Medicare Program; Approval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers, 4586-4589 [E6-1049]
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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices
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requirements; and ability to provide us
with the necessary data for validation.
Section 1865(b)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accreditation
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from our receipt of
a completed application to publish
approval or denial of the application.
The purpose of this proposed notice
is to inform the public of our
¨
consideration of the TUV Healthcare
¨
Specialists’ (TUVHS’) request to become
a national accreditation organization for
hospitals. This notice also solicits
public comment on the ability of
¨
TUVHS requirements to meet or exceed
the Medicare CoPs for hospitals.
III. Evaluation of Deeming Authority
Request
¨
On December 2, 2005, the TUV
¨
Healthcare Specialists (TUVHS)
submitted all the necessary materials to
enable us to make a determination
concerning its request for approval as a
deeming organization for hospitals.
Under section 1865(b)(2) of the Act and
our regulations at § 488.8 (Federal
review of accreditation organizations),
¨
our review and evaluation of TUVHS
will be conducted in accordance with,
but not necessarily limited to, the
following factors:
¨
• The equivalency of TUVHS’
standards for hospitals as compared
with our comparable hospital CoPs.
¨
• TUVHS’ survey process to
determine the following:
—The composition of the survey team,
surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
¨
—The comparability of TUVHS’
processes to those of State agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
¨
—TUVHS’ processes and procedures for
monitoring providers or suppliers
found out of compliance with
¨
TUVHS’ program requirements. These
monitoring procedures are used only
¨
when TUVHS identifies
noncompliance. If noncompliance is
identified through validation reviews,
the survey agency monitors
corrections as specified at § 488.7(d).
¨
—TUVHS’ capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
¨
—TUVHS’ capacity to provide us with
electronic data in ASCII comparable
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code, and reports necessary for
effective validation and assessment of
the organization’s survey process.
¨
—The adequacy of TUVHS’ staff and
other resources, and its financial
viability.
¨
—TUVHS’ capacity to adequately fund
required surveys.
¨
—TUVHS’ policies with respect to
whether surveys are announced or
unannounced.
¨
—TUVHS’ agreement to provide us with
a copy of the most current ac
creditation survey together with any
other information related to the
survey as we may require (including
corrective action plans).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Collection of Information
Requirements
SUMMARY: In this final notice we
respond to public comments on our
September 30, 2005 notice with
comment period and announce our
decision concerning an application
submitted by Advanced Medical Optics
(AMO) to adjust the Medicare payment
amounts for certain intraocular lenses
(IOLs) on the basis that they are new
technology intraocular lenses (NTIOLs).
This is the third of three statutorily
required Federal Register documents.
On May 27, 2005, we published a notice
in the 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 30731) that solicited interested
parties to submit requests for review of
the appropriateness of the payment
amount for an IOL furnished by an
ambulatory surgical center. On
September 30, 2005, we published a
notice with comment period 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) acknowledging timely
receipt of one application. In this final
notice, we announce our decision to
approve the NTIOL application
submitted by Advanced Medical Optics
(AMO) for Tecnis (model numbers
Z9000, Z9001, and Z9003).
EFFECTIVE DATE: This notice is effective
on February 27, 2006.
FOR FURTHER INFORMATION CONTACT:
Michael Lyman, (410) 786–6938.
SUPPLEMENTARY INFORMATION:
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
V. Response to Public Comments and
Notice Upon Completion of Evaluation
Because of the large number of
comments we normally receive on
Federal Register documents published
for comment, 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 proposed notice.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this proposed
notice, we will publish a final notice in
the Federal Register responding to the
public comments and announcing the
result of our evaluation.
VI. Executive Order 12866 Statement
In accordance with the provisions of
Executive Order 12866, this proposed
notice was not reviewed by the Office of
Management and Budget.
Authority: Section 1865 of the Social
Security Act (42 U.S.C. 1395bb).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: January 20, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare and
Medicaid Services.
