Medicare Program; Disapproval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers, 15337-15340 [05-5593]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
VI. Regulatory Impact Statement
We have examined the impact of this
final notice as required by Executive
Order 12866 and the Regulatory
Flexibility Act (RFA) (Pub. L. 98–354).
Executive Order 12866 directs agencies
to assess all costs and benefits of
available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects; distributive impacts;
and equity). The RFA requires agencies
to analyze options for regulatory relief
for small businesses. For purposes of the
RFA, States and individuals are not
considered small entities.
Also, section 1102(b) of the Act
requires the Secretary to prepare a
regulatory impact analysis for any
notice that may have a significant
impact on the operations of a substantial
number of small rural hospitals. Such
an analysis must conform to the
provisions of section 604 of the RFA.
For purposes of section 1102(b) of the
Act, we consider a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area and has
fewer than 100 beds.
This final notice recognizes CHAP as
a national accreditation organization for
HHAs that request participation in the
Medicare program. There are neither
significant costs nor savings for the
program and administrative budgets of
Medicare. Therefore, this final notice is
not a major rule as defined in Title 5,
United States Code, section 804(2) and
is not an economically significant rule
under Executive Order 12866. We have
determined, and the Secretary certifies,
that this final notice will not result in
a significant impact on a substantial
number of small entities and will not
have a significant effect on the
operations of a substantial number of
small rural hospitals. Therefore, we are
not preparing analyses for either the
RFA or section 1102(b) of the Act.
In an effort to better assure the health,
safety, and services of beneficiaries in
HHAs already certified as well as
provide relief to State budgets in this
time of tight fiscal restraints, we deem
HHAs accredited by CHAP as meeting
our Medicare requirements. Thus, we
continue our focus on assuring the
health and safety of services by
providers and suppliers already
certified for participation in a costeffective manner.
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget. In accordance
with Executive Order 13132, we have
VerDate jul<14>2003
16:11 Mar 24, 2005
Jkt 205001
determined that this final notice will
not significantly affect the rights of
States, local or tribal governments.
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—Supplemental Medical Insurance
Program)
Dated: February 11, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–5034 Filed 3–24–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3112–FN; 0938–ZA49]
Medicare Program; Disapproval of
Adjustment in Payment Amounts for
New Technology Intraocular Lenses
Furnished by Ambulatory Surgical
Centers
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
SUMMARY: In this final notice, we
summarize timely public comments
received in response to our July 23,
2004 notice with public comment
period and announce our decision
concerning applications submitted by
Alcon Laboratories, Incorporated
(Alcon) and Advanced Medical Optics
(AMO) (formerly Pharmacia & Upjohn
Company) 1 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 February 27, 2004, we published a
notice in the Federal Register 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 July 23, 2004, we
published a notice with comment
period entitled ‘‘Adjustment in Payment
Amounts for New Technology
Intraocular Lenses Furnished by
Ambulatory Surgical Centers’’
Medical Optics acquired Pharmacia &
Upjohn Company’s surgical product line on June
28, 2004 and is now the party of interest for
purposes of this Final Notice.
PO 00000
1 Advanced
Frm 00062
Fmt 4703
Sfmt 4703
15337
acknowledging timely receipt of
application materials from Alcon and
AMO. In this final notice, we announce
our decision to disapprove the NTIOL
applications submitted by both Alcon
and AMO.
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
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 a flat rate
payment adjustment of $50 for IOLs that
we determine are NTIOLs. The payment
adjustment applies for a 5-year period
that begins when we recognize a
payment adjustment for the first IOL in
a new 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
2004 (CY 2004).
We have previously approved two
classes of NTIOLs: Multifocal and
Reduction in Preexisting Astigmatism.
These IOLs were approved for NTIOL
status during calendar year 2000.
