Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs), 30731-30733 [05-10760]
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review. We
are requesting an emergency review
because the collection of this
information is needed before the
expiration of the normal time limits
under OMB’s regulations at 5 CFR part
1320. This is necessary to ensure
compliance with an initiative of the
Administration. We cannot reasonably
comply with the normal clearance
procedures. The use of normal clearance
procedures is reasonably likely to cause
a statutory deadline to be missed.
This survey will support the required
evaluation of the Medicare Home Health
Independence Demonstration mandated
under Section 702 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA).
Section 702 of the MMA requires the
Secretary to collect data on effects of the
demonstration on quality of care,
patient outcomes, and any additional
costs to Medicare. One year after the
project’s termination (currently
projected to be October, 2006), the
Secretary is to submit a report including
recommendations to exempt
permanently and severely disabled
homebound beneficiaries from the
traditional homebound restrictions. The
purpose of this survey is to develop the
information Congress seeks, and to
provide CMS with a sound basis for
making the mandated
recommendations. This survey is
designed to study the health and quality
of life impacts of changing the eligibility
requirement, and to provide descriptive
information about the demonstration’s
target population.
CMS is requesting OMB review and
approval of this collection by June 27,
2005, with a 180-day approval period.
Written comments and recommendation
will be accepted from the public if
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received by the individuals designated
below by June 27, 2005.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
regulations/pra or e-mail your request,
including your address, phone number,
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
mailed and/or faxed to the designees
referenced below by June 27, 2005:
Centers for Medicare and Medicaid
Services, Office of Strategic
Operations and Regulatory Affairs,
Room C5–13–27, 7500 Security
Boulevard, Baltimore, MD 21244–
1850. Fax Number: (410) 786–0262,
Attn: William N. Parham, III, CMS–
10158; and,
OMB Human Resources and Housing
Branch, Attention: Christopher
Martin, New Executive Office
Building, Room 10235, Washington,
DC 20503.
Dated: May 23, 2005.
Michelle Shortt,
Acting Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 05–10706 Filed 5–25–05; 9:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3144–N]
RIN 0938–ZA49
Medicare Program; Calendar Year 2005
Review of the Appropriateness of
Payment Amounts for New Technology
Intraocular Lenses (NTIOLs) Furnished
by Ambulatory Surgical Centers
(ASCs)
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice solicits interested
parties to submit requests for review of
the appropriateness of the payment
amount for a particular intraocular lens
PO 00000
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Fmt 4703
Sfmt 4703
30731
furnished by an ambulatory surgical
center.
DATES: Requests for review must be
received at the address provided no
later than 5 pm E.S.T. on June 27, 2005.
ADDRESSES: Mail requests for review
(one original and three copies) to the
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: Michael
Lyman, Mailstop C1–09–06, 7500
Security Blvd., Baltimore, Maryland
21244–1850.
FOR FURTHER INFORMATION CONTACT:
Michael Lyman, (410) 786–6938.
SUPPLEMENTARY INFORMATION: On
October 31, 1994, the Social Security
Act Amendments of 1994 (SSAA 1994)
(Pub. L. 103–432) were enacted. Section
141(b)(1) of SSAA 1994 required us to
develop and implement a process under
which interested parties may request a
review of the appropriateness of the
payment amount for intraocular lenses
(IOLs) furnished by ambulatory surgical
centers (ASCs) under section
1833(i)(2)(A)(iii) of the Social Security
Act (the Act) on the basis that those
lenses constitute a class of new
technology intraocular lenses (NTIOLs).
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 ambulatory surgical centers (ASCs);
defined the terms relevant to the
process; and established an initial 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 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
NTIOL. After July 16, 2002, we have the
option of changing the $50 adjustment
amount through proposed and final
rulemaking in connection with
ambulatory surgical center services. We
have opted not to change the adjustment
amount for calendar year 2005 (CY 05).
Review Process for Establishing Classes
of New Technology Intraocular Lenses
(NTIOLs)
We will classify an IOL as a NTIOL if
the lens meets the definition of a ‘‘new
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices
technology IOL’’ in 42 CFR 416.180,
which incorporates section 141(b)(2) of
SSAA 1994. Under that section, a ‘‘new
technology IOL’’ is defined as ‘‘an IOL
that CMS determines has been approved
by the Food and Drug Administration
(FDA) for use in labeling and
advertising the IOL’s claims of specific
clinical advantages and superiority over
existing IOLs with regard to reduced
risk of intraoperative or postoperative
complication or trauma, accelerated
postoperative recovery, reduced
induced astigmatism, improved
postoperative visual acuity, more stable
postoperative vision, or other
comparable clinical advantages.’’
