Originally Published MDDI December 2003NEWSTRENDS

Erin Bradford

December 1, 2003

3 Min Read
CMS Expands Coverage for Heart Assist Device

Originally Published MDDI December 2003

NEWSTRENDS

The LVAS connects to the left ventricle.

Erin Bradford

The Centers for Medicare and Medicaid Services (CMS) have issued a national coverage decision analysis expanding reimbursement for an expensive device to treat patients with end-stage heart failure.

Last December, MD&DI reported that FDA had approved HeartMate, a left-ventricular-assist system (LVAS) manufactured by Thoratec Corp. (Pleasanton, CA), for use in destination therapy for end-stage heart failure. Then, in April 2003, the agency approved Thoratec's updated HeartMate XVE. 

CMS's reimbursement approval, however, indicates that a more widespread adoption of the device is imminent, says Keith Grossman, president and CEO of Thoratec. “Without Medicare reimbursement, there basically is no market [for the product]. It's not a therapy. It is really that dramatic,” he explains. “Medicare reimbursement will be the on/off switch for this business. It will have an all-important effect on where this therapy goes.”

LVASs work by assuming the pumping action of the heart. Inserted into the abdomen, the device connects to the heart's left ventricle. Blood leaving the ventricle is shunted from the heart through the HeartMate. The device in turn pumps the blood to the aorta, dispersing it to the rest of the body. Batteries worn on a belt power the HeartMate's motor.

“With this particular therapy, it's a pretty dramatic surgical intervention with a very dramatic clinical outcome, and also, it's a fairly considerable cost investment,” explains Grossman. “But, unless the patient has the means to pay, it's not enough just to have FDA approval; somebody has to pay the bill. And given that most of these patients are older patients, the majority of them will have Medicare. So, whatever Medicare does becomes critically important.”

In addition to the payment approval, CMS also raised the rates that hospitals receive for implanting the device. The University of Maryland Medical Center (UMMC; Baltimore) and Johns Hopkins Hospital (Baltimore) are among the few dozen hospitals that will immediately qualify for the increased reimbursements. Hospitals had received a base payment rate of $54,000; CMS indicated it would climb to $70,000.

Grossman credits communication with CMS as the factor that helped the agency issue the coverage decision so quickly. Thoratec was in contact with CMS from the early stages of clinical trials and solicited input from the centers regarding the trials. With this line of communication established, Thoratec found that obtaining a coverage decision was much easier than it would normally have been, because CMS already understood many of the implications of the LVAS. 

“Once we had a completed trial to show them, we found that our working relationship with them was really fantastic,” Grossman explained. “The investigators had a patient population that reflected the Medicare patients; so we weren't taking them data on a bunch of 30-year-olds and asking them to pay for 67-year-olds. [The technology] was for a patient population that didn't have any other options.”

To companies hoping to expedite the CMS coverage-approval process, Grossman stresses the importance of open communication with the agency. “It's never too early to begin working with CMS,” Grossman advised. “Get their input and their buy-in to the clinical trial and what the outcomes will be. Also, think very hard about adding cost evaluation to your clinical trial, even if it's an added dimension to the trial that you'd prefer not to do.”

In response to the CMS announcements, AdvaMed released a statement applauding the agency's efforts to ensure that patients have improved access to lifesaving LVASs. “The positive national coverage decision and subsequent payment correction to increase the per-procedure payment is a positive step forward and will increase diffusion of this breakthrough technology,” the association wrote. The statement expressed concerns, however, about CMS's lack of a transparent and systematic process for determining coverage and setting payment levels.

Copyright ©2003 Medical Device & Diagnostic Industry

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