Life Science Compliance Update

July

2017

LSCU SPECIAL FEATURE: Into the Nexus – Anti-Kickback Statute (“AKS”) versus Value-Driven Health Care

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As health care reform continues to be a hot topic, there is discussion occurring regarding whether regulatory and compliance laws such as the Anti-Kickback Statute (“AKS”) are antiquated, outdated, and also require modernization, with a focus on improving patient outcomes and reducing overall healthcare costs. As such, the premise remains that the current legal framework is not necessarily compatible with transforming the health care delivery system, and needs to be revamped while still serving to provide substantive protections against fraud and abuse. This two-part series explores the landscape and recent developments in this area.

Part 1: An Uncertain Future in a Dynamic Landscape
By Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

Part 2: The Tension Increases – Online Auctions Violate the AKS
By Calisha D. Myers, Esq., Staff Writer and Dr. Seth B. Whitelaw, Editor, Life Science Compliance Update


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May

2017

The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion

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Clay Willis, Life Science Director and Chris Cobourn, Managing Director, Huron Life Sciences

The purpose of this article is give manufacturers some initial background on the topics and some tools that could be considered. The review methodology described has been proven to help manufacturers and has been the starting point for developing an on-going monitoring.


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October

2016

What You Don’t Know About AMP Can Hurt You – Part 3 Can You Defend Your AMP?

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Chris Cobourn, Managing Director, Huron Life Sciences

As part of a three-part series on the Average Manufacturer Price (AMP), this month’s article explores the continuing and evolving scrutiny on AMP by the OIG, and the focus on a manufacturer’s accurate methodologies and reasonable assumptions related to the calculation of AMP.


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August

2016

What You Don’t Know About AMP Can Hurt You – Part 2 This is Not Your Father’s AMP

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Chris Cobourn, Managing Director, Huron Life Sciences1

As part of a series on the Average Manufacturer Price (AMP), this month’s article explores the of AMP from the beginning of the Medicaid Drug Rebate Program (MDRP) to where it is today and why there is so much public scrutiny on this once obscure statutory price calculation.

1 The author of this article is a consultant with Huron Life Sciences, which serves the continuum of life sciences organizations to deliver unique solutions that bridge the process of scientific discovery and sustainable business model creation with strategies that reduce the risks associated with regulatory and government scrutiny. Views expressed in this article are that of the authors and not necessarily those of Huron Consulting Group, or its clients, and should not be interpreted as legal advice. If you have questions about specialty pharmacy relationships or any other considerations, please feel free to contact Chris Coburn at 207-841-1353 or ccobourn@huronconsultinggroup.com.


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July

2016

What You Don’t Know About AMP Can Hurt You – Part 1 In the Beginning

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Chris Cobourn, Managing Director, Huron Life Sciences

Since the US Government uses AMP to set Medicaid rebates, as well as the Medicaid Federal Upper Limit (FUL), it is vital the pharmaceutical manufacturers, and their compliance teams understand the concept to prevent possible missteps. This article is Part 1 of a series discussing the history, current usage, and future of the Average Manufacturer Price (AMP).


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June

2016

Pricing Bills Are Popping Up Everywhere

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Nicodemo (Nico) Fiorentino, Esq., Senior Advisor, Research & Compliance, for G&M Health LLC, and Editorial Board Member, Life Science Compliance Update and Christina Bello, Esq., Regulatory Compliance Advisor, for G&M Health LLC

The price of prescription drugs has created much controversy in recent years. This article examines why the pharmaceutical industry is under such scrutiny despite the fact that expenditures for drug costs have remained steady, explores State and federal legislative response to this perceived problem, and posits the future regulatory landscape regarding prescription drug pricing.


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June

2016

Through the Worm Hole (Part 3) – Setting a Standard for GP Compliance

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Chris Cobourn, Managing Director, Huron Life Sciences

This is Part 3 of a series of articles designed to help life sciences compliance professionals understand the complex, and sometimes contradictory, universes of publicly funded health programs, such as Medicaid and Medicare, and the impact on participating drug manufacturers. This article focuses on the how to evaluate GP Compliance, what manufacturers should do to ensure that they are in full compliance with the programs, and the role of the Compliance Office.


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May

2016

Through the Worm Hole (Part 2) – Welcome to Alphabet Soup, Government Pricing, and the Acronyms That Come Along

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Chris Cobourn, Managing Director, Huron Life Sciences
This is Part 2 of a series of articles designed to help life sciences compliance professionals understand the complex, and sometimes contradictory, universes of publicly funded health programs, such as Medicaid and Medicare, and the impact on participating drug manufacturers. This article focuses on the operational requirements of the programs for drug manufacturers in the US. In Part 3 of the series, we will look at how to evaluate Compliance, and what manufacturers should do to ensure that they are in full compliance with the programs.


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April

2016

A Basic Geometry Lesson – FDA’s Off-label Losses

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Kaitlin P. Fallon, Esq., Staff Writer for Life Science Compliance Update

The new decision in United States v. Vascular Solutions, Inc., provides the third point in a curve of the FDA’s regulation of off-label promotion. This article provides a detailed explanation of the case, including the relevant jury instruction, an overview of the 2014 FDA Guidance document on scientific and medical publications, and possibilities for next steps for compliance officers.


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March

2016

The Black Hole – AMP as Viewed from A Pharmaceutical Manufacturer’s Compliance Office

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By: Chris Cobourn, Managing Director, Huron Life Sciences

The Centers for Medicare and Medicaid Services (“CMS”) have finally promulgated the final rule on Covered Outpatient Drugs including the Average Medicaid Price (AMP) calculation. This article explores what pharmaceutical compliance offices need to know to help their organizations mitigate the risks from not understanding the new provisions.


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January

2016

Pricing -The New Compliance Frontier

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By: Seth Whitelaw, JD, LLM, SJD, Editor and Kaitlin Fallon, Esq., Staff Writer for Life Science Compliance Update

The U.S. Senate Finance Committee recently released a report on the pricing of Gilead’s hepatitis C drug, Sovaldi. After reviewing over 20,000 internal company documents, Senators Wyden (D-OR) and Grassley (D-IA) concluded that Gilead pursued a revenue driven strategy. This article explores the report and its implications for life science compliance programs.


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