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CMS discusses reason for scrutiny of costs for recalled devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 16, 2007

Previously we told you about CMS's focus on healthcare costs related to recalled and replacement devices. CMS expressed concern about recent recalls of devices such as implantable cardioverter-defibrillator (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

In the final rule for the 2008 Physician Fee Schedule, CMS responded to comments addressing recalled and replacement devices. CMS had solicited comments in the proposed rule about how to identify and address the costs Medicare incurs with regard to device recalls. CMS said in the preamble to the final rule that several commenters agreed that such recalls resulted in additional costs, but argued those costs should be borne by the device manufacturers rather than Medicare and other payers. Commenters expressed concern that physicians would be penalized for serving patients affected by recalls.

CMS said it did not intend to penalize physicians caring for patients affected by recalls. Instead CMS said it intends "to ensure that costs of the additional physicians' services and diagnostic tests associated with recalled devices are recognized and appropriately addressed." CMS said it will consider commenters' concerns and suggestions as it develops a plan to address the issue.

To view the final rule, visit the CMS Web site and click the tab for "Newsroom." It will be published in the Federal Register on November 27.

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