[Federal Register Volume 68, Number 40 (Friday, February 28, 2003)]
[Notices]
[Pages 9680-9681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3099-N]


Medicaid Program; Annual 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 April 18, 2003.

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 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 
titled ``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. That rule set forth the 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 intraocular 
lenses (IOLs) that we determine are NTIOLs. This payment adjustment is 
good for a 5-year period that begins when we recognize a payment 
adjustment for the first intraocular lens in a new subset of an 
existing class of intraocular lens or a new class of technology, as 
explained below. Any subsequent IOL 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 may change the $50 
adjustment amount through a notice with comment period. There will be 
no adjustment change for calendar year 2003.

Review Process for Establishing Classes of New Technology Intraocular 
Lenses

    We evaluate requests for the designation of an IOL as an NTIOL by 
doing the following:
    (1) Publishing a notice in the Federal Register announcing the 
deadline and requirements for submitting a request for us to review 
payment for an IOL.
    (2) Receiving requests to review the appropriateness of the payment 
amount for an IOL.
    (3) Compiling a list of the requests we receive and identify the 
IOL manufacturer's name, the model number of the IOL to be reviewed, 
the interested party or parties that submit requests, and a summary of 
the interested party's grounds for requesting review of the 
appropriateness of the IOL payment amount.
    (4) Publishing a notice in the Federal Register listing the 
requests, and giving the public 30 days to comment on the IOLs for 
which a review was requested.
    (5) Reviewing the information submitted with the request to review, 
and requesting confirmation from the Food and Drug Administration (FDA) 
about labeling applications that have been approved on the model lens 
under review. We also request a recommendation from the FDA about 
whether or not the lens model represents a new class of technology that 
sets it apart from other IOLs.
    Using a baseline of the date of the last determination of new 
classes of intraocular lenses, 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 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) announcing 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 
ambulatory surgical center 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 
new technology IOL in Sec.  416.180 (Definitions).

Requests To Review

    A request to review must include all of the following information:
    [sbull] The name of the manufacturer, the model number, and the 
trade name of the IOL.
    [sbull] A copy of the FDA's summary of the IOL's safety and 
effectiveness.

[[Page 9681]]

    [sbull] A copy of the labeling claims of specific clinical 
advantages approved by the FDA for the IOL.
    [sbull] A copy of the IOL's original FDA approval notification.
    [sbull] Reports of modifications made after the original FDA 
approval.
    [sbull] Other information that supports the requestor's claim (that 
is, 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, 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, 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 
intraocular lenses 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 is merely soliciting 
interested parties to submit requests for review of the appropriateness 
of the payment amount with regard to a particular intraocular lens 
furnished by an ambulatory surgical center.
    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 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 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 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.

    Authority: Section 1832(a)(2)(F)(i) and 1833(i)(2)(a) of the 
Social Security Act (42 U.S.C. 1395k(a)(2)(F)(i) and 
1395l(i)(2)(A)).

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

    Dated: February 24, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 03-4734 Filed 2-27-03; 8:45 am]
BILLING CODE 4120-01-P