00-10970. Medicare Program; Lenses Eligible for an Adjustment in Payment Amount for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers

AGENCY:

Health Care Financing Administration (HCFA), HHS.

ACTION:

Notice.

SUMMARY:

This notice announces the lenses that we have determined meet the criteria and definition of a new technology intraocular lens (NTIOL). These lenses are eligible for a payment adjustment of $ 50 when furnished by an ambulatory surgical center (ASC).

DATES:

Effective date of this notice: May 18, 2000.

Expiration date of this notice: May 18, 2005.

FOR FURTHER INFORMATION CONTACT:

Mary Stojak, [phone].

SUPPLEMENTARY INFORMATION:

Background

In our regulations at 42 CFR Part 416, Subpart F, we describe the process an interested party may use to request that we review the appropriateness of the payment amount for NTIOLs furnished by ASCs. On December 20, 1999, we published a notice with comment period (64 FR 71148) listing lenses for which we had received requests for a review for payment adjustment. In accordance with those regulations, we asked the FDA to review the requests to determine whether the claims of specific clinical advantage and superiority over existing intraocular lenses had been approved for labeling and advertising purposes. HCFA uses only FDA's labeling review to determine if lenses meet the NTIOL criteria. FDA conveyed their analysis of the lenses to HCFA in a December 22, 1999 memorandum. Based on that information, HCFA determined that two of the lenses met the NTIOL criteria, but four did not. The approved lenses and model numbers are listed in the “Lenses Eligible for the Payment Adjustment” section of this notice.

The following lenses that were considered for payment adjustment did not meet our criteria for NTIOLs:

(1) Alcon, manufacturer of Acrysof Models MA30BA and MA60BM, claimed these lenses provide a reduction in the rate of Nd:YAG capsulotomy and posterior capsule opacification. The FDA determined that these lenses did not demonstrate clinical advantages over existing lenses with respect to the claims made by the manufacturer.

(2) Allergan, manufacturer of AMO Silicone Posterior Chamber Models SI40NB and SI55NB, claimed the rate of Nd:YAG capsulotomy and posterior capsule opacification were lower after two years. The FDA determined that these lenses did not demonstrate clinical advantages over existing lenses for the claims made by the manufacturer.

(3) CIBA Vision Corporation, manufacturer of MemoryLens Models U940A and U940S, claimed that these lenses are the only small incision pre-rolled hydrophylic acrylic lenses in today's global market. They did not identify any specific clinical advantages. Based on their labeling claims, the FDA has determined that these lenses did not demonstrate any specific clinical advantages over existing lenses.

(4) Pharmacia and Upjohn, manufacturer of CeeOn Heparin Surface Modified Models 720C, 722C, 726C, 727C, 730C, 734C, 777C, 809C through 815C, and 820C, claimed that the amount of cellular deposits and the number of giant cells are reduced with their lenses. The FDA determined that these lenses did not demonstrate a clinical advantage over other approved IOLs.

We received 110 comments in response to the notice listing the lenses requesting a review. Of these, the majority were from ophthalmologists. The remainder of the comments were from professional organizations, ambulatory surgical centers, and one manufacturer of intraocular lenses.

Analysis of, and Responses to, Public Comments on Lenses Requesting Review for an Adjustment in Payment Amount

Comment: Over 100 of the comments received were testimonials in support of one or more of the lenses announced in the notice. The support was based on experience the commenters have had with a lens or lenses. A summary of these comments follow: 80 commenters supported the Alcon Acrysof lens, 29 commenters supported the Allergan Array Multifocal lens, 3 commenters supported the Pharmacia & Upjohn CeeOn lens, 3 commenters supported the STAAR Surgical Toric Optic lens, 1 commenter supported the Allergan AMO Silicone Posterior Chamber lens, and 3 commenters supported all of the lenses. These commenters suggested that these lenses be classified as new technology intraocular lenses, and, therefore, be eligible for the payment adjustment.

Response: We appreciate the commenters' interests in these lenses, and are pleased that these lenses have improved the quality of life of Medicare beneficiaries. Regulations at 42 CFR 416.180 require the FDA to determine whether the lens has specific clinical advantages and superiority over existing intraocular lenses. Testimonials that support the claims of an intraocular lens to be considered an NTIOL cannot substitute for the FDA's approval. The FDA must rely on published clinical data to decide that a lens has specific clinical advantages and superiority over existing lenses in order to be considered an NTIOL.

Comment: Two commenters made reference to the payment adjustment for intraocular lenses and the need to implement the payment process in a timely manner.

Response: Payment issues are outlined in our regulations at 42 CFR 416.185. This section codifies the payment amount, and describes the time frame for implementation of the payment adjustment. The effective date of the payment adjustment is 30 days after the publication of this notice, which must be published within 90 days of the end of the comment period of the notice listing the lenses requesting review. Since the Federal Register notice listing the requests was published on December 20, 1999 (64 FR 71148), the effective date of the payment adjustments can be no later than May 18, 2000. Retroactive payment adjustments will be made, if necessary.

Comment: One commenter suggested that the manufacturers of the Alcon Acrysof lens and the Allergan AMO Posterior Chamber lens should not be able to claim that their lenses are superior to existing intraocular lenses in the rate of Nd:YAG capsulotomy. The commenter claims that the studies performed by these manufacturers showed only that their lenses were superior to one particular model.

Response: The manufacturers of these lenses have not demonstrated clinical advantages and superiority over existing lenses, as the regulations require.

Lenses Eligible for the Payment Adjustment

In determining which lenses meet the criteria and definition of an NTIOL, we relied on the clinical data and evidence submitted to the FDA by the various manufacturers, demonstrating that these lenses have specific clinical advantages and superiority over existing lenses. These claims must be approved by the FDA for use in advertising and labeling. The lenses eligible for a payment adjustment are identified by a characteristic or subset of an NTIOL. The payment adjustment is effective for 5 years from the effective date of this notice. Any subsequent NTIOL with the same characteristic, and determined to be eligible for a payment adjustment, will receive the payment adjustment for the remainder of the 5 year period. Based on the FDA's approval process as required by our regulations, the following lenses are eligible for a payment adjustment of $50 when furnished by an ambulatory surgical center:

Manufacturer: Allergan

Lens and Model Number: AMO Array Multifocal Model SA40N

Characteristic: Multifocal

Procedure Code: Q1001—NTIOL Category 1

Manufacturer: STAAR Surgical Company

Lens and Model Numbers: Elastic Ultraviolet-Absorbing Silicone Posterior Chamber

Intraocular Lens with Toric Optic Models AA4203T, AA4203TF, and AA4203TL

Characteristic: Reduction in Preexisting Astigmatism

Procedure Code: Q1002— NTIOL Category 2

Payment Adjustments made to ASCs

Payment adjustments made to ASCs that provide these lenses will be effective on May 18, 2000 and continue until May 18, 2005.

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. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: April 11, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration.