Two years after CHF Solutions (NSDQ:CHFS) acquired Baxter‘s (NYSE:BAX) Aquadex fluid filtration device for $5 million, the company’s executives are working to weave together the evidence they need to land reimbursement in the U.S. and expand patient access for its technology.
The Aquadex system is designed to filter water and salt from patients experiencing fluid overload due to heart failure. CHF Solutions, formerly known as Sunshine Heart, has plenty of clinical evidence to back up the device’s efficacy, according to VP of quality assurance & regulatory affairs Megan Brandt.
“Now I’m working to pull that economic story together, based off of clinical data that we have. While we may not have reimbursement, we can show that if you treat with our product, you can reduce hospital readmissions,” Brandt told MassDevice.com ahead of her appearance this summer at DeviceTalks Minnesota.
Cutting back on hospital readmission rates has been a primary focus of healthcare organizations in recent years, especially since the Affordable Care Act was implemented. The ACA included a program that penalizes hospitals based on their readmission rates for certain diseases, Brandt noted, including heart failure.
“So that’s where our value proposition comes in,” she explained, noting that it’s often the larger, more mature healthcare centers that are open to the line of thought that preventing patients from returning to the hospital will reduce costs. But it can be challenging to convince smaller providers to invest in saving money down the road if there isn’t an immediate return.
To overcome that hurdle, Brandt uses the hospitals’ own data to show how CHF Solutions’ technology could cut costs.
“We walk them through their own data, which is publicly available, and say, ‘Let’s talk about where you’re at and go from there,'” she said.
Looking ahead, Brandt is keeping an eye on the Trump administrations’ efforts to reform, or repeal, the ACA. She is also interested in the FDA’s initiatives to incorporate patient preference in the design of clinical trials.
“It’s going to be interesting to watch this trend in terms of what the patient prefers as they become an important stakeholder in this process,” Brandt said.