Medicare Program; Public Meeting on July 18, 2016 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2017, 29863-29865 [2016-11269]
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Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
AGENCY:
determinations on the CMS Web site, as
well as the deadline for submitting
comments regarding these
determinations will be published on the
CMS Web site).
ADDRESSES: The public meeting will be
held in the main auditorium of the
Centers for Medicare & Medicaid
Services (CMS), Central Building, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
FOR FURTHER INFORMATION CONTACT:
Glenn McGuirk, (410) 786–5723.
SUPPLEMENTARY INFORMATION:
This notice announces a
public meeting to receive comments and
recommendations (including
accompanying data on which
recommendations are based) 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) 2017. This meeting
also provides a forum for those who
submitted certain reconsideration
requests regarding final determinations
made last year on new test codes and for
the public to provide comment on the
requests.
DATES:
Meeting Date: The public meeting is
scheduled for Monday, July 18, 2016
from 9:00 a.m. to 3:00 p.m., Eastern
Daylight Savings Time (E.D.T.)
Deadline for Registration of Presenters
and Submission of Presentations: All
presenters for the public meeting must
register and submit their presentations
electronically to Glenn McGuirk at
Glenn.McGuirk@cms.hhs.gov by July 1,
2016 E.D.T.
Deadline for Submitting Requests for
Special Accommodations: Requests for
special accommodations must be
received no later than 5:00 p.m. on July
1, 2016 E.D.T.
Deadline for Submission of Written
Comments: We intend to publish our
proposed determinations for new test
codes and our preliminary
determinations for reconsidered codes
(as described below in section II.
Format) for CY 2017 by early September
2016. Interested parties may submit
written comments on these
determinations by early October, 2016,
to the address specified in the
ADDRESSES section of this notice or
electronically to Glenn McGuirk at
Glenn.McGuirk@cms.hhs.gov (the
specific date for the publication of these
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 of the Department of
Health and Human Services (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 on November 23,
2001 in the Federal Register (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 Healthcare
Common Procedure Coding System
(HCPCS) code is assigned on or after
January 1, 2005 (hereinafter referred to
as ‘‘new tests’’). 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. Pertinent to this notice,
section 1833(h)(8)(B)(i) and (ii) of the
Act requires the Secretary to make
available to the public a list that
includes any such test for which
708–9300 for TDD Relay/1–800–877–
8339 for toll free.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sarah L. Stewart,
Deputy General Counsel.
Centers for Medicare & Medicaid
Services
[FR Doc. 2016–11454 Filed 5–11–16; 11:15 am]
[CMS–1646–N]
BILLING CODE 6735–01–P
Medicare Program; Public Meeting on
July 18, 2016 Regarding New and
Reconsidered Clinical Diagnostic
Laboratory Test Codes for the Clinical
Laboratory Fee Schedule for Calendar
Year 2017
FEDERAL RESERVE SYSTEM
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The notices are available for
immediate inspection at the Federal
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the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
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2016.
A. Federal Reserve Bank of St. Louis
(Yvonne Sparks, Community
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1. First State Bank of St. Charles
Employee Stock Ownership Plan, St.
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Board of Governors of the Federal Reserve
System, May 9, 2016.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2016–11242 Filed 5–12–16; 8:45 am]
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29863
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY:
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establishment of a payment amount is
being considered for a year and, on the
same day that the list is made available,
causes to have published a notice in the
Federal Register of a meeting to receive
comments and recommendations
(including accompanying data on which
recommendations are based) from the
public on the appropriate basis for
establishing payment amounts for the
tests on such list. This list of codes for
which the establishment of a payment
amount under the clinical laboratory fee
schedule (CLFS) is being considered for
calendar year (CY) 2017 is posted on the
CMS Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/
index.html?redirect=/
ClinicalLabFeeSched/. Section
1833(h)(8)(B)(iii) of the Act requires that
we convene the 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 bases of payment are used to
establish payment amounts for new
tests. The first basis, called
‘‘crosswalking,’’ is used when a new test
code is determined to be comparable to
an existing test code, multiple existing
test codes, or a portion of an existing
test code. The new test code is assigned
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 billed
amount, the local fee schedule amount,
or the national limitation amount. (See
§ 414.508(a).)
