Officials at the Centers for Medicare and Medicaid Services have reversed a proposal to expand coverage for carotid artery stenting in asymptomatic patients.
Instead, Medicare will continue to cover percutaneous transluminal angioplasty of the carotid artery concurrent with stenting, mainly in patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis of 70% or greater.
Medicare also will continue to cover the procedure in patients at high risk for CEA with symptomatic carotid artery stenosis between 50% and 70% in Category B Investigational Device Exemption (IDE) trials and in postapproval studies. The procedure will be covered only in asymptomatic patients under limited circumstances. Medicare will cover patients who are at high risk for CEA and have asymptomatic carotid artery stenosis of 80% or greater as part of a Category B IDE trial or a postapproval study.
The proposed decision to expand coverage of carotid artery stenting in asymptomatic patients outside of the protection of clinical trials and postapproval studies was “premature,” CMS said in its decision memo. However, officials also noted that registry and postapproval studies show a trend toward improving outcomes, and so they have continued coverage for patients who are enrolled in clinical trials or are part of postapproval studies.
Reversals of CMS-proposed coverage decisions are rare, a CMS spokesman said.
The policy reversal means that the agency will not proceed with plans to restrict coverage for patients 80 years of age or older to clinical trials and postapproval studies. And CMS also will not go forward with its proposal to require a surgeon to perform a consultation to ascertain a patient's high-risk status before undergoing carotid artery stenting (INTERNAL MEDICINE NEWS, March 1, 2007, p. 27).
Although CMS has rolled back most of the provisions of its February 2007 carotid artery stenting proposal, some aspects will remain in place. For example, CMS plans to implement the clarifications regarding embolic protection devices and the facility certification and recertification process.
Under the coverage decision, carotid artery stenting is covered only when used with an embolic protection device. The procedure will not be covered if the deployment of the distal embolic protection device is not possible.
Overall, the CMS coverage demo is fair and evidence based, said Dr. Eric R. Bates, a cardiologist and professor of internal medicine at the University of Michigan in Ann Arbor. “Everybody gets a little something out of it,” he said.
The decision not to expand coverage to asymptomatic patients makes sense and is based on the available evidence, he said. However, since it continues to cover the procedure in clinical trials and postapproval studies, it still leaves the door open for improvements in the technology, case selection, and operator skills, he said.
“I don't think you can be too critical of the decision,” Dr. Bates said.
But although CMS has done a good job of requiring evidence before expanding coverage, Dr. Bates said he is concerned that too many hospitals have been approved to perform carotid artery stenting for high-risk patients. Currently, 1,057 hospitals have met CMS minimum facility standards to perform the procedure in high-risk patients.
The coverage decision reversal is good news in the eyes of many in the neurology community who had urged CMS officials to be cautious in expanding coverage in this area. Both the American Academy of Neurology and the American Association of Neurological Surgeons submitted comments to CMS in which they said that available evidence did not warrant expansion.
The groups noted that the CMS proposal was based on case series data and company registries, which can be biased and are not helpful in determining efficacy.
In comments to the agency, officials at AANS recommended that CMS review its policies regarding carotid endarterectomy in high-risk asymptomatic patients. Both carotid artery stenting and CEA should be evaluated among those patients in a randomized clinical trial statistically powered to determine efficacy, AANS said.
“There is insufficient evidence regarding the relative risk of [carotid artery stenting] versus CEA in all asymptomatic high-risk subgroups to suggest that either procedure is superior to best medical therapy,” AANS wrote in comments to CMS. “Accordingly, it would be inappropriate and not in the best interest of patient care to change the [carotid artery stenting National Coverage Determination] to include asymptomatic high-risk patients in any age group at this time.”
Efforts to expand coverage now would make the development and completion of a randomized trial comparing CEA, carotid artery stenting, and medical therapy difficult, if not impossible, the American Stroke Association said in comments to CMS.