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.
The OIG plan for 2015, re-released in May, with updates from the plan that was released in October 2014, demonstrates a pattern of what we have seen in the past, as well as the addition of a few new items. Of note, the OIG will continue its investigative actions focused around their strike force teams (formed in 2007) and the Health Care Fraud Prevention and Enforcement Action Team (HEAT) (started in 2009). The OIG highlighted that their strike force activities from October 1, 2014 to March 21, 2015 have resulted in more than $163 million in fines and charges against 69 individuals or entities. The OIG will also continue to investigate companies that manipulate payment codes and submit false claims, as well as review business arrangements that could violate the Anti-Kickback Statute.
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]