Medicare Program; Public Meeting in Calendar Year 2012 for New Clinical Laboratory Tests Payment Determinations, 31620-31622 [2012-12982]
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31620
Federal Register / Vol. 77, No. 103 / Tuesday, May 29, 2012 / Notices
Dated: May 4, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2012–12633 Filed 5–25–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1441–N]
Medicare Program; Public Meeting in
Calendar Year 2012 for New Clinical
Laboratory Tests Payment
Determinations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces a
public meeting to receive comments and
recommendations from the public on
the appropriate basis for establishing
payment amounts for new or
substantially revised Healthcare
Common Procedure Coding System
(HCPCS) codes being considered for
Medicare payment under the clinical
laboratory fee schedule (CLFS) for
calendar year (CY) 2013.
DATES: Meeting Dates: The public
meeting is scheduled for Monday, July
16, 2012, from 9:00 a.m. to 5:00 p.m.,
and Tuesday, July 17, 2012, from 9:00
a.m. to 12:00 p.m. All times are Eastern
Daylight Savings Time.
Deadline for Registration of
Presenters: All presenters for the public
meeting must register by July 6, 2012.
Deadline for Written/Electronic
Presentations: Written presentations
must also be electronically submitted to
on or before July 6, 2012.
Deadline for Submitting Requests for
Special Accommodations: Requests for
special accommodations must be
received no later than 5:00 p.m., on July
6, 2012.
Deadline for Submission of Written
Comments: Interested parties may
submit written comments on the
proposed payment determinations by
September 28, 2012, to the address
specified in the ADDRESSES section of
this notice.
ADDRESSES: The public meeting will be
held in the main auditorium of the
central building of the Centers for
Medicare & Medicaid Services (CMS),
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
FOR FURTHER INFORMATION CONTACT:
Glenn McGuirk, (410) 786–5723.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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I. Background
Section 531(b) of the Medicare,
Medicaid, and SCHIP Benefits
Improvement and Protection Act of
2000 (BIPA) (Pub. L. 106–554) requires
the Secretary to establish procedures for
coding and payment determinations for
new clinical diagnostic laboratory tests
under Part B of title XVIII of the Social
Security Act (the Act) that permit public
consultation in a manner consistent
with the procedures established for
implementing coding modifications for
International Classification of Diseases
(ICD–9–CM). The procedures and public
meeting announced in this notice for
new tests are in accordance with the
procedures published in the Federal
Register on November 23, 2001 (66 FR
58743), to implement section 531(b) of
BIPA.
Section 942(b) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173) added section 1833(h)(8) of
the Act. Section 1833(h)(8)(A) of the Act
requires the Secretary to ‘‘establish by
regulation procedures for determining
the basis for, and amount of, payment
for any clinical diagnostic laboratory
test with respect to which a new or
substantially revised HCPCS code is
assigned on or after January 1, 2005’’
(hereinafter referred to as, ‘‘new test’’).
A code is considered to be
‘‘substantially revised’’ if ‘‘there is a
substantive change to the definition of
the test or procedure to which the code
applies (such as a new analyte or a new
methodology for measuring an existing
analyte-specific test).’’ (See section
1833(h)(8)(E)(ii) of the Act.)
Section 1833(h)(8)(B) of the Act sets
forth the process for determining the
basis for, and the amount of, payment
for new tests. Section 1833(h)(8)(B)(i)
and (ii) of the Act requires the Secretary
to—(1) ‘‘make available to the public
(through an Internet Web site and other
appropriate mechanisms)a list that
includes any such test for which
establishment of a payment amount is
being considered for a year’’; and (2)
‘‘on the same day such list is made
available, causes to have published in
the Federal Register notice of a meeting
to receive comments and
recommendations (and data on which
recommendations are based) from the
public on the appropriate basis * * *
for establishing payment amounts for
the tests on such list.’’ The list of codes
for which the establishment of a
payment amount under the CLFS is
being considered for CY 2013 is posted
on our Web site at https://
www.cms.hhs.gov/ClinicalLabFeeSched.
