- Email: [email protected]
Here Comes the Sunshine: Industry’s Payments to Cardiothoracic Surgeons
Here Comes the Sunshine: Industry’s Payments to Cardiothoracic Surgeons Rizwan Ahmed, MD,* Sunjae Bae, KMD, MPH,* Caitlin W. Hicks, MD, MS, Babak J. Orandi, MD, PhD, Chady Atallah, MD, Eric K. Chow, MS, Allan B. Massie, MD, PhD, Joseph Lopez, MD, MBA, Robert S. Higgins, MD, and Dorry L. Segev, MD, PhD Division of Plastic and Reconstructive Surgery, Duke University Medical Center, Durham, North Carolina; Department of Surgery, Johns Hopkins School of Medicine; and Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, Maryland
Background. The Physician Payment Sunshine Act was implemented to provide transparency to financial transactions between industry and physicians. Under this law, the Open Payments Program (OPP) was created to publicly disclose all transactions and inform patients of potential conflicts of interest. Collaboration between industry and cardiothoracic surgeon-scientists is essential in developing new approaches to treating patients with cardiac disease. The objective of this study is to characterize industry payments to cardiothoracic surgeons as reported by the OPP. Methods. We used the first wave of Physician Payment Sunshine Act data (August 2013 to December 2013) to assess industry payments made to cardiothoracic surgeons. Results. Cardiothoracic surgeons (n [ 2,495) received a total of $4,417,545 during a 5-month period. Cardiothoracic surgeons comprised 0.5% of all persons in the OPP and received 0.9% of total disclosed industry funding. Among cardiothoracic surgeons receiving funding, 34% received payments less than $100, 43% received payments
of $100 to $999, 19% received payments of $1,000 to $9,999, 4% received payments of $10,000 to $99,999, and 0.2% received payments of more than $100,000. The median was $181 (interquartile range [IQR]: $60 to $843) and the mean ± standard deviation was $1,771 ± $7,664. The largest payment to an individual surgeon was $159,444. The three largest median payments made to cardiothoracic surgeons by expense category were royalty fees $8,398 (IQR: $536 to $12,316), speaker fees $3,600 (IQR: $1,500 to $8,000), and honoraria $3,344 (IQR: $1,563 to $7,350). Conclusions. Among cardiothoracic surgeons who are listed as recipients of nonresearch industry payments, 50% of cardiothoracic surgeons received less than $181. Awareness of the OPP data is critical for cardiothoracic surgeons, as it provides a means to prevent potential public misconceptions about industry payments within the specialty that may affect patient trust.
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this process, and created the Open Payments Program (OPP) database to make the national payment data available to the general public. Before the public release, individuals and institutions are given an opportunity to review and dispute the data [3]. In a 2004 nationwide survey of 3,167 physicians, 83% of US physicians reported receiving gifts, and 28% reported receiving payments for consulting, lecturing, or enrolling patients in trials [4]. Subsequent data have demonstrated that more than half of patients would trust their physician less if the physician accepted gifts or payments from
nder the Affordable Care Act of 2010, the Physician Payments Sunshine Act (PPSA) was implemented to provide transparency regarding the financial relationships between physicians and the biomedical industry [1]. As of August 1, 2012, manufacturers of drugs, biologic agents, medical devices, and supplies are now mandated to submit payment records and other “transfers of value” made to physicians and teaching hospitals [2, 3]. This legislation was intended to provide patients with a resource that would inform them of potential conflicts of interest (COI) between medical providers and industry, thus enabling them to make fully informed decisions when choosing a health care provider [2]. The Centers for Medicare and Medicaid Services was tasked to oversee
(Ann Thorac Surg 2016;-:-–-) Ó 2016 by The Society of Thoracic Surgeons
Dr Segev discloses a financial relationship with Sanofi, Novartis, and Astellas Pharma US.
Accepted for publication June 13, 2016. *Drs Ahmed and Bae contributed equally to this work. Address correspondence to Dr Segev, Department of Surgery, Johns Hopkins Medical Institutions, 720 Rutland Ave, Ross 771B, Baltimore, MD 21205; email: [email protected].
Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier
The Appendix can be viewed in the online version of this article [http://dx.doi.org/10.1016/j.athoracsur.2016. 06.053] on http://www.annalsthoracicsurgery.org.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2016.06.053
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industry [5]. Market research has revealed that US pharmaceutical companies spend as much as $57.5 billion, or 24.4% of their revenue, on marketing and product promotion [6]. However, before the OPP database, the amount industry paid directly to physicians was never published on a national level [3]. Collaborations between physicians and industry, including those that involve financial disbursements, have the potential to drive significant advances in patient care. Within the field of cardiac surgery, for example, development of the left ventricular assist device was the result of a combined effort between cardiothoracic surgeons and industry [7]. In recognition of the importance of these relationships, the American Association for Thoracic Surgery and The Society of Thoracic Surgeons have both published codes of ethics in an effort to promote appropriate collaborative efforts between cardiothoracic surgeons and industry that will maximize clinical benefit and potential innovation without compromising the professional integrity of involved parties [8]. Despite these important initiatives, little is known about current financial ties between cardiothoracic surgeons and industry. Given that potential COI can undermine research findings and clinical decisions [9–11], it is essential to quantify and describe the nature of these relationships, especially now that these data are publically available to any interested party. In this study, we characterize the national distribution of industry payments to cardiothoracic surgeons using the newly available OPP database.
