CMS designates aspheric lens as NTIOL

Baltimore-The Centers for Medicare and Medicaid Services (CMS) has designated a three-piece, aspheric, foldable IOL (Affinity Collamer Model CQ2015A, STAAR Surgical Co.) as a new technology IOL (NTIOL), according to the company.

“This is the first step in our plans to refresh our entire U.S. cataract product offerings,” said Barry G. Caldwell, president and chief executive officer, STAAR Surgical.

The approval for NTIOL reimbursement status means that Medicare will provide an additional reimbursement of $50 per lens when the lens is implanted in a Medicare patient in an ambulatory surgical center. The NTIOL subset for reduced spherical aberrations, to which this lens has been approved, allows for the additional reimbursement from March 17, 2008, until Feb. 26, 2011.

To receive NTIOL designation, an IOL first must be approved by the FDA, with labeling and advertising consistent with the specific claim or characteristic for which CMS approval is being sought. In addition, evidence must exist that the use of the IOL results in measurable, clinically meaningful, improved patient outcomes in comparison with use of currently available lenses.