CMS Rules Out Carotid Expansion
The Centers for Medicare and Medicaid Services (CMS) will not expand coverage for carotid artery percutaneous transluminal angioplasty with stenting, according to a final decision memo issued by the agency last month. The American College of Cardiology, the Society for Vascular Medicine, and the Society of Vascular and Interventional Neurology had asked the agency in December 2007 to add coverage for patients at high risk for carotid endarterectomy because of defined anatomic factors, and who have symptomatic carotid artery stenosis of 50%–90% or greater or asymptomatic carotid artery stenosis of at least 80%. However, the CMS ruled there was not enough evidence to support coverage, adding that the agency was “aware of other data that has yet to be published,” and that once it was available, it would “determine the need for an expedited review and reconsideration.”
Pfizer Settles Bextra Claims
Pfizer Inc. has struck a multimillion-dollar agreement to resolve most of the pending claims involving Bextra (valdecoxib), which was withdrawn from the market in 2005. The company agreed to pay $60 million to attorneys general in 33 states and the District of Columbia and to adopt certain compliance practices in response to suits alleging that the company violated state laws in its promotion and marketing of Bextra. Pfizer also said it was setting aside $745 million in anticipation of a final settlement of pending personal injury claims involving it's other COX-2 inhibitor, Celebrex (celecoxib). That amount should resolve more than 90% of the suits alleging that Celebrex caused heart attack, stroke, or other injury in those who took the drug. Several courts have ruled that the plaintiffs had failed to prove that the drug led to these effects. Pfizer settled to remove the cloud over the drug, it said in a statement.
Heparin a Top Cause for Injuries
Heparin—specifically a tainted version tied to Chinese suppliers—accounted for the second-highest number of serious drug reactions in the first quarter of 2008, according to an analysis of Food and Drug Administration data by the Institute for Safe Medicine Practices. The FDA received reports of 779 cases of serious adverse reactions and 102 deaths possibly related to the tainted heparin during the first 3 months of this year. The product associated with the most reports was varenicline (Chantix); there were 1,001 cases and 50 deaths potentially related to use of the smoking cessation therapy. An earlier warning about varenicline from ISMP was followed by an FDA warning about its psychiatric side effects. Overall, there were a record number of serious injuries reported in the first quarter: 20,745 cases. The 4,824 deaths recorded was the highest total since 2004, according to the ISMP. Most drugs are relatively safe; a small number of drugs accounted for a large volume of reports, said ISMP. For injuries, that list included fentanyl, interferon-beta, infliximab, etanercept, clopidogrel, pregabalin, acetaminophen, and oxycodone.
Imaging Cuts Reduce Costs
Medicare Part B payments for physician-performed imaging services dropped almost 13% between 2006 and 2007 mainly because of caps on physician payments called for under the Deficit Reduction Act (DRA) of 2005, according to an analysis from the Government Accountability Office (GAO). Under the DRA, Medicare fees for certain imaging services provided in the physician's office may not exceed what Medicare pays under the hospital outpatient prospective payment system. The imaging payment cap went into effect on Jan. 1, 2007. As a result, Medicare Part B per-beneficiary expenditures for imaging services fell from $419 in 2006 to $375 in 2007. Expenditures for advanced imaging services such as computer tomography and MRI fell even more. Although per-beneficiary expenditures dropped, utilization of services continued to rise, according to the GAO, which did the analysis at the request of Congress. The GAO concluded that beneficiary access at the national level was not affected by the payment cuts. However, the medical technology trade organization AdvaMed said the report indicated that the payments cuts were deeper than expected and are not in the interest of patients. Requiring accreditation of equipment and personnel in physician offices and developing appropriateness criteria would be a better approach to curb high imaging expenses, according to AdvaMed.