TITLE 42 - PUBLIC HEALTH

CHAPTER IV - CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - MEDICARE PROGRAM

PART 416 - AMBULATORY SURGICAL SERVICES

subpart f - ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY INTRAOCULAR LENSES FURNISHED BY AMBULATORY SURGICAL CENTERS

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).