Section 6002 of the Affordable Care Act (ACA)—commonly known as the Physician Payment Sunshine Act (PPSA)—requires the public reporting of payments or other value transfers made to physicians and teaching hospitals by manufacturers and group purchasing organizations of drugs, devices, biologicals, and medical supplies that are covered by Medicare, Medicaid or the Children’s Health Insurance Program.
Companies will have to start keeping track of payments beginning January 1, 2012 and the start date of reporting is March 31, 2013, with the first report being published on September 30, 2013. Everything over $10 must be reported, unless they fall within the given list of exceptions.
Consequently, a recent article in the Journal of the American Medical Association (JAMA) asserted that the Sunshine Act “promises a new era of transparency for the US health care system.” The article assets that PPSA “constitutes an important step toward comprehensive, user-friendly, point-of-need availability of information about physicians’ and investigators’ financial relationships with industry.”
However, this article clearly ignored recent comments provided at an open door forum, hosted by the Centers for Medicare and Medicaid (CMS), in which a number of stakeholders expressed concerns about how PPSA rules will be implemented.
For the JAMA authors, they hope that PPSA will provide “any user of a major biomedical research database such as PubMed, clinicaltrials.gov, or NIH RePORTER, access to a Web page listing an author’s, investigator’s, or grantee’s financial relationships by following an embedded hyperlink.”
In fact, like the recent group of “journalists” using payment data from ProPublica, the JAMA authors envision future “academic careers” mining the PPSA databases to publish “scholarly” papers on “potential conflicts of interest” and bias, instead of solving real medical issues and problems facing America. The authors believe that the PPSA data “will be useful for many purposes, including greater consciousness of physician payments and increased ability to monitor physician behavior.”
The authors note that the data “will also facilitate independent analysis of the relationships between financial ties and research and clinical outcomes, not only allowing the research community to monitor conflicts of interest but also encouraging companies to scrutinize their financial relationships with individual researchers.” However, it remains uncertain how “independent” this analysis will actually be given researchers will not be making their careers identifying “no conflicts.” It is more likely that researchers will be tempted to call everything a conflict to gain better academic recognition.
Problems with PPSA
Despite their optimistic future career prospects, there are already problems with PPSA. As discussed during the forum conference call, many stakeholders recognized that CMS is already going to be getting so much data from manufacturers on physician payments that it will be challenging enough to collect this information, organize it, and then make such information public. For example, one participant noted that in just a mid-sized pharmaceutical company, there could easily be more than 1 million transactions, with over 300,000 physicians. When you multiply that by all the companies in the U.S., this means a tremendously overwhelming amount of information and data to collect and analyze.
In addition, stakeholders expressed the need for CMS to define each payment categories clearly, so that consumers, health care providers, and researchers can use the data correctly. Moreover, many participants emphasized the potential for payment categories to overlap, and the need for CMS to ensure that reported payments do not fall into multiple categories or are counted twice. Stakeholders are also concerned that some payment categories are too specific and will create problems, such as payments for travel to include destination.
Despite the issues that CMS will already face implementing PPSA, the JAMA authors believe there are limitations to the legislation as well. The authors believe that PPSA has limitations because 1) it does not cover payments to nonphysician investigators and 2) it does not incorporate a unique identifier that would permit linkages among databases.
The authors believe that “these limitations constrain the PPSA’s reach and inhibit the ability of interested parties to use these data to understand the nature and effects of industry’s financial relationships with the biomedical research enterprise.” In particular, the authors believe that while the entity that funded a study is clearly identified, they are more worried about the difficult learning whether an investigator received payments. As a result, the authors believe that without investigator data:
- Universities and research hospitals will have difficulty learning of payments to their faculty or staff.
- Investigators’ incentives to be concerned about the fact or appearance of conflict of interest will be diminished when their research cannot easily be linked to their financial relationships.
- It will be difficult to examine whether payments are linked to research outcomes.
