[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR416.180]



[Page 818-819]

 

                         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



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a particular bioengineered material could comprise one subset, while all 

that rely on a particular optical innovation could comprise another.