Corporate Compliance

Medicare reviewing pay for off-label use of coated stents

Compliance Monitor, March 14, 2007

Medicare is currently reviewing whether to pay for "off-label" use of drug-coated stents, according to HealthDay.

The review comes as new studies revealed that about 60% of drug-coated stents are used in cases not approved by the Food and Drug Administration (FDA).

The data on this "off-label" use is reported in a series of articles published in the March 8 issue of the New England Journal of Medicine.

The FDA currently approves the use of the stents in patients with a single blocked artery and no associated medical problems.

But the studies reveal that many patients are receiving multiple stents, sometimes under emergency conditions, and when there are other medical problems, according to HealthDay.

On-label use is limited to the use of two stents; while off-label covers three or more.

To read the HealthDay story, click here.

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