Medicare May Not Restrict Payments for Drug-Coated Stents

    According to the Wall Street Journal, an official at the Centers for Medicare and Medicaid Services (CMS) said the government would “probably not” restrict coverage of drug-coated stents in response to concerns that they increase the risk of blood clots, which could put stent makers–Johnson & Johnson, Boston Scientific, and soon Medtronic–at ease.
    As of July, 89% of stents used in the United States were coated, according to the Journal. Their use fell to 62% in September, after evidence emerged that they slightly increase the risk of blood clots a year or more after implantation, when compared with plain-metal stents.
    In February, CMS said it was considering a process to restrict “off-label” insurance coverage for the stents in response to a December 2006 hearing by the FDA about clotting risk. Coated stents cost about $2,300, compared with roughly $800 for bare stents.
    The FDA and Medicare had indicated they were concerned about the use of such stents off-label, or outside the categories approved by the FDA. Coated stents haven’t been rigorously studied in patients with heart attacks, small arteries or multiple clogged arteries, although the stents are used in these applications.
    A recent FDA panel concluded there wasn’t enough evidence to assess the risks and benefits of stents in off-label patients, who constitute roughly 85% of all stent patients, according to various estimates. Although the FDA hasn’t approved the marketing of such stents for off-label patients, Medicare generally pays for such uses. Last year, the agency spent $4.3 billion on coated-stent operations.
Source: The Wall Street Journal