The California Department of Insurance announced a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act involving the marketing of blockbuster prescription drug HUMIRA.
AbbVie agreed to reform its HUMIRA marketing practices in California, including disclosing that registered nurses employed as “Ambassadors” to interact with patients about HUMIRA are actually paid by the company, not a medical provider, and reforming how HUMIRA is marketed to health care providers.
In addition, as provided for in the Act, AbbVie has also paid a combined $24 million to the State of California and the whistleblower who brought the case to the Department’s attention.
In October 2016, the Department began an investigation into AbbVie after recieving a whistleblower case filed by a registered nurse who was employed as an AbbVie Ambassador in Florida.
After its investigation, the Department intervened in that case and filed a Superseding Complaint alleging that whistleblower violated California’s Insurance Frauds Prevention Act. Among other things, the Department alleged that AbbVie violated the Act by unlawfully providing free and valuable professional goods and services to physicians to induce and reward AbbVie prescriptions.
The Department alleged that Nurse Ambassadors interfered with the flow of doctor-patient communications and did not directly answer questions pertaining to AbbVie marketing activities constituted kickbacks in violation of the Act, including, for example, the provision of meals and drinks to providers outside the context of speakers programs.
While AbbVie continues to deny the allegations, as a part of the settlement, AbbVie agreed to reforms, including:
— Ambassadors will disclose to patients that they are provided by AbbVie and do not work under the direction of the patient’s health care provider.
— The company will implement a policy modification prohibiting HUMIRA sales representatives from inviting HUMIRA prescribing health care providers to offsite business meals, except as part of the AbbVie speaker programs.
— AbbVie will provide patients with the U.S. FDA-approved HUMIRA medication guide and Ambassadors will direct patients to the medication guide and their health care provider regarding side effects and safety risk.
— The company will provide guidance and training that Ambassadors shall not have patient-specific discussions with providers who prescribe AbbVie.
— AbbVie employees will be prohibited from describing Ambassadors to health care providers as “extensions of their offices” and from providing to providers any contact information for Ambassadors who interact with HUMIRA patients.
— AbbVie employees and Ambassadors will not actively participate in conversations between patients and insurance companies.
The complete list of AbbVie’s business practice reforms can be found in the settlement.