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

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