The CMS is considering coverage of artificial heart devices for Medicare patients who are enrolled in Food and Drug Administration-approved clinical trials of the devices, according to an agency news release.
CMS officials will make a final ruling on the proposed coverage policy by May, but under the plan, patients with severe biventricular heart failure and no immediate prospects for a donor heart would qualify for coverage of the device. Artificial hearts are used in patients who are at imminent risk of death. The devices replace a portion of the patients heart and can be used temporarily until a donor is matched or permanently to extend a patients life.
Our proposal relaxes a long-standing noncoverage policy, gives access to our beneficiaries and promotes evidence development through FDA-approved studies of this advanced technology, said acting CMS Administrator Kerry Weems in a written statement. The proposed policy change is the result of 22 years of clinical trials run chiefly by two devicemakers showing the artificial heart as a potentially viable method of intervention for specific types of heart patients awaiting transplant. -- by Shawn Rhea
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