Senator Calls--Again--for White House to Release Sunshine Act Rules

Posted 23 January 2013 By Alexander Gaffney, RF News Editor

A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are "unacceptable."

Sen. Charles Grassley (R-IA), is the ranking Republican member of the Senate Committee on the Judiciary, and along with former Sen. Herb Kohl (D-WI) sponsored and wrote the Physician Payments Sunshine Act (Sunshine Act), which eventually became part of the 2010 Patient Protection and Affordable Care Act (PPACA).

The Sunshine Act was developed in response to what the senators said was a growing body of evidence that payments made by medical device, pharmaceutical and biopharmaceutical industries were influencing prescribing habits. Doctors receiving the payments were more likely to prescribe that company's products, sometimes even over the bioequivalent, FDA-approved generic product.

But even as the act passed a closely divided Congress and was signed into law, its provisions have been nowhere to be found despite the law's statutory deadlines.

"The Sunshine Act required that CMS release final regulations by 1 October 2011, so that pharmaceutical and medical device manufacturers could begin collecting payment data by 1 January 2012, and submitting data to the Department of Health and Human Services (DHHS) by 31 March 2013," Grassley explained in a letter to Jacob Lew, White House chief of staff. "Congress designed the law so that the data would be publicly available by 30 September 2013. Unfortunately, the final regulations are now more than 15 months overdue."

"At best, the public may miss an entire year's worth of data collection-perhaps more," Grassley added.  "This is unacceptable."

Those rules are currently under review at the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA), which is charged with reviewing all regulations for cost effectiveness and appropriateness. The office has at times been notorious for lengthy, unexplained delays in approving rules. A US Food and Drug Administration (FDA) rule to require medical devices to be affixed with a unique identifying number-the so-called UDI rule-for example, was delayed for more than a year without explanation.

The rule was passed on to OIRA in late November 2012. At the time, Grassley speculated that the regulation could be on hold until immediately after the election-a potential gift to industry members in return for additional support, the theory went-but so far the rule is still missing in action.

And to Grassley, that delay is causing harms not only to consumers, but to industry actors acting in good faith as well. "These delays are disrupting the considerable efforts of the pharmaceutical and medical device manufacturers that are already investing in systems to comply with the law, as well as voluntary efforts of universities and even the National Institutes of Health to promote more transparent relationships between physicians and industry," he wrote.

The senator concluded by demanding that if the rules are not to be released by 24 January 2013, that the White House explain the delay and provide the date by which the executive branch expects to have published the rule.

The rule is being published under the purview of regulatory authority invested in the Centers for Medicaid and Medicare Services (CMS), a division of DHHS.

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Categories: FDA

Tags: Lew, White House, Delay, Sunshine Act, Letter, Payment, Latest News, DHHS, CMS, Grassley, PPACA

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