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Sunshine Act data collection delayed to January 2013, says USA’s CMS

In a web site posting last week, The US Center for Medicare and Medicaid Services (CSM) announced that manufacturers will not be required to collect data under the physician payment Sunshine provisions of the Patient Protection and Affordable Care Act before next January.

The CMS said it is “committed to addressing the valuable input received during the comment period, and to ensuring the accuracy of the data collected. In order to provide time for organizations to prepare for data submission and to sufficiently address the important input we received during the rulemaking process, CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013.”

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The Sunshine provisions, developed by US Senators Chuck Grassley (Republican, Iowa) and Herb Kohl (Democrat, Wisconsin), among other things, require manufacturers of drugs, devices, biologicals, and medical supplies that are covered under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) to report annually to the CMS certain payments or other transfers of value to physicians and teaching hospitals. Although the statute requires the first report to be submitted by March 31, 2013 for payments made in calendar year 2012, the CMS has long exceeded its statutory deadline of October 1, 2011 for issuing implementing procedures.

The CMS published a proposed rule last December, and will not be issuing a final rule until “later this year.” According to the notice, the postponement of required data collection will give the CMS an opportunity to address over 300 comments submitted on the proposed rule, and will give applicable manufacturers additional time to prepare for transparency report submission.

Senators tell CMS of their disappointment

US Senators Grassley and Kohl, authors of the Physician Payments Sunshine Act, issued a statement on the situation, with Sen Grassley saying: “It’s disappointing that CMS won’t even collect data at all this year. The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later. It’s important that CMS get this right in every way, including the usefulness and accuracy of the information. Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”

Sen Kohl added: “While I am disappointed by this delay and the timeline, I do look forward to working with CMS to finalize the rules so that data collection can begin in January 2013.”

The senators developed the Physician Payments Sunshine Act, which was signed into law in 2010, after revelations of significant under-reporting of the amount of payments received by certain doctors from drug and device companies. The new law requires public disclosure of the financial relationships between physicians and the pharmaceutical, medical device and biologics industries. The law required the Department of Health and Human Services (HHS) to establish reporting procedures for applicable manufacturers to submit information, as well as procedures for making that information available to the public, by October 1, 2011.

Sens Grassley and Kohl have written to the acting CMS administrator with questions about implementation, including when the CMS will begin data collection. The text of the Grassley-Kohl April 4 letter to the acting CMS administrator is available on Sen Grassley’s web site, as is the acting CMS administrator’s May 3 response, at:http://www.grassley.senate.gov/news/press_releases.cfm

Categories:   Regulatory

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