[Federal Register Volume 67, Number 36 (Friday, February 22, 2002)]
[Notices]
[Pages 8270-8272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3061-FN]
RIN: 0938-AH15


Medicare Program; Disapproval of Alcon Laboratories' Request for 
an Adjustment in Payment Amounts for New Technology Intraocular Lenses 
Furnished by Ambulatory Surgical Centers

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our disapproval of Alcon 
Laboratories' request for a $50 adjustment in payment amount for lenses 
reviewed for determination as a new technology intraocular lens 
(NTIOL).

FOR FURTHER INFORMATION CONTACT: Betty Shaw, (410) 786-6100.

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I. Background

    In our regulations at 42 CFR part 416, subpart F, we describe the 
process an interested party must use to request that

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we review the appropriateness of the payment amount for a new 
technology intraocular lens (NTIOL) furnished by ambulatory surgical 
centers (ASCs). On October 26, 2001, we published a notice with comment 
period in the Federal Register (66 FR 54261) listing the lenses for 
which we had received requests for a review for payment adjustment. We 
received only one request, on May 16, 2001 from Alcon Laboratories for 
its Acrysof lenses MA30BA, MA60BM, MA50BM, MA60MA, MA30AC, and MA60AC. 
Alcon Laboratories claimed these lenses provide a reduction in the rate 
of Nd:YAG capsulotomy and posterior capsule opacification (PCO). MA30BA 
and MA60BM were previously submitted in 1999 and we subsequently 
determined that these lenses did not demonstrate clinical advantages 
over existing lenses with respect to reduction in Nd:YAG capsulotomy 
and reduced posterior capsule opacification by reduction in lens 
epithelial cells (LECs) (65 FR 25738, 25739).
    In accordance with our NTIOL procedures, we asked the Food and Drug 
Administration (FDA) to review Alcon's new request to determine whether 
the claims of specific clinical advantage and superiority over existing 
intraocular lenses (IOLs) had been approved for labeling and 
advertising purposes. Our regulations require FDA's approval of its 
claims for advertising and labeling in order for an IOL to be 
classified as an NTIOL. The FDA conveyed its analysis of the lenses to 
CMS in an August 16, 2001 memorandum.
    The FDA determined that the Acrysof lenses did not demonstrate 
clinical superiority over a representative sample of lenses outside the 
new class with respect to a reduced rate of Nd:YAG capsulotomy and PCO. 
Alcon Laboratories provided articles that could arguably support 
clinical advantages over a particular silicone IOL. However, Alcon 
Laboratories' FDA approved labeling states that there were no 
differences in Nd:YAG rate between the Acrysof lens and the silicone 
IOL studied.

II. Analysis of and Responses to Public Comments

    We also received 20 comments in response to the notice listing the 
lenses requesting a review. Of these, 17 were from ophthalmologists. 
The other three comments were from one public interest group and two 
competing manufacturers of IOLs.
    Comment: Seventeen of the commenters supported the Alcon 
Laboratories Acrysof lenses announced in the notice. All of these 
commenters were practicing ophthalmologists. The comments received were 
testimonials of support based on the commenters' experiences with the 
Acrysof lenses. Commenters stated that the lenses reduced formation and 
migration of lens epithelial cells (LECs), and that there is a lower 
incidence of PCO, thus reducing Nd:YAG laser capsulotomy rates. The 
commenters also stated that the Acrysof lens unfolded more predictably, 
and with less force, thereby reducing the risk of inadvertent 
malpositioning of the lens.
    Response: We appreciate the commenters' testimonials with regard to 
intra-operative and post-operative experiences with the Acrysof lenses. 
However, testimonials are substantially less reliable than published 
clinical data in deciding whether a lens has specific clinical 
advantages and superiority over existing lenses in order to be 
considered an NTIOL.
    Comment: One commenter stated that claims that Acrysof lenses are 
superior to polyacrylic or second-generation silicone IOLs are not 
supported by published data.
    Response: We agree with the commenter.
    Comment: One commenter indicated that more recent studies report 
lower incidences of PCO with silicone IOLs than earlier reports, 
leading to a recent decrease in Nd:YAG laser capsulotomy rates. The 
commenter noted that the decrease was attributed to improvements in 
surgical technique rather than improvements in lens material or design.
    Response: The manufacturer of these lenses has not demonstrated 
clinical advantages and superiority over existing lenses, as the 
regulations require.

