FDA Issues

The Food and Drug Administration (FDA) issued two draft guidance reports related to the PPACA Generic Drug User Fee Act (GDUFA). The “Drug User Fee Amendments of 2012: Questions and Answers” provides answers to common questions on the requirements and commitments of the GDUFA. The second guidance, “Self-Identification of Generic Drug Facilities, Sites, and Organizations,” provides guidance to generic drug manufacturers on how to meet the self-identification requirements under the GDUFA.

DME Bids Due

CMS announced that Medicare durable medical equipment (DME) suppliers in the nine geographic areas of Round One will have from around October 15th through December 14th to submit bids for the next three-year contracting period which begins January 1, 2014. CMS said the bidding program already has saved Medicare $202 million in the first year of the program

CMMI Advances Primary Care Initiative

CMS announced the selection of five hundred primary care practices to participate in the PPACA generated “Comprehensive Primary Care” program administered by the Center for Medicare and Medicaid Innovation (CMMI) which will pay the providers an additional $20 per beneficiary for enhanced primary care management.

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