CMS Likely Will Not Restrict Coverage For Drug-Coated Stents

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Coverage For Drug-Coated Stents

CMSlikely will not restrict Medicare coverage for drug-coated stents inresponse to recent concerns that they can increase risk for bloodclots, according to Marcel Salive, director of medical and surgicalservices at the agency's coverage and analysis group, the Wall Street Journal reports.

InFebruary, CMS officials said that they had begun to consider a processto restrict Medicare coverage for "off-label" uses of drug-coatedstents in response to an FDAadvisory committee hearing in December 2006 on whether the devices canincrease risk for blood clots. Committee members concluded that theylacked adequate evidence to assess the risks and benefits of off-labeluses of drug-coated stents.

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On Tuesday at an industryconference in Washington, D.C., Salive said that CMS likely will nottake "tangible action" in response to the committee hearing. CMS in2006 spent $4.3 billion on surgeries to implant drug-coated stents, andan estimated 85% of those procedures involved off-label uses of thedevices. According to the Journal, the statement by Salive "could bring a little comfort to stent makers" Boston Scientific and Johnson & Johnson because any "restriction in coverage would have been bad news" for the companies (Winstein, Wall Street Journal, 10/24).

Medicare Spending
In related news, Medicare has spent less on treatments to reopenblocked coronary arteries since drug-coated stents reached the marketin 2003, according to a study presented on Tuesday by Jason Ryan, acardiologist at Beth Israel Deaconess Medical Center, the New York Times reports. For the study -- sponsored by Cordis,the division of J&J that manufactures drug-coated stents --researchers analyzed Medicare data from 2001 and 2004 from a sample ofbeneficiaries.

The study found that, after adjustment forinflation, Medicare in 2004 spent $29,663 for each beneficiary whoreceived treatment for blocked arteries, compared with $31,343 in 2001,a 5.4% decrease. According to the Times, the study "comeswith several caveats." The study in large part attributed the decreasein spending to a reduction in the percentage of Medicare beneficiarieswho underwent heart bypass surgery to treat blocked arteries -- lessthan one-fourth in 2004, compared with almost one-third in 2001.

However,because researchers "followed spending on the patients for only 13months after their initial procedures, ... it was too short to examineone of bypass surgery's supposed cost advantages -- that althoughbypass costs more initially, it keeps arteries open far longer and soreduces spending on repeat procedures," the Times reports (Feder, New York Times, 10/23).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily HealthPolicy Report is published for kaisernetwork.org, a free service of The HenryJ. Kaiser Family Foundation.

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