No Light Shining on Drug Samples

Q. Are the drug companies now required to report drug samples they give my practice, per the “Sunshine Act”?

A. No. Drug samples are one of the exclusions from the industry reporting requirements. Certified and accredited continuing medical education also is excluded from reporting, thanks to action by the American Medical Association and state associations, including TMA.  

The Physician Payments Sunshine Act requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. In addition, manufacturers and group purchasing organizations must report certain ownership interests held by physicians and their immediate family members.

Under Centers for Medicare & Medicaid Services (CMS) rules (PDF), manufacturers are required to collect and track payment, transfer and ownership information beginning Aug. 1, 2013.

CMS is calling its national transparency program “OPEN PAYMENTS.” Manufacturers will report the data for August through December 2013 to CMS by March 31, 2014, and annually thereafter. Most of the information in the reports will be available on a public, searchable website that CMS will make available by Sept. 30, 2014.

You will be able to check a consolidated report at the end of the annual reporting period, prior to public posting, and be able to challenge reports that are inaccurate or misleading.

Meanwhile, AMA recommends that you check with any manufacturer from which you have received payment or any item of value to see what information it is tracking and intends to report. If you hold any ownership interests in a manufacturer or group purchasing organization, you should also check to ascertain what ownership interest(s) it intends to report.

AMA has created a toolkit for Physician Financial Transparency Reports with tips, FAQs, and information about challenging inaccurate reports.

Published Aug. 27, 2013

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Last Updated On

October 16, 2015

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