The Problem
Clinicians may be unaware that industry payments to physicians are now publicly searchable under the Physician Payments Sunshine Act. Furthermore, the extent of industry’s financial involvement in subspecialty practice has not been previously accessible. As an example, 6948 direct, research-unrelated payments totaling $1,957,004 were made to 765 gynecologic oncologists in 2014, the first full year of data available. A total of 153 companies reported at least 1 payment; however, the 10 manufacturers reporting the highest total payment amount accounted for 82% of all payments to physicians. In all, 48 gynecologic oncologists received >$10,000 from manufacturers, accounting for $1,202,228, or 61%, of total payments.
A Solution
Obstetrician-gynecologists, including gynecologic oncologists, should be aware of their publicly reported payments from industry and ensure reports’ accuracy. Professional organizations, including the Society of Gynecologic Oncology (SGO), should strongly consider proactively developing guidelines regarding interactions with industry for their general memberships.
Introduction
As part of the Affordable Care Act, the Centers for Medicare and Medicaid Services (CMS) issued final regulations in February 2013 implementing the Physician Payments Sunshine Act. In an attempt to improve transparency of financial connections between manufacturers and health care providers, the Sunshine Act requires manufacturers of drugs, devices, and other medical supplies to report all payments or in-kind compensation of significant value (defined as >$10 per instance or totaling >$100 in a year) to CMS. CMS, in turn, maintains a public, searchable database with details regarding the reporting company, the physician receiving payment, and the nature and purpose of the payment. Separate databases are maintained for hospitals and physicians. Payments to physicians are further separated into direct funding for clinical research, ownership of stock and investments, and “general payments,” which include compensation for consulting, travel and lodging, educational lectures, meals, and honoraria. In this article, we focus on the general payments database, as there is less guidance available to clinicians on how to manage these interactions with industry, compared to existing oversight of research funding and stock ownership. Given the potential influence on the opinions and behavior of patients, physicians, and the public, it is critical for obstetrician-gynecologists and subspecialists to be aware of publicly available data connecting physicians to industry.
An analysis of payment data from the fourth quarter of 2013 suggested that the median payment from industry to gynecologic oncologists may be particularly high compared to other specialties. As a case in point, we therefore considered compensation data from 2014, the first full year released by CMS. Statistics for individual gynecologic oncologists are available through the CMS Web site; summary data and implications are presented in this article. Of note, physicians who are not named in disclosures from manufacturers do not appear in the CMS database.
Materials and Methods
Industry-reported payments to gynecologic oncologists were extracted from the open payments database, maintained by the CMS ( https://www.cms.gov/openpayments/index.html ). Data collection was limited to the general payments data set from 2014, the first full year of data collected. This data set, released by CMS on June 30, 2015, includes payments made by applicable manufacturers to physicians for purposes not connected to a research agreement or protocol, and not related to investment or ownership. The general payments data summarize payments totaling $2.02 billion from 1444 companies to 607,000 physicians across all specialties. The data set includes, among other items, the names of the manufacturer reporting payment; the name, specialty, and a unique identifier for the physician receiving payment; the nature of payment received (eg, honorarium, consultant’s fee); and the amount of the payment. Analysis was limited to physicians identified as specialists in gynecologic oncology. Standard descriptive statistics were utilized.
Materials and Methods
Industry-reported payments to gynecologic oncologists were extracted from the open payments database, maintained by the CMS ( https://www.cms.gov/openpayments/index.html ). Data collection was limited to the general payments data set from 2014, the first full year of data collected. This data set, released by CMS on June 30, 2015, includes payments made by applicable manufacturers to physicians for purposes not connected to a research agreement or protocol, and not related to investment or ownership. The general payments data summarize payments totaling $2.02 billion from 1444 companies to 607,000 physicians across all specialties. The data set includes, among other items, the names of the manufacturer reporting payment; the name, specialty, and a unique identifier for the physician receiving payment; the nature of payment received (eg, honorarium, consultant’s fee); and the amount of the payment. Analysis was limited to physicians identified as specialists in gynecologic oncology. Standard descriptive statistics were utilized.
Results
Applicable manufacturers reported a total of $1,957,004 over 6948 direct, research-unrelated payments to gynecologic oncologists in 2014. A total of 153 companies reported at least 1 payment; however, the 10 manufacturers reporting the highest total payment amount accounted for 82% of all payments to physicians ( Figure 1 ). Furthermore, the 2 manufacturers reporting the highest total payments (Intuitive Surgical Inc and Genentech Inc.) together account for $1,137,647, or 58%, of the total payments reported by all 153 manufacturers. Median total payment per manufacturer was $332, with 25th and 75th percentiles $71 and $4339, respectively. Of payments from manufacturers, 99% were categorized as related to an educational event (29%), consulting fee (24%), travel and lodging (18%), speaking fee unrelated to education (15%), food and beverage (10%), and honoraria (3%) ( Figure 2 ).
