The Physician Payments Sunshine Act was enacted in 2010 as part of the Patient Protection and Affordable Care Act to increase the transparency of financial relationships between health care providers and drug–device manufacturers.1,2 A prevalence as high as 94% of physicians report financial ties with industry, and there is evidence to suggest that these financial ties can influence physician behavior, although there is no evidence for or against this assumption in obstetrics and gynecology.3 Furthermore, the majority of patients believe that these relationships should be disclosed by physicians.4,5 Under the Sunshine Act, drug and device manufacturers who develop at least one product covered by Medicare or Medicaid must report all payments made to licensed physicians regardless of physician participation in these government programs.6
Prior work suggests that obstetrics and gynecology subspecialists receive a significant amount of money from industry. First, gynecologic oncologists were highlighted as having industry payments of $1.9 million made to 765 gynecologic oncologists in 2014.7 That article highlighted the need for professional organizations to consider proactively developing guidelines regarding interactions with industry for their general membership. The second article examined presentations at the Society of Gynecologic Surgeons annual meeting and determined if proper disclosure was performed.8 In total, 62% of physicians had transactions reported totaling $1.99 million; however, only 7% disclosed these relationships.
Quantifying payments made to obstetrician–gynecologists (ob-gyns) from industry is an important first step to establishing the presence or absence of conflicts of interest. This has not been done across the field. If this information were known, it could be shared with patients and other health care providers to allow them to determine its importance.
Quantifying payments made to ob-gyns from industry is an important first step to establishing the presence or absence of conflicts of interest. The purpose of this cross-sectional study is to evaluate financial relationships between ob-gyns and industry, including the prevalence, magnitude, and the nature of payments.
MATERIALS AND METHODS
This is a cross-sectional study of the Open Payments Database, reviewed from August 1, 2013 to December 31, 2015.9 The Centers for Medicare and Medicaid Services began data collection on physician payments in August 2013 and released these data in September 2014 in the Open Payments Database, which is the largest repository of industry financial relationships with physicians and is publicly accessible online.9 Industry financial payments include all payments or transfers of value made from drug or device manufacturers to physicians. Not all ob-gyns are listed in the Open Payments, because not all physicians receive payments from industry. Considering this, we used data from the National Provider Identification database to identify the entire cohort of practicing U.S. ob-gyns. This served as the denominator for payments and allowed for comparison between groups. We identified generalists, female pelvic medicine and reconstructive surgeons, generalists, gynecologic oncologists, maternal–fetal medicine, and reproductive endocrinology and infertility physicians in the Open Payments Database based on their taxonomy codes in the National Provider Identification database. Taxonomy codes are required by law for all health care providers under the Health Insurance Portability and Accountability Act.10 The conflict of interest and physician demographics data were joined from publically available government databases. The National Provider Identification database, after evaluation by the Department of Health and Human Services Office of the Inspector General, was found to have virtually all required variables and the records were complete and appropriate to query.11 Open Payments data may be disputed by physicians. No data under dispute were used for this evaluation.12 Because most, but not all, practitioners identified in this manner have completed a subspecialty certification, an additional review of practitioners was performed before data analysis to exclude entries of nonsubspecialists and trainees. For U.S.-trained ob-gyns, this determination was made using publicly available data from and the American Board of Medical Specialties (certificationmatters.org).
The non–American Board of Obstetrics and Gynecology, Inc–certified subspecialties of family planning, minimally invasive gynecologic surgery, and reproductive infectious disease were analyzed as generalists considering that the majority of these physicians also have a large component of generalist practice. As a result of their low populations as well as to protect their privacy, subspecialties of hospice and palliative medicine as well as critical care were not included. In addition, many of physicians boarded in these two subspecialties were also boarded in gynecologic oncology and were treated as gynecologic oncologists when appropriate. Double-boarded subspecialists were categorized as the subspecialty in which they were first boarded.
