[Federal Register Volume 69, Number 141 (Friday, July 23, 2004)]
[Notices]
[Pages 44029-44031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3112-NC2]
RIN 0938-ZA49


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

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with public comment period.

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SUMMARY: This notice with public comment period acknowledges receipt of 
materials submitted by entities requesting review of the 
appropriateness of the Medicare payment amount for new technology 
lenses furnished by Ambulatory Surgical Centers (ASCs). In response to 
the February 27, 2004 Federal Register notice entitled ``Medicare 
Program; Calendar Year 2004 Review of the Appropriateness of Payment 
Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by 
Ambulatory Surgical Centers'' we received a total of three timely 
applications for review by the March 29, 2004 public comment due date. 
Of the three received, one application was withdrawn by the requester. 
In this notice we summarize timely applications received and solicit 
public comments on the two intraocular lenses (IOL) under review.

DATES: To be assured consideration, comments regarding the intraocular 
lenses specified in this notice must be received at one of the 
addresses provided below, no later than 5 p.m. on August 23, 2004.

ADDRESSES: In commenting, please refer to file code CMS-3112-NC2. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments (attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word).
    2. By mail. You may mail written comments (one original and two 
copies) to the following address ONLY: Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Attention: CMS-3112-
NC2, P.O. Box 8010, Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Gay W. Burton, (410) 786-4564.

SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments 
from the public on the appropriateness of the Medicare payment amount 
for new technology intraocular lenses furnished by an ambulatory 
surgical center (ASC) listed in section II of this notice. You can 
assist us by referencing the file code CMS-3112-NC2.
    Inspection of Public Comments: All public comments received before 
the close of the comment period are available for viewing by the 
public, including any personally identifiable or

[[Page 44030]]

confidential business information that is included in a comment. After 
the close of the comment period, we post all electronic comments 
received before the close of the comment period on our public web-site. 
Comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, at the headquarters of the Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 
p.m. To schedule an appointment to view public comments, please 
telephone (410) 786-9994.
    This Federal Register document is 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.gpoaccess.gov/fr/index.html.

I. Regulatory Background

    On October 31, 1994, the Social Security Act Amendments of 1994 
(SSAA 1994) (Pub. L. 103-432) were enacted. Section 141(b) of SSAA 1994 
requires us to develop and implement a process under which interested 
parties may request, for a class of new technology intraocular lens 
(NTIOLs), a review of the appropriateness of the payment amount for 
intraocular lenses (IOLs) furnished by ASCs under section 
1833(i)(2)(A)(iii) of the Social Security Act (the Act).
    On June 16, 1999, we published a final rule in the Federal Register 
entitled ``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. The June 16, 1999 final rule 
established a process for adjusting payment amounts for NTIOLs 
furnished by ASCs; defined the terms relevant to the process; and 
established a flat rate payment adjustment of $50 for IOLs that we 
determine are NTIOLs. The payment adjustment applies for a 5-year 
period that begins when we recognize a payment adjustment for the first 
IOL in a new subset of an existing class of IOLs or a new class of 
technology, as explained below. Any subsequent IOLs with the same 
characteristics as the first IOL recognized for a payment adjustment 
will receive the adjustment for the remainder of the 5-year period 
established by the first recognized IOL. In accordance with the payment 
review process specified in Sec.  416.185(f)(2), after July 16, 2002, 
the $50 adjustment amount can be modified through proposed and final 
rulemaking in connection with ambulatory surgical center services. To 
date however, we made no changes to the payment amount and have opted 
not to change the adjustment for calendar year 2004 (CY 2004).

II. Applications for New Technology Intraocular Lens (NTIOLs) for 
Calendar Year 2004

    On February 27, 2004, we published a notice in the Federal Register 
entitled ``Medicare Program; Calendar Year 2004 Review of the 
Appropriateness of Payment Amounts for New Technology Intraocular 
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (69 
FR 9322) to solicit requests for review of NTIOL applications.
    Three requests for review were submitted to us by the March 29, 
2004 public comment due date. Of the three timely applications 
submitted, one requester withdrew the application. We declined to 
accept an additional request for review, which was received after the 
March 29, 2004 comment due date, and lacked the required supporting 
documentation. We received the following timely review requests:
    1. Manufacturer: Alcon Laboratories, Inc. Model Numbers: 
ACRYSOF[reg] Natural IOL; Models: SB30AL and SN60AT.
    Reason for Requesting Review: The manufacturer, Alcon Laboratories, 
Inc. indicates that the specified lenses are the first FDA-approved 
IOLs that filter light in a manner that approximates the human 
crystalline lens in the 400 to 475 blue light wavelength range, 
thereby, mitigating the risk of blue light-mediated damage to the 
retina and may be considered as providing more stable postoperative 
vision.
    2. Manufacturer: Pharmacia & Upjohn Co. (A Subsidiary of Pfizer 
Inc.) Model Numbers: Tecnis[reg], with Z-Sharp Optic Technology, 
Foldable Posterior Chamber IOL; Models Z9000 and Z9001.
    Reason for Requesting Review: The manufacturer, Pharmacia & Upjohn 
Co. indicates that these lenses are the first FDA-approved IOLs to use 
a modified prolate anterior optic surface in place of a conventional 
spherical optic. The manufacturer has also indicated that the 
Technis[reg] lens has demonstrated a significant reduction of ocular 
spherical aberration resulting in improved functional vision, 
particularly in low light conditions such as night driving, compared to 
conventional spherical optic IOLs.

III. Collection of Information Requirements

    Because the requirements referenced in this notice will not affect 
10 or more persons on an annual basis, this notice does not impose any 
information collection and record keeping requirements that are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble of that document.

V. Regulatory Impact Statement

    We have examined the impacts of this notice as required by 
Executive Order 12866 (September 1993, Regulatory Planning and Review), 
the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-
354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 
1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866, (as amended by Executive Order 13258, which 
merely reassigns responsibility of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We have determined that this notice is not a major rule because it 
merely summarizes the timely applications received and solicits 
comments on IOLs under review.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and government agencies. 
Most hospitals and most other providers and suppliers are small 
entities, either by nonprofit status or by having revenues of $8.5 
million or less in any 1 year. We have determined that this notice will 
not affect small businesses.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a regulation may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. This analysis must conform to

[[Page 44031]]

the provisions of section 603 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area and has fewer 
than 100 beds. We have determined that this notice does not have a 
significant impact on the operations of a substantial number of small 
rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in an expenditure in any 1 year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million. We have determined that this notice 
will not have a consequential effect on the governments mentioned or on 
the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State, 
local, or tribal governments, preempts State law, or otherwise has 
Federalism implications. We have determined that this notice does not 
have an economic impact on State, local, or tribal governments.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

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

    Dated: July 13, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-16659 Filed 7-22-04; 8:45 am]
BILLING CODE 4120-01-P