Agendia Inc. Settles Multi-Million Dollar Lawsuit Over Fraudulent Billing Practices

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News Summary

Agendia Inc., alongside the Knoxville Comprehensive Breast Center and the Knoxville Dermatopathology Laboratory, has agreed to a settlement exceeding $3.8 million due to allegations of deceptive breast cancer testing billing practices. This lawsuit, filed by the U.S. Attorney’s Office for the Eastern District of Tennessee, highlighted false claims related to the MammaPrint test. The settlements are a direct response to allegations of providing unnecessary tests for financial gain, emphasizing the need for integrity in healthcare billing practices.

Knoxville – Agendia Inc., along with the Knoxville Comprehensive Breast Center and the Knoxville Dermatopathology Laboratory, have settled a multi-million dollar lawsuit initiated by the United States Attorney’s Office for the Eastern District of Tennessee for deceptive billing practices related to breast cancer testing. The settlements total over $3.8 million, aimed at addressing allegations of false claims made to government healthcare benefit programs.

The settlements delineate that Agendia Inc. will pay at least $3.25 million, while the Knoxville Comprehensive Breast Center is responsible for $322,500. Additionally, the Knoxville Dermatopathology Laboratory will pay $207,500 as part of the resolution to the lawsuit. The illegal activities reportedly spanned a period from August 1, 2019, to September 30, 2022.

Central to the allegations is Agendia’s submission of false claims for the MammaPrint testing to Medicare, Medicaid, and other government payors. MammaPrint is a genomic test that assesses the risk of breast cancer recurrence and evaluates the potential benefits of chemotherapy for patients. However, the U.S. Attorney’s Office asserted that the claims submitted for this testing were deemed “not reasonable or medically necessary.”

Moreover, allegations indicate that Agendia engaged in improper practices by providing extravagant dinners, improper honoraria, gift cards, and payments to healthcare providers who ordered the MammaPrint tests. The Knoxville Comprehensive Breast Center and Knoxville Dermatopathology Laboratory were accused of “knowingly participating” in the fraudulent scheme established by Agendia.

Dr. Raymond Brig and Lane Albertson, who brought forth the claims under the whistleblower provisions of the False Claims Act, will receive approximately $294,725 each from the settlements. This amount may increase to a potential total of $921,725 depending on the specific conditions of the settlement agreement.

The Knoxville Comprehensive Breast Center, which was founded in 1983 and is recognized as the first breast cancer center in the area, was not reachable for comments as communication lines were unresponsive at the time of inquiry. In addition, the Knoxville Dermatopathology Laboratory, another institution implicated in this lawsuit, has indicated that it will cease all services effectively on April 16, 2025, according to automatic replies received following outreach attempts.

The U.S. Attorney’s investigation into the fraudulent practices underscores a broader concern regarding the integrity of billing practices within the healthcare sector, particularly those relating to government-funded programs. The settlements signal a commitment to holding organizations accountable for healthcare fraud and ensuring that patients receive necessary and helpful care rather than unnecessary tests driven by deceitful financial motivation.

The outcome of these settlements may inspire further scrutiny and vigilance in the practices of healthcare providers and laboratories in their dealings with testing and billing. The implications of this case extend beyond Knoxville, emphasizing the importance of ethical conduct within medical institutions across the country.