CMS proposes increased coverage for stenting
The Centers for Medicare & Medicaid Services (CMS) has proposed an expansion of its coverage of carotid artery stenting (CAS). The proposed National Coverage Determination (NCD) includes a coverage expansion that reflects the latest evidence on the effective use of stenting, a procedure that reduces the occurrence of stroke, in the Medicare population, according to a CMS release.
“CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease,” said CMS Acting Administrator Leslie V. Norwalk, Esq. “We are working with health professionals and others to reduce the occurrence of stroke in the Medicare population.”
Per the department’s current policy, patients with no symptoms of carotid artery stenosis (narrowing of the arteries) and who are at high risk for CEA (Carotid Endarterectomy) are only covered when CAS procedures are performed in FDA Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the Medicare clinical trial policy. If the change goes through the coverage will be expanded for CAS to this group of patients who have greater than 80 percent carotid artery stenosis, CMS said.
Medicare might also modify coverage for patients who are 80 years of age and older. There is concern over the safety of CAS when performed in older patients. This proposed decision allows for coverage of patients age 80 and above only when CAS procedures are performed in Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the clinical trial policy, CMS said.
CMS has also proposed a formalization of the certification and recertification process for hospitals that are inserting carotid stents.
Read the full draft memorandum at: www.cms.hhs.gov. CMS has requested comments regarding this proposal which can be submitted at: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=194.
“CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease,” said CMS Acting Administrator Leslie V. Norwalk, Esq. “We are working with health professionals and others to reduce the occurrence of stroke in the Medicare population.”
Per the department’s current policy, patients with no symptoms of carotid artery stenosis (narrowing of the arteries) and who are at high risk for CEA (Carotid Endarterectomy) are only covered when CAS procedures are performed in FDA Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the Medicare clinical trial policy. If the change goes through the coverage will be expanded for CAS to this group of patients who have greater than 80 percent carotid artery stenosis, CMS said.
Medicare might also modify coverage for patients who are 80 years of age and older. There is concern over the safety of CAS when performed in older patients. This proposed decision allows for coverage of patients age 80 and above only when CAS procedures are performed in Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the clinical trial policy, CMS said.
CMS has also proposed a formalization of the certification and recertification process for hospitals that are inserting carotid stents.
Read the full draft memorandum at: www.cms.hhs.gov. CMS has requested comments regarding this proposal which can be submitted at: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=194.