Payments made to obstetrics and gynecology subspecialists by companies were analyzed with respect to 1) types of payments, 2) demographic attributes of obstetrics and gynecology subspecialists, and 3) comparisons between obstetrics and gynecology subspecialists. Types of payments were defined by the Centers for Medicare and Medicaid Services: royalties and licensing, ownership or investment interests, charitable contributions, grants, education, honoraria, faculty compensation, consulting fees, entertainment, food, travel, and lodging. Payments were examined with respect to the number and dollar values of these payments. The characteristics of obstetrics and gynecology subspecialists in the database were examined with respect to practice setting and geographic region with geographic regions designated as defined by the American College of Obstetricians and Gynecologists (ACOG). Matching of physician names in the Open Payments Database to the National Provider Identification database was done using code written in R 3.2.5 and confirmed to be 99% accurate by a hand search of 5% of records.
Frequency data were compared using the Fisher test or χ2 test, as appropriate. Continuous data were compared using the Mann-Whitney test for variables that were not normally distributed and with the t test for variables that are normally distributed. All tests are two-tailed. Values of P<.05 were considered statistically significant. This study was approved for exempted, nonhuman subjects research by the Colorado Multiple institutional review board, protocol #17-1257. All data collected were publically available.
A total of 517,077 nonresearch payments totaling $79,965,244 were made to 23,292 ob-gyns from August 1, 2013, to December 31, 2015. Physicians who received payments were predominantly female, younger than 65 years old, allopathic physicians who graduated from U.S. medical schools in the late 1990s, and were board-certified subspecialists (P<.001 for all; Table 1). Half of all ob-gyns (49.69%) received payments of any amount from drug or device manufacturers or both. Of the 23,292 ob-gyns who received industry payments, 26.9% received less than $100, 50.6% received payments between $101 and $1,000, 19.4% received between $1,001 and $10,000, 2.7% received between $10,001 and $100,000, and 0.3% received more than $100,000 (Fig. 1Table 2). Subspecialists receive more money for industry financial contributions than generalists (median payment of $500 vs median payment of $296, P<.001 with median test; Table 3). Compensation for honoraria, faculty compensation, and consulting was the largest dollar value for the category of payments (Fig. 2). Although there was no statistical difference in the number of financial ties among physicians practicing in different ACOG districts (P<.2; Fig. 3), physicians practicing in ACOG district VII, encompassing the East South–Central portion of the United States and including Alabama, Arkansas, Kansas, Louisiana, Mississippi, Missouri, Oklahoma, and Tennessee, received statistically more total dollars from industry than other ACOG districts (Fig. 4). In total, physicians in ACOG district VII received more than 25% of the total dollar amount being paid from industry to practicing ob-gyns, a total of more than $16.6 million (P<.001). The geographic distribution of payments across the United States illustrates that larger dollar values are also paid in metropolitan areas when adjusted for population (Fig. 5).
Given the large population (n=20,975) and diverse nature of obstetrics and gynecology generalists, the same is reflected in their $48.8 million in received financial contributions. Generalists received smaller dollar amounts compared with subspecialists (median generalist payment $296 vs median subspecialist payment $500, P<.001). The most common type of payment was for food and beverage, entertainment, and travel for which there were 427,298 individual payments, accounting for 94% of the $48.8 million in financial contributions.
Board-certified female pelvic medicine and reconstructive surgery physicians (n=449) comprised 1.9% of all ob-gyns receiving payments and received a total of $22,028,891. Female pelvic medicine and reconstructive surgery physicians received the largest median dollar amount compared with generalists and to subspecialists alike (median payment of $1,812 female pelvic medicine and reconstructive surgery vs $296 generalist, P<.001 and median payment of $1,812 female pelvic medicine and reconstructive surgery vs $355 other subspecialists, P<.001). The entertainment, food and beverage, travel, and lodging category represented the most common type of payment. Royalties and licensing represented the highest valued type of payment ($16,364,413), but were received by less than 1% of female pelvic medicine and reconstructive surgery physicians (n=4). The largest single payment to any female pelvic medicine and reconstructive surgery was $14.75 million in a royalty or licensure from Medtronic, Inc to one female pelvic medicine and reconstructive surgery physician.
The total payments were $3,547,942 to gynecologic oncologists (n=557), ranging from a minimum payment of less than $1 to a maximum payment of $27,900. Behind female pelvic medicine and reconstructive surgery physicians, gynecologic oncologists received the second highest amount of money from industry as compared with other subspecialists (median of $913 vs $401, P<.001). Most payments to gynecologic oncologists fell into the honoraria, faculty compensation, and consulting fee categories, and this constituted 47.8% of the total dollar value of payments.
