Medicare Compliance & Reimbursement

CMS backs off from threats to restrict off-label coverage

The drug-coated stent debate continues to rage.

Researchers who analyzed Medicare data on a sample of patients from 2001-2004 have concluded that coated stents are saving Medicare 5.4 percent--adjusted for inflation--to re-open blocked arteries, The New York Times reports.

Reasons for the savings: Nearly one third of Medicare patients received bypass surgery in 2001. By 2004, just one-fourth of Medicare patients received bypasses. Also, compared to bare stents, drug-coated stents reduce the need for repeat procedures.

"The surgeons would probably be screaming," said Jason Ryan, MD, MPH, a cardiologist at Beth Israel Deaconess Medical Center in Boston, who presented the data Oct. 23. According to the Times, the researchers are trying to get their results published in a peer-reviewed journal, "after which they would consider analyzing the data over a longer period."

Poppycock, critics counter. They point to the fact that funds for the study came from stent-maker Cordis, a Johnson & Johnson subsidiary. Researchers followed patients for only 13 months, critics add, so they don't have a true picture of long-term savings.

Finally, when you factor in the money Medicare pays for Plavix, a blood thinner that drug-coated stent patients must take, you come up with only $776 extra per patient, the Times reports.

Meanwhile, Medicare appears to be backing off from an earlier threat to restrict "off-label" coverage for drug-coated stents, the Wall Street Journal reported Oct. 24.

Coated stents cost $2,300, compared to $800 for bare stents. Last year, the agency spent $4.3 billion on drug-coated stents, the Journal says. Earlier this year, Medicare said it was considering coverage restrictions after a Food & Drug Administration hearing about clotting risks associated with coated stents.

But the jury is still out on drug-coated stents. Stephen E. Phurrough, Medicare's director of coverage and analysis, points out that both bypass surgery and stents are questionable expenses, reports The New York Times.

Phurrough cites the "Courage" clinical trial, which showed that patients with chest pains who took the best available drugs and followed healthy lifestyles were just as well off five years later as stent patients.