Life Science Compliance Update

April

2017

COMMENTS

0

340B and You – Thoughts on Program Oversight for Pharmaceutical Manufacturers

Written by , Posted in Feature Article

Chris Cobourn, Managing Director, Huron Life Sciences

The 340B Drug Discount Program plays an important role in the United States healthcare system by providing healthcare services primarily to entities that serve low-income populations. The program also is complex and evolving, so compliance challenges will abound for years to come. This article examines those complexities and compliance challenges.

March

2017

COMMENTS

0

Privacy Regulation: The Final Frontier of Life Science Compliance

Written by , Posted in Feature Article

Matthew Gunzenhauser

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 first in a two-part series.

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

Feeling Needy – The Why, What and How of Needs Assessments

Written by , Posted in Abstract, Feature Article

Tynan P. Olechny, MBA/MPH, CVA, Consulting Principal, PYA, and Christina L. Hummel, MBA, Senior Consultant, PYA

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.

December

2016

COMMENTS

0

The Seventeenth Annual PCC: Day 1 Highlights

Written by , Posted in Abstract, Feature Article

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

The Annual Pharmaceutical and Medical Device Compliance Congress is an important opportunity for industry compliance professionals and regulators to exchange information and learn from one another. This year was no exception and this article briefly recaps the highlights from the conference’s first day.

October

2016

COMMENTS

0

Value Based Contracts and Government Pricing – A Cross Functional View

Written by , Posted in Abstract, Feature Article

Chris Cobourn, Managing Director and Clay Willis, Director Huron Life Sciences

Value Based Contracts are becoming increasingly important and commonplace. VBCs also have important implications for Government Pricing programs. Therefore, life sciences companies need to take a coordinated and collaborative approach towards compliance that involves multiple stakeholders to evaluate the agreements and the potential impact on Government Pricing.

October

2016

COMMENTS

0

Getting to the Hub of the Matter – Analyzing the Compliance Needs for Hub Services

Written by , Posted in Abstract, Feature Article

Tom Gregory, Partner, Fraud Investigation & Dispute Services, Ernst & Young LLP

Within the pharmaceutical industry there are new operating models emerging. One form of emerging arrangement is the increasing use of “hub services.” This article explores the breadth and variety of hub services and arrangements and the many challenges in ensuring appropriate compliance oversight created.

September

2016

COMMENTS

0

At the Punishment Wheel: Are Medical Device Companies Getting Preferential Treatment?

Written by , Posted in Abstract, Feature Article

Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update
The DOJ and FDA are starting to back off prosecuting cases involving just off-label claims, after making several unsuccessful attempts. However, the recent Genentech settlement may illuminate a path to success for the DOJ utilizing the False Claims Act. This article outlines the Genentech case, why it is different from other off-label cases, and what compliance officers can do to prevent their company from experiencing the same fate.

August

2016

COMMENTS

0

Tis The Season – 2015 Open Payments Highlights and Risk Management Considerations

Written by , Posted in Abstract, Feature Article

Mark Linver, Jeff Fisher, Juan Tessi of Huron Life Sciences

On June 30th, 2016 CMS published the third year of Open Payments data. With more than two full years of transaction level spend data publicly available, an opportunity exists for Life Sciences companies to utilize Open Payments data as an additional tool in their technology-enabled risk management strategies.

Menu Title