Beetham T. Buprenorphine prior authorization removal: low hanging fruit in the opioid overdose crisis. Harvard Public Health Review. 2019;25.
The overdose crisis in the United States is not abating. The number of overdose mortalities has never been higher, and synthetic opioid mortalities increased 45% from 2016 to 2017 (Scholl, et al., 2019). The scope is daunting, but there is “low-hanging fruit” yet to be addressed. Though seldom mentioned in public debate, effective treatment is available, yet access to it is mired in red tape.
Buprenorphine is a life-saving treatment, most commonly known by the buprenorphine/naloxone combination drug, Suboxone. Buprenorphine reduces cravings, illicit opioid substance use, transmission of infectious diseases, criminal activity, and improves social functioning (Mattick, Breen, Kimber, & Davoli, 2014; Rinaldo & Rinaldo, 2013; Volkow, Frieden, Hyde, & Cha, 2014). Furthermore, it is positively associated with substantial reductions in both overdose and all-cause mortality (Sordo et al., 2017), and improves the likelihood of successful long-term recovery (Connery, 2015; Hser et al., 2016). The value of buprenorphine in curbing the epidemic is unequivocally established and unanimously supported by authorities on the issue including the director of the National Institute on Drug Abuse (Volkow, Frieden, Hyde, & Cha, 2014), the American Society of Addiction Medicine (American Society of Addiction Medicine, 2018), the Centers for Disease Control and Prevention (CDC, 2017), the World Health Organization (World Health Organization, 2009), and the American Medical Association (AMA), all of whom recommend that medication be first-line treatment for opioid use disorder (OUD) (American Medical Association [AMA], 2018). Buprenorphine and methadone are the most effective treatments for OUD (Sordo et al., 2017), though rather than patients being required to dose daily at an opioid treatment program (i.e., “methadone clinic”), buprenorphine can be accessed from the providers’ offices. The scalability of buprenorphine is therefore promising and ought to be capitalized on, yet the growth in its use is slowing when it should be increasing to meet demand (Wakeman & Barnett, 2018).
Mitigating barriers to providing buprenorphine treatment is critical. One hurdle is a set of regulations that requires providers to become specially certified to prescribe buprenorphine and imposes patient capacity constraints on the amount of prescriptions (AMA, 2017c). Physicians frequently report concerns over time, bureaucracy, cumbersome regulations, diversion, lack of OUD education, and inadequate reimbursement (DeFlavio, Rolin, Nordstrom, & Kazal, 2015; Huhn & Dunn, 2017). State payers also report an insufficient number of physicians prescribing and inadequate funds (Molfenter et al., 2015). There is an additional barrier that could improve several of these hurdles if addressed: prior authorizations (PAs). It is not arduous to remedy but it is rarely discussed.
Prior authorizations is a technique designed to minimize short term costs for the insurer by requiring that the provider obtain insurer approval prior to covering the cost of the treatment. Treatment can be delayed or payment denied as part of this process. PAs are frequently used to enforce restrictions imposed by the insurer, the nature of which are often opaque and can differ a great deal by insurer (Rinaldo & Rinaldo, 2013). Approvals can be contingent upon requirements set by the insurer that are not supported by evidence, such as rationing buprenorphine to save money or ensure safety (Clark, Samnaliev, Baxter, & Leung, 2011). Other conditions may include “step therapy” which requires trying cheaper, less effective options first, quantity limits for patients’ daily doses or lifetime limits, rigid tapering schedules, and ongoing detailed counseling documentation (Rinaldo & Rinaldo, 2013; Ruoff, 2016). Requirements are often more stringent for Medicaid patients than those who are privately insured, and non-existent for those who can afford to pay in cash (Rinaldo & Rinaldo, 2013) which will set a patient back hundreds of dollars per prescription and office visit (Beetham et al., 2019).
PA policies can dissuade providers from prescribing. The approval process is time consuming and bureaucratic, with the vast majority of physicians reporting in an AMA survey that PAs are a high or extremely high burden for providers and staff (AMA, 2017a). Almost 70% of Medicaid plans require PAs for buprenorphine (Andrews et al., 2018), and PAs are the highest rated barrier to prescribing among buprenorphine providers treating Medicaid populations (Kermack, Flannery, Tofighi, McNeely, & Lee, 2017). This is a disincentive to treat patients when there is unmet need. Almost half of U.S. counties do not have any buprenorphine-providing physicians (Andrilla, Coulthard, & Larson, 2017), opioid treatment programs are operating at over 80% capacity (Jones, Campopiano, Baldwin, & McCance-Katz, 2015), and 80% of individuals with OUD are not receiving any treatment (Saloner & Karthikeyan, 2015). It is paramount to expand the number of buprenorphine providers and make it easier to treat patients.
