Assessing Buprenorphine Treatment Utilization and SAMHSA DATA Waiver Provider Distribution in 2021: A Real-World Analysis in California

doi:10.21203/rs.3.rs-4676680/v1

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Assessing Buprenorphine Treatment Utilization and SAMHSA DATA Waiver Provider Distribution in 2021: A Real-World Analysis in California

https://doi.org/10.21203/rs.3.rs-4676680/v1

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Qualified clinicians must obtain a practitioner waiver (i.e., “DATA-waiver”) to offer buprenorphine, a medication for opioid use disorder (OUD). However, many counties experience fewer buprenorphine prescriptions due to factors such as “DATA-waiver” providers underutilizing their buprenorphine prescribing ability. Our study aimed to compare the availability of active buprenorphine-prescribing clinicians in California to the Substance Abuse and Mental Health Services Administration (SAMSHA)-listed DATA waived prescribers under each 5-digit ZIP Code. This study utilized the buprenorphine prescription record data in 2021 from California’s Controlled Substance Utilization Review and Evaluation System (CURES). The list of the locators for all X-waiver clinicians was obtained from the SAMHSA webpage. Among 1,600 ZIP Codes where patients resided, 62.1% housed DATA-waived physicians, and 57.8% had active buprenorphine-prescribing clinicians. A disproportional distribution between buprenorphine-prescribing clinicians and DATA-waived physicians was evident. Among physicians listed in the SAMHSA roster, not all were actively prescribing buprenorphine. Significant disparities in access to active prescribers and DATA waiver prescribers persist between rural and urban areas in California. Addressing these issues requires resource allocation and inter-professional collaboration. The 2022 Omnibus bill's policy changes hold promise, necessitating further effort into OUD-based policy changes.

Earth and environmental sciences/Ecology/Ecological epidemiology

Health sciences/Medical research/Epidemiology

Health sciences/Medical research/Outcomes research

Buprenorphine

DATA-waiver

Opioid use disorder

Medication for opioid use disorder

geospatial

health disparity

The opioid epidemic in the United States has cast a dark shadow, resulting in a distressing surge in fatalities. In the battle against opioid use disorder (OUD), medications for opioid use disorder (MOUD) have emerged as the bedrock solution. Within the realm of MOUD, methadone and buprenorphine have been substantiated by a wealth of evidence as first-line treatments of OUD. However, the prescribing landscape for methadone presents a challenge due to stringent federal regulations mandating dispensation exclusively through authorized clinics and in liquid form ^1,2. On the other hand, buprenorphine boasts several pharmacokinetic advantages over methadone, making it a compelling choice for use in primary care settings and as take-home medications ¹. The Drug Addiction Treatment Act (DATA) of 2000 ³ marked a pivotal moment by allowing qualified physicians to obtain a waiver, commonly referred to as a "DATA waiver," enabling them to prescribe buprenorphine medications for treating OUD. Despite this progressive step, studies have shown that many DATA-waivered physicians were not inclined to prescribe buprenorphine¹. Astonishingly, roughly 40% of appointment requests from buprenorphine patients were denied by prescribers ⁴. In light of these challenges, our California research aimed to shed light on the percentage of DATA-waived clinicians actively prescribing buprenorphine within each 5-digit ZIP Code. Leveraging California's prescription drug monitoring program (PDMP) data, our study seeks to quantify the gaps in accessing buprenorphine.

Our study harnessed real-world data sourced from California's Controlled Substance Utilization Review and Evaluation System (CURES), a state-operated PDMP database that documents the dispensation of Schedule II-V prescription drugs by outpatient pharmacies in California. Buprenorphine, categorized as a controlled Schedule III drug, is comprehensively included in the CURES database. We extracted all buprenorphine prescription records from California's CURES database from January 1 to December 31, 2021. These records encompassed variables, including the patient's city, state, and 5-digit ZIP code of residence, as well as the 5-digit ZIP code of both the prescriber and the dispensing pharmacy, product name, National Drug Code (NDC), form, strength, and quantity of the prescribed drug. Our data collection from CURES enabled us to identify the active buprenorphine-prescribing clinicians and patients who were buprenorphine recipients within each ZIP Code in California, utilizing unique prescriber and patient identifiers. We then procured an exhaustive roster of “DATA waived” clinicians, including their 5-digit ZIP Codes, counties, and practice addresses, from the Substance Abuse and Mental Health Services Administration (SAMHSA) Behavioral Health Treatment Services Locator database ⁵. In the final phase, we linked these two datasets by the 5-digit ZIP code, yielding a final dataset that encompasses the corresponding county/city names for each ZIP Code and the counts of patients receiving buprenorphine, active buprenorphine-prescribing clinicians, and DATA-waived clinicians operating within each ZIP Code. The study was exempted from review by Chapman University’s Institutional Review Board because the data were de-identified.

