Policy & Medicine Compliance Update
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FEBRUARY 2019 Issue
Issue Summary:
For the February issue, we have chosen to focus on patient services programs, including nurse educator programs. Our feature article outlines a compliance survey results from the Helio Health Group on manufacturer patient services activities. Next, we review the latest developments in the areas of nurse educator programs, white-coat marketing, and reimbursement support services.
We then move on to an interview with Matt Wetzel, AdvaMed Vice President & Deputy General Counsel, discussing the new revisions to the Code of Ethics on Interactions with Health Care Professionals which take effect in 2020. Finally, given it is the new year, we thought it appropriate to take stock of where things stand on the privacy front with the GDPR implementation and what remains to be done.
FEATURE
Patient Services Compliance Survey – Trends and Insights into this Highly Scrutinized Area
By Minna Bak, Senior Manager, Marci Juneau, Partner, and Manny Tzavlakis, Managing Partner, Helio Health Group
Summary: Patient services programs and the associated risks across the life sciences industry vary in shape and style, especially as the government is beginning to heavily investigate the activities conducted by manufacturers in this area. This article highlights some of the differences in the industry as seen through an annual patient services compliance survey conducted by Helio Health Group.
TAGS: Patient Services, Nurse Educator Programs, Survey
Nurse Educator Programs
Turning Up the Heat on Nurse Educator Programs
By Nicodemo Fiorentino, Esq., Associate Editor & Board Member
Summary: This article provides an in-depth overview of the ongoing legal battle involving manufacturers and their vendors as it relates to nurse educator programs, white-coat marketing, and reimbursement support services. It identifies the numerous parties involved, as well as the California Department of Insurance’s intervention in one case and Fifth Circuit Magistrate Judge’s adopted and uncontested reports and recommendations. The article also provides an overview of the relevant Health and Human Services Office of Inspector General advisory opinions and other guidance on these topics and recommendations for by life science companies using, or planning to use, nurse educators
TAGS: Nurse Educator Programs, California, Qui Tam, White-Coat Marketing, Reimbursement
Code Update
Prepping for 2020 – AdvaMed Adopts A Revised Code of Ethics for U.S. HCP Interactions
Interview with Matt Wetzel, Vice President & Deputy General Counsel, Advanced Medical Technology Association
Summary: The Advanced Medical Technology Association recently announced revisions to its longstanding Code of Ethics on Interactions with Health Care Professionals in the United States (AdvaMed U.S. Code). These revisions, described in greater detail below, become effective January 1, 2020.
TAGS: AdvaMed, Code of Ethics, HCP Interactions, Medical Devices
Privacy
Eight Months After the GDPR: Where Do We Stand?
By Jordan L. Fischer, Esq., Co-Founder & Managing Partner of XPAN Law Group, LLC
Summary: Eight months have passed since the EU’s GDPR became effective. This article recaps what has happened and what remains to be done.
TAGS: GDPR, Data Privacy, EU
