Category Archives: Compliance

We are only a few months away from the August 1st deadline to track payments made to healthcare practitioners and teaching hospitals.  As the date nears CMS has recently released informative fact sheets and a PDF file of covered teaching hospitals. These fact sheets can be found here and are written for Manufacturers, Physicians, TeachingContinue Reading

The recent release of the Foreign Corrupt Practices Act (FCPA) Resource Guide by the U.S. Department of Justice and the U.S.  Securities and Exchange Commission provides exceptionally helpful guidance to organizations on complying with various anti-bribery statutes.  It also provides another strong statement from the government relating to the importance of an effective compliance programContinue Reading

The vast majority of medical device companies utilize independent distributors to sell and market their products to healthcare professionals.  When distributors are in the field, they are representing the organization whose products they are marketing.  If your distributors act in an unprofessional or illegal manner it exposes your company to compliance risks and almost asContinue Reading

As evidenced by recent settlements and numerous investigations of medical device companies, including the recent Johnson & Johnson Risperdal settlement of over $1,000,000,000, the government is VERY interested in off label promotion. While in general it is permissible for a product to be used off label when clinically appropriate it is NEVER appropriate for aContinue Reading