42 C.F.R. Subpart F—Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers
Title 42 - Public Health
Source: 64 FR 32205, June 16, 1999, unless otherwise noted.
As used in this subpart, the following definitions apply: Class of new technology intraocular lenses (IOLs) means all of the IOLs, collectively, that CMS determines meet the definition of “new technology IOL” under the provisions of this subpart. Interested party means any individual, partnership, corporation, association, society, scientific or academic establishment, professional or trade organization, or any other legal entity. New technology IOL means an IOL that CMS determines has been approved by the FDA for use in labeling and advertising the IOL's claims of specific clinical advantages and superiority over existing IOLs with regard to reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages. New technology subset means a group of IOLs that CMS determines meet the criterion for being treated as new technology IOLs and that share a common feature or features that distinguish them from other IOLs. For example, all new technology IOLs that are made of a particular bioengineered material could comprise one subset, while all that rely on a particular optical innovation could comprise another. (a) CMS publishes a (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 (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 (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 (i) Payment adjustments are effective beginning 30 days after the publication of CMS's determinations in the Any party who is able to furnish the information required in §416.195 may request that CMS review the appropriateness of the payment amount provided under section 1833(i)(2)(A)(iii) of the Act with respect to an IOL that meets the definition of a new technology IOL in §416.180. (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). (a) CMS recognizes the IOL(s) that define a new technology subset for purposes of this subpart as belonging to the class of new technology IOLs for a period of 5 years effective from the date that CMS recognizes the first new technology IOL for a payment adjustment. (b) Any IOL that CMS subsequently recognizes as belonging to a new technology subset receives the new technology payment adjustment for the remainder of the 5-year period established with CMS's recognition of the first IOL in the subset. (c) Beginning 5 years after the effective date of CMS's initial recognition of a new technology subset, payment adjustments cease for all IOLs that CMS designates as belonging to that subset and payment reverts to the standard payment rate set under section 1833(i)(2)(A)(iii) of the Act for IOL insertion procedures performed in ASCs. (d) ASCs that furnish an IOL designated by CMS as belonging to the class of new technology IOLs must submit claims using specific billing codes to receive the new technology IOL payment adjustment.
Title 42: Public Health
PART 416—AMBULATORY SURGICAL SERVICES
Subpart F—Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers
§ 416.180 Definitions.
§ 416.185 Payment review process.
§ 416.190 Who may request a review.
§ 416.195 A request to review.
§ 416.200 Application of the payment adjustment.
