[Federal Register Volume 66, Number 208 (Friday, October 26, 2001)]
[Notices]
[Pages 54261-54262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26036]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3061-NC]
RIN 0938-AH15


Medicare Program; Adjustment in Payment Amounts for New 
Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers

AGENCY: Centers for Medicare & Medicaid Services (CMS), formerly the 
Health Care Financing Administration (HCFA), HHS.

ACTION: Notice with comment period.

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SUMMARY: This notice announces the request we received from Alcon 
Laboratories seeking review of the appropriateness of the Medicare 
payment amount for new technology intraocular lenses furnished by an 
ambulatory surgical center. This document also announces the 30-day 
period for the public to comment on the appropriateness or the payment 
amount of the IOL for which a review was requested.

DATES: We will consider comments regarding the lenses listed in this 
notice if we receive them at the appropriate address, as provided 
below, no later than 5 p.m. on November 26, 2001.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Centers for Medicare & Medicaid Services, Department 
of Health and Human Services (HHS), Attention: CMS-3061-NC, P.O. Box 
8017, Baltimore, MD 21244-8017.
    If you prefer, you may deliver your written comments (1 original 
and 3 copies) to one of the following addresses: Room 443-G, Hubert H. 
Humphrey Building, 200 Independence Avenue, SW., Washington, DC, 20201, 
or Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, Maryland 
21244.
    Because of the staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code CMS-3061-NC. For information on viewing public comments, 
see the beginning of the SUPPLEMENTARY INFORMATION section.

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

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments:
    Comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, in Room C5-14-03 of the Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD, on Monday 
through Friday of each week from 8:30 a.m. to 5 p.m. (Phone (410) 786-
7195 or (410) 786-7201.)
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Government Printing Office. The Web site address is: http://www.access.gpo.gov/nara/index.html.

I. Background

    On June 16, 1999, we published a final rule in the Federal Register 
titled ``Adjustment in Payment Amounts for New Technology Intraocular 
Lenses Furnished by Ambulatory Surgical Centers' (64 FR 32198), which 
added subpart F to 42 CFR part 416.
    In accordance with the June 16, 1999 final rule, we published a 
notice in the Federal Register, titled ``Annual Review of the 
Appropriateness of Payment Amounts for New Technology Intraocular 
Lenses Furnished by Ambulatory Surgical'' (66 FR 18959) on April 12, 
2001. In this notice, we solicited interested parties to submit 
requests for review of the appropriateness of the payment amount with 
regard to a particular intraocular lens.

II. Provisions of this Notice

    On May 16, 2001, the following request was submitted to the Centers 
for Medicare & Medicaid Services for review:
    Manufacturer: Alcon Laboratories.
    Model Numbers: ACRYSOF  Acrylic Foldable Sterile UV-
Absorbing Multipiece Posterior Chamber Lenses, Models MA30BA ,MA60BM, 
MA50BM, MA60MA, MA30AC, MA60AC.
    Reason for Requesting Review: The manufacturer states that these 
lenses provide the following:

--Reduced risk of intra- or post-operative complications or trauma by a 
reduction in the area of lens epithelial cells (LEC), a major 
contributor to posterior capsule opacification (PCO) when compared with 
silicone and PMMA lenses, as evidenced by reduced Sommering's Ring 
scores.
--Ability to fold smaller, requiring a smaller incision than required 
for PMMA lenses, inducing less astigmatism thereby promoting 
accelerated postoperative recovery. Smaller size allows the lens to be 
easily explanted through the original incision.
--Reduced induced astigmatism because the lens can be inserted into the 
anterior ocular chamber with an average incision size of 3.5mm.
--Improved postoperative visual acuity due to their findings that the 
loss of visual acuity associated with

[[Page 54262]]

biocompatibility and inflammatory response was statistically 
significantly greater in patients with polymethylmethacrylate (PMMA) as 
compared to silicone or ACRYSOF lenses.
--More stable postoperative vision by reducing need for Nd:YAG 
capsulotomy. There is a difference in ND:YAG capsulotomy rates between 
ACRYSOF and a similar designed PMMA lens but not between 
ACRYSOF and a silicone lens.
--A high refractive index material that allows the thinner 
ACRYSOF lens to impart the same optical correction as a 
comparable diopter silicone or PMMA IOL.
--A clinical advantage for diabetic patients requiring posterior 
segment surgery to manage visual problems related to condensation and 
silicone oil. ACRYSOF Lens allows removal of silicone oil 
with relative ease.
--A clinical advantage for pediatric and uveitic patients due to the 
combination of foldability and size of the ACRYSOF lens.
--A decrease in anterior capsule movement when compared to similarly 
designed silicone PMMA lenses.

    This notice solicits comments on the appropriateness of the payment 
amount for the IOL for which a review was requested.

    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 
13951(i)(2)(A)).

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

    Dated: September 25, 2001.
Thomas A Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-26036 Filed 10-25-01; 8:45 am]
BILLING CODE 4120-01-P