[FR Doc. 06–748 Filed 1–26–06; 8:45 am]
BILLING CODE 4120–01–P
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Centers for Medicare and Medicaid
Services
[CMS–3144–FN]
0938–ZA49
Medicare Program; Approval of
Adjustment in Payment Amounts for
New Technology Intraocular Lenses
Furnished by Ambulatory Surgical
Centers
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
I. Background
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
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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices
a process under which interested parties
may request a review of the
appropriateness of the payment amount
for intraocular lenses furnished by 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.
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 having the
same characteristics as the first IOL
recognized for a payment adjustment
will receive the same adjustment for the
remainder of the 5-year period
established by the first recognized
NTIOL. In accordance with the payment
review process specified in § 416.185,
after July 16, 2002, the $50 adjustment
amount can be modified through
proposed and final rulemaking in
connection with ASC services. To date,
we have made no changes to the
payment amount and have opted not to
change the adjustment for calendar year
2005 (CY 2005).
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II. NTIOL Applications Submitted for
Calendar Year 2005
On May 27, 2005 we published a
notice in the 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 30731) that solicited interested
parties to submit requests for review of
the appropriateness of the payment
amount for an IOL furnished by an
ambulatory surgical center. In response
to the May 27, 2005 notice, we received
one timely request for review:
1. Manufacturer: Advanced Medical
Optics (AMO); Model Numbers: Tecnis
(model numbers Z9000, Z9001, and
Z9003). Tecnis Models Z9000 and
Z9001 are made from silicone material.
The Tecnis Model Z9003 is made from
acrylic material. All three lenses
provide the same functionality, differing
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only in material. Accordingly, we are
treating these lenses as the same lens.
On September 30, 2005 we published
in the Federal Register a notice with
comment period entitled ‘‘Medicare
Program; Calendar Year 2005 Review of
the Appropriateness of Payment
Amounts for New Technology
Intraocular Lenses Furnished by
Ambulatory Surgical Centers (ASCs)’’
(70 FR 57297) acknowledging timely
receipt of one application.
III. Criteria and Process for NTIOL
Determination
We will classify an IOL as an NTIOL
if the lens meets the definition of a
‘‘new technology IOL’’ in § 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 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.’’
The process we use for evaluating
requests for NTIOL designation and
reviewing the appropriateness of the
payment amount for a NTIOL furnished
by ASCs is described in our regulations
at part 416, subpart F and in the
September 30, 2005 Federal Register
notice.
This process includes—
• Publishing a public notice in the
Federal Register identifying
requirements and the deadline for
submitting a request;
• Processing requests to review the
appropriateness of the payment amount
for an IOL;
• 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;
• Publishing an annual public notice
in the Federal Register that lists the
requests and provides for a public
comment period;
• 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 the FDA’s recommendations as
to whether or not the IOL model
submitted represents a new class of
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technology that sets it apart from other
IOLs. Using a baseline of the date of the
last determination of a new class of
IOLs, the FDA states an opinion based
on proof of superiority over existing
lenses of the same type of material or
over lenses providing specific clinical
advantages and superiority over existing
IOLs as described in the preceding
paragraph;
• 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;
• Designating a type of material or a
predominant characteristic of an NTIOL
that sets it apart from other IOLs to
establish a new class;
• Publishing a notice in the Federal
Register announcing the IOLs that we
have determined are ‘‘new technology’’
IOLs. These NTIOLs qualify for a $50
payment adjustment (or other amount
announced through notice and comment
rulemaking); and
• Adjusting payments effective 30
days after the publication of the final
notice announcing our determinations
described in the preceding paragraph of
this section.
In accordance with our NTIOL
application review procedures, we
asked the FDA to review the AMO
application to determine whether the
manufacturer’s claims of specific
clinical advantages and superiority over
existing IOLs had been approved for
labeling and advertising purposes. Our
regulations require the FDA’s approval
of a requestor’s claims for advertising
and labeling in order for an IOL to be
classified as a NTIOL.
IV. Analysis of and Responses to Public
Comments
We received 12 timely public
comments in response to the September
30, 2005 notice with comment period on
the NTIOLs under review. Eleven were
from ophthalmologists in support of
NTIOL status for the Tecnis lenses.
