In the words of Cleveland HeartLab CEO Jake Orville, business has “exploded” since the beginning of the year, just months after his company launched a proprietary test for cardiac inflammation under a fee-for-service model.
Cleveland HeartLab is a CLIA-certified and CAP-accredited reference lab that does an array of lipid and inflammation tests for clients. The Cleveland Clinic spun off the company with a cardiac inflammation biomarker developed by Dr. Stanley Hazen and his colleagues there.
CardioMPO — Hazen’s test for cardiac inflammation marker myeloperoxidase — didn’t take off as a test kit for clients to do themselves. But as a star in a lineup of cardiac risk tests done by Cleveland HeartLab, it has led to explosive growth.
Clients have adopted Cleveland HeartLab’s services at a rate “beyond what we had hoped for,” Orville said. He and his colleagues started the year doing hundreds of tests per month. Now, they are doing thousands of tests per month.
To accommodate the business growth, the company has doubled its workforce, adding 11 employees, including PhDs, MDs and the like, since January for a total of 21 employees.
Now that Cleveland HeartLab has proved its concept, it is eyeing longer-term goals as a revenue-supported company. “I tell people my stress is down but my anxiety is up,” Orville said. “Now, we can just screw it up.”
A favorable reimbursement decision by the Centers for Medicare and Medicaid Services (CMS) in January helped boost adoption of the Cleveland HeartLab test.
“We won the first-ever appeal under new CMS guidelines” that aim at putting financial incentives behind disease prevention, Orville said. At the same time some companies saw drops in reimbursements for their tests, Cleveland HeartLab saw a 250 percent rise in reimbursement for its hallmark inflammation test.
The reimbursement win likely comes from CardioMPO’s predictive value. Myeloperoxidase is an enzyme that indicates inflammation in the artery walls of the heart, which can predict fatal heart attacks or strokes.
As some policy makers try to shift the nation’s healthcare model toward prevention, tests that can predict disease may rise to the top of the reimbursement heap. “Spending $50 in preventing a $10,000 or $20,000 event is something that CMS has said it believes in,” Orville said.
Cleveland HeartLab also will host its first conference — Where Inflammation Meets Lipids — at the Cleveland Clinic, beginning Sunday. “We have close to 100 registrants,” Orville said. “We have 130 people coming to the luncheon with Gov. Tommy Thompson. And we have close to 150 nights booked at the InterContinental Hotel.
“That is a couple hundred thousand dollars of economic impact for an early stage company,” Orville said.”We’re very proud of that.”