The health care system recognizes that financial relationships with medical industry have the potential to improve health care through collaborative innovation but also to predispose patients to biased clinical care.1,2 Conflict of interest occurs when clinical practices are influenced by the financial gain of these relationships, superseding a clinician's best judgment.2,3 Such conflicts, if not managed appropriately, may compromise clinical care, weaken patients' trust in their health care providers, and potentially contribute to wasteful health care spending.1,2,4 Accordingly, the American College of Obstetricians and Gynecologists (the College) provides recommendations regarding a structured manner in which obstetrician–gynecologists (ob-gyns) can maintain financial ties with industry while preserving their primary obligation to patients.3
The Physician Payments Sunshine Act passed in 2010 as part of the Affordable Care Act mandates that medical manufacturers report financial relationships in the form of payments made to physicians and teaching hospitals to the Centers for Medicare & Medicaid Services.6–8 The Centers for Medicare & Medicaid Services posts these payments online with the goal of promoting transparency and helping to dissuade conflicts of interest.2 We performed a literature search using PubMed and Google Scholar from 2009 to the present. The terms searched included “open payments,” “industry payments,” “sunshine act,” “open payments and OBGYN,” “industry payments and OBGYN,” “open payments and obstetrics,” “open payments and obstetrics and gynecology,” “industry payments and obstetrics and gynecology.” Since the first publication of payment data, a few studies have objectively assessed industry payments to other surgical specialties,9–12 but no studies have evaluated payments made in 2014 to ob-gyns, since they were made publically available on 6/30/2015.
The primary objective of this study was to evaluate nonresearch payments made to ob-gyns from the medical industry in 2014. Our secondary objective was to promote awareness of published payments to encourage ob-gyns to participate in disclosure of their fiscal relationships to patients and to take an active role in maintaining accuracy of their payments data.
MATERIALS AND METHODS
We conducted a retrospective study of payments made from medical industry to physicians from January 1, 2014, to December 31, 2014, which were made publically available on the Centers for Medicare & Medicaid Services website on June 30, 2015.7,8 Internal review board approval was not needed for this study because no patient information was used and the data included in the study are publically available through the Centers for Medicare & Medicaid Services website. All nonresearch payments associated with individually identified health care providers were included. Deidentified payments, which are those payments not associated with a health care provider or those payments with missing information as well as payments made to hospitals or those associated with medical research were excluded from this study. Research funding was excluded from this analysis to promote generalizability of our findings because research payments are often of very high value and they are distributed to relatively few physicians.
All identified payments from 2014 were downloaded from the Centers for Medicare & Medicaid Services website and payments made to physicians listed as medical doctors and doctors of osteopathy in the United States were selected. These payments were grouped according to physician specialty using the Centers for Medicare & Medicaid Services standardized “provider taxonomy” code list and submitted by manufacturers and group purchasing organizations.8 There were 482 listed specialties based on these taxonomy codes. Specialties were then further classified into 35 subspecialty groups, which were defined by the Association of American Medical Colleges 2012 Physician Specialty Data Book.13 The specialty and subspecialty groups were developed from the taxonomy codes submitted by manufacturers and group purchasing organizations and do not necessarily reflect those established by the Accreditation Council for Graduate Medical Education or the American Board of Obstetrics and Gynecology. Individual payments made to ob-gyns were identified and the compared with other specialties and obstetrics and gynecology subspecialties were compared with each other.
Payments are characterized by total value transferred, defined as the total sum of money given to a definable group; median annual amount per physician; nature of payments; and highest paying manufacturers. The median annual amount paid per physician was used, because it reflects the value by physician instead of the value by payment. Number of payments per physician was not analyzed intentionally, because of the possibility that this value may over- or underestimate the strength of a financial relationship. For example, a physician may have received 100 payments for less than $5 each, considerably less money than a physician who received only one payment totaling $5,000. Median rather than mean annual payment was selected as a measure of central tendency because of the extreme ranges between the minimum and maximum payments. This variation tended to inflate the mean annual payment. Interquartile ranges were used to quantify statistical dispersion.
Nature of payments is categorized based on information reported by manufacturers and group purchasing organizations. As on the Open Payments website, the categories include consulting fees, categorical compensation, education-related payments, travel and lodging, royalties and licensing, food and beverage-related payments, honoraria, grants, gifts, charitable contributions, and entertainment.7 Univariate analysis was performed with Microsoft Excel 2010, SPSS 22, and SAS.
