Hospitals

Physician Payments Sunshine Act: How to fix its flaws

Starting in 2013, drug and device companies will have to report all payments to physicians to a publicly accessible database, courtesy of the Physician Payments Sunshine Act, which was embedded in the health care reform law. Alas, there are serious flaws in the legislation, says Harvard professor Daniel Carpenter, writing in this week’s Journal of […]

Starting in 2013, drug and device companies will have to report all payments to physicians to a publicly accessible database, courtesy of the Physician Payments Sunshine Act, which was embedded in the health care reform law. Alas, there are serious flaws in the legislation, says Harvard professor Daniel Carpenter, writing in this week’s Journal of the American Medical Association:

First, it does not cover payments to nonphysician investigators. Second, it does not incorporate a unique identifier that would permit linkages among databases. Although the PPSA requires companies to include physicians’ National Provider Identifiers (NPIs) in their annual submissions to DHHS, it explicitly prohibits DHHS from disclosing NPIs in its public reports—and in any case, NPIs would not encompass nonphysician recipients. Together, these limitations constrain the PPSA’s reach and inhibit the ability of interested parties to use these data to understand the nature and effects of industry’s financial relationships with the biomedical research enterprise.

To remedy these flaws, Carpenter suggests:

First, an entity with access to payments data submitted to DHHS and the capability to function in a clearinghouse role could establish and administer a database of unique researcher identifiers. Second, DHHS could mandate that companies include recipients’ researcher identifiers in their annual reports. Third, DHHS could include recipients’ researcher identifiers in its annual public disclosure of companies’ payments. Fourth, a means to incentivize registration of nonphysician and non-US investigators will be required. For example, institutional review boards might condition study approval on investigators’ provision of their researcher identifiers, or biomedical journals might require inclusion of authors’ researcher identifiers with submitted manuscripts.

Carpenter also suggests that the National Library of Medicine, which runs PubMed, become the online database. That makes sense. It already allows anyone with access to a computer to search the vast medical literature. Why not add conflicts of interest among physicians and researchers to its search function?

However, it will probably require the Department of Health and Human Services to adopt a rule to make these changes. It may even require a tweak in the law to cover non-physician investigators. Hopefuly, Sen. Charles Grassley, who pushed for the PPSA, will take the necessary steps to ensure its maximum utility.

The author, Merrill Goozner, is an award-winning journalist and author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs” who writes regularly at Gooznews.com.

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