment infrastructure. Unlike methadone, which is also prescribed for treatment of OUD, buprenorphine can be provided within primary care settings, where OUD can be managed alongside other chronic conditions. Easing the requirements around buprenorphine prescribing further supports ongoing efforts to integrate behavioral health into primary care. It also signals a normalization of this treatment approach that may serve to reduce the stigma of OUD.

The new guidelines follow a previous attempt – in the final week of the Trump administration – to remove the waiver requirement for physicians while maintaining it for other prescribers. That action was halted by the Biden administration shortly thereafter, with federal officials citing the need to review both the content and process for making these changes.

NASHP published a blog reviewing how changing waiver requirements could lead to state-level policy changes at that time. Several of those considerations, revised to reflect the new practice guidelines, are highlighted below:

• States that integrated buprenorphine prescribing practices into their licensing regulations for prescribers may need to amend regulations to reflect changes to provider requirements. In some states, such regulations are also intended to promote prescribing safety, requiring that providers document connections to counseling and other supports, an effort designed to minimize potential diversion of buprenorphine.
• As states have worked to build treatment capacity for OUD, they have integrated the required training for the waiver into their efforts, often partnering with professional associations to provide the in-person training hours. States have also dedicated funding to these trainings in both state budgets and via State Opioid Response (SOR) grant dollars.
• Reimbursement for these services may be administratively tied to the requirement to have a waivered prescriber among OUD care team members. As states have developed Medicaid waiver demonstrations and amended state plans to include OUD treatment services, language requiring waivered prescribers was incorporated to align with the federal policy. All of these documents, directives, and billing practices may need to be reviewed or amended by states to ensure that providers – now without the waiver- can seek reimbursement.

Providers will still need to follow federal protocols that require submission of a Notice of Intent to the Substance Abuse and Mental Health Administration (SAMHSA) that indicates that they will be making use of the exemption; providers wishing to prescribe to up to 100 patients will need to complete existing training and qualification requirements.

For more information on how states are building OUD treatment capacity, please visit NASHP’s State Policy Center for Opioid Use Disorder Treatment and Access, developed in partnership with the Foundation for Opioid Response Efforts (FORE).