Medicare Program; Rechartering, Membership, and Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on August 1, 2017, 27705-27707 [2017-12545]
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Federal Register / Vol. 82, No. 115 / Friday, June 16, 2017 / Notices
Board of Governors of the Federal Reserve
System, June 13, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
implementation of a proposed
Commission action.
*
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*
*
*
PERSON TO CONTACT FOR INFORMATION:
Judith Ingram, Press Officer, Telephone:
(202) 694–1220.
Dayna C. Brown,
Secretary and Clerk of the Commission.
[FR Doc. 2017–12575 Filed 6–15–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Services
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FEDERAL RESERVE SYSTEM
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Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
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Unless otherwise noted, comments
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must be received at the Reserve Bank
indicated or the offices of the Board of
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A. Federal Reserve Bank of Boston
(Prabal Chakrabarti, Senior Vice
President) 600 Atlantic Avenue, Boston,
Massachusetts 02210–2204. Comments
can also be sent electronically to
BOS.SRC.Applications.Comments@
bos.frb.org:
1. Banco Santander, S.A., Madrid,
Spain; to retain 100 percent of the
voting shares of Banco Popular Espanol,
S.A., Madrid, Spain, and thereby, retain
shares of TotalBank, Miami, Florida.
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Medicare Program; Rechartering,
Membership, and Announcement of
the Advisory Panel on Clinical
Diagnostic Laboratory Tests Meeting
on August 1, 2017
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
rechartering of the Advisory Panel on
Clinical Diagnostic Laboratory Tests (the
Panel), designation of a new chairperson
to the Panel, and the next public
meeting date for the Panel on Tuesday,
August 1, 2017. The purpose of the
Panel is to advise the Secretary of the
Department of Health and Human
Services (DHHS) and the Administrator
of the Centers for Medicare & Medicaid
Services (CMS) on issues related to
clinical diagnostic laboratory tests
(CDLTs). The Panel will make
recommendations to the Secretary and
the Administrator regarding
crosswalking and gapfilling for new and
reconsidered laboratory codes that are
discussed during the Public Meeting
Regarding New and Reconsidered
Clinical Diagnostic Laboratory Test
Codes for the Clinical Laboratory Fee
Schedule for Calendar Year (CY) 2018
(2017 CLFS Public Meeting), and
provide input on other CY 2018 CLFS
issues that are designated in the Panel’s
charter and specified on meeting
agenda. The Secretary approved the
rechartering of the Panel on April 25,
2017 for a 2-year period effective
through April 25, 2019.
DATES: Meeting Date: The meeting of the
Panel is scheduled for Tuesday, August
1, 2017, from 9:00 a.m. to 5:00 p.m.,
Eastern Daylight Savings Time (E.D.T.).
We note that the Panel will also attend
the 2017 CLFS Public Meeting and will
gather information and ask questions to
presenters if they choose. Notice of the
2017 CLFS Public Meeting is published
elsewhere in this issue of the Federal
Register. As we also indicate in that
notice, in the event the 2017 CLFS
SUMMARY:
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27705
Public Meeting needs to extend to
August 1, 2017, the 2017 CLFS Public
Meeting will begin at 9:00 a.m., E.D.T.
and the Panel Meeting will convene
immediately following the conclusion of
that meeting.
Meeting Registration: The public may
attend the Panel Meeting in person,
view via webcast, or listen via
teleconference. Beginning Monday, June
19, 2017 and ending Friday, July 14,
2017 at 5:00 p.m. E.D.T., registration to
attend the Panel Meeting in person may
be completed online at https://cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonClinical
DiagnosticLaboratoryTests.html. On this
Web page, under ‘‘Panel Meetings,’’
click the ‘‘Register for August 1, 2017
Panel Meeting’’ link and enter the
required information. All of the
following information must be
submitted when registering:
• Name
• Company name
• Address
• Email addresses
Note: Participants who do not plan to
attend the Panel Meeting in person on
August 1, 2017 should not register. No
registration is required for participants
who plan to view the Panel Meeting via
webcast or listen via teleconference.
Participants planning to attend only the
2017 CLFS Public Meeting (on July 31,
2017), or both the 2017 CLFS Public
Meeting and the Panel Meeting (on
August 1, 2017), should register only
once for the 2017 CLFS Public Meeting.