PAs also delay and deter access for patients. Over 90% of physicians report that prior authorizations delay access to necessary care and that issues related to PAs have led to patients abandoning treatment (AMA, 2017a). Delaying medication for a patient experiencing opioid withdrawal is a deadly gamble, yet patients with OUD face delays that would not be considered acceptable for patients with other medical conditions that have a high risk of mortality, such as a cardiac patient reporting chest pain.
Supporters of these restrictions often cite diversion concerns, as buprenorphine can be misused and is subject to dependency. It can elicit euphoria when misused (though less so than oxycodone or methadone), and can contribute to overdoses particularly when taken with sedatives, though deaths are rare (Kintz, 2001; Substance Abuse and Mental Health Services Administration [SAMHSA], 2016a). Buprenorphine is safer than other opioids because its effects (including respiratory depression) plateau at moderate doses (SAMHSA, 2016b). The most frequently used formulation has an additional “abuse deterrent” built into the medication; naloxone will initiate withdrawal symptoms if injected. Importantly, a majority of those using buprenorphine without medical supervision report doing so to prevent cravings and withdrawal, or because they cannot afford formal treatment (Bazazi, Yokell, Fu, Rich, & Zaller, 2011; Monte, Mandell, Wilford, Tennyson, & Boyer, 2009; Schuman-Olivier et al., 2010). Remaining diversion concerns can be better addressed by alternative methods that do not impede access to care, such as improving the functioning and utilization of prescription drug monitoring programs and increasing treatment accessibility.
A persistent stigma associated with substance dependence and negative myths surrounding buprenorphine underlie these barriers (Wakeman & Barnett, 2018). The widespread falsehood that buprenorphine treatment is “trading one addiction for another” engenders a hostile environment for treatment and needs to be dispelled. There is additionally a deep inequity underlying these PA access barriers, because patients who can afford cash-pay treatment are not subject to these contingencies. Unnecessary PA driven delays, treatment interruptions, time-consuming additional office visits, and the burden of initiating and coordination authorization requests can all be bypassed.
Some of the inequity experienced by those with OUD was intended to be addressed by the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Act Equity Act passed in 2008. This prohibits insurers from imposing more restrictive limits on addiction treatment than on other medical services, such as requiring PA more often for behavioral health than other health services. However, states often take a passive approach to this parity verification (Ruoff, 2016). Parity violation complaints can be useful to this end; the New York Attorney General (AG) opened an investigation in 2016 in response to hundreds of complaints. This resulted in two large insurance companies removing their buprenorphine PAs in a matter of months (Anthem, Inc. & Empire BlueCross BlueShield, 2017; Cigna, 2016), and the AMA soon followed with a letter imploring all AGs to take similar action (AMA, 2017b). Filing parity complaints and encouraging state AGs to open parity violation investigations can both bring awareness to violations, as well as arm the AGs with stronger grounds for inquiry to enforce parity. Though this is a crucial strategy to enforce fairness and mitigate treatment access barriers, further action is needed.
The nature of this epidemic requires emergency measures, and an exception needs to be made for buprenorphine prior authorizations. Private and public insurers should remove administrative barriers, state and local jurisdictions should lift their requirements, and policymakers and regulators should increase oversight and enforce parity laws. Most effectively, legislation should be passed on state and federal levels to remove prior authorizations, which some governors have begun to do (Governor’s Working Group on Opioids Update, 2016; Press Release of Gov Tom Wolf, 2018). Removing prior authorizations should be a critical component of a broader set of policies aimed at increasing treatment access. Though there are some reasonable apprehensions by proponents of prior authorizations, many of the concerns can be better addressed through a well-functioning prescription drug monitoring program. Any diversion or buprenorphine misuse risk pales in comparison to the magnitude of the current problem, and buprenorphine needs to be more accessible than heroin or fentanyl. Emergency measures are needed, and with 130 opioid-related deaths daily (CDC, 2017), the urgency cannot be understated. Though the overdose crisis is a high-salience issue frequently discussed in the public domain, the accompanying PAs and restrictions are rarely mentioned. Mitigating barriers to accessing an effective, life-saving medication for a population at high risk of mortality needs to be a top priority to curb this public emergency.
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Tamara Beetham is a PhD student in the Department of Health Policy and Management in the economics track with concentrations in public finance and industrial organization. Her research interests include access to evidence-based treatment and improving health equity through the incentive structure of mental health and addiction regulatory policy, particularly with respect to opioid use disorder. She currently has pilot project funding as a principal investigator from the National Institutes of Drug Abuse through RAND OPTIC evaluating state telehealth policies on addition treatment access. Her research has been published in journals such as JAMA, Health Affairs, Annals of Internal Medicine, and the Harvard Public Health Review, and has been profiled or mentioned in outlets such as The New York Times, National Public Radio, the Associated Press, and a RAND Policy Brief. She holds an MPH from Harvard University and a BA from the University of Colorado.