Patients and Methods Study Population The study population represented the subset of all the US allopathic and osteopathic physicians who received at least one nonresearch payment as cardiothoracic surgeon during the 5-month period of August 1, 2013, to December 31, 2013, in the OPP.
Data Sources Payments made to cardiothoracic surgeons between August 1, 2013, and December 31, 2013, were obtained from the OPP dataset, available on the Centers for Medicare and Medicaid Services website (http://www. cms.gov/openpayments). Physician-level payments were aggregated using a unique physician identification number. In the OPP data, the paying company reports a physician’s specialty and a physician is given the opportunity to verify the description of their specialty. As a result, if a physician was trained in a subspecialty or has multiple specializations, he or she could have been reported as either specialty. For example, if a physician was trained as general surgeon and also completed a cardiothoracic fellowship, he or she could have been listed as either a general surgeon or a cardiothoracic surgeon. For the purposes of this study, the largest payment that an individual received in a particular specialty determined their specialty.
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Payments Made to All Health Care Providers and Cardiothoracic Surgery The OPP dataset was used to ascertain the total amount of payments made by industry to all health care providers. Health care providers consisted of physicians, dentists, podiatrists, technicians, and nurse practitioners. This total was then compared to the total amount of payments made to cardiothoracic surgeons.
Distributions of Payments Made to Cardiothoracic Surgeons The total amount of money each cardiothoracic surgeon received was presented as a box-and-whisker plot to depict graphically the median, interquartile range, and overall range of values. The amount received was categorized as follows: less than $100, $100 to $999, $1,000 to $9,999, and more than $10,000 and presented as bar graphs. All companies and their sum of payments made to cardiothoracic surgeons were identified (Appendix). Payments of the 10 highest paying companies and their distribution by amount categories were shown. Heat maps were used to show the geographic distribution of industry payments and the average payments per cardiothoracic surgeon by state.
Payment Categories The OPP payments were reported under the following categories: consulting fees; food and beverage; honoraria; education; travel and lodging; entertainment; gifts; nonresearch training grants; services other than consulting, including speaking at a venue other than a continuing education program (CEP [abbreviated as “speaker nonCEP”]); and speaking for a nonaccredited and noncertified continuing education program (abbreviated as “speaker CEP”). The number of cardiothoracic surgeons who received payments for each payment category was quantified. Payments for speakers at accredited CEP events were not included in this analysis, as this payment category is not reported in the OPP database.
Statistical Analysis Analyses were performed with Stata 12.0/MP for Linux (StataCorp, College Station, TX). The methods of Louis and Zeger [12] were used to report 95% confidence intervals.
Results Payments Made to All Physicians During this first OPP reporting period, industry made payments totaling $476,021,752 to 475,975 health care providers. The median payment for a health care provider was $67 (interquartile range [IQR]: $22 to $179), with a mean of $1,000. During the 5-month OPP study, the four highest paid health care providers each received a total of $7,356,276, $3,994,022, $3,921,410 and $3,849,711.
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Payments to Cardiothoracic Surgeons Cardiothoracic surgeons (n ¼ 2,495) who met the described inclusion criteria received a total of $4,417,545 during a 5month study period. Overall, cardiothoracic surgeons comprised 0.52% of health care providers and received 0.93% of the total payment amounts. The median payment for cardiothoracic surgeons was $181 (IQR: $60 to $843) with a mean standard deviation of $1,771 $7,664; the four highest paid cardiothoracic surgeons received $159,444, $131,080, $119,779, and $114,384. Thirty-four percent (n ¼ 843) received payments less than $100; 43% (n ¼ 1,081) received payments between $100 and $999; 19% (n ¼ 471) received between $1,000 and $9,999; 4% (n ¼ 95) received payments between $10,000 and $99,999; and 0.2% (n ¼ 5) received payments in excess of $100,000 (Fig 1).
Payments by Expense Category A total of $4,417,545 was paid in the form of 15,204 single payments to cardiothoracic surgeons. Total payments by expense category were $1,037,370 (23.5%) for travel and lodging; $1,005,350 (22.8%) for consulting fees; $909,034 (20.6%) for speaker non-CEP; $608,403 (13.8%) for food and beverage; $399,262 (5.4%) for honoraria; $237,748 (5.4%) for education; $166,887 (3.8%) for royalty or license; $40,675 (0.9%) for nonresearch grants; $8,216 (0.2%) for gifts; $5,000 (0.1%) for certified but unaccredited speaker non-CEP; and $599 (0.01%) for entertainment (Table 1). The median for payments and the number of cardiothoracic surgeons paid by expense category were $8,398 (IQR: $536 to $12,316) royalty or license to 0.4% (n ¼ 9); $3,600 (IQR: $1,500 to $8,000) speaker non-CEP fees to 4.9%
AHMED ET AL INDUSTRY’S PAYMENTS TO CARDIOTHORACIC SURGEONS
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(n ¼ 121); $3,344 (IQR: $1,563 to $7,350) honoraria to 2.2% (n ¼ 54); $3,103 (IQR: $1,225 to $6,500) consulting fees to 7.8% (n ¼ 1,157); $1,250 (IQR: $1,250 to $1,250) certified but unaccredited non-CEP speaker fees to 0.2% (n ¼ 49); $880 (IQR: $444 to $1,413) travel and lodging to 27.7% (n ¼ 692); $750 (IQR: $700 to $39,225) nonresearch grants to 0.1% (n ¼ 3); $51 (IQR: $28 to $908) gifts to 0.3% (n ¼ 8); $47 (IQR: $14 to $230) education to 9.0% (n ¼ 225); and $21 (IQR: $16 to $37) entertainment to 0.6% (n ¼ 15; Table 1).