We refer readers to the Public Meeting
Regarding New and Reconsidered
Clinical Diagnostic Laboratory Test
Codes for the CLFS for CY 2018 notice
published elsewhere in this issue of the
Federal Register for instructions on
registering. Participants planning to
attend only the Panel Meeting (August
1, 2017) must register using the above
link and instructions. Comments and
presentations on new and reconsidered
CDLTs will be made during the 2017
CLFS Public Meeting (on July 31, 2017).
We note that here because the Panel will
address crosswalking and gapfilling for
new and reconsidered laboratory codes
that are discussed during 2017 CLFS
Public Meeting and may wish to ask
follow-up questions to presenters at the
Panel Meeting (on August 1, 2017).
Issues concerning the CY 2018 CLFS
that are designated in the Panel’s charter
and specified in the meeting agenda will
be discussed at the Panel Meeting. The
deadline to register to be a presenter and
to submit written presentations for
agenda items during the Panel Meeting
(that is, presentations on issues other
than payment for new and reconsidered
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Federal Register / Vol. 82, No. 115 / Friday, June 16, 2017 / Notices
CDLTs considered at the 2017 CLFS
Public Meeting) is Friday, July 14, 2017.
Issues to be discussed will be specified
in the Panel Meeting agenda, to be
published approximately 2 weeks before
the meeting (a preliminary agenda is
described in Section II. of this notice).
Comments and presentations should not
address issues not specified in the
agenda for the Panel Meeting. If issues
are added to the agenda, we would be
interested in public comments or
presentations related to those additional
issues. Commenters and presenters may
register via email to the designated
CLFS-dedicated email box listed in the
sradovich on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT
section of this notice. Presentations
should be sent via email to the same
email address.
Meeting Location, Webcast, and
Teleconference: The Panel Meeting will
be held in the Auditorium of the CMS,
Central Office, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Alternately, the public may view the
Panel Meeting via a webcast or listen by
teleconference. During the scheduled
Panel Meeting, webcasting is accessible
online at https://cms.gov/live.
Teleconference dial-in information will
appear on the final Panel Meeting
agenda, which will be posted on the
CMS Web site when available at https://
cms.gov/Regulations-and-Guidance/
Guidance/FACA/AdvisoryPanelon
ClinicalDiagnosticLaboratoryTests.html.
Meeting Format: This Panel Meeting
is open to the public. The on-site checkin for visitors will be held from 8:30
a.m. to 9:00 a.m. E.D.T. on Monday, July
31, 2017, preceding the 2017 CLFS
Public Meeting, and again at 8:30 a.m.
to 9:00 a.m. E.D.T. on August 1, 2017 for
visitors attending only the Panel
Meeting.
During the 2017 CLFS Public Meeting,
the public, along with the Panel, will
hear and pose questions to presenters
concerning crosswalking and gapfilling
for new and reconsidered CDLTs for
calendar year CY 2018. Following the
opening remarks of the Panel Meeting,
the Panel will address any issues
relating to the CY 2018 CLFS new and
reconsidered laboratory codes,
including making recommendations to
the Secretary of HHS and the
Administrator of CMS regarding
crosswalking and gapfilling for new and
reconsidered laboratory codes discussed
during the CLFS Public Meeting. The
Panel will also provide input on other
CY 2018 CLFS issues that are designated
in the Panel’s charter and specified on
the meeting agenda. The Panel will hear
oral presentations from the public for a
total time period of no more than 1
hour.
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FOR FURTHER INFORMATION CONTACT:
Glenn C. McGuirk, Designated Federal
Official (DFO), 410–786–5723, email
CDLTPanel@cms.hhs.gov. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145. For
additional information on the Panel,
please refer to the CMS Web site at
https://www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory
PanelonClinicalDiagnostic
LaboratoryTests.html.
SUPPLEMENTARY INFORMATION:
I. Background
The Advisory Panel on Clinical
Diagnostic Laboratory Tests is
authorized by section 1834A(f)(1) of the
Social Security Act (the Act) (42 U.S.C.
1395m–1), as established by section
216(a) of the Protecting Access to
Medicare Act of 2014 (PAMA) (Pub. L.
