42 C.F.R. § 416.180 Definitions.
Title 42 - Public Health
As used in this subpart, the following definitions apply: Class of new technology intraocular lenses (IOLs) means all of the IOLs, collectively, that CMS determines meet the definition of “new technology IOL” under the provisions of this subpart. Interested party means any individual, partnership, corporation, association, society, scientific or academic establishment, professional or trade organization, or any other legal entity. New technology IOL means an IOL that CMS determines has been approved by the FDA for use in labeling and advertising the IOL's claims of specific clinical advantages and superiority over existing IOLs with regard to reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages. New technology subset means a group of IOLs that CMS determines meet the criterion for being treated as new technology IOLs and that share a common feature or features that distinguish them from other IOLs. For example, all new technology IOLs that are made of a particular bioengineered material could comprise one subset, while all that rely on a particular optical innovation could comprise another.
Title 42: Public Health
PART 416—AMBULATORY SURGICAL SERVICES
Subpart F—Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers
§ 416.180 Definitions.