The second basis called ‘‘gapfilling,’’
is used when no comparable existing
test is available. When using this
method, instructions are provided to
each Part A and Part B Medicare
Administrative Contractor (MAC) to
determine a payment amount for its Part
B geographic area) for use in the first
year. The contractor-specific amounts
are established for the new test code
using the following sources of
information, if available: (1) Charges for
the test and routine discounts to
charges; (2) resources required to
perform the test; (3) payment amounts
determined by other payers; and (4)
charges, payment amounts, and
resources required for other tests that
may be comparable or otherwise
relevant. (See § 414.508(b) and § 414.509
for more information regarding the
gapfilling process.)
Under section 1833(h)(8)(B)(iv) of the
Act, the Secretary, taking into account
the comments and recommendations
(and accompanying data) received at the
public meeting, develops and makes
available to the public a list of proposed
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determinations with respect to the
appropriate basis for establishing a
payment amount for each 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. Under section
1833(h)(8)(B)(v) of the Act, taking into
account the comments received on the
proposed determinations during the
public comment period, the Secretary
then develops and makes available to
the public a list of final determinations
of final payment amounts for new test
codes along with the rationale for each
determination, the data on which the
determinations are based, and responses
to comments and suggestions received
from the public.
After the final determinations have
been posted on the CMS Web site, the
public may request reconsideration of
the basis and amount of payment for a
new test as set forth in § 414.509.
Pertinent to this notice, those requesting
that CMS reconsider the basis for
payment or, for crosswalking,
reconsider the payment amount as set
forth in § 414.509(a) and (b)(1) may
present their reconsideration requests at
the following year’s public meeting
provided that the requestor made the
request to present at the public meeting
in the written reconsideration request.
For purposes of this notice, we refer to
these codes as the ‘‘reconsidered
codes.’’ The public may comment on the
reconsideration requests. (See the
November 27, 2007 CY 2008 Physician
Fee Schedule final rule with comment
period (72 FR 66275 through 66280) for
more information on these procedures.)
II. Format
We are following our usual process,
including an annual public meeting to
determine the appropriate basis and
payment amount for new and
reconsidered test codes under the CLFS
for CY 2017.
This meeting is open to the public.
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 make recommendations for
specific new and reconsidered test
codes for the CY 2017 CLFS.
We note that the July 2016 Clinical
Diagnostic Laboratory Tests (CDLT)
Advisory Panel meeting and the
laboratory public meeting will be a joint
meeting this year, on July 18, 2016. The
announcement for the CDLT Advisory
Panel meeting will be included in a
separate Federal Register notice.
Because of time constraints,
presentations must be brief, lasting no
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longer than 10 minutes, and must be
accompanied by three written copies. In
addition, presenters should make copies
available for approximately 50 meeting
participants, since CMS will not be
providing additional copies. Written
presentations must be electronically
submitted to CMS on or before July 1,
2016. 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, CMS 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. For reconsidered and new
test codes, presenters should address all
of the following 5 items:
(1) Reconsidered or new test codes
and descriptor.
(2) Test purpose and method.
(3) Costs.
(4) Charges.
(5) Recommendation with rationale
for one of the two bases (crosswalking
or gapfilling) for determining payment
for reconsidered and 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 regarding
reconsidered and new test codes that do
not address the above five items for
presenters may be considered
incomplete and may not be considered
by CMS when making a determination.
However, we may request missing
information following the meeting to
prevent a recommendation from being
considered incomplete.