113–93), enacted on April 1, 2014). The
Panel is subject to the Federal Advisory
Committee Act (FACA), as amended (5
U.S.C. Appendix 2), which sets forth
standards for the formation and use of
advisory panels.
Section 1834A(f)(1) of the Act directs
the Secretary of the Department of
Health and Human Services (the
Secretary) to consult with an expert
outside advisory panel established by
the Secretary, composed of an
appropriate selection of individuals
with expertise in issues related to
clinical diagnostic laboratory tests. Such
individuals may include molecular
pathologists, researchers, and
individuals with expertise in laboratory
science or health economics.
The Panel will provide input and
recommendations to the Secretary and
the Administrator of the Center for
Medicare & Medicaid Services (CMS),
on the following:
• The establishment of payment rates
under section 1834A of the Act for new
clinical diagnostic laboratory tests,
including whether to use crosswalking
or gapfilling processes to determine
payment for a specific new test; and
• The factors used in determining
coverage and payment processes for
new clinical diagnostic laboratory tests.
• Other aspects of the new payment
system under section 1834A of the Act.
A notice announcing the
establishment of the Panel and soliciting
nominations for members was
published in the October 27, 2014
Federal Register (79 FR 63919 through
63920). In the August 7, 2015 Federal
Register (80 FR 47491), we announced
membership appointments to the Panel
along with the first public meeting date
for the Panel, which was held on August
26, 2015. Subsequent meetings of the
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Panel were also announced in the
Federal Register. Since the last meeting,
the Secretary approved re-chartering of
the Panel on April 25, 2017. The new
charter is effective through April 25,
2019 and may be found on the CMS
Web site at https://cms.gov/Regulationsand-Guidance/Guidance/FACA/
AdvisoryPanelonClinicalDiagnostic
LaboratoryTests.html. Karen Nakano,
M.D. has been designated as the new
Panel Chair after the retirement of the
former Panel Chair.
The Panel charter provides that Panel
meetings will be held up to 4 times
annually and the Panel Chair will serve
for a period of 3 years, which may be
extended at the discretion of the CMS
Administrator or his or her duly
appointed designee. Additionally, the
Panel Chair facilitates the meeting and
the Designated Federal Official (DFO) or
DFO’s designee must be present at all
meetings.
II. Agenda
The Agenda for the August 1, 2017,
Panel Meeting will provide for
discussion and comment on the
following topics as designated in the
Panel’s charter:
• CY 2018 CLFS new and
reconsidered test codes, to be posted on
June 16, 2017, on the CMS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
ClinicalLabFeeSched/Laboratory_
Public_Meetings.html.
• Other CY 2018 CLFS issues
designated in the Panel’s charter and
further described on the Agenda.
A detailed Agenda will be posted
approximately 2 weeks before the
meeting, on the CMS Web site at https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory
PanelonClinicalDiagnosticLaboratory
Tests.html.
III. Meeting Attendance
The Panel’s meeting on August 1,
2017 is open to the public. Priority will
be given to those who pre-register and
attendance may be limited based on the
number of registrants and the space
available.
Persons wishing to attend this
meeting, which is located on federal
property, must register by following the
instructions in the ‘‘Meeting
Registration’’ section of this notice. A
confirmation email will be sent to the
registrants shortly after completing the
registration process.
IV. Security, Building, and Parking
Guidelines
The following are the security,
building, and parking guidelines:
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Federal Register / Vol. 82, No. 115 / Friday, June 16, 2017 / Notices
• Persons attending the meeting,
including presenters, must be preregistered and on the attendance list by
the prescribed date.
• Individuals who are not preregistered in advance may not be
permitted to enter the building and may
be unable to attend the meeting.
• Attendees must present a
government-issued photo identification
(ID) to the Federal Protective Service or
Guard Service personnel before entering
the building. Without a current, valid
photo ID, persons may not be permitted
entry to the building.
• Security measures include
inspection of vehicles, inside and out, at
the entrance to the grounds.
• All persons entering the building
must pass through a metal detector.
• All items brought into CMS
including personal items, for example,
laptops and cell phones, are subject to
physical inspection.
• The public may enter the building
30 to 45 minutes before the meeting
convenes each day.
