Full length articlePrescribing patterns of buprenorphine waivered physicians
Introduction
The United States is in the midst of a devastating epidemic of opioid overdoses that is closely linked with rising rates of opioid use disorders. In the U.S., an estimated 2.2 million people aged 12 and older, or nearly nine people per 1000, met diagnostic criteria for an opioid use disorder (OUD) (American Psychiatric Association, 2013) in the past year (Jones et al., 2015, Jones, 2016). Drug overdoses – largely driven by substantial increases in prescription opioid and heroin overdoses – are now the leading cause of injury death in the U.S. (Murphy et al., 2013), and the annual economic costs of prescription opioid use disorders and overdoses alone are estimated at over $78 billion (Florence et al., 2016). Medication-assisted treatment (MAT), the use of medications such as methadone, buprenorphine, or naltrexone in combination with behavioral health services, is recognized as an effective evidence-based practice for treating OUD (Bart, 2012, Schackman et al., 2012, Thomas et al., 2014). Despite the evidence base supporting MAT, it remains significantly underutilized due to a range of factors including insufficient capacity, inadequate reimbursement, long waiting lists in many communities, lack of institutional support, and a lack of consumer knowledge about MAT (Roman et al., 2011, Hutchinson et al., 2014, Sigmon, 2015).
The Drug Addiction Treatment Act of 2000 (DATA 2000) enabled qualified physicians (hereafter referred to as waivered physicians) to obtain a waiver from the Controlled Substances Act allowing them to prescribe buprenorphine-containing medications approved for the treatment of OUD. DATA 2000 initially allowed waivered physicians to only manage up to 30 patients concurrently on buprenorphine due to concerns about diversion (U.S. Congress, 2000). In 2006, the Office of National Drug Control Policy Reauthorization Act of 2006 modified restrictions to grant approval for treating up to 100 patients at a time to physicians waivered at the 30 patient-limit for at least one year (Office of National Drug Control Policy (ONDCPRA), 2006), a change associated with a subsequent increase in the amount of buprenorphine dispensed (Stein et al., 2015b). Still, insufficient office-based opioid treatment capacity persists, particularly in rural areas (Sigmon, 2014, Knudsen, 2015, Sigmon, 2015). In response to requests to further raise or eliminate the patient limit (U.S. Congress, 2015, Gitlow, 2014), the U.S. Department of Health and Human Services promulgated a final rule in July 2016 (The White House, 2016) which increased the buprenorphine patient limit to 275 for certain qualified physicians. In a related effort, recent Congressional passage of the Comprehensive Addiction and Recovery Act (CARA) authorized nurse practitioners and physician assistants to prescribe buprenorphine for OUD for up to 30 patients, or 100 patients after one year with 30 (U.S. Congress, 2016).
Raising waivered prescribers’ patient limits will allow prescribers to accept new patients while still treating ongoing patients, thereby increasing both the number of patients receiving buprenorphine and also potentially resulting in longer buprenorphine treatment episodes. However, factors such as concerns over increased DEA scrutiny of medical records (Providers' Clinical Support System (PCSS), 2011), the need to closely monitor patients for potential relapse or medication diversion (Center for Substance Abuse Treatment (CSAT), 2004), low insurance reimbursement rates for services associated with buprenorphine prescribing such as office visits and urine drug screens (Walley et al., 2008), insufficient access to behavioral health services for concurrent counseling (Hutchinson et al., 2014), and the challenges inherent and stigma associated with treating these complex patients may diminish physicians’ willingness to prescribe buprenorphine. This potentially limits the impact of raising buprenorphine patient limits. Several prior studies (without respect to assessing accompanying psychosocial services) suggest that many buprenorphine prescribing physicians may be treating relatively few patients and that numerous waivered prescribers may not be prescribing (Hutchinson et al., 2014, Sigmon, 2015), but studies examining buprenorphine prescribing patterns (Sigmon, 2015, Stein et al., 2016) have often been unable to identify prescribers’ waiver status, preventing an examination of waivered physicians approved to treat 100 patients, who are most likely to be affected by raising patient limits.
