The Open Payments Database has been operating for 3 years
The Physician Payments Sunshine Act (PPSA), a component of the Affordable Care Act, is a disclosure law requiring drug, device, and biologic companies to report transfers of value to physicians and teaching hospitals to the Centers for Medicare & Medicaid Services (CMS). Companies began recording data in 2013, and datasets are released annually on the Open Payments database (OPD).

This article analyzes data from OPD records from August 2013 to December 2015, covering general, ownership, and research payments. The overall data set was grouped by recipient, specialty, payment type, number, and value. Orthopaedic data were further analyzed by specialty and individual physician.

Overview of the 2013–2015 data
As of our analysis, the OPD contained 29 months of payments data, which translate to approximately $16.77 billion, including 28.2 million payments to 812,000 physicians and 1,180 teaching hospitals. Half the total value has gone to research, a third to general payments, and the remainder to ownership interests, which include physician stocks, loans, bonds, and shares in applicable manufacturers. Teaching hospitals receive approximately one-quarter of general payments and more than 95 percent of "covered-recipient" research payments. All ownership interests go to physicians.

The general payments category covers any nonownership or research payments, and includes the following:

• food and beverage
• travel and lodging
• entertainment
• honoraria
• gifts
• royalty and licensure payments
• grants
• consulting fees
• educational expenses
• charitable contributions

Although general payments comprise most recorded data, they account for a third of the value ($2 billion annually). Within this category, royalty and license payments account for approximately 35 percent of the total, even though they represent just 0.12 percent of all records. Food and beverage comprises approximately 85 percent of records yet represents less than 10 percent of the value. Relative values of the categories within general payments have not changed over time.

The average general payment to physicians was $183, while that to teaching hospitals was $12,500. If divided equally among all physicians, each would receive approximately $3,750 annually, with approximately $650 for food, beverage, travel, and lodging.

In 2014 and 2015, more than 2,100 general payments were $0.01 or less; more than 300,000 were valued at $1 or less. Approximately 4 million payments were $10 or less, and 20 million (approximately 90 percent) were less than $100.

Of the nearly 500 specialties represented in the OPD, general orthopaedic surgeons received the largest proportion of general payments in all recording years. Other top grossing specialties included general internal medicine, cardiology, and neurosurgery.

The proportions of general payments vary among surgical and medical specialties. The largest proportion of payments to surgical subspecialties were royalty and licensure payments, while those to medical specialties were compensation for nonconsulting services. Food, beverage, travel, and lodging, when divided on a per-physician basis, were not significantly different.

Ownership payments
Ownership payments accounted for approximately $1 billion annually. Of the 620,000 physicians listed, only 4,500 received ownership payments. Specialties with the most ownership payments were internal medicine (58 percent of the total), orthopaedic surgery (14 percent), and cardiovascular disease (12 percent).

Research payments
Research payments comprise the largest proportion of general payments—$9.5 billion of $16.8 billion. As expected, most payments were to teaching hospitals. Specialties receiving high amounts of research payments included internal medicine, ophthalmology, and psychiatry. Orthopaedic surgery ranked 12th in 2013 and 2015, and 18th in 2014.

Although it is relatively easy to determine who receives general and ownership payments, it is difficult to determine where most research payments go. Some are unidentified due to the exemption allowing delay in publication for research and development; most, however, are categorized to "noncovered recipient" entities and individuals (not a teaching hospital or physician), making these essentially inaccessible to the public.

Orthopaedic surgery
Of the 620,000 physicians in OPD, orthopaedic surgeons number approximately 22,000 (approximately 78 percent of practicing surgeons who do receive some sort of payment as detailed in the OPD) and receive approximately 20 percent of the total payment value. If total general payments to orthopaedic surgeons were divided equally, each would have received approximately $18,000 annually.

This number, however, is misleading because the median annual payment per surgeon is $375. For the top 10 percent of orthopaedists, however, median annual payments rise sharply to approximately $41,000, and for the top 1 percent, payments approach $650,000. Most (93 percent) of the general payments to the top 1 percent of orthopaedic surgeons represent royalty and licensure payments.

Within orthopaedics, the largest proportion of general payments went to general orthopaedic surgeons, followed by the specialties of spine and adult reconstruction. Although food and beverage payments account for almost 90 percent of all transactions to physicians (10 percent of total value), they account for 70 percent of records (2 percent of value) to orthopaedic surgeons. Conversely, although royalty and license payments to orthopaedic surgeons constitute just 2.5 percent of records, they dwarf other categories in value, accounting for more than 70 percent of value (vs. 35 percent to other physicians).

