CMS releases Sunshine Act final rule

Data collection on gifts to start Aug. 1
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After more than a year's delay, the Centers for Medicare & Medicaid Services announced a final rule to the Sunshine Act. Officially called the "National Physician Payment Transparency Program: Open Payments," the final rule will require drug and device manufacturers that receive government reimbursements to collect data on gifts and payments to teaching hospitals and physicians, starting on Aug. 1.

The final rule also requires manufacturers and group-purchasing organizations to disclose physician ownership and other investments. If they fail to comply, companies face fines of up to $1 million, according to Dow Jones Newswires.

Following months of Senate urging, the rule finalizes health reform provisions to increase transparency between providers and manufacturers to reduce conflicts of interest--an approach recommended by the Medicare Payment Advisory Commission and the Institute of Medicine in 2009.

The manufacturers will report the August to December 2013 data to CMS by March 31, 2014, which will then become public on Sept. 30, 2014.

Providers will have 45 days to review the data before it goes live on the public website.

CMS said the agency recognizes the collaboration between groups but maintains that conflicts of interest can influence research, education and clinical decision making.

"Increased transparency regarding the extent and nature of relationships between physicians, teaching hospitals and industry manufacturers will permit patients to make better informed decisions when choosing healthcare professionals and making treatment decisions and deter inappropriate financial relationships which can sometimes lead to increased healthcare costs," the final rule states.

"There are going to be a lot of academics and physicians out there who are going to say it's not worth $500 to end up on this website," David Rothman, professor of social medicine at Columbia University, told Dow Jones. "It's possible that the very publicity given to the relationship is going to discourage the relationship."

Providers question whether the fines or the public data will, in fact, change prescribing behavior. According to a 2012 Archives of Internal Medicine study, financial disclosures did little to change physicians prescribing habits.

However, a BMJ study last week shows that U.S. doctors who graduate with an active policy restricting gifts are less likely to prescribe newly marketed psychotropic drugs, suggesting that such conflict-of-interest policies do work. Researchers also found that the longer students were exposed to the policy, the more likely their prescribing rates would go down.

For more information:
- here's the CMS statement
- check out the final rule (.pdf)
- read the Dow Jones Newswires article
- here's the BMJ study and announcement

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