The Missing Sunshine Rule May Appear, After All

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By Ed Silverman // January 31st, 2013 // 7:55 am

After more than a year of anticipation, the long-awaited Sunshine Act rule may finally be a step closer to being released. Following weeks of review by the White House Office of Management & Budget, the transparency regulation is apparently on its way to the Centers for Medicare & Medicaid Services, sources say.

It remains unclear exactly when the rule, which became law as part of the Affordable Care Act, will be publicly released by CMS, but this is a significant sign of progress, given the interminable delay that has frustrated a wide array of drug and device makers, biotechs and consumer advocacy groups that want the transparency rule to take effect.

The Sunshine Act rule would set ways for gathering and publishing data containing financial ties between physicians and drug and device makers, and group purchasing organizations. The data would include all ownership or investment interests held by a doctor or family member, and that information must also be disclosed. Penalties for violations can range from $1,000 to $100,000.

The rule came about over concerns that industry marketing will unduly influence physician prescribing and medical research and the rule is an outgrowth of a Senate probe several years ago into those sorts of financial ties. In fact, the first draft was introduced as a separate bill in September 2007 by US Senators Chuck Grassley and Herb Kohl (read here). But the Obama administration has blown past the deadline.

As we recently noted, a final rule was due by October 1, 2011. Drug and device makers were supposed to have started collecting their own physician payment information as of January 1, 2012, and submit the information to the US Department of Health and Human Services by March 31, 2013. The White House began reviewing the rule several weeks ago, but has been silent on its progress or when it would be returned to CMS and publicly released.

As a result, the delay has raised concerns that meeting transparency goals will be difficult and a gaggle of individuals, companies and organizations have written the White House to urge the OIRA to move faster. Among them was Medtronic (MDT), Eli Lilly (LLY), Pew Charitable Trusts, National Coalition on Health Care, AARP, AFL-CIO, Families USA, National Research Center for Women & Families, former editors of the New England Journal of Medicine and several US Senators.

Since then, the OMB’s Office of Information and Regulatory Affairs has declined to comment and CMS has only indicated that the rule would be released as soon as possible (see the back story and what ‘soon’ might really mean). We have again asked CMS for comment and will update you accordingly.

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