Medicare Program; Calendar Year 2006 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs) and Correction, 25176-25178 [06-3973]
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Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006 / Notices
for-profit institutions, and State, Local
or Tribal governments; Number of
Respondents: 100,000; Total Annual
Responses: 100,000; Total Annual
Hours: 100,000.
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/
PaperworkReductionActof1995, or email 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.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on June 27, 2006.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—B, Attention:
William N. Parham, III, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 24, 2006.
Michelle Shortt,
Acting Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. E6–6385 Filed 4–27–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3171–N; and 0938–ZA91]
Medicare Program; Calendar Year 2006
Review of the Appropriateness of
Payment Amounts for New Technology
Intraocular Lenses (NTIOLs) Furnished
by Ambulatory Surgical Centers
(ASCs) and Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
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. Also, this notice corrects
typographical errors in the notice with
public comment period that appeared in
the September 30, 2005 Federal Register
entitled ‘‘Medicare Program; Calendar
Year 2005 Review of the
Appropriateness of Payment Amounts
for New Technology Intraocular Lenses
(NTIOLs) Furnished by Ambulatory
VerDate Aug<31>2005
17:14 Apr 27, 2006
Jkt 208001
Surgical Centers (ASCs)’’ (70 FR 57297),
and in the final notice that appeared in
the January 27, 2006 Federal Register
entitled ‘‘Medicare Program; Approval
of Adjustment in Payment Amounts for
New Technology Intraocular Lenses
Furnished by Ambulatory Surgical
Centers’’ (71 FR 4586).
DATES: Requests for review must be
received at the address provided no
later than 5 p.m. on May 30, 2006.
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:
I. Background
A. Statutory Requirements
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 the Secretary of the
Department of Health and Human
Services 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, the Centers for
Medicare & Medicaid Services (CMS)
(then known as the Health Care
Financing Administration), 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 IOL request that
we review and approve with the same
characteristics as the first IOL
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Sfmt 4703
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. We have opted not to
change the adjustment amount for
calendar year 2006 (CY 06).
B. CMS 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
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.’’ Thus,
an IOL must first be an FDA approved
IOL before we can designate that IOL as
an NTIOL.
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 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 confirming the FDA
labeling for the IOL model under
review. We also review the available
evidence relevant to FDA’s labeling
approval as to whether or not the IOL
model submitted represents a new class
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006 / Notices
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
approved label, 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.
(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.
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.
F. Application of the Payment
Adjustment
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
section 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.
As provided in § 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. The process to
apply for inclusion in an existing
NTIOL subset is described at: https://
www.cms.hhs.gov/CoverageGenInfo/
downloads/
AppforcurrentNTIOLsubset.pdf.
D. Requests to Review
II. Provisions of This Notice
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 current FDA
approved label supporting claims of
specific clinical advantages 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.).
A. Calendar Year 2006 Review of the
Appropriateness of Payment Amounts
for New Technology Intraocular Lenses
(NTIOLs) Furnished by Ambulatory
Surgical Centers (ASCs)
jlentini on PROD1PC65 with NOTICES
C. Who May Request a Review
E. Privileged or Confidential
Information
To the extent that information
received from an IOL manufacturer can
reasonably be characterized as a trade
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Jkt 208001
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.
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25177
B. Summary of Corrections to the
September 30, 2005 and January 27,
2006 Federal Register Notices
In this notice, we also correct a
typographical error that appeared in the
September 30, 2005 Federal Register
entitled ‘‘Medicare Program; Calendar
Year 2005 Review of the
Appropriateness of Payment Amounts
for New Technology Intraocular Lenses
(NTIOLs) Furnished by Ambulatory
Surgical Centers (ASCs)’’ (70 FR 57297)
and in the final notice that published in
the Federal Register on January 27,
2006 entitled ‘‘Medicare Program;
Approval of Adjustment in Payment
Amounts for New Technology
Intraocular Lenses Furnished by
Ambulatory Surgical Centers’’ (71 FR
4586). We approved the NTIOL
application submitted by AMO for
Tecnis IOL model numbers Z9000,
Z9001, and ZA9003. However, we made
a typographical error and listed the
Tecnis IOL model as ‘‘Z9003’’ instead
of ‘‘ZA9003’’ in both the September 30,
2005 notice with public comment
period and the January 27, 2006 final
notice. In this notice, we correct the
Tecnis IOL model number Z9003 and
replace it with Tecnis IOL model
number ZA9003.
C. Corrections to September 30, 2005
and January 27, 2006 Federal Register
Notices
In FR Doc. 05–19483, published on
September 30, 2005, (70 FR 57297), we
are making the following correction:
1. On page 57299, in the first column,
in the 16th line, ‘‘Z9003’’ is corrected to
read ‘‘ZA9003’’.
In FR Doc. E6–1049, published on
January 27, 2006 (71 FR 4586), we are
making the following corrections:
1. On page 4586, in the third column,
in the second paragraph, in the last line,
‘‘Z9003’’ is corrected to read ‘‘ZA9003’’.
2. On page 4587, in the first column,
in the last paragraph, lines 4 and 6,
‘‘Z9003’’ is corrected to read ‘‘ZA9003’’.
3. On page 4588, in the first column,
in the 16th line from the bottom,
‘‘Z9003’’ is corrected to read ‘‘ZA9003’’.
4. On page 4588, in the second
column, in the third paragraph, in the
second line, ‘‘Z9003’’ is corrected to
read ‘‘ZA9003’’.
