Recent Trends in Whistleblower Protection under Dodd–Frank

By Edward J. Buthusiem & Gary F. Miller, Jr.

The enactment of the Dodd–Frank Act was intended to provide the SEC with an important weapon in its mission to seek and vigorously prosecute the commission of securities and other types of frauds domestically and overseas. By providing to whistleblowers monetary incentives ranging between 10 percent and 30 percent of fines assessed, the whistleblower program has gained an element of popularity—some would say notoriety—amongst would-be reporters of putative wrongdoing. Recent Federal Court decisions, however, have created significant roadblocks that could blunt the Dodd–Frank juggernaut.

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Compliance Officers: Three Common Mistakes to Avoid

By Edward J. Buthusiem

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.

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PODs: Proceed with Extreme Caution

By Edward J. Buthusiem, Cheray Lynch Sieminski, Vahan Minassian

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.

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Five Steps to Sunshine: Strategies for Complying with CMS Reporting Requirements

By Edward J. Buthusiem, Cheray Lynch Sieminski, Vahan Minassian

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]

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