[Federal Register: July 23, 2004 (Volume 69, Number 141)]
[Notices]
[Page 44029-44031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy04-73]
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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Of the three received, one application was withdrawn by the requester.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
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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
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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