[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR416.195]

[Page 681]
 
                         TITLE 42--PUBLIC HEALTH
 
                             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).