Distributions of Payments Made by Companies There were 205 companies that made 15,204 individual payments. The payment median was $43 (IQR: $17 to $125), and the mean was $291 $1,671 (Appendix). The 10 highest paying companies accounted for $2,702,473 (61.2 %) of the total payments. The three highest paying companies were Edwards Lifesciences ($654,844), Medtronic Vascular ($374,983), and Atricure, Inc ($310,669). The distribution of payments by category from these 10 companies is shown in Figure 2.
Geographic Distribution In terms of total payments to cardiothoracic surgeons by state, the top five states were California ($434,595), Pennsylvania ($425,033), New York ($344,890), Arizona ($331,314), and Texas ($326,794). The five lowest states were Wyoming ($88), Alaska ($647), Vermont ($1,196), South Dakota ($1,847), and Idaho ($2,233; Fig 3A). In terms of average payment per surgeon, the highest five states were Louisiana ($7,379), Arizona ($5,431), Utah ($4,149), Washington, DC ($3,524), and Washington Fig 1. Distribution of payments received by US cardiothoracic surgeons. The median payment for cardiothoracic surgeons was $181 (interquartile range: $60 to $843) with a mean standard deviation of $1,771 7,664; the four highest paid cardiothoracic surgeons received $159,444, $131080, $119,779, and $114,384. Among cardiothoracic surgeons 34% (n ¼ 843) received payments under $100, 43% (n ¼ 1,081) received payments between $100 and $999, 19% (n ¼ 471) received between $1,000 and $9,999, 4% (n ¼ 95) received between $10,000 and $99,999, and 0.2% (n ¼ 5) received payments in excess of $100,000.
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Table 1. Industry Payments by Expense Category Expense Category Travel and lodging Consulting fee Speaker non-CEP Food and beverage Honoraria Education Royalty or license Nonresearch grant Gift Speaker certified CEP Entertainment
Total Amount $1,037,370 $1,005,350 $909,034 $608,403 $399,262 $236,748 $166,887 $40,675 $8,216 $5,000
(23.5%) (22.8%) (20.6%) (13.8%) (9.0%) (5.4%) (3.8%) (0.9%) (0.2%) (0.1%)
$599 (0.01%)
CEP ¼ continuing educational program;
Median (IQR) per Payment $195 $2,100 $2,000 $28 $2,500 $47 $3,325 $750 $28 $1,250
($64–$412) ($950–$4,500) ($510–$2,500) ($15–$82) ($1,531–$3,000) ($13–$438) ($300–$10,319) ($700–$39,225) ($28–$190) ($1,250–$1,250)
$19 ($16–$23)
CT ¼ cardiothoracic;
2,777 2,85 337 11,253 140 364 16 3 9 4 16
IQR ¼ interquartile range;
($3,107). The five states with lowest payment per surgeon were Wyoming ($44), Alaska ($647), Arkansas ($7,388), Montana ($3,825) and New Hampshire ($3,064; Fig 3B).
Comment With the recent implementation of the PPSA, physicianindustry relationships are under increasing scrutiny. Industry reporting of financial remuneration for travel, gifts, and services rendered is now mandated by the Centers for Medicare and Medicaid Services, and the resulting data are made publically available through the OPP database [13]. The results of our study demonstrate that US cardiothoracic surgeons, who comprise 0.5% of all qualifying health Fig 2. Category of payments from the 10 companies that had the highest total amount of payments made to cardiothoracic surgeons. Navy blue indicates speaker non– continuing education program (CEP); brown, speaker CEP certified; green, consulting fee; orange, education; teal, food and beverages; red, grant; lavender, honoraria; chartreuse, royalty or license; and burgundy, travel and lodging.
No. of Payments
Median (IQR) per CT Surgeon $880 $3,103 $3,600 $138 $3,344 $47 $8,398 $750 $51 $1,250
($444–$1,413) ($1,225–$6,500) ($1,500–$8,000) ($50–$300) ($1,563–$7,350) ($14–$230) ($536–$12,316) ($700–$39,225) ($28–$908) ($1,250–$1,250)
$21 ($16–$37)
No. of CT Surgeons 692 142 121 2,407 54 225 9 3 8 4
(27.7%) (5.7%) (4.9%) (96.5%) (2.2%) (9.0%) (0.4%) (0.1%) (0.3%) (0.2%)
15 (0.6%)
No. ¼ number.
care providers, received 0.9% of all nonresearch industry payments according to the OPP database. The median payment received was $180, and more than a third of cardiothoracic surgeons received less than $100 in total payments; only 4% received more than $10,000. Although payments for travel and lodging were most prevalent overall, the three largest payment categories per surgeon were royalty or license fees, speaker fees, and honoraria. We are unable to assess or judge the potential beneficial aspects of the relationship between industry and cardiothoracic surgeons. Theoretical advantages include the opportunities for industry to gain greater insights about preclinical and innovative therapies and devices before widespread adoption or Food and Drug
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Fig 3. (A) Total payments made to cardiothoracic surgeons by state. In terms of total payments per surgeon, the top five states were California ($434,595), Pennsylvania ($425,033), New York ($344,890), Arizona ($331,314), and Texas ($326,794). The five lowest states were Wyoming ($88), Alaska ($647), Vermont ($1,196), South Dakota ($1,847), and Idaho ($2,233). (B) Average payments per surgeon by state. In terms of average payment per surgeon, the highest five states were Louisiana ($7,379), Arizona ($5,431), Utah ($4,149), Washington, DC ($3,524) and Washington ($3,107). The lowest 5 states were Wyoming ($44), Alaska ($647), Arkansas ($7,388), Montana ($3,825), and New Hampshire ($3,064).