We evaluate requests for the
designation of an IOL as an NTIOL by
doing the following:
(1) Publishing a public notice in the
Federal Register that identifies the
requirements and deadline for
submitting a request for a review of the
appropriateness of the payment amount
for an IOL.
(2) Processing requests to review the
appropriateness of the payment amount
for an IOL.
(3) Compiling a list of the requests we
receive that identify the IOL
manufacturer, IOL model number under
review, name of the requester, and a
summary of the request for review of the
appropriateness of the IOL payment
amount.
(4) Publishing an annual public notice
in the Federal Register that lists the
requests and provides the public with
30 days to submit comments on the
IOLs for which a review was requested.
(5) Reviewing the information
submitted with the applicant’s request
for review, and requesting confirmation
from the FDA about labeling
applications that have been approved on
the IOL model under review. We also
request FDA’s recommendations as to
whether or not the IOL model submitted
represents a new class of technology
that sets it apart from other IOLs.
(6) Determining which lenses meet
the criteria to qualify for the payment
adjustment based on clinical data and
evidence submitted for review, the
FDA’s analysis, public comments on the
lenses, and other available information.
NTIOL applicants should provide good
evidence-based studies supporting the
claimed clinical benefits. We are
interested in receiving data showing
functional clinical improvements, as
opposed to improvements that have
statistical significance without
functional clinical significance.
(7) Designating a type of material or
a predominant characteristic of an
NTIOL that sets it apart from other IOLs
to establish a new class.
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16:42 May 26, 2005
Jkt 205001
(8) Publishing a notice in the Federal
Register (within 90 days after we
publish the notice identified in
paragraph (4) of this section) that
announces the IOLs that we have
determined are ‘‘new technology’’ IOLs.
These NTIOLs qualify for a $50 (or other
amount that we may adopt through
notice and comment rulemaking)
payment adjustment for a 5-year period.
(9) Adjusting payments effective 30
days after the publication of the final
notice announcing our determinations
described in paragraph (8) of this
section.
Who May Request a Review
As specified in § 416.190, any party
who is able to furnish the information
required in § 416.195 may request that
we review the appropriateness of the
payment amount provided under
§ 1833(i)(2)(A)(iii) of the Act for an IOL
that, as claimed by the party, meets the
definition of a new technology IOL in
§ 416.180.
Requests To Review
As specified in § 416.195(a), a request
to review must include all of the
following information:
• The name of the manufacturer, the
model number, and the trade name of
the IOL.
• A copy of the FDA’s summary of
the IOL’s safety and effectiveness.
• A copy of the labeling claims of
specific clinical advantages approved by
the FDA for the IOL.
• A copy of the IOL’s original FDA
approval notification.
• Reports of modifications made after
the original FDA approval.
• Other information that supports the
requestor’s claim (including clinical
trials, case studies, journal articles, etc.).
Privileged or Confidential Information
To the extent that information
received from an IOL manufacturer can
reasonably be characterized as a trade
secret or as privileged or confidential
commercial or financial information,
§ 416.195(b) requires that we maintain
the confidentiality of the information
and protect it from disclosure not
otherwise authorized or required by
Federal law as allowed under
Exemption 4 of the Freedom of
Information Act (5 U.S.C. 552(b)(4)) and,
with respect to trade secrets, the Trade
Secrets Act (18 U.S.C. 1905). We
recommend that the requestor clearly
identify all information that is to be
characterized as confidential.
Application of the Payment Adjustment
As provided in § 416.200, we
recognize all IOL(s) that meet the
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Frm 00058
Fmt 4703
Sfmt 4703
definition of a new technology IOL for
purposes of subpart F of part 416 as
belonging to a class of NTIOLs for a
period of 5 years effective from the date
that we recognize the first NTIOL in that
subset. Any IOL that we subsequently
recognize as belonging to a new
technology subset receives the new
technology payment adjustment for the
remainder of the 5-year period
established with our recognition of the
first NTIOL in the subset. Beginning 5
years after the effective date of our
initial recognition of a new technology
subset, the payment adjustment ceases
for all IOLs that we have designated as
belonging to that subset.