One comment was received from
another manufacturer who makes an
IOL with similar aspheric optic design
characteristics. The comments we
received and our responses are as
follows:
Comments: The commenting
ophthalmologists strongly supported
NTIOL designation for the Tecnis
lenses. Most of these commenters
reported positive experiences from
patients in whom they implanted the
Tecnis lenses during cataract surgery.
The commenters reported improved
contrast vision, reduced overall ocular
spherical aberration, improved
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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices
functional vision, and significantly
better contrast sensitivity and contrast
acuity. One stated that surgeons should
not use substandard lenses when better
lenses are available. Another commenter
provided a research article concluding
the Tecnis lens provided improved
visual acuity and functional acuity
contrast testing compared to
conventional spherical silicone and
acrylic IOLs. This article had been
previously submitted by AMO in its
2004 and 2005 calendar year NTIOL
submissions.
We also received a comment
supporting NTIOL status for the Tecnis
lenses that suggested they be classified
as ‘‘Aspheric Optic’’ NTIOLs. The
commenter also requested that one of its
IOL products having aspheric optic
design characteristics, as well as an IOL
of another manufacturer, be placed in
this newly created ‘‘Aspheric Optic’’
NTIOL class.
We agree with the commenters in
their support of the Tecnis lenses. We
do not agree with the comment that the
Tecnis lenses be classified as
‘‘Aspheric Optic’’ NTIOLs. NTIOL
classes are defined by clinical outcomes
which provide benefits to Medicare
beneficiaries. The two previously
created NTIOL classes are ‘‘Multifocal’’
and ‘‘Reduction in Preexisting
Astigmatism.’’ We disagree with the
commenter’s suggestion to create a new
‘‘Aspheric Optic’’ NTIOL class as this
class would not be based upon clinical
outcome. We recommend that the
commenter who claimed that one of its
IOLs has aspheric optic design
characteristics submit an application
with evidence showing clinical benefits
of its lenses during the 2006 NTIOL
application period. We appreciate all
commenters’ interest in the NTIOL
process.
V. NTIOL Decision—Approval of
Advanced Medical Optics Application
Tecnis
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AMO
Lenses; Models Z9000,
Z9001, and Z9003
In CY 2004, AMO applied for NTIOL
designation for the Tecnis lenses. As
part of the 2004 NTIOL review, CMS
requested FDA review of AMO’s NTIOL
application. FDA’s review confirmed
that the clinical trial performed by AMO
demonstrated that results under several
conditions tested were statistically
significantly better with the Tecnis
lens than with the control acrylic IOL.
However, we denied AMO’s CY 2004
NTIOL application for the Tecnis
lenses due to the lack of evidence that
the Tecnis design improvements
provided clinical benefits to patients.
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15:17 Jan 26, 2006
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AMO resubmitted its NTIOL request
in CY 2005 and provided additional
information on the clinical relevance of
reduced postoperative spherical
aberration and increased contrast
sensitivity. In the CY 2005 application,
AMO provided additional peerreviewed published studies, a metaanalysis, and a justification of the
choice of comparator lens, none of
which were included in the CY 2004
application. To demonstrate clinical
superiority, AMO submitted journal
articles and AMO-sponsored research
reporting improved functional vision
resulting from compensation for corneal
spherical aberration. We reviewed the
additional literature submitted by AMO
in its CY 2005 application and found it
to be acceptable and supportive of our
requirements.
AMO claims the Tecnis IOLs create
a new class of IOLs compensating for
corneal spherical aberration. AMO
states this improves contrast sensitivity,
functional performance, and especially
safer night driving. Based on the
additional information from AMO, CMS
approves AMO’s claims of clinical
advantages and superiority of the
Tecnis IOL for ocular spherical
aberrations and simulated night driving.
We find the AMO Tecnis Lenses
Models Z9000, Z9001, and Z9003 meet
the NTIOL definition and are to be given
the new NTIOL classification of
Reduced Spherical Aberration.