The problem with the first assertion is that universities and research hospitals largely all have conflict of interest and transparency policies that require faculty to report all of this information in the first place. These entities ensure that their faculty and staff meet the appropriate federal guidelines for research, and PPSA recognized this by specifically not including investigator data.
The fact that institutions collect investigator payment information renders the authors second point moot. Investigators will still have clear boundaries and regulations monitoring their research based on the disclosures they make to their institutions. If anything, publishing their information in PPSA might have the opposite of effect of driving investigators away from research (i.e. working on controversial projects, such as genetics or animal testing).
Finally, it should not be difficult to examine whether payments are linked to research outcomes for the same reason noted above: institutions will have investigators financial disclosures and can make the appropriate determinations when outcomes are published.
Nevertheless, the authors offer four potential remedies that “would allow the PPSA to fulfill its promise.”
- Establish and administer a database of unique researcher identifiers
- DHHS could mandate that companies include recipients’ researcher identifiers in their annual reports.
- DHHS could include recipients’ researcher identifiers in its annual public disclosure of companies’ payments.
- Incentivize registration of nonphysician and non-US investigators
The authors suggest incentives such as “institutional review boards conditioning study approval on investigators’ provision of their researcher identifiers, or biomedical journals requiring inclusion of authors’ researcher identifiers with submitted manuscripts.” The authors suggest that “the National Library of Medicine (NLM) may be best positioned to perform this task,” since NLM already houses many of the major databases that would be linked through the researcher identifier system.
The article also argues that a unique identifier has legal authority already, since the federal government has long required the registration and unique identification of physicians as well as of organizations such as hospitals and health plans.
Discussion
The authors believe that with a system of unique researcher identifiers in place, “readers of articles or abstracts using PubMed or other online bibliographic databases would be able to hyperlink to a publicly available page listing the investigator’s payments.” In addition, they assert that “patients and others seeking studies on clinicaltrials.gov would be able to access data on investigators’ financial relationships.”
They also noted that “analysts would be able to examine whether payments are concentrated among certain kinds of researchers or in certain subfields of research, as well as whether they are systematically associated with particular research outcomes.”
But one thing the authors fail to address: what kind of objective information will users of this system have? Will members of the public only see dollar signs or will they actually see how a physician was paid fair-market value for his services to educate 100 physicians how to use a spirometer, or how to implant a stent? Will researchers have access to information that a physician’s consulting services helped the development of a new diabetes drugs that will save the lives of millions of Americans? Probably not.
Rather, the authors believe that the main purpose of the system is so that those physicians who work with industry will have the “knowledge that their behavior is being observed.” In other words, the database stands as a way to scare physicians into working and collaborating with industry, for fear that the fair-market reimbursement they receive for their services will be scrutinized (i.e. ProPublica).
Conclusion
For the authors, the purpose of the database is to make “researchers think more carefully about the payments they accept.” But what evidence do they show that researchers don’t already do so? None. Their reasoning and suggestions are flawed and problematic because they suggest an inherent problem in research and industry funding that, except for a few rare cases, is nonexistent. The authors own bias and criticism of industry is used to further their claims, instead of neutrally discussing the potential effects their system could have.
Researchers who devote their time and efforts to investigate new drugs and devices have the best interest of the public and their patients in mind, and deserve to be compensated for their time. While transparency is always an important goal of any democratic society, we must ensure that this principle does not stigmatize research in a way that will chill collaboration and medical progress.
Moreover, the authors do not clearly think about the real costs associated with PPSA and adding this unique identifier system. Payments would have to be constantly added and updated, checked, and changed for corrections. There could be dozens of payments, for tens of thousands of doctors, all over $10. This is no simple task, and the staff and resources it will take to implement PPSA will already be extremely burdensome.
Ultimately, PPSA already has enough issues to deal with in the implementation stage. While installing this transparent system will lead to better integrity in the health care system, the federal government simply cannot adopt another system on top of this. We don’t even know yet what the PPSA data will show or do, and it may be years before the information shows anything at all. Until then, CMS should focus on the rules Congress enacted, especially since institutions have in place systems to address the authors concerns.