• All visitors must be escorted in
areas other than the lower and first-floor
levels in the Central Building.
• The main-entrance guards will
issue parking permits and instructions
upon arrival at the building.
V. Special Accommodations
Individuals requiring special
accommodations must include the
request for these services during
registration.
VI. Panel Recommendations and
Discussions
The Panel’s recommendations will be
posted after the meeting on the CMS
Web site at https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonClinical
DiagnosticLaboratoryTests.html.
sradovich on DSK3GMQ082PROD with NOTICES
VIII. Copies of the Charter
The Secretary’s Charter for the
Advisory Panel on Clinical Diagnostic
Laboratory Tests is available on the
CMS Web site at https://cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonClinical
DiagnosticLaboratoryTests.html or may
obtain a copy of the charter by
submitting a request to the contact listed
in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Dated: June 2, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2017–12545 Filed 6–15–17; 8:45 am]
BILLING CODE 4120–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–21]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by July 17, 2017.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
DATES:
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27707
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Withholding
Medicare Payments to Recover
Medicaid Overpayments and
Supporting Regulations in 42 CFR
447.31; Use: Certain Medicaid providers
that are subject to offsets for the
collection of Medicaid overpayments
may terminate or substantially reduce
their participation in Medicaid, leaving
the state Medicaid agency unable to
recover the amounts due. Recovery
procedures allow for determining the
amount of overpayments and offsetting
the overpayments by withholding the
provider’s Medicare payments. To
effectuate the withholding, the state
agency must provide their respective
CMS regional office with certain
documentation that identifies the
provider and the Medicaid overpayment
amount. The agency must also
demonstrate that the provider was
notified of the overpayment and that
demand for the overpayment was made.
An opportunity to appeal the
overpayment determination must be
afforded to the provider by the Medicaid
state agency. Lastly, Medicaid state
agencies must notify CMS when to
terminate the withholding; Form
Number: CMS–R–21 (OMB control
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Agencies
[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Notices]
[Pages 27705-27707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12545]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1669-N]
Medicare Program; Rechartering, Membership, and Announcement of
the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on
August 1, 2017
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the rechartering of the Advisory Panel
on Clinical Diagnostic Laboratory Tests (the Panel), designation of a
new chairperson to the Panel, and the next public meeting date for the
Panel on Tuesday, August 1, 2017. The purpose of the Panel is to advise
the Secretary of the Department of Health and Human Services (DHHS) and
the Administrator of the Centers for Medicare & Medicaid Services (CMS)
on issues related to clinical diagnostic laboratory tests (CDLTs). The
Panel will make recommendations to the Secretary and the Administrator
regarding crosswalking and gapfilling for new and reconsidered
laboratory codes that are discussed during the Public Meeting Regarding
New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the
Clinical Laboratory Fee Schedule for Calendar Year (CY) 2018 (2017 CLFS
Public Meeting), and provide input on other CY 2018 CLFS issues that
are designated in the Panel's charter and specified on meeting agenda.
The Secretary approved the rechartering of the Panel on April 25, 2017
for a 2-year period effective through April 25, 2019.
DATES: Meeting Date: The meeting of the Panel is scheduled for Tuesday,
August 1, 2017, from 9:00 a.m. to 5:00 p.m., Eastern Daylight Savings
Time (E.D.T.). We note that the Panel will also attend the 2017 CLFS
Public Meeting and will gather information and ask questions to
presenters if they choose. Notice of the 2017 CLFS Public Meeting is
published elsewhere in this issue of the Federal Register. As we also
indicate in that notice, in the event the 2017 CLFS Public Meeting
needs to extend to August 1, 2017, the 2017 CLFS Public Meeting will
begin at 9:00 a.m., E.D.T. and the Panel Meeting will convene
immediately following the conclusion of that meeting.
Meeting Registration: The public may attend the Panel Meeting in
person, view via webcast, or listen via teleconference. Beginning
Monday, June 19, 2017 and ending Friday, July 14, 2017 at 5:00 p.m.
