Humana Lawsuit Against Pharmaceutical Company and Specialty Pharmacy Highlight Additional Risks of Patient Support Initiatives

In yet another high-profile legal action, health insurance giant, Humana, has demonstrated its appetite to go after pharmaceutical manufacturers, supporting hubs and specialty pharmacies involved in patient assistance programs.  This past week, Humana sued Biogen, a manufacturer of multiple sclerosis drugs, alleging that it engaged in a complex scheme to get patients on its medications for free, then causing those patients to become enrolled in various government-funded health benefit programs (such as Medicare Part D).  According to the complaint, the manufacturer would “seed” the patients, by providing drugs for free to patients who lacked insurance.  Thereafter, once the patients were established on therapy (and thus, unable or unlikely to quickly come off the drugs), the manufacturer would cause them to become enrolled with health benefits programs covered administered, among others, by Humana.  Humana further alleges that Biogen would provide “illegal copayment assistance,” using charitable organizations as conduits for inducements and kickbacks to patients.

This case is significant for two reasons. 

First, it highlights the risk that pharmaceutical manufacturers, hubs and specialty pharmacies alike face when settling with the government over False Claims Act allegations.  Biogen had settled with the Federal government in late 2020 to resolve claims that it had engaged in a prohibited kickback scheme using charitable foundations as conduits to pay the copay obligations of Medicare patients, and using a specialty pharmacy vendor to help facilitate this.  Humana’s complaint largely mirrors the allegations made by the government that belied the settlement.  Humana’s suit shows a keenness by payers to not only track such settlements, but to bring complex cases piggy-backing off of these settlements.

Second, this case highlights the importance of carefully scrutinizing relationships with other vendors, such as specialty pharmacies and hubs.  Both the government’s settlement and Humana’s suit highlight the role that the hub/specialty pharmacy played, and uniquely, Humana has added the specialty pharmacy as a defendant in the civil suit. 

How Frier Levitt Can Help

Frier Levitt assists manufacturers and pharmacies in not only structuring patient support programs, but in defending government investigations and civil suits into these types of conduct.  Frier Levitt has defended numerous pharmacies, providers and pharmaceutical companies in suits brought by payers and PBMs. 

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