Physicians Still Foggy on Accuracy of Sunshine Act Data

On September 30, the Centers for Medicare & Medicaid Services (CMS) released the first round of Open Payments data. More than 4 million payments – valued at almost $3.5 billion – from drug and device companies to physicians and teaching hospitals between August 1 and December 31, 2013, were detailed – valued at almost $3.5 billion.

This data release is part of the Physician Payments Sunshine Act, created by the Affordable Care Act, which was designed to increase transparency and accountability in health care by publically listing consulting fees, research grants, travel reimbursement, and other gifts received by physicians and teaching hospitals from manufacturers.

However, many physicians are asking the $3.5-billion question: How accurate are the data detailed in the Open Payment system?

On the same day as the data release, American Society of Hematology President Linda J. Burns, MD, released a statement on behalf of ASH expressing concerns about these data, pointing out that the data in the system “are only beneficial if they are complete and accurate.” Dr. Burns was not alone in her concerns – the American Medical Association issued a statement expressing similar sentiments.

ASH Clinical News recently spoke with Dr. Burns, and Raed Dweik, MD, a lung specialist and chair of the Innovation Management and Conflict of Interest Committee at the Cleveland Clinic, about the Sunshine Act, the initial release of data, and possible improvements to the transparency process in health care.

Echoes of Another Problematic Government Website Launch …

A quick refresher of the bumpy road to this data release: To meet the requirements of the Sunshine Act, pharmaceutical and device manufacturers had to submit payment information to CMS in summer 2014. Physicians were not required to register with the website (OpenPaymentsData.CMS.gov), but had to register if they wanted a chance to review – and possibly dispute – any submitted payment information before it was released to the public. CMS originally allotted a 45-day period from July 14 to August 27 for physicians to review and dispute the data, followed by a 15-day correction period.

According to Dr. Dweik, the Open Payments system and CMS put together a thorough system designed to properly identify physicians in an attempt to reduce the possibility of reporting errors.

“When registering for the website, it verified your identity almost like you were getting a credit card,” Dr. Dweik said. “You had to enter your name, Social Security number, medical license number, and answer questions like, for example, ‘Who held your last mortgage?’”

Dr. Dweik gave CMS credit for the rigorousness of the registration process. Prior to Open Payments, he said, several websites attempted to provide similar transparency in the health-care industry, but these sites lacked a vetting process and often reported erroneous “conflicts of interest” for physician “Jane Smith,” who may not have been the correct “Jane Smith” with the conflict.

However, this rigorous registration process also carried some drawbacks. According to Dr. Burns, it was a bit frustrating.

“I am an educated person and even I had difficulty registering,” Dr. Burns said. “The first time I attempted to access the site I spent about an hour trying to get in, only to have the system go down.”

On August 3, within a month of opening the Open Payments system for review and dispute, CMS was forced to pull the site down temporarily after at least one physician reported that the data posted in his profile had been mixed together with the information of another physician with the same name.

After resolving a “technical issue,” the Open Payments site was re-opened August 15, and the review period was extended to account for the days when the website was offline.

Are These Data Complete and Accurate?

Dr. Dweik also spent time registering for the Open Payment website and reviewing his list of manufacturer payments. Among his payments, he noticed a listing for a lunch that he knew he did not attend, and he entered a dispute for the payment.

In an attempt to keep any potential conflicts visible, the Cleveland Clinic maintains a comprehensive conflict-of-interest database for its employees. As chair of its Conflict of Interest Committee, Dr. Dweik was familiar with both his own payments, and those listed for the hospital.

“When the [Open Payments] system went back up, I reviewed the data for the Cleveland Clinic and myself, and noticed that a lot of information was missing,” Dr. Dweik said. “[CMS] said it estimated that about 30 percent of data were missing, but I think it is probably more like 70 percent.”

The lunch payment disappeared when the Open Payments system went public in September. Dr. Dweik does not know whether the manufacturer agreed with his dispute and removed the payment, whether CMS decided not to publish all of the disputed data, or whether it is part of the information that was missing when the system re-launched.

Data Without Context

Even in cases where the published payment information is accurate and complete, Drs. Burns and Dweik are both concerned by the fact that the website provides so little context for the public – especially considering that the site was originally designed to inform and educate patients.

“I support transparency, but I also want people to be aware that there have to be relationships between physicians and industry to help further the practice of medicine,” Dr. Burns said. “Conflict-of-interest measures are clearly put into place to ensure that physicians act in an appropriate manner, but it will only harm patients if we are not able to continue to have close working relationships to bring novel drugs and devices to patient care.”

