The Centers for Medicare & Medicaid Services (CMS) today announced it intends to expand coverage of ventricular assist devices (VADs) as permanent cardiac support for certain Medicare beneficiaries and make a technical correction to payment to ensure appropriate access to the procedure.
When this new coverage becomes effective, it will provide VADs for Medicare patients who have chronic end-stage heart failure, are not candidates for heart transplantation and meet the inclusion criteria outlined in the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure trial (REMATCH).
"With this decision, Medicare is taking another step in bringing the latest in medical technology to the elderly and disabled Americans it serves," said CMS Administrator Tom Scully. "This decision is based on the best available scientific evidence following a clinical trial that showed VADs can extend and improve the quality of life in patients with heart failure.
"We are also making a payment correction that will increase the per procedure payment to ensure appropriate access to this new potentially lifesaving device," said Scully.
Heart failure is the gradual decline in the heart's pumping capabilities and affects nearly 5 million Americans. There are varying degrees of heart failure from mild to severe. It is most prevalent in the elderly and is the leading cause of hospitalizations in the Medicare population.
Ventricular assist devices are mechanical pumps that can assume some of the functions of the damaged heart. They are effective in restoring hemodynamics and enhancing end organ blood flow in the body.
Currently, VADs are only covered as a bridge to heart transplant or as support for blood circulation after open-heart surgery. The new coverage would provide them as a destination therapy (permanent mechanical cardiac support). The REMATCH trial, sponsored by the National Institutes of Health (NIH), is the only published trial that has studied the use of ventricular assist devices as destination therapy, and has identified the end stage heart failure patients who will benefit from this device.
"We will continue to track both the patient outcomes and procedure payments and make further appropriate adjustments as this technology becomes more broadly available," said Scully.
Details of the decision memorandum announced today can be found at http://www.cms.gov/ncdr/searchdisplay.asp?id=79.