The Government Accountability Office (GAO) has recently issued two important reports discussing important aspects of the roll-out of the federal exchange and cost-effective preventive measures in U.S. healthcare. The first report, published on July 30, 2014, examines the problematic roll-out of Healthcare.gov. In this report, entitled “HEALTHCARE.GOV – Ineffective Planning ... Read More »

On September 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) will release information to the public relating to certain payments to physicians and teaching hospitals (collectively “Covered Providers”) from drug/device manufacturers and group purchasing organizations, as well as information on physician ownership and investment interests in certain drug/device ... Read More »

On July 1, 2014, the Food and Drug Administration (FDA) released several documents applicable to compounding pharmacies, which are in the business of preparing custom-tailored drugs intended for patients. The first document is draft interim guidance that describes the FDA’s expectations regarding compliance with current good manufacturing practice requirements. It focuses on ... Read More »

The Department of Health and Human Services (HHS) has recently released a new security risk assessment tool for the purpose of aiding covered entities and business associates in their never-ending duty of ensuring HIPAA/HITECH compliance with their operations.Under HIPAA/HITECH, covered entities and business associates must conduct regular risk assessments of ... Read More »

On April 24, 2014, the Food and Drug Administration (FDA) issued its long-awaited proposed regulations (Deeming Regulations) to bring electronic cigarettes, cigars, pipe tobacco, water pipe (hookah) tobacco, dissolvables and nicotine gels (Newly Covered Products) under the agency’s tobacco regulatory authority. The Deeming Regulations would subject Newly Covered Products to ... Read More »

Within one week of President Obama’s signing a law that will give the U.S. Food and Drug Administration (FDA) partial jurisdiction over compounding pharmacies, the FDA has taken important action that will effectively change how the industry is regulated. Read More »