[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: 42CFR416.185]

[Page 687-688]
 
                         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. 416.185  Payment review process.

    (a) CMS publishes a Federal Register notice announcing the deadline 
and requirements for submitting a request for CMS to review payment for 
an IOL.
    (b) CMS receives a request to review the appropriateness of the 
payment amount for an IOL.
    (c) CMS compiles a list of the requests it receives and identifies 
the IOL manufacturer's name, the model number of the IOL to be reviewed, 
the interested party or parties that submit requests, and a summary of 
the interested party's grounds for requesting review of the 
appropriateness of the IOL payment amount.
    (d) CMS publishes the list of requests in a Federal Register notice 
with comment period, giving the public 30

[[Page 688]]

days to comment on the IOLs for which review was requested.
    (e) CMS reviews the information submitted with the request to 
review, any timely public comments that are submitted regarding the list 
of IOLs published in the Federal Register, and any other timely 
information that CMS deems relevant to decide whether to provide a 
payment adjustment as specified in Sec. 416.200. CMS makes a 
determination of whether the IOL meets the definition of a new 
technology IOL in Sec. 416.180.
    (f) If CMS determines that a lens is a new technology IOL, CMS 
establishes a payment adjustment as follows:
    (1) Before July 16, 2002--$50.
    (2) After July 16, 2002--$50 or the amount announced through 
proposed and final rulemaking in connection with ambulatory surgical 
center services.
    (g) CMS designates a predominant characteristic of a new technology 
IOL that both sets it apart from other IOLs and links it with other 
similar IOLs with the same characteristic to establish a specific subset 
of new technology within the ``class of new technology IOLs.''
    (h) Within 90 days of the end of the comment period following the 
Federal Register notice identified in paragraph (d) of this section, CMS 
publishes in the Federal Register its determinations with regard to IOLs 
that it has determined are ``new technology'' lenses that qualify for a 
payment adjustment.
    (i) Payment adjustments are effective beginning 30 days after the 
publication of CMS's determinations in the Federal Register.