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Outpatient Payment Proposal In Brief

This article was originally published in The Gray Sheet

Executive Summary

Alcon seeks new NTIOL class: CMS says in its 2011 outpatient payment proposal, released July 2, that it is reviewing a request from Alcon Laboratories to establish a new class of new-technology intraocular lenses (NTIOL) for the firm's Acrysof Natural lenses, which use blue light filtering to improve driving safety under glare conditions. CMS notes that in 2004 it considered and rejected a request to create a separate ambulatory surgical center payment class for another intraocular lens based on blue light filtering. The agency seeks public comment on peer reviewed data that would support or disprove Alcon's claims about the device's clinical benefits, especially in the Medicare population. If a new class is created, CMS would pay an extra $50 for five years for each outpatient procedure using the lens. Since 2000, CMS has created three new NTIOL classes, including a class for lenses designed to reduce spherical aberrations to improve visual acuity; four companies with such products will continue to receive a $50 premium through Feb. 26, 2011 (1"The Gray Sheet" March 24, 2008)

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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)

Staar lens wins CMS new technology IOL recognition

Medicare will provide an additional reimbursement of $50 per lens when Staar Surgical's Afinity Collamer Aspheric foldable intraocular lens is provided to a cataract patient in an ambulatory surgical center, following the lens' designation as a new technology intraocular lens by CMS, announced March 17. To receive NTIOL recognition, an IOL must be FDA-approved with labeling and advertising consistent with the specific claim for which CMS approval is being sought, and the IOL must provide measurable, clinically meaningful improved patient outcomes over other available IOLs. The Staar Afinity IOL, which has been cleared for enhanced reimbursement through Feb. 26, 2011, reduces spheric aberrations to improve visual acuity, Staar says

US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.





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