Life Science Compliance Update

August

2017

The Fine Art of Policy Management

Written by , Posted in Compliance operations, Uncategorized

Matt Kelly, Editor & CEO at Radical Compliance

Management of corporate policies is a primary challenge for compliance officers in today’s life sciences sector. Recent guidance from the Justice Department and OIG-HHS about effective compliance programs does elaborate on what a strong policy management program should do. In this article, we examine five basic abilities that all policy management programs should have—things that your program must be able to do, regardless of your organization’s specific structure and processes, if you want an effective program that can endure in today’s highly regulated environment.


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August

2017

Independent Review Organizations (“IRO”) and Conflicts of Interest – Much Ado About Nothing or a Serious Problem

Written by , Posted in Compliance operations

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

As part of the process of entering into civil and criminal settlement negotiations with the government resulting from allegations of noncompliance, life science companies are increasingly seeking the retention of third-party regulatory compliance and auditing companies, designated collectively as independent review organizations (“IROs”) to facilitate such process. Recently, there is renewed skepticism and heightened criticism over the companies’ use of such IROs, especially given revelations that companies are choosing IROs that they may have had business relationships with in the past or present. Despite this, the U.S. Department of Justice (“DOJ”) and other government oversight agencies argue that the current status quo is effectively working, including the already established standards, qualifications, and other guidelines for the selection of an IRO. This article examines the various view points and what it means for the life science compliance professional.


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July

2017

Effectiveness, The Holy Grail of Compliance – Both the DOJ & OIG Weigh In

Written by , Posted in Compliance operations

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

Measuring the effectiveness of compliance programs is no easy task since governing agencies have not published a template that will work in all cases; compliance measurements are unique to each company’s size, operations, resources and risks factors. Although there is no “one size fits all” program, both the DOJ and the OIG (in conjunction with the Health Care Compliance Association (“HCCA”)) recently issued guidelines and recommendations for healthcare organizations to design, implement, evaluate and improve their compliance programs. Unfortunately, this may have been done in a vacuum as neither agency appeared to have consulted with one another. There are similarities, differences, and ambiguities between the two agencies’ point of views. This article serves to compare and contrast the compliance guidelines as set forth by the DOJ and OIG within weeks of each other.


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May

2017

Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk

Written by , Posted in Compliance operations

Lauren Barnett, Senior Compliance Content Specialist and Sean Murphy, Product and Marketing Manager, PharmaCertifyTM by NXLevel Solutions

Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a growing milieu of subject matter, from off-label promotion, HIPAA, and data security, to anti-bribery laws around the globe. The rush to cover all the topics across all the potential audiences can lead to a convoluted curriculum, with gaps or redundancies in terms of which audiences receive what training. Building a curriculum that appropriately addresses the company’s unique risks is an important first step, but a regularly-scheduled analysis of all content, and audiences and delivery methods, is critical to ensure on-going effectiveness against risk.


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March

2017

Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?

Written by , Posted in Compliance operations

Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the second in the two-part series.


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March

2017

Accountability: The shifting landscape of compliance responsibilities

Written by , Posted in Compliance operations

Darren Jones, Managing Partner, Polaris Management Partners

The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.


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February

2017

Product Price Hikes – When Business and Compliance Collide

Written by , Posted in Compliance operations

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.


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January

2017

Maintaining Independence & Objectivity – OIG Releases New IRO Guidance

Written by , Posted in Compliance operations

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.


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December

2016

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

Written by , Posted in 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.


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December

2016

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

Written by , Posted in 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.


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December

2016

The Seventeenth Annual PCC: Day 2 Highlights

Written by , Posted in Compliance operations

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.


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November

2016

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

Written by , Posted in 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.


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October

2016

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

Written by , Posted in 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

Like Taxes and Inflation – HHS Revises Civil Monetary Penalties Upwards

Written by , Posted in 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.


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October

2016

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

Written by , Posted in 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.


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