MEDICARE ANNOUNCES EXPANDED COVERAGE FOR CAROTID ARTERY STENTING, ABARELIX, INSULIN PUMPS, AUTOLOGOUS STEM CELL TRANSPLANS
The Centers for Medicare & Medicaid Services (CMS) today announced it intends to expand Medicare coverage of carotid artery stenting to patients who are at high risk if they were to undergo the alternative procedure, a surgery known as carotid endarterectomy or CEA.
CMS also proposed coverage of Abarelix for selected patients undergoing palliative treatment of prostate cancer. On December 15, 2004 CMS announced a proposal to expand coverage of autologous stem cell transplants for AL Amyloidosis.
In a final coverage decision also announced today, CMS said it is expanding Medicare coverage of insulin infusion pumps for diabetes.
“These decisions are part of Medicare’s ongoing commitment to provide new and beneficial services to its beneficiaries,” said CMS Administrator Mark B. McCLellan, M.D., Ph.D.
CEA is a surgical procedure used to prevent stroke in which the surgeon removes fatty deposits or plaques from the carotid arteries, the two main arteries in the neck supplying blood to the brain. Carotid artery stenting is a less invasive, alternative procedure to CEA, in which a catheter is used to place the stent that will widen the narrowed artery.
Proposed Medicare coverage for carotid artery stenting is restricted to patients who would be at high risk of complications from CEA, and who have symptomatic narrowing of the carotid artery of 70 percent or more. Coverage will also be made available to asymptomatic high risk patients who are enrolled in prospective clinical studies.
To help ensure optimal patient outcomes, the proposed decision will limit coverage of carotid stenting to facilities and providers who have demonstrated competence in performing the evaluation, procedure, and necessary follow-up care.
CMS intends to ensure facility and provider competence and to protect patient safety by collecting procedure related data through a national evaluation system (registry). Competency will be based on published clinical guidelines that outline physician training standards and facility support requirements for carotid artery stenting.
“This decision to expand coverage of carotid artery stenting to high risk patients will provide Medicare beneficiaries with broader access to the latest technology available for management of their carotid artery disease,” said Sean Tunis, M.D., CMS’ chief medical officer. “We are determined to help to reduce the incidence of stroke in our population, while also ensuring patient safety and quality of care by monitoring facility and provider performance. We are also committed to using this data to provide better evidence to doctors and patients as they make critical decisions about their care.”
Previously, CMS only covered percutaneous transluminal angioplasty of the carotid artery concurrent with stent placement in clinical trials being conducted prior to Food and Drug Administration (FDA) approval (so-called Category B Investigational Device Exemption [IDE] clinical trial) and more recently in FDA required post approval studies. Carotid artery stenting to treat indications not included in this expansion of coverage, such as asymptomatic carotid stenosis or symptomatic disease with less narrowing (50-70 percent) is still eligible for coverage under these policies.
Autologous stem cell transplantation (AuSCT) can treat AL Amyloidosis, a rare blood disorder that affects the heart, kidneys, nervous system and gastrointestinal system and results in extensive organ system impairment. In this transplantation, stem cells are retrieved from a patient’s bone marrow or blood, stored, and then transplanted back into the patient following high dose chemotherapy used to treat various cancers.
For patients age 63 years or younger this procedure is currently covered at the local contractor’s discretion. Since October 1, 2000, primary AL amyloidosis has had a national non-coverage determination (NCD) for Medicare beneficiaries 64 years of age or older.
After analyzing the medical and scientific evidence for AuSCT for AL Amyloidosis and considering the recommendations of professional societies and other experts in the field, CMS determined that AuSCT would improve the care of Medicare beneficiaries with primary AL Amyloidosis. CMS concluded that AuSCT can provide a health benefit for Medicare beneficiaries of any age with primary AL Amyloidosis and proposes coverage for beneficiaries who meet three specific criteria regarding extent of disease, particularly involvement of the kidneys or heart.
CMS proposes that Abarelix be covered for the palliative treatment of beneficiaries with advanced symptomatic prostate cancer, in whom luteinizing hormone-releasing hormone (LHRH) agonist therapy is not appropriate, who refuse surgical castration, and who have one or more of the following: risk of neurological compromise due to metastases; ureteral or bladder outlet obstruction due to local encroachment or metastatic disease; or severe bone pain from skeletal metastases persisting on narcotic analgesia.
The proposed decision will make available an alternative cancer drug for Medicare beneficiaries with advanced symptomatic prostate cancer who may otherwise experience some medical difficulties using the currently recommended course of treatment.
Insulin pumps have been covered by Medicare since 1999 for diabetic patients who had specific levels of C-peptide in the blood. CMS posted a proposed decision in September 2004 proposing to expand coverage. CMS has reviewed comments on the draft proposal, and the final NCD will allow coverage of an alternative test, called beta cell autoantibody, to identify beneficiaries with type 1 diabetes that would benefit from the insulin pump. The decision will also expand the coverage of insulin pumps for beneficiaries with type 2 diabetes by standardizing the C-peptide testing and relaxing the criteria for those with kidney disease.
The decision on insulin pumps is final and effective immediately. The three proposed new coverage policies are available for review at the CMS coverage website at http://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.html Posting of the proposals marks the beginning of a 30-day public comment period. After close of the comment period, CMS will have 60 days to review the comments and issue a final policy.