Data access and cost of compliance
To date, the 2013–2015 General Payment datasets (https://openpaymentsdata.cms.gov) have been accessed fewer than 10,000 times, with an estimated 24,000 views per month and approximately 39,800 total visits during a 6-month period. Conversely, CMS, in its April 2016 Report to Congress, stated that OPD had 1.1 million unique page-views, and that the OPD had been downloaded almost 50,000 times.

CMS estimated the cost of the first dataset at $269 million, with projected annual costs exceeding $180 million. Other sources estimate the cost at $200,000 per company per year, making the annual cost approximately $300 million.

Inconsistencies in data
Although CMS has reduced the number of inconsistencies in data recording, several problems remain. Multiple reports of inaccurate data and conflicting numbers have been published. A study comparing the financial disclosures of 537 cardiologists to those made by pharmaceutical companies found an error rate of 71.6 percent. Another study found that more than 90 percent of companies had incorrectly identified a physician. Additionally, 43,571 physicians (7 percent of the total) were misclassified from 2014 to 2015. Finally, several orthopaedic residents have found they were listed on OPD, despite residents not being a reportable class.

What does the data mean?
Since the inception of the PPSA, pharmaceutical, device, and biologic manufacturers, as well as teaching hospitals, physicians, and CMS have expended significant resources to collect, report, and confirm these data.

The values distributed annually have remained consistent, with the largest proportion to research. Although most records are for food and beverage, these payments account for slightly more than 3 percent of the total value. Specialties receiving the largest proportion of general payments are those with the largest numbers of physicians (internal medicine), or those significantly involved in device or pharmaceutical development (orthopaedic surgery/cardiovascular medicine).

Analysis of OPD datasets is difficult, due partly to their intrinsic inaccuracies and massive size. Vastly different results have been reported in publications analyzing the 2013 dataset. Additionally, although OPD now allows searching by individual physician, contextual information is limited, making it difficult for patients to interpret the data or use it to make better-informed healthcare decisions.

Data collection requires tremendous cost, estimated between $200 million and $300 million annually. This does not include the cost and inconvenience that physicians and teaching hospitals incur during the reporting process. With more than 90 percent of payments less than $100, and hundreds of thousands of payments of $1 or less, it remains to be seen whether this level of transparency is worth the significant administrative burden.

Additionally, it is not clear that patients care. Although patients favor transparency and disclosure, several studies have concluded minimal influence of physician-industry interactions on the decision-making process. At this time, according to OPD, all general payment datasets combined had been accessed less than 10,000 times; additionally, two separate Internet analytic software databases reported relatively few website visits.

Long-term implications of the PPSA remain unclear. Although slight variations occur from year-to-year, the number, proportion, and value of payments have remained relatively stable. No evidence supports the impression that the PPSA has caused substantive change in prescribing habits or implant use. Publication of OPD data has not affected industry-physician relationships or industry-supported research. Although a Massachusetts study found a decrease in overall payments and in the number of recipient physicians, with an increase in average payments, a similar effect has not been shown nationally. At the time of this publication, no lawsuits resulting from PPSA data have occurred.

Thomas J. Parisi, MD, JD; Daniel Levy; Richard W. Rutherford, MD; Jason Jennings, MD; and Douglas A. Dennis, MD, are with Colorado Joint Replacement, Porter Adventist Hospital, in Denver. Harry E. Rubash, MD, is with the department of orthopaedic surgery at Massachusetts General Hospital, Boston.

Updated Law
Since its adoption on Feb. 15, 2013, the PPSA has undergone multiple revisions. Exemptions for reporting indirect compensation to physician speakers at CME events have been removed and are reported in the 2016 dataset. Also new is the requirement to report the market name for drugs, biologics, devices, and medical supplies. Reporting of stocks, stock options, and ownership interest payments as distinct categories will also be required. Additionally, the 2016 dataset no longer reports payment records with no value.

Two additional bills have been introduced but have not yet passed the House or the Senate. One would expand "covered recipients" to include nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, certified nurse-midwives, and physician assistants. The other bill would exempt companies from disclosing textbooks and medical journals given to physicians, as well as payments for CME and speaking engagements that do not promote a specific product.

Open Payments Program Information
Physicians may register at any time and AAOS strongly encourages early registration so that inaccurate or incomplete data can be identified and issues resolved before the data are made public. For more information and links to CMS resources on the Open Payments program, consider visiting the following webpages:
AAOS resources: www.aaos.org/Advocacy/Sunshine
CMS resources: www.cms.gov/openpayments

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