[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
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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