Policy & Medicine Compliance Update
Don’t have a subscription yet? Subscribe Here ?rid=m4O2wt.
MARCH 2019 Issue
Issue Summary:
As the first quarter of 2019, we decided to turn our focus to the dynamic duo of False Claims Act and Anti-kickback Statute. Starting things out, we look back at FY2018 recoveries and settlements to see what the data can tell us about the future. Next, we examine the Dechert LLP annual survey of shareholder actions to see how this increased risk and enforcement actions involving false claim allegations go hand-in-hand.
We also feature a two-part series on the Granston memo and its impacts on qui tam litigation. Then we move on to cover the recent changes to the anti-kickback landscape with passage of the Eliminating Kick-Backs and Recovery Act of 2018. Rounding out the issue, Porzio Life Sciences presents a compelling case on using Big Data and AI can improve most compliance programs.
FEATURE
FALSE CLAIMS ACT
The Rise and (Mostly) Fall of False Claims Act Recoveries
By Jennifer O’Leary, JD, LICSW, Staff Writer for Policy and Medicine Compliance Update
Summary: FY2018 saw a decline in the amount of recovery the Department of Justice received from False Claim Act settlements and judgments. Healthcare continues to dominate False Claims Act cases while non-healthcare cases decline. Additionally, the new Granston Memo and revisions to the Yates Memo are also contributing to the decline in recovery.
TAGS: FCA, Granston, Yates
SHAREHOLDER LITIGATION
Life Sciences Securities Litigation – A Significant Risk Lurking in the Background
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update[i]
Summary: Dechert LLP recently released its annual survey of the Life Sciences Securities Class Action Litigation landscape. The survey identifies key trends in these suits and provides risk reduction strategies for life sciences companies to lessen this significant risk and avoid being a target of such suits.
TAGS: Securities, Shareholders, Litigation, Dechert, Survey
QUI TAM LITIGATION
Gazing into the Crystal Ball (Part 1) – Qui Tam Litigation After Granston’s Memo
By Gwendolyn Ball, Staff Writer, Policy & Medicine Compliance Update
Summary: Although widely hailed by industry as a step in the right direction, the results of the Granston memo not as clear cut. This article explores the memo considering recent activities to try determining what the future might hold.
TAGS: FCA, Qui Tam, Granston Memo
Gazing into the Crystal Ball (Part 2) – The Impact to Escobar After Granston’s Memo
By Robert N. Wilkey, Esq., Senior Staff Writer for Life Science Compliance Update
Summary: The “Granston Memo” set out Justice Department efforts to assert its statutory authority pursuant to the False Claims Act to intervene in FCA related cases and if necessary, seek to dismiss any qui tam actions over a relator’s objection. While the impact of the Granston Memo remains uncertain, in a recent Amicus Brief to the United States Supreme Court, the DOJ has decided to weigh in, advising the Court that it plans to seek dismissal of a several qui tam related cases it deems not in the public’s interest. As such it is highly anticipated that 2019, will be a pivotal year in terms of the DOJ’s concerted efforts to become actively involved in FCA related cases.
TAGS: FCA, Qui Tam, Granston Memo, Escobar
Anti-Kickback Statute
Remaking the Anti-kickback Landscape – EKRA Adds a New Rule to the Existing Healthcare Fraud Enforcement Spectrum
By Jennifer O’Leary, JD, LICSW, Staff Writer for Policy & Medicine Compliance Update
Summary: The passage of a new federal anti-kickback law extends federal regulations beyond the boundaries of federal healthcare programs. The Eliminating Kick-Backs and Recovery Act of 2018 ventures into the private and commercial healthcare sector, exposing entities business practices to risk previously unexperienced under the federal Anti-kickback Statute and the Stark law.
TAGS: Kickbacks, EKRA, Safe Harbors, Inducements
Compliance Operations
Big Data Presents Big Opportunities: Using Artificial Intelligence to Minimize the Risks Associated with HCP Engagements
By Stephanie M. Garfield, JD, Compliance Associate and Michael T. O’Connor, Vice President, Compliance Technology, Porzio Life Sciences
Summary: Life sciences companies can more effectively analyze their data if they incorporate Artificial Intelligence tools into their Compliance Programs. By automating certain types of review, AI can increase efficiency while simultaneously mitigating risk, allowing companies to maximize their risk prevention efforts while continuing to rely on compliance professionals for tasks that require human judgment. This article suggests two ways that life sciences companies can use AI to screen for risks related to the engagement of health care professionals
TAGS: Big Data, AI, Machine Learning, HCPs, Kickbacks
[i] Policy & Medicine Compliance Update is a monthly publication for life science compliance professionals. Views expressed in this article are solely that of the author and should not be interpreted or relied upon as legal advice. This article is provided for informational purposes only and merely provides a general description of the law. Readers should consult their own counsel for specific legal advice.