II. NTIOL Applications Submitted for
Calendar Year 2004
On February 27, 2004, we published
a notice in the Federal Register entitled
E:\FR\FM\25MRN1.SGM
25MRN1
15338
Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
‘‘Medicare Program; Calendar Year 2004
Review of the Appropriateness of
Payment Amounts for New Technology
Intraocular Lenses (NTIOLs) Furnished
by Ambulatory Surgical Centers (ASCs)’’
(69 FR 9322). In response to the
February 27, 2004 notice, we received
the following timely requests for review:
1. Manufacturer: Alcon Laboratories,
Inc. Model Numbers: ACRYSOF
Natural IOL; Models: SB30AL (5.5 mm
optic) and SN60AT (6.0 mm optic).
These two models are made out of the
same material and differ only in optic
size. Accordingly, we are treating the
two lenses as the same lens.
2. Manufacturer: Advanced Medical
Optics. Model Numbers: Tecnis, with
Z-Sharp Optic Technology, Foldable
Posterior Chamber IOL; Models Z9000
(12 mm diameter) and Z9001 (13 mm
diameter). These two models are also
made out of the same material and differ
only in diameter. Accordingly, we are
also treating these lenses as the same
lens.
On July 23, 2004, we published in the
Federal Register a notice with comment
period entitled ‘‘Medicare Program;
Adjustment in Payment Amounts for
New Technology Intraocular Lenses
Furnished by Ambulatory Surgical
Centers’’ (69 FR 44029) that summarized
these timely applications and solicited
public comments on the IOLs submitted
by Alcon and AMO.
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
February 27, 2004 Federal Register
notice.
This process includes—
• Publishing a public notice in the
Federal Register identifying
VerDate jul<14>2003
16:11 Mar 24, 2005
Jkt 205001
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 the
following payment adjustment: (a)
Determinations made before July 16,
2002—$50; (b) Determinations made
after July 16, 2002—$50 or the amount
announced through proposed and final
rules in connection with ASC services;
and
• Adjusting payments effective 30
days after the publication of the final
notice announcing our determinations
described in paragraph (8) of this
section.
In accordance with our NTIOL
application review procedures, we
asked the FDA to review the Alcon and
AMO NTIOL applications to determine
whether the manufacturers’ claims of
specific clinical advantages and
superiority over existing IOLs had been
approved for labeling and advertising
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
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 14 timely public
comments in response to the July 23,
2004 notice with comment period on
the NTIOLs under review. Of these, 11
were from ophthalmologists, two were
from IOL manufacturers, and one was
from a private citizen. The comments
we received and our responses are as
follows:
Comment: Five commenters
supported the Alcon Laboratories, Inc.
Acrysof lenses without distinguishing
between the two models presented, and
five commenters supported the AMO
Tecnis lenses without distinguishing
between the two models presented.
Based on their positive experiences with
the IOLs, these commenters requested
that the IOLs under review be classified
as NTIOLs, and therefore, eligible for
the payment adjustment.
Response: We appreciate the
commenters’ interests in these lenses
and are pleased that these lenses have
improved the quality of life of Medicare
beneficiaries. However, anecdotal
evidence supporting NTIOL status is not
sufficient to characterize an IOL as a
NTIOL. Our regulations at § 416.180
prohibit us from characterizing an IOL
as a NTIOL unless the FDA has
approved for use in labeling and
advertising the IOL’s claims of specific
clinical advantages and superiority over
existing IOLs. The FDA must rely on
published clinical data to make this
determination. Testimonials in support
of an IOL being reclassified as a NTIOL
cannot substitute for the FDA’s
approval. We present the FDA review in
section V.
Comment: Two comments from
ophthalmologists opposed NTIOL status
for the Alcon Laboratories, Inc.
Acrysof lenses, contending that the
relationship between blue light and
macular degeneration is speculative.
The comments did not distinguish
between the two models presented.
Response: Based upon our review of
the literature, we agree with the
commenters that the relationship
between blue light and macular
degeneration is speculative and not
proven by available evidence. We
present our review of the literature in
section V.
Comment: We received one comment
from an IOL manufacturer opposing
NTIOL status for the Alcon Laboratories,
Inc. Acrysof IOLs, contending that the
FDA failed to approve Alcon’s claims of
E:\FR\FM\25MRN1.SGM
25MRN1
Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
specific clinical advantages. The
comment did not distinguish between
the two models presented.
