Commentary on Jin <i>et al</i> . (2020): Regulatory and allocative policies inform access to opioid agonist therapy

Opioid agonist therapy (OAT) access is restricted by regulatory and allocative treatment policies. Oppressive social conditions inform the creation and implementation of policies and treatment systems that limit access to life-saving care. Jin et al. [1] had the difficult task of summarizing opioid agonist therapy (OAT) delivery practice indicators from around the world (n = 41 countries). They observed variation in OAT eligibility criteria (e.g. age, step-therapy), increased frequency of OAT underdosing, differences in access to unsupervised OAT dosing, variation in urine drug screen practices, and concerningly, the provision of patient information to law enforcement agencies in some jurisdictions [1]. The review, however, did not explicitly explore how broader structural elements inform OAT clinical practice and treatment system design, specifically, policy. Access to OAT is informed through an amalgamation of contemporary and historic social conditions (e.g. racism, classism, capitalism, and moralism/stigma) and how society and decision makers conceptualize addiction (e.g. moral/criminal model versus brain disease model [2]). In turn, these elements are institutionalized through regulatory and allocative treatment policies, dictating the design of treatment systems, which subsequently influences how OAT is delivered (where, when, and by whom) and who receives care. In the United States (US), OAT is regulated unlike any other pharmaceutical product. Methadone and buprenorphine administration and prescribing occur within the context of special regulatory systems. Methadone must be dispensed, often through observed daily dosing, in federally certified opioid treatment programs (OTPs) [3]. To prescribe buprenorphine, physicians must receive a special federal-waiver (i.e. the X-waiver) and are limited in the number of patients they can prescribe to [3]. In contrast, in Canada, methadone and buprenorphine may be prescribed and administered through the pharmacy system without special federal requirements [4]. This special regulatory apparatus is just one of several categories of OAT access barriers (e.g. provider, institutional, and financial among others) [5]. Furthermore, the two-tiered design of the US OAT regulatory system [6-8] propagates OAT access inequities, based on race [9, 10], class [10], and educational-demographics [11]. OTPs across the US are more likely to be located in highly segregated Black and Hispanic/Latinx neighborhoods, compared with buprenorphine, which is more readily available in highly segregated White neighborhoods [9]. In a study of office-based buprenorphine access, Black patients are less likely to receive buprenorphine (adjusted OR = 0.23; 95% CI = 0.13–0.44) as compared with White patients [10]. These findings build on the original evaluation of the buprenorphine waiver system where researchers observed differences among patients who received buprenorphine versus methadone; specifically, buprenorphine patients were more likely to be White, employed, and with some college education [11]. In addition to differences in access by OAT type, racial disparities in OAT access persist. Compared with White women, Black and Hispanic women are significantly less likely to receive any medication for OUD treatment [12]. Similarly, Black veterans receiving care in the Veterans Health Administration have lower odds of starting buprenorphine compared to White patients [13]. In addition to regulatory constraints, allocative policies inform and dictate OAT access. This is of particular importance in societies where the delivery of health care services is commodified and privatized [14]. In the US, a standardized national health insurance program or delivery system does not exist; instead, the US has a fragmented collection of governmental health insurance programs for specific sub-populations (e.g. Medicare, Medicaid, and Tricare), and for-profit and not-for-profit health insurance enterprises. A commodified health services delivery and health insurance market aims to “…optimize the market from their perspective and for their benefit” [15]. Therefore, the US economic production system informs and dictates health care service delivery, which is reflected in payer polices, and, subsequently, access to OAT [16]. Until recently (January 2020), for example, Medicare, the US federally sponsored health insurance plan for patients age 65 and above and those with disabilities, did not cover services received in an OTP [17]. Moreover, private Medicare Part D plans decreased buprenorphine coverage options from 2007 to 2018, as opioid-related overdoses were increasing [18]. Further, many Medicaid programs continue to impose buprenorphine coverage restrictions [19]. Access to OAT, in the US and internationally, is undoubtedly constrained and restricted by federal and local regulatory and allocative treatment policies. Social conditions and oppressive elements inform the creation and implementation of these policies, treatment system design, and subsequently access to care. None. Many thanks to Dr. Dennis McCarty for his comment and review of this commentary. National Institute on Drug Abuse (F30DA044700). The content of this manuscript does not represent the views of the US Government.

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