A fast-growing Framingham company is responding to inquiries from federal investigators examining whether diagnostic firms improperly paid doctors who send them patients’ blood specimens to test their risk for cardiovascular disease.
Boston Heart Diagnostics Corp. said in a statement that it is “fully cooperating with the government’s information requests” in an investigation being conducted by the Department of Justice and the inspector general’s office of the Department of Health and Human Services.
The inquiry was first disclosed by The Wall Street Journal, which earlier this month reported that investigators were focusing on a Virginia company, Health Diagnostic Laboratory Inc., but also looking into a group of rival companies, including seven-year-old Boston Heart, as well as Quest’s Berkeley HeartLab, Singulex Inc., and Atherotech Diagnostics Lab.
Those companies have paid processing fees to the offices of physicians who send them blood samples that can be screened to identify patients vulnerable to conditions such as heart disease, stroke, or diabetes.
While the fees are considered reimbursement for packaging and labeling the specimens, investigators reportedly are trying to determine whether they are illegally designed to generate revenue by giving doctors incentives to order unnecessary tests.
Neither the Justice Department nor the inspector general’s office would confirm the investigations. But on June 25, the inspector general’s office issued a “special fraud alert” that said processing fees may violate a federal antikickback law if they exceed market value for the services covered, if doctors are paid in a method that compensates them by volume collected, or if they are paid for tests that are not reasonable or necessary or that Medicare already covers.
Boston Heart paid up to $15 per specimen to physician offices for process and handling before the fraud alert was issued but then halted payments.
In the Boston Heart statement, spokeswoman Cherie Lucier said, “Ensuring strict compliance and ethical conduct are core values for our company. We support any industry developments that ensure a safe, transparent, and fair market.”
The statement also said Boston Heart’s cardiovascular tests are aimed at “high risk and secondary prevention” patients, including people with multiple risk factors. “We are not a primary screening company,” the company said. “Additionally, Boston Heart does not preserve patient samples for the purpose of running new [tests] that it may bring to market.”
Founded in 2007 as Boston Heart Lab, the company received investment funds from Bain Capital Ventures in 2010 and changed its name to Boston Heart Diagnostics the next year.
Last year, it ranked eighth on consulting firm Deloitte’s list of the 500 fastest-growing technology, media, telecommunications, life sciences, and clean technology companies in North America.
Boston Heart grew 32,031 percent during between 2008 and 2012, according to the ranking.