Response: While the manufacturer
claims clinical advantages for blue light
filtering in its application for NTIOL
status, the manufacturer does not make
this claim in its FDA-approved labeling.
As previously stated, claims of clinical
superiority must be approved by the
FDA for use in labeling and advertising
for an IOL to qualify as a NTIOL under
§ 416.180. We believe that the
relationship between blue light and
macular degeneration is not adequately
substantiated by the literature.
Comment: We received one comment
from an IOL manufacturer opposing
NTIOL status for the AMO Tecnis
lenses, claiming they provide no useful
improvements over existing IOLs.
Response: The literature submitted by
the manufacturer validates AMO’s
claims of increased contrast sensitivity
for the Tecnis IOLs only when the
lenses are compared to one other IOL.
However, both the literature submitted
by AMO and our independent review of
the literature did not show that the
Tecnis lenses demonstrate increased
contrast sensitivity over the spectrum of
available IOLs. We believe that for a
lens to be approved as an NTIOL, it
must offer benefits superior to those
offered by more than one other available
lens.
V. NTIOL Decision—Disapproval of
July 23, 2004 Applications by Alcon
and AMO
A. Alcon Acrysof Natural Lenses;
Model Numbers SB30AL and SN60AT
Alcon claims to have created a class
of IOL that reduces chronic blue light
exposure to the retina and reduces longterm retinal damage (macular
degeneration). However, these claims
are absent from the IOLs’ FDA-approved
labeling and advertising. In addition, a
July 12, 2004 FDA letter to CMS
concerning Alcon’s NTIOL application
states, in part, as follows: ‘‘* * * At this
point, it appears as though there is no
definitive explanation in regards to the
extent blue light plays in retinal
damage. Retinal damage is a multifactorial issue, because so many things
(e.g., environment, nutrition, etc.) may
also impact the degree of damage, if
any.’’
The same FDA letter also states that
Alcon did not receive FDA approval to
make the claim in its labeling that ‘‘the
blue light filtering quality of the
ACRYSOF Natural IOL provides a
specific clinical advantage over existing
IOLs in mitigating the risk of blue lightmediated damage to the retina.’’ In
VerDate jul<14>2003
16:11 Mar 24, 2005
Jkt 205001
contrast, the FDA approved labeling
states only that blue light transmittal is
reduced ‘‘without negatively affecting
color vision.’’ No claims of clinical
superiority for reducing blue light
transmission are made in the labeling.
Accordingly, because the FDA has not
approved labeling supporting Alcon’s
claim that these lenses, independent of
the other influencing factors, reduce
long-term retinal damage, we cannot
approve Alcon’s application to adjust
the Medicare payment amounts for
these lenses. Additionally, we reviewed
the literature submitted by Alcon and
performed our own literature search.
There is insufficient published peerreviewed evidence addressing the cause
and effect relationship between the blue
light filtering effects of an IOL and
retinal damage.
B. AMO Tecnis Lenses with Z-Sharp
Optic Technology, Foldable Posterior
Chamber IOL; Models Z9000 and Z9001
In a July 12, 2004 letter to CMS
regarding AMO’s NTIOL application,
the FDA states that ‘‘* * * significantly
less with the Tecnis lens than with the
acrylic lens. The simulated night
driving results (functional vision) under
several of the conditions tested and the
visual acuity results were statistically
significantly better in [the] eye
implanted with the Technis lens.
However, another objective [of] the
study was to demonstrate the mesopic
(6 cd/m2) intra-individual difference in
the postoperative quality of vision using
sine-wave contrast sensitivity testing
between the Tecnis lens (Z9000) and a
lens with a spherical optic. In this
clinical investigation, the contrast
sensitivity results were not significantly
different as stated in the labeling.’’
We interpret this FDA statement, as
well as our own literature review, to
mean that while there may be a
difference in contrast sensitivity
between the Tecnis lens and two other
IOLs tested, that difference is not
statistically significant. We also
reviewed the literature submitted by
AMO and performed our own literature
search. We believe there is insufficient
published peer-reviewed evidence
addressing the cause and effect
relationship between the implanted
Tecnis lens and a reduction in contrast
sensitivity. However, we encourage
AMO to resubmit this application with
additional data from published peerreviewed evidence.
