Whistleblower Law Blog

New Proposed Rules to Require Drug and Medical Device Companies to Report Payments to Physicians

On December 14, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule that would require drug and medical device manufacturers to report their payments to physicians to federal regulators. These rules will implement the “physician payments sunshine” provisions of the 2010 Patient Protection and Affordable Care Act (ACA).

The proposed rules aim to increase the transparency of the relationships between health care providers and the manufacturers of drugs, medical devices, biological, and medical supplies covered by Medicaid, Medicare, or the Children’s Health Insurance Program.  The proposed rule would require such manufacturers to report certain “payments or transfers of value provided to physicians or teaching hospitals” to the federal government every year. In addition to these reports, the ownership interests or investments of physicians in these kinds of manufacturers or companies would also have to be reported. These reports would be made publically available online under the proposed rules.

CMS noted that while Section 6002 of the ACA requires that physician payment data be collected beginning January 1, 2012, the agency has proposed that manufactures not start collecting the data until the rules are finalized. Collected data for 2012 would still need to be disclosed to CMS by March 31, 2013.

The proposed rules will be published in the December 19, 2011 edition of the Federal Register and CMS will accept comments on the rules until February 17, 2012.  The final rules are expected sometime in 2012.

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