[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR416.180]

[Page 687]
 
                         TITLE 42--PUBLIC HEALTH
 
                    CHAPTER IV--CENTERS FOR MEDICARE
                          & MEDICAID SERVICES,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 416--AMBULATORY SURGICAL SERVICES--Table of Contents
 
Subpart F--Adjustment in Payment Amounts for New Technology Intraocular 
             Lenses Furnished by Ambulatory Surgical Centers
 
Sec. 416.180  Definitions.

    Source: 64 FR 32205, June 16, 1999, unless otherwise noted.


    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.