In a significant healthcare fraud case, Agendia, Inc., Knoxville Comprehensive Breast Center (KCBC), and Knoxville Dermatopathology Laboratory (KDL) have agreed to settle False Claims Act allegations for sums totalling more than $3.75 million. The U.S. Attorney's Office reported that the involved parties submitted deceptive claims for the MammaPrint breast cancer test to government health care programs, leading to a costly fallout.
From August 1, 2019, through September 30, 2022, Agendia was accused of enabling improper MammaPrint testing requests that were neither reasonable nor medically necessary. The molecular diagnostics company will pay $3,250,000 and additional amounts if the company is sold. Separate settlements see KCBC and KDL paying $322,500 and $207,500, respectively, for their parts in the scheme. "False claims submitted to these programs for costly genomic testing that was not reasonable and medically necessary and inducing referrals through improper payments made to referring providers are not victimless offenses," U.S. Attorney Francis M. Hamilton III stated in the press release.
Furthermore, certain claims by Agendia were considered deceptive due to alleged kickbacks to physicians for test referrals, which included lavish dinners and payments. "Violations of the Anti-Kickback Statute related to laboratory testing waste valuable federal health care program funds and undermine the integrity of medical decision-making," Special Agent in Charge Kelly J. Blackmon from the Department of Health and Human Services Office of Inspector General (HHS-OIG) conveyed, according to the U.S. Attorney's Office.
The settlements also resolved allegations regarding KCBC and KDL's collaboration in generating non-essential referrals, compounded by Agendia's illegal incentives. "Wrongful billing for unnecessary medical testing undermines the integrity of the Federal Employees Health Benefits Program, generating costs for the government but no benefit to patients," Special Agent in Charge Derek M. Holt from the U.S. Office of Personnel Management Office of the Inspector General told the U.S. Attorney's Office, acknowledging the joint effort to confront healthcare deceit.
Whistleblower provisions under the False Claims Act were used in uncovering the fraud. Dr. Raymond Brig and Mr. Lance Albertson filed separate qui tam lawsuits and are set to receive a combined minimum of $296,725 from the settlements. The case reflects the use of individual reports in initiating legal action related to healthcare fraud. Individuals with information about potential misuse can contact the U.S. Department of Health and Human Services tip line at 800-HHS-TIPS (800-447-8477). Assistant U.S. Attorneys Alan G. McGonigal and Alexa Ortiz Hadley represented the government in the Eastern District of Tennessee.
