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EDITORIAL: Speed up work on payment disclosure


This news story was published on December 26, 2011.
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Star Tribune, Minneapolis

Two-and-a-half months after blowing a congressional deadline, federal officials have finally gotten around to rolling out the Physician Payments Sunshine Act— a historic new law requiring medical device and pharmaceutical industries to disclose payments to doctors.

The agency charged with making the new law a reality — the Centers for Medicare and Medicaid Services, or CMS — was supposed to have issued draft compliance guidelines by Oct. 1. Instead, it completed that key step on Dec. 14.

Better late than never, but officials need to make up for lost time and move thoughtfully but quickly to finalize the guidelines after stakeholders have weighed in.

The sunshine law, passed as part of the historic 2010 Affordable Care Act, called for the collection of payment information to begin Jan. 1. The CMS foot-dragging has pushed this timetable back indefinitely, causing uncertainty and confusion.

The agency owes it to the law’s many patient and industry advocates to ensure that as much 2012 information is collected as possible. If the CMS moves expeditiously, it’s possible that six months of data could be collected next year.

The information is slated to be made available to the public on a website in 2013.

“CMS needs to clarify the effective dates so drugmakers and medical device makers know their exact obligations and the public knows when the information will be available,” said Sen. Charles Grassley, an Iowa Republican who championed the act along with Wisconsin Democratic Sen. Herb Kohl.

The CMS also owes the public an explanation for the delay.

Physicians can earn large sums for research and other collaboration with industry. That work is critical for medical innovation, but the information should be made public so that potential conflicts of interest can be evaluated.

Minnesota, as one of the world’s centers for medical device manufacturing, has a critical interest in ensuring that the law rolls out smoothly. The state’s own pioneering payment disclosure law for health professionals also served as an impetus for national requirements.

The delay is regrettable, but the draft rules deserve their good reviews from industry and from advocates such as Allan Coukell,the Pew Health Group’s medical director.

The proposed guidelines offer welcome clarity on which manufacturers and hospitals must comply with the law. In addition, the draft rules head off a potential loophole in which payments made to a physician via a third-party organization may have gone unreported.

The agency still needs to clarify some definitions of key terms and what the website will look like. It also needs to ensure that the delay in the law’s rollout does not inadvertently interfere with existing state laws collecting this data.

A reminder of why the Sunshine Act is needed came this week in Minnesota. A University of Minnesota review found that surgeon Dr. David Pollyhad not adequately disclosed his financial ties to Medtronic in a presentation and in two journal publications.

The new law, with its reporting requirements for industry, would act as a cross-check for institutional disclosure requirements, making it less likely that this information will slip through the cracks. The CMS needs to make this new law a priority and brook no further delays.

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