E.D.T., registration to attend the Panel Meeting in person may be
completed online at https://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. On this Web
page, under ``Panel Meetings,'' click the ``Register for August 1, 2017
Panel Meeting'' link and enter the required information. All of the
following information must be submitted when registering:
Name
Company name
Address
Email addresses
Note: Participants who do not plan to attend the Panel Meeting in
person on August 1, 2017 should not register. No registration is
required for participants who plan to view the Panel Meeting via
webcast or listen via teleconference. Participants planning to attend
only the 2017 CLFS Public Meeting (on July 31, 2017), or both the 2017
CLFS Public Meeting and the Panel Meeting (on August 1, 2017), should
register only once for the 2017 CLFS Public Meeting. We refer readers
to the Public Meeting Regarding New and Reconsidered Clinical
Diagnostic Laboratory Test Codes for the CLFS for CY 2018 notice
published elsewhere in this issue of the Federal Register for
instructions on registering. Participants planning to attend only the
Panel Meeting (August 1, 2017) must register using the above link and
instructions. Comments and presentations on new and reconsidered CDLTs
will be made during the 2017 CLFS Public Meeting (on July 31, 2017). We
note that here because the Panel will address crosswalking and
gapfilling for new and reconsidered laboratory codes that are discussed
during 2017 CLFS Public Meeting and may wish to ask follow-up questions
to presenters at the Panel Meeting (on August 1, 2017).
Issues concerning the CY 2018 CLFS that are designated in the
Panel's charter and specified in the meeting agenda will be discussed
at the Panel Meeting. The deadline to register to be a presenter and to
submit written presentations for agenda items during the Panel Meeting
(that is, presentations on issues other than payment for new and
reconsidered
[[Page 27706]]
CDLTs considered at the 2017 CLFS Public Meeting) is Friday, July 14,
2017. Issues to be discussed will be specified in the Panel Meeting
agenda, to be published approximately 2 weeks before the meeting (a
preliminary agenda is described in Section II. of this notice).
Comments and presentations should not address issues not specified in
the agenda for the Panel Meeting. If issues are added to the agenda, we
would be interested in public comments or presentations related to
those additional issues. Commenters and presenters may register via
email to the designated CLFS-dedicated email box listed in the FOR
FURTHER INFORMATION CONTACT section of this notice. Presentations
should be sent via email to the same email address.
Meeting Location, Webcast, and Teleconference: The Panel Meeting
will be held in the Auditorium of the CMS, Central Office, 7500
Security Boulevard, Baltimore, Maryland 21244-1850. Alternately, the
public may view the Panel Meeting via a webcast or listen by
teleconference. During the scheduled Panel Meeting, webcasting is
accessible online at https://cms.gov/live. Teleconference dial-in
information will appear on the final Panel Meeting agenda, which will
be posted on the CMS Web site when available at https://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
Meeting Format: This Panel 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.
E.D.T. on Monday, July 31, 2017, preceding the 2017 CLFS Public
Meeting, and again at 8:30 a.m. to 9:00 a.m. E.D.T. on August 1, 2017
for visitors attending only the Panel Meeting.
During the 2017 CLFS Public Meeting, the public, along with the
Panel, will hear and pose questions to presenters concerning
crosswalking and gapfilling for new and reconsidered CDLTs for calendar
year CY 2018. Following the opening remarks of the Panel Meeting, the
Panel will address any issues relating to the CY 2018 CLFS new and
reconsidered laboratory codes, including making recommendations to the
Secretary of HHS and the Administrator of CMS regarding crosswalking
and gapfilling for new and reconsidered laboratory codes discussed
during the CLFS Public Meeting. The Panel will also provide input on
other CY 2018 CLFS issues that are designated in the Panel's charter
and specified on the meeting agenda. The Panel will hear oral
presentations from the public for a total time period of no more than 1
hour.
FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal
Official (DFO), 410-786-5723, email CDLTPanel@cms.hhs.gov. Press
inquiries are handled through the CMS Press Office at (202) 690-6145.
For additional information on the Panel, please refer to the CMS Web
site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
SUPPLEMENTARY INFORMATION:
I. Background
The Advisory Panel on Clinical Diagnostic Laboratory Tests is
authorized by section 1834A(f)(1) of the Social Security Act (the Act)
(42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting
Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), enacted on
April 1, 2014). The Panel is subject to the Federal Advisory Committee
Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth
standards for the formation and use of advisory panels.
