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Four regulatory news updates in ophthalmology
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From late October through November, notable regulatory decisions were made by the U.S. Food and Drug Administration, Centers for Medicare and Medicaid Services and the Irish Health Products Regulatory Authority – from recommendations to approve a multifocal toric IOL to positive reimbursement statuses for implants and injections.
Ocular Surgery News spotlights four regulatory decisions made that ophthalmologists should know to better treat patients who require such procedures.
FDA panel recommends premarket approval application for AcrySof IQ ReSTOR multifocal toric IOL
In an overwhelming panel vote, the U.S. Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted to recommend Alcon’s premarket approval application for the AcrySof IQ ReSTOR +3.0 D multifocal toric IOL. Get the whole story.
Iluvien earns marketing authorization in Ireland
The implant is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany. Get the whole story.
CMS to reimburse VisionCare’s implantable miniature telescope
VisionCare Ophthalmic Technologies has announced that the Centers for Medicare and Medicaid Services will reimburse the company’s implantable miniature telescope under a revised Ambulatory Payment Classification designation, according to VisionCare press release. Get the whole story.
Omeros granted CMS pass-through reimbursement status for Omidria
The Center for Medicare and Medicaid Services has granted Omeros Corporation with transitional pass-through status for Omidria 1%/0.3%, according to an Omeros press release.
This status — effective Jan. 1, 2015 — will allow ambulatory surgery centers and other outpatient facilities to bill Medicare and other insurance providers for the phenylephrine and ketorolac injection using a temporary Healthcare Common Procedure Coding System code unique to Omidria. Get the whole story.