Policy & Medicine Compliance Update
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NOVEMBER 2019 Issue
Issue Summary:
Our focus for this month’s issue is regulatory updates, but first we start with the latest Patient Services Compliance Survey from Helio Health Group together with recent Avanir settlement and indictments. Next, we look at the recent development surrounding drug importation, proposed modifications to the Anti-Kickback Statute and the Stark Law, as well as the proposed changes to Open Payments. Finally, we continue our coverage on the opioid crisis with a detailed examination of the recent and sharply critical DOJ OIG report on DEA’s opioid diversion efforts.
FEATURE
Helio Patient Services Compliance Survey – The Latest Trends and Lessons Learned
By Minna Bak, Senior Manager, and John Poulin, Partner, Helio Health Group
Summary: Patient services programs are continuing to evolve as life sciences companies consider the associated risks, which have been highlighted by government investigations and regulations. This article highlights the major trends and lessons learned in the industry as seen through the third annual patient services compliance survey conducted by Helio Health Group.
TAGS: Patient Services, Nurse Educator Programs, Survey
Enforcement
When Having a Monopoly Is Not Enough: Avanir Comes Under Fire for Inappropriate Marketing Practices
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: In September 2019, the United States Department of Justice announced a settlement with Avanir resolving allegations that the company paid kickbacks to physicians and engaged in false marketing, promotion, and billing of Nuedexta. On the same date, two doctors and two pharmaceutical representatives were indicted on federal charges for their roles in a kickback conspiracy. This article outlines those resolutions and new charges. Thus, Avanir serves as an important case study for all compliance professionals.
TAGS: Avanir, Kickbacks, Conspiracy, Promotion, Billing
Regulatory updates
Drug Importation Experiences a Rebirth
By Gwendolyn Ball, Staff Writer
Summary: Although drug importation has been a topic of debate for more than 15 years, the continuing struggle to contain rising drug prices has rekindled interest in pursuing importation as a possible remedy. This article explores the recent state efforts in Vermont, Colorado, Maine and Florida and how those efforts once more are shaping Federal policy.
TAGS: Importation, FDA, Colorado, Maine, Florida, Drug Pricing
Shifting the Landscape – HHS Proposes Modifications to the Anti-Kickback Statute & the Stark Law
By Gwendolyn Ball, Staff Writer
Summary: In October 2019, HHS published two new proposed rules, which will significantly change the current landscape governed by the Anti-Kickback Statute and the Stark Law. This article discusses the details and potential impact of these proposals. The comment period on the proposed rules closes on December 31st.
TAGS: AKS, Stark Law, Safe Harbors, Value-Based Payments
Tinkering with Open Payments – CMS Proposes New Changes in Response to Comments & Legislation
By Nicodemo Fiorentino, Associate Editor, Policy & Medicine Compliance Update
Summary: Centers for Medicare & Medicaid Services recently published proposed revisions to the Open Payments program in its annual Physician Fee Schedule proposed rule. The proposed revisions expand the definition of covered recipient and make changes to the nature of payment categories, standardize data on reported covered products and updates the national drug code reporting requirements for drugs and biologicals.
TAGS: CMS, Open Payments, Covered Recipient, Nature of Payments, NDC
OPIOIDS
Spreading the Blame – DEA Criticized for Its Role in the Opioid Crisis
By Dr. Seth B. Whitelaw, Editor
Summary: The DOJ OIG in October released a report sharply critical about the DEA’s efforts to address the use and diversion of opioids. This article takes an in-depth look at what the report found.
TAGS: Opioids, DEA