Statistical analysis

Descriptive analysis and gradient maps were employed to delineate the spatial distribution of ZIP Codes hosting DATA-waived clinicians and active prescribers, categorized by patient volumes. To categorize communities, our study employed the United States Department of Agriculture’s Rural-Urban Commuting Area Codes (RUCAC), encompassing classifications for metropolitan, micropolitan, small-town, and rural areas. We pictured the spatial relationship of DATA waived clinicians, active buprenorphine prescribers, and patient volume under each ZIP code in nine class bivariate choropleth maps. A bivariate choropleth map ^6,7 is a thematic map that displays two variables on a single map by combining two different sets of colors. We applied the quantile classification method and classified the number of prescribers, patients, and clinicians with DATA waivers into three groups: low, medium, and high. Consequently, the bivariate choropleth maps illustrated the relationships between these groups, focusing on two selected variables from a spatial perspective, as detailed in the figures. Ultimately, we employed linear regression models to assess the association of patient volume and the numbers of DATA-waived clinicians and active prescribers with the demographics and socio-economic attributes sourced from the US Zip Codes Database (Pareto Software™, version 2023). The Institutional Review Board at Chapman University granted an exemption to review the study, acknowledging the deidentified nature of the dataset.

Between January and December 2021, 88,202 patients with buprenorphine prescriptions were recorded across 1,600 ZIP codes in the CURES. Of these ZIP Codes, 62.1% had 8,013 actively practicing buprenorphine-prescribing clinicians, and 57.8% had 6,699 DATA waiver-certified physicians across 925 ZIP codes. Our results from California reveal that 86% of patients reside in metropolitan regions, with only 1.6% in rural settings. A disproportionate 92% of DATA waivers and 92% of active prescribers are concentrated in metropolitan areas, with just 0.93% and 0.26% in rural areas, respectively (Fig. 1).

However, the distribution of these services was not uniform, with significantly higher concentrations in urban centers such as the Bay Area, Los Angeles, and San Diego, as highlighted in Fig. 1. ZIP codes in urban areas with higher population densities or major medical centers include 92103 (San Diego, covering Hillcrest and Mission Hills), 94110 (San Francisco, primarily the Mission District), 95128 (San Jose, around Valley Medical Center and parts of the West San Carlos neighborhood), 94553 (Martinez, the county seat of Contra Costa County), 90033 (Los Angeles, including Boyle Heights and the area around LAC + USC Medical Center), 95817 (Sacramento, home to the UC Davis Medical Center), 95128 (San Jose, near Valley Medical Center, a large public hospital), and 90033 (Los Angeles, location of LAC + USC Medical Center). These ZIP codes had the largest numbers of active buprenorphine prescribers (Fig. 1).

White and Black communities tended to have more patients on buprenorphine as well as DATA waiver prescribers (Supplementary Table 1 and Fig. 1). Older age and high income were negatively associated with high patient volume and DATA waiver prescribers (Supplementary Table 1 and Fig. 1). However, physicians are more likely to prescribe and register in the SAMHSA DATA waiver roster in neighborhoods with higher values of owner-occupied homes (Supplementary Table 1). A few ZIP codes had active patients but no registered SAMHSA DATA-waiver providers, including 92585 (Sun City, growing community with new housing developments), 90303 (Inglewood, diverse community with a significant African American population), 96007 (Anderson, rural area), 95003 (Aptos, rural area), 95380 (Turlock, agricultural hub), 93023 (Ojai, relatively small city), 95713 (Colfax, recreational town), 95552 (Korbel, outdoor recreational town), 95842 (Sacramento, suburban area), 93444 (Nipomo, suburban area), 91306 (Winnetka, residential neighborhood), 93505 (California City, focus on renewable energy and aerospace industries), and 94933 (Forest Knolls, rural community with a focus on natural beauty and outdoor activities). This distribution highlights the disparity in access to buprenorphine-prescribing clinicians and DATA waiver-certified physicians, with certain urban areas demonstrating a significantly higher provision of services than rural and suburban regions.

Figure 2 (A) provides a detailed analysis of the relationship between active buprenorphine prescribers and patients across California. The map reveals a generally well-distributed pattern, with prescribers aligning with patient numbers in most communities. No communities exhibit significant imbalances, such as an excessive number of patients with a shortage of prescribers or a surplus of prescribers with a limited patient population. Figure 2(B) illustrates the relationship between active prescribers and clinicians holding DATA waivers. Certain regions, particularly those near Riverside and northern California, still face a shortage of these waived clinicians. Unlike the balanced distribution between prescribers and patients in Fig. 2(A), 20 ZIP Codes in Fig. 2(B) expose spatial disparities between DATA waivers and active prescribers. Remarkably, 16 ZIP codes display a notable abundance of DATA-waived clinicians but a deficiency of prescribers, primarily clustered in the Los Angeles area, indicated by dark pink in Fig. 2(B). Conversely, 4 ZIP codes exhibit a surplus of prescribers compared to the number of DATA-waived clinicians, as indicated by cyan in Fig. 2(B). This underscores the unique distribution between DATA-waived clinicians and buprenorphine prescribers.

