Months after a series of malfunctions led to the national recall of a heart valve device, providers are looking to expand its use by pushing the CMS to finalize a proposed increase in payment for the device.
Tucked deep inside the 2017 inpatient hospital proposed pay rule released in April was a suggested pay bump for the MitraClip, a device used to help treat mitral regurgitation (MR), a disorder in which the heart valve that separates the upper and lower chambers does not properly close. These devices are for patients for whom surgery would be too risky.
The proposed bump would result in an increase of $4,000 on average in reimbursement. The devices retail for $30,000 and hospitals last year spent between $37,000 and $50,000 in acquisition and surgical implantation costs per device, according to CMS data.
Providers welcomed the proposal.
“The current reimbursement structure for MitraClip procedures generates a significant loss to organizations around the nation,” a comment letter from Northwestern Memorial Hospital's Bluhm Cardiovascular Institute says, adding what the agency was paying out was “making it increasingly difficult to find the necessary resources to provide lifesaving therapies.”
“Financial implications have precluded many potential patients from receiving this therapy,” Dr. Gilbert Tang, director of Valve Disease Center at Westchester Medical Center in New York said in a letter. “Improving the reimbursement will help significantly the adoption of this technology.”
But just a few months ago, devicemaker Abbott Laboratories recalled its product because a number of surgeons were unable to detach the clip from the catheter used to implant it. They were therefore forced to perform emergency open-heart surgery. One death was reported as a result of severe comorbidities after surgery.
Abbott instituted a Class I recall, which is the most serious, indicating that use of the device can cause serious injury or death.
There are 3,534 MitraClip devices on the market. The FDA approved the MitraClip in October 2013.
Reimbursement concerns have plagued use of the device almost since its introduction. When the MitraClip first hit the market, providers were concerned that the CMS was not reimbursing them enough to cover the longer length of stay and higher costs that come with implementation of the device, which sold for about $30,000 at the time. Hospitals say they were being underpaid by as much as $17,000.
The CMS declined to change its codes as interventional cardiologists requested but did offer a new technology add-on payment that resulted in an estimated $27 million in additional payments for fiscal 2015.
Medicare covers only the device if the heart team and hospital involved in the procedure participate in a registry that follows patients for at least one year and tracks patient outcomes.