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Fmt 4703
Sfmt 4703
Section 1833(h)(8)(B)(iii) of the Act
requires that we convene a public
meeting not less than 30 days after
publication of the notice in the Federal
Register. These requirements are
codified at 42 CFR part 414, subpart G.
Two methods are used to establish
payment amounts for new tests. The
first method called ‘‘crosswalking’’ is
used when a new test is determined to
be comparable to an existing test,
multiple existing test codes, or a portion
of an existing test code. The new test
code is assigned to the local fee
schedule amounts and the national
limitation amount of the existing test.
Payment for the new test is made at the
lesser of the local fee schedule amount
or the national limitation amount. (See
§ 414.508(a).)
The second method called
‘‘gapfilling’’ is used when no
comparable existing test is available.
When using this method, instructions
are provided to each Medicare carrier or
Part A and Part B Medicare
Administrative Contractor (MAC) to
determine a payment amount for its
carrier geographic area(s) for use in the
first year. The carrier-specific amounts
are established for the new test code
using the following sources of
information, if available: charges for the
test and routine discounts to charges;
resources required to perform the test;
payment amounts determined by other
payers; and charges, payment amounts,
and resources required for other tests
that may be comparable or otherwise
relevant. In the second year, the test
code is paid at the national limitation
amount, which is the median of the
carrier-specific amounts. (See
§ 414.508(b).)
II. Proposals in the CY 2013 Physician
Fee Schedule Proposed Rule
We are following our process to
determine the appropriate basis and
payment amount for new test codes
under the CLFS for CY 2013. Some of
these tests are molecular pathology
tests. Stakeholders in the molecular
pathology community continue to
debate whether Medicare should pay for
molecular pathology tests under the
CLFS or the physician fee schedule
(PFS). Medicare pays for clinical
diagnostic laboratory tests through the
CLFS and for services that ordinarily
require physician work through the PFS.
We believe that we would benefit from
additional public comments on whether
these tests are clinical diagnostic
laboratory tests or whether they are
services that should be paid under the
PFS. Therefore, we intend to solicit
public comments on this issue in the CY
2013 PFS proposed rule as well as
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Federal Register / Vol. 77, No. 103 / Tuesday, May 29, 2012 / Notices
public comment on pricing policies for
these tests under the PFS. We will make
final decisions with respect to
molecular pathology codes in the CY
2013 PFS final rule with comment
period, and we will post on our Web
site the final payment determinations
for any codes paid under the CLFS in
November.
In addition, we intend to post our
proposed determinations with respect to
the appropriate basis for establishing a
payment amount under the CLFS for
each of these new test codes by
September 28, 2012. If we later decide,
based on comments received in
response to the proposals set forth in the
CY 2013 PFS proposed rule, that any of
these codes are not clinical diagnostic
laboratory test codes, we will post our
final payment determinations only for
the new test codes that we determine
are clinical diagnostic laboratory test
codes that will be paid under the CLFS.
We intend to post these final payment
determinations in November (at the
same time as the CY 2013 PFS final rule
with comment period is published).
Comments and recommendations on
whether these codes represent clinical
diagnostic laboratory tests that should
be paid under the CLFS or services that
should be paid under the PFS should be
provided in response to the proposals
set forth in the CY 2013 PFS proposed
rule. For purposes of this public
meeting, comments and
recommendations should be limited to
the appropriate basis for establishing
payment amounts for the new test codes
under the CLFS for CY 2013.
III. Format
srobinson on DSK4SPTVN1PROD with NOTICES
Meeting Overview
This meeting to receive comments
and recommendations (including
accompanying data on which
recommendations are based) on the
appropriate payment basis for the new
test codes contained on the preliminary
list is open to the public. The meeting
provides a forum for interested parties
to make presentations and submit
written comments on new test codes.
