Medical Device Daily

Skittish investors, already spooked over the past year by recent chinks in the drug-eluting stent (DES) clinical data armor, hit the panic button after an article in the Wall Street Journal yesterday indicated that the Centers for Medicare and Medicaid Services is considering restricting coverage of the devices due to the safety concerns raised.

However, CMS yesterday told Medical Device Daily that the WSJ article's conclusions about its intentions were not accurate, thus perhaps calming investor fears concerning reduced coverage — at least for now.

"We know the FDA has raised concerns [about DES efficacy], so we're studying the issue. But we haven't opened any coverage decision, and we don't know if we will," a CMS spokesperson told MDD.

"Staff are always keeping up with developments and evolving evidence throughout the healthcare technology sector, assessing whether new evidence warrants CMS attention," said Barry Straube, CMS chief medical officer, in a statement. "There is no plan for any change in current policy towards drug-eluting stents at the present time."

The author of the WSJ article apparently read more into a conversation about national coverage decisions (NCDs) than was actually there, inferring from a discussion that an NCD is likely, when in fact, no such determination has been made.

There have been plenty of researchers raising concerns about the use of DES recently, particularly for so-called "off label use" in high-risk patients such as diabetics and those who have already had a heart attack.

In September, researchers at the European Society of Cardiology (ESC; Sophia Antipolis, France) annual meeting in Barcelona, Spain, indicated that DES devices may increase the risk of potentially fatal blood clots in the form of late thrombosis (Medical Device Daily, Sept. 6, 2006) Similar concerns were brought in the BASKET-LATE study presented at the March 2006 American College of Cardiology Scientific Sessions in Atlanta.

The WSJ article noted that Medicare paid about $14.7 billion for DES operations in 2005. That figure represented about half of all implants of the devices that year. And a reduction of coverage by CMS would seriously pare back these revenues.

"As always, we would provide CMS the data it needs to ensure that this life-improving technology is available to the broadest range of appropriate patients," according to a spokesperson for Boston Scientific (Natick, Massachusetts). Boston Scientific and Johnson & Johnson (J&J; New Brunswick, New Jersey) are the only two companies with approvals to sell the devices in the U.S.

Stock in Boston Scientific, J&J, Medtronic (Minneapolis) and Abbott Laboratories (Abbott Park, Illinois) — all companies involved in the DES market — took a hit based on the news from the WSJ.

Some on Wall Street sought to quell fears about the WSJ report.

Larry Biegelsen, a Prudential Financial analyst, said it was his understanding that CMS has no immediate plans to open a National Coverage Decision on DES. Referring to the WSJ report, he wrote in a research report, "to the best of our knowledge, nothing is imminent."

In another piece of DES-related news, a new study, published in the American Journal of Cardiology last week, found that patients with coated stents were more likely to be alive after nine months than those implanted with bare-metal stents (BMS).

The observational study showed that DES devices reduced the risk of myocardial infarction, or/and death by 23% and 32%, vs. 3.7% and 4.7% in BMS patients. The study involved 2,359 patients over a nine-month period.

However, the study, sponsored by J&J, provided no data on deaths after nine months, when much of the clotting occurs, according to previous studies.