A recently unsealed suit against Alere Inc., initially filed by two whistleblowers in a Florida federal court in 2015, reveals multiple allegations of False Claims Act (FCA) and Anti-Kickback Statute violations against the diagnostic test-maker.

The whistleblowers, former Alere vice president of business development Michael Nolan and Jacob Whitfield, a former Alere regional sales director, allege in a nearly one-hundred page complaint that the company engaged in multiple activities across 29 states that violated both the FCA and Anti-Kickback statutes. Per the complaint, Nolan and Whitfield claim that Alere:

  • Marketed and encouraged providers to submit patient labs for “confirmatory” testing with Alere that were not medically necessary;
  • Developed its own forms to induce providers to order unnecessary medical testing;
  • Coached providers to “up-code” by submitting forms with higher-paying diagnoses;
  • Processed tests based on forms submitted by Alere employees instead of doctors;
  • Provided health care providers with medical devices valued at over $40,000 for free or at a reduced price in exchange for running more tests and purchasing Alere’s chemical reangents; and
  • Made cash payments to doctors and others disguised as speaker fees or reimbursements for travel to conferences.

Nolan and Whitfield also filed the suit on behalf of 29 states and brings counts under each of those jurisdictions’ false claims statutes. The U.S. government has declined to intervene in the Alere lawsuit, leaving the whistleblowers to pursue the case on their own