[Federal Register Volume 71, Number 82 (Friday, April 28, 2006)]
[Notices]
[Pages 25176-25178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3171-N; and 0938-ZA91]


Medicare Program; Calendar Year 2006 Review of the 
Appropriateness of Payment Amounts for New Technology Intraocular 
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs) and 
Correction

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

ACTION: Notice.

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SUMMARY: This notice solicits interested parties to submit requests for 
review of the appropriateness of the payment amount for a particular 
intraocular lens furnished by an ambulatory surgical center. Also, this 
notice corrects typographical errors in the notice with public comment 
period that appeared in the September 30, 2005 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 57297), and in the final notice that appeared in the January 27, 
2006 Federal Register entitled ``Medicare Program; Approval of 
Adjustment in Payment Amounts for New Technology Intraocular Lenses 
Furnished by Ambulatory Surgical Centers'' (71 FR 4586).

DATES: Requests for review must be received at the address provided no 
later than 5 p.m. on May 30, 2006.

ADDRESSES: Mail requests for review (one original and three copies) to 
the Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: Michael Lyman, Mailstop C1-09-06, 7500 
Security Blvd., Baltimore, Maryland 21244-1850.

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

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Requirements

    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 the Secretary of the Department of Health and Human 
Services to develop and implement a process under which interested 
parties may request a review of the appropriateness of the payment 
amount for intraocular lenses (IOLs) furnished by ambulatory surgical 
centers (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 (NTIOLs).
    On June 16, 1999, the Centers for Medicare & Medicaid Services 
(CMS) (then known as the Health Care Financing Administration), 
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 IOL request that we review and approve with the same 
characteristics as the first IOL recognized for a payment adjustment 
will receive the adjustment for the remainder of the 5-year period 
established by the first recognized NTIOL. After July 16, 2002, we have 
the option of changing the $50 adjustment amount through proposed and 
final rulemaking. We have opted not to change the adjustment amount for 
calendar year 2006 (CY 06).

B. CMS Review Process for Establishing Classes of New Technology 
Intraocular Lenses (NTIOLs)

    We will classify an IOL as a 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 Food and Drug Administration (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.'' Thus, an IOL must first be an FDA 
approved IOL before we can designate that IOL as an NTIOL.
    We evaluate requests for the designation of an IOL as an NTIOL by 
doing the following:
    (1) Publishing a public notice in the Federal Register that 
identifies the requirements and deadline for submitting a request for a 
review of the appropriateness of the payment amount for an IOL.
    (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 notice in the Federal Register that lists 
the requests and provides the public with 30 days to submit comments on 
the IOLs for which a review was requested.
    (5) Reviewing the information submitted with the applicant's 
request for review, and confirming the FDA labeling for the IOL model 
under review. We also review the available evidence relevant to FDA's 
labeling approval as to whether or not the IOL model submitted 
represents a new class

[[Page 25177]]

of technology that sets it apart from other IOLs.
    (6) Determining which lenses meet the criteria to qualify for the 
payment adjustment based on clinical data and evidence submitted for 
review, the FDA approved label, public comments on the lenses, and 
other available information. NTIOL applicants should provide good 
evidence-based studies supporting the claimed clinical benefits. We are 
interested in receiving data showing functional clinical improvements.
    (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 (within 90 days 
after we publish the notice identified in paragraph (4) of this 
section) that announces the IOLs that we have determined are ``new 
technology'' IOLs. These NTIOLs qualify for a $50 (or other amount that 
we may adopt through notice and comment rulemaking) payment adjustment 
for a 5-year period.
    (9) Adjusting payments effective 30 days after the publication of 
the final notice announcing our determinations described in paragraph 
(8) of this section.

C. Who May Request a Review

    As specified in Sec.  416.190, any party who is able to furnish the 
information required in Sec.  416.195 may request that we review the 
appropriateness of the payment amount provided under section 
1833(i)(2)(A)(iii) of the Act for an IOL that, as claimed by the party, 
meets the definition of a new technology IOL in Sec.  416.180.

D. Requests to Review

    As specified in Sec.  416.195(a), a request to review must include 
all of the following information:
     The name of the manufacturer, the model number, and the 
trade name of the IOL.
     A copy of the FDA's summary of the IOL's safety and 
effectiveness.
     A copy of the current FDA approved label supporting claims 
of specific clinical advantages for the IOL.
     A copy of the IOL's original FDA approval notification.
     Reports of modifications made after the original FDA 
approval.
     Other information that supports the requestor's claim 
(including clinical trials, case studies, journal articles, etc.).

E. Privileged or Confidential Information

    To the extent that information received from an IOL manufacturer 
can reasonably be characterized as a trade secret or as privileged or 
confidential commercial or financial information, Sec.  416.195(b) 
requires that we maintain the confidentiality of the information and 
protect it from disclosure not otherwise authorized or required by 
Federal law as allowed under Exemption 4 of the Freedom of Information 
Act (5 U.S.C. 552(b)(4)) and, with respect to trade secrets, the Trade 
Secrets Act (18 U.S.C. 1905). We recommend that the requestor clearly 
identify all information that is to be characterized as confidential.

