[Federal Register Volume 70, Number 189 (Friday, September 30, 2005)]
[Notices]
[Pages 57297-57299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19483]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3144-NC; 0938-ZA49]


Medicare Program; Calendar Year 2005 Review of the 
Appropriateness of Payment Amounts for New Technology Intraocular 
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with public comment period.

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SUMMARY: In this notice with public comment period, we announce the 
requests we have received from entities seeking review of the 
appropriateness of the Medicare payment amount for new technology 
lenses furnished by ambulatory surgical centers (ASCs). Interested 
parties submitted these requests for review in response to our May 27, 
2005 Federal Register notice 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).'' We received one timely application for review by the 
June 27, 2005 due date listed in that Federal Register notice. In this 
notice with comment period, we summarize the timely application 
received and solicit public comments on the one intraocular lens (IOL) 
under review.

DATES: To be assured consideration, comments regarding the intraocular 
lenses specified in this notice must be received at one of the 
addresses provided below, no later than 5 p.m. on October 31, 2005.

ADDRESSES: In commenting, please refer to file code CMS-3144-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this notice to http://

[[Page 57298]]

www.cms.hhs.gov/regulations/ecomments (attachments should be in 
Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft 
Word).
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attn: CAPT Michael Lyman, CMS-3144-NC, Mail Stop C1-09-
06, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments (one 
original and two copies) to the following address only:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3144-NC, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.

    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members.

Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201; or
7500 Security Boulevard, Baltimore, MD 21244-1850.

    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Michael Lyman, (410) 786-6938.

SUPPLEMENTARY INFORMATION:

I. Regulatory 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, with respect to a class of new 
technology intraocular lens (NTIOLs), a review of the appropriateness 
of the payment amount for intraocular lenses (IOLs) furnished by ASCs 
under section 1833(i)(2)(A)(iii) of the Social Security Act (the Act).
    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 ASCs (Sec.  416.185); defined the terms relevant to the 
process (Sec.  416.180); and established an initial flat rate payment 
adjustment of $50 for IOLs that we determined were NTIOLs (Sec.  
416.185(f)(1)). As provided in section 416.200, the payment adjustment 
applies for a 5-year period that begins when we recognize a payment 
adjustment for the first NTIOL. Any subsequent IOLs with the same 
characteristics as the first IOL recognized for a payment adjustment 
will receive the same payment adjustment for the remainder of the 5-
year period established by the first recognized NTIOL (Sec.  
416.200(b)). In accordance with the payment review process specified in 
Sec.  416.185(f)(2), after July 16, 2002, we have authority to modify 
the $50 adjustment amount through proposed and final rulemaking in 
connection with ambulatory surgical center services. To date however, 
we have made no changes to the payment amount and have opted not to 
change the adjustment for calendar year 2005 (CY 2005).
    We will classify an IOL as an NTIOL if the lens meets the 
definition of a ``new technology IOL'' in 42 CFR 416.180, which 
incorporates section 141(b)(2) of SSAA 1994. Under that section, a 
``new technology IOL'' is defined as ``an IOL that CMS determines has 
been approved by the 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 an NTIOL 
furnished by ASCs is described in our regulations at 42 CFR part 416, 
subpart F and in the February 27, 2004 Federal Register notice. This 
process includes: (1) Publishing a public notice in the Federal 
Register identifying requirements and the deadline for submitting a 
request; (2) Processing requests to review the appropriateness of the 
payment amount for an IOL; (3) Compiling a list of the requests we 
receive that identify the IOL manufacturer, IOL model number under 
review, name of the requester, and a summary of the request for review 
of the appropriateness of the IOL payment amount; (4) Publishing an 
annual public notice in the Federal Register that lists the requests 
and provides for a 30-day public comment period; (5) 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 proof of superiority over 
existing IOLs as described in the preceding paragraph; (6) 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; (7) Designating a type of material or a predominant 
characteristic of an NTIOL that sets it apart from other IOLs to 
establish a new class; (8) Publishing a notice in the Federal Register 
announcing the IOLs that we have determined are ``new technology'' 
IOLs. These NTIOLs qualify for a $50 payment adjustment or the amount 
announced through proposed and final rules in connection with ASC 
services; and (9) Adjusting payments effective 30 days after the 
publication of the final notice announcing our determinations described 
in paragraph (8) of this section.