Dr. Dweik also fully supports the idea of transparency. The major difference, though, between the conflicts of interest made public on Cleveland Clinic’s website and those made public in the Open Payments system, is that the Cleveland Clinic attempts to put these relationships in context for its patients as part of the overall individual physician profile, he said.

“With the CMS system, patients can see if a physician was paid a certain amount, but they have no way of knowing if that amount was reasonable or not,” Dr. Dweik said.

The Open Payments system could detail a variety of industry/physician relationships. Some of those relationships are appropriate, Dr. Dweik said – for example, attending an industry-sponsored educational lunch, helping to invent a device or procedure and receiving royalties, or possibly being a sought-after thought leader in a particular specialty. In other cases, the ethics of the relationships might be more questionable.

In a statement announcing the publication of the data, CMS wrote: “Financial ties among medical manufacturers’ payments and health-care providers do not necessarily signal wrongdoing. Given the importance of discouraging inappropriate relationships without harming beneficial ones, CMS is working closely with stakeholders to better understand the current scope of the interactions among physicians, teaching hospitals, and industry manufacturers. CMS encourages patients to discuss these relationships with their health-care providers.”

In addition, CMS does provide a page on its Open Payments website called “Open Payments Data in Context” to help users learn about Open Payments and what it may mean for physicians, industry, and patients.

“We believe a system like [Open Payments] would be most helpful if it provided contextual information, and that is not necessarily the case right now,” Dr. Dweik said.

Public Access and Transparency

Finally, Dr. Dweik mentioned that the current Open Payments search system it not very user-friendly. Although the goal of the site is to get potential conflicts of interest out to the public, Dr. Dweik questioned how easily the public will even be able to gain access to this information.

Case in point: A Google search for “Sunshine Act” – arguably the most popular term associated with the financial relationships between the doctors and medical manufacturers – does not point to the Open Payments website. Interested parties need to know the name “Open Payments” to find the appropriate site. Once on the homepage, it is not immediately evident how one could begin to search for a specific physician’s name and payment information.

(Editor’s note: In response to complaints about the difficulty in searching the Open Payments database, CMS implemented a search tool option on October 17, allowing users to search “identified data” for physician name, teaching hospital, or company making payments. “Identified data” refers to data that were matched by CMS to a single doctor or teaching hospital and available for review and dispute for 45 days. However, according to CMS, a significant portion of the first wave of Open Payments data is “de-identified” due to inconsistent and inaccurate payment information and, thus, not searchable with this tool.)

While more work may be necessary to improve the Open Payments system, Dr. Burns said that ASH fully supports the idea of transparency in the industry and the Sunshine Act and encourages physicians to take the requirements of the law very seriously.

“Our membership needs to be aware of how the Sunshine Act affects them and affects the health-care industry,” Dr. Burns said. “Any questions they have should be forwarded to ASH, which is working for them on a national level.” — By Leah Lawrence


References

  • American Society of Hematology. Statement from ASH President Linda J. Burns, MD, on release of Sunshine Act data. www.hematology.org/Newsroom/Press-Releases/2014/3250.aspx. Accessed November 3, 2014.
  • Centers for Medicare & Medicaid Services. Open Payments System Reopens, Extends Physician Registration and Review Period. www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2014-Press-releases-items/2014-08-15.html. Accessed November 3, 2014.
  • Centers for Medicare & Medicaid Services. Open Payments data fact sheet. www.cms.gov/OpenPayments/Downloads/Fact-Sheet-Sept-30-2014-Published-Data.pdf. Accessed November 3, 2014.
  • David Mann. Dark clouds for the Sunshine Act. www.epstudiossoftware.com/?p=1536. Accessed November 3, 2014.

SIDEBAR

Follow the Money

During a five-month period in 2013, drug and device manufacturers paid doctors and teaching hospitals nearly $3.5 billion. Here’s a brief breakdown of where that money went:

  • Research payments: $1.49 billion
  • Speaking and consulting fees: $380 million
  • Royalties and licenses: $302 million
  • Promotional talks and honoraria: $228 million
  • Consulting: $158 million
  • Travel, lodging, and entertainment: $96 million
  • Food and beverage: $93 million
  • Grants, education, and facilities: $70 million
  • Training: $19 million
  • Ownership and investment: $11 million

These payments were made to approximately 546,000 individual physicians and almost 1,360 teaching hospitals, from 1,419 manufacturers and group purchasing organizations who reported payments. As of September 30, 2014, a small portion of physicians and hospitals registered to review payments – but that number will likely increase:

  • More than 26,000 physicians and 400 teaching hospitals registered to review payments
  • 12,579 records were disputed
  • 9,000 record disputes remained unresolved
  • 17,994 records were affirmed

Stay tuned for another refresh of Open Payments data: Beginning in June 2015, future reports will be published annually and will include a full 12 months of data.

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