[Federal Register: December 20, 1999 (Volume 64, Number 243)]
[Notices]               
[Page 71148-71149]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de99-99]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-3024-NC]
RIN 0938-AH15

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

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice with comment period.

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SUMMARY: This notice announces the requests we have received from 
entities seeking review of the appropriateness of the Medicare payment 
amount for new technology intraocular lenses furnished by Ambulatory 
Surgical Centers (ASCs). Interested parties submitted these requests 
under the provisions of a final rule published June 16, 1999. This rule 
detailed the process for requesting a review of these lenses.

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 January 19, 2000.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services (HHS), Attention: HCFA-3024-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 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 HCFA-3024-NC. 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 443-G of 
the Department's office at 200 Independence Avenue, SW., Washington, 
D.C., on Monday through Friday of each week from 8:30 a.m. to 5 p.m. 
(phone: (202) 690-7890).

FOR FURTHER INFORMATION CONTACT: Claude Mone, (410) 786-5666.

SUPPLEMENTARY INFORMATION: The following application requests have been 
submitted timely to the Health Care Financing Administration for 
review:

[[Page 71149]]

    1. Manufacturer: Alcon Laboratories
    Model Numbers: Acrysof Models MA30BA and MA60BM
    Reason for Requesting Review: The manufacturer states that these 
lenses provide a reduction in the following:
--The rate of Nd:YAG capsulotomy.
--Posterior capsule opacification (PCO) by reduction in lens epithelial 
cells (LECs).
    2. Manufacturer: Allergan
    Model Numbers: AMO Silicone Posterior Chamber with UV Absorber 
Models SI40NB and SI55NB
    Reason for Requesting Review: The manufacturer states that all of 
the following are significantly lower after 2 years of using these 
lenses:
--Visual acuity loss from best postoperative acuity.
--Incidence of Nd:YAG capsulotomy.
--Posterior capsule opacification (PCO) value.
    3. Manufacturer: Allergan
    Model Number: AMO Array Multifocal Model SA40N
    Reason for Requesting Review: The manufacturer states that this 
lens demonstrates all of the following when compared to a monofocal 
lens:
--Improved near visual acuity.
--Increased depth of focus.
--Reduced spectacle usage for bilaterally implanted patients.
    4. Manufacturer: Mentor Corporation (Acquired by CIBA Vision 
Corporation on July 1, 1999)
    Model Numbers: MemoryLens Model Numbers U940A and U940S
    Reason for Requesting Review: The manufacturer states that these 
lenses are the only small incision pre-rolled hydrophilic acrylic 
lenses in today's global market. The manufacturer did not identify any 
specific clinical advantages.
    5. Manufacturer: Pharmacia & Upjohn Company
    Model Numbers: CeeOn Heparin Surface Modified (HSM) Models 720C, 
722C, 726C, 727C, 730C, 734C, 777C, 809C through 815C, and 820C
    Reason for Requesting Review: The manufacturer states that the 
amount of cellular deposits and the number of giant cells are reduced 
with their HSM lenses when compared to non-HSM lenses.
    6. Manufacturer: STAAR Surgical Company
    Model Numbers: Elastic Ultraviolet-Absorbing Silicone Posterior 
Chamber Intraocular Lens with Toric Optic Models AA4203T, AA4203TF, and 
AA4203TL
    Reason for Requesting Review: The manufacturer states that these 
lenses have the following advantages when compared to spherical (only) 
lenses:
--Improved uncorrected visual acuity.
--Decreased refractive cylinder resulting from corneal astigmatism.

    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: December 13, 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 99-32791 Filed 12-17-99; 8:45 am]
BILLING CODE 4120-01-P