Taking into account the comments
and recommendations (and
accompanying data) received at the
public meeting, we intend to post our
proposed determinations with respect to
the appropriate basis for establishing a
payment amount for each new test code
and our preliminary determinations
with respect to the reconsidered codes
along with an explanation of the reasons
for each determination, the data on
which the determinations are based, and
a request for public written comments
on these determinations on the CMS
Web site by early September 2016. This
Web site can be accessed at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
ClinicalLabFeeSched/
index.html?redirect=/
ClinicalLabFeeSched/. We also will
include a summary of all comments
received by August 8, 2016 (15 business
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days after the meeting). Interested
parties may submit written comments
on the proposed determinations for new
test codes or the preliminary
determinations for reconsidered codes
by early October, 2016, to the address
specified in the ADDRESSES section of
this notice or electronically to Glenn
McGuirk at Glenn.McGuirk@
cms.hhs.gov (the specific date for the
publication of the determinations on the
CMS Web site, as well as the deadline
for submitting comments regarding the
determinations, will be published on
the CMS Web site). Final determinations
for new test codes to be included for
payment on the CLFS for CY 2017 and
reconsidered codes will be posted on
the CMS Web site in November 2016,
along with the rationale for each
determination, the data on which the
determinations are based, and responses
to comments and suggestions received
from the public. The final
determinations with respect to
reconsidered codes are not subject to
further reconsideration. With respect to
the final determinations for new test
codes, the public may request
reconsideration of the basis and amount
of payment as set forth in § 414.509.
III. Registration Instructions
The Division of Ambulatory Services
in the CMS Center for Medicare is
coordinating the public meeting
registration. Beginning June 6, 2016,
registration may be completed on-line at
the following Web site: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
ClinicalLabFeeSched/
index.html?redirect=/
ClinicalLabFeeSched/. All the following
information must be submitted when
registering:
• Name.
• Company name.
• Address.
• Telephone numbers.
• Email addresses.
When registering, individuals who
want to make a presentation must also
specify, which new test codes 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.
IV. Security, Building, and Parking
Guidelines
The meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
recommend allowing additional time to
clear security. It is suggested that you
arrive at the CMS facility between 8:15
a.m. and 8:30 a.m., so that you will be
able to arrive promptly at the meeting
by 9:00 a.m. 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.
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 that
information upon registering for the
meeting. The deadline for registration is
listed in the DATES section of this notice.
Dated: April 11, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–11269 Filed 5–12–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Tribal Child Support
Enforcement Direct Funding Request: 45
CFR 309—Plan.
OMB No.: 0970–0218.
Description: The final rule within 45
CFR part 309, published in the Federal
Register on March 30, 2004, contains a
regulatory reporting requirement that, in
order to receive funding for a Tribal IV–
D program a Tribe or Tribal organization
must submit a plan describing how the
Tribe or Tribal organization meets or
plans to meet the objectives of section
455(f) of the Social Security Act,
including establishing paternity,
establishing, modifying, and enforcing
support orders, and locating
noncustodial parents. The plan is
required for all Tribes requesting
funding; however, once a Tribe has met
the requirements to operate a
comprehensive program, a new plan is
not required annually unless a Tribe
makes changes to its title IV–D program.
Tribes and Tribal organizations must
respond if they wish to operate a fully
funded program. This paperwork
collection activity is set to expire in
December 31, 2016.
Respondents: Tribes and Tribal
Organizations.
ANNUAL BURDEN ESTIMATES
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Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
45 CFR 309—Plan ..........................................................................................
60
2
480
57,600
Estimated Total Annual Burden
Hours: 57,600.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
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Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
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information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
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]]>Agencies
[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29863-29865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11269]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1646-N]
Medicare Program; Public Meeting on July 18, 2016 Regarding New
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the
Clinical Laboratory Fee Schedule for Calendar Year 2017
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a public meeting to receive comments and
recommendations (including accompanying data on which recommendations
are based) 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) 2017. This meeting also provides a forum for those who
submitted certain reconsideration requests regarding final
determinations made last year on new test codes and for the public to
provide comment on the requests.
DATES:
Meeting Date: The public meeting is scheduled for Monday, July 18,
2016 from 9:00 a.m. to 3:00 p.m., Eastern Daylight Savings Time
(E.D.T.)
