Changes in international legislation and trends in enforcement have continued to be a moving target for 2014 and 2015. In the area of FCPA enforcement, several trends provide guidance on what companies need to be conscientious about in the coming year. In the area of international regulations, there continues to be an upswing in the number of countries that have added new regulations or tightened requirements around existing legislation to send a message regarding their efforts to reduce corruption.
Assessing your 2015 Compliance Goals
It is hard to believe that we are half way through the year. Now entering prime vacation season, the office tends to be a little quieter and the work flow slower. This brief reprieve from the office hustle and bustle provides compliance professionals a great opportunity to look back at what has been accomplished thus far this year and prepare for what is to come as we quickly move into the second half of the year. Whether you started the year by conducting a formal risk assessment and prepared a formal remediation and compliance plan, or simply jotted some compliance goals on the office whiteboard, now is the perfect time to check the boxes on the tasks that were completed and see what is left to do. It is also important to ensure the plan you put in place at the beginning of the year still “makes sense” both based on your internal business environment as well as enforcement trends and expectations for the year made known by government agencies such as the DOJ and OIG. Taking advantage of the slower summer to do these things now will prove invaluable so that you can hit the ground running in the fall with a focused and achievable compliance game plan that will allow you to check the boxes all the way down your list.
Mistakes are common. We all make them. According to my teenage kids, I make mistakes every single day! Some mistakes are benign; no one gets hurt. But some mistakes are costly and can lead to potentially catastrophic results. Whereas some individuals may have the luxury of making the same mistake twice, for many a single mistake may cause irreparable harm. Nowhere is this more evident than in the compliance field.
U.S. legislators and enforcement agencies have grown increasingly concerned with physician-owned distributors (PODs) and their relationship with hospitals and other providers. Because physicians may refer patients to hospitals—and use specific products in connection with such referrals—the government asserts that PODs have the potential to unduly influence physician decision making, encourage overutilization of certain products and services, create unfair competition and otherwise increase unnecessary healthcare spending by Federal programs.
U.S. and global regulators heavily scrutinize financial arrangements between healthcare professionals (HCPs) and life sciences companies, including orthopaedic manufacturers and distributors. Recent prosecutions and settlements involving drug and device manufacturers frequently allege that certain payments and other incentives provided to physicians are being improperly made in order to promote their products. Indeed, several prominent medical device companies have been subject to investigations and corporate integrity agreements stemming from alleged improper consulting payment arrangements with physicians.[^1]