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OIG issues Advisory Opinion addressing clinical study patient subsidies

USA - June 12 2015 The U.S. Department of Health and Human Services Office of Inspector General (OIG) has offered several new points of guidance for medical device…

Meenakshi Datta, Catherine Y. Starks

HHS regulatory agenda forecasts impending agency action on key healthcare issues

USA - June 2 2015 Agenda Items Include 340B Rules and Guidance, Three Significant Office of Inspector General (OIG) Final Rules, Affordable Care Act (ACA)…

Stephanie P. Hales, Paul E. Kalb, Donielle McCutcheon

Human subjects research protections proposed rule finally moves forward for White House review

USA - February 25 2015 On February 24, the Office of Management and Budget's Office of Internal Regulatory Affairs (OIRA) accepted for review the Department of Health and…

Dora Hughes

Recent changes and proposal related to the Medicare Part D program signal increased costs to pharmaceutical industry

USA - February 13 2015 Last week, there were two separate key developments related to the Medicare Part D program. On February 2, President Obama released the Fiscal Year…

Meenakshi Datta, Han Ming Ho, Dora Hughes

OIG’s annual Work Plan targets pharmaceutical, medical device, and laboratory cost and reimbursement issues

USA - November 11 2014 On October 31, 2014, the Office of the Inspector General of the U.S. Department of Health and Human Services (OIG) released its annual Work Plan for…

Meenakshi Datta, Mark B. Langdon, Hae-Won Min Liao, William A. Sarraille, Trevor L. Wear