Robert E. Wanerman
Epstein Becker Green
Articles
Disruptor Meets Regulator, and Regulator Wins: Lessons Learned from Theranos
USA - July 27 2016 On July 7, 2016, the Centers for Medicare and Medicaid Services ("CMS") imposed several administrative penalties on Theranos, a clinical laboratory…
Obstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for Precision Medicine
USA - March 27 2018 A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the…
Six Key Changes to the Common Rule
USA - February 16 2017 On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first…
“Good Faith” Off-Label Promotions Saved Ex-Acclarent Execs from Felony Misbranding Indictments
USA - August 4 2016 Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it…
The SUPPORT for Patients and Communities Act: Part 1: New Federal Anti-Kickback Law - Eliminating Kickbacks in Recovery Act of 2018
USA - December 10 2018 President Trump recently signed sweeping bipartisan legislation to combat the opioid epidemic. TheSubstance Use-Disorder Prevention that Promotes…
Charles C. Dunham, IV, Matthew Sprankle, Richard W. Westling
