Internal review covers sales, marketing and pricing practices. In the latest development, New York-based Bristol-Myers Squibb Co. says the U.S. attorney's office in Massachusetts - a particularly aggressive office when it comes to health care fraud enforcement - wants the results of an internal compliance review the company is conducting of its sales and marketing practices. In an Aug. 8 filing with the Securities and Exchange Commission, the company notes that its review is designed to assess how well its practices comport with the anti-kickback statute. The review includes such hot-button compliance issues as Medicaid best-price requirements, drug pricing and Medicaid rebates. Shortly after discussing it with the U.S. attorney's office in Massachusetts, Bristol-Myers received a subpoena relating to the review, the company says in the SEC filing. Lesson Learned: Drugmakers should expect continued aggressive scrutiny on a series of key compliance issues, including kickbacks, average wholesale price issues, Medicaid rebates and best-price requirements.
As government scrutiny builds on pharma companies' sales and marketing practices, drugmakers are facing investigations from every quarter: the Department of Justice, state attorneys general, the HHS Office of Inspector General and even Congress.