BACKGROUND AND OBJECTIVE
Pharmaceutical manufacturers spend billions of dollars annually on payments to physicians in the form of food, gifts, educational materials, and speaker and consulting fees. Payments related to brand-name cardiovascular and diabetes drugs have recently been associated with higher rates of prescribing, despite lower-cost alternatives being available.1,2,3 Given the growing misuse of prescription opioids and accompanying public health risks, we used Centers for Medicare & Medicaid Services Open Payments data, along with Medicare Part D prescribing data, to examine associations between opioid-related payments from pharmaceutical manufacturers to physicians and opioid prescribing. We assessed both average prescribed dose and whether the prescribed dose exceeded Centers for Disease Control and Prevention (CDC) opioid dosage recommendations.4
METHODS
We included opioid-related non-research payments from pharmaceutical manufacturers to doctors of medicine, osteopathy, dentistry, optometry, and chiropractic from August 2013 through December 2015, a time period for which we had access to both payment and prescribing data. Using provider identifiers, we linked payments to Medicare Part D prescription claims for opioids over the same period, excluding prescriptions for methadone and buprenorphine, and for patients with hospice claims or diagnoses of cancer during the study period.
Recent CDC chronic pain opioid prescribing guidelines recommend physicians use caution when prescribing dosages ≥ 50 mg morphine equivalents per day (MME/day) and to avoid dosages ≥ 90 MME/day.4 We used these thresholds as markers of high- or low-dose prescribing (though not to assess guideline compliance, as available prescription data was from prior to guideline publication). Because patients frequently received opioid prescriptions from multiple physicians, the individual patient-individual physician cluster was our unit of analysis. For each patient-physician cluster, we calculated MME/day by dividing the total dosage prescribed by the total days of drug supplied. Our primary outcome was the binary measure of whether a patient’s opioid prescriptions by a physician were ≥ 90 MME/day, while ≥ 50 MME/day and mean daily MME were secondary outcomes.
We performed descriptive analysis, then used multiple logistic regression to examine associations between opioid-related payments and prescribing of both ≥ 90 and ≥ 50 MME/day, overall and stratified by physician specialty categories. We then examined associations between opioid-related payments and mean daily MME prescribed using generalized linear mixed models using a 2% random sample of beneficiaries, accounting for clustering among physicians and patients. Analyses were adjusted for physician specialty, patient age, sex, race, dual-eligibility status, Medicare copayment status, and clinical comorbidity using the Hierarchical Condition Category score. Analysis was conducted using Stata and R. The Yale University Institutional Review Board exempted the study from review.
FINDINGS
During the study period, there were 416,678 opioid-related payments from pharmaceutical manufacturers to 63,941 physicians (Table 1). The median payment value was $13 (interquartile range 10–17). In addition, there were 141,237,664 prescriptions for opioids to 17,808,859 beneficiaries by 750,063 physicians. Approximately 45% of Part D beneficiaries received opioid prescriptions; 23% filled prescriptions averaging 50–89 MME/day, and 7% ≥ 90 MME/day. Opioid-related payments were associated with a higher likelihood of exceeding prescribed dosages of 90 MME/day (OR = 1.27, 95% CI, 1.25–1.30, p < 0.001) and 50 MME/day (OR = 1.14, 95% CI, 1.12–1.15, p < 0.001), overall and for nearly all physician specialty categories (Table 2), as well as with a 4.5% higher mean daily MME (95% CI, 4.0–5.0%, p < 0.001).
DISCUSSION
Our analysis demonstrates that opioid-related payments to physicians from pharmaceutical manufacturers were associated with greater likelihood of Medicare beneficiaries without claims for hospice or diagnoses of cancer being prescribed opioids at higher dosages. Our findings build on a recent analysis suggesting pharmaceutical manufacturer payments related to opioids may influence opioid prescribing,5 and with prior research demonstrating associations between industry payments and physician prescribing.1,2,3 The median payment value of $13 is also consistent with prior Open Payments analyses3, 5, 6 and points to the potential influence of even small payments.
Our study is limited by its cross-sectional design, demonstrating only correlations between payments and prescribing. It is possible, for example, that manufacturers market to physicians who already prescribe higher opioid doses. In addition, we may underestimate opioid use as Medicare beneficiaries may pay for prescriptions out-of-pocket, particularly those available as generics. Nevertheless, our findings highlight the influence and potential patient and public health risks that may be associated with industry payments to physicians, such as higher-risk opioid prescribing.
Data Availability
The datasets generated or analyzed as part of this study are not available due to restrictions on the use and sharing of Medicare beneficiary and prescribing data. The payments data are publicly available at https://www.cms.gov/openpayments/. Statistical code used to generate results is available from the corresponding author upon request.
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WF and JSR conceived and designed the study, assisted by all authors. WF acquired the data and performed analyses and interpretation with the assistance of all authors. WF drafted the manuscript and all authors critically revised it. JSR supervised the study.
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At the time of writing, Drs. Fleischman and Agrawal were employees of the Centers for Medicare & Medicaid Services, which administers the Open Payments program. Drs. Gross and Ross receive support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing. Dr. Gross receives funding from 21st Century Oncology and the National Comprehensive Cancer Center-Pfizer program for research. Dr. Ross receives support through Yale University from the Centers of Medicare and Medicaid Services to develop and maintain performance measures that are used for public reporting, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for post-market surveillance of medical devices, from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program, from the Blue Cross Blue Shield Association to better understand medical technology evaluation, and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency (CRIT) at Yale.
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Fleischman, W., Agrawal, S., Gross, C.P. et al. Association of Pharmaceutical Manufacturer Payments to Physicians and Prescribing Dosage of Opioids. J GEN INTERN MED 34, 1074–1076 (2019). https://doi.org/10.1007/s11606-019-04897-9
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DOI: https://doi.org/10.1007/s11606-019-04897-9