F. Application of the Payment Adjustment

    As provided in Sec.  416.200, we recognize all IOL(s) that meet the 
definition of a new technology IOL for purposes of subpart F of part 
416 as belonging to a class of NTIOLs for a period of 5 years effective 
from the date that we recognize the first NTIOL in that subset. Any IOL 
that we subsequently recognize as belonging to a new technology subset 
receives the new technology payment adjustment for the remainder of the 
5-year period established with our recognition of the first NTIOL in 
the subset. Beginning 5 years after the effective date of our initial 
recognition of a new technology subset, the payment adjustment ceases 
for all IOLs that we have designated as belonging to that subset. The 
process to apply for inclusion in an existing NTIOL subset is described 
at: http://www.cms.hhs.gov/CoverageGenInfo/downloads/AppforcurrentNTIOLsubset.pdf.

II. Provisions of This Notice

A. Calendar Year 2006 Review of the Appropriateness of Payment Amounts 
for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory 
Surgical Centers (ASCs)

    Under our rules at 42 CFR part 416, subpart F, we are soliciting 
requests for review of the appropriateness of the payment amount for 
IOLs furnished by an ASC. Requests for review must comply with our 
regulations at Sec.  416.195 and be received at the address provided by 
the date specified in the DATES section of this notice. We will 
announce timely requests for review in a subsequent notice that will 
allow for public comment. Currently, if we determine that an 
intraocular lens meets the definition of a new technology intraocular 
lens, the lens will be eligible for a payment adjustment of $50.

B. Summary of Corrections to the September 30, 2005 and January 27, 
2006 Federal Register Notices

    In this notice, we also correct a typographical error that appeared 
in the September 30, 2005 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 57297) and in the final notice that 
published in the Federal Register on January 27, 2006 entitled 
``Medicare Program; Approval of Adjustment in Payment Amounts for New 
Technology Intraocular Lenses Furnished by Ambulatory Surgical 
Centers'' (71 FR 4586). We approved the NTIOL application submitted by 
AMO for Tecnis[supreg] IOL model numbers Z9000, Z9001, and ZA9003. 
However, we made a typographical error and listed the Tecnis[supreg] 
IOL model as ``Z9003'' instead of ``ZA9003'' in both the September 30, 
2005 notice with public comment period and the January 27, 2006 final 
notice. In this notice, we correct the Tecnis[supreg] IOL model number 
Z9003 and replace it with Tecnis[supreg] IOL model number ZA9003.

C. Corrections to September 30, 2005 and January 27, 2006 Federal 
Register Notices

    In FR Doc. 05-19483, published on September 30, 2005, (70 FR 
57297), we are making the following correction:
    1. On page 57299, in the first column, in the 16th line, ``Z9003'' 
is corrected to read ``ZA9003''.
    In FR Doc. E6-1049, published on January 27, 2006 (71 FR 4586), we 
are making the following corrections:
    1. On page 4586, in the third column, in the second paragraph, in 
the last line, ``Z9003'' is corrected to read ``ZA9003''.
    2. On page 4587, in the first column, in the last paragraph, lines 
4 and 6, ``Z9003'' is corrected to read ``ZA9003''.
    3. On page 4588, in the first column, in the 16th line from the 
bottom, ``Z9003'' is corrected to read ``ZA9003''.
    4. On page 4588, in the second column, in the third paragraph, in 
the second line, ``Z9003'' is corrected to read ``ZA9003''.

III. Collection of Information Requirements

    Because the requirements referenced in this notice will not affect 
10 or more persons on an annual basis, this notice does not impose any 
information collection and recordkeeping requirements that are subject 
to review by the Office of Management and

[[Page 25178]]

Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

IV. 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 19, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 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 annually). We have determined 
that this notice is not a major rule because it merely solicits 
interested parties to submit requests for review of the appropriateness 
of the payment amount with regard to a particular IOL furnished by an 
ASC.
    The RFA requires agencies to analyze options for small business 
regulatory relief. 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 or less in any 1 year period. Approximately 83 
percent of ASCs generate revenues of $18.5 million or less and are 
considered small business entities according to the Small Business 
Administration. Although a substantial number of ASCs may be affected, 
we do not believe there will be significant economic impact on small 
businesses for the reason stated above.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule 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 notice, which affects only ASCs, will have no effect on 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 one year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million. Because this notice only affects ASCs, 
we have determined that it 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. Because this notice merely solicits interested 
parties to submit requests for review of the appropriateness of the 
payment amount with regard to a particular IOL furnished by an ASC, we 
have determined that it 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) and 1833(i)(2)(a)(iii) of 
the Social Security Act (42 U.S.C. 1395k(a)(2)(F)(i) and 
1395l(i)(2)(A)(iii)).

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

    Dated: April 19, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-3973 Filed 4-27-06; 8:45 am]
BILLING CODE 4120-01-P