Life Science Compliance Update

February

2017

COMMENTS

0

February 2017: Life Science Compliance Update

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

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February 2017 LSCU Cover

Issue Summary

This month we decided to look at both the compliance trends for 2017, as well as some of the “hot topics.” These hot topics include Patient Assistance Programs, Pharmaceutical Price Hikes and the new French anti-corruption law. We round out our coverage with the year-end enforcement highlights from the DOJ, OIG and FDA.


Feature

Arrow

Avoiding the Patient Assistance Program Spotlight
Kristin Rand, JD, MS, Compliance Officer, Seattle Genetics
Abstract

In efforts to understand the rising cost of some drugs Patient Assistance programs, particularly independent foundations, have become a focus of government investigations. This article explains what PAPs are, why they may be viewed as suspect and provides tips for providing patient assistance in a compliant manner.

Compliance Operations

Arrow

Product Price Hikes – When Business and Compliance Collide
Mark Scallon, Partner, FRA Life Sciences and Derek Patterson, Principal, FRA
Abstract

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.

Enforcement

Arrow

Anti-corruption: all roads lead to enforcement
Caroline Franco, Amy Greenstein, Darren Jones & Veronique Monjardet
Abstract

When it comes to corruption, Life Sciences companies are a frequent target of investigation and enforcement. The French enactment of Sapin II is the latest in a long line of laws to combat corruption. This article explores Sapin II and why the authors feel that Life Sciences companies are among the best positioned to comply with Sapin II’s requirements.

Arrow

2017 Trending Towards a Banner Year for Industry Compliance
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

There are strong indications that 2017 is already trending towards a banner year for industry compliance, including most notably the continued and active efforts by the U.S. Department of Justice (“DOJ”), U.S. Securities and Exchange Commission (“SEC”) and other government agencies, to investigate, prosecute, and settle with life science companies for issues related to noncompliance, lack of transparency, and the falsification of science based data. There are also a few pending investigations by the DOJ involving various generic drug companies, including allegations of illegal pricing agreements and collusion, which will similarly impact compliance in 2017.

Arrow

Are the Safe Harbors Still Safe? – OIG Issues Final Rule
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

The Department of Health and Human Services Office of Inspector General published a final rule, after considering various comments from stakeholders, about safe harbor provisions of the Anti-Kickback statute. This article goes into detail of what the changes were, and how they affect various health care providers.

Arrow

Valeant and Philidor Controversy Comes to a Head
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Valeant Pharmaceuticals, Inc. has had quite the year – they have been under scrutiny since October 2015. However, in November 2016, one former Valeant executive and one former Philidor executive, were arrested and charged with criminal complaints. This article outlines those complaints, and the actions the individuals allegedly took to be criminally charged.

Free Speech

Arrow

FDA’s Meeting on Promotion – Can We Glimpse the Future?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.

Antitrust

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Antitrust and Generic Drugs – A Rare Combination
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Generic drug companies have been on the radar of the Department of Justice (“DOJ”) for several years, and recently the DOJ filed the first documents in the first suit against a generic drug manufacturer. Interestingly, they chose to start with a little-known company, after the company already went after the executives for racketeering charges. This article outlines several different actions focused on generic pharmaceutical manufacturers that are presently working their way through the courts.

February

2017

COMMENTS

0

Antitrust and Generic Drugs – A Rare Combination

Written by , Posted in Antitrust

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

Generic drug companies have been on the radar of the Department of Justice (“DOJ”) for several years, and recently the DOJ filed the first documents in the first suit against a generic drug manufacturer. Interestingly, they chose to start with a little-known company, after the company already went after the executives for racketeering charges. This article outlines several different actions focused on generic pharmaceutical manufacturers that are presently working their way through the courts.

February

2017

COMMENTS

0

FDA’s Meeting on Promotion – Can We Glimpse the Future?

Written by , Posted in Free Speech

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

In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.

February

2017

COMMENTS

0

Valeant and Philidor Controversy Comes to a Head

Written by , Posted in Abstract, Enforcement

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

Valeant Pharmaceuticals, Inc. has had quite the year – they have been under scrutiny since October 2015. However, in November 2016, one former Valeant executive and one former Philidor executive, were arrested and charged with criminal complaints. This article outlines those complaints, and the actions the individuals allegedly took to be criminally charged.

February

2017

COMMENTS

0

Are the Safe Harbors Still Safe? – OIG Issues Final Rule

Written by , Posted in Abstract, Enforcement

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

The Department of Health and Human Services Office of Inspector General published a final rule, after considering various comments from stakeholders, about safe harbor provisions of the Anti-Kickback statute. This article goes into detail of what the changes were, and how they affect various health care providers.

February

2017

COMMENTS

0

2017 Trending Towards a Banner Year for Industry Compliance

Written by , Posted in Enforcement

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

There are strong indications that 2017 is already trending towards a banner year for industry compliance, including most notably the continued and active efforts by the U.S. Department of Justice (“DOJ”), U.S. Securities and Exchange Commission (“SEC”) and other government agencies, to investigate, prosecute, and settle with life science companies for issues related to noncompliance, lack of transparency, and the falsification of science based data. There are also a few pending investigations by the DOJ involving various generic drug companies, including allegations of illegal pricing agreements and collusion, which will similarly impact compliance in 2017.

February

2017

COMMENTS

0

Anti-corruption: all roads lead to enforcement

Written by , Posted in Enforcement

Caroline Franco, Amy Greenstein, Darren Jones & Veronique Monjardet

When it comes to corruption, Life Sciences companies are a frequent target of investigation and enforcement. The French enactment of Sapin II is the latest in a long line of laws to combat corruption. This article explores Sapin II and why the authors feel that Life Sciences companies are among the best positioned to comply with Sapin II’s requirements.

February

2017

COMMENTS

0

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.

February

2017

COMMENTS

0

Avoiding the Patient Assistance Program Spotlight

Written by , Posted in Feature Article

Kristin Rand, JD, MS, Compliance Officer, Seattle Genetics

In efforts to understand the rising cost of some drugs Patient Assistance programs, particularly independent foundations, have become a focus of government investigations. This article explains what PAPs are, why they may be viewed as suspect and provides tips for providing patient assistance in a compliant manner.

January

2017

COMMENTS

0

January 2017: Life Science Compliance Update

Written by , Posted in January 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.

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

Arrow

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

Arrow

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

Arrow

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

Arrow

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.

Arrow

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.

Arrow

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.

Arrow

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.

January

2017

COMMENTS

0

Not All Discounts Are Equal: Evaluating When Discounts May Be Construed as Unlawful

Written by , Posted in Abstract, Enforcement

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

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.

January

2017

COMMENTS

0

Nursing Facilities & Kickbacks – Is the DOJ Shifting Away from Pharma?

Written by , Posted in Abstract, Enforcement

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

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.

January

2017

COMMENTS

0

Co-Payment & Deductible Waivers as Illegal Inducements

Written by , Posted in Abstract, Enforcement

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

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.

January

2017

COMMENTS

0

Planning for the Future – HHS OIG’s 2017 Work Plan

Written by , Posted in Abstract, Enforcement

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

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.

January

2017

COMMENTS

0

Sailing with a New Safe Harbor in Sight: The EU-U.S. Privacy Shield

Written by , Posted in Abstract, Privacy

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

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.

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