The development of the codes for
clinical laboratory tests is largely
performed by the CPT Editorial Panel
and will not be further discussed at the
meeting. Comments submitted should
pertain to the payment basis for
establishing a payment amount for the
new test codes posted on the CMS Web
site.
Meeting Agenda and Instructions for
Presenters
The on-site check-in for visitors will
be held from 8:30 a.m., to 9:00 a.m.,
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Jkt 226001
followed by opening remarks.
Registered persons from the public may
discuss and recommend payment
determinations for specific new test
codes for the CY 2013 CLFS.
Because of time constraints,
presentations must be brief, lasting no
longer than 10 minutes, and must be
accompanied by three written copies. In
addition, CMS recommends that
presenters make copies available for
approximately 50 meeting participants,
since additional copies will not be
provided. Written presentations must
also be electronically submitted to CMS
on or before July 6, 2012. In the past, the
meeting was held on a single day. This
year’s meeting will be held for an
additional half day, extending the
meeting to allow enough time for
everyone who is interested in presenting
information in person to be
accommodated. However, presentation
slots will be assigned on a first-come,
first-served basis. In the event that there
is not enough time for presentations by
everyone who is interested in
presenting, we will gladly accept
written presentations from those who
were unable to present due to time
constraints. Presentations should be
sent via email to Glenn McGuirk, at
Glenn.McGuirk@cms.hhs.gov. Presenters
should address all of the following
items:
• New test code(s) and descriptor.
• Test purpose and method.
• Costs.
• Charges.
• A recommendation, with rationale,
for one of the two methods (crosswalking or gap-filling) for determining
payment for new tests.
Additionally, the presenters should
provide the data on which their
recommendations are based. Written
presentations from the public meeting
will be available upon request, via
email, to Glenn McGuirk at
Glenn.McGuirk@cms.hhs.gov.
Presentations that do not address the
above five items may be considered
incomplete and may not be considered
by CMS when making a payment
determination. We may request missing
information following the meeting in
order to prevent a recommendation from
being considered incomplete.
Taking into account the comments
and recommendations (and
accompanying data) received at the
public meeting, we will post our
proposed determinations with respect to
the appropriate basis for establishing a
payment amount for each such code, an
explanation of the reasons for each
determination, the data on which the
determinations are based, and a request
for public written comments on the
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31621
proposed determinations on the CMS
Web site by early September 2012. This
Web site can be accessed at https://
www.cms.hhs.gov/ClinicalLabFeeSched.
We also will include a summary of all
comments received by August 6, 2012
(15 business days after the meeting).
Interested parties may submit written
comments on the proposed payment
determinations by September 28, 2012,
to the address specified in the
ADDRESSES section of this notice. Final
payment determinations on new test
codes to be included for payment on the
CLFS for CY 2013 will be posted on the
CMS Web site in November 2012 along
with the rationale for each such
determination, the data on which the
determinations are based, and responses
to comments and suggestions received
from the public.
After the final payment
determinations have been posted on the
CMS Web site, the public may request
reconsideration of the basis for, and
amount of payment for, a new test as set
forth in § 414.509. (See the November
27, 2007 final rule (72 FR 66275 through
66280).)
IV. Registration Instructions
The Division of Ambulatory Services
in CMS is coordinating the public
meeting registration. Beginning June 18,
2012, registration may be completed online at the following web address:
https://www.cms.hhs.gov/
ClinicalLabFeeSched. All the following
information must be submitted when
registering:
• Name.
• Company name.
• Address.
• Telephone number(s).
• Email address(es).
When registering, individuals who
want to make a presentation must also
specify on which new test code(s) they
will be presenting comments. A
confirmation will be sent upon receipt
of the registration. Individuals must
register by the date specified in the
DATES section of this notice.
