[Federal Register: February 27, 2004 (Volume 69, Number 39)]
[Page 9322-9323]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe04-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3112-N]
RIN 0938-ZA49
Medicare Program; Calendar Year 2004 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 p.m. E.S.T. on March 29, 2004.
ADDRESSES: Mail requests for review (one original and three copies) to
the Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: Betty Shaw, Mailstop C1-09-06, 7500 Security
Blvd., Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: Betty Shaw, (410) 786-6100.
SUPPLEMENTARY INFORMATION: On October 31, 1994, the Social Security Act
Amendments of 1994 (SSAA 1994) (Pub. L. 103-432) were enacted. Section
141(b) of SSAA 1994 requires us to develop and implement a process
under which interested parties may request, for a class of new
technology intraocular lens (NTIOLs), 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 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 a 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 subset of an existing class of
IOLs or 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 IOL. After July 16,
2002, we have the option of changing the $50 adjustment amount through
a notice with a comment period. We have opted not to change that
adjustment amount for calendar year 2004 (CY 04).
Review Process for Establishing Classes of New Technology Intraocular
Lenses (NTIOLs)
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 announces a deadline for submitting a
request for us to review payment 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 Food and Drug
Administration (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.
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 that
are classified by a predominant characteristic such as reducing the
risk of intraoperative or postoperative complications or trauma, or
demonstrating accelerated postoperative recovery, reduced induced
astigmatism, improved postoperative visual acuity, more stable
postoperative vision, or other comparable clinical advantages.
(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 (within 120 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 the following payment
adjustment:
(a) Determinations made before July 16, 2002--$50.
(b) Determinations made after July 16, 2002--$50 or the amount
announced through proposed and final rules in connection with ASC
services.
(9) Adjusting payments effective 30 days after the publication of
the notice announcing our determinations described in paragraph (8) of
this section.
Who May Request a Review
Any party who is able to furnish the information required in Sec.
416.195 (A request to review) 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 meets the definition of a
[[Page 9323]]
new technology IOL in Sec. 416.180 (Definitions).
Requests To Review
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, and 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, 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,
for 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. Under the Freedom of Information Act
(FOIA), we may not withhold publication of information based on the
type of information contained, but rather on an identifiable harm that
release of that information would present.
Application of the Payment Adjustment
We recognize the IOL(s) that define a new technology subset for
purposes of subpart F of part 416 as belonging to the class of NTIOLs
for a period of 5 years effective from the date that we recognize the
first new technology IOL within the subset for a payment adjustment.
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.
II. 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 a lens as an
NTIOL, the lens will be eligible for a payment adjustment of $50 or a
different amount implemented through proposed and final rules.
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 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.).
IV. Regulatory Impact Statement
We have examined the impacts of this rule 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 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 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 $26
million to $29 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 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 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 one 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.
(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare-
-Hospital Insurance Program; and No. 93.774, Medicare--Supplementary
Medical Insurance Program)
Dated: February 5, 2004.
Dennis G. Smith,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-4274 Filed 2-26-04; 8:45 am]
BILLING CODE 4120-01-P