Physician Payment Sunshine Act

September 30, 2014

“Publicity is justly commended as a remedy for social and industrial diseases. Sunlight is said to be the best of disinfectants; electric light the most efficient policeman.”

-Justice Louis Brandeis, 1913

 

By Stephanie Morain

 

On September 30, after months of delays, the Open Payments database will finally go live. A product of the Physician Payment Sunshine Act (PPSA), the database will provide an unprecedented amount of information on financial relationships between physicians and industry.

 

The PPSA has been heralded as a milestone in the movement to reduce conflicts of interest in medicine. By requiring disclosure of relationships between physicians and industry, the law aims to influence the behavior both of the companies subject to reporting requirements, and to physicians who engage with them.

 

Physicians, concerned about patient distrust or peer reproach, may avoid financial relationships with regulated industries. Companies, in turn, concerned about their public image, may reduce payments likely to draw unfavorable media attention or government investigations.

 

Early indicators suggest that some changes may already be occurring. A ProPublica analysis of physician-industry relationships indicated that several of the nation’s largest pharmaceutical companies dramatically reduced payments to physicians for promotional speeches—a reduction ProPublica attributes as due at least in part to increased transparency and heightened public scrutiny of such relationships.

 

However, even supporters of efforts to mitigate financial conflicts of interest have raised skepticism about whether the law will have the intended effects. First, there’s no guarantee that patients will access information about their doctors. Rosenthal & Mello note that earlier effort for transparency in health–quality reporting–suggests little cause for optimism.

 

While various groups have taken great pains to make information about physician quality publicly available—such as a cardiac surgeon’s mortality rate—patients are often unaware that such data exists. Furthermore, even if patients do access transparency reports on financial relationships, they may have difficulty distinguishing beneficial aspects of relationships from those that might be cause for greater concern.

 

In a recent commentary for the Annals of Internal Medicine, I, along with my coauthors, Nancy Kass, Charles Flexner, and Jeremy Sugarman, highlight one particular relationship that may be prone to misinterpretation. Under the new rules, companies will be required to disclose the value of drugs donated for clinical trials. This includes studies conducted within large networks funded by the NIH, including those for oncology and HIV/AIDS.

 

Unlike payments for speaking fees or marketing purposes, the physician receives no direct benefit from donated drugs. Nevertheless, the new rules will require the value of these donations to be attributed to the study’s principal investigator as “research payments.”

 

As we discuss in the article, the value of these donations will likely be large, and may dwarf the value of the types of payments that have historically elicited concern, such as gifts, meals, or consulting fees.

 

Consider, for example, a trial for sofosbuvir—the new once-daily treatment for hepatitis C infection that has been capturing headlines both for its effectiveness, and for its high price tag. The retail value of this drug is $1000 per dose, and a curative course of treatment lasts 12 weeks. A physician who enrolls even 10 patients in this trial would be presented in the database as receiving $840,000 in research payments from Gilead, sofosbuvir’s manufacturer.

 

Attributing such large sums to individual physicians seems misleading. While providing context for the nature of these payments may avoid confusion, the current rules do not require that companies provide such information, raising uncertainty as to how patients and other users will interpret these disclosures.

 

In bringing attention to this issue, my aim is not to undercut the larger goals of the Sunshine Act. The literature is replete with examples of the potential risks posed by financial conflicts of interest to research integrity, and to high-quality, high-value care.

 

Transparency into these relationships can play an important role in mitigating these risks.  However, care must be taken to ensure that regulations don’t discourage participation in socially valuable research.

 

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Morain SR, Flexner C, Kass NE, Sugarman J. Forecast for the Physician Payment Sunshine Act: Partly to Mostly Cloudy? Annals of Internal Medicine. Published Online September 30, 2014

 

Stephmorainanie Morain is a Hecht-Levi Fellow with the Berman Institute. She conducts both empirical and normative research into issues at the intersection of ethics, law, and health policy. 

 

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