We offered a comprehensive overview of the distribution and accessibility of buprenorphine-prescribing clinicians and DATA-waived physicians across California in 2021. Our research supported the findings of previous investigations that have highlighted many providers with DATA waivers who did not prescribe buprenorphine ⁸. While California had a significant number of active providers ⁹, it was evident that substantial disparities in access to these critical healthcare services persisted. One significant trend is the concentration of active providers in urban areas such as the Bay Area, Los Angeles, and San Diego. This underscores the potential influence of population density on healthcare access, aligning with findings from other states ^10,11. Previous research has highlighted that nearly two-thirds of rural counties have at least one clinician with a DEA waiver, while over half of small and remote rural counties lack this provision ¹². In smaller, more close-knit communities, there might be greater stigma associated with seeking treatment for substance use disorders. While suburban and rural areas faced limited availability of active providers in our study, it's essential to note that some areas still managed to maintain access to these critical services. Redding and El Centro demonstrated that pockets of active providers can still be found in regions where their services are critically needed.

A closer analysis of the geographical distribution of active prescribers and clinicians with DATA waivers offered insights into the complexities of service provision. California displayed an equitable alignment of prescribers with patient volumes, reflecting the state's commitment to providing accessible buprenorphine treatment options. However, our findings uncovered disparities, particularly in Los Angeles, where certain areas have an overabundance of DATA-waived clinicians but a shortage of prescribers, while others exhibit the reverse scenario. This observation raised questions about the effective coordination and communication among healthcare providers in optimizing service distribution.

In the existing literature, African Americans reported more refusals when seeking buprenorphine prescriptions during patient visits ¹³. Intriguingly, our research in California indicates a higher concentration of patients and DATA-waived providers in Black communities. However, this trend was not significant for active buprenorphine prescribers. Furthermore, our observations indicate that DATA-waived clinicians and active prescribers are predominantly situated in neighborhoods with higher home values. Prior studies have suggested a positive correlation between home values ¹⁴ and the presence of larger hospitals in some ZIP codes. Similarly, our investigation reveals a strong association between home values and the availability of DATA-waived clinicians and active prescribers in California. The health insurance landscape within a community may influence the demand for buprenorphine and the presence of active prescribers, yet its impact on the availability of DATA-waived clinicians remains relatively constrained. One plausible rationale is the incompleteness of the SAMHSA Treatment Locator, given its voluntary enrollment process ¹⁵. Many physicians are hesitant to register due to concerns about overwhelming patient volumes ¹⁵. Despite the SAMHSA DATA-waived provider directory being accessible to individuals seeking MOUD, the distribution of active prescribers often diverges from the listed providers for reasons including accepted insurance types, logistical factors, and doctors’ varying inclinations to treat patients with opioid use disorder.

Our study's data linkage relied solely on a 5-digit ZIP Code due to Health Insurance Portability and Accountability Act (HIPAA) constraints, ensuring individual anonymity. However, this approach may not accurately identify DATA-waived clinicians who are not actively engaged in prescribing. The imperative to enhance timely access to buprenorphine treatment for OUD through policy changes has long been acknowledged. The 2022 Omnibus bill represents a significant step forward by eliminating the federal mandate for practitioners to secure a DATA waiver before prescribing buprenorphine. This progressive shift aims to expand the reach of this effective treatment, enhance its availability, and ensure greater accessibility for individuals seeking OUD care. Our pre-2022 Omnibus bill investigation underscored a noticeable contrast between active buprenorphine prescribers and clinicians possessing DATA waivers, emphasizing the necessity for such progressive measures. However, we are unable to address the reasons why not all DATA-waived prescribers actively prescribed. The policy change to remove legislative and regulatory restrictions after the Omnibus bill might motivate prescribers to manage more patients. Further research is needed to evaluate the effectiveness of this policy change.

In conclusion, California has made significant strides in providing buprenorphine to patients in need. However, addressing regional disparities in access to these services is imperative. Future endeavors should prioritize strategically allocating resources to regions with a shortage of active prescribers.

Author contributions: Y. W. and T. H. wrote the main manuscript text and prepared figures and tables. M. R., C. C., M. H., J. G., and K. M. reviewed the manuscript and provided feedback.

Funding: The American Association of Colleges of Pharmacy (AACP) New Investigator Award supported the research.

Data availability statement: The dataset is available upon request with Department of Justice.

Acknowledgment: We acknowledge that any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the California Department of Justice CURES Program, AACP, and the authors’ affiliation.

Competing Interests Statement: The author(s) declare no competing interests.

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No competing interests reported.

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Assessing Buprenorphine Treatment Utilization and SAMHSA DATA Waiver Provider Distribution in 2021: A Real-World Analysis in California

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