CMS revised its carotid artery stenting policy Dec. 9 to ensure that new embolic protection devices used in conjunction with carotid stents are covered by Medicare, and to clarify that the stenting procedure cannot be covered without the use of a protection device.

In the decision memo, the agency officially declined to expand the population that is covered for the procedure outside of FDA clinical trials. This is the third time since 2005 CMS has raised prospects of expanding coverage to a greater proportion of FDA-approved patients, but ultimately decided against it (¹ Also see "New Data Gives Carotid Stenting A Third Shot At Broader Medicare Coverage" - Medtech Insight, 23 March, 2009.).

The agency instead used this most recent coverage analysis, opened in March, to revise its policy for embolic protection. Embolic protection devices collect debris that breaks loose during interventional procedures. They are used to prevent strokes from stenting of the carotid artery, which is close to the brain.

The previous coverage policy required use of "FDA-approved carotid artery stenting systems and embolic protection devices." The new language more specifically requires "FDA approved or cleared embolic protection devices." The change is intended to make clear that protection devices that have been separately 510(k)-cleared are covered as part of the requirement, in addition to those that are included as part of a carotid stent system's PMA.

"As carotid stenting continues to be widely performed, new embolic protection devices, without specific accompanying stent systems, have been developed and several have received FDA 510(k) clearance," CMS notes. Manufacturers of 510(k)-cleared EPDs include Invatec, Lumen Biomedical, ev3 and W.L. Gore.

CMS also clarified that a carotid stenting procedure is not covered "if deployment of the embolic protection device is not technically possible, and not performed."

With current offerings, "We believe that the use of embolic protection is always possible," CMS writes. Specifically, it points to the recent availability of embolic protection devices (e.g., Gore's Flow Reversal system) that are employed in a proximal position to the stent, rather than a distal location.

CMS also removed the word "distal" from embolic protection devices in its policy to avoid confusion.

- Monica Hogan ( ² m.hogan@elsevier.com )

CMS Clarifies Medicare Policy For Embolic Protection With Carotid Stenting

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