[Federal Register Volume 69, Number 39 (Friday, February 27, 2004)]
[Rules and Regulations]
[Pages 9322-9323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4274]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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