Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more
A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more
With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more
1/13/2017
/ Affordable Care Act ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Exclusions ,
False Claims Act (FCA) ,
Final Rules ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OIG ,
Safe Harbors ,
Social Security Act