CMS Likely Will Not Restrict Coverage For Drug-Coated Stents

Main Category: Medical Devices / Diagnostics
Also Included In: Medicare / Medicaid / SCHIP;  Cardiovascular / Cardiology
Article Date: 25 Oct 2007 - 12:00 PDT

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CMS likely will not restrict Medicare coverage for drug-coated stents in response to recent concerns that they can increase risk for blood clots, according to Marcel Salive, director of medical and surgical services at the agency's coverage and analysis group, the Wall Street Journal reports.

In February, CMS officials said that they had begun to consider a process to restrict Medicare coverage for "off-label" uses of drug-coated stents in response to an FDA advisory committee hearing in December 2006 on whether the devices can increase risk for blood clots. Committee members concluded that they lacked adequate evidence to assess the risks and benefits of off-label uses of drug-coated stents.

On Tuesday at an industry conference in Washington, D.C., Salive said that CMS likely will not take "tangible action" in response to the committee hearing. CMS in 2006 spent $4.3 billion on surgeries to implant drug-coated stents, and an estimated 85% of those procedures involved off-label uses of the devices. 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 reopen blocked coronary arteries since drug-coated stents reached the market in 2003, according to a study presented on Tuesday by Jason Ryan, a cardiologist 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 of beneficiaries.

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

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

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