Life Science Compliance Update

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.

May

2017

COMMENTS

0

Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances

Written by , Posted in Enforcement

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

As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the guidances was a Final Rule regarding tobacco products and their regulation. Several Industry groups banded together and submitted a Citizen’s Petition to the FDA, requesting a stay of the rule. This article outlines the regulation, the petition, and the FDA’s response.

May

2017

COMMENTS

0

A Port in Any Storm – Adding New Safe Harbors to the Anti-Kickback Statute

Written by , Posted in Enforcement

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

On December 7, 2016, the HHS Office of the Inspector General (“OIG”) approved new safe harbors to the federal anti-kickback statute (“AKS”) and amendments to the civil monetary penalty (“CMP”) rules, including recognizing new statutory exceptions, seeking to alleviate blanket prohibitions, and regulatory measures to promote access to care. In doing so, the OIG is ushering in a new era for compliance and providing life science companies some refuge from the regulatory storm.

April

2017

COMMENTS

0

Going Back to the Roots of the False Claims Act – Baxter Settles cGMP Allegations

Written by , Posted in Enforcement

Seth Whitelaw, JD, LL.M., S.J.D., Editor and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This article explores the most recent case involving Baxter Healthcare Corporation and some of its troubling implications.

April

2017

COMMENTS

0

The Murky Future of Physician Owned Distributorships (“PODs”)?

Written by , Posted in Enforcement

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

On January 9, 2017, a physician was recently sentenced for his role in a criminal health care fraud scheme totaling approximately $2.8 million and focused on False Claims Act (FCA) related allegations concerning this physicians’ participation in very complex and elaborate physician-owned distributorships (PODs). PODS are described by the government as physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their patients at hospitals or ambulatory surgical centers. In recent years, PODs have been subjected to heightened regulatory scrutiny and oversight because of the potential for abuse, fraud, and conflicts of interest; as a result, the future of PODs remains highly uncertain.

April

2017

COMMENTS

0

TEVA – Using Legitimate Distributor Payments to Conceal Bribes

Written by , Posted in Enforcement

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

On December 22, 2016, the Securities and Exchange Commission (SEC) announced that Teva Pharmaceutical Industries Limited had agreed to pay more than $519 million to settle parallel civil and criminal charges that it violated the Foreign Corrupt Practices Act (FCPA) by paying bribes to foreign government officials in Russia, Ukraine, and Mexico. The interesting aspect of this settlement is as the government alleges, the bribes were concealed in the form of legitimate payments to distributors.

April

2017

COMMENTS

0

Project Exclusion: The OIG’s Latest Attempt to Make Its Exclusion Authority Real

Written by , Posted in Enforcement

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

On January 11, 2017, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS), issued a new robust set of policy and rule-making guidelines, significantly clarifying and reaffirming regulatory efforts to place both individuals and corporations that engage in fraudulent Medicare and Medicaid programs on the Agency’s exclusionary list. Although such regulatory enhancements strengthen the Agency’s overall approach to combating fraudulent activity, it also seeks to impart a level of “objective fairness” in such process.

March

2017

COMMENTS

0

March

2017

COMMENTS

0

Do DPA’s Work? – The BioMet Case Study

Written by , Posted in Enforcement

Robert N. Wilkey, Esq., LSCU Staff Writer

On January 12, 2017, the U.S. Department of Justice (DOJ) announced publicly that Zimmer Biomet Holdings, Inc. (Zimmer BioMet) had agreed to pay a $17.4 million criminal penalty “in connection with a scheme to pay bribes to government officials in Mexico and for violations of the internal controls provisions of the Foreign Corrupt Practices Act (FCPA) involving the company’s operations in Mexico and Brazil.” This is not the first time BioMet faced allegations involving its business practices in foreign countries, and in 2012 entered a deferred prosecution agreement (DPA). The BioMet settlement highlights the significant liability life health science companies face when failing to adhere to DPAs and how large-scale settlements are used by the government to ensure industry compliance.

March

2017

COMMENTS

0

Medical Devices & False Claims – Shire’s Settlement Is One for the History Books

Written by , Posted in Enforcement

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

We have seen many large False Claims and Anti-kickback settlements with pharmaceutical companies and the prescriptions they manufacture. Now, a medical device company has gotten into difficulty for many of the same types of violative activities. This article provides an overview of the allegations and the settlement.

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.

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.

Gravityscan Badge
Menu Title