42 C.F.R. § 416.180 – Basis and scope.

(a) Basis. This subpart implements section 141 of Public Law 103-432, which provides for adjustments to payment amounts for new technology intraocular lenses (IOLs) furnished at ambulatory surgical centers (ASCs).
(b) Scope. This subpart sets forth—
1. (1) The process for interested parties to request that CMS review the appropriateness of the ASC facility fee for insertion of an IOL. This process includes a review of whether that payment is reasonable and related to the cost of acquiring a lens determined by CMS as belonging to a class of new technology IOLs;
2. (2) Factors that CMS considers for determination of a new class of new technology IOLs; and
3. (3) Application of the payment adjustment.