VI. Collection of Information
Requirements
Because the requirements referenced
in this final 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.
VII. 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 19,
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,
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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 final notice is
not a major rule. 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 $6 million to $29 million in
any 1 year. Individuals and States are
not included in the definition of a small
entity. We are not preparing an analysis
for the RFA because we have
determined that this final notice will
not have a significant economic impact
on a substantial number of small
entities.
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
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 Core-Based Statistical Area and has
fewer than 100 beds. We are not
preparing an analysis for section 1102(b)
of the Act because we have determined
that this final notice will 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 whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
That threshold level is currently
approximately $120 million. This final
notice will have no consequential effect
on State, local, or tribal governments or
on the private sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it publishes 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.
Since this final notice does not impose
any costs on State or local governments,
the requirements of E.O. 13132 are not
applicable.
In accordance with the provisions of
Executive Order 12866, this final notice
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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. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program).
Dated: January 9, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare and
Medicaid Services.
[FR Doc. E6–1049 Filed 1–25–06; 4:00 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3162–N]
Medicare Program; Meeting of the
Medicare Coverage Advisory
Committee—March 30, 2006
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
rmajette on PROD1PC67 with NOTICES
AGENCY:
SUMMARY: This notice announces a
public meeting of the Medicare
Coverage Advisory Committee (MCAC).
The Committee generally provides
advice and recommendations about
whether scientific evidence is adequate
to determine whether certain medical
items and services are reasonable and
necessary under the Medicare statute.
The charter also permits the MCAC to
develop recommendations about other
specific issues of Medicare coverage.
This meeting concerns authoritative
drug compendia that may be used in
determining the medically accepted
indications of drugs and biologicals
used in an anti-cancer
chemotherapeutic regimen under Part B
of the Medicare program. Notice of this
meeting is given under the Federal
Advisory Committee Act (5 U.S.C. App.
2, section 10(a)).
DATES: The public meeting will be held
on Thursday, March 30, 2006 from 7:30
a.m. until 4:30 p.m. e.s.t.
Deadlines: Deadline for Presentations
and Comments: Written comments and
presentations must be received by
February 27, 2006, 5 p.m., e.s.t.
Deadline for Registration To Attend
Meeting: For security reasons,
individuals wishing to attend this
meeting must register by close of
business on March 23, 2006.
Special Accommodations: Persons
attending the meeting who are hearing
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or visually impaired, or have a
condition that requires special
assistance or accommodations, are
asked to notify the Executive Secretary
by March 23, 2006 (see FOR FURTHER
INFORMATION CONTACT).
ADDRESSES: The meeting will be held in
the main auditorium of the Centers for
Medicare & Medicaid Services, 7500
Security Blvd, Baltimore, MD 21244.
FOR FURTHER INFORMATION CONTACT:
Michelle Atkinson, Executive Secretary,
by telephone at 410–786–2881 or by email at Michelle.Atkinson@cms.hhs.gov.
Web site: You may access up-to-date
information on this meeting at https://
www.cms.hhs.gov/FACA/
02_MCAC.asp#TopOfPage.
Presentations and Comments:
Interested persons may present data,
information, or views orally or in
writing on issues pending before the
Committee. Please submit written
comments to Michelle Atkinson, by email at Michelle.Atkinson@cms.hhs.gov
or by mail to the Executive Secretary for
MCAC, Coverage and Analysis Group,
Office of Clinical Standards and
Quality, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Mail Stop C1–09–06,
Baltimore, MD 21244.
SUPPLEMENTARY INFORMATION:
I. Background
On December 14, 1998, we published
a notice in the Federal Register (63 FR
68780) to describe the Medicare
Coverage Advisory Committee (MCAC),
which provides advice and
recommendations to us about clinical
issues. This notice announces a public
meeting of the Committee.
Meeting Topic: The Committee will
discuss evidence and hear presentations
and public comments regarding the
desired characteristics of published
authoritative compendia that may be
used by CMS to determine the
medically accepted indications of drugs
and biologicals employed in an anticancer chemotherapeutic regimen under
Part B of the Medicare program, section
1861(t)(2) of the Social Security Act.
