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CMS Releases Proposed Reporting Requirements

CMS Releases Proposed Reporting Requirements for Drug, Device, Biological and Supply Manufacturers and Group Purchasing Organizations

January 19, 2012

Authors: William J. Roberts

The Centers for Medicare and Medicaid Services (“CMS”) recently released proposed regulations to implement the reporting and transparency requirements set forth in the Patient Protection and Affordable Care Act. The proposed regulations (the “Proposed Rule”)1 require certain manufacturers of drugs, devices, biologicals or medical supplies to report to CMS certain payments or transfers of value to physicians and teaching hospitals. The Proposed Rule also requires such manufacturers and certain group purchasing organizations (“GPOs”) to report certain ownership and investment interests. Although the Proposed Rule is not final and does not change current law or regulation until a final rule is issued, we are providing this alert to give you a better understanding of what may be expected of you, to help you prepare for the inevitable data collection requirements and to assist you in deciding whether to submit comments to CMS on the Proposed Rule.

Click here to view the complete alert, including Q&A on the topic.


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