V. Special Accommodations
Individuals attending the meeting
who are hearing or visually impaired
and have special requirements, or a
condition that requires special
assistance, should provide the
information upon registering for the
meeting. The deadline for such
registrations is listed in the DATES
section of this notice.
VI. Security, Building, and Parking
Guidelines
The meeting will be held in a Federal
government building; therefore, Federal
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29MYN1
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Federal Register / Vol. 77, No. 103 / Tuesday, May 29, 2012 / Notices
security measures are applicable. In
planning your arrival to the CMS
facility, we recommend allowing
additional time to clear security.
Attendees should arrive between 8:15
a.m. and 8:30 a.m., in order to be
prompt for the 9:00 a.m. meeting.
Individuals who are not registered in
advance will not be permitted to enter
the building and will be unable to
attend the meeting. The public may not
enter the building earlier than 8:15 a.m.
(45 minutes before the convening of the
meeting).
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel. Persons without
proper identification may be denied
access to the building.
• Interior and exterior inspection of
vehicles (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Passing through a metal detector
and inspection of items brought into the
building. We note that all items brought
to CMS, whether personal or for the
purpose of demonstration or to support
a demonstration, are subject to
inspection. We cannot assume
responsibility for coordinating the
receipt, transfer, transport, storage, setup, safety, or timely arrival of any
personal belongings or items used for
demonstration or to support a
demonstration.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: May 22, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–12982 Filed 5–25–12; 8:45 am]
srobinson on DSK4SPTVN1PROD with NOTICES
16:12 May 25, 2012
Food and Drug Administration
[Docket No. FDA–2012–N–0274]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Reporting and Recordkeeping for
Dietary Supplements as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 28,
2012.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0428. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act—21 U.S.C. 379aa–1(b)(1)
(OMB Control Number 0910–0635)—
Extension
The Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (DSNDCPA) (Pub. L.
109–462, 120 Stat. 3469) amends the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) with respect to serious
BILLING CODE 4120–01–P
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HUMAN SERVICES
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adverse event reporting and
recordkeeping for dietary supplements
and nonprescription drugs marketed
without an approved application.
Section 761(b)(1) of the FD&C Act (21
U.S.C. 379aa–1(b)(1)) requires the
manufacturer, packer, or distributor
whose name (under section 403(e)(1) of
the FD&C Act (21 U.S.C. 343(e)(1)))
appears on the label of a dietary
supplement marketed in the United
States to submit to FDA all serious
adverse event reports associated with
the use of a dietary supplement,
accompanied by a copy of the product
label. The manufacturer, packer, or
distributor of a dietary supplement is
required by the DSNDCPA to use the
MedWatch form (FDA 3500A) when
submitting a serious adverse event
report to FDA. In addition, under
section 761(c)(2) of the FD&C Act, the
submitter of the serious adverse event
report (referred to in the statute as the
‘‘responsible person’’) is required to
submit to FDA a followup report of any
related new medical information the
responsible person receives within 1
year of the initial report.
Section 761(e)(1) of the FD&C Act (21
U.S.C. 379aa–1(e)(1)) requires that
responsible persons maintain records
related to the dietary supplement
adverse event reports they receive,
whether or not the adverse event is
serious. Under the statute, the records
must be retained for a period of 6 years.
As required by section 3(d)(3) of the
DSNDCPA, FDA issued guidance to
describe the minimum data elements for
serious adverse event reports for dietary
supplements. In the Federal Register of
July 14, 2009 (74 FR 34024), FDA
announced the availability of guidance
entitled ‘‘Guidance for Industry:
Questions and Answers Regarding
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act.’’ The guidance discusses
how, when, and where to submit serious
adverse event reports for dietary
supplements and followup reports. The
guidance also provides FDA’s
recommendation on records
maintenance and access for serious and
non-serious adverse event reports and
related documents.