In 2014, there were a total of 10,818,054 nonresearch-related payments totaling $2,558,382,377. This total amount is the sum of all undisputed nonresearch payments made to any individual medical provider or teaching hospital. From those, 9,863,254 payments, totaling $1,815,948,182, were made to 518,210 individual physicians (medical doctors or doctors of osteopathy).
Payments to physicians were assigned to each of the 35 specialty categories listed in the Association of American Medical Colleges 2012 Physician Specialty Data Book and compared. Of the 518,210 individual physicians listed as having received a payment, 29,783 were identified as ob-gyns. Obstetrics and gynecology, therefore, was the fourth most highly represented specialty among the 35 categories. Ob-gyns received 3.1% (n=311,485) of all payments made, which was the seventh most of any specialty (Table 1).
Obstetrics and gynecology, as a specialty, ranked 10th for highest total value transferred to one specialty. In total, ob-gyns received $60,004,472, which was 3.3% of the total value transferred to medical doctors and doctors of osteopathy in 2014. An ob-gyn had the eighth highest maximum payment made to a single physician, $14,750,000. The median amount paid to ob-gyns, including all obstetrics–gynecology subspecialties, was $140 (interquartile range $50–347). This median payment ranked 20th out of the 35 specialties (Table 1).
There were 10 obstetrics and gynecology-related subspecialties associated with payments made in 2014; they are listed in Table 2. Physicians listed as general obstetrics and gynecology physicians received the most payments (n=258,778) and they received the greatest percentage of the total value transferred to all obstetrics and gynecology-related subspecialties with $48,064,177 (80% of the total value transferred) (Table 2). There were only five physicians listed as bariatric subspecialists, and they received nine payments, which totaled the least amount of any of the obstetrics and gynecology subspecialties ($1,241). Physicians listed as urogynecologists received the highest median annual amount per obstetrics and gynecology physician, $234 (interquartile range $82–896). Ob-gyns listed as critical care specialists received the lowest median annual payment per physician at $28 (interquartile range $14–84) (Table 2).
The top 10% of the highest paid identified ob-gyns (n=2,978), based on total annual amount from 2014, received $54,968,892 or 92% of the total value transferred to all obstetrics and gynecology physicians. The median annual payment per physician for the top 10% of the highest paid ob-gyns was $3,217 (interquartile range $1,504–6,430). The top 1% of the highest paid ob-gyns (n=297) received $44,486,955 or 74% of the total value transferred to all ob-gyns. The median annual payment per physician for the top 1% of the highest paid ob-gyns was $33,202 (interquartile range $33,202–59,043). The maximum payment listed as made to any single ob-gyn in 2014 was $14,751,142, which was 25% of the total value transferred to all ob-gyns, and was a payment made for royalties and licensing fees.
When the nature of payments was evaluated, royalties and licensing payments comprised the highest proportion of the total value transferred to ob-gyns, totaling $29,600,000, 50% of the total value transferred in 2014. Payments for royalties and licensing were distributed among only 30 physicians in 96 payments. Compensation for services other than consulting such as serving as a speaker at a venue other than a continuing education program made up the next greatest share of the total value transferred at 13% (Table 3). Charitable contributions made up only two payments totaling $416, and entertainment made up the second least common reason for a payment to ob-gyns in 2014 with only 39 payments totaling $2,580 made. Food and beverages were overwhelmingly listed as the most commonly occurring payment nature (n=274,365), making up 88% of all payments (Table 3). Ninety-seven percent of the obstetrics and gynecology physicians listed received payments for food and beverages (n=29,001) (Table 3).
There were 384 manufacturers and group purchasing organizations that made payments to ob-gyns, 187 of which made between 1 and 10 payments. Seventy-six percent of manufacturers made less than 100 payments to physicians in 2014. The top 15 highest paying manufacturers paid $49,876,090 (83% of the total value transferred) to ob-gyns and are listed in Table 4. The top five manufacturers paid $38,960,666, which was 65% of the total value transferred to ob-gyns.
