Manufacturer Settles State Fraud Violations Related to Nurse Ambassador Program
August 10, 2020— AbbVie has agreed to pay $24 million to settle fraud claims in connection with its HUMIRA Ambassador Program. At issue were allegations that the manufacturer caused to be submitted claims for payment to private insurers in the State of California in violation of its Insurance Frauds Prevention Act. The case stems from accusations of a registered nurse who filed suit as a whistleblower.
In addition to the monetary settlement terms, AbbVie agreed to implement a series of conditions in association with its continued operation of its HUMIRA product support program, of which the Ambassadors are a component. These non-monetary terms include requirements related to the following:
- Speaker Programs: Minimum number of attendee responses prior to off-site speaker programs as well as substantive requirements for materials associated with such programs,
- Enrollment Materials: Statements as to the company’s role on program enrollment materials,
- Prescriber Relationships: Affirmative disclosures to patients about the relationship of the nurse ambassadors to their health care provider (HCP) as well as a prohibition against patient-specific discussions between program nurses and prescribing HCPs,
- Health Insurance Contact: Limitations on nurse ambassador participation in patient calls with health insurers,
- Patient Interactions: Substantive restrictions on nurse ambassador responses to patient questions, limiting them to the product’s FDA Medication Guide, and
- Nurse Compensation: Separation of patients’ product adherence from nurse ambassador compensation and performance evaluation.
Abbvie did not admit liability in the matter and denied all allegations. Additional details on the case are available in the California settlement agreement. Related claims remain pending in the Northern District of Illinois. See U.S. ex rel. Suarez v, AbbVie, Inc., 1:15-cv-08928 (N.D. Ill.).
All details in this alert are based on documents made publicly available by the Insurance Commissioner of California.
If you have questions regarding the alert or implementing appropriate controls related to patient support programs, like nurse ambassadors, please contact Razor Legal Solutions here (https://www.razorlegalsolutions.com/contact).
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