Life Science Compliance Update
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry.



April 2018: Life Science Compliance Update

Written by , Posted in April 2018 LSC Update, Home page, This Month in Compliance

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Data Analytics & Detecting Medicare Fraud – A Promising Idea Still Awaiting Proof of Concept
By Gwendolyn Ball
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For analyzing so-called “Big Data” sets, data analytics is an invaluable set of tools and techniques. Now the HHS OIG plans to expand its efforts to use data analytics to detect Medicare fraud. While promising, it remains to be proven that the tool and techniques will be cost-effective in this context.

April 2018 Issue Summary

April 2018 LSCU Cover
If we had to pick a theme for this month’s issue it would be change. First off, we explore the rapidly escalating and changing chorus of voices surrounding DRUG PRICING TRANSPARENCY. Next, we look at the CMS’S efforts to address ALTERNATIVE PAYMENT MECHANISMS in the context of the existing legal and regulatory framework. In the same vein, we explore what DATA ANALYTICS means in the context of detecting and preventing healthcare fraud. On the enforcement front it is the aftermath of MEDTRONIC’S MULTI-STATE SETTLEMENT as well as the latest child of ESCOBAR. Finally, we round out the issue with a look at GUIDANCE DOCUMENTS.


The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder
Nicodemo Fiorentino, Esq., Member, Life Science Compliance Update Editorial Board
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Drug pricing transparency, as a concept at least, is here to stay. However, the details of what that means and the new obligations that pharmaceutical companies will need to deal with are yet to be determined. For pharmaceutical compliance professionals, 2018 will continue to be a time of high uncertainty and an ever-increasing workload. This article examines the current state and what the future may hold.


Coming into the Modern Era – CMS Creates Interagency Task Force to Examine Alternative Payment Mechanisms
Gwen Ball, Staff Writer, Life Science Compliance Update
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To control rising costs under Medicare, the Affordable Care Act, and Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) created some “value-based programs” (“VBPs”) which provide incentives for cost cutting while ensuring the quality of patient care. VBPs inherently rely on collaboration between referring physicians and other healthcare providers as well as share Electronic Health Record (“EHR”) systems, thereby conflicting with the old fee-for-service fraud protection provided by the Anti-Kickback Statute and the Stark Law. CMS Administrator Verma recently called for an interagency task force to study removal of these barriers to new, cost-effective methods of healthcare delivery under Medicare. However, the administrator notes that real progress on this issue may require Congressional action as well.


It’s Not All About the Money – Medtronic’s Infusion Multi-State Settlement Agreement
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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In a closely watched matter culminating years of litigation, Medtronic in December 2017, entered into a $12 Million multi-state settlement resolving allegations that the medical device company had misled consumers about the safety, efficacy, and effectiveness of its Infuse® Bone Graft Device (“Infuse”). The settlement represents continued coordination among States to prosecute marketing fraud and false advertising within the medical device industry.


The Escobar Hurdle – False Claims, Materiality, and Dismissal
Robert N. Wilkey, Esq.
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U.S. ex rel. Ruckh v. CMC II LLC et al. (“Ruckh”) was a closely followed False Claims Act case, because a Florida Federal Court opted to vacate a nearly $350 Million FCA verdict involving a nursing home operator. The case is significant because it demonstrates the ongoing impact of a party’s failure to meet the Escobar materiality standard.


The War on Patient Assistance Programs Takes a New Twist – The Tortured History of Caring Voice Coalition
Kaitlin Fallon Wildoner, Esq., and Seth B. Whitelaw, J.D., LL.M, S.J.D.
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In the most recent chapter in the ongoing battle over the priority of patient assistance programs, the Caring Voice Coalition recently announced it would not provide financial assistance for any diseases in 2018. As a result of this announcement, HHS OIG is turning to PhRMA for help.


The End of Guidance Documents or Simply a Reminder of Well-Established Administrative Law Principles
Kaitlin Fallon Wildoner, Esq., and Seth B. Whitelaw, J.D., LL.M, S.J.D.
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As discussed in several news outlets, the Trump Administration recently announced that it would begin to enforce long-standing administrative law principles and limit the weight guidance documents carry in government actions against private companies and individuals. While the ramifications of this decision are still months away from realization, this article outlines the principles and the possible effects we will see in the future from this decision.

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