Background information about this
topic, including panel materials, is
available on the Internet at https://
www.cms.hhs.gov/coverage/.
II. Procedure
This meeting is open to the public.
The Committee will hear oral
presentations from the public for
approximately 45 minutes. The
Committee may limit the number and
duration of oral presentations to the
time available. If you wish to make
formal presentations, you must notify
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4589
the Executive Secretary named in the
FOR FURTHER INFORMATION CONTACT
section and submit the following by the
Deadline for Presentations and
Comments date listed in the DATES
section of this notice: a brief statement
of the general nature of the evidence or
arguments you wish to present, the
names and addresses of proposed
participants, and a written copy of your
presentation. Your presentation should
consider the questions we have posed to
the Committee and focus on the issues
specific to the topic. The questions will
be available on our Web site at https://
www.cms.hhs.gov/FACA/
02_MCAC.asp#TopOfPage. We require
that you declare at the meeting whether
or not you have any financial
involvement with manufacturers of any
items or services being discussed (or
with their competitors).
After the public and CMS
presentations, the Committee will
deliberate openly on the topic.
Interested persons may observe the
deliberations, but the Committee will
not hear further comments during this
time except at the request of the
chairperson. The Committee will also
allow a 15 minute unscheduled open
public session for any attendee to
address issues specific to the topic. At
the conclusion of the day, the members
will vote, and the Committee will make
its recommendation.
III. Registration Instructions
The Coverage and Analysis Group is
coordinating meeting registration. While
there is no registration fee, individuals
must register to attend. You may register
by contacting Maria Ellis at 410–786–
0309, mailing address: Coverage and
Analysis Group, OCSQ; Centers for
Medicare & Medicaid Services; 7500
Security Blvd, Mailstop: C1–09–06;
Baltimore, MD 21244, or by e-mail at
Maria.Ellis@cms.hhs.gov. Please provide
your name, address, organization,
telephone and fax number, and e-mail
address.
You will receive a registration
confirmation with instructions for your
arrival at the CMS complex. You will be
notified if the seating capacity has been
reached.
This meeting is located on Federal
property; therefore, for security reasons,
any individuals wishing to attend this
meeting must register by close of
business on March 23, 2006.
IV. Security, Building, and Parking
Guidelines
This meeting will be held in a Federal
Government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
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]]>Agencies
[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Notices]
[Pages 4586-4589]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1049]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-3144-FN]
0938-ZA49
Medicare Program; Approval of Adjustment in Payment Amounts for
New Technology Intraocular Lenses Furnished by Ambulatory Surgical
Centers
AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: In this final notice we respond to public comments on our
September 30, 2005 notice with comment period and announce our decision
concerning an application submitted by Advanced Medical Optics (AMO) to
adjust the Medicare payment amounts for certain intraocular lenses
(IOLs) on the basis that they are new technology intraocular lenses
(NTIOLs).
This is the third of three statutorily required Federal Register
documents. On May 27, 2005, we published a notice in the 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 30731) that solicited interested parties to submit requests for
review of the appropriateness of the payment amount for an IOL
furnished by an ambulatory surgical center. On September 30, 2005, we
published a notice with comment period 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) acknowledging timely receipt of
one application. In this final notice, we announce our decision to
approve the NTIOL application submitted by Advanced Medical Optics
(AMO) for Tecnis[supreg] (model numbers Z9000, Z9001, and Z9003).
EFFECTIVE DATE: This notice is effective on February 27, 2006.
FOR FURTHER INFORMATION CONTACT: Michael Lyman, (410) 786-6938.
SUPPLEMENTARY INFORMATION:
I. Background
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
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a process under which interested parties may request a review of the
appropriateness of the payment amount for intraocular lenses furnished
by 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.
