[Federal Register: March 25, 2005 (Volume 70, Number 57)]
[Notices]
[Page 15337-15340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr05-64]
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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.
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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).
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\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.
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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