Earlier this month, the California Insurance Commissioner announced that AbbVie had entered into a settlement agreement with the California Department of Insurance (CDOI) to resolve allegations that the pharmaceutical manufacturer violated the California Insurance Frauds Prevention Act by improperly marketing its product HUMIRA through the company's Nurse Educator Program. The settlement is the latest resolution in a string of investigations into product and reimbursement support programs operated by manufacturers, often in connection with specialty pharmaceutical products.
As a part of the settlement, AbbVie did not concede any wrongdoing, but agreed to resolve the litigation by paying $24 million, a fraction of the $1.2 billion claim that CDOI had originally sought. AbbVie also committed to certain marketing practices that are in keeping with industry standards for the implementation of similar nurse educator programs. Among other obligations related to speaker programs and offsite business meals, AbbVie agreed to take the following actions:
Nurse Ambassadors will disclose to patients that they are employed by AbbVie and that they do not work under the direction of a patient’s provider.
AbbVie employees and Nurse Ambassadors will not be allowed to actively participate in conversations between patients and insurance companies, and cannot describe themselves as extensions of health care provider offices. They may only listen in on such conversations after disclosing who they are and for the sole purpose of helping patients understand the conversations when necessary.
AbbVie will include specific language in its HUMIRA Complete enrollment form disclosing that its Nurse Ambassadors are provided by AbbVie and other relevant employees should not describe Ambassadors as “extensions” of a health care provider’s office.
AbbVie will provide patients with the FDA-approved HUMIRA medication guide and in response to questions about the side effects and the safety risks of HUMIRA, Nurse Ambassadors are to respond with information contained in and consistent with the medication guide, and inform patients to direct all medical or treatment-related questions to the patient’s health care provider.
Nurse Ambassadors may not have patient-specific discussions with HUMIRA-prescribing health care providers.
Nurse Ambassadors may not have their individual performance evaluated or compensated based on patient adherence to HUMIRA.
The settlement with CDOI appears to resolve lingering uncertainty with the government’s view of manufacturer support programs dating back to the 2015 settlement of the Warner-Chilcott case related to reimbursement support assistance. There, the U.S. Attorney’s Office for the District of Massachusetts seemed to take the position that manufacturer-sponsored product support services were inherently problematic. That case was followed by a series of qui tam cases and related government investigations based on allegations that manufacturer-sponsored reimbursement support and nurse educator programs were per se violations of the Anti-Kickback Statute and the civil False Claims Act. While those investigations initially looked like they might post a serious threat to the viability of such support programs, the Department of Justice (DOJ) ultimately decided not only to decline to intervene in 11 qui tam actions against multiple manufacturers, but also took the additional and unprecedented step of filing motions to dismiss the actions for insufficient merit. In particular, DOJ found that “federal health care programs have a strong interest in ensuring that, after a physician has appropriately prescribed a medication, patients have access to basic product support relating to their medication.” DOJ further recognized that manufacturer support programs are a “common industry practice” and those programs can be “appropriate and beneficial.”
Despite DOJ’s recognition of the value of reimbursement support and nurse educator programs, CDOI’s pursuit of AbbVie – notwithstanding DOJ’s and the State of California’s failure to intervene in the False Claims Act cases – left open a question of whether product support programs still may be viewed as inherently problematic under certain state laws. AbbVie’s settlement with CDOI appears to close out this last threat. By allowing AbbVie to continue the Nurse Ambassador program, subject to safeguards, the CDOI settlement is further confirmation that manufacturers can provide patients with nurse educator support so long as those programs are transparent about the manufacturer’s involvement and the programs are structured to comply with available government guidance and industry best practices.