II. Applications for New Technology Intraocular Lens (NTIOLs) for 
Calendar Year 2005

    On May 27, 2005 we published the first notice in the Federal 
Register entitled ``Medicare Program; Calendar Year 2005 Review of the

[[Page 57299]]

Appropriateness of Payment Amounts for New Technology Intraocular 
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' to 
solicit requests for review of applications for a payment adjustment 
with respect to a class of NTIOLs.
    We received one request for the $50 payment adjustment by the June 
27, 2005 due date specified in the notice:
    Manufacturer and Requestor: Advanced Medical Optics (AMO); 1700 E. 
St. Andrew Place; P.O. Box 25162; Santa Ana, California 92799-5162.
    Model Numbers: Tecnis<SUP>[reg]</SUP> Models Z9000, Z9001 and 
Z9003.
    Reason for Requesting Review: The requestor states that the 
Tecnis[supreg] IOLs were designed to improve contrast sensitivity, 
reduce ocular spherical aberration, and improve the functional vision 
of cataract surgery patients with implanted IOLs.
    Tecnis<SUP>[reg]</SUP> Models Z9000 and Z9001 were previously 
submitted for NTIOL designation in calendar year 2004 and were 
determined by CMS to be ineligible for NTIOL designation due to a lack 
of evidence that the design improvements provided a clinical benefit to 
patients. AMO has resubmitted its NTIOL request and provided additional 
information on the clinical relevance of increased contrast 
sensitivity. AMO provided FDA-approved product labeling claiming 
improved functional vision compared with another IOL. AMO also provided 
additional studies, a meta-analysis, and justification of the choice of 
comparator lens that were not included in the previous 2004 NTIOL 
application.
    Submitting Comments: We welcome comments from the public on the 
appropriateness of the Medicare payment amount for the Tecnis' IOLs 
listed in this notice with public comment period. You can assist us by 
referencing the file code CMS-3144-NC.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. After the close of the 
comment period, CMS posts all electronic comments received before the 
close of the comment period on its public Web site. Comments received 
timely will be available for public inspection as they are received, 
generally beginning approximately 3 weeks after publication of a 
document, at the headquarters of the Centers for Medicare & Medicaid 
Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday 
through Friday from 8:30 a.m. to 4 p.m. Please contact us by phone at 
(800) 743-3951 to schedule an appointment to view public comments 
associated with this notice.
    Copies: You can view and photocopy this Federal Register document 
at most libraries designated as Federal Depository Libraries and at 
many other public and academic libraries throughout the country that 
receive the Federal Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The web site address is: http://www.access.gpo.gov/fr/index.html.

Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, 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 preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

III. Regulatory Impact Statement

    We have examined the impact of this notice as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 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 notice is not a major rule because it 
merely summarizes the timely applications received and solicits 
comments on IOLs under review.
    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 small governmental 
jurisdictions. 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 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 603 
of the RFA. For purposes of section 1102(b) of the Act, we define a 
small rural hospital as a hospital that is located outside of a 
Metropolitan Statistical Area and has fewer than 100 beds. We have 
determined that this notice 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 
private sector, of $110 million. We have determined that this 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 promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State, 
local, or tribal governments, preempts State law, or otherwise has 
federalism implications. We have determined that this notice does not 
have an economic impact on State, local, or tribal governments.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Sections 1832(a)(2)(F)(i) (42 U.S.C. 
1395k(a)(2)(F)(i)) and 1833(i)(2)(A)(iii) (42 U.S.C. 
1395l(i)(2)(A)(iii)) of the Social Security Act, and Section 141(b) 
of the Social Security Act Amendments of 1994, Pub. L. 103-432).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: September 23, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-19483 Filed 9-29-05; 8:45 am]
BILLING CODE 4120-01-P