Section 1834A(f)(1) of the Act directs the Secretary of the
Department of Health and Human Services (the Secretary) to consult with
an expert outside advisory panel established by the Secretary, composed
of an appropriate selection of individuals with expertise in issues
related to clinical diagnostic laboratory tests. Such individuals may
include molecular pathologists, researchers, and individuals with
expertise in laboratory science or health economics.
The Panel will provide input and recommendations to the Secretary
and the Administrator of the Center for Medicare & Medicaid Services
(CMS), on the following:
The establishment of payment rates under section 1834A of
the Act for new clinical diagnostic laboratory tests, including whether
to use crosswalking or gapfilling processes to determine payment for a
specific new test; and
The factors used in determining coverage and payment
processes for new clinical diagnostic laboratory tests.
Other aspects of the new payment system under section
1834A of the Act.
A notice announcing the establishment of the Panel and soliciting
nominations for members was published in the October 27, 2014 Federal
Register (79 FR 63919 through 63920). In the August 7, 2015 Federal
Register (80 FR 47491), we announced membership appointments to the
Panel along with the first public meeting date for the Panel, which was
held on August 26, 2015. Subsequent meetings of the Panel were also
announced in the Federal Register. Since the last meeting, the
Secretary approved re-chartering of the Panel on April 25, 2017. The
new charter is effective through April 25, 2019 and may be found on the
CMS Web site at https://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. Karen Nakano,
M.D. has been designated as the new Panel Chair after the retirement of
the former Panel Chair.
The Panel charter provides that Panel meetings will be held up to 4
times annually and the Panel Chair will serve for a period of 3 years,
which may be extended at the discretion of the CMS Administrator or his
or her duly appointed designee. Additionally, the Panel Chair
facilitates the meeting and the Designated Federal Official (DFO) or
DFO's designee must be present at all meetings.
II. Agenda
The Agenda for the August 1, 2017, Panel Meeting will provide for
discussion and comment on the following topics as designated in the
Panel's charter:
CY 2018 CLFS new and reconsidered test codes, to be posted
on June 16, 2017, on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html.
Other CY 2018 CLFS issues designated in the Panel's
charter and further described on the Agenda.
A detailed Agenda will be posted approximately 2 weeks before the
meeting, on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
III. Meeting Attendance
The Panel's meeting on August 1, 2017 is open to the public.
Priority will be given to those who pre-register and attendance may be
limited based on the number of registrants and the space available.
Persons wishing to attend this meeting, which is located on federal
property, must register by following the instructions in the ``Meeting
Registration'' section of this notice. A confirmation email will be
sent to the registrants shortly after completing the registration
process.
IV. Security, Building, and Parking Guidelines
The following are the security, building, and parking guidelines:
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Persons attending the meeting, including presenters, must
be pre-registered and on the attendance list by the prescribed date.
Individuals who are not pre-registered in advance may not
be permitted to enter the building and may be unable to attend the
meeting.
Attendees must present a government-issued photo
identification (ID) to the Federal Protective Service or Guard Service
personnel before entering the building. Without a current, valid photo
ID, persons may not be permitted entry to the building.
Security measures include inspection of vehicles, inside
and out, at the entrance to the grounds.
All persons entering the building must pass through a
metal detector.
All items brought into CMS including personal items, for
example, laptops and cell phones, are subject to physical inspection.
The public may enter the building 30 to 45 minutes before
the meeting convenes each day.
All visitors must be escorted in areas other than the
lower and first-floor levels in the Central Building.
The main-entrance guards will issue parking permits and
instructions upon arrival at the building.
V. Special Accommodations
Individuals requiring special accommodations must include the
request for these services during registration.
VI. Panel Recommendations and Discussions
The Panel's recommendations will be posted after the meeting on the
CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
VIII. Copies of the Charter
The Secretary's Charter for the Advisory Panel on Clinical
Diagnostic Laboratory Tests is available on the CMS Web site at https://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html or may obtain a
copy of the charter by submitting a request to the contact listed in
the FOR FURTHER INFORMATION CONTACT section of this notice.
Dated: June 2, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-12545 Filed 6-15-17; 8:45 am]
BILLING CODE 4120-01-P