[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Notices]
[Pages 30731-30733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3144-N]
RIN 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.

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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.

DATES: Requests for review must be received at the address provided no 
later than 5 pm E.S.T. on June 27, 2005.

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: 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 (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, 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 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 in connection with ambulatory surgical center services. We 
have opted not to change the adjustment amount for calendar year 2005 
(CY 05).

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

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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.''
    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 public 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 requesting confirmation from the FDA about 
labeling applications that have been approved on the IOL model under 
review. We also request 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.
    (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. NTIOL applicants should provide good evidence-
based studies supporting the claimed clinical benefits. We are 
interested in receiving data showing functional clinical improvements, 
as opposed to improvements that have statistical significance without 
functional clinical significance.
    (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.

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 Sec.  
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.

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 labeling claims of specific clinical 
advantages approved by the FDA 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.).

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.

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.

I. Provisions of This Notice

    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.

II. 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 record keeping requirements that are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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 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

[[Page 30733]]

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 affect 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 21, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-10760 Filed 5-26-05; 8:45 am]
BILLING CODE 4120-01-P