III. Criteria for Determination

    We evaluate requests for the designation of an IOL as an NTIOL by 
using the following criteria:
    (1) Has the requestor identified the new class of IOLs to which its 
lens belongs based on a type of material and/or predominant 
characteristic that it does not share with lenses outside of the new 
class?
    (2) Has the requestor demonstrated that its lens is clinically 
superior to a representative sample of lenses outside of the new class? 
Clinical superiority includes reducing the risk of intraoperative or 
postoperative complication or trauma, or demonstrating accelerated 
postoperative recovery, reduced induced astigmatism, improved 
postoperative visual acuity, more stable postoperative vision, or other 
comparable clinical advantages.
    (3) Has the requestor demonstrated that the clinical superiority is 
produced by the material and/or predominant characteristic that defines 
the new class?
    (4) Has the FDA approved the claim of clinical superiority for 
labeling and advertising?

IV. Decision

    In determining which lenses meet the criteria and definition of an 
NTIOL, we relied on the clinical data and evidence submitted to us by 
Alcon Laboratories, public comments, and the FDA's approval of Alcon's 
claims. We independently reached the same decision as the FDA.
    In regard to the first criterion, it is appears that Alcon is 
claiming that the Acrysof lenses are a new class because of outcomes 
resulting in reduced LEC migration and reduced incidence of Nd:YAG 
posterior capsulotomy. However, the criterion specifically states that 
a new class must be based on a material and/or predominant 
characteristic. CMS asserts that ``predominant characteristic,'' like 
material characteristic, would be some physical property of the lens, 
and that it would be this material or predominant characteristic that 
would lead to the outcome benefit. Alcon did not define the material 
and/or predominant characteristic of the Acrysof lenses that would 
constitute a new technology class.
    The second criterion in Section III of this notice states that the 
lens must be shown superior to a representative sample of lenses 
outside of this new class. Not only did Alcon fail to define what the 
new class is for Acrysof, it also did not provide a systematic 
comparison of the lens to other IOLs. For example, if Alcon identified 
Acrysof as a new class of foldables, then a comparison of Acrysof to 
all foldables would be an example of one systematic comparison.
    The third criterion states that the clinical superiority seen is 
produced by the new material and/or predominant characteristic that 
defined the new class. As stated above, there was no definitive 
demonstration that a new class was achieved, nor was there a thorough, 
systematic comparison of said new class lens to other lenses outside 
the class. Thus, Alcon failed to meet this third criterion.
    The fourth criterion states that the lens in question must have 
received FDA approval for the claimed superiority. The FDA did approve 
Acrysof's claims of superiority in reduced LEC migration and reduced 
incidence of Nd:YAG posterior

[[Page 8272]]

capsulotomy as compared to one similarly designed PMMA IOL (PMMA is the 
only type of non-foldable IOL currently being distributed). However, 
the FDA has not approved a claim that Acrysof is superior to all non-
foldable lenses or to any other type of foldable lens. Therefore, Alcon 
has not met criterion four. We conclude that the Acrysof lenses 
described in this notice are not NTIOLs, and, therefore, not eligible 
for the additional $50 payment.

    Authority: Sections 1832 (a)(2)(F)(i) and 1833(i)(2)(A) of the 
Social Security Act (42 U.S.C. 1395k(a)(2)(F)(i) and 1395l(i)(2)(A).

(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare-
Hospital Insurance Program; and No. 93.774, Medicare-Supplementary 
Medical Insurance Program)

    Dated: January 20, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-4354 Filed 2-21-02; 8:45 am]
BILLING CODE 4120-01-P