Administration approval. These benefits cannot be underestimated. However, a large body of literature has previously explored the impact of financial COI on clinical care, research outcomes, and physician behavior [10–13, 19]. Although many studies suggest that industry’s support for research, clinical care, and innovation is essential, there is frequently concern that financial relationships between commercial entities and clinical providers carry the potential for undue influence. Consistent with this notion, a 2012 Cochrane review recently demonstrated that research studies involving drug or device development that are sponsored by industry tend to lead to more favorable efficacy compared with nonindustry sponsored studies [14]. Hence, accurate COI reporting by physicians is essential. The OPP database reports three forms of payments: (1) Ownership and investments; (2) research payments made mostly to institutions; and (3) nonresearch payments made to individuals, reported in this study.
Conflicts of interest do not necessarily preclude appropriate clinical care, either real or perceived. However, a substantial number of patients believe that physician disclosure of financial ties is an important aspect of care [5, 15]. Furthermore, patients’ perceptions of industry payments to physicians are dependent upon the amount and nature of the payment. For example, in a 2006 New England Journal of Medicine multicenter study of 253 patients by Hampson and associates [15], the researchers demonstrate that more than 80% of patients think it is ethical for physicians to receive reimbursement for consulting or speaking from a company. In contrast, Green and coworkers [5] recently reported in a multicenter survey of 220 patients that nearly 60% of patients would trust their physician less if they accepted an industry gift of more than $100 or went on an industry-sponsored trip or sporting event. In our study, we demonstrate that 66% of cardiothoracic surgeons received more than $100 in payments from industry. Although the median payment was $180, it was
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higher than the $100 cutoff defined by Green and coworkers [5], and higher than median payment of $125 for transplant surgeons and $115 for plastics surgeons in the OPP database [16, 17]. Furthermore, we demonstrate that industry-sponsored travel either as direct payment or reimbursement are common among cardiothoracic surgeons; although just over one quarter (28%) of providers were reimbursed for travel and lodging, this category received the highest amount of total industry payments ($1,037,370). Although patient perceptions around OPPreported data are not currently known, all of these findings may raise concern among patients for potential physician bias based on previously reported trends [5]. However, consulting fees comprised the second highest amount of total industry payments ($1,005,350), and the three largest payment categories per surgeon were royalty or license fees, speaker fees, and honoraria, all of which would presumably fall within the preview of acceptable physician-industry relationships [15]. When taken together, the results of our study suggest that cardiothoracic involvement with industry is within reason, but perhaps with some higher payment for travel. We believe that this inaugural report is the beginning of an important professional discussion for industry, health care providers, physicians, and patients. The impact of published OPP data for patients and the public remains to be determined. There is substantial debate on the appropriateness and implications of OPP data, including concerns about how industry and physicians may adapt to PPSA reporting rules [18]. To date, available OPP data is limited to a 5-month reporting period, which likely carries some inaccuracies owing to lack of longitudinal data. In addition, there may be inaccuracies in reporting metrics given that the PPSA is in its infancy. The accuracy and applicability of the data remains to be determined, and carries with it already acknowledged limitations such as a lack of reporting of drug sample and continuing medical education-certified program payments [17]. However, these limitations should be at least partially addressed as the PPSA evolves over time, and as studies similar to ours report on preliminary OPP database findings [16, 19]. The advent of the OPP database allows for the characterization of current physician-industry relationships at national, regional, and physician levels. There is a need to study industry payments made to lawyers, politicians, and lobbyists as well. Currently, the availability of these data as part of a public forum will undoubtedly allow physicians better monitoring of industry relationships and self-regulation. If reviewed responsibly, it could be used to provide health care providers with an opportunity to identify and avoid potentially compromising payment trends before they present a real or a perceived problem to clinical care. By working to adhere to commonly accepted societal guidelines and ethical standards and transparent physician-industry reporting [8], the field of cardiothoracic surgery will continue to demonstrate its leadership in professional matters and be able to maintain its rewarding and mutually beneficial relationship with industry to provide cutting edge treatments to patients in an effective and unbiased manner.
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This work was supported by grant number K24DK10182801 from the National Institute of Diabetes and Digestive and Kidney Diseases. The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.