The guidance recommends that the
responsible person document the
attempts to obtain the minimum data
elements for a serious adverse event
report. Along with these records, the
guidance recommends that the
responsible person keep the following
other records: (1) Communications
between the responsible person and the
initial reporter of the adverse event and
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]]>Agencies
[Federal Register Volume 77, Number 103 (Tuesday, May 29, 2012)]
[Notices]
[Pages 31620-31622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12982]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1441-N]
Medicare Program; Public Meeting in Calendar Year 2012 for New
Clinical Laboratory Tests Payment Determinations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a public meeting to receive comments and
recommendations from the public on the appropriate basis for
establishing payment amounts for new or substantially revised
Healthcare Common Procedure Coding System (HCPCS) codes being
considered for Medicare payment under the clinical laboratory fee
schedule (CLFS) for calendar year (CY) 2013.
DATES: Meeting Dates: The public meeting is scheduled for Monday, July
16, 2012, from 9:00 a.m. to 5:00 p.m., and Tuesday, July 17, 2012, from
9:00 a.m. to 12:00 p.m. All times are Eastern Daylight Savings Time.
Deadline for Registration of Presenters: All presenters for the
public meeting must register by July 6, 2012.
Deadline for Written/Electronic Presentations: Written
presentations must also be electronically submitted to on or before
July 6, 2012.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than 5:00
p.m., on July 6, 2012.
Deadline for Submission of Written Comments: Interested parties may
submit written comments on the proposed payment determinations by
September 28, 2012, to the address specified in the ADDRESSES section
of this notice.
ADDRESSES: The public meeting will be held in the main auditorium of
the central building of the Centers for Medicare & Medicaid Services
(CMS), 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: Glenn McGuirk, (410) 786-5723.
SUPPLEMENTARY INFORMATION:
I. Background
Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554)
requires the Secretary to establish procedures for coding and payment
determinations for new clinical diagnostic laboratory tests under Part
B of title XVIII of the Social Security Act (the Act) that permit
public consultation in a manner consistent with the procedures
established for implementing coding modifications for International
Classification of Diseases (ICD-9-CM). The procedures and public
meeting announced in this notice for new tests are in accordance with
the procedures published in the Federal Register on November 23, 2001
(66 FR 58743), to implement section 531(b) of BIPA.
Section 942(b) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section
1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act requires the
Secretary to ``establish by regulation procedures for determining the
basis for, and amount of, payment for any clinical diagnostic
laboratory test with respect to which a new or substantially revised
HCPCS code is assigned on or after January 1, 2005'' (hereinafter
referred to as, ``new test''). A code is considered to be
``substantially revised'' if ``there is a substantive change to the
definition of the test or procedure to which the code applies (such as
a new analyte or a new methodology for measuring an existing analyte-
specific test).'' (See section 1833(h)(8)(E)(ii) of the Act.)
Section 1833(h)(8)(B) of the Act sets forth the process for
determining the basis for, and the amount of, payment for new tests.
Section 1833(h)(8)(B)(i) and (ii) of the Act requires the Secretary
to--(1) ``make available to the public (through an Internet Web site
and other appropriate mechanisms)a list that includes any such test for
which establishment of a payment amount is being considered for a
year''; and (2) ``on the same day such list is made available, causes
to have published in the Federal Register notice of a meeting to
receive comments and recommendations (and data on which recommendations
are based) from the public on the appropriate basis * * * for
establishing payment amounts for the tests on such list.'' The list of
codes for which the establishment of a payment amount under the CLFS is
being considered for CY 2013 is posted on our Web site at https://www.cms.hhs.gov/ClinicalLabFeeSched.
Section 1833(h)(8)(B)(iii) of the Act requires that we convene a
public meeting not less than 30 days after publication of the notice in
the Federal Register. These requirements are codified at 42 CFR part
414, subpart G.
Two methods are used to establish payment amounts for new tests.
The first method called ``crosswalking'' is used when a new test is
determined to be comparable to an existing test, multiple existing test
codes, or a portion of an existing test code. The new test code is
assigned to the local fee schedule amounts and the national limitation
amount of the existing test. Payment for the new test is made at the
lesser of the local fee schedule amount or the national limitation
amount. (See Sec. 414.508(a).)