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 recordkeeping
requirements that are subject to review
by the Office of Management and
E:\FR\FM\28APN1.SGM
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Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006 / Notices
jlentini on PROD1PC65 with NOTICES
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
IV. 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
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 effect on
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
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17:14 Apr 27, 2006
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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 19, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 06–3973 Filed 4–27–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4113–N]
Medicare Program; Meeting of the
Advisory Panel on Medicare
Education, May 25, 2006
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 May
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25, 2006. 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
May 25, 2006 from 9 a.m. to 3:30 p.m.,
e.d.t.
Deadline for Presentations and
Comments: May 18, 2006, 12 noon,
e.d.t.
ADDRESSES: The meeting will be held at
the City Center Hotel, 1143 New
Hampshire Avenue, NW., Washington,
DC 20036, (202) 775–0800.
FOR FURTHER INFORMATION CONTACT:
Lynne Johnson, Health Insurance
Specialist, Division of Partnership
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/04_APME.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.
SUPPLEMENTARY INFORMATION: 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 council or committee for the
purpose of advising him 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.
E:\FR\FM\28APN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 82 (Friday, April 28, 2006)]
[Notices]
[Pages 25176-25178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3973]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3171-N; and 0938-ZA91]
Medicare Program; Calendar Year 2006 Review of the
Appropriateness of Payment Amounts for New Technology Intraocular
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs) and
Correction
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. Also, this
notice corrects typographical errors in the notice with public comment
period that appeared in the September 30, 2005 Federal Register
entitled ``Medicare Program; Calendar Year 2005 Review of the
Appropriateness of Payment Amounts for New Technology Intraocular
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (70
FR 57297), and in the final notice that appeared in the January 27,
2006 Federal Register entitled ``Medicare Program; Approval of
Adjustment in Payment Amounts for New Technology Intraocular Lenses
Furnished by Ambulatory Surgical Centers'' (71 FR 4586).
DATES: Requests for review must be received at the address provided no
later than 5 p.m. on May 30, 2006.
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:
I. Background
A. Statutory Requirements
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 the Secretary of the Department of Health and Human
Services 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, the Centers for Medicare & Medicaid Services
(CMS) (then known as the Health Care Financing Administration),
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 IOL request that we review and approve 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. We have opted not to change the adjustment amount for
calendar year 2006 (CY 06).
B. CMS 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 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.'' Thus, an IOL must first be an FDA
approved IOL before we can designate that IOL as an NTIOL.
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 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 confirming the FDA labeling for the IOL model
under review. We also review the available evidence relevant to FDA's
labeling approval as to whether or not the IOL model submitted
represents a new class
[[Page 25177]]
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 approved label, 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.
(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.
C. 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 section
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.
D. 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 current FDA approved label supporting claims
of specific clinical advantages 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.).
E. 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.
F. 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. The
process to apply for inclusion in an existing NTIOL subset is described
at: https://www.cms.hhs.gov/CoverageGenInfo/downloads/
AppforcurrentNTIOLsubset.pdf.
II. Provisions of This Notice
A. Calendar Year 2006 Review of the Appropriateness of Payment Amounts
for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory
Surgical Centers (ASCs)
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.
B. Summary of Corrections to the September 30, 2005 and January 27,
2006 Federal Register Notices
In this notice, we also correct a typographical error that appeared
in the September 30, 2005 Federal Register entitled ``Medicare Program;
Calendar Year 2005 Review of the Appropriateness of Payment Amounts for
New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory
Surgical Centers (ASCs)'' (70 FR 57297) and in the final notice that
published in the Federal Register on January 27, 2006 entitled
``Medicare Program; Approval of Adjustment in Payment Amounts for New
Technology Intraocular Lenses Furnished by Ambulatory Surgical
Centers'' (71 FR 4586). We approved the NTIOL application submitted by
AMO for Tecnis[supreg] IOL model numbers Z9000, Z9001, and ZA9003.
However, we made a typographical error and listed the Tecnis[supreg]
IOL model as ``Z9003'' instead of ``ZA9003'' in both the September 30,
2005 notice with public comment period and the January 27, 2006 final
notice. In this notice, we correct the Tecnis[supreg] IOL model number
Z9003 and replace it with Tecnis[supreg] IOL model number ZA9003.
C. Corrections to September 30, 2005 and January 27, 2006 Federal
Register Notices
In FR Doc. 05-19483, published on September 30, 2005, (70 FR
57297), we are making the following correction:
1. On page 57299, in the first column, in the 16th line, ``Z9003''
is corrected to read ``ZA9003''.
In FR Doc. E6-1049, published on January 27, 2006 (71 FR 4586), we
are making the following corrections:
1. On page 4586, in the third column, in the second paragraph, in
the last line, ``Z9003'' is corrected to read ``ZA9003''.
2. On page 4587, in the first column, in the last paragraph, lines
4 and 6, ``Z9003'' is corrected to read ``ZA9003''.
3. On page 4588, in the first column, in the 16th line from the
bottom, ``Z9003'' is corrected to read ``ZA9003''.
4. On page 4588, in the second column, in the third paragraph, in
the second line, ``Z9003'' is corrected to read ``ZA9003''.
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 recordkeeping requirements that are subject
to review by the Office of Management and
[[Page 25178]]
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
IV. 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 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 effect 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 19, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-3973 Filed 4-27-06; 8:45 am]
BILLING CODE 4120-01-P