I. Provisions of This Notice
Under our rules at 42 CFR part 416,
subpart F, we are soliciting requests for
review of the appropriateness of the
payment amount for IOLs furnished by
an ASC. Requests for review must
comply with our regulations at
§ 416.195 and be received at the address
provided by the date specified in the
DATES section of this notice. We will
announce timely requests for review in
a subsequent notice that will allow for
public comment. Currently, if we
determine that an intraocular lens meets
the definition of a new technology
intraocular lens, the lens will be eligible
for a payment adjustment of $50.
II. 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 (44 U.S.C. 3501
et seq.).
III. Regulatory Impact Statement
We have examined the impact of this
notice as required by Executive Order
12866 (September 1993, Regulatory
Planning and Review), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), and Executive Order 13132.
Executive Order 12866 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
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Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices
major rules with economically
significant effects ($100 million or more
annually). We have determined that this
notice is not a major rule because it
merely solicits interested parties to
submit requests for review of the
appropriateness of the payment amount
with regard to a particular IOL
furnished by an ASC.
The RFA requires agencies to analyze
options for small business regulatory
relief. 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 $6
million to 29 million or less in any 1
year period. Approximately 83 percent
of ASCs generate revenues of $18.5
million or less and are considered small
business entities according to the Small
Business Administration. Although a
substantial number of ASCs may be
affected, we do not believe there will be
significant economic impact on small
businesses for the reason stated above.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604 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, which
affects only ASCs, will have no affect on
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 one year by State, local, or tribal
governments, in the aggregate, or by the
private sector, of $110 million. Because
this notice only affects ASCs, we have
determined that it 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. Because this notice merely
solicits interested parties to submit
requests for review of the
appropriateness of the payment amount
with regard to a particular IOL
furnished by an ASC, we have
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16:42 May 26, 2005
Jkt 205001
determined that it 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: Sections 1832(a)(2)(F)(i) and
1833(i)(2)(a)(iii) of the Social Security Act (42
U.S.C. 1395k(a)(2)(F)(i) and
1395l(i)(2)(A)(iii)).
(Catalog of Federal Domestic Assistance
Program No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: April 21, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–10760 Filed 5–26–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4095–N]
Medicare Program; Meeting of the
Advisory Panel on Medicare
Education, June 21, 2005
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: In accordance with the
Federal Advisory Committee Act, 5
U.S.C. Appendix 2, section 10(a) (Pub.
L. 92–463), this notice announces a
meeting of the Advisory Panel on
Medicare Education (the Panel) on June
21, 2005. The Panel advises and makes
recommendations to the Secretary of
Health and Human Services and the
Administrator of the Centers for
Medicare & Medicaid Services on
opportunities to enhance the
effectiveness of consumer education
strategies concerning the Medicare
program. This meeting is open to the
public.
DATES: The meeting is scheduled for
June 21, 2005, from 9 a.m. to 3:30 p.m.,
e.d.t.
Deadline for Presentations and
Comments: June 14, 2005, 12 noon,
e.d.t.
ADDRESSES: The meeting will be held at
the Marriot at Metro Center, 775 12th
Street, NW., Washington, DC 20005,
(202) 737–2200.
FOR FURTHER INFORMATION CONTACT:
Lynne Johnson, Health Insurance
Specialist, Division of Partnership
PO 00000
Frm 00059
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30733
Development, Center for Beneficiary
Choices, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Mail stop S2–23–05,
Baltimore, MD 21244–1850, (410) 786–
0090. Please refer to the CMS Advisory
Committees’ Information Line (1–877–
449–5659 toll free)/(410–786–9379
local) or the Internet (https://
www.cms.hhs.gov/faca/apme/
default.asp) for additional information
and updates on committee activities, or
contact Ms. Johnson via e-mail at
Lynne.Johnson@cms.hhs.gov. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145.
Section
222 of the Public Health Service Act (42
U.S.C. 217a), as amended, grants to the
Secretary of Health and Human Services
(the Secretary) the authority to establish
an advisory panel for the purpose of
advising the Secretary in connection
with any of his functions. The Secretary
signed the charter establishing this
Panel on January 21, 1999 (64 FR 7849),
and approved the renewal of the charter
on January 14, 2005. The Panel advises
and makes recommendations to the
Secretary and the Administrator of the
Centers for Medicare & Medicaid
Services (CMS) on opportunities to
enhance the effectiveness of consumer
education strategies concerning the
Medicare program.
The goals of the Panel are as follows:
• To develop and implement a
national Medicare education program
that describes the options for selecting
a health plan under Medicare.
• To enhance the Federal
government’s effectiveness in informing
the Medicare consumer, including the
appropriate use of public-private
partnerships.
