Leah B. Foley United States Attorney for the District of Massachusetts | Department of Justice
PenRad Technologies, Inc., a medical software company based in Raleigh, North Carolina, has agreed to pay $529,069 to resolve allegations that it caused health care providers to submit claims for unnecessary breast cancer screenings to Medicare and MassHealth.
The case centers on PenRad’s implementation of the Tyrer-Cusick risk calculator in its Series 7 software. The Tyrer-Cusick model is a widely used tool for assessing a patient’s risk of developing breast cancer. According to documentation for the model, “competing mortality”—the consideration of other causes of death—should be enabled when calculating risk scores in clinical settings.
Despite this recommendation and internal guidance at PenRad supporting the use of competing mortality, the company sometimes installed the calculator with this feature disabled when customers upgraded their software. In some cases, PenRad did not clearly inform customers about the importance of enabling competing mortality. As a result, at least one customer unknowingly used the calculator with competing mortality turned off, leading to inflated risk scores for some patients. This led to medically unnecessary Magnetic Resonance Imaging (MRIs), which were then billed to Medicare and MassHealth.
PenRad admitted responsibility for these actions as part of the settlement agreement. The company received credit under Department of Justice guidelines for its cooperation during the investigation.
The settlement also resolves claims brought under the False Claims Act’s whistleblower provisions. These allow private individuals to file lawsuits on behalf of the government and share in any recovery. In this case, Community Health Programs, Inc., acting as relator, will receive a portion of the settlement funds.
The announcement was made by United States Attorney Leah B. Foley; Ted E. Docks, Special Agent in Charge at the Federal Bureau of Investigation’s Boston Division; and Roberto Coviello, Special Agent in Charge at the U.S. Department of Health and Human Services Office of Inspector General. Assistant U.S. Attorney Brian M. LaMacchia and Assistant Attorney General Scott Grannemann from Massachusetts handled legal proceedings related to this matter.