The second method called ``gapfilling'' is used when no comparable
existing test is available. When using this method, instructions are
provided to each Medicare carrier or Part A and Part B Medicare
Administrative Contractor (MAC) to determine a payment amount for its
carrier geographic area(s) for use in the first year. The carrier-
specific amounts are established for the new test code using the
following sources of information, if available: charges for the test
and routine discounts to charges; resources required to perform the
test; payment amounts determined by other payers; and charges, payment
amounts, and resources required for other tests that may be comparable
or otherwise relevant. In the second year, the test code is paid at the
national limitation amount, which is the median of the carrier-specific
amounts. (See Sec. 414.508(b).)
II. Proposals in the CY 2013 Physician Fee Schedule Proposed Rule
We are following our process to determine the appropriate basis and
payment amount for new test codes under the CLFS for CY 2013. Some of
these tests are molecular pathology tests. Stakeholders in the
molecular pathology community continue to debate whether Medicare
should pay for molecular pathology tests under the CLFS or the
physician fee schedule (PFS). Medicare pays for clinical diagnostic
laboratory tests through the CLFS and for services that ordinarily
require physician work through the PFS. We believe that we would
benefit from additional public comments on whether these tests are
clinical diagnostic laboratory tests or whether they are services that
should be paid under the PFS. Therefore, we intend to solicit public
comments on this issue in the CY 2013 PFS proposed rule as well as
[[Page 31621]]
public comment on pricing policies for these tests under the PFS. We
will make final decisions with respect to molecular pathology codes in
the CY 2013 PFS final rule with comment period, and we will post on our
Web site the final payment determinations for any codes paid under the
CLFS in November.
In addition, we intend to post our proposed determinations with
respect to the appropriate basis for establishing a payment amount
under the CLFS for each of these new test codes by September 28, 2012.
If we later decide, based on comments received in response to the
proposals set forth in the CY 2013 PFS proposed rule, that any of these
codes are not clinical diagnostic laboratory test codes, we will post
our final payment determinations only for the new test codes that we
determine are clinical diagnostic laboratory test codes that will be
paid under the CLFS. We intend to post these final payment
determinations in November (at the same time as the CY 2013 PFS final
rule with comment period is published).
Comments and recommendations on whether these codes represent
clinical diagnostic laboratory tests that should be paid under the CLFS
or services that should be paid under the PFS should be provided in
response to the proposals set forth in the CY 2013 PFS proposed rule.
For purposes of this public meeting, comments and recommendations
should be limited to the appropriate basis for establishing payment
amounts for the new test codes under the CLFS for CY 2013.
III. Format
Meeting Overview
This meeting to receive comments and recommendations (including
accompanying data on which recommendations are based) on the
appropriate payment basis for the new test codes contained on the
preliminary list is open to the public. The meeting provides a forum
for interested parties to make presentations and submit written
comments on new test codes. The development of the codes for clinical
laboratory tests is largely performed by the CPT Editorial Panel and
will not be further discussed at the meeting. Comments submitted should
pertain to the payment basis for establishing a payment amount for the
new test codes posted on the CMS Web site.
Meeting Agenda and Instructions for Presenters
The on-site check-in for visitors will be held from 8:30 a.m., to
9:00 a.m., followed by opening remarks. Registered persons from the
public may discuss and recommend payment determinations for specific
new test codes for the CY 2013 CLFS.
