Earlier this week, the California Insurance Commissioner filed a wide-ranging lawsuit against AbbVie, the maker of Humira, seeking over $1.2 billion in damages. In addition to allegations of run-of-the-mill kickbacks to physicians, the lawsuit alleged an intricate network of “nurse ambassadors” designed to improperly boost prescriptions for Humira.
This lawsuit, which was interestingly brought under California”s Insurance Frauds Prevention Act as part of a growing trend of State Insurance Commissioners filing civil actions over claims submitted to private insurers, alleged that AbbVie had created a nationwide network of “nurse ambassadors” who performed a variety of services that otherwise would have been shouldered by physician practices. The services included helping patients with insurance authorizations for Humira, visiting patient homes to administer Humira, or training patients on self-administering Humira injections. While these services are clearly beneficial to patients and physicians, California equated them to an in-kind kickback to physicians and patients, and alleged that they were aimed squarely at getting health care providers to write more Humira prescriptions and for patients to take more refills.
These allegations highlight a growing scrutiny of “White Coat Marketing” by pharmaceutical companies and others. Allegedly in response to concerns that sales reps might be getting little to no face time with doctors, pharmaceutical and biotech companies began employing nurses or certified educators (or a third party hires nurses on the company’s behalf) to provide independent medical advice in connection with its product line when, in fact, the nurses or educators act as undercover sales representatives for the company. Regulators have contended that because these individual have the impression of medical training, or the “white coat,” it risks blurring the trust between doctors and patients.
Since early last year, several companies have faced scrutiny for white coat marketing, including Eli Lilly, Gilead Sciences, Amgen and Bayer Pharmaceuticals. Regulators alleged that through these patient support programs, the companies encourage doctors to “off-load their patients” to the nurse educators to manage their diseases, providing effectively “free employees” given to doctors in exchange for the doctors’ commitment to recommend the company’s products.
These enforcement actions only highlight the delicate balance life sciences companies and healthcare providers face in balancing beneficial patient care and truthful education, with the semblance of improperly promoting or talking up a company’s specific products and services. Importantly, while the suits have focused on actions by pharmaceutical companies and ancillary companies (such as reimbursement hubs and nursing agencies), many other types of healthcare providers must equally take caution to comport with applicable guidance. Home infusion providers and pharmacies that routinely employ or contract with nursing support services or patient educators must ensure that measures are put in place to avoid improperly favoring or promoting the provider’s products or services.
Ultimately, firms must develop Standard Operating Procedures and compliance plans to ensure that any recommendations done by clinical support personnel are accurate, not deceptive, passive and general in nature, and not targeted to a particular patient, among other criteria.
Frier Levitt has represented numerous healthcare providers and life science companies in structuring compliance programs and drafting marketing SOPs. We assist clients in properly structuring marketing arrangements and patient support programs, to ensure compliance with a variety of healthcare laws, including federal anti-kickback laws. To discuss a review of your company’s policies and practices, contact Frier Levitt today.
