Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs), 57297-57299 [05-19483]
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Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices
the EMTALA TAG is to review
regulations affecting hospital and
physician responsibilities under
EMTALA to individuals who come to a
hospital seeking examination or
treatment for medical conditions.
FOR FURTHER INFORMATION CONTACT:
Beverly J. Parker, (410) 786–5320.
George Morey, (410) 786–4653. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1866(a)(1)(I), 1866(a)(1)(N),
and 1867 of the Social Security Act (the
Act) impose specific obligations on
Medicare-participating hospitals that
offer emergency services. These
obligations concern individuals who
come to a hospital emergency
department and request or have a
request made on their behalf for
examination or treatment for a medical
condition. EMTALA applies to all these
individuals, regardless of whether or not
they are beneficiaries of any program
under the Act. Section 1867 of the Act
sets forth requirements for medical
screening examinations for emergency
medical conditions, as well as necessary
stabilizing treatment or appropriate
transfer.
Regulations implementing the
EMTALA legislation are set forth at 42
CFR 489.20(l), (m), (q) and (r)(1), (r)(2),
(r)(3), and 489.24. Section 945 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173), requires
that the Secretary establish a Technical
Advisory Group (TAG) for advice
concerning issues related to EMTALA
regulations and implementation.
Section 945 of the MMA specifies that
the EMTALA TAG—
• Shall review the EMTALA
regulations;
• May provide advice and
recommendations to the Secretary
concerning these regulations and their
application to hospitals and physicians;
• Shall solicit comments and
recommendations from hospitals,
physicians, and the public regarding
implementation of such regulations; and
• May disseminate information
concerning the application of these
regulations to hospitals, physicians, and
the public.
The EMTALA TAG, as chartered
under the legal authority of section 945
of the MMA, is also governed by the
provisions of the Federal Advisory
Committee Act (FACA) (5 U.S.C.
Appendix 2) for the selection of
members and the conduct of all
meetings.
VerDate Aug<31>2005
16:14 Sep 29, 2005
Jkt 205001
In the May 28, 2004 Federal Register
(69 FR 30654), we specified the
statutory requirements regarding the
charter, general responsibilities, and
structure of the EMTALA TAG. That
notice also solicited nominations for
members based on the statutory
requirements for the EMTALA TAG. In
the August 27, 2004 Federal Register
(69 FR 52699), we solicited nominations
again for members in two categories
(patient representatives and a State
survey agency representative) for which
no nominations were received in
response to the May 28, 2004 Federal
Register notice. In the March 15, 2005
Federal Register (70 FR 12691), we
announced the inaugural meeting of the
EMTALA TAG and the membership
selection. That meeting was held on
March 30 and 31, 2005. On May 18,
2005 (70 FR 28541) we announced the
second meeting of the EMTALA TAG
with a purpose to hear public testimony
and consider written responses from
medical societies and other
organizations on specific issues
considered by the EMTALA TAG at its
inaugural meeting. The second TAG
meeting was held on June 15, 16, and
17, 2005.
On September 23, 2005, (70 FR
55903), we announced the third meeting
of the EMTALA TAG, for the purpose of
enabling the EMTALA TAG to hear
additional testimony and further
consider written responses from
medical societies and other
organizations on specific issues
considered by the TAG at previous
meetings. The third TAG meeting is
scheduled for October 26, 27, and 28,
2005
II. Selection of New EMTALA TAG
Member
In the March 15, 2005 Federal
Register (70 FR 12691), we announced
the EMTALA TAG membership. One of
those original members, a hospital
representative, has been unable to
complete his term of service. To enable
the TAG to continue to function as
required by section 945 of the MMA and
to ensure that the concerns of hospitals
are appropriately considered during
TAG deliberations, another member has
been selected to serve as a hospital
representative. The new member is Rory
Jaffe, M.D., M.B.A., of the University of
California/Davis Medical Center. Dr.
Jaffe was selected from the original list
of nominees for the EMTALA TAG.
Authority: Section 945 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
PO 00000
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Fmt 4703
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57297
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. 05–19484 Filed 9–29–05; 8:45 am]
BILLING CODE 4120–01–P
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)
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with public comment
period.
AGENCY:
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 issues
in this notice to https://
E:\FR\FM\30SEN1.SGM
30SEN1
57298
Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices
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
VerDate Aug<31>2005
16:14 Sep 29, 2005
Jkt 205001
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 (§ 416.185); defined the terms
relevant to the process (§ 416.180); and
established an initial flat rate payment
adjustment of $50 for IOLs that we
determined were NTIOLs
(§ 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 5year period established by the first
recognized NTIOL (§ 416.200(b)). In
accordance with the payment review
process specified in § 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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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
E:\FR\FM\30SEN1.SGM
30SEN1
Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices
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 Models
Z9000, Z9001 and Z9003.
Reason for Requesting Review: The
requestor states that the Tecnis IOLs
were designed to improve contrast
sensitivity, reduce ocular spherical
aberration, and improve the functional
vision of cataract surgery patients with
implanted IOLs.
Tecnis 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 FDAapproved 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
VerDate Aug<31>2005
16:14 Sep 29, 2005
Jkt 205001
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: https://
www.access.gpo.gov/fr/.
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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
57299
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
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 70, Number 189 (Friday, September 30, 2005)]
[Notices]
[Pages 57297-57299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19483]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
issues in this notice to https://
[[Page 57298]]
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: https://
www.access.gpo.gov/fr/.
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
