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Cyberonics Urges CMS Panel To Block Proposed Reduction In VNS Payment

This article was originally published in The Gray Sheet

Executive Summary

CMS' proposed payment cuts for Cyberonics' Vagus Nerve Stimulation (VNS) System will prevent some epilepsy patients from accessing the seizure control therapy, according to the company

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Medicare News In Brief

MedPAC addresses CED program: Members of the Medicare Payment Advisory Commission called for greater clarity on CMS' statutory authority to make coverage-with-evidence-development decisions as part of national coverage policies. The advisory group also wants to see more stable and consistent sources of funding for the program. MedPAC analyst Nancy Ray updated the commission on the Medicare agency's use of CED during a Nov. 5 meeting in Washington, D.C. Ray noted that challenges in obtaining public and private funding for clinical trials and patient registries have caused delays in gathering evidence to meet the requirements of the conditional coverage decisions. She added that having a clearer statutory foundation might enable the agency to better develop a formal mechanism to identify and select services for CED and to better articulate standards for collecting CED data. Besides an August national coverage determination for genetic warfarin response screening that included a CED component, CMS has made little use of the tool in the past few years. CMS officials have stated that they believe the CED program is underutilized (1"The Gray Sheet" Oct. 19, 2009)

Medicare News In Brief

MedPAC addresses CED program: Members of the Medicare Payment Advisory Commission called for greater clarity on CMS' statutory authority to make coverage-with-evidence-development decisions as part of national coverage policies. The advisory group also wants to see more stable and consistent sources of funding for the program. MedPAC analyst Nancy Ray updated the commission on the Medicare agency's use of CED during a Nov. 5 meeting in Washington, D.C. Ray noted that challenges in obtaining public and private funding for clinical trials and patient registries have caused delays in gathering evidence to meet the requirements of the conditional coverage decisions. She added that having a clearer statutory foundation might enable the agency to better develop a formal mechanism to identify and select services for CED and to better articulate standards for collecting CED data. Besides an August national coverage determination for genetic warfarin response screening that included a CED component, CMS has made little use of the tool in the past few years. CMS officials have stated that they believe the CED program is underutilized (1"The Gray Sheet" Oct. 19, 2009)

Medicare In Brief

Neurostimulator payments: Medicare reimbursement for outpatient procedures to implant neurostimulator leads would increase 44% under the agency's proposed 2010 Outpatient Prospective Payment System (OPPS) rule, released July 1. The proposed boost follows a double-digit decrease in payment for the same procedure in 2009, which occurred despite protests from Cyberonics, maker of the Vagus Nerve Stimulation System for controlling epileptic seizures (1"The Gray Sheet" Sept. 1, 2008). CMS says the fluctuations in median costs for implantation of neurostimulator electrodes for the cranial nerve and for insertion of left ventricular pacing electrodes "are a consequence of the small number of single bills upon which the median costs are based and the small number of providers of these services." The agency also plans to consolidate the current three APC codes for neurostimulator generator implantation into two. Comments on the OPPS proposal are due Aug. 31; a final rule is expected by Nov. 1

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