Medical Software Company Agrees to Pay $500,000 to Resolve Allegations of Causing Medically Unnecessary Breast Cancer Screening Claims

BOSTON – PenRad Technologies, Inc. (PenRad), a software company headquartered in Raleigh, N.C., has agreed to pay $529,069 to resolve allegations that it violated the False Claims Act by causing health care providers to bill Medicare and MassHealth for medically unnecessary breast cancer screenings.

PenRad’s software allowed health care providers to use the Tyrer-Cusick risk calculator to assess patients’ breast cancer risk. The Tyrer-Cusick model is a publicly available risk-assessment tool that health care providers use to calculate patients’ risk of developing breast cancer and to make treatment decisions. The risk calculator, which was developed by researchers unaffiliated with PenRad, allows a user the option of either calculating a patient’s risk score by enabling or disabling “competing mortality.”  If enabled, competing mortality considers the risk that the patient will die from something other than breast cancer. The Tyrer-Cusick documentation recommended that, in a clinical setting, competing mortality be enabled.

At the time it released its Series 7 software, PenRad was aware that the Tyrer-Cusick documentation recommended enabling competing mortality in clinical settings, and internally, PenRad recommended to employees the enabling of competing mortality. However, if PenRad customers upgraded to Series 7 in subsequent years and added the Tyrer-Cusick risk calculator function, PenRad sometimes installed the Tyrer-Cusick risk calculator with competing mortality disabled for that customer and did not consistently communicate to its customers when enabling the Tyrer-Cusick risk calculator that competing mortality should be enabled. At least one PenRad customer unknowingly using the calculator with competing mortality disabled led to some patients receiving elevated risk scores, which caused those patients to receive medically unnecessary Magnetic Resonance Imaging (MRIs).  Healthcare providers billed some of those medically unnecessary MRIs to Medicare and MassHealth.  

As part of the settlement, PenRad admitted, acknowledged, and accepted responsibility for the facts supporting the settlement. The settlement credits PenRad for cooperation under the Department of Justice’s Guidelines for Taking Voluntary Disclosure, Cooperation and Remediation into Account in False Claims Act Matters.

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The relator will receive a portion of today’s settlement. The qui tam case is captioned U.S. ex rel. Community Health Programs, Inc. v. PenRad Technologies, Inc., No. 22-cv-10680-MGM (D. Mass.).  

United States Attorney Leah B. Foley; Ted E. Docks, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division; and Roberto Coviello, Special Agent in Charge at the U.S. Department of Health and Human Services, Office of Inspector General made the announcement today. Assistant U.S. Attorney Brian M. LaMacchia, Chief of the Affirmative Civil Enforcement Unit, handled the matter, along with Assistant Attorney General Scott Grannemann, Medicaid Fraud Division at the Massachusetts Office of the Attorney General.