Because of time constraints, presentations must be brief, lasting
no longer than 10 minutes, and must be accompanied by three written
copies. In addition, CMS recommends that presenters make copies
available for approximately 50 meeting participants, since additional
copies will not be provided. Written presentations must also be
electronically submitted to CMS on or before July 6, 2012. In the past,
the meeting was held on a single day. This year's meeting will be held
for an additional half day, extending the meeting to allow enough time
for everyone who is interested in presenting information in person to
be accommodated. However, presentation slots will be assigned on a
first-come, first-served basis. In the event that there is not enough
time for presentations by everyone who is interested in presenting, we
will gladly accept written presentations from those who were unable to
present due to time constraints. Presentations should be sent via email
to Glenn McGuirk, at Glenn.McGuirk@cms.hhs.gov. Presenters should
address all of the following items:
New test code(s) and descriptor.
Test purpose and method.
Costs.
Charges.
A recommendation, with rationale, for one of the two
methods (cross-walking or gap-filling) for determining payment for new
tests.
Additionally, the presenters should provide the data on which their
recommendations are based. Written presentations from the public
meeting will be available upon request, via email, to Glenn McGuirk at
Glenn.McGuirk@cms.hhs.gov. Presentations that do not address the above
five items may be considered incomplete and may not be considered by
CMS when making a payment determination. We may request missing
information following the meeting in order to prevent a recommendation
from being considered incomplete.
Taking into account the comments and recommendations (and
accompanying data) received at the public meeting, we will post our
proposed determinations with respect to the appropriate basis for
establishing a payment amount for each such code, an explanation of the
reasons for each determination, the data on which the determinations
are based, and a request for public written comments on the proposed
determinations on the CMS Web site by early September 2012. This Web
site can be accessed at https://www.cms.hhs.gov/ClinicalLabFeeSched. We
also will include a summary of all comments received by August 6, 2012
(15 business days after the meeting). Interested parties may submit
written comments on the proposed payment determinations by September
28, 2012, to the address specified in the ADDRESSES section of this
notice. Final payment determinations on new test codes to be included
for payment on the CLFS for CY 2013 will be posted on the CMS Web site
in November 2012 along with the rationale for each such determination,
the data on which the determinations are based, and responses to
comments and suggestions received from the public.
After the final payment determinations have been posted on the CMS
Web site, the public may request reconsideration of the basis for, and
amount of payment for, a new test as set forth in Sec. 414.509. (See
the November 27, 2007 final rule (72 FR 66275 through 66280).)
IV. Registration Instructions
The Division of Ambulatory Services in CMS is coordinating the
public meeting registration. Beginning June 18, 2012, registration may
be completed on-line at the following web address: https://www.cms.hhs.gov/ClinicalLabFeeSched. All the following information must
be submitted when registering:
Name.
Company name.
Address.
Telephone number(s).
Email address(es).
When registering, individuals who want to make a presentation must
also specify on which new test code(s) they will be presenting
comments. A confirmation will be sent upon receipt of the registration.
Individuals must register by the date specified in the DATES section of
this notice.
V. Special Accommodations
Individuals attending the meeting who are hearing or visually
impaired and have special requirements, or a condition that requires
special assistance, should provide the information upon registering for
the meeting. The deadline for such registrations is listed in the DATES
section of this notice.
VI. Security, Building, and Parking Guidelines
The meeting will be held in a Federal government building;
therefore, Federal
[[Page 31622]]
security measures are applicable. In planning your arrival to the CMS
facility, we recommend allowing additional time to clear security.
Attendees should arrive between 8:15 a.m. and 8:30 a.m., in order to be
prompt for the 9:00 a.m. meeting. Individuals who are not registered in
advance will not be permitted to enter the building and will be unable
to attend the meeting. The public may not enter the building earlier
than 8:15 a.m. (45 minutes before the convening of the meeting).
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel. Persons without proper identification may be denied access
to the building.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of demonstration or to support a
demonstration, are subject to inspection. We cannot assume
responsibility for coordinating the receipt, transfer, transport,
storage, set-up, safety, or timely arrival of any personal belongings
or items used for demonstration or to support a demonstration.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: May 22, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-12982 Filed 5-25-12; 8:45 am]
BILLING CODE 4120-01-P