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
15339
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 $8.5 million or less in any
1 year. We have determined that this
final notice will not affect small
businesses.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a regulation may have
a significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
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 final notice does
not have a significant impact on the
operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule that may result in an expenditure
in any 1 year by State, local, or tribal
governments, in the aggregate, or by the
E:\FR\FM\25MRN1.SGM
25MRN1
15340
Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
private sector, of $110 million. We have
determined that this final notice will
not have a consequential effect on the
governments mentioned or on the
private sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it 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.
We have determined that this final
notice does not have an economic
impact on State, local, or tribal
governments.
In accordance with the provisions of
Executive Order 12866, this final notice
was not reviewed by the Office of
Management and Budget.
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh)
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: March 14, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–5593 Filed 3–24–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1297–N]
Medicare Program; Public Meetings in
Calendar Year 2005 for All New Public
Requests for Revisions to the
Healthcare Common Procedure Coding
System (HCPCS) Coding and Payment
Determinations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
dates and location of the Healthcare
Common Procedure Coding System
(HCPCS) public meetings to be held in
calendar year 2005 to discuss our
preliminary coding and payment
determinations for all new public
requests for revisions to the HCPCS.
These meetings provide a forum for
interested parties to make oral
presentations or to submit written
comments in response to preliminary
coding and payment determinations.
Discussion will be directed toward
SUMMARY:
VerDate jul<14>2003
16:11 Mar 24, 2005
Jkt 205001
responses to our specific preliminary
recommendations and will include all
items on the public meeting agenda.
DATES: Meeting Dates: Given the
expansion of the public meeting
process, we have scheduled 8 additional
meeting times for 2005: Tuesday, June 7;
Wednesday, June 8; Tuesday, June 14;
Wednesday, June 15; Thursday, June 16;
Tuesday, June 21; Wednesday, June 22;
and Thursday, June 23. We may not
need all 8 days. Once the review and
coding recommendation process is
underway, we will have a firmer idea of
the exact number of days needed to
schedule the public meetings. We will
consider each meeting individually, and
we may modify the meeting dates and
times published in this notice.
Final confirmation of meeting dates,
times, and agenda items will be posted
3 weeks in advance of each scheduled
meeting on the official HCPCS Web site:
https://www.cms.hhs.gov/medicare/
hcpcs. Each meeting day will begin at 9
a.m. and end at 5 p.m., E.S.T.
ADDRESSES: The public meetings will be
held in the auditorium at Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore,
Maryland 21244.
FOR FURTHER INFORMATION CONTACT:
Gloria Knight, (410) 786–4598, Jennifer
Carver, (410) 786–6610.
Web Site: Additional details regarding
the public meeting process for all new
public requests for revisions to the
HCPCS, along with information on how
to register and guidelines for an
effective presentation, will be posted at
least 1 month before the first meeting
date on the official HCPCS Web site:
https://www.cms.hhs.gov/medicare/
hcpcs.
Individuals who intend to provide a
presentation at a public meeting need to
familiarize themselves with this
information. The HCPCS Web site will
also include ‘‘The Healthcare Common
Procedures Coding System (HCPCS)
Procedures,’’ a description of the new
HCPCS coding process, along with a
detailed explanation of the procedures
used to make coding and payment
determinations for all the products,
supplies, and services that are coded in
the HCPCS. A summary of each public
meeting will be posted on the HCPCS
Web site by the end of July 2005.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Congress
passed the Medicare, Medicaid, and
SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA) (Pub. L.
106–554). Section 531(b) of BIPA
mandated that we establish procedures
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
that permit public consultation for
coding and payment determinations for
new durable medical equipment (DME)
under Medicare Part B of title XVIII of
the Social Security Act (the Act). The
procedures and public meetings
announced in this notice for new DME
are in response to the mandate of
section 531(b) of BIPA.
We published a notice in the
November 23, 2001 Federal Register (66
FR 58743) with information regarding
the establishment of the public meeting
process for DME.
