Two years into the Sunshine Act: synopsis of opportunities, challenges, learnings, and potential implications

Abstract

Responsible transparency helps to promote integrity between industry and researchers and has the potential to increase public trust. As part of its inevitable evolution, the Open Payments database is likely to have opportunities to increase and improve the context around the data that it reports, thus leading to a decrease in the currently encountered confusion and misinterpretation of the data. A major challenge faced by the Centers for Medicare and Medicaid Services is to make the data more informative and educational, to allow the Sunshine Act to meet its transparency goals while improving healthcare innovation.

Keywords:

• Industry
• Medical writing
• Sunshine Act
• Transparency

Introduction

The Physician Payments Sunshine Act (Sunshine Act), passed in the US in 2010 as part of the Patient Protection and Affordable Care Act, was designed to increase the transparency of payments made to physicians and healthcare professionals (HCPs)¹. The Sunshine Act is undoubtedly associated with the public call for greater transparency in the pharmaceutical and device industries (industry). The Sunshine Act requires that specific financial transactions between industry and certain HCPs be reported and made publically available annually. In broad terms, the law requires that industry report anything of value (in cash or in kind services) given to a physician or teaching hospital¹.

Concerns about the relationship between industry and HCPs, and the potential for industry to influence HCP prescribing patterns, are far from new. In 1991, JAMA published guidelines regarding industry gifts to physicians. In the same year, The New England Journal of Medicine (NEJM) published an article by then US Food and Drug Administration (FDA) Commissioner David A. Kessler MD, that questioned the influence of industry on sponsored continuing medical education (CME) programs. Fast forward in time, and we see numerous publications expressing concerns about misleading drug advertising, government inquiries into the omission of data from peer-reviewed publications that report the results of industry-sponsored clinical trials, and an industry publication with recommendations to close the credibility gap^2–4. Over the course of time, we have seen a number of US states enact legislation requiring public reporting of various financial relationships between industry and HCPs⁵ and, finally, the US Federal Government mandated Sunshine Act¹. Further to this, we have seen a number of similar laws and/or guidance enacted and policies developed in Europe, Canada and Asia⁵.

The final Rules for Implementation of the Sunshine Act (the Rules) were published in February 2013 by the Centers for Medicare and Medicaid Services (CMS), the government body responsible for oversight of Sunshine Act reporting⁶. Possibly due to its complexity, the Act took 3 years from passage of the law to promulgation of the final rules. Three years later, and 2 years after the first public release of data, significant educational opportunities may still exist, again perhaps due to the complexity of the law.

Although prior to the Sunshine Act extensive data on some financial relationships were already in the public domain, e.g. due to corporate integrity agreements (CIAs) and state-level laws, the Sunshine Act is much broader in scope. In preparation, the largest medical association, the American Medical Association (AMA), advised its members to “be prepared for inquiries from the media, your patients and your friends” and provided a set of “talking points” for members⁷.

The Sunshine Act: a brief overview

A central premise of the Sunshine Act (also sometimes called Open Payments) is that full public transparency regarding the financial relationships between HCPs and industry could help patients make better-informed decisions about their HCPs, and perhaps also help control healthcare costs⁶. According to the Rules, this will be accomplished by collecting specific data about these financial relationships and making them available on a public website⁶. Although implementation of the Act itself is still in its infancy, there is strong consensus that transparency is beneficial and aids in making informed decisions^8,9. However, many observers have cited that for Open Payments to be fully successful in achieving its main goals, in addition to making this complex data publically available, data must also be both accurate and placed in appropriate context, so as to enable appropriate interpretations of what this data may mean^9,10. Presently, there is insufficient research or dependable data on how Open Payments information will be interpreted and used.

What’s clear?

The Rules clearly delineate, at a high level, who must report (applicable manufacturers [AMs] and group purchasing organizations [GPOs]), and who must be reported on (covered recipients [CRs] and teaching hospitals [THs])⁶. These groups are defined as:

• AMs: manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program

• GPOs: medical group purchasing organizations might be able to bring the purchasing power and negotiating leverage of large medical consortiums or hospital systems to doctors’ offices

• CRs: doctors of medicine, osteopathy, dentistry, dental surgery, podiatry, optometry, and chiropractic medicine

  • medical residents and employees of the reporting AM are exempt

• THs: hospitals that received payment(s) under a Medicare direct graduate medical education, inpatient hospital prospective payment system, indirect medical education (IME), or psychiatric hospital IME programs^6,11.

