By Juan M. Hincapie-Castillo and Amie J. Goodin
Policies to mitigate the drug overdose crisis continue to fall short, as evidenced by increasing rates of opioid-involved overdoses and deaths in the United States. The COVID-19 pandemic has exacerbated this overdose crisis, and efforts are urgently needed to mitigate harm.
Individuals who have problematic opioid use are most frequently involved in opioid-involved overdoses, meaning that the use of a prescription opioid, or much more commonly a non-prescription opioid (such as non-medically sourced fentanyl or heroin), is used in a way that adversely affects the person’s life. Problematic opioid use may lead to a diagnosis of opioid use disorder (OUD). The medication buprenorphine has been proven to reduce opioid-involved overdose and harms and is one of few OUD treatments available as a prescription that can be dispensed by community pharmacies rather than from specialized facilities or specialty providers.
The federal government and several states have implemented strategies to improve and promote OUD treatment access, especially for the relatively inexpensive and effective medication buprenorphine. However, there are significant barriers that remain that preclude adequate and timely access to buprenorphine.
Prescribing of buprenorphine, which is classified as a controlled substance, is subject to additional requirements to that of other opioid medications. For example, prescribers of buprenorphine must obtain a waiver from the Substance Abuse and Mental Health Services Administration (SAMHSA) prior to writing prescriptions to treat OUD, and those practitioners who wish to treat more than 30 patients are mandated to undertake training.
In addition to these waivers, certain payers and insurance plans have implemented prior authorization (PA) requirements that require a prescriber must submit a PA to get advanced approval by the payer to signify that the payer agrees to cover the medication. This strategy may be used by payers as a mechanism to discourage claims. PAs are typically used for cost control, but they have also been applied to regulate use of medications for treatment of OUD. The additional steps needed for accessing lifesaving therapies by requiring prescribers to create and submit PAs are deterrents that can result in treatment delays, relapse, and worse health outcomes for patients who are already in a vulnerable state. Concerns for limiting medication access among the Medicaid population are particularly worrisome, as fewer providers are willing to accept Medicaid insurance due to the additional administrative barriers for reimbursement as well as the reduced compensation as compared with private payers.
In our recent study published in JAMA Health Forum, we evaluated the effect of removing all prior authorization requirements in Medicaid programs for California and Illinois using publicly available prescribing data. We observed a significant increase in buprenorphine prescription fills in Illinois but not California after these two states removed their PA requirements for Medicaid.
Illinois removed the PA process for buprenorphine via legislation whereas California did it by regulatory policy change within the Medi-Cal program. The different findings we observed are probably explained by different administrative burdens for processing PAs in these two states and the prior pre-policy trends that showed sustained increases in buprenorphine use in California.
An accompanying commentary for our study highlights the intricacies and challenges in evaluating policy changes such as this. The ecosystem and medico-legal landscape of opioid regulation is subject to several layers of oversight across overlapping jurisdictions, which requires careful thought on measurement of policy interruptions and alternative causes to explain changes in use trends. By starting with a comprehensive legal scan of policies regarding PA requirements for MOUD across state Medicaid programs, our team decided to only attempt a quantitative evaluation for those states that fully removed PA requirements and had enough points of data before and after policy implementation for correct estimation of trends.
PA requirements for life saving medications like buprenorphine must be removed by all payers. Lives of individuals with OUD are not disposable, and pharmaceutical policy must facilitate, not hinder, timely and adequate access to medication and supporting care.
Juan M. Hincapie-Castillo, PharmD, MS, PhD, is assistant professor of epidemiology at the University of North Carolina at Chapel Hill. Amie J. Goodin, PhD, MPP, is assistant professor of pharmaceutical outcomes and policy at the University of Florida. Dr. Hincapie-Castillo and Dr. Goodin are Research Fellows at the Center for Public Health Law Research.