Life Science Compliance Update

February

2017

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Product Price Hikes – When Business and Compliance Collide

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Mark Scallon, Partner, FRA Life Sciences and Derek Patterson, Principal, FRA

2016 was the year of the price increase, as leading industry players experienced significant public outrage over what appeared to be extreme price increases. What is compliance’s role when it comes to price increases? Does the ethics and compliance function get to weigh in on how decisions to raise the prices of products are reached, or does this function lie solely with the business? This article explores those questions.

January

2017

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Maintaining Independence & Objectivity – OIG Releases New IRO Guidance

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

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.

December

2016

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Has Integrity Become a Commodity? – Warning Signs of Bad Behavior for Compliance Professionals

Written by , Posted in Abstract, Compliance Operations

James Bone

This article takes a fresh look at trends in changing norms of ethical behavior by senior management and the challenge for compliance officers to recognize and address these changes at the enterprise level. A body of research is beginning to emerge to help inform compliance officers of new approaches to identify and address the threat of deteriorating ethical behavior before damage is done. A review of research in behavioral science points to examples of predictable outcomes where certain conditions create incentives for a change in ethical outcomes.

December

2016

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Medical Affairs and Marketing: The Evolving Role of the Compliance Officer

Written by , Posted in Abstract, Compliance Operations

Ronald G. Walls, M.D., Walls Strategic Consultants

Historically, medical affairs and marketing have directed both the generation and dissemination of information about their products. Digital technologies have weakened that control, opening an array of new, independent information channels. This article explores the unprecedented and unmet need for industry to have their compliance officers be trained to be as social media compliance officers.

December

2016

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The Seventeenth Annual PCC: Day 2 Highlights

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

This article is a continuation of the previous article that discussed the first day of the 17th Annual Pharmaceutical and Medical Device Compliance Congress. This article covers the highlights from Day 2 of the conference.

October

2016

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The Dilemma of Co-Pay Charities and Patient Access to Medication

Written by , Posted in Abstract, Compliance Operations

Lenna M. Babigian, M.H.S., Paralegal, LCSU Staff Writer

Increasingly creative methods are being used by big pharma to increase sales. Drug manufacturers are donating billions of dollars to not-for-profit organizations that fund co-pay assistance programs for patients. Pharmaceutical company profits are through the roof and these not-for-profit organizations are growing at incredible rates. Even though patients are receiving much-needed financial help, there is an abundance of legal and ethical concerns.

October

2016

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Retaliation, Pre-taliation, and Whistleblower Hotlines: How Compliance Officers Can Fight the Biggest Challenge They Face

Written by , Posted in Abstract, Compliance Operations

Matt Kelly, Editor & CEO at Radical Compliance

Handling whistleblowers is one of the biggest challenges facing most compliance officers. Furthermore, recent actions taken by the SEC are de facto policy pronouncements expanding the range of whistleblower risks compliance officers face. This article will review the three primary concerns that compliance officers have about whistleblowers: how to stop retaliation; how to avoid pre-taliation; and how to design whistleblower hotlines.

October

2016

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Like Taxes and Inflation – HHS Revises Civil Monetary Penalties Upwards

Written by , Posted in Abstract, Compliance Operations

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

The Department of Health and Human Services has issued an Interim Final Rule, adjusting for inflation the maximum civil monetary penalty amounts for various civil monetary penalty authorities within HHS. This article elaborates on the increases, as well as what they may mean for the future of compliance.

October

2016

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Helping the Patient – Co-Pay Reimbursement Can Be Okay in Certain Circumstances

Written by , Posted in Abstract, Compliance Operations

Robert N. Wilkey, Esq., Staff Writer and Seth Whitelaw, Editor, for Life Science Compliance Update

The OIG’s recent Advisory Opinion suggest that under certain circumstances patient co-pay reimbursement programs are allowable. This article examines that opinion and highlights the types of controls that are likely needed.

October

2016

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The Blue Ribbon Panel Raises the Bar on Ethics & Compliance

Written by , Posted in Abstract, Compliance Operations

Calisha Myers, Esq., Staff Writer for Life Science Compliance Update

According to the Ethics & Compliance Initiative (ECI), ethics and compliance programs should not be “check the box programs” that solely conform to minimum regulatory or judicial requirements precisely because these requirements are too limited in scope and will take more effort to maintain relevance within the organization. Moreover, with regulatory enforcement and public scrutiny increasing globally, and the rising cost of misconduct, organizations need to know (and we are sure, want to know) how to address issues that may arise in the most cost-effective manner. This second report is a follow-up to our March story on the draft version of the Blue Ribbon report and provides action items for organizations wishing to improve their E&C programs.

July

2016

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The Olympus Settlement – What It Can Tell Us About the Compliance Officer

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Calisha Myers, Esq., Staff Writer – Life Science Compliance Update

When dissecting recent settlements, we normally look at the underlying events and process failures. The recent Olympus settlement, however, provides us a rare glimpse into the nature of the Compliance Officer himself and how that can affect matters.

July

2016

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Give Thanks for Your Compliance Officers – Reviewing Public Citizen’s Study of Pharmaceutical Settlements

Written by , Posted in Abstract, Compliance Operations

By Kaitlin Fallon Wildoner, Esq., Staff Writer, Life Science Compliance Update

Thanks to an increase in experienced compliance officers, settlements and court judgments between pharmaceutical manufacturers and the federal and state governments are shrinking. While there are many possible theories for the reduction, we would like to think it’s thanks to pharmaceutical compliance officers.

July

2016

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It’s A Brave New World or Is It? – CIAs and Their Ability to Create Change

Written by , Posted in Abstract, Compliance Operations

Melissa Hunt, J.D., LL.M., Sr. Manager, Healthcare Compliance, Seattle Genetics

Corporate Integrity Agreement (CIAs) are a tool commonly employed by the HHS OIG to resolve healthcare fraud issues. This article explores the issue of whether CIAs really strengthen company compliance programs. This author is not so sure.

May

2016

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Breathing Life into Privilege – Internal Corporate Investigations, Attorney-Client Privilege, and the False Claims Act

Written by , Posted in Abstract, Compliance Operations

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Recent legal cases have highlighted the important issue of whether or not attorney-client privilege attaches to internal corporate investigations particularly if the investigations involve serious civil or criminal allegations relating to a breach of the public trust, including bribery, corruption, and violations of the False Claims Act (FCA).

May

2016

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What to Do When They Come for You – Creating a Search Warrant Response Plan

Written by , Posted in Abstract, Compliance Operations

Robert Ferri, Of Counsel, Porzio Bromberg & Newman, P.C. and Keren F. Bisnauth, Associate, Porzio Bromberg & Newman, P.C.
The authorities unexpectedly appear at your door with a search warrant. You have no contingency plan. Now, here they are, and you don’t know what to do. Don’t let this scenario happen to you. Here are some steps to help you navigate, and survive, the execution of a search warrant on the premises of your business.

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