Dikran Toroser, PhD, ISMPP CMPPTM, Amgen, Inc.; Kim Pepitone, ISMPP CMPPTM, Cactus Communications
Since the Physician Payments Sunshine Act (Sunshine Act) was enacted in 2010, questions about its provisions and ultimate impact on transparency have circulated among physicians, the pharmaceutical industry, and other stakeholders. Now, more than two years since the final rules for implementation of the Sunshine Act became effective, data are available to assess the reported financial transactions, potential impact on transparency, and the possibility for changes in the future. In addition, new legislation was recently passed that could also affect health care and transparency.
Brief Overview of an Intricate New Picture
The Sunshine Act, passed in the US in 2010 as part of the Patient Protection and Affordable Care Act (PPACA), was designed to increase transparency of payments made by industry to physicians. In broad terms, the law requires that industry report anything of value (in cash or in-kind services) given to a physician or teaching hospital.
The 21st Century Cures Act (Cures Act) was signed into law by President Obama on December 13, 2016. Under this law, the US will potentially see increased funding to support expanded medical research and faster new drug approvals.
A central premise of the Sunshine Act (also known as Open Payments) is that full public transparency regarding the financial relationships between health care providers (HCPs) and industry could help patients make better-informed decisions about their HCPs. Presently, there is insufficient research on how the Open Payments information will be interpreted and used.
According to the US Centers for Medicare and Medicaid Services (CMS), some changes occurred from 2014 to 2015, as a result of the Sunshine Act (which were the first two full reporting years). Although the distribution of total spend across categories stayed essentially the same (dollar value reported was 7.3 billion for 11.9 million records and 7.5 billion for 11.8 million records for 2015 and 2014, respectively), CMS noted that spending:
- decreased in honoraria, gifts, education, faculty for accredited programs, entertainment, and services other than consulting, and
- increased in charitable contributions, faculty for non-accredited programs, and royalty or license.
However, the released data were summarized in a graph as percentage changes; dollar values were not widely provided, making it difficult to understand the absolute scope of change.
Sunshine Paints a Complex Picture
For Sunshine, the Rules delineate who must report (applicable manufacturers [AMs] and group purchasing organizations [GPOs]), and who must be reported on (covered recipients [CRs] and teaching hospitals [THs]). The Open Payments website provides a wealth of information on this.
With a new administration that seems especially frosty towards the PPACA, the parent of Sunshine, it seems unclear what the inevitable evolution of Sunshine will entail. Recent publications have discussed two areas of the Sunshine Act that might benefit from further clarification:
- The lack of a concrete definition of what must be reported
- The frequent lack of sufficient context for the reported data, which often hinders a full understanding.
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.” Reporting such support as a TOV may potentially create a negative impression, such as the appearance of payment for authorship. However, this impression may not be justified.
It is noteworthy that when industry provides non-monetary support for publications, as defined by recent best practices and guidelines, it is done with the explicit agreement that the authors have the final decision-making responsibility and authority over the content of the publication. The CMS Open Payments database is publically available and searchable. However, the context for the data is not necessarily intuitive. Increased information on the specific context and nature of the transactions and relationships reported as research may be helpful to the user.
Early iterations of the Cures Act included proposed language that would exclude the reporting of textbooks, reprints, and other educational materials as a TOV. Although the Cures Act provides increased funding to support expanded medical research and faster new drug approvals, the version that was signed into law did not include this hoped-for exclusion.
The potential impact of the Sunshine Act, and its impact on some types of HCP-industry relationships, has recently been reviewed; however, there are still insufficient data on potential changes that the Act could bring about. Interestingly, for the publications space, 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. For example, while some companies report all writing support to CRs as a TOV, others report only support for investigator initiated studies. A third interpretation is that medical writing support is a “cost of doing business,” and do not report this support under any circumstances.
As part of its inevitable evolution, the Open Payments database is likely to have opportunities to increase and improve context of payments. Although there may be a drive to cut red tape, additional complexity is assured in this intricate space. For example, it will be interesting to observe how the Food and Drug Administration (FDA) will interpret and implement related requirements of the Cures Act.
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 Interest
D Toroser is an employee of Amgen Inc. K Pepitone 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 herein.