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 having the same characteristics as
the first IOL recognized for a payment adjustment will receive the same
adjustment for the remainder of the 5-year period established by the
first recognized NTIOL. In accordance with the payment review process
specified in Sec. 416.185, after July 16, 2002, the $50 adjustment
amount can be modified through proposed and final rulemaking in
connection with ASC services. To date, we have made no changes to the
payment amount and have opted not to change the adjustment for calendar
year 2005 (CY 2005).
II. NTIOL Applications Submitted for Calendar Year 2005
On May 27, 2005 we published a notice in the 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 30731) that solicited interested parties to submit requests for
review of the appropriateness of the payment amount for an IOL
furnished by an ambulatory surgical center. In response to the May 27,
2005 notice, we received one timely request for review:
1. Manufacturer: Advanced Medical Optics (AMO); Model Numbers:
Tecnis[supreg] (model numbers Z9000, Z9001, and Z9003). Tecnis[supreg]
Models Z9000 and Z9001 are made from silicone material. The
Tecnis[supreg] Model Z9003 is made from acrylic material. All three
lenses provide the same functionality, differing only in material.
Accordingly, we are treating these lenses as the same lens.
On September 30, 2005 we published in the Federal Register a notice
with comment period entitled ``Medicare Program; Calendar Year 2005
Review of the Appropriateness of Payment Amounts for New Technology
Intraocular Lenses Furnished by Ambulatory Surgical Centers (ASCs)''
(70 FR 57297) acknowledging timely receipt of one application.
III. Criteria and Process for NTIOL Determination
We will classify an IOL as an NTIOL if the lens meets the
definition of a ``new technology IOL'' in Sec. 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 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.''
The process we use for evaluating requests for NTIOL designation
and reviewing the appropriateness of the payment amount for a NTIOL
furnished by ASCs is described in our regulations at part 416, subpart
F and in the September 30, 2005 Federal Register notice.
This process includes--
Publishing a public notice in the Federal Register
identifying requirements and the deadline for submitting a request;
Processing requests to review the appropriateness of the
payment amount for an IOL;
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;
Publishing an annual public notice in the Federal Register
that lists the requests and provides for a public comment period;
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 the 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. Using a baseline of the date of the last
determination of a new class of IOLs, the FDA states an opinion based
on proof of superiority over existing lenses of the same type of
material or over lenses providing specific clinical advantages and
superiority over existing IOLs as described in the preceding paragraph;
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;
Designating a type of material or a predominant
characteristic of an NTIOL that sets it apart from other IOLs to
establish a new class;
Publishing a notice in the Federal Register announcing the
IOLs that we have determined are ``new technology'' IOLs. These NTIOLs
qualify for a $50 payment adjustment (or other amount announced through
notice and comment rulemaking); and
Adjusting payments effective 30 days after the publication
of the final notice announcing our determinations described in the
preceding paragraph of this section.
In accordance with our NTIOL application review procedures, we
asked the FDA to review the AMO application to determine whether the
manufacturer's claims of specific clinical advantages and superiority
over existing IOLs had been approved for labeling and advertising
purposes. Our regulations require the FDA's approval of a requestor's
claims for advertising and labeling in order for an IOL to be
classified as a NTIOL.
IV. Analysis of and Responses to Public Comments
We received 12 timely public comments in response to the September
30, 2005 notice with comment period on the NTIOLs under review. Eleven
were from ophthalmologists in support of NTIOL status for the
Tecnis[supreg] lenses. One comment was received from another
manufacturer who makes an IOL with similar aspheric optic design
characteristics. The comments we received and our responses are as
follows:
Comments: The commenting ophthalmologists strongly supported NTIOL
designation for the Tecnis[supreg] lenses. Most of these commenters
reported positive experiences from patients in whom they implanted the
Tecnis[supreg] lenses during cataract surgery. The commenters reported
improved contrast vision, reduced overall ocular spherical aberration,
improved
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functional vision, and significantly better contrast sensitivity and
contrast acuity. One stated that surgeons should not use substandard
lenses when better lenses are available. Another commenter provided a
research article concluding the Tecnis[supreg] lens provided improved
visual acuity and functional acuity contrast testing compared to
conventional spherical silicone and acrylic IOLs. This article had been
previously submitted by AMO in its 2004 and 2005 calendar year NTIOL
submissions.
