[Federal Register Volume 66, Number 71 (Thursday, April 12, 2001)]
[Notices]
[Pages 18959-18961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9041]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-3057-N]


Medicare Program; Annual Review of the Appropriateness of Payment 
Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by 
Ambulatory Surgical Centers (ASCs)

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

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

SUMMARY: This notice is 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.

DATES: Requests for review must be received at the address provided no

[[Page 18960]]

later than 5:00 p.m. E.S.T. on May 14, 2001.

ADDRESSES: Mail requests for review (one original and three copies) to 
the Health Care Financing Administration, Department of Health and 
Human Services, Attention Betty Shaw, Mailstop S3-02-01, 7500 Security 
Blvd. Baltimore, Maryland 21244-1850.

FOR FURTHER INFORMATION CONTACT: Betty Shaw, (410) 786-6100; or Mary 
Stojak, (410) 786-6939.

SUPPLEMENTARY INFORMATION

I. Background

    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, with respect to a class of new technology 
intraocular lens (IOLs), a review of the appropriateness of the payment 
amount for IOLs furnished by 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 416. That rule set forth the process for 
adjusting payment amounts for new technology intraocular lenses 
(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 (before July 16, 2002) to 
be 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 would receive the adjustment for the remainder of the 5-year 
period established by the first recognized IOL.

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 FDA about labeling applications 
that have been approved on the model lens under review. We also request 
a recommendation from FDA about whether or not the lens model 
represents a new class of technology, or a new technology subset of an 
existing class of technology. (A new technology subset is a group of 
IOLs that we determine meets the criterion for being treated as new 
technology IOLs and that share a common feature or features that 
distinguish them from other IOLs. For example, all new technology IOLs 
that are made of a particular bioengineered material could comprise one 
subset, while all that rely on a particular optical innovation could 
comprise another.)
    Using a baseline of the date of the last determinations 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 and/or 
over lenses that are classified by a predominant characteristic as 
reducing the risk of intraoperative or postoperative complication 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 the FDA review, public comments on the 
lenses submitted for review, and other available information. (We send 
results of the reviews to the requestors by mail.)
    (7) Designating a predominant characteristic of an NTIOL that both 
sets it apart from other IOLs and links it with other similar IOLs with 
the same characteristic to establish a specific subset of new 
technology within the ``class of NTIOLs.''
    (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 rulemaking 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 may request that we review the appropriateness of the 
payment amount provided under section 1833(i)(2)(A)(iii) of the Act 
with respect to an IOL that meets the definition of a new technology 
IOL in Sec. 416.180.

Requests to Review

    A request for 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. (Note: The supplemental that approves for certain claims 
will not have a summary on safety and effectiveness, but the original 
will have it.)
     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 
(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, 
with respect to trade secrets, the Trade Secrets Act (18 U.S.C. 1905). 
We recommend the requestor clearly identify all information that is to 
be characterized as confidential. The Freedom of Information Act does 
not prohibit the disclosure of any information; rather it allows us to 
withhold certain information based on identifiable harms as described 
above.

[[Page 18961]]

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 416 subpart F, we are soliciting requests 
for review of the appropriateness of the payment amount with respect to 
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 to be 
an NTIOL, the lens will be eligible for a payment adjustment of $50.

III. Collection of Information Requirements

    Given that the requirements referenced in this notice will not 
effect 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

    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.
    We have reviewed this notice under the threshold criteria of 
Executive Order 13132 of August 4, 1999, Federalism. We have determined 
that the notice does not significantly affect the rights, roles, and 
responsibilities of States.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4) requires that agencies assess anticipated costs and benefits 
before issuing any rule that may result in an expenditure by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $100 million in any one year. This notice will not have an 
effect on the governments mentioned, and the private sector costs will 
not be greater than the $100 million threshold.

    Authority: Sections 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. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: February 2, 2001.
Michael McMullan,
Acting Deputy Administrator, Health Care Financing Administration.
[FR Doc. 01-9041 Filed 4-11-01; 8:45 am]
BILLING CODE 4120-01-P