The public meeting process
previously limited to DME has been
expanded to include all new public
requests for revisions to the HCPCS.
This change will provide more
opportunities for the public to become
aware of coding changes under
consideration, as well as opportunities
for CMS to gather public input.
II. Registration
Registration Procedures: Registration
can be completed online at https://
www.cms.hhs.gov/medicare/hcpcs. To
register by telephone, contact Public
Meeting Coordinators Gloria Knight at
(410) 786–4598 or Jennifer Carver at
(410) 786–6610. The following
information must be provided when
registering: name, company name and
address, telephone and fax numbers, email address, and special needs
information. Registrants must also
indicate whether they are the ‘‘primary
speaker’’ for an agenda item. Primary
speakers must be designated by the
entity that submitted the HCPCS coding
request. A CMS staff member will
confirm your registration by mail, email, or fax.
Registration Deadline: Individuals
must register for each date they plan
either to attend or to provide a
presentation. The deadline for
registration of all the meeting dates is
Tuesday, May 17, 2005.
III. Presentations and Comment Format
A. Primary Speaker Presentations
The entity that requested revisions to
the HCPCS coding system for a
particular agenda item may designate
one ‘‘primary speaker’’ to make a
presentation for a maximum of 15
minutes. Fifteen minutes is the total
time interval for the presentation, and
must incorporate the demonstration, setup, and distribution of material. In
establishing the public meeting agenda,
we may group multiple, related requests
under the same agenda item. In that
case, we will decide whether additional
time will be allotted, and may opt to
increase the amount of time allotted to
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Notices]
[Pages 15337-15340]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3112-FN; 0938-ZA49]
Medicare Program; Disapproval of Adjustment in Payment Amounts
for New Technology Intraocular Lenses Furnished by Ambulatory Surgical
Centers
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: In this final notice, we summarize timely public comments
received in response to our July 23, 2004 notice with public comment
period and announce our decision concerning applications submitted by
Alcon Laboratories, Incorporated (Alcon) and Advanced Medical Optics
(AMO) (formerly Pharmacia & Upjohn Company) \1\ to adjust the Medicare
payment amounts for certain intraocular lenses (IOLs) on the basis that
they are new technology intraocular lenses (NTIOLs).
---------------------------------------------------------------------------
\1\ Advanced Medical Optics acquired Pharmacia & Upjohn
Company's surgical product line on June 28, 2004 and is now the
party of interest for purposes of this Final Notice.
---------------------------------------------------------------------------
This is the third of three statutorily required Federal Register
documents. On February 27, 2004, we published a notice in the Federal
Register 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 July 23, 2004, we
published a notice with comment period entitled ``Adjustment in Payment
Amounts for New Technology Intraocular Lenses Furnished by Ambulatory
Surgical Centers'' acknowledging timely receipt of application
materials from Alcon and AMO. In this final notice, we announce our
decision to disapprove the NTIOL applications submitted by both Alcon
and AMO.
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 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 a flat rate payment adjustment
of $50 for IOLs that we determine are NTIOLs. The payment adjustment
applies for a 5-year period that begins when we recognize a payment
adjustment for the first IOL in a new 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 2004 (CY 2004).
We have previously approved two classes of NTIOLs: Multifocal and
Reduction in Preexisting Astigmatism. These IOLs were approved for
NTIOL status during calendar year 2000.
II. NTIOL Applications Submitted for Calendar Year 2004
On February 27, 2004, we published a notice in the Federal Register
entitled
[[Page 15338]]
``Medicare Program; Calendar Year 2004 Review of the Appropriateness of
Payment Amounts for New Technology Intraocular Lenses (NTIOLs)
Furnished by Ambulatory Surgical Centers (ASCs)'' (69 FR 9322). In
response to the February 27, 2004 notice, we received the following
timely requests for review:
1. Manufacturer: Alcon Laboratories, Inc. Model Numbers:
ACRYSOF[supreg] Natural IOL; Models: SB30AL (5.5 mm optic) and SN60AT
(6.0 mm optic). These two models are made out of the same material and
differ only in optic size. Accordingly, we are treating the two lenses
as the same lens.
