athenahealth and Biogen Anti-Kickback Settlements

athenahealth Electronic Health Record Settlement

The U.S. Department of Justice has shown renewed commitment to enforcing federal anti-kickback statutes. Recently, an electronic health record (EHR) company, athenahealth Inc. (Athena), agreed to pay $18.25 million to settle allegations that it violated the False Claims Act. The United States alleged Athena was paying unlawful kickbacks to generate sales of its EHR product athenaClinicals. Specifically, Athena violated the Anti-Kickback Statute through three of its marketing programs. These illegal programs consisted of the following: (1) providing free tickets and amenities to prospective and existing customers, (2) paying kickbacks to existing customers under a “Lead Generation” program, and (3) entering into deals with vendors that discontinued their own EHR technology offerings to refer their clients to Athena.

In response to Athena’s settlement, U.S. Attorney Andrew E. Lelling for the District of Massachusetts said in a press release, “Across the country, physicians rely on electronic health records software to provide vital patient data. Kickbacks corrupt the market for health care services and risk jeopardizing patient safety.” Additionally, Lelling vowed that the government would “…aggressively pursue organizations that fail to play by the rules” and clarified that “EHR companies are no exception.”

This settlement resulted from a lawsuit filed under qui tam, or whistleblower, provisions of the False Claims Act, which permits private individuals to sue on behalf of the government for false claims and share in any recovery. In this case, the government intervened and took over the action. While the whistleblower shares to be awarded have not yet been determined in this settlement, it is clear that the government is sending a strong message to anyone thinking about engaging in fraudulent activity in health care.

Biogen Settlement

Similar to Athena, pharmaceutical company Biogen, Inc. (Biogen) has recently agreed to pay $22 million to resolve alleged False Claims Act violations for paying kickbacks. Here, the government claimed that Biogen illegally used foundations as a conduit to pay the copays of Medicare patients taking Biogen’s multiple sclerosis drugs Avonex and Tysabri. The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration to induce Medicare patients to purchase the company’s drugs.

Discussing the Biogen settlement, the Acting Assistant Attorney Jeffrey Bossert Clark of the Department of Justice’s Civil Division said in a press release that this settlement “demonstrates the government’s commitment to hold accountable companies that pay kickbacks to undermine important constraints on rising drug costs.” Clark also emphasized, “[d]rug companies that illegally manipulate charitable patient assistance programs to subsidize copays for their own products will be held accountable.” These allegations were also originally raised in a case filed under the whistleblower, or qui tam, provisions of the False Claims Act. The whistleblower in this action will receive $3,960,000 of the settlement.

In conclusion, the Athena and Biogen settlements illustrate the government’s renewed commitment to combatting health care fraud through the False Claims Act.