We also received a comment supporting NTIOL status for the
Tecnis[supreg] lenses that suggested they be classified as ``Aspheric
Optic'' NTIOLs. The commenter also requested that one of its IOL
products having aspheric optic design characteristics, as well as an
IOL of another manufacturer, be placed in this newly created ``Aspheric
Optic'' NTIOL class.
We agree with the commenters in their support of the Tecnis[supreg]
lenses. We do not agree with the comment that the Tecnis[supreg] lenses
be classified as ``Aspheric Optic'' NTIOLs. NTIOL classes are defined
by clinical outcomes which provide benefits to Medicare beneficiaries.
The two previously created NTIOL classes are ``Multifocal'' and
``Reduction in Preexisting Astigmatism.'' We disagree with the
commenter's suggestion to create a new ``Aspheric Optic'' NTIOL class
as this class would not be based upon clinical outcome. We recommend
that the commenter who claimed that one of its IOLs has aspheric optic
design characteristics submit an application with evidence showing
clinical benefits of its lenses during the 2006 NTIOL application
period. We appreciate all commenters' interest in the NTIOL process.
V. NTIOL Decision--Approval of Advanced Medical Optics Application
AMO Tecnis[supreg] Lenses; Models Z9000, Z9001, and Z9003
In CY 2004, AMO applied for NTIOL designation for the
Tecnis[supreg] lenses. As part of the 2004 NTIOL review, CMS requested
FDA review of AMO's NTIOL application. FDA's review confirmed that the
clinical trial performed by AMO demonstrated that results under several
conditions tested were statistically significantly better with the
Tecnis[supreg] lens than with the control acrylic IOL. However, we
denied AMO's CY 2004 NTIOL application for the Tecnis[supreg] lenses
due to the lack of evidence that the Tecnis[supreg] design improvements
provided clinical benefits to patients.
AMO resubmitted its NTIOL request in CY 2005 and provided
additional information on the clinical relevance of reduced
postoperative spherical aberration and increased contrast sensitivity.
In the CY 2005 application, AMO provided additional peer-reviewed
published studies, a meta-analysis, and a justification of the choice
of comparator lens, none of which were included in the CY 2004
application. To demonstrate clinical superiority, AMO submitted journal
articles and AMO-sponsored research reporting improved functional
vision resulting from compensation for corneal spherical aberration. We
reviewed the additional literature submitted by AMO in its CY 2005
application and found it to be acceptable and supportive of our
requirements.
AMO claims the Tecnis[supreg] IOLs create a new class of IOLs
compensating for corneal spherical aberration. AMO states this improves
contrast sensitivity, functional performance, and especially safer
night driving. Based on the additional information from AMO, CMS
approves AMO's claims of clinical advantages and superiority of the
Tecnis[supreg] IOL for ocular spherical aberrations and simulated night
driving.
We find the AMO Tecnis[reg] Lenses Models Z9000, Z9001, and Z9003
meet the NTIOL definition and are to be given the new NTIOL
classification of Reduced Spherical Aberration.
VI. Collection of Information Requirements
Because the requirements referenced in this final 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.
VII. 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 19, 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 final notice is not a major rule. 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 $6 million to $29
million in any 1 year. Individuals and States are not included in the
definition of a small entity. We are not preparing an analysis for the
RFA because we have determined that this final notice will not have a
significant economic impact on a substantial number of small entities.
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 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 Core-
Based Statistical Area and has fewer than 100 beds. We are not
preparing an analysis for section 1102(b) of the Act because we have
determined that this final notice will 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 whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. This final notice will
have no consequential effect on State, local, or tribal governments or
on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it publishes 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. Since this final notice does not impose any
costs on State or local governments, the requirements of E.O. 13132 are
not applicable.
In accordance with the provisions of Executive Order 12866, this
final notice
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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. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program).
Dated: January 9, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. E6-1049 Filed 1-25-06; 4:00 pm]
BILLING CODE 4120-01-P
