Published 11/1/2014
Elizabeth Fassbender

Problems Overshadow Sunshine Act Data

Database includes big numbers but little context; substantial data missing

The Open Payments (Sunshine Act) database that opened on Sept. 30 was supposed to shed light on the financial relationships between drug and device makers and physicians and teaching hospitals. But according to media and consumer advocates, the website design, missing data, and lack of context has made analyzing those relationships difficult. Their complaints echo those of physicians who, for months prior to the data release, tried to access the system to review the information submitted by industry about them.

According to the Centers for Medicare & Medicaid Services (CMS), the Open Payments database contains 4.4 million payment records valued at nearly $3.5 billion attributable to 546,000 individual physicians and almost 1,360 teaching hospitals. Payments cover consulting fees, royalties, research grants, travel reimbursements, and other gifts, from more than 1,400 manufacturers and group purchasing organizations (GPOs). The disclosure rules apply to a wide range of medical professionals, including physicians, dentists, chiropractors, podiatrists, and optometrists who are legally authorized to practice.

Not only is the data difficult for the average consumer to interpret without additional context, but the website itself is far from user-friendly. Uploading the data for analysis can take hours; searching for an individual’s name results in either a blank page with no explanation or a multitude of columns that require constant scrolling to identify payment amounts, payers, and the form and nature of the payments.

“Good luck to the consumers heading to the website to see if their doctors are getting money from drug and device makers. Or the doctors trying to check whether they or their colleagues are in it,” wrote reporter Charles Ornstein in the New York Times. (As this issue of AAOS Now went to press, CMS released a search tool that made it faster to find physicians and identify types of payments. However, multiple listings for the same physician may be found, indicating that further refinement of the database is needed.)

Sunshine stats
Those who have taken the time to analyze the data have released the following information:

  • The typical doctor on the list received about $1,750 during the August to December 2013 reporting period.
  • At least 130 doctors received more than $100,000 during that same period.
  • Research funding accounted for nearly $1.5 billion of payments during the reporting period.
  • An additional $302 million was paid as royalties and licenses.
  • Approximately $2.2 billion in payments was published as “de-identified” data, meaning that it appeared without a recipient physician name or teaching hospital.
  • Another $1.1 billion in payments was not published by CMS; approximately half of that amount was due to unresolved disputes at the end of the review period and the other half due to requests by manufacturers and GPOs for a delay in publication.

“CMS is committed to transparency, and this is an opportunity for the public to learn about the relationships among health care providers, and pharmaceutical and device companies,” said CMS Administrator Marilyn Tavenner. “This initial public posting of data is only the first phase of the Open Payments program. In coming weeks, we will be adding additional data and tools that will give consumers, researchers, and others a detailed look into this industry and its financial arrangements.”

Disputed data
As previously reported in AAOS Now, physicians who registered on the CMS Enterprise Portal had the opportunity to review and dispute the reported information that they believed was inaccurate or incomplete. However, many physicians insisted that the window for correcting payment information was too short and that technical issues together with a difficult registration process prevented them from identifying errors in their profiles.

According to CMS, approximately 26,000 physicians and more than 400 teaching hospitals registered to review their data. More than 12,500 records were disputed, and three quarters of the disputes remained unresolved at the end of the review period.

As a result, about 40 percent of the records were de-identified due to inconsistent physician information and about one-third of the data was withheld due to concerns about the accuracy of the submitted information.

CMS also noted that about 190,000 research payments for products that haven’t been approved or for new uses of existing products were not made public. Another 199,000 payments were not included due to issues such as trade secrets.

Influence or innovation?
The Open Payments program was mandated by Congress and is the latest effort by CMS to make healthcare cost data available to the public and is meant to “help consumers understand the financial relationships between the health care industry, and physicians and teaching hospitals.” The push for greater transparency was largely driven by concerns that financial ties between doctors and industry may alter prescribing decisions or lead to other conflicts of interest.

Although supporters of the transparency initiative believe the efforts will “provide useful information to patients about the relationships their doctors have with industry and to curb the influence of payments on medical care,” according to an article in the Wall Street Journal, many companies and physician organizations defend payments as “necessary to conduct research and communicate how products should be used.”

The New York Times also acknowledged the dual impact of these interactions: “While some relationships may leave doctors open to scrutiny, other ties are important for innovation.” For example, physicians should be compensated for legitimate interactions that serve to advance medicine. These payments might include royalties, licensing fees, grants, and rental fees associated with education.

CMS also notes that financial ties between manufacturers and healthcare providers do not necessarily signal wrongdoing. “While these data could discourage payments and other transfers of value that might have an inappropriate influence on research, education, and clinical decision-making, they could also help identify relationships that lead to the development of beneficial new technologies,” said Shantanu Agrawal, deputy administrator and director of the Center for Program Integrity at CMS.

According to Sen. Chuck Grassley (R-Iowa), co-author of the Sunshine Act, transparency shouldn’t stop doctors from receiving appropriate payments. Rather, the program “should empower consumers to learn whether their doctors take payments and if so, why, and whether that matters to them,” he wrote. “Eventually, the database will become a valuable resource for all of us with a stake in our country’s healthcare system—individual consumers, insurance companies, and taxpayers who pay for Medicare and Medicaid.”

Next steps
Steps to further refine the database are already under way. CMS plans to release information about payments made during 2014 in June 2015; it will also update the 2013 data to include the currently de-identified and disputed information. To help physicians ensure that industry reports about them are accurate, CMS has developed a payment tracking mobile app.

On Sept. 18, 2014, Rep. Michael Burgess (R-Texas) introduced H.R. 5539, which would amend the Sunshine Act by excluding the value of “peer-reviewed journals, journal reprints, journal supplements, and medical textbooks” from the reporting requirement. The legislation would also add the following to the current list of reporting exclusions: “[a] transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician.” The move comes after numerous medical societies and legislators unsuccessfully urged Ms. Tavenner to exclude the distribution of textbooks and scientific peer-reviewed medical journal materials from the reporting requirements under the Sunshine Act.

At the 2014 Board of Councilors/Board of Specialty Societies Fall Meeting, Robert M. Portman, an attorney with the firm Powers Pyles Sutter & Verville PC, provided an overview of the Sunshine Act and steps physicians can take. “It’s likely that several things will be reported as indirect transfers of value that physicians didn’t anticipate,” he noted. He advised AAOS members to keep track of any payments they receive so that they can later dispute information reported, review the information submitted by manufacturers, initiate disputes as soon as possible, and develop talking points to use with patients or media.

Elizabeth Fassbender is the communications specialist in the AAOS office of government relations; she can be reached at fassbender@aaos.org

Bottom Line

  • The Open Payments database includes information on financial relationships (payments and other transfers of value) between physicians and other healthcare professionals and manufacturers and group purchasing organizations.
  • Considerable controversy has surrounded the release of the data as a result of numerous errors and delays; at least one-third of the data has been withheld from the initial public release.
  • Physicians should track their interactions with industry, review the data, and dispute any errors to ensure the accuracy of the data released to the public.

Whats Covered?

Additional Information: