[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57297-57299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se05-96]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3144-NC; 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 with public comment period.
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SUMMARY: In this notice with public comment period, we announce the
requests we have received from entities seeking review of the
appropriateness of the Medicare payment amount for new technology
lenses furnished by ambulatory surgical centers (ASCs). Interested
parties submitted these requests for review in response to our May 27,
2005 Federal Register notice entitled ``Medicare Program; Calendar Year
2005 Review of the Appropriateness of Payment Amounts for New
Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical
Centers (ASCs).'' We received one timely application for review by the
June 27, 2005 due date listed in that Federal Register notice. In this
notice with comment period, we summarize the timely application
received and solicit public comments on the one intraocular lens (IOL)
under review.
DATES: To be assured consideration, comments regarding the intraocular
lenses specified in this notice must be received at one of the
addresses provided below, no later than 5 p.m. on October 31, 2005.
ADDRESSES: In commenting, please refer to file code CMS-3144-NC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
[[Page 57298]]
http://www.cms.hhs.gov/regulations/ecomments (attachments should be in
Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft
Word).
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attn: CAPT Michael Lyman, CMS-3144-NC, Mail Stop C1-09-
06, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address only:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3144-NC, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201; or
7500 Security Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Michael Lyman, (410) 786-6938.
SUPPLEMENTARY INFORMATION:
I. Regulatory Background
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, with respect to a class of new
technology intraocular lens (NTIOLs), a review of the appropriateness
of the payment amount for intraocular lenses (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
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 ASCs (Sec. 416.185); defined the terms relevant to the
process (Sec. 416.180); and established an initial flat rate payment
adjustment of $50 for IOLs that we determined were NTIOLs (Sec.
416.185(f)(1)). As provided in section 416.200, the payment adjustment
applies for a 5-year period that begins when we recognize a payment
adjustment for the first NTIOL. Any subsequent IOLs with the same
characteristics as the first IOL recognized for a payment adjustment
will receive the same payment adjustment for the remainder of the 5-
year period established by the first recognized NTIOL (Sec.
416.200(b)). In accordance with the payment review process specified in
Sec. 416.185(f)(2), after July 16, 2002, we have authority to modify
the $50 adjustment amount through proposed and final rulemaking in
connection with ambulatory surgical center services. To date however,
we have made no changes to the payment amount and have opted not to
change the adjustment for calendar year 2005 (CY 2005).
We will classify an IOL as an NTIOL if the lens meets the
definition of a ``new 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 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.''
The process we use for evaluating requests for NTIOL designation
and reviewing the appropriateness of the payment amount for an NTIOL
furnished by ASCs is described in our regulations at 42 CFR part 416,
subpart F and in the February 27, 2004 Federal Register notice. This
process includes: (1) Publishing a public notice in the Federal
Register identifying requirements and the deadline for submitting a
request; (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 for a 30-day public comment period; (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 the
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
providing specific clinical advantages and proof of superiority over
existing IOLs as described in the preceding paragraph; (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
announcing the IOLs that we have determined are ``new technology''
IOLs. These NTIOLs qualify for a $50 payment adjustment or the amount
announced through proposed and final rules in connection with ASC
services; and (9) Adjusting payments effective 30 days after the
publication of the final notice announcing our determinations described
in paragraph (8) of this section.
II. Applications for New Technology Intraocular Lens (NTIOLs) for
Calendar Year 2005
On May 27, 2005 we published the first notice in the Federal
Register entitled ``Medicare Program; Calendar Year 2005 Review of the
[[Page 57299]]
Appropriateness of Payment Amounts for New Technology Intraocular
Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' to
solicit requests for review of applications for a payment adjustment
with respect to a class of NTIOLs.
We received one request for the $50 payment adjustment by the June
27, 2005 due date specified in the notice:
Manufacturer and Requestor: Advanced Medical Optics (AMO); 1700 E.
St. Andrew Place; P.O. Box 25162; Santa Ana, California 92799-5162.
Model Numbers: Tecnis[reg] Models Z9000, Z9001 and
Z9003.
Reason for Requesting Review: The requestor states that the
Tecnis[supreg] IOLs were designed to improve contrast sensitivity,
reduce ocular spherical aberration, and improve the functional vision
of cataract surgery patients with implanted IOLs.
Tecnis[reg] Models Z9000 and Z9001 were previously
submitted for NTIOL designation in calendar year 2004 and were
determined by CMS to be ineligible for NTIOL designation due to a lack
of evidence that the design improvements provided a clinical benefit to
patients. AMO has resubmitted its NTIOL request and provided additional
information on the clinical relevance of increased contrast
sensitivity. AMO provided FDA-approved product labeling claiming
improved functional vision compared with another IOL. AMO also provided
additional studies, a meta-analysis, and justification of the choice of
comparator lens that were not included in the previous 2004 NTIOL
application.
Submitting Comments: We welcome comments from the public on the
appropriateness of the Medicare payment amount for the Tecnis' IOLs
listed in this notice with public comment period. You can assist us by
referencing the file code CMS-3144-NC.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. After the close of the
comment period, CMS posts all electronic comments received before the
close of the comment period on its public Web site. Comments received
timely will be available for public inspection as they are received,
generally beginning approximately 3 weeks after publication of a
document, at the headquarters of the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday
through Friday from 8:30 a.m. to 4 p.m. Please contact us by phone at
(800) 743-3951 to schedule an appointment to view public comments
associated with this notice.
Copies: You can view and photocopy this Federal Register document
at most libraries designated as Federal Depository Libraries and at
many other public and academic libraries throughout the country that
receive the Federal Register.
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. The web site address is: http://www.access.gpo.gov/fr/index.html
.
Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
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 16, 1980, Pub. L. 96-354),
section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866, (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) 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 in any 1 year).
We have determined that this notice is not a major rule because it
merely summarizes the timely applications received and solicits
comments on IOLs under review.
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 small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$8.5 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 regulation 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 1 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: Sections 1832(a)(2)(F)(i) (42 U.S.C.
1395k(a)(2)(F)(i)) and 1833(i)(2)(A)(iii) (42 U.S.C.
1395l(i)(2)(A)(iii)) of the Social Security Act, and Section 141(b)
of the Social Security Act Amendments of 1994, Pub. L. 103-432).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: September 23, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-19483 Filed 9-29-05; 8:45 am]
BILLING CODE 4120-01-P