• To expand outreach to vulnerable
and underserved communities,
including racial and ethnic minorities,
in the context of a national Medicare
education program.
• To assemble an information base of
best practices for helping consumers
evaluate health plan options and build
a community infrastructure for
information, counseling, and assistance.
The current members of the Panel are:
Dr. Drew E. Altman, President and Chief
Executive Officer, Henry J. Kaiser
Family Foundation; Dr. Jane Delgado,
Chief Executive Officer, National
Alliance for Hispanic Health; Clayton
Fong, President and Chief Executive
Officer, National Asian Pacific Center
on Aging; Thomas Hall, Chairman and
Chief Executive Officer, Cardio-Kinetics,
Inc.; The Honorable Bobby Jindal,
United States Congress; David Knutson,
Director, Health System Studies, Park
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Notices]
[Pages 30731-30733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10760]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3144-N]
RIN 0938-ZA49
Medicare Program; Calendar Year 2005 Review of the
Appropriateness of Payment Amounts for New Technology Intraocular
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice solicits interested parties to submit requests for
review of the appropriateness of the payment amount for a particular
intraocular lens furnished by an ambulatory surgical center.
DATES: Requests for review must be received at the address provided no
later than 5 pm E.S.T. on June 27, 2005.
ADDRESSES: Mail requests for review (one original and three copies) to
the Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: Michael Lyman, Mailstop C1-09-06, 7500
Security Blvd., Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: Michael Lyman, (410) 786-6938.
SUPPLEMENTARY INFORMATION: On October 31, 1994, the Social Security Act
Amendments of 1994 (SSAA 1994) (Pub. L. 103-432) were enacted. Section
141(b)(1) of SSAA 1994 required us to develop and implement a process
under which interested parties may request a review of the
appropriateness of the payment amount for intraocular lenses (IOLs)
furnished by ambulatory surgical centers (ASCs) under section
1833(i)(2)(A)(iii) of the Social Security Act (the Act) on the basis
that those lenses constitute a class of new technology intraocular
lenses (NTIOLs).
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 ambulatory surgical centers (ASCs); defined the terms
relevant to the process; and established an initial 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 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 NTIOL. After July 16, 2002, we have the option of
changing the $50 adjustment amount through proposed and final
rulemaking in connection with ambulatory surgical center services. We
have opted not to change the adjustment amount for calendar year 2005
(CY 05).
Review Process for Establishing Classes of New Technology Intraocular
Lenses (NTIOLs)
We will classify an IOL as a NTIOL if the lens meets the definition
of a ``new
[[Page 30732]]
technology IOL'' in 42 CFR 416.180, which incorporates section
141(b)(2) of SSAA 1994. Under that section, a ``new technology IOL'' is
defined as ``an IOL that CMS determines has been approved by the Food
and Drug Administration (FDA) for use in labeling and advertising the
IOL's claims of specific clinical advantages and superiority over
existing IOLs with regard to reduced risk of intraoperative or
postoperative complication or trauma, accelerated postoperative
recovery, reduced induced astigmatism, improved postoperative visual
acuity, more stable postoperative vision, or other comparable clinical
advantages.''
We evaluate requests for the designation of an IOL as an NTIOL by
doing the following:
(1) Publishing a public notice in the Federal Register that
identifies the requirements and deadline for submitting a request for a
review of the appropriateness of the payment amount for an IOL.
(2) Processing requests to review the appropriateness of the
payment amount for an IOL.
(3) Compiling a list of the requests we receive that identify the
IOL manufacturer, IOL model number under review, name of the requester,
and a summary of the request for review of the appropriateness of the
IOL payment amount.
(4) Publishing an annual public notice in the Federal Register that
lists the requests and provides the public with 30 days to submit
comments on the IOLs for which a review was requested.
(5) Reviewing the information submitted with the applicant's
request for review, and requesting confirmation from the FDA about
labeling applications that have been approved on the IOL model under
review. We also request FDA's recommendations as to whether or not the
IOL model submitted represents a new class of technology that sets it
apart from other IOLs.
(6) Determining which lenses meet the criteria to qualify for the
payment adjustment based on clinical data and evidence submitted for
review, the FDA's analysis, public comments on the lenses, and other
available information. NTIOL applicants should provide good evidence-
based studies supporting the claimed clinical benefits. We are
interested in receiving data showing functional clinical improvements,
as opposed to improvements that have statistical significance without
functional clinical significance.
(7) Designating a type of material or a predominant characteristic
of an NTIOL that sets it apart from other IOLs to establish a new
class.
