[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: 42CFR416.185]



[Page 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. 416.185  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 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.