In a March 2013 post on the Insider blog, we noted the issuance by the Centers for Medicare and Medicaid Services (CMS) of a long-awaited final rule mandating the collection of information regarding payments that drug and device manufacturers have made to physicians and teaching hospitals. As we noted in the post, the rule was promulgated pursuant to the “Physician Payments Sunshine” provisions that were part of the Affordable Care Act, and the goal of the rule was to provide transparency into the financial relationships that exist between physicians and industry. In a preliminary effort to assess the potential utility of the payment data that was to be released, our post reviewed the “Dollars for Docs” database that the investigative entity ProPublica maintains on its website, and found that while the ProPublica database provides extensive and noteworthy information, it perhaps raises more questions than it answers about the monetary relationships between medical professionals on the one hand, and manufacturers on the other.
Perhaps not surprisingly, the post regarding the Physician Payments Sunshine provisions and the “Dollars for Docs” website produced its own share of debate and controversy. For example, in thoughtful and measured comments regarding our post, ProPublica Senior Reporter Charles Ornstein responded that the blog post “ma[de] it appear that patients could find out more about these payments somewhere outside of Dollars for Docs,” when in fact the ProPublica database compiled information that resided in multiple “sub-websites” and was “not easy to search, analyze or sort.” Mr. Ornstein further noted that ProPublica provided patients with a checklist of questions that they could ask their doctors about the financial relationships at issue. And, based on the mutually-held view that “more information would be useful about the payments,” Mr. Ornstein expressed the hope that we would “use further columns to advocate that the necessary context be made available by the [drug and device] companies.”
Now, over eighteen months later, the CMS database regarding industry-to-physician payments – which the CMS now refers to as the “Open Payments” system – has finally gone live. In fact, just yesterday CMS released the physician payment data that it obtained from manufacturers and group purchasing organizations for the period from August through December 2013. Extensive review of the data and assessment of its presentation has no doubt already commenced, and given the reputational issues at stake, debate will certainly soon follow as to whether the Open Payments system lives up to the goals that it was intended to achieve.
Notably, though, even the lead up to the final launch of the Open Payments database was marked by a considerable degree of controversy, discord, and dispute. For example, on August 15, 2014, after a period of time in which physicians and teaching hospitals were able to register on the system and access the data relevant to them, the American Medical Association (AMA) issued a press release in which it contended that physicians have not been able to review and seek correction of the data submitted about them, and further asserted that “poor functionality” of the government website would contribute to the publication of inaccurate data. Approximately two weeks later, on August 28, 2014, the AMA issued another press release, asserting that ongoing technical issues with the Open Payments system demonstrated that it was “not ready to go public,” and warning that the release of inaccurate information could “lead to misinterpretations, harm reputations and cause patients to question trust in their physicians.”
Several industry trade groups also joined in the criticisms. On September 22, 2014, theAdvanced Medical Technology Association (AdvaMed), the Biotechnology Industry Organization (BIO), and the Pharmaceutical Research and Manufacturers of American (PhRMA) collectively authored and submitted a letter to the Administrator of CMS,Marilyn Tavenner. While expressing support for the principles underlying the Physician Payments Sunshine Act, the letter from these trade groups warned that the public website “must provide clear background information and context regarding . . . industry relationships,” and argued that “providing context for reported payments and other transfers of value is critical to ensuring patients do not form mistaken impressions that all payments to physicians are suspect.” The trade groups complained in their letter that they nonetheless had “not been given an opportunity to review how CMS intends to present the crucial contextual information or to consult with CMS on its content.” They further contended, based on what was understood to be CMS’s intention to withhold one-third of the data submitted to it, that the use of partial data made “the need for context . . . even more critical.”
What to make of the various views that have been expressed over time about the Physician Sunshine Payment provisions and the Open Payment system? Interestingly, throughout the many months that have led up to the release of the Open Payments system, the bottom-line message of many of the various stakeholders has been consistent. Whether expressed on behalf of public-interest organizations such as ProPublica, or trade organizations such as PhRMA and the AMA, the theme has been the same: when it comes to understanding the significance of industry-to-physician payments, context is critical. But what constitutes accurate context is often in the eye of the beholder. And with the physician payment data having finally been released for the public to see, the only certainty is that now, the battle over context begins.