Deadline for Registration of Presenters and Submission of
Presentations: All presenters for the public meeting must register and
submit their presentations electronically to Glenn McGuirk at
Glenn.McGuirk@cms.hhs.gov by July 1, 2016 E.D.T.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than 5:00
p.m. on July 1, 2016 E.D.T.
Deadline for Submission of Written Comments: We intend to publish
our proposed determinations for new test codes and our preliminary
determinations for reconsidered codes (as described below in section
II. Format) for CY 2017 by early September 2016. Interested parties may
submit written comments on these determinations by early October, 2016,
to the address specified in the ADDRESSES section of this notice or
electronically to Glenn McGuirk at Glenn.McGuirk@cms.hhs.gov (the
specific date for the publication of these determinations on the CMS
Web site, as well as the deadline for submitting comments regarding
these determinations will be published on the CMS Web site).
ADDRESSES: The public meeting will be held in the main auditorium of
the Centers for Medicare & Medicaid Services (CMS), Central Building,
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 of the Department of Health and Human Services
(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 on November 23, 2001 in the Federal Register
(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
Healthcare Common Procedure Coding System (HCPCS) code is assigned on
or after January 1, 2005 (hereinafter referred to as ``new tests''). 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.
Pertinent to this notice, section 1833(h)(8)(B)(i) and (ii) of the Act
requires the Secretary to make available to the public a list that
includes any such test for which
[[Page 29864]]
establishment of a payment amount is being considered for a year and,
on the same day that the list is made available, causes to have
published a notice in the Federal Register of a meeting to receive
comments and recommendations (including accompanying data on which
recommendations are based) from the public on the appropriate basis for
establishing payment amounts for the tests on such list. This list of
codes for which the establishment of a payment amount under the
clinical laboratory fee schedule (CLFS) is being considered for
calendar year (CY) 2017 is posted on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/?redirect=/ClinicalLabFeeSched/. Section
1833(h)(8)(B)(iii) of the Act requires that we convene the 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 bases of payment are used to establish payment amounts for new
tests. The first basis, called ``crosswalking,'' is used when a new
test code is determined to be comparable to an existing test code,
multiple existing test codes, or a portion of an existing test code.
The new test code is assigned 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 billed amount, the local fee schedule
amount, or the national limitation amount. (See Sec. 414.508(a).)
The second basis called ``gapfilling,'' is used when no comparable
existing test is available. When using this method, instructions are
provided to each Part A and Part B Medicare Administrative Contractor
(MAC) to determine a payment amount for its Part B geographic area) for
use in the first year. The contractor-specific amounts are established
for the new test code using the following sources of information, if
available: (1) Charges for the test and routine discounts to charges;
(2) resources required to perform the test; (3) payment amounts
determined by other payers; and (4) charges, payment amounts, and
resources required for other tests that may be comparable or otherwise
relevant. (See Sec. 414.508(b) and Sec. 414.509 for more information
regarding the gapfilling process.)
Under section 1833(h)(8)(B)(iv) of the Act, the Secretary, taking
into account the comments and recommendations (and accompanying data)
received at the public meeting, develops and makes available to the
public a list of proposed determinations with respect to the
appropriate basis for establishing a payment amount for each 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. Under section 1833(h)(8)(B)(v) of the
Act, taking into account the comments received on the proposed
determinations during the public comment period, the Secretary then
develops and makes available to the public a list of final
determinations of final payment amounts for new test codes along with
the rationale for each determination, the data on which the
determinations are based, and responses to comments and suggestions
received from the public.
After the final determinations have been posted on the CMS Web
site, the public may request reconsideration of the basis and amount of
payment for a new test as set forth in Sec. 414.509. Pertinent to this
notice, those requesting that CMS reconsider the basis for payment or,
for crosswalking, reconsider the payment amount as set forth in Sec.
