01-26036. 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.

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, [phone].

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 [phone] or [phone].)

Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at [phone] (or toll-free at 1-888-293-6498) or by faxing to [phone]. The cost for each copy is $9. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the Federal Register.

This Federal Register document is also available from the Federal Register online database through GPO Access, a service of the U.S. 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 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.