This study contributes to our understanding of waivered prescribers’ treatment of patients with OUD by examining prescribing trends among prescribers with a 30 or 100 patient limit, as well as prescribers whose DEA number is unassociated with a waiver. This information will contribute to the understanding of clinicians, advocates, and policymakers of how changes in wavered prescribers’ patient limits are likely to affect buprenorphine treatment of OUD.
Section snippets
Population and data
We used Ohio, California, and Maine prescription monitoring program (PMP) data housed in Brandeis University’s Prescription Behavior Surveillance System (PBSS) (Centers for Disease Control and Prevention (CDC), 2011, Paulozzi et al., 2015) to identify all prescriptions for oral (sublingual or buccal) buprenorphine or buprenorphine/naloxone formulations approved for OUD treatment. These three states were chosen because their regulations allow for use of PMP data in research, and because of their
Prescribers
We identified a total of 10,599 unique buprenorphine prescribers (Table 1), representing 4.8% of all prescribers of controlled substances reported to the PMP in the three states over the 4-year period. California had the most buprenorphine prescribers (n = 7376), followed by Ohio (n = 1950) and Maine (n = 728). Approximately 82% (n = 8638) of buprenorphine prescribers initiated a treatment episode. These prescribers initiated 468,148 buprenorphine treatment episodes for 223,694 patients from January 1,
Discussion
Our examination of buprenorphine prescribing patterns by prescriber waiver status found that 100-patient waivered prescribers are substantially more active than 30-patient waivered prescribers. They treated approximately four times as many patients monthly, had longer treatment episodes, and had far fewer months in which they prescribed buprenorphine to no patients. However, both 30- and 100-patient waivered physicians had a meaningful number of prescribing-months in which they treated no
Conclusion
Despite these limitations, our findings contribute to our evolving understanding of buprenorphine prescribing patterns. Historically, the majority of patients with OUD receiving treatment obtained it at opioid treatment programs or other specialized treatment settings. The majority of patients in these specialty settings are being treated for substance use disorders, and these settings commonly provide a range of supports and services addressing the physical and mental health comorbidities and
Role of funding source
The research was partially supported by the U.S. Department of Health and Human Services ContractHHSP23320095649WC DALTCP-1-3.
Contributors
Cindy Thomas: Lead author: design, analysis, writing.
Erin Doyle: Programmer/statistician, data analysis.
Peter Kreiner: Design, analysis and writing.
Christopher Jones: Design, analysis, and writing.
Joel Dubenitz: Design, analysis, and writing.
Alexis Horan: Design, analysis, and writing.
Bradley Stein: Principal investigator, design, analysis, writing.
All contributors approved of the manuscript before submitting.
Conflicts of interest
The authors report no conflicts of interest related to this study.
Acknowledgments
The authors would like to acknowledge the research assistance of Hilary Peterson of the RAND Corporation and the editorial assistance of Wendy Colnon of Brandeis University. Parts of this work were presented at the Addiction Health Services Research Annual Meeting, Seattle WA, October 13, 2016.
References (41)
- et al.
Expanding treatment capacity for opioid dependence with office-based treatment with buprenorphine: national surveys of physicians
J. Subst. Abuse Treat.
(2010) - et al.
Geographic variation in opioid prescribing in the U.S
J. Pain
(2012) - et al.
Using medication-assisted treatment for substance use disorders: evidence of barriers and facilitators of implementation
Addict. Behav.
(2011) - et al.
Supply of buprenorphine waivered physicians: the influence of state policies
J. Subst. Abuse Treat.
(2015) Increasing Access to Medication to Treat Opioid Addiction- Increasing Access for the Treatment of Opioid Addiction with Medications
(2014)Diagnostic and Statistical Manual of Mental Disorders
(2013)Advancing Access to Addiction Medications: Implications for Opioid Addiction Treatment
(2013)ASAM National Practice Guideline for the Use of Medications for the Treatment of Addiction Involving Opioid Use
(2015)Survey Results: Addiction Survey Results: Addiction Specialists Weigh in on the DATA 2000 Patient Limits
(2015)- et al.
The availability of ancillary counseling in the practices of physicians prescribing buprenorphine
J. Addict. Med.
(2016)