Policy Considerations for Rural MOUD Programs
There are a number of policies, including statutes and regulations, that apply to medication-assisted treatment (MAT) services and programs that provide medication for opioid use disorder (MOUD). Rural programs must understand and consider how these policies apply when developing and implementing a rural MAT or MOUD program.
Controlled Substances Act
The Controlled Substances Act, established in 1971, is the federal drug policy under which certain drugs are regulated. All drugs are classified into one of five drug schedules based on their medical use, potential for misuse, and likelihood for dependence. Schedule I drugs are considered most dangerous, with no medical use and the highest chance of misuse and dependence (for example, heroin), while Schedule V drugs have low potential for misuse but contain small amounts of controlled substances, (for example cough syrup with codeine). Use of opioids is regulated through this act, as well as the use of and distribution of some medications for treating opioid use disorder (OUD) — specifically methadone (Schedule II) and buprenorphine (Schedule III).
Narcotic Addict Treatment Act of 1974
The Narcotic Addict Treatment Act of 1974 legalized use of methadone to treat OUD, provided it was dispensed through dedicated methadone clinics, otherwise known as opioid treatment programs (OTPs). The Substance Abuse and Mental Health Services Administration (SAMHSA) has developed information on becoming an accredited and certified OTP, including the Federal Guidelines for Opioid Treatment Programs – 2015 manual.
Drug Addiction Treatment Act of 2000 (DATA 2000)
The Drug Addiction Treatment Act (DATA) of 2000 expanded established regulations to enable physicians to prescribe buprenorphine in settings other than OTPs, such as in physician offices, clinics, and primary care settings. The Act requires physicians to complete specialized training prior to applying for a buprenorphine waiver. This act helped increase access to MOUD, but restricted the number of patients a provider can treat at one time. Originally, providers could treat no more than 30 patients at a time during their first year following a waiver, though the law has been amended to increase those limits.
In 2021, the U.S. Department of Health and Human Services (HHS) released new practice guidelines expanding administration of buprenorphine for treating OUD. The practice guidelines outline certain conditions in which eligible providers can prescribe medication to treat up to 30 patients at one time without undergoing the certification requirements outlined in the regular DATA-waiver (X-waiver) process. This allows more physicians to prescribe medication to treat OUD.
Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, providers must see a patient in person before prescribing any controlled substance, including buprenorphine. There are several exemptions to the in-person prescribing requirements that allow providers to use telemedicine to prescribe a controlled substance without a prior in-person visit. The COVID-19 pandemic public health emergency also led to additional policy changes to allow providers to use telehealth to initiate and continue MOUD prescribing for the duration of the public health emergency.
Comprehensive Addiction and Recovery Act of 2016 (CARA)
The Comprehensive Addiction and Recovery Act of 2016 (CARA) expanded a number of earlier provisions regarding MOUD and increased emphasis on coordinating efforts across many aspects of the opioid epidemic, including prevention, treatment, recovery, and more. CARA includes a provision allowing non-physicians to prescribe buprenorphine, which made it possible for qualified nurse practitioners and physician assistants to be prescribers. Additionally, through an amendment, CARA includes provisions to allow providers to treat up to 100 patients during their first year of certification, provided they meet certain SAMHSA qualifications.
Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (SUPPORT Act)
The SUPPORT Act of 2018 expanded access to MAT and MOUD through a number of provisions. It expanded the waiver regarding patient caps to make it slightly less restrictive for eligible providers to treat up to 100 patients in their first year. To increase the maximum number of patients, eligible providers must meet one of the following conditions:
- Be board certified in addiction medicine or addiction psychiatry
Provide MAT or MOUD in a “qualified practice setting” which is further defined by SAMHSA
Statutes, Regulations, and Guidelines as a setting that:
- “provides professional coverage for patient medical emergencies during hours when the practitioner's practice is closed;
- provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services;
- uses health information technology systems such as electronic health records;
- is registered for their State prescription drug monitoring program (PDMP) where operational and in accordance with Federal and State law; and
- accepts third-party payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or Federal health benefits.”
In addition, the SUPPORT Act expanded access to MAT and MOUD through increased flexibility to healthcare providers in prescribing medication. Qualifying providers who are able to prescribe buprenorphine include nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwives. By expanding the types of providers who can prescribe medications, and expanding the patient caps, the SUPPORT Act allows for significantly more patients to receive MOUD treatment in a given location or practice setting. This is particularly impactful in rural areas, where the number of treatment locations are often more limited.