414.509(a) and (b)(1) may present their reconsideration requests at the
following year's public meeting provided that the requestor made the
request to present at the public meeting in the written reconsideration
request. For purposes of this notice, we refer to these codes as the
``reconsidered codes.'' The public may comment on the reconsideration
requests. (See the November 27, 2007 CY 2008 Physician Fee Schedule
final rule with comment period (72 FR 66275 through 66280) for more
information on these procedures.)
II. Format
We are following our usual process, including an annual public
meeting to determine the appropriate basis and payment amount for new
and reconsidered test codes under the CLFS for CY 2017.
This meeting is open to the public. 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 make
recommendations for specific new and reconsidered test codes for the CY
2017 CLFS.
We note that the July 2016 Clinical Diagnostic Laboratory Tests
(CDLT) Advisory Panel meeting and the laboratory public meeting will be
a joint meeting this year, on July 18, 2016. The announcement for the
CDLT Advisory Panel meeting will be included in a separate Federal
Register notice.
Because of time constraints, presentations must be brief, lasting
no longer than 10 minutes, and must be accompanied by three written
copies. In addition, presenters should make copies available for
approximately 50 meeting participants, since CMS will not be providing
additional copies. Written presentations must be electronically
submitted to CMS on or before July 1, 2016. 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, CMS 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. For
reconsidered and new test codes, presenters should address all of the
following 5 items:
(1) Reconsidered or new test codes and descriptor.
(2) Test purpose and method.
(3) Costs.
(4) Charges.
(5) Recommendation with rationale for one of the two bases
(crosswalking or gapfilling) for determining payment for reconsidered
and 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 regarding reconsidered and new
test codes that do not address the above five items for presenters may
be considered incomplete and may not be considered by CMS when making a
determination. However, we may request missing information following
the meeting to prevent a recommendation from being considered
incomplete.
Taking into account the comments and recommendations (and
accompanying data) received at the public meeting, we intend to post
our proposed determinations with respect to the appropriate basis for
establishing a payment amount for each new test code and our
preliminary determinations with respect to the reconsidered codes along
with an explanation of the reasons for each determination, the data on
which the determinations are based, and a request for public written
comments on these determinations on the CMS Web site by early September
2016. This Web site can be accessed at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/?redirect=/ClinicalLabFeeSched/. We also will include a
summary of all comments received by August 8, 2016 (15 business
[[Page 29865]]
days after the meeting). Interested parties may submit written comments
on the proposed determinations for new test codes or the preliminary
determinations for reconsidered codes by early October, 2016, to the
address specified in the ADDRESSES section of this notice or
electronically to Glenn McGuirk at Glenn.McGuirk@cms.hhs.gov (the
specific date for the publication of the determinations on the CMS Web
site, as well as the deadline for submitting comments regarding the
determinations, will be published on the CMS Web site). Final
determinations for new test codes to be included for payment on the
CLFS for CY 2017 and reconsidered codes will be posted on the CMS Web
site in November 2016, along with the rationale for each determination,
the data on which the determinations are based, and responses to
comments and suggestions received from the public. The final
determinations with respect to reconsidered codes are not subject to
further reconsideration. With respect to the final determinations for
new test codes, the public may request reconsideration of the basis and
amount of payment as set forth in Sec. 414.509.
III. Registration Instructions
The Division of Ambulatory Services in the CMS Center for Medicare
is coordinating the public meeting registration. Beginning June 6,
2016, registration may be completed on-line at the following Web site:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/?redirect=/ClinicalLabFeeSched/. All the
following information must be submitted when registering:
Name.
Company name.
Address.
Telephone numbers.
Email addresses.
When registering, individuals who want to make a presentation must
also specify, which new test codes 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.
IV. Security, Building, and Parking Guidelines
The meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, we recommend allowing additional time to clear security.
It is suggested that you arrive at the CMS facility between 8:15 a.m.
and 8:30 a.m., so that you will be able to arrive promptly at the
meeting by 9:00 a.m. 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.
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 that information upon registering
for the meeting. The deadline for registration is listed in the DATES
section of this notice.
Dated: April 11, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-11269 Filed 5-12-16; 8:45 am]
BILLING CODE 4120-01-P
