Suspension of vaccine manufacturer's license halves U.S. supply. If you expected to get your supply of flu vaccine from Chiron Corp., you may be out of luck.
First, Chiron said in August it found tainted doses of the vaccine in its England factory. Chiron planned to ship only about half of the nearly 100 million doses it expected to furnish this flu season, according to press reports. The discovery delayed those remaining shipments from September to October.
Then the United Kingdom's regulatory agency suspended Chiron's license to manufacture Fluvirin vaccine for three months, putting the remaining 46 to 48 million doses out of reach.
"The loss of the Chiron flu vaccine poses a serious challenge to our vaccine supply for the upcoming flu season," the Department of Health and Human Services says in a release. HHS is pursuing contingency plans to get hold of more vaccine from other sources, although it doesn't know "whether it's possible to get more vaccine," HHS acknowledges.
That leaves home health agencies like Northern California-based Sutter VNA with no idea whether they'll receive any flu vaccine to administer this season, reports The San Francisco Chronicle. "We are as shocked as everyone else," Sutter spokesperson Gerri Ginsburg told the paper. Sutter planned to give up to 100,000 vaccinations in Northern California.
HHAs that ordered FluMist nasal spray from MedImmune or vaccine from Aventis Pasteur Inc., the other main vaccine manufacturer, are on surer footing. But the Centers for Disease Control and Prevention urges that vaccinations go to priority populations first, including adults age 65 and older and persons with chronic medical conditions. The CDC recommendations are at
www.cdc.gov/flu/. You could furnish more insulin pumps under new Medicare coverage guidelines for the items. In previous national coverage decisions, the Centers for Medicare & Medicaid Services used C peptide testing as a requirement for covering subcutaneous insulin infusion, CMS explains in a draft decision memorandum. But in March Medtronic requested that CMS remove C peptide testing as a requirement for insulin pump coverage, and the American Association of Clinical Endocrinologists backed up the request.
Commercial payors don't require the C peptide test. And when individuals switch over to Medicare, up to 25 percent of patients have to go off subcutaneous insulin infusion when they don't qualify under the test, Medtronic argued.
CMS relented on the requirement, and now beneficiaries must either 1) meet an updated fasting C peptide test once or 2) be beta cell autoantibody positive, CMS says in the draft memo. Benes also must meet the other criteria for insulin pump coverage.
More information is online at
www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=109. Home care could be a feature of the new demonstration program to manage high-cost Medi-care beneficiaries.
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