Since the release of the Final Rule by the Department of Health and Human Services (HHS) in February 2013,1 the Physicians Payment Sunshine Act, more formally referred to as Open Payments, has been in place for almost 18 months. However, it will likely be over the course of the next few months where the implications of the law and its contentious requirements will start to be fully realized. On Sept. 30, records of payments or transfers of value (TOV) issued by pharmaceutical, biologic, and medical device manufacturers to physicians or teaching hospitals are set to be made available by the Centers for Medicare & Medicaid Services (CMS) on a public searchable website. All manufacturers of products covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) will be required to report such information annually, including tracking all payments of more than $10 made to investigators and clinical trial research sites. The Sunshine Act, passed as part of the Affordable Care Act in 2010, was instituted to prevent inappropriate influence on research, education, and clinical decision-making and to avoid conflicts of interest that can compromise clinical integrity and patient care.
Affected parties have spent the last year trying to interpret the law’s complex reporting requirements, while meeting a March 31 deadline for reporting aggregate 2013 payment data to CMS (collected from Aug. 1–Dec. 31, 2013). By last month, companies were required to submit detailed 2013 payment/transfer of value data. And although there is still skepticism that the information will actually go public by Sept. 30, a panel of experts at DIA’s 50th Annual Meeting in San Diego agreed that for any entity involved in the transfer of information that ultimately helps patients—whether it’s medical affairs, medical communications, medical science liaisons, medical writing, industry-sponsored publications, etc.—they must be ready to adapt to the new changes and expect more, not less transparency globally, as other regions are expected to follow the US lead. To that end, it is crucial, the speakers said, for life sciences companies and other stakeholders to understand the implementation of the new law, and communicate that with their investigators and clinicians. Guidance on transfer of value is country-specific and appears to be evolving quickly, one expert noted. However, transfer of value as it relates to scientific publications in the Sunshine Act remains unclear, she said, with interpretation generally company-specific. The speakers stressed the importance of educating authors about a company or customer’s specific policy on transfer of value.
The panel discussed the impact of the Sunshine Act on medical and scientific communications, particularly in relation to journal reprints and publications support; the role of the medical science liaison; and the potential consequences of the new law on actually hindering the interchange of valuable research. Overall, the discussion has seemingly moved well beyond issues involved in defining expenses for meals and travel, for example, to attempts to more firmly understand the reporting requirements in areas such as research payments. The scope of research covered under the Sunshine Act includes preclinical research and FDA-sanctioned Phase I to Phase IV clinical trials. The law applies to investigator-initiated studies and product development that are subject to a written agreement/contract or a research protocol, including those trials conducted through a CRO or other intermediary. The entire research payment must be reported, including the entity paid and the study principle investigators. Speakers pointed out that it is optional to report the context of the clinical trial.
The discussion also noted the importance of medical science liaisons in addressing payments disputes that arise directly with the clinicians. According to the Federal Register, there will be a 45-day review period of reported payment information prior to public disclosure. The review will be done via a secure website, which covered recipients will be able to access. Following the review, there is a 15-day period for dispute resolution. Recognizing the expanse of data involved, CMS published a notice in May encouraging additional feedback on dispute resolution and the corrections process. The agency was accepting comments until early June.
DIA panel experts noted that there is concern around the ability of clinicians who are busy running their practices and dealing with other responsibilities to appropriately review the payment data in the 45-day window, and then, once a dispute is initiated and submitted, to resolve those quickly; manufacturers will be similarly challenged to resolve payment disputes within the 15-day period. Speakers acknowledged the potential of dealing with disgruntled clinicians as the payment disclosure system takes effect. For medical science liaisons, who may be confronted about research-related payments, the need to stay informed on their company’s public policies as well as evolving research and dispute resolution processes is crucial, experts said. Medical science liaisons may also be called upon to triage reported payment disputes.
Challenges in reporting research and other forms of payment under the Sunshine Act may be highlighting a broader concern in the world of drug development and clinical trials. One speaker on the DIA panel raised the possibility of potential unintended consequences stemming from the law. Among those may be the reaction of key opinion leaders in the medical community who may be hesitant to contribute to a research paper, fearing their names will appear on a pharma payments list. A related consequence may be the impact on the quality of publications, if clinicians are less likely, as authors, to translate valuable data and put it in a clinical context. Reverting primarily to authors from inside the industry is a possible option, but many journals only accept papers authored by practitioners and investigators. The sentiment is if clinicians share less research, due to the Sunshine Act, it may ultimately hurt patients. The law, however, provides limited information, speakers said, with respect to the role of non-industry authorship of papers that communicate medical research results. CMS has indicated, according to one speaker, that payments for medical research writing and/or publication should be included in the research payment.
Another topic of emphasis surrounding the Sunshine Act is the issue of journal reprints and the classification placed on articles from scientific journals that are disseminated to physicians as transfers of value, and, therefore, reportable to CMS. A panelist presented a survey of how pharma and biotech medical information departments are addressing the reporting of reprints and other educational materials as a transfer of value. In a question about unsolicited requests from physicians, 78% of departments surveyed said they report reprints as transfers of value when they send them as part of their response. Thirteen-percent indicated they no longer send reprints, due to the Sunshine Act. Such actions haven’t necessarily translated to a considerable drop in volume of unsolicited requests for medical information. The survey found that following the implementation of the Sunshine Act reporting requirements, 57% of respondents report no change in their inquiry volume, while 14% say the volume of inquiries has decreased.
1. Department of Health and Human Services, “Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests; Final Rule,” 2013.