The Open Payments website provides a wealth of information on this and, since its first release in 2014, CMS has made significant improvements in the site’s utility. Readers can now find useful information such as background on the law, including a detailed table that lists 14 types of payments, along with definitions and examples; financial transaction details; a frequently asked questions portal; and an avenue to contact the CMS¹².

What’s cloudy?

This paper discusses two areas of the Sunshine Act that might benefit from further clarification. The first is the lack of concrete definition of what must be reported; the second is the frequent lack of sufficient context for the reported data, which may often hinder a full understanding and foster misinterpretation. At times, these issues intersect.

The Rules broadly define what must be reported as “payment or other transfer of value” (TOV), with TOV defined as “a transfer of anything of value” (Rules)⁶. The Rules do discuss various scenarios under which CRs may receive “payment or other TOV”, but do not delineate all of the scenarios that might constitute a TOV. CMS’ FAQs provide additional (though not exhaustive) examples¹².

One area of importance to medical publication professionals is whether provision of writing and editorial support to CR authors constitutes a TOV. The lack of clarity in the Rules in this specific area has resulted in diverse interpretation, with some in industry reporting such support as a TOV and others not doing so¹³. CMS FAQs state: “Under open payments, a payment reported as research falls within a research payment category if it is subject to either: (1) a written agreement; (2) a contract; or (3) a research protocol. Payments for medical research writing and/or publication would be included in the research payment, if the activity (here, medical research writing/publication) was included in the written agreement or research protocol and paid as a part of the research payment”¹⁴. Hence, most lack of clarity relates to medical writing support outside of this context.

According to some recent publications, reporting such support as a TOV may potentially create a negative impression, such as the appearance of payment for authorship^7,15. However, this impression is not justified. It is noteworthy that when industry provides non-monetary support for publications, as defined by recent best practices and guidelines¹⁶, it is done with the explicit agreement that the authors have the final decision-making responsibility and authority over the content of the publication¹⁶. Although this is helpful, it cannot absolutely guarantee ethical conduct in every case.

The CMS Open Payments database is publically available and searchable. However, the context for the data is not necessarily intuitive or easy to understand¹⁷. For example, the Open Payments summary page shows the totals associated with the records published in 2013 compared with those for 2014 in a way that could suggest nearly twice as much expenditure in 2014 vs. 2013. It may not be immediately apparent that the reporting time frame for 2013 was only for the last 5 months of the year and that, if extrapolated to a full year, both the dollar value and the number of records would be more comparable in number¹⁸.

Increased information on the specific context and nature of the transactions and relationships reported as research may also be helpful to the user. When searching the database by an individual physician’s name and specific year, e.g. 2015, one is provided with the following:

• An overview of the total dollars received in the calendar year

• A breakdown by category (i.e. general, research, associated research, ownership).

When searching the research category dataset spreadsheet specifically, some lack of context is apparent. As an example, when filled in, the column titled Context of Research provides a descriptive summary, e.g. “The amount reported represents either an aggregate of cash payments – eg, clinical study services, reimbursements for expenses or pass-through costs, or an aggregate of in-kind value – eg, supplies, equipment…”¹².

Thus, although the database names individual investigators as recipients of large sums associated with clinical trials, it is not clear as to whether the physician received a payment. Typically, research payments usually cover the cost of the trial, ranging from administrative costs through the cost of equipment and drugs, and do not reflect direct payment or other TOV to physicians¹⁸. Without context, an uninformed user could presume that an individual investigator may have personally received large sums of money when, in fact, this was not the case^9,18. An easier-to-navigate database, with context surrounding financial transactions, would benefit all and help achieve the end goal: greater transparency surrounding industry and physician relationships.

Due to the incredibly large amount of data compiled and communicated, understandably, implementation presented a number of technical challenges¹⁹. The website experienced glitches, and physician disputes regarding the accuracy of data resulted in the withholding of as much as one third of the data for the first year²⁰. The CMS has described both improvements made and plans for additional improvements to the database to help offset some of the challenges encountered by users^12,17. At present, the public response to the database has been described as “subdued”²¹. It will be interesting to see whether the notion that “the public does not use existing health-related databases to help their healthcare decisions” holds true for Open Payments²².

