Life Science Compliance Update

July

2017

COMMENTS

0

July 2017: Life Science Compliance Update

Written by , Posted in Home page, July 2017 LSC Update, This Month in Compliance

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July 2017 LSCU Cover

Issue Summary

For the July issue, we have focused compliance program effectiveness. Our feature this month explores compliance resourcing challenges for small to mid-sized pharmaceutical companies. We follow this up with a detailed review of the new DOJ and OIG guidance documents. We also take a hard look at project pricing and how the current legal and regulatory structure may impinge on efforts to reduce costs. Finally, we take a look at the latest developments in transparency and false claims enforcement.


Feature

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This is Not Your Parent’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies
Patrik Florencio, Esq., Steven Franchetti, Seth Whitelaw, J.D., LL.M., S.J.D.
Abstract

At the 14th Annual CBI Pharmaceutical Compliance Congress held in April 2017, almost half the attendees were from small to mid-sized companies that generate $3 billion or less in annual revenue. At the same time, the compliance burdens for all pharmaceutical companies continue to increase. This article explores the output of industry experts in attendance at CBI’s small to mid-sized breakout regarding the need for minimum compliance program resources as well as survey data showing that certain companies are funding their compliance programs in line with these needed minimum resources.

Compliance Operations

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Effectiveness, The Holy Grail of Compliance – Both the DOJ & OIG Weigh In
Sally Foroughi, Staff Writer, Life Science Compliance Update and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

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.

Transparency

Arrow

The California Hurdle – SB 790 and Pharma
Jenny McVey, Life Sciences Manager, FRA
Abstract

Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems as though others are following suit. The California state Senate passed SB 790 in May 2017, a bill restricting pharmaceutical companies from giving gifts and incentives to medical professionals. This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.

Pricing

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

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

False Claims

Arrow

Pharmaceutical and Device Manufacturers: Buyer Seller Beware
John Kelly, Matt Curley and Rob Platt
Abstract

Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as well as whistleblowers seeking large payouts for disclosing potential wrongdoing. There are a number of risk areas (some new, some not-so-new) that provide the basis for the government and relators to pursue alleged violations of the False Claims Act liability. Some of those areas are discussed below.

Arrow

Punting on the Issue of FCA and Statistical Sampling
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether the government has veto power over False Claims Act (FCA) settlements, particularly where liability is established by use of statistical sampling, opted to forego rendering a decision on such issue, and leaving wide open the use and appropriateness of statistical sampling in FCA related cases

July

2017

COMMENTS

0

Punting on the Issue of FCA and Statistical Sampling

Written by , Posted in False Claims

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

In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether the government has veto power over False Claims Act (FCA) settlements, particularly where liability is established by use of statistical sampling, opted to forego rendering a decision on such issue, and leaving wide open the use and appropriateness of statistical sampling in FCA related cases.

July

2017

COMMENTS

0

Pharmaceutical and Device Manufacturers: Buyer Seller Beware

Written by , Posted in False Claims

John Kelly, Matt Curley and Rob Platt

Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as well as whistleblowers seeking large payouts for disclosing potential wrongdoing. There are a number of risk areas (some new, some not-so-new) that provide the basis for the government and relators to pursue alleged violations of the False Claims Act liability. Some of those areas are discussed below.

July

2017

COMMENTS

0

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

Written by , Posted in Pricing

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

July

2017

COMMENTS

0

The California Hurdle – SB 790 and Pharma

Written by , Posted in Transparency

Jenny McVey, Life Sciences Manager, FRA

Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems as though others are following suit. The California state Senate passed SB 790 in May 2017, a bill restricting pharmaceutical companies from giving gifts and incentives to medical professionals. This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.

July

2017

COMMENTS

0

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.

July

2017

COMMENTS

0

This is Not Your Parent’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies

Written by , Posted in Feature Article

Patrik Florencio, Esq., Steven Franchetti, Seth Whitelaw, J.D., LL.M., S.J.D.

At the 14th Annual CBI Pharmaceutical Compliance Congress held in April 2017, almost half the attendees were from small to mid-sized companies that generate $3 billion or less in annual revenue. At the same time, the compliance burdens for all pharmaceutical companies continue to increase. This article explores the output of industry experts in attendance at CBI’s small to mid-sized breakout regarding the need for minimum compliance program resources as well as survey data showing that certain companies are funding their compliance programs in line with these needed minimum resources.

June

2017

COMMENTS

0

June 2017: Life Science Compliance Update

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

The full text of this issue is available to our subscribers. If you are a subscriber please log in now. If you are not a subscriber, and would like to become one, please click on the subscribe link or read about all of the benefits a subscription brings by clicking on the Subscribe menu item above.

June 2017 LSCU Cover

Issue Summary

This month we focus on the very real compliance issue of connecting with patients. First, Nico Fiorentino explores the history and latest case involving the use of clinical educators. Then we take another look at the issue of patient assistance programs and the most recent batch of subpoenas. Next Jenny McVey and Mark Scallon explore the General Data Protection Regulation which is set to have substantial impact on the life sciences industry. Finally, we look at the latest developments in transparency, false claims act cases and the 21st Century Cures Act.


