September 30, 2014
CMS Releases Open Payments Data; Concerns Raised Over Accuracy and Context
October 6, 2014—The Centers for Medicare & Medicaid Services (CMS) has announced the release of the first round of Open Payments data intended to help consumers understand the financial relationships between the health care industry and physicians and teaching hospitals. The Open Payments program was created as part of the Physician Payment Sunshine Act and passed into law under the 2010 Affordable Care Act. The physician payment dataset and other background are online at www.cms.gov/openpayments as of September 30.
According to CMS, the Open Payments program lists consulting fees, research grants, travel reimbursements, and gifts that the health care industry — including medical device manufacturers and pharmaceutical companies — provided to physicians and teaching hospitals during the last 5 months of 2013. The data are said to contain 4.4 million payments valued at nearly $3.5 billion attributable to 546,000 individual physicians and almost 1,360 teaching hospitals.
CMS advised that financial ties among medical manufacturers’ payments and health care providers do not necessarily signal wrongdoing. The agency stated that 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 also encourages patients to discuss these relationships with their health care providers.
In the agency's announcement, CMS Administrator Marilyn Tavenner commented, “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. 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.”
Shantanu Agrawal, MD, deputy administrator and director of the Center for Program Integrity at CMS, added, “Using this new data, it is now possible to conduct a wide range of analyses of payments made by drug and device manufacturers. Open Payments does not identify which financial relationships are beneficial and which could cause conflicts of interest. It simply makes the data available to the public. So 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.”
As summarized in the announcement, manufacturers submitted data to CMS this past summer, and CMS performed initial matching to aggregate payments to a single physician or teaching hospital. After the data were collected and displayed, registered physicians and teaching hospitals had the opportunity to review payments reported about them and dispute information they believed to be inaccurate.
CMS stated that more than 26,000 physicians and 400 teaching hospitals registered in the Open Payments system to review payments attributed to them. During the review and dispute period, CMS identified payment records that had inconsistent physician information, such as National Provider Identifier (NPI) for one doctor and a license number for another.
However, in response to CMS's action, the American Medical Association (AMA) issued a statement from President Robert M. Wah, MD, advising that the AMA was "very concerned about the accuracy of the data released" by CMS, while noting significant problems with the Open Payments reporting process and citing the figures quoted by CMS.
Dr. Wah stated, "Only 26,000 physicians out of the nearly 550,000 physicians affected by the Sunshine Act were able to register to review their data and seek correction of any inaccuracies. CMS provided a short period of time to review and correct any inaccurate data that was submitted by industry. Several factors unfortunately hindered participation by many of the physicians impacted including a complex, non–user friendly, and cumbersome registration process to review data and request corrections of any inaccuracies. Meanwhile, the government website was plagued by repeated shutdowns and other issues. Notably, CMS has indicated problems with one-third of the data, which raises significant questions about the accuracy of the data content."
In comments to Endovascular Today, Steven K. Ladd, Founder and President of Primacea, Inc., discussed some of the issues encountered in the Open Payments rollout. Mr. Ladd and his colleague Steven J. Cagnetta, Founder and Chief Counsel at Primacea, are the authors of the Physician Counsel column that addresses topics such as Open Payments and transparency in physician-industry collaborations in Endovascular Today.
“It wasn’t that doctors couldn’t eventually complete the registration and forms, it was that it was extremely frustrating and time-consuming to do so," commented Mr. Ladd. "Physicians are willing to comply with the program, but after hours of dealing with confusing instructions, system glitches, and failed inputs, many gave up.”
Another significant shortcoming of the program is the lack of “contextual usage” information being provided. Mr. Ladd noted that in working with his client-physicians on complying with the Open Payments program, very few payment reports had provided the contextual information that should explain the reason for a company’s compensation (ie, consultation on drug or device development, conducting a clinical study, presenting or attending an education seminar on product). He observed that this is the most important aspect of the program—why the compensation is being paid. Not only was this information rarely provided by companies in the first round of Open Payments data, the request for the explanation is deep down in the form and easily overlooked by physicians. Of all the millions of payment reports, it would not be surprising if only a small fraction had completed contextual usage section, stated Mr. Ladd.
Mr. Ladd indicated that CMS and the contractor who built the system made it very difficult for the health care organizations and physicians to get information into it, as well as for the public to get information out of it.
“It seems that there was never an attempt to have a usable interface experience as part of the program’s process," said Mr. Ladd. "Any good software developer knows that in order to make a good online experience, you must spend time thinking about how each user will engage the site. Based on the number of click-throughs required and the nonintuitive design, clearly, not much time was spent here. The CMS contractor created a system that may have fulfilled the letter of the law, but the spirit of the law — providing genuine transparency — is completely lost. Nothing about this program carries out the desired “sunshine” effect of providing the public a clear understanding of the relationship of the medical industry and healthcare providers.”
The AMA's statement on the Open Payments release supports the overall goals of the initiative, but expresses serious concerns regarding the effects of a flawed execution.
"Patients deserve to have access to accurate information, yet publishing inccurate data leads to misinterpretations, harms reputations, and undermines the trust that patients have in their physicians. It can also discourage research and care-delivery improvements that benefit patients," said Dr. Wah in the statement. "While the AMA strongly opposes inappropriate, unethical interactions between physicians and industry, there are relationships that can help drive innovation in patient care and provide significant resources for professional medical education that ultimately benefits patients. We look forward to working with CMS to improve the Open Payments system to ensure the data is presented in an accurate and informative way to help patients understand and interpret the information correctly."
In its announcement, CMS stated that in cases in which the agency was unable to match the physician information or the record was not available for review and dispute, but the company had attested that the payment had been made, the personally identifiable information has been suppressed temporarily in the record. Approximately 40% of the records just published are deidentified. The agency says that this data will be fully identifiable in 2015 after the reporting entity submits corrected data, and physicians and teaching hospitals have had a chance to review and dispute the data. In addition, data that were disputed and not resolved by the end of the September 11 review period have not been published and will be updated at a later date.
Over time, CMS expects to make enhancements such as introducing new tools to allow for easier data searches. This improved search functionality will be intended to allow users to more easily review payments received by their personal physician or search criteria such as specialty, location, or types of payments received.
Beginning in June 2015, future reports will be published annually and will include a full 12 months of payment data.