Yesterday, the Centers for Medicare and Medicaid Services issued a watershed set of conditions in a decision to cover a new device for repairing damaged heart valves.
Patients and product developers take note. The ruling is a vivid example of how our healthcare is going to get reimbursed now that Washington calls more of the shots.
At issue is a device for repairing the main valve carrying blood out of the heart. As people age, this aortic valve can become brittle. As the valve narrows, it can cause debilitating heart failure, and even death.
Fixing the problem used to require open-heart surgery. In November, FDA approved a device that lets doctors repair the valve using a tiny catheter that introduces a replacement valve through an artery in the leg. FDA only approved the device for patients who are too sick to have the open-heart procedure. Yesterday, CMS said it will pay for the procedure, but with a lot of extraordinary strings attached.
First, CMS only agreed to cover the device for its FDA approved use and only if the manufacturer agrees to continue studying the device in its FDA approved indication. The FDA approval, already based on unusually large and long-term trials that enrolled thousands of patients, was not enough to secure clear Medicare coverage.
CMS is also going to tightly control the ability for the device to be used in less sick patients. It will require any patient who wants the procedure to be assessed by two separate cardiac surgeons to certify they were not suitable for open-heart surgery.
If CMS agrees to cover use of the new valve in some patients who are also eligible for open-heart surgery, then Medicare will only pay for these procedures in the context of ongoing clinical trials. The agency has flirted with requiring “superiority” trials for this purpose—a high burden of proof that would force patients to be randomly selected to receive the new valve device or the open-heart procedure.
CMS is also restricting the number of doctors that can perform the new procedure.
CMS’ goal here is to cut down on the number of procedures. The same device has been approved in Europe for almost 5 years and has gained widespread use by patients who want to forgo very invasive open-heart surgeries—for good reason. The minimally invasive approach poses a lot less hardship on patients.
This ruling will force people to get open-heart surgeries that might have been avoidable. These decisions used to be left to patients and doctors. Now it’s clear that for costly procedures, Washington will be making more of these choices for us.