Maternal–fetal medicine physicians (n=649) received a significantly smaller amount of money compared with all other subspecialists (median maternal–fetal medicine payment $100 vs median subspecialist payment $936, P<.001) and received fewer dollars compared with obstetrics and gynecology generalists as well (median generalist payment $296 vs median maternal–fetal medicine payment $100, P<.001). There was no regional variation in the percentage and dollar value of maternal–fetal medicine financial relationships, but similarly to all other subspecialists except female pelvic medicine and reconstructive surgery, most payments fell under the honoraria, faculty compensation, and consulting fee category.
Reproductive endocrinology and infertility physicians (n=662) received the second highest median number of payments from industry as compared with other subspecialists (median of 25 payments). Similar, to all other subspecialists except female pelvic medicine and reconstructive surgery, reproductive endocrinology and infertility physicians received most payments in the category of honoraria, faculty compensation, and consulting funds. These payments totaled $2,829,951.
Payments to physicians from manufacturers and pharmaceutical companies have been an area of interest for patients, physicians, and hospitals; these data have also recently come into the forefront of media coverage of health care providers and big business alike. Recognizing the importance of disclosing potential conflicts of interest, ACOG has required presenters at its annual clinical meeting to disclose any such conflicts of interest since 1985. Payments to ob-gyns from industry have not been well studied, and through analysis of the Open Payments Database, we found that approximately half of practicing ob-gyns receive financial payments of some kind from a pharmaceutical or device maker. Examining the effects of these payments on clinical care is certainly an important area for future research. Additionally, individuals or departments could review the Open Payments Database to ensure agreement with data therein. Professional societies might incentivize more accurate disclosures (eg, cross-check a sample of abstract disclosures with the database and reject those with incomplete disclosures). American College of Obstetricians and Gynecologists districts with higher payments might discuss this with membership at district meetings.
The majority of these payments totaled less than $400 per health care provider, which is less than the mean amount received by surgical providers in other specialties, including orthopedics, urology, neurosurgery, and ophthalmology.13 However, obstetrics and gynecology subspecialists in total receive more financial support from industry than general obstetrics and gynecology providers and the difference in payments is statistically significant. Lastly, the median payment value for obstetrics and gynecology subspecialists surpasses the median payment to orthopedic surgeons who historically have led all prior physician specialties in total and mean industry payments.14
Limitations of this study include the retrospective nature of the data provided by the Centers for Medicare and Medicaid Services and the lack of a national clearinghouse for physicians. Although the Open Payments Database is currently the most comprehensive resource available for understanding financial relationships with physicians, there are some limitations to its use. First, the Open Payments Database does not differentiate between payments that are beneficial for patient outcomes and those that are not. Although royalties and consulting fees can be viewed as a potential conflict of interest for physicians, they also represent the sequelae of innovation and expertise in obstetrics–gynecology, which advance and benefit patient care. Given the variety in the nature, prevalence, and magnitude of industry financial relationships, it will be essential for future research to elucidate the specific effect of these payments on prescribing and surgical device selection habits. Second, not all industry financial relationships are included in the Open Payments Database such as payments related to research on new products and new uses of existing products and those paid to nurse practitioners and physician assistants. Furthermore, the Centers for Medicare and Medicaid Services withheld approximately 200,000 records with a total value of $1.1 billion from the initial data release.15,16 There have also been concerns about the difficulty for physicians in accessing their reported financial relationships for review and possibly disputing these payments.17 Lastly, no system yet exists for independent verification of the accuracy of reporting by companies listed in the database.18
The strengths of this study include visualization of a previously unanswered question regarding financial ties to industry and the potential for conflicts of interest among various groups of ob-gyns. The ability to match demographics and geographic location with financial payments is unique. We also included device manufacturer payments that have recently been released and were not analyzed in prior obstetrics and gynecology literature. One benefit of using the National Provider Identification database for information is that it is updated monthly, and, when cross-referenced with taxonomy code, it becomes even more reliable, lending strength to our analysis.
There is a paucity of data regarding financial relationships between industry and ob-gyns; however, our study demonstrates that these relationships exist in all obstetrics and gynecology subspecialties. Considering this, future research should be directed at how these relationships affect research productivity and practice patterns, including the prescribing of medication.
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