---
kind: "section"
citation: "42 C.F.R. § 416.195"
title: "42"
number: "416.195"
heading: "Determination of membership in new classes of new technology IOLs."
url: "https://uscodex.org/cfr/42/416.195"
---

# §416.195. Determination of membership in new classes of new technology IOLs.

- (a) **Factors to be considered.** CMS uses the following criteria to determine whether an IOL qualifies for a payment adjustment as a member of a new class of new technology IOLs when inserted at an ASC:
  - (1) **The IOL is considered new.** CMS will evaluate an application for a new technology IOL only if the IOL type has received initial FDA premarket approval within the 3 years prior to the new technology IOL application submission date.
  - (2) The IOL shall have a new lens characteristic in comparison to currently available IOLs. The labeling, which must be approved by FDA, shall contain a claim of a specific clinical benefit imparted by the new lens characteristic.
  - (3) The IOL is not described by an active or expired class of new technology IOLs; that is, it does not share a predominant, class-defining characteristic associated with improved clinical outcomes with members of an active or expired class.
  - (4) Any specific clinical benefit referred to in [paragraph (a)(2)](#a-2) of this section must be supported by evidence that demonstrates that the IOL results in a measurable, clinically meaningful, improved outcome. Improved outcomes include:
    - (i) Reduced risk of intraoperative or postoperative complication or trauma;
    - (ii) Accelerated postoperative recovery;
    - (iii) Reduced induced astigmatism;
    - (iv) Improved postoperative visual acuity;
    - (v) More stable postoperative vision;
    - (vi) **Other comparable clinical advantages.**
- (b) **CMS determination of eligibility for payment adjustment.** CMS reviews the information submitted with a completed request for review, public comments submitted timely, and other pertinent information and makes a determination as follows:
  - (1) **The IOL is eligible for a payment adjustment as a member of a new class of new technology IOLs.**
  - (2) The IOL is a member of an active class of new technology IOLs and is eligible for a payment adjustment for the remainder of the period established for that class.
  - (3) The IOL does not meet the criteria for designation as a new technology IOL and a payment adjustment is not appropriate.

## Notes

### Amendments

[71 FR 68226, Nov. 24, 2006, as amended at 77 FR 68558, Nov. 15, 2012; 80 FR 70604, Nov. 13, 2015]

### Source

Source: 71 FR 68226, Nov. 24, 2006, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.

### Source

Source: 47 FR 34094, Aug. 5, 1982, unless otherwise noted.

### Amendments

[71 FR 68226, Nov. 24, 2006, as amended at 77 FR 68558, Nov. 15, 2012; 80 FR 70604, Nov. 13, 2015]