Were you watching last week when the most eligible bachelor in the world got married? The $13 million George Clooney wedding generated the expected hoopla, with crowds of boats churning the canals of Venice snapping photos of the bride and groom. Like many before, this event focused on high-profile people, but soon people may take a backseat to the modern headliner: Big data.
If you read The Wall Street Journal, The New York Times, The Chicago Tribune, or your email medical highlights, then you surely caught the splash last week about the CMS Open Payment website. Everyone is talking about this first glimpse of the data covering industry payments to physicians. Given the controversy, CMS is quick to note that public release of this data is required by Section 6002 of the Affordable Care Act (ACA). This transparency reporting program is commonly called the Sunshine Act.
Open Payments Reporting
A Federally run program, Open Payments publishes the payments physicians and teaching hospitals receive from industry, including pharmaceutical companies and medical device manufacturers. Any payment or benefit of greater than $10 at one time or an aggregate of greater than $100 in the course of a year qualifies for reporting. For example, if a pharmaceutical representative provides dinner at a cost of $200 for a practice with 10 doctors, then each doctor would have received a benefit or payment of $20, which must be reported. The reporting is done by industry, in this case the pharmaceutical or medical device company ,to prevent creating a reporting burden for the providers.
The data on Open Payments lists each individual physician payment in one of 3 categories: general payments, research payments, and physician ownership or interest. Of note, the ownership or interest in a manufacturer extends to the immediate family of the physician including spouses and children. 40% of records are de-identified due to data discrepancies like mismatched NPI numbers and names. It is also reported that 30% of records were incomplete and couldn’t be published at this time.
The first data published on September 30 included reporting from August 1, 2013 to December 31, 2013. During that time 4.4 million payments totaling $3.5 billion were made to 546,000 physicians and 1,360 teaching hospitals. This averages to $795 per payment, but the distribution of payments is unclear. Many physicians received small honoraria for speaking or meals while other physicians received millions of dollars in payment to support clinical research projects.
CMS Open Payments Perspective
A May 2013 New England Journal of Medicine article, “The Sunshine Act – Effects on Physicians” by Shantanu Argrawal and Peter Budetti from the CMS Center for Program Integrity along with Niall Brennan from the CMS office of Information Products and Data Analytics, provides background information for the Open Payments program. Interest in public disclosure of industry physician relationships began after the 2007 publication of the NEJM article, “A National Survey of Physician-Industry Relationships” by David Blumenthal and others. This 2007 study revealed that 94% of U.S. physicians had a “relationship with industry “as follows:
- 83% of physicians had received gifts
- 28% had received payment for services
- 60% of the payments were related to Medical Education
- 40% went to physicians who were involved in developing Clinical Practice Guidelines
As a result of this 2007 survey, the Institute of Medicine (IOM) published recommendations to physicians to limit and manage relationships that might produce conflicts of interest, and the American Medical Association (AMA) and other provider groups adopted codes of ethics.
According to the 2013 NEJM Agrawal article, the Sunshine Act Open Payment public reporting of industry and physician relationships should help “more informed and engaged healthcare consumers to choose physicians using this information along with publically available quality and resource utilization data.” The fact that Dr. Agrawal is the Medical Director for the CMS Center for Program Integrity whose stated mission is “to prevent and detect waste, abuse, and fraud in Medicare and Medicaid” highlights the controversy: Is the public list designed to help consumers talk to their doctors or to shine a public light on physician misbehavior?
CMS has repeatedly stated that the purpose of Open Payments is to “shed light on the nature and extent of these financial relationships…without harming beneficial ones.” In other words, “Just because there are financial ties doesn’t mean that anyone is doing anything wrong.” CMS and Congressman Chuck Grassley insist that Open Payments is a “consumer resource,” meaning that when patients see their physicians they can inquire about these relationships and be reassured that their care is not being influenced by pharmaceutical companies and Group Purchasing Organizations (GPOs).
The Open Payments Debate
The debate from the AMA and others is that the net is big and most of these manufacturer-provider relationships are valuable and important for healthcare innovation. However, being on the list will feel like public shaming to many physicians. This large data set does not provide enough context for anyone, much less patients, to make any determination about the appropriateness of the relationship. As a result, the data can be misleading. In addition there are significant concerns about inaccurate data. In fact, 40% of the publicly reported data had to be de-identified and about 30% of the records submitted to CMS couldn’t be published at all due to data discrepancies.
On behalf of the AMA, Randi Kahn* offered a good summary statement following the Open Payment website publication:
“Patients deserve to have access to accurate information, yet publishing inaccurate 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.
“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.”
It might be wise to visit Open Payments to search for your name in case your patients have any questions. Let us know what you think about the value of the Open Payments website for patients. Are patients asking you about your relationships with industry? We invite you to share your thoughts and experiences in the comments.
Addendum:
Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations
Excerpt of 42 CFR Parts 402 and 403
[CMS–5060–F]
RIN 0938–AR33
Medicare, Medicaid, Children’s Health
Insurance Programs; Transparency
Reports and Reporting of Physician
Ownership or Investment Interests
2. Transparency Overview
We recognize that collaboration among physicians, teaching hospitals, and industry manufacturers contributes to the design and delivery of life-saving drugs and devices and we received many comments supporting this statement. However, as discussed in the proposed rule and in the public comments submitted, payments from manufacturers to physicians and teaching hospitals can also introduce conflicts of interest that may influence research, education, and clinical decision-making in ways that compromise clinical integrity and patient care, and may lead to increased health care costs.
We recognize that disclosure alone is not sufficient to differentiate beneficial financial relationships from those that create conflict of interests or are otherwise improper. Moreover, financial ties alone do not signify an inappropriate relationship. However, transparency will shed light on the nature and extent of relationships, and will hopefully discourage the development of inappropriate relationships and help prevent the increased and potentially unnecessary health care costs that can arise from such conflicts.
*Media Contact: Randi Kahn, AMA Media & Editorial, (202) 789-7442, Randi.Kahn@ama-assn.org
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