Medicare won't expand coverage for stents

Washington -- In a surprising and unusual reversal, the Centers for Medicare & Medicaid Services has decided against expanding Medicare coverage of carotid artery stenting for patients who are at risk for stroke -- a move the agency had proposed three months before.

In a final decision memo issued April 30, CMS announced that it would leave Medicare's coverage policy unchanged for the time being. The program will continue covering stenting for patients who have a high level of carotid artery stenosis and associated stroke symptoms, such as paralysis, weakness or speech problems.

In a Feb. 1 proposed national coverage decision, federal officials said they were considering expanding coverage to patients with sufficiently narrowed arteries who are asymptomatic. Under current regulations, those patients can receive federal help with the procedure's costs only if they are part of a Food and Drug Administration-approved clinical trial of the stenting technology.

CMS acknowledged in its proposed coverage expansion that it did not apply the necessary standard to available clinical data to determine whether the risk of stroke, heart attack and death from the stenting procedure itself was low enough for the asymptomatic population when compared with other treatments.

"In reevaluating the study results, professional society evidence-based guidelines and public comments, we now believe that our proposed decision to remove the added safety and patient protection components of clinical trials and post-approved studies was premature," stated Steve E. Phurrough, MD, writing on behalf of the Coverage and Analysis Group that he chairs at CMS.

The final decision not to make the expansion came as an unexpected disappointment for some physicians, including cardiologists and vascular surgeons who had supported all or part of the original proposal. Carotid artery stenting in many cases provides an equally safe or less-risky alternative to patients than the more invasive carotid endarterectomy, they said.

The FDA has approved the use of stents for asymptomatic patients whose arteries are at least 80% blocked and who have significant physiological and/or anatomical comorbidities. The disparity between the FDA's stance and CMS' insistence on coverage only through clinical trials is confusing for physicians to navigate and difficult for patients to understand, especially given the more limited access that clinical trials offer, said William A. Gray, MD, a cardiologist and the director of endovascular services at New York-Presbyterian Hospital/Columbia University.

Carotid artery stenting can cost a patient $8,000 or more, meaning that some candidates for the procedure cannot afford to receive it unless Medicare pays for it.

"This gets us into this area of therapeutic limbo, where patients have device approval but no payment to follow it," said Dr. Gray, who was a lead investigator on some of the trials that prompted CMS to make its initial expansion proposal. "So patients are undergoing surgery at high risk when stenting is an alternative that has been shown to be at least as safe and equally effective in preventing stroke." Although CMS' desire to collect more data on stenting through trials is laudable, expansion of Medicare coverage would also produce useful clinical results from a broad range of patients for whom a clinical registry is not an option today, he said.

Physicians are split

Not all physicians were disappointed by the CMS decision.

The American Academy of Neurology, for instance, strongly opposed the proposed national coverage decision. Current medical data show that the risk of stroke and death from the stenting procedure itself is too high to justify Medicare coverage for patients who do not show symptoms, neurologists said.

"Allowing carotid artery stenting in this asymptomatic patient group will lead to more stroke and death than it will prevent, an outcome clearly not intended by CMS," said Thomas R. Swift, MD, former chair of neurology at the Medical College of Georgia and AAN's president. "High risk for carotid endarterectomy does not necessarily confer high risk for stroke."

The organization had applauded CMS for proposing to limit coverage in the symptomatic group to beneficiaries who are younger than 80. But by not changing the current regulations, this prohibition will not go into effect. That means octogenarians who meet the requirements can continue to receive stenting coverage without enrolling in a clinical trial, which Dr. Swift and others see as problematic due to the high rate of complications in this age group.

The Society for Vascular Surgery supported part of the proposed expansion but warned CMS against going too far. Instead of also covering stenting for asymptomatic patients with physiological high risks for surgery, such as coronary disease, the society recommended that CMS only consider expanding the coverage to anatomical high-risk members of the group, such as patients with carotid lesions.

By holding off on opening the door to any new coverage while it collects more data on patient outcomes in the physiological risk group, CMS acted in a thoughtful matter in weighing the risks and benefits, said K. Craig Kent, MD, director of vascular services for New York Presbyterian Hospital Network and president of the society.

The disappointment among some vascular surgeons that Medicare will not cover any asymptomatic patients outside of trials is tempered by the fact that CMS is waiting for clinicians to develop better medical guidelines for when to use the technology based on surgical risk. "It's not that stenting is not appropriate," Dr. Kent said. "What hasn't really been defined yet is what that high risk entails."

Such studies could take years to produce results. Until then, some physicians who disagreed with the CMS decision acknowledged that the agency is in a tough spot. Given the broad array of physician specialties that are involved in looking out for these patients' best interests, the government will keep getting mixed messages from doctors on both sides of the issue, said Dr. Gray.

"As long as there are differences in opinions among these different societies, CMS is going to have a difficult time justifying a change that moves them from where they are today," he said.