References 1. Centers for Medicare and Medicaid Services (CMS), HHS. Medicare, Medicaid, children’s health insurance programs; transparency reports and reporting of physician ownership or investment interests. Final rule. Fed Regist 2013;78:9457–528. 2. Rosenthal MB, Mello MM. Sunlight as disinfectant—new rules on disclosure of industry payments to physicians. N Engl J Med 2013;368:2052–4. 3. Agrawal S, Brennan N, Budetti P. The Sunshine Act—effects on physicians. N Engl J Med 2013;368:2054–7. 4. Campbell EG, Gruen RL, Mountford J, Miller LG, Cleary PD, Blumenthal D. A national survey of physician-industry relationships. N Engl J Med 2007;356:1742–50. 5. Green MJ, Masters R, James B, Simmons B, Lehman E. Do gifts from the pharmaceutical industry affect trust in physicians? Fam Med 2012;44:325–31. 6. Gagnon MA, Lexchin J. The cost of pushing pills: a new estimate of pharmaceutical promotion expenditures in the United States. PLoS Med 2008;5:e1. 7. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009;361:2241–51. 8. Sade RM, American Association for Thoracic Surgery Ethics Committee, The Society of Thoracic Surgeons Standards and Ethics Committee. Standards for relations of cardiothoracic surgical organizations with industry. J Thorac Cardiovasc Surg 2011;142:12–7. 9. Rohrich RJ. The process of publishing industry-affiliated articles in plastic and reconstructive surgery. Plast Reconstr Surg 2014;133:757–60. 10. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000;283:373–80. 11. Weinfurt KP, Friedman JY, Allsbrook JS, Dinan MA, Hall MA, Sugarman J. Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure. J Gen Intern Med 2006;21:901–6. 12. Louis TA, Zeger SL. Effective communication of standard errors and confidence intervals. Biostatistics 2009;10:1–2. 13. Centers for Medicare and Medicaid Services (CMS). Open payments (Physician Payments Sunshine Act). Fact sheet for physicians. Available at: http://www.cms.gov/regulationsand-guidance/legislation/national-physician-payment-trans parency-program/downloads/physician-fact-sheet.pdf. Accessed May 29, 2015. 14. Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev 2012;12:MR000033. 15. Hampson LA, Agrawal M, Joffe S, Gross CP, Verter J, Emanuel EJ. Patients’ views on financial conflicts of interest in cancer research trials. N Engl J Med 2006;355:2330–7. 16. Ahmed R, Chow EK, Massie AB, et al. Where the sun shines: industry’s payments to transplant surgeons. Am J Transplant 2016;16:292–300. 17. Ahmed R, Lopez J, Bae S, et al. Where the sun shines: industry’s payments to plastic surgeons. Plast Reconstr Surg 2015;136(Suppl):58. 18. Lichter PR. Implications of the Sunshine Act—revelations, loopholes, and impact. Ophthalmology 2015;122:653–5. 19. Chang JS. The Physician Payments Sunshine Act: data evaluation regarding payments to ophthalmologists. Ophthalmology 2015;122:656–61.
Background. The Physician Payment Sunshine Act was implemented to provide transparency to financial transactions between industry and physicians. Under this law, the Open Payments Program (OPP) was created to publicly disclose all transactions and inform patients of potential conflicts of interest. Collaboration between industry and cardiothoracic surgeon-scientists is essential in developing new approaches to treating patients with cardiac disease. The objective of this study is to characterize industry payments to cardiothoracic surgeons as reported by the OPP. Methods. We used the first wave of Physician Payment Sunshine Act data (August 2013 to December 2013) to assess industry payments made to cardiothoracic surgeons. Results. Cardiothoracic surgeons (n [ 2,495) received a total of $4,417,545 during a 5-month period. Cardiothoracic surgeons comprised 0.5% of all persons in the OPP and received 0.9% of total disclosed industry funding. Among cardiothoracic surgeons receiving funding, 34% received payments less than $100, 43% received payments
of $100 to $999, 19% received payments of $1,000 to $9,999, 4% received payments of $10,000 to $99,999, and 0.2% received payments of more than $100,000. The median was $181 (interquartile range [IQR]: $60 to $843) and the mean ± standard deviation was $1,771 ± $7,664. The largest payment to an individual surgeon was $159,444. The three largest median payments made to cardiothoracic surgeons by expense category were royalty fees $8,398 (IQR: $536 to $12,316), speaker fees $3,600 (IQR: $1,500 to $8,000), and honoraria $3,344 (IQR: $1,563 to $7,350). Conclusions. Among cardiothoracic surgeons who are listed as recipients of nonresearch industry payments, 50% of cardiothoracic surgeons received less than $181. Awareness of the OPP data is critical for cardiothoracic surgeons, as it provides a means to prevent potential public misconceptions about industry payments within the specialty that may affect patient trust.
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this process, and created the Open Payments Program (OPP) database to make the national payment data available to the general public. Before the public release, individuals and institutions are given an opportunity to review and dispute the data [3]. In a 2004 nationwide survey of 3,167 physicians, 83% of US physicians reported receiving gifts, and 28% reported receiving payments for consulting, lecturing, or enrolling patients in trials [4]. Subsequent data have demonstrated that more than half of patients would trust their physician less if the physician accepted gifts or payments from
nder the Affordable Care Act of 2010, the Physician Payments Sunshine Act (PPSA) was implemented to provide transparency regarding the financial relationships between physicians and the biomedical industry [1]. As of August 1, 2012, manufacturers of drugs, biologic agents, medical devices, and supplies are now mandated to submit payment records and other “transfers of value” made to physicians and teaching hospitals [2, 3]. This legislation was intended to provide patients with a resource that would inform them of potential conflicts of interest (COI) between medical providers and industry, thus enabling them to make fully informed decisions when choosing a health care provider [2]. The Centers for Medicare and Medicaid Services was tasked to oversee
(Ann Thorac Surg 2016;-:-–-) Ó 2016 by The Society of Thoracic Surgeons
Dr Segev discloses a financial relationship with Sanofi, Novartis, and Astellas Pharma US.
Accepted for publication June 13, 2016. *Drs Ahmed and Bae contributed equally to this work. Address correspondence to Dr Segev, Department of Surgery, Johns Hopkins Medical Institutions, 720 Rutland Ave, Ross 771B, Baltimore, MD 21205; email: [email protected].
Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier
The Appendix can be viewed in the online version of this article [http://dx.doi.org/10.1016/j.athoracsur.2016. 06.053] on http://www.annalsthoracicsurgery.org.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2016.06.053
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AHMED ET AL INDUSTRY’S PAYMENTS TO CARDIOTHORACIC SURGEONS
industry [5]. Market research has revealed that US pharmaceutical companies spend as much as $57.5 billion, or 24.4% of their revenue, on marketing and product promotion [6]. However, before the OPP database, the amount industry paid directly to physicians was never published on a national level [3]. Collaborations between physicians and industry, including those that involve financial disbursements, have the potential to drive significant advances in patient care. Within the field of cardiac surgery, for example, development of the left ventricular assist device was the result of a combined effort between cardiothoracic surgeons and industry [7]. In recognition of the importance of these relationships, the American Association for Thoracic Surgery and The Society of Thoracic Surgeons have both published codes of ethics in an effort to promote appropriate collaborative efforts between cardiothoracic surgeons and industry that will maximize clinical benefit and potential innovation without compromising the professional integrity of involved parties [8]. Despite these important initiatives, little is known about current financial ties between cardiothoracic surgeons and industry. Given that potential COI can undermine research findings and clinical decisions [9–11], it is essential to quantify and describe the nature of these relationships, especially now that these data are publically available to any interested party. In this study, we characterize the national distribution of industry payments to cardiothoracic surgeons using the newly available OPP database.
Patients and Methods Study Population The study population represented the subset of all the US allopathic and osteopathic physicians who received at least one nonresearch payment as cardiothoracic surgeon during the 5-month period of August 1, 2013, to December 31, 2013, in the OPP.
Data Sources Payments made to cardiothoracic surgeons between August 1, 2013, and December 31, 2013, were obtained from the OPP dataset, available on the Centers for Medicare and Medicaid Services website (http://www. cms.gov/openpayments). Physician-level payments were aggregated using a unique physician identification number. In the OPP data, the paying company reports a physician’s specialty and a physician is given the opportunity to verify the description of their specialty. As a result, if a physician was trained in a subspecialty or has multiple specializations, he or she could have been reported as either specialty. For example, if a physician was trained as general surgeon and also completed a cardiothoracic fellowship, he or she could have been listed as either a general surgeon or a cardiothoracic surgeon. For the purposes of this study, the largest payment that an individual received in a particular specialty determined their specialty.
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Payments Made to All Health Care Providers and Cardiothoracic Surgery The OPP dataset was used to ascertain the total amount of payments made by industry to all health care providers. Health care providers consisted of physicians, dentists, podiatrists, technicians, and nurse practitioners. This total was then compared to the total amount of payments made to cardiothoracic surgeons.
Distributions of Payments Made to Cardiothoracic Surgeons The total amount of money each cardiothoracic surgeon received was presented as a box-and-whisker plot to depict graphically the median, interquartile range, and overall range of values. The amount received was categorized as follows: less than $100, $100 to $999, $1,000 to $9,999, and more than $10,000 and presented as bar graphs. All companies and their sum of payments made to cardiothoracic surgeons were identified (Appendix). Payments of the 10 highest paying companies and their distribution by amount categories were shown. Heat maps were used to show the geographic distribution of industry payments and the average payments per cardiothoracic surgeon by state.
Payment Categories The OPP payments were reported under the following categories: consulting fees; food and beverage; honoraria; education; travel and lodging; entertainment; gifts; nonresearch training grants; services other than consulting, including speaking at a venue other than a continuing education program (CEP [abbreviated as “speaker nonCEP”]); and speaking for a nonaccredited and noncertified continuing education program (abbreviated as “speaker CEP”). The number of cardiothoracic surgeons who received payments for each payment category was quantified. Payments for speakers at accredited CEP events were not included in this analysis, as this payment category is not reported in the OPP database.
Statistical Analysis Analyses were performed with Stata 12.0/MP for Linux (StataCorp, College Station, TX). The methods of Louis and Zeger [12] were used to report 95% confidence intervals.
Results Payments Made to All Physicians During this first OPP reporting period, industry made payments totaling $476,021,752 to 475,975 health care providers. The median payment for a health care provider was $67 (interquartile range [IQR]: $22 to $179), with a mean of $1,000. During the 5-month OPP study, the four highest paid health care providers each received a total of $7,356,276, $3,994,022, $3,921,410 and $3,849,711.
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Payments to Cardiothoracic Surgeons Cardiothoracic surgeons (n ¼ 2,495) who met the described inclusion criteria received a total of $4,417,545 during a 5month study period. Overall, cardiothoracic surgeons comprised 0.52% of health care providers and received 0.93% of the total payment amounts. The median payment for cardiothoracic surgeons was $181 (IQR: $60 to $843) with a mean standard deviation of $1,771 $7,664; the four highest paid cardiothoracic surgeons received $159,444, $131,080, $119,779, and $114,384. Thirty-four percent (n ¼ 843) received payments less than $100; 43% (n ¼ 1,081) received payments between $100 and $999; 19% (n ¼ 471) received between $1,000 and $9,999; 4% (n ¼ 95) received payments between $10,000 and $99,999; and 0.2% (n ¼ 5) received payments in excess of $100,000 (Fig 1).
