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Monday, January 20, 2025

Palo Alto-Based Guardant Health Settles for Over $900K Over Alleged Stark Law Violations and False Claims Act - Hoodline

Guardant Health, Inc., the precision oncology company headquartered in Palo Alto, has agreed to a settlement of over $900,000 after allegations surfaced that it knowingly violated the False Claims Act, as well as the Defense Health Agency regulations. This follows an announcement made by U.S. Attorney Ismail J. Ramsey, together with officials from the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) and the Department of Defense Office of Inspector General, Defense Criminal Investigative Service (DCIS).

The allegations stemmed from a case where a physician in Austin, Texas, recommended a close friend and later his step-daughter to be employed at Guardant. Once employed, the physician's referral of services to Guardant subsequently spiked, indicating a potential quid pro quo arrangement. Through these actions, Guardant is alleged to have violated the Stark Law – a statute that governs physician referrals and prohibits conflicts of interest – and to have submitted false claims to Medicare Part B and TRICARE, as reported by the U.S. Department of Justice.

In response to the government's claims, Guardant Health took what the United States acknowledges as "significant steps" towards remediation, including voluntarily disclosing the conduct to the HHS-OIG. The company has agreed to pay $913,932.93 to resolve the False Claims Act allegations and an additional $31,082.00 in an administrative settlement with DHA, detailed by the prosecutors...



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