Policy & Medicine Compliance Update
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APRIL 2019 Issue
Issue Summary:
For the April issue, we start by examining the increasingly important topic of risk assessments. First, Jenny McVey and I look at whether life science companies are truly managing compliance risks by apply the fundamental principles. Second, we look at the OIG’s fraud risk indicator and how it may impact both FCA cases and CIAs. Next, we switch gears to the enforcement world. We start off with Nicodemo Fiorentino’s update on the Patient Assistance Program settlements, followed by Covidien’s recent AKS settlement, and we finish up with a look at the recent guilty plea by an Olympus executive for Federal, Food, Drug and Cosmetic Act violations.
FEATURE
Are Life Science Companies Truly Managing Compliance Risks? Risk Management Basics
By: Jenny McVey, Ph.D., Associate Director of Risk Strategy, Novo Nordisk, Inc., Dr. Seth Whitelaw, Editor, Policy & Medicine Update (analytics information provided by Jenny Bi, Manager at FRA)
Summary: The general principles of risk management are important to help companies manage the risks associated with meeting strategic objectives. This is the first in a two-part series that explores whether life science compliance professionals truly are applying the key principles and concepts of risk management effectively to manage corporate compliance program risks.
TAGS: Risk Assessment, Risk Management
Operations
What Does It All Mean for OIG? – Declining CIAs and a New Fraud Risk Indicator
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Policy & Medicine Compliance Update
Summary: Following an April 2016 guidance regarding the way HHS OIG evaluates parties involved in FCA settlements, the Agency recently announced a new transparency initiative, the Fraud Risk Indicator score, which is set to provide patients and other stakeholders unparalleled transparency into the world of FCA settlements and CIAs. This article takes an in-depth look at the new indicator and some potential forthcoming issues with it.
TAGS: Risk Assessment, Risk Factors, Fraud Risk Indicator, OIG
ENFORCEMENT
And the Beat Goes On – Patient Assistance Program Settlements Continue
By Nicodemo Fiorentino, Associate Editor, Policy & Medicine Compliance Update
Summary: The industry-wide investigation into the use of independent patient assistance programs continues with few signs it will end soon. This article serves as update to our November 2018 article, including an updated chart of the companies under scrutiny together with those that have settled or that have announced agreements-in-principle to settle. The article also consolidates the allegations from the settled cases highlighting the similarities and differences among them. Finally, in a new development, we discuss the summonses issued by the Internal Revenue Service.
TAGS: PAP, IRS, U.S. Attorney, Patient Assistance
It’s Not Always About the Money – Covidien Settles AKS Suit, But Without Admitting Wrongdoing
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: In response to concerns about Covidien’s marketing practices, two of its former sales managers and a third person with knowledge of the practices, brought qui tam cases against Covidien alleging AKS and FCA violations. The allegations surrounded, not the payment of cash bribes, but rather the provision of remuneration “in kind,” that was designed to increase the profile of and drive patients to specific vein ablation clinics. This article explores yet another tactic to provide kickbacks to healthcare providers.
TAGS: Covidien, Medtronic, AKS, In-Kind, FCA
How Shifting Responsibility Opened the Door to Olympus and a Former Executive to Plead Guilty to FFDCA Violations
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: Following an outbreak of antibiotic-resistant infections in endoscopy patients, the FDA, CDC and DOJ launched investigations into adverse events surrounding the use of duodenoscopes. In the course of those investigations, the DOJ determined that one of the manufacturers, Olympus, allegedly knew of multiple adverse events surrounding their duodenoscopes, but failed to report those timely to the FDA. The DOJ subsequently charged Olympus, and one its regulatory executives, with distributing misbranded medical devices in interstate commerce. This article highlights why companies must take their obligations seriously to comply with Food, Drug, and Cosmetic Act and that failure to do so can subject the company and its employees to civil and criminal penalties.
TAGS: FDA, MDR, Misbranding, Criminal