2. Manufacturer: Advanced Medical Optics. Model Numbers:
Tecnis[supreg], with Z-Sharp Optic Technology, Foldable Posterior
Chamber IOL; Models Z9000 (12 mm diameter) and Z9001 (13 mm diameter).
These two models are also made out of the same material and differ only
in diameter. Accordingly, we are also treating these lenses as the same
lens.
On July 23, 2004, we published in the Federal Register a notice
with comment period entitled ``Medicare Program; Adjustment in Payment
Amounts for New Technology Intraocular Lenses Furnished by Ambulatory
Surgical Centers'' (69 FR 44029) that summarized these timely
applications and solicited public comments on the IOLs submitted by
Alcon and AMO.
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 February 27, 2004 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 the following payment adjustment: (a) Determinations made
before July 16, 2002--$50; (b) Determinations made after July 16,
2002--$50 or the amount announced through proposed and final rules in
connection with ASC services; and
Adjusting payments effective 30 days after the publication
of the final notice announcing our determinations described in
paragraph (8) of this section.
In accordance with our NTIOL application review procedures, we
asked the FDA to review the Alcon and AMO NTIOL applications to
determine whether the manufacturers' 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 14 timely public comments in response to the July 23,
2004 notice with comment period on the NTIOLs under review. Of these,
11 were from ophthalmologists, two were from IOL manufacturers, and one
was from a private citizen. The comments we received and our responses
are as follows:
Comment: Five commenters supported the Alcon Laboratories, Inc.
Acrysof[supreg] lenses without distinguishing between the two models
presented, and five commenters supported the AMO Tecnis[supreg] lenses
without distinguishing between the two models presented. Based on their
positive experiences with the IOLs, these commenters requested that the
IOLs under review be classified as NTIOLs, and therefore, eligible for
the payment adjustment.
Response: We appreciate the commenters' interests in these lenses
and are pleased that these lenses have improved the quality of life of
Medicare beneficiaries. However, anecdotal evidence supporting NTIOL
status is not sufficient to characterize an IOL as a NTIOL. Our
regulations at Sec. 416.180 prohibit us from characterizing an IOL as
a NTIOL unless the FDA has approved for use in labeling and advertising
the IOL's claims of specific clinical advantages and superiority over
existing IOLs. The FDA must rely on published clinical data to make
this determination. Testimonials in support of an IOL being
reclassified as a NTIOL cannot substitute for the FDA's approval. We
present the FDA review in section V.
Comment: Two comments from ophthalmologists opposed NTIOL status
for the Alcon Laboratories, Inc. Acrysof[supreg] lenses, contending
that the relationship between blue light and macular degeneration is
speculative. The comments did not distinguish between the two models
presented.
Response: Based upon our review of the literature, we agree with
the commenters that the relationship between blue light and macular
degeneration is speculative and not proven by available evidence. We
present our review of the literature in section V.
Comment: We received one comment from an IOL manufacturer opposing
NTIOL status for the Alcon Laboratories, Inc. Acrysof[supreg] IOLs,
contending that the FDA failed to approve Alcon's claims of
[[Page 15339]]
specific clinical advantages. The comment did not distinguish between
the two models presented.
Response: While the manufacturer claims clinical advantages for
blue light filtering in its application for NTIOL status, the
manufacturer does not make this claim in its FDA-approved labeling. As
previously stated, claims of clinical superiority must be approved by
the FDA for use in labeling and advertising for an IOL to qualify as a
NTIOL under Sec. 416.180. We believe that the relationship between
blue light and macular degeneration is not adequately substantiated by
the literature.
Comment: We received one comment from an IOL manufacturer opposing
NTIOL status for the AMO Tecnis[supreg] lenses, claiming they provide
no useful improvements over existing IOLs.
Response: The literature submitted by the manufacturer validates
AMO's claims of increased contrast sensitivity for the Tecnis[supreg]
IOLs only when the lenses are compared to one other IOL. However, both
the literature submitted by AMO and our independent review of the
literature did not show that the Tecnis[supreg] lenses demonstrate
increased contrast sensitivity over the spectrum of available IOLs. We
believe that for a lens to be approved as an NTIOL, it must offer
benefits superior to those offered by more than one other available
lens.