Payments by Expense Category A total of $4,417,545 was paid in the form of 15,204 single payments to cardiothoracic surgeons. Total payments by expense category were $1,037,370 (23.5%) for travel and lodging; $1,005,350 (22.8%) for consulting fees; $909,034 (20.6%) for speaker non-CEP; $608,403 (13.8%) for food and beverage; $399,262 (5.4%) for honoraria; $237,748 (5.4%) for education; $166,887 (3.8%) for royalty or license; $40,675 (0.9%) for nonresearch grants; $8,216 (0.2%) for gifts; $5,000 (0.1%) for certified but unaccredited speaker non-CEP; and $599 (0.01%) for entertainment (Table 1). The median for payments and the number of cardiothoracic surgeons paid by expense category were $8,398 (IQR: $536 to $12,316) royalty or license to 0.4% (n ¼ 9); $3,600 (IQR: $1,500 to $8,000) speaker non-CEP fees to 4.9%
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(n ¼ 121); $3,344 (IQR: $1,563 to $7,350) honoraria to 2.2% (n ¼ 54); $3,103 (IQR: $1,225 to $6,500) consulting fees to 7.8% (n ¼ 1,157); $1,250 (IQR: $1,250 to $1,250) certified but unaccredited non-CEP speaker fees to 0.2% (n ¼ 49); $880 (IQR: $444 to $1,413) travel and lodging to 27.7% (n ¼ 692); $750 (IQR: $700 to $39,225) nonresearch grants to 0.1% (n ¼ 3); $51 (IQR: $28 to $908) gifts to 0.3% (n ¼ 8); $47 (IQR: $14 to $230) education to 9.0% (n ¼ 225); and $21 (IQR: $16 to $37) entertainment to 0.6% (n ¼ 15; Table 1).
Distributions of Payments Made by Companies There were 205 companies that made 15,204 individual payments. The payment median was $43 (IQR: $17 to $125), and the mean was $291 $1,671 (Appendix). The 10 highest paying companies accounted for $2,702,473 (61.2 %) of the total payments. The three highest paying companies were Edwards Lifesciences ($654,844), Medtronic Vascular ($374,983), and Atricure, Inc ($310,669). The distribution of payments by category from these 10 companies is shown in Figure 2.
Geographic Distribution In terms of total payments to cardiothoracic surgeons by state, the top five states were California ($434,595), Pennsylvania ($425,033), New York ($344,890), Arizona ($331,314), and Texas ($326,794). The five lowest states were Wyoming ($88), Alaska ($647), Vermont ($1,196), South Dakota ($1,847), and Idaho ($2,233; Fig 3A). In terms of average payment per surgeon, the highest five states were Louisiana ($7,379), Arizona ($5,431), Utah ($4,149), Washington, DC ($3,524), and Washington Fig 1. Distribution of payments received by US cardiothoracic surgeons. The median payment for cardiothoracic surgeons was $181 (interquartile range: $60 to $843) with a mean standard deviation of $1,771 7,664; the four highest paid cardiothoracic surgeons received $159,444, $131080, $119,779, and $114,384. Among cardiothoracic surgeons 34% (n ¼ 843) received payments under $100, 43% (n ¼ 1,081) received payments between $100 and $999, 19% (n ¼ 471) received between $1,000 and $9,999, 4% (n ¼ 95) received between $10,000 and $99,999, and 0.2% (n ¼ 5) received payments in excess of $100,000.
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Table 1. Industry Payments by Expense Category Expense Category Travel and lodging Consulting fee Speaker non-CEP Food and beverage Honoraria Education Royalty or license Nonresearch grant Gift Speaker certified CEP Entertainment
Total Amount $1,037,370 $1,005,350 $909,034 $608,403 $399,262 $236,748 $166,887 $40,675 $8,216 $5,000
(23.5%) (22.8%) (20.6%) (13.8%) (9.0%) (5.4%) (3.8%) (0.9%) (0.2%) (0.1%)
$599 (0.01%)
CEP ¼ continuing educational program;
Median (IQR) per Payment $195 $2,100 $2,000 $28 $2,500 $47 $3,325 $750 $28 $1,250
($64–$412) ($950–$4,500) ($510–$2,500) ($15–$82) ($1,531–$3,000) ($13–$438) ($300–$10,319) ($700–$39,225) ($28–$190) ($1,250–$1,250)
$19 ($16–$23)
CT ¼ cardiothoracic;
2,777 2,85 337 11,253 140 364 16 3 9 4 16
IQR ¼ interquartile range;
($3,107). The five states with lowest payment per surgeon were Wyoming ($44), Alaska ($647), Arkansas ($7,388), Montana ($3,825) and New Hampshire ($3,064; Fig 3B).
Comment With the recent implementation of the PPSA, physicianindustry relationships are under increasing scrutiny. Industry reporting of financial remuneration for travel, gifts, and services rendered is now mandated by the Centers for Medicare and Medicaid Services, and the resulting data are made publically available through the OPP database [13]. The results of our study demonstrate that US cardiothoracic surgeons, who comprise 0.5% of all qualifying health Fig 2. Category of payments from the 10 companies that had the highest total amount of payments made to cardiothoracic surgeons. Navy blue indicates speaker non– continuing education program (CEP); brown, speaker CEP certified; green, consulting fee; orange, education; teal, food and beverages; red, grant; lavender, honoraria; chartreuse, royalty or license; and burgundy, travel and lodging.