Feature

Arrow

White Coat” Marketing Gone Awry
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
Abstract

Achieving patient adherence to prescribed medication through clinical educator programs is not a new concept. Neither is the U.S. Office of Inspector General of the Health and Human Services longstanding concern of the inherent issues these programs pose when offered and provided by the pharmaceutical industry. A recently unsealed False Claims Act whistleblowers’ complaint provides an example of the delicate balance companies face in ensuring compliance with federal and state laws, regulations, sub-regulatory guidance, and industry codes. Expect additional cases in the future, especially if you think your “compliant” educator program is a pandora’s box.

Enforcement

Arrow

The Battle Over Patient Assistance Programs Heats Up
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Patient assistance programs have been in the spotlight for the past few years as the drug pricing controversy comes to a head. This article outlines some of the recent subpoenas, with a focus on the most recent subpoena to make the news, that of Pfizer.

Privacy

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Europe Moves to the Next Level in Protecting Personal Data – The GDPR & Research
Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA
Abstract

As cross-border business and technology advances, the European Union’s need to address data privacy protection continually rises. The General Data Protection Regulation will soon be enforceable and undoubtedly will have impact on how pharmaceutical and medical device companies conduct clinical trials and research studies. This article reviews key updates for companies to consider for their clinical trials and research functions as the May 25, 2018 enforcement date approaches.

Transparency

Arrow

Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance UpdateTM by NXLevel Solutions
Abstract

Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.

False Claims

Arrow

Genentech & Escobar: Using Materiality to Escape False Claims Liability
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

In constructively bringing an end to a False Claims Act (“FCA”) whistleblower suit alleging Genentech, Inc.(“Genentech”) of defrauding Medicare by way of concealing substantive health care analytics data involving purported side effects of the company’s cancer drug Avastin the Third Circuit of Appeals in a recent decision determined that the Plaintiff in this matter had failed to demonstrate that any noncompliance had an impact on government payments. Specifically, the Court applied the prevailing standard in Escobar that an FCA lawsuit must demonstrate that any misrepresentation is “material” to the government’s payment decision. In dismissing this suit and invoking this heightened standard of materiality, the Third Circuit not only reinforces Escobar but places the now clear burden on FCA Plaintiffs to demonstrate that any noncompliance was material to alleged fraudulent payments.

Arrow

An FCA Journey – Allergan to Pay $53M to DOJ
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Allergan has been hit with hefty fines over the past several months. This article outlines the recent DOJ settlement, Allergan’s alleged wrongdoing, and the settlement amount agreed to by the government and Allergan.

Legislation

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The 21st Century Cures Act: Is It Worth the Cost for Lifesciences?
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

The 21st Century Cures Act (“Act”), which provides substantial funding for medical research, seeks to alleviate the regulatory process for developmental and experimental treatments and to implement reform measures on mental health care. This article explores whether the long-term the Act’s benefits will outweigh the costs.

June

2017

COMMENTS

0

The 21st Century Cures Act: Is It Worth the Cost for Lifesciences?

Written by , Posted in Legislation

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

The 21st Century Cures Act (“Act”), which provides substantial funding for medical research, seeks to alleviate the regulatory process for developmental and experimental treatments and to implement reform measures on mental health care. This article explores whether the long-term the Act’s benefits will outweigh the costs.

June

2017

COMMENTS

0

June

2017

COMMENTS

0

Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?

Written by , Posted in Transparency

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

Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.

June

2017

COMMENTS

0

Genentech & Escobar: Using Materiality to Escape False Claims Liability

Written by , Posted in False Claims

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

In constructively bringing an end to a False Claims Act (“FCA”) whistleblower suit alleging Genentech, Inc.(“Genentech”) of defrauding Medicare by way of concealing substantive health care analytics data involving purported side effects of the company’s cancer drug Avastin the Third Circuit of Appeals in a recent decision determined that the Plaintiff in this matter had failed to demonstrate that any noncompliance had an impact on government payments. Specifically, the Court applied the prevailing standard in Escobar that an FCA lawsuit must demonstrate that any misrepresentation is “material” to the government’s payment decision. In dismissing this suit and invoking this heightened standard of materiality, the Third Circuit not only reinforces Escobar but places the now clear burden on FCA Plaintiffs to demonstrate that any noncompliance was material to alleged fraudulent payments.

June

2017

COMMENTS

0

Europe Moves to the Next Level in Protecting Personal Data – The GDPR & Research

Written by , Posted in Privacy

Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA

As cross-border business and technology advances, the European Union’s need to address data privacy protection continually rises. The General Data Protection Regulation will soon be enforceable and undoubtedly will have impact on how pharmaceutical and medical device companies conduct clinical trials and research studies. This article reviews key updates for companies to consider for their clinical trials and research functions as the May 25, 2018 enforcement date approaches.

June

2017

COMMENTS

0

The Battle Over Patient Assistance Programs Heats Up

Written by , Posted in Enforcement

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

Patient assistance programs have been in the spotlight for the past few years as the drug pricing controversy comes to a head. This article outlines some of the recent subpoenas, with a focus on the most recent subpoena to make the news, that of Pfizer.

June

2017

COMMENTS

0

White Coat” Marketing Gone Awry

Written by , Posted in Feature Article

Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

Achieving patient adherence to prescribed medication through clinical educator programs is not a new concept. Neither is the U.S. Office of Inspector General of the Health and Human Services longstanding concern of the inherent issues these programs pose to when offered and provided by the pharmaceutical industry. A recently unsealed False Claims Act whistleblowers’ complaint provides an example of the delicate balance companies face in ensuring compliance with federal and state laws, regulations, sub-regulatory guidance, and industry codes. Expect additional cases in the future, especially if you think your “compliant” educator program is a pandora’s box.