V. NTIOL Decision--Disapproval of July 23, 2004 Applications by Alcon
and AMO
A. Alcon Acrysof[supreg] Natural Lenses; Model Numbers SB30AL and
SN60AT
Alcon claims to have created a class of IOL that reduces chronic
blue light exposure to the retina and reduces long-term retinal damage
(macular degeneration). However, these claims are absent from the IOLs'
FDA-approved labeling and advertising. In addition, a July 12, 2004 FDA
letter to CMS concerning Alcon's NTIOL application states, in part, as
follows: ``* * * At this point, it appears as though there is no
definitive explanation in regards to the extent blue light plays in
retinal damage. Retinal damage is a multi-factorial issue, because so
many things (e.g., environment, nutrition, etc.) may also impact the
degree of damage, if any.''
The same FDA letter also states that Alcon did not receive FDA
approval to make the claim in its labeling that ``the blue light
filtering quality of the ACRYSOF[reg] Natural IOL provides a specific
clinical advantage over existing IOLs in mitigating the risk of blue
light-mediated damage to the retina.'' In contrast, the FDA approved
labeling states only that blue light transmittal is reduced ``without
negatively affecting color vision.'' No claims of clinical superiority
for reducing blue light transmission are made in the labeling.
Accordingly, because the FDA has not approved labeling supporting
Alcon's claim that these lenses, independent of the other influencing
factors, reduce long-term retinal damage, we cannot approve Alcon's
application to adjust the Medicare payment amounts for these lenses.
Additionally, we reviewed the literature submitted by Alcon and
performed our own literature search. There is insufficient published
peer-reviewed evidence addressing the cause and effect relationship
between the blue light filtering effects of an IOL and retinal damage.
B. AMO Tecnis[supreg] Lenses with Z-Sharp Optic Technology, Foldable
Posterior Chamber IOL; Models Z9000 and Z9001
In a July 12, 2004 letter to CMS regarding AMO's NTIOL application,
the FDA states that ``* * * significantly less with the Tecnis[supreg]
lens than with the acrylic lens. The simulated night driving results
(functional vision) under several of the conditions tested and the
visual acuity results were statistically significantly better in [the]
eye implanted with the Technis[reg] lens. However, another objective
[of] the study was to demonstrate the mesopic (6 cd/m2)
intra-individual difference in the postoperative quality of vision
using sine-wave contrast sensitivity testing between the Tecnis[supreg]
lens (Z9000) and a lens with a spherical optic. In this clinical
investigation, the contrast sensitivity results were not significantly
different as stated in the labeling.''
We interpret this FDA statement, as well as our own literature
review, to mean that while there may be a difference in contrast
sensitivity between the Tecnis[supreg] lens and two other IOLs tested,
that difference is not statistically significant. We also reviewed the
literature submitted by AMO and performed our own literature search. We
believe there is insufficient published peer-reviewed evidence
addressing the cause and effect relationship between the implanted
Tecnis[supreg] lens and a reduction in contrast sensitivity. However,
we encourage AMO to resubmit this application with additional data from
published peer-reviewed evidence.
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 $8.5 million or
less in any 1 year. We have determined that this final notice will not
affect small businesses.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a regulation may have a significant
impact on the operations of a substantial number of small rural
hospitals. This analysis must conform to 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 final notice does not have a significant impact on
the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in an expenditure in any 1 year by
State, local, or tribal governments, in the aggregate, or by the
[[Page 15340]]
private sector, of $110 million. We have determined that this final
notice will not have a consequential effect on the governments
mentioned or on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it 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. We have determined that this final notice does
not have an economic impact on State, local, or tribal governments.
In accordance with the provisions of Executive Order 12866, this
final notice was not reviewed by the Office of Management and Budget.
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: March 14, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-5593 Filed 3-24-05; 8:45 am]
BILLING CODE 4120-01-P