Impact on the research process

An important focus of the Sunshine Act is on research-related TOV^7,19. Some recent reports have noted a coincident decrease in research spending with the implementation of the Act; however, it seems premature to suggest a causal association between the Act and changes in research funding²³. A recent report concluded that professional guidance on how to interpret elements of the Sunshine Act is not extensive, and that the lack of information could potentially have a “chilling effect” on physicians’ desire to participate in clinical trials and publish results¹⁵. Thus far, the guidance provided to physicians on the Act and the interpretation of non-monetary support from industry is at best sparse^7,24.

Some physician specialty groups have published information to help aid in understanding the context of the information contained in the Open Payments database. Overall, these analyses suggest that, for the most part, individual physicians are not receiving large payments from industry, and also comment on the importance of these ongoing relationships from their perspective. For example, Harvey et al. found that <4% of radiologists had received non-research payments valued at >$10.00 per physician²⁵. Parikh et al. found that pediatricians in general received the lowest per physician payment from industry (median $15.00) and that orthopedists were in the highest per physician payment group (median $32.00)²⁶. The analyses by both of these groups did not include research payments, reinforcing the earlier comments by Fishman and Morain regarding, in general, the end use of the large financial transactions reported in the Open Payments database^9,18.

Concerns have been raised over public misperception, which may potentially have unpredictable effects on physicians’ behavior. Physicians may perhaps unnecessarily limit their interactions with manufacturers, perhaps limiting their participation in clinical research, which may be detrimental to research and innovation⁷. Additionally, some researchers may become more reluctant to be authors of industry sponsored research if TOVs attributed to them are perceived negatively by their home institutions¹⁹.

Importantly, whether provision of writing and editorial support for scientific publication by pharmaceutical companies is a reportable TOV has not been uniformly interpreted across the industry^7,19,24. Because publication is a fundamental part of the research process, it will be important to monitor whether the Act may trigger some investigators to decline offers to serve as authors on industry-sponsored publications based on concerns about TOV reporting^7,24. A decrease in physician–manufacturer relationships could result in an increase in industry authors and a decrease in clinician authors, which would lead to a loss of invaluable real-world clinical insights from industry-sponsored medical publications and potentially hinder medical advances²⁷. Notably, the effect of the Sunshine Act on the publication development process could be compounded by policies of certain institutions that regulate the interaction of their faculty with industry¹⁹.

Implications for patients

As noted previously, one intent of the Sunshine Act is to provide information that can help patients make informed decisions regarding their physicians. A search of the literature (peer-reviewed and grey) reveals little as to whether patients are in fact utilizing the information in the Open Payments database. A publication by Saver questions whether patients will be able to discern between large research payments that cover the operating costs of a large clinical trial and a direct payment to a physician⁸. Several studies have found that although research subjects were interested in disclosure and transparency, many believed that disclosure of financial relationships between investigators and study sponsors would not influence their decision-making^28–30.

Some researchers believe that the Sunshine Act may cause an inverse unintended impact on patient care. Some studies suggest that physicians may overcompensate for the disclosure of their financial ties to industry by unjustifiably limiting advice to patients regarding a specific drug or device in order to prevent the appearance of bias³¹.

The benefits of publishing the results of industry-sponsored clinical trials in peer-reviewed journals include release of data into the public domain that has been vetted by experts; provision of full details regarding the clinical trial protocol and procedures for data analysis; and placement of the trial results into clinical context by clinical trial investigators who are also the leading practitioners in a particular field. If there is a reduction in these clinical practice insights, end-users of the publications, i.e. HCPs, may not have the best information to inform optimal patient-care decisions.

Summary

Responsible transparency helps to promote integrity between industry and researchers and has the potential to increase public trust^7,24. As part of its inevitable evolution, the Open Payments database is likely to have opportunities to increase and improve the context around the data that it reports, thus leading to a decrease in the currently encountered confusion and misinterpretation of the data. A major challenge faced by the CMS is to make the data more informative and educational, to allow the Sunshine Act to meet its transparency goals while improving healthcare innovation¹⁰.

Transparency

Declaration of funding

This editorial was not funded.

Disclaimer: The opinions expressed herein are those of the authors, do not necessarily reflect the opinions of their employers, and are not intended as legal advice.

Declaration of financial/other relationships

D.T. has disclosed that he is an employee of Amgen Inc. K.P. has disclosed that she is a contracted consultant for Cactus Communications. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

CMRO peer reviewer 1 has disclosed that she/he is an employee of Celgene Corp. CMRO peer reviewer 2 has no relevant financial or other relationships to disclose.