[Federal Register Volume 65, Number 86 (Wednesday, May 3, 2000)]
[Notices]
[Pages 25738-25740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-3030-N]
RIN 0938-AH15


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.

[[Page 25739]]


ACTION: Notice.

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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, (410) 786-6939.

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

[[Page 25740]]

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.
[FR Doc. 00-10970 Filed 5-2-00; 8:45 am]
BILLING CODE 4120-01-P