[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: 42CFR416.195]



[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. 416.195  A request to review.



    (a) Content of a request. The request must include all of the 

following information:

    (1) The name of the manufacturer, the model number, and the trade 

name of the IOL.

    (2) A copy of the FDA's summary of the IOL's safety and 

effectiveness.

    (3) A copy of the labeling claims of specific clinical advantages 

approved by the FDA for the IOL.

    (4) A copy of the IOL's original FDA approval notification.

    (5) Reports of modifications made after the original FDA approval.

    (6) Other information that CMS finds necessary for identification of 

the IOL.

    (b) Confidential information. To the extent that information 

received from an IOL manufacturer can reasonably be characterized as a 

trade secret or as privileged or confidential commercial or financial 

information, CMS maintains the confidentiality of the information and 

protects it from disclosure not otherwise authorized or required by 

Federal law as allowed under Exemption 4 of the Freedom of Information 

Act (5 U.S.C. 552(b)(4)) and, with respect to trade secrets, the Trade 

Secrets Act (18 U.S.C. 1905).



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