Staar new-tech IOLs
This article was originally published in The Gray Sheet
Executive Summary
Staar Surgical's Afinity Collamer Aspheric Single Piece and Elastimide Silicone intraocular lenses join the class of new technology IOLs that qualify for $50 extra payment from CMS based on improved outcomes compared with traditional lenses, the company announces July 24. The bonus payments will expire Feb. 26, 2011. Other lenses with the same special designation for reducing spherical aberrations include AMO's Tecnis, Alcon's Acrysof IQ, Bausch & Lomb's Sofport and Staar's Afinity Collamer Aspheric Three Piece (1"The Gray Sheet" March 24, 2008, In Brief). The Elastimide lens is available immediately, while the Single Piece lens will launch later this quarter, Staar says
You may also be interested in...
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
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.