The Centers for Medicare and Medicaid Services (CMS) recently released proposed regulations on public disclosure of drug and device industry payments and gifts to physicians. The regulations would implement the ground-breaking Physician Payment Sunshine Act (“Sunshine Act”) passed in 2010 as part of the Affordable Care Act.
The law is a strong move toward greater transparency for patients and toward reclaiming public trust in the medical profession. It requires pharmaceutical, medical device and biologic manufacturers to disclose payments to physicians and teaching hospitals on a public database. Anyone will be able to see how much a physician is being paid or what gifts were given to physicians by these companies, above a minimum threshold of $10.
Disappointingly, CMS has announced that it will not require manufacturers to begin collecting this data before January 1, 2013; the agency said it intends to issue a final rule later this year. As part of the Affordable Care Act, the Sunshine Act would be voided if the Supreme Court were to strike down the entire ACA, but the Court is not expected to issue such a broad ruling.
The hope behind the Sunshine Act is that public disclosure of payments will deter physicians from accepting payments from industry and create a culture of transparency in which the public can evaluate payment information and potential bias. The research community is certainly eager to access and analyze the payment data, but will patients seek out this information and use this site?
During the hearing for the Sunshine Act in 2008, Senator Norm Coleman (R-MN) asked just this: “[How would the public] actually use this data when shopping around for health care services?” Although the law advances patients’ interests in knowing what payments pharmaceutical and device manufacturers are making to physicians, whether patients will visit a federal disclosure site and know how to interpret the posted data remain open questions.
Making The Sunshine Act Site More Attractive And Useful For Patients
To increase the likelihood that patients will use the disclosure site, it should include background information so that patients understand the underlying concern that industry payments to physicians may affect medical care. Though a wide body of research has found that physician-industry interactions can adversely influence clinical decision-making, there are still significant misconceptions about the impact of conflicts of interests on the practice of medicine.
An increasing number of patients disapprove of large gifts to physicians from the pharmaceutical industry, but there is significant variability in patients’ awareness of relationships, perceptions of the acceptability of gifts and interactions, and the perceived effects of physician-industry ties. A majority of patients still approve of drug samples, small gifts and financial interactions in clinical trials, while nearly half approve of payments for conferences and travel expenses. Surveys also find that patients think other physicians are more likely to be biased by payments and gifts from industry than their own physicians.
Federal health administrators have a responsibility to educate the public about the meaning and context of conflicts of interest and industry payments to physicians, not just display numbers disclosed by manufacturers. The site should explain that payments are not inherently a corrupting influence, but that they create a “competition of interests,” placing a doctor at risk of making clinical or research decisions based on motivations other than patients’ best interests. Patients, and physicians, also need to understand that financial conflicts of interest can lead to unintentional bias in subtle ways—and that even providers with the best of intentions can be affected.
The site should contain examples with references, such as those found in the Institute of Medicine’s 2009 report Conflict of Interest in Medical Research, Education and Practice. For instance, a review included in this report found that physicians who received industry-sponsored conference travel had 4.5 to 10 fold increases in prescribing rates of the sponsor drug. The Sunshine Act site must also offer a balanced view, acknowledging that collaborations with industry can contribute to innovative medical research.
In addition, if patients are to be able to make sense of the data it is critical that the site be designed in a simple manner. The content needs to be both easily understood by the average patient and straightforward to navigate. This means having clear and consistent definitions for the categories of payments disclosed and also publishing a glossary and user’s guide. In the guide, patients could learn how to compare two doctors or how to differentiate between equity and royalties. Disclosure of information that cannot be easily interpreted by patients will not serve the primary purpose of the law.
Lastly, patients need to know how to incorporate this new information into their health care choices and experiences. Disclosure may be interpreted as a sign of honesty and thus lead to an increase in trust in a doctor—or it may decrease trust and undermine the legitimacy of clinical advice. More research is needed to clarify the best method of disclosing conflicts of interest to patients and to understand how patients utilize this information. Fact sheets and videos about how to initiate a dialogue about disclosure would be helpful for both providers and patients; this way, the site can be used as a launching off point for further discussions in the doctor’s office. Groups such as The Pew Prescription Project have experience in making educational materials about conflicts of interest accessible to the public and could assist with developing guides.
Disclosure As A Means To Understanding
In response to Senator Coleman’s question about whether consumers would use a federal disclosure site, a senior vice president at the medical device company Zimmer said, “[I]t’s probably not going to change the mind of many patients, but they have a right to know.” Patients have more than just a right to know—they also deserve to have tools to evaluate and synthesize disclosure information. Disclosure is only a means to an end.
As CMS develops the disclosure website, the patient must be kept at the forefront of implementation. A patient-centered site should be considered the foundation of this law. An improved understanding and open discussion about these payments will strengthen the patient-doctor relationship, diminish commercial influences on physicians’ prescribing practices, and ultimately benefit patient care.