No. of Payments
Median (IQR) per CT Surgeon $880 $3,103 $3,600 $138 $3,344 $47 $8,398 $750 $51 $1,250
($444–$1,413) ($1,225–$6,500) ($1,500–$8,000) ($50–$300) ($1,563–$7,350) ($14–$230) ($536–$12,316) ($700–$39,225) ($28–$908) ($1,250–$1,250)
$21 ($16–$37)
No. of CT Surgeons 692 142 121 2,407 54 225 9 3 8 4
(27.7%) (5.7%) (4.9%) (96.5%) (2.2%) (9.0%) (0.4%) (0.1%) (0.3%) (0.2%)
15 (0.6%)
No. ¼ number.
care providers, received 0.9% of all nonresearch industry payments according to the OPP database. The median payment received was $180, and more than a third of cardiothoracic surgeons received less than $100 in total payments; only 4% received more than $10,000. Although payments for travel and lodging were most prevalent overall, the three largest payment categories per surgeon were royalty or license fees, speaker fees, and honoraria. We are unable to assess or judge the potential beneficial aspects of the relationship between industry and cardiothoracic surgeons. Theoretical advantages include the opportunities for industry to gain greater insights about preclinical and innovative therapies and devices before widespread adoption or Food and Drug
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Fig 3. (A) Total payments made to cardiothoracic surgeons by state. In terms of total payments per surgeon, the top five states were California ($434,595), Pennsylvania ($425,033), New York ($344,890), Arizona ($331,314), and Texas ($326,794). The five lowest states were Wyoming ($88), Alaska ($647), Vermont ($1,196), South Dakota ($1,847), and Idaho ($2,233). (B) Average payments per surgeon by state. In terms of average payment per surgeon, the highest five states were Louisiana ($7,379), Arizona ($5,431), Utah ($4,149), Washington, DC ($3,524) and Washington ($3,107). The lowest 5 states were Wyoming ($44), Alaska ($647), Arkansas ($7,388), Montana ($3,825), and New Hampshire ($3,064).
Administration approval. These benefits cannot be underestimated. However, a large body of literature has previously explored the impact of financial COI on clinical care, research outcomes, and physician behavior [10–13, 19]. Although many studies suggest that industry’s support for research, clinical care, and innovation is essential, there is frequently concern that financial relationships between commercial entities and clinical providers carry the potential for undue influence. Consistent with this notion, a 2012 Cochrane review recently demonstrated that research studies involving drug or device development that are sponsored by industry tend to lead to more favorable efficacy compared with nonindustry sponsored studies [14]. Hence, accurate COI reporting by physicians is essential. The OPP database reports three forms of payments: (1) Ownership and investments; (2) research payments made mostly to institutions; and (3) nonresearch payments made to individuals, reported in this study.
Conflicts of interest do not necessarily preclude appropriate clinical care, either real or perceived. However, a substantial number of patients believe that physician disclosure of financial ties is an important aspect of care [5, 15]. Furthermore, patients’ perceptions of industry payments to physicians are dependent upon the amount and nature of the payment. For example, in a 2006 New England Journal of Medicine multicenter study of 253 patients by Hampson and associates [15], the researchers demonstrate that more than 80% of patients think it is ethical for physicians to receive reimbursement for consulting or speaking from a company. In contrast, Green and coworkers [5] recently reported in a multicenter survey of 220 patients that nearly 60% of patients would trust their physician less if they accepted an industry gift of more than $100 or went on an industry-sponsored trip or sporting event. In our study, we demonstrate that 66% of cardiothoracic surgeons received more than $100 in payments from industry. Although the median payment was $180, it was
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higher than the $100 cutoff defined by Green and coworkers [5], and higher than median payment of $125 for transplant surgeons and $115 for plastics surgeons in the OPP database [16, 17]. Furthermore, we demonstrate that industry-sponsored travel either as direct payment or reimbursement are common among cardiothoracic surgeons; although just over one quarter (28%) of providers were reimbursed for travel and lodging, this category received the highest amount of total industry payments ($1,037,370). Although patient perceptions around OPPreported data are not currently known, all of these findings may raise concern among patients for potential physician bias based on previously reported trends [5]. However, consulting fees comprised the second highest amount of total industry payments ($1,005,350), and the three largest payment categories per surgeon were royalty or license fees, speaker fees, and honoraria, all of which would presumably fall within the preview of acceptable physician-industry relationships [15]. When taken together, the results of our study suggest that cardiothoracic involvement with industry is within reason, but perhaps with some higher payment for travel. We believe that this inaugural report is the beginning of an important professional discussion for industry, health care providers, physicians, and patients. The impact of published OPP data for patients and the public remains to be determined. There is substantial debate on the appropriateness and implications of OPP data, including concerns about how industry and physicians may adapt to PPSA reporting rules [18]. To date, available OPP data is limited to a 5-month reporting period, which likely carries some inaccuracies owing to lack of longitudinal data. In addition, there may be inaccuracies in reporting metrics given that the PPSA is in its infancy. The accuracy and applicability of the data remains to be determined, and carries with it already acknowledged limitations such as a lack of reporting of drug sample and continuing medical education-certified program payments [17]. However, these limitations should be at least partially addressed as the PPSA evolves over time, and as studies similar to ours report on preliminary OPP database findings [16, 19]. The advent of the OPP database allows for the characterization of current physician-industry relationships at national, regional, and physician levels. There is a need to study industry payments made to lawyers, politicians, and lobbyists as well. Currently, the availability of these data as part of a public forum will undoubtedly allow physicians better monitoring of industry relationships and self-regulation. If reviewed responsibly, it could be used to provide health care providers with an opportunity to identify and avoid potentially compromising payment trends before they present a real or a perceived problem to clinical care. By working to adhere to commonly accepted societal guidelines and ethical standards and transparent physician-industry reporting [8], the field of cardiothoracic surgery will continue to demonstrate its leadership in professional matters and be able to maintain its rewarding and mutually beneficial relationship with industry to provide cutting edge treatments to patients in an effective and unbiased manner.
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This work was supported by grant number K24DK10182801 from the National Institute of Diabetes and Digestive and Kidney Diseases. The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.
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