In all, 765 gynecologic oncologists were identified as having received payments from manufacturers. This represents approximately 77% of gynecologic oncologists practicing nationwide; the Foundation for Women’s Cancer’s Find a Gynecologic Oncologist database identified 1007 board-certified and board eligible gynecologic oncologists in 2014. Median total payment to gynecologic oncologists identified in the general payments database was $219, with 25th and 75th percentiles $69 and $1205, respectively. In all, 48 gynecologic oncologists received >$10,000 in total payment from manufacturers (median $17,158), accounting for $1,202,228, or 61%, of the total payments. Another 48 physicians received between $5000-10,000 (median $6694), accounting for an additional 17% of total payments.
Comment
Three of every 4 gynecologic oncologists practicing in the United States received compensation from pharmaceutical or medical device manufacturers in 2014. This is consistent with a large, cross-sectional survey of multiple subspecialties estimating that annually upwards of 80% of physicians receive payment from industry. As the open payments database is increasingly accessed by patients, research participants, and the press, it is critical for physicians to verify the accuracy of entries under their names. Unfortunately, preliminary data released in 2014 contained significant inaccuracies. CMS reported later that year that the systemic errors accounting for the majority of these errors were corrected for the data to be released in 2015. Information on the process of disputing a disclosure is available at https://www.cms.gov/openpayments/about/resources.html .
Industry payments to physicians are intended to influence clinical behaviors, and they are successful in doing so. A review of 29 studies of the impact of industry interactions on physician behaviors and attitudes found that interactions with pharmaceutical industry representatives or speakers, compensated meals/travel/lodging, and honoraria consistently increased preferential prescribing patterns and requests to add sponsored medications to hospital formularies. Physician compensation from industry also correlates directly with overall increased health care spending, partially as a result of preferential prescribing.
Unfortunately, physicians are unlikely to be aware of their bias, and therefore unlikely to be able to consciously offset their industry-influenced preferences. Transparency policies assume that public disclosure of financial connections between physicians and industry will empower patient-consumers to: (1) avoid care from physicians who have an unacceptable degree of connection to industry, and (2) appropriately compensate for the known biases of physicians who have had interaction with industry. Both of these expectations are unrealistic. Access to specialty gynecologic cancer care is limited in much of the United States ; many women therefore do not have the luxury of seeking out an oncologist with the desired level of industry interaction. Patients are also unlikely to be able to assess and compensate for physicians’ treatment biases, even if aware of financial connections to industry. Some patients may paradoxically feel pressure to comply with recommendations to avoid seeming to mistrust their physician. Knowledge of financial relationships with industry is therefore likely to decrease patients’ trust in their physicians without recourse. It has been suggested that transparency could lead to social pressure on physicians to decrease interactions with industry. While there is evidence for a trend in this direction, overall prevalence of industry interactions remains very high.
Physicians are unable to identify and offset their own biases regarding industry, and patients cannot shoulder this burden themselves. How then, should transparency of possible conflicts of interest be managed in the clinical setting? Some lessons can be learned from attempts to manage financial conflicts of interest in clinical research. Personal financial interests (ie, not direct funding of research) are common in authors publishing oncology research. However, in 1 multicenter survey of cancer patients participating in clinical trials, a large majority would not change their decision to participate based on disclosure of investigators’ financial ties to the study medication; most patients furthermore thought that such ties are permissible. Most importantly, although 40% of participants thought direct disclosure to enrollees was important, an equal number thought that disclosure of a central mechanism to manage investigators’ financial interests was preferable. In our view, these considerations support monitoring of financial connections between physicians and industry by professional bodies, as a supplement to (if not a replacement for) direct disclosure to patients.
Professional societies, including the SGO, should establish guidelines regarding appropriate limits and management of personal compensation from industry, recognizing that partnership between clinicians and drug/device development is essential to innovations and improvements in clinical care. Societies’ existing guidance regarding financial conflicts of interest may not sufficiently address interactions with industry outside of research activities.
For example, the SGO policy and procedure statement on conflicts of interest currently applies only to society officers, board members, committee and task force members, and senior administrative staff. Further, the policy suggests as a litmus test “whether a particular interest or relationship, if disclosed to the full membership of the society would be likely to cause embarrassment for the society and/or the individual involved or evoke suspicion about the motives behind any society action.” Under the Sunshine Act, gynecologic oncologists’ financial relationships are publicly disclosed every year. Accordingly, the SGO should consider the development of best practices recommendations regarding financial interactions with industry targeted to the general membership, rather than simply members with special roles within the organization.
The American Congress of Obstetricians and Gynecologists (ACOG) official guidance on professional relationships with industry may be instructive, as many subspecialists are board-certified obstetrician-gynecologists and therefore are included in the intended audience for this document ( Table ). ACOG strongly discourages participation in industry-sponsored speakers’ bureaus, and recommends minimization of industry influence on continuing medical education activities, consistent with the policies of several other professional bodies. Of particular interest to surgical specialists, ACOG draws on the conflict of interest policies of the Society of Thoracic Surgeons and the American Association for Thoracic Surgery regarding industry-led training activities for medical devices.