(8) Publishing a notice in the Federal Register (within 90 days
after we publish the notice identified in paragraph (4) of this
section) that announces the IOLs that we have determined are ``new
technology'' IOLs. These NTIOLs qualify for a $50 (or other amount that
we may adopt through notice and comment rulemaking) payment adjustment
for a 5-year period.
(9) Adjusting payments effective 30 days after the publication of
the final notice announcing our determinations described in paragraph
(8) of this section.
Who May Request a Review
As specified in Sec. 416.190, any party who is able to furnish the
information required in Sec. 416.195 may request that we review the
appropriateness of the payment amount provided under Sec.
1833(i)(2)(A)(iii) of the Act for an IOL that, as claimed by the party,
meets the definition of a new technology IOL in Sec. 416.180.
Requests To Review
As specified in Sec. 416.195(a), a request to review must include
all of the following information:
The name of the manufacturer, the model number, and the
trade name of the IOL.
A copy of the FDA's summary of the IOL's safety and
effectiveness.
A copy of the labeling claims of specific clinical
advantages approved by the FDA for the IOL.
A copy of the IOL's original FDA approval notification.
Reports of modifications made after the original FDA
approval.
Other information that supports the requestor's claim
(including clinical trials, case studies, journal articles, etc.).
Privileged or Confidential Information
To the extent that information received from an IOL manufacturer
can reasonably be characterized as a trade secret or as privileged or
confidential commercial or financial information, Sec. 416.195(b)
requires that we maintain the confidentiality of the information and
protect it from disclosure not otherwise authorized or required by
Federal law as allowed under Exemption 4 of the Freedom of Information
Act (5 U.S.C. 552(b)(4)) and, with respect to trade secrets, the Trade
Secrets Act (18 U.S.C. 1905). We recommend that the requestor clearly
identify all information that is to be characterized as confidential.
Application of the Payment Adjustment
As provided in Sec. 416.200, we recognize all IOL(s) that meet the
definition of a new technology IOL for purposes of subpart F of part
416 as belonging to a class of NTIOLs for a period of 5 years effective
from the date that we recognize the first NTIOL in that subset. Any IOL
that we subsequently recognize as belonging to a new technology subset
receives the new technology payment adjustment for the remainder of the
5-year period established with our recognition of the first NTIOL in
the subset. Beginning 5 years after the effective date of our initial
recognition of a new technology subset, the payment adjustment ceases
for all IOLs that we have designated as belonging to that subset.
I. Provisions of This Notice
Under our rules at 42 CFR part 416, subpart F, we are soliciting
requests for review of the appropriateness of the payment amount for
IOLs furnished by an ASC. Requests for review must comply with our
regulations at Sec. 416.195 and be received at the address provided by
the date specified in the DATES section of this notice. We will
announce timely requests for review in a subsequent notice that will
allow for public comment. Currently, if we determine that an
intraocular lens meets the definition of a new technology intraocular
lens, the lens will be eligible for a payment adjustment of $50.
II. 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 (44 U.S.C. 3501 et seq.).
III. Regulatory Impact Statement
We have examined the impact of this notice as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 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
[[Page 30733]]
major rules with economically significant effects ($100 million or more
annually). We have determined that this notice is not a major rule
because it merely solicits interested parties to submit requests for
review of the appropriateness of the payment amount with regard to a
particular IOL furnished by an ASC.
The RFA requires agencies to analyze options for small business
regulatory relief. 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 $6
million to 29 million or less in any 1 year period. Approximately 83
percent of ASCs generate revenues of $18.5 million or less and are
considered small business entities according to the Small Business
Administration. Although a substantial number of ASCs may be affected,
we do not believe there will be significant economic impact on small
businesses for the reason stated above.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 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, which affects only ASCs, will have no affect on 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 one year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $110 million. Because this notice only affects ASCs,
we have determined that it 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. Because this notice merely solicits interested
parties to submit requests for review of the appropriateness of the
payment amount with regard to a particular IOL furnished by an ASC, we
have determined that it 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: Sections 1832(a)(2)(F)(i) and 1833(i)(2)(a)(iii) of
the Social Security Act (42 U.S.C. 1395k(a)(2)(F)(i) and
1395l(i)(2)(A)(iii)).
(Catalog of Federal Domestic Assistance Program No. 93.773
Medicare--Hospital Insurance Program; and No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: April 21, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-10760 Filed 5-26-05; 8:45 am]
BILLING CODE 4120-01-P
