Life Science Compliance Update

January

2017

January 2017: Life Science Compliance Update

Written by , Posted in January 2017 LSC Update, This Month in Compliance

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January 2017 LSCU Cover

Issue Summary

Happy New Year to all our loyal subscribers and contributors! This year marks the 3rd Anniversary for the Life Science Compliance Update. Thank you! This month we focus on needs assessments, new IRO guidelines on independence, the Privacy Shield, and of course, the latest enforcement developments that impact compliance. May 2017 be a year of wondrous progress and prosperity!


Feature

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Feeling Needy – The Why, What and How of Needs Assessments
Tynan P. Olechny, MBA/MPH, CVA, Consulting Principal, PYA, and Christina L. Hummel, MBA, Senior Consultant, PYA
Abstract

Given trade association guidance and recent government involvement in life sciences transactions, this article emphasizes the importance of developing and implementing needs assessments related to engaging healthcare professionals to provide services to pharmaceutical or medical device companies. It describes a four-step process for identifying and documenting the business purpose of such arrangements, including 1) developing and implementing a written needs assessment policy, 2) identifying the business purpose, 3) completing a provider analysis, and 4) addressing additional considerations and documenting the need.

Compliance Operations

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Maintaining Independence & Objectivity – OIG Releases New IRO Guidance
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

The Health and Human Services Office of Inspector General has released new guidance on an important topic, Independent Review Organizations within Corporate Integrity Agreements. This article goes through the recent guidance and explains the requirements of objectivity and independence. The conclusion also provides several practical takeaways from the new guidelines.

Data, Metrics & Analytics

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Managing Medical Inquiries in an Era of Data Analytics
Tom Gregory, Partner and Megan Ellison Manager, Fraud Investigation & Dispute Services, Ernst & Young LLP
Abstract

Although compliance professionals tend to view Corporate Integrity Agreements (“CIAs”) as setting the basic compliance standards, in the area of medical inquiry monitoring, they appear to buck the trend by relying on data analytics. This article explores what these professionals are doing and why.

Privacy

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Sailing with a New Safe Harbor in Sight: The EU-U.S. Privacy Shield
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
Abstract

Beginning August 1, 2016, the United States Department of Commerce began accepting self-certifications to the EU-U.S. Privacy Shield from organizations looking to transfer personal data collected within the European Union to the United States. This article provides an overview of the Privacy Shield, its interplay with privacy issues companies face with compliance with the EFPIA Disclosure Code, provisions related to pharmaceutical and medical products (i.e., clinical data, adverse event reporting), and whether the Privacy Shield can survive.

Enforcement

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Planning for the Future – HHS OIG’s 2017 Work Plan
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Health and Human Services Office of Inspector General has released their 2017 Work Plan. The updated work plan includes some new and revised audits and evaluations, as well as some older audits and evaluations that OIG continues to focus on. This article goes through many of the items focused on the drug and device world and discusses what compliance officers should do with this Work Plan.

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Co-Payment & Deductible Waivers as Illegal Inducements
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

Health insurance providers and out-of-network providers, have found themselves in murky water by providing waivers of co-payments, coinsurance, and deductibles to patients treated by out-of-network laboratories and other providers, where commercial insurers continue to seek legal reimbursement actively, recovery and collection claims against such providers, alleging in pertinent part False Claims Act (“FCA”), Anti-Kickback Statute Violations (“AKS”), and other legal claims. Such efforts are requiring Courts to identify, determine, evaluate, and when waivers of co-payments, coinsurance, and deductibles, constitute such FCA and AKS violations.

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Nursing Facilities & Kickbacks – Is the DOJ Shifting Away from Pharma?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

DOJ may have a new focus for Anti-Kickback Statute violations: care facilities and their owners. This year alone, at least two high-profile cases have emerged where a care facility wound up in high-profile enforcement actions involving anti-kickback violations. This article examines the cases and explores why life science compliance professionals should pay attention to them.

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Not All Discounts Are Equal: Evaluating When Discounts May Be Construed as Unlawful
Robert N. Wilkey, Esq., Staff Writer and Dr. Seth B. Whitelaw, Editor for Life Science Compliance Update
Abstract

Discounts within the health care industry are historically viewed as not being subject to the U.S. Federal Anti-Kick Back Statutes (“AKS”). Recently, the U.S. Department of Justice (“DOJ”) and U.S. Courts have sought to clarify, refine, and otherwise limit the scope of the discount “safe harbor” provision, putting the life sciences and health industry on notice that not all discounts are necessarily immune from AKS violations. As a result, companies are no longer blindly able to rely on “safe harbor” protections and need to re-evaluate their discount programs.

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