Medicare Program; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on September 12, 2016, 55461-55462 [2016-19848]
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Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
Appendix A
FEE SCHEDULE FOR EACH VESSEL
SIZE
Vessel size (GRT 1)
Inspection fee
Extra Small (<3,000 GRT) ....
Small (3,001–15,000 GRT) ..
Medium (15,001–30,000
GRT) .................................
Large (30,001–60,000 GRT)
Extra Large (60,001–120,000
GRT) .................................
Mega (>120,001 