The highest paying manufacturer was Medtronic USA, Inc., which paid 45% of the total value transferred ($26,826,296), yet this company paid only 1% of the total number of payments to ob-gyns in 2014 (n=3,788) (Table 4). Although Intuitive Surgical, Inc. made only 6% of all payments (n=20,164), they paid the highest median annual amount per physician at $372 (interquartile range $57–1,784). Although Pfizer only accounted for 3% of the total value transferred, they made the greatest number of payments of all manufacturers with 37,758 payments, 12% of payments made to ob-gyns.
We report that ob-gyns received a significant portion of medical industry payments in 2014. They ranked seventh in total number of payments received and ranked fourth in total number of physician recipients within a specialty. We observe that, nonetheless, individual ob-gyns, mostly, received relatively small payments, as suggested by a median payment ranking in the lower half compared with all 35 specialty groupings used in this study.
Within the field of obstetrics and gynecology, we found that 65% of the total value transferred in 2014 came from medical device companies including Medtronics USA and Intuitive Surgical, suggesting a large proportion of payments was related to gynecologic surgery. We also found that payment dollars were not evenly distributed among all ob-gyns, because the highest valued payments (royalties licensing fees), which accounted for 50% of the total value transferred, went to only 30 of the 29,783 physicians who received payments in 2014. This trend of the top recipients having received the majority of payment dollars is not unique to ob-gyns. Similar disparities were seen in studies looking at 2013 payments to other surgical specialties, in which the top 1–10% of payment earners received between 69.5% and 95% of the total amount paid to the specialties studied.9–12,14 According to recommendations by the College's Ethics Committee, physicians receiving substantial sums of money from medical industry have a particular obligation to their patients to disclose these transactions and to discuss their effect on clinical decision-making.3 The College did not quantify the term “substantial” in their recommendations.
The primary limitation of this study concerns the reliability of the payment data, which is dependent on industry reporting.9,12 As a result of payment discrepancies related to legislative loopholes in reporting practices afforded to manufacturers, 62% of the total value transferred in 2013, $2.3 billion, was posted as deidentified.7 The omission of individual identification from a significant fraction of 2013 payments undermined perceptions of transparency and reliability.12 By increasing access for physicians to participate in the payment vetting process and contextualizing manufacturer reporting, the reliability of the open payments data has improved.8 Unlike the 2013 data, which posted only 5 months of payments, the 2014 payment data, used in this study, included 12 months of payments and were regarded to be of higher quality because only $5.1 million (0.2% of the total value transferred) was not individually identified.8
The strength of this study is that it provides an objective evaluation of information available to the public regarding some of the most frequent transactions between physicians and medical industry. We can conclude that although a significant number of ob-gyns have some sort of financial relationship with medical industry, the majority of transactions appears to be small and related to food and beverages. We recognize that the monetary value of most financial transfers from industry to ob-gyns appears insufficient to influence clinical decision-making. However, literature suggests that even small gifts may affect health care provider practices and that physicians may not always recognize practice changes that occur in association with industry interactions.15,16
This study is part of a growing body of literature objectively evaluating specialty-specific payments from medical industry to physicians.9–12,14 However, despite these studies' findings, conclusions about the long-term effect of the Open Payments Program on curbing conflicts of interest and improving health care costs and physician–patient relationships remain largely speculation. A large part of this uncertainty is the result of the complexities involved in defining and identifying when clinical integrity is compromised by fiscal relationships with industry. The effects of industry payments on the clinical practice of physicians and the effects of medical guidelines developed to regulate them remain uncertain.
Perhaps the final important conclusion to be made from this work is that physicians have the opportunity to play crucial roles in promoting transparency and managing conflicts of interest. By discussing industry payments with patients, and in maintaining accuracy of posted information, doctors can help maximize the beneficial effects of disclosure, avoid inappropriate influence, and perpetuate the high integrity inherent in doctor–patient relationships. The benefit of transparency is lost when reported information is inaccurate, and physicians can help regulate the quality of available information through the vetting process. Physicians can register on the Centers for Medicare & Medicaid Services website to receive and monitor their payment information.17–19 Physicians should keep records of individual payments and dispute those that seem inaccurate.17 Ongoing involvement from both physicians and medical industry will ensure reliable data are made available to the public and will contribute to future research efforts that assist in realizing the potential benefits of the Open Payments Program.18
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