§ 416.195 Determination of membership in new classes of new technology IOLs.

(a) Factors to be considered. CMS uses the following criteria to determine whether an IOL qualifies for a payment adjustment as a member of a new class of new technology IOLs when inserted at an ASC: (1) The IOL is considered new. CMS will evaluate an application for a new technology IOL only if the IOL type has received initial FDA premarket approval within the 3 years prior to the new technology IOL application submission date. (2) The IOL shall have a new lens characteristic in comparison to currently available IOLs. The labeling, which must be approved by FDA, shall contain a claim of a specific clinical benefit imparted by the new lens characteristic. (3) The IOL is not described by an active or expired class of new technology IOLs; that is, it does not share a predominant, class-defining characteristic associated with improved clinical outcomes with members of an active or expired class. (4) Any specific clinical benefit referred to in paragraph (a)(2) of this section must be supported by evidence that demonstrates that the IOL results in a measurable, clinically meaningful, improved outcome. Improved outcomes include: (i) Reduced risk of intraoperative or postoperative complication or trauma; (ii) Accelerated postoperative recovery; (iii) Reduced induced astigmatism; (iv) Improved postoperative visual acuity; (v) More stable postoperative vision; (vi) Other comparable clinical advantages. (b) CMS determination of eligibility for payment adjustment. CMS reviews the information submitted with a completed request for review, public comments submitted timely, and other pertinent information and makes a determination as follows: (1) The IOL is eligible for a payment adjustment as a member of a new class of new technology IOLs. (2) The IOL is a member of an active class of new technology IOLs and is eligible for a payment adjustment for the remainder of the period established for that class. (3) The IOL does not meet the criteria for designation as a new technology IOL and a payment adjustment is not appropriate.