02-4354. 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.

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, [phone].

SUPPLEMENTARY INFORMATION:

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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 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 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.