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What’s New/Significant
An Aug. 7 settlement between the California Department of Insurance and AbbVie Inc. highlights both the importance of, and some of the potential limitations on, nurse educator programs. The settlement provides some of the first state enforcement guidance to the industry, focused on ensuring both the educational nature of nurse educator programs and the integrity of the doctor-patient relationship. It also reveals potential inconsistencies in the policies and enforcement priorities of California and the U.S. Department of Justice, which has indicated that nurse educators can play a critical role in patient interactions, especially in rare and devastating diseases with limited treatment options that are often highly complex from a safety, efficacy and administration perspective. While this inconsistency suggests an environment of continued uncertainty and risk for companies with nurse educator programs, the settlement terms provide some potential programmatic best practices.
Allegations
The Department’s investigation began after a whistleblower complaint brought by Lazaro Suarez, R.N., a “nurse ambassador,” through his employment with Quintiles Transactional Holdings Inc., a vendor providing nurse educator program services, for the company’s prescription drug HUMIRA (adalimumab).
The Department’s heavily redacted complaint alleged that the company was providing kickbacks to induce providers to prescribe the drug, including providing free nurse ambassador services that operated as “an extension” of provider offices, delivering “extensive, costly, and time-consuming nursing support services so prescribers and their practices do not have to.” This, according to the complaint, resulted in interference with doctor-patient communications, because nurse ambassadors acted as a “stand in” for prescribers; allowed them to gain access to patients to “ensure [patients] fill their prescriptions, start to take, and/or continue to use [the drug]”; and provided significant impetus for providers to choose a drug that “comes with free nurses and administrative staff” over “another that requires the provider to pay professional salaries[.]”
The complaint also alleged kickbacks in the form of access and reimbursement support services, as well as cash, meals and gifts to prescribers.
Scope of Settlement
The company expressly denied both the Department’s allegations and any liability, and the settlement does not include any admission of liability. It also doesn’t include any concession by the Department that the claims were not well founded.
Under the settlement, the company agreed to pay $24 million — California keeps $15 million and Suarez, as the whistleblower, receives $9 million — for alleged violations of the California Insurance Frauds Protection Act, although the payment is not identified as either a penalty or a fine.
The settlement permits the company to continue to run its nurse ambassador program with certain modifications:
- The company will implement and maintain training, clarifying that nurse ambassadors offer only education and support to patients prescribed a company product.
- Company employees will be prohibited from describing nurse ambassadors to health care providers as “extensions of their offices” and from giving providers contact information for nurse ambassadors who interact with patients.
- The company will provide guidance and training directing nurse ambassadors not to have patient-specific discussions with providers.
- Nurse ambassadors will not be evaluated or compensated based on patient adherence to the company’s drug.
- Nurse ambassadors will disclose to patients that they are provided by the company and they do not work under the direction of their health care provider.
- The company’s enrollment form will also disclose that nurse ambassadors are provided by the company.
- The company will provide patients with the U.S. FDA-approved drug medication guide, and the nurse ambassadors will direct patients to the medication guide and to their health care provider regarding side effects and safety risks and any medical and/or treatment-related questions.
- Company employees and nurse ambassadors will not actively participate in conversations between patients and their insurance companies.