Life Science Compliance Update

May 22, 2017

The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion


The purpose of this article is to give manufacturers some initial background on the topics and some tools that could be considered.The review methodology described has been proven to help manufacturers and has been the starting point for developing an on-going monitoring.

Over the last few years, the 340B Program has experienced rapid expansion as the result of participation by new covered entities under the Affordable Care Act (“ACA”) and from covered entities contracting with multiple contract pharmacies. As it has grown, the 340B Program has come under significant scrutiny from the Government Accountability Office (“GAO”), the U.S. Department of Health and Human Services (“HHS”), and Congress, primarily to address what is perceived as an inadequate level of oversight by the Health Resources and Services Administration (“HRSA”) as well as a lack of specificity around the program’s requirements. HRSA was attempting to issue final regulations around the program but even those were frozen earlier this year with the Trump adminstrations regulatory freeze.

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May 19, 2017

Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support


Although the new code of conduct for member medical device and in-vitro diagnostic companies operating in the European marketplace has come into force the first day of this year, a grace period has been granted before new principles become effective. This article reviews the changes medical device and in-vitro diagnostic companies should consider implementing to adhere to the new principles for third-party educational support set forth by the MedTech Europe Code.

MedTech Europe Code of Ethical Business (“Code”) will become effective on January 1, 2018. Now with only seven months left in the Transition Period, it is a good time to examine how medical device and in-vitro diagnostic companies have been preparing. While most the standards and requirements are not new to Member Companies (“Companies”), the Code introduces several updates, which include:

  • a ‘fifth principle’ of holding image and perception of the industry in high regard,
  • new chapters with consolidated definition of events and demonstration products, and
  • changes around the support of third-party educational conferences, which will be the focus of this article.

Although the constant need to adapt to regulatory change is nothing new to those operating within the compliance space, many would agree that transitioning everyday business operations to comply with new requirements is easier said than done. This article will summarize the key changes the Code requires around educational conference support and provide some insights and considerations for in-house ethics and compliance functions.

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May 17, 2017

Whack a Mole: Pricing Bills Keep Popping Up Everywhere


Over the last several years, the pharmaceutical industry has seen a steady increase in state legislation targeting the cost of prescription drugs. Although the cost of prescription drugs account for a small fraction of healthcare costs within the United States, the industry cannot escape being the number one target. The 2017 legislative session makes it clear that pharmaceutical manufacturers remains surrounded on all fronts. This article examines those states that succeeded in 2016, legislation that has been introduced in 2017, and the rough road ahead.

While the debate on prescription drug prices is not a new phenomenon, the growing chorus from federal and state legislatures, the health care industry, lobbyists and organizations, and most importantly, consumers, has led to an onslaught of legislation targeting the pharmaceutical manufacturers and prescription drug costs. Since 2015, the number of states putting forth legislation has increased over 170% (see Chart 1), whereas the amount of legislation introduced by states has increased over 400% (see Chart 2). Currently, nineteen states have introduced over forty pricing transparency and disclosure bills.

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