[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Notices]
[Pages 4586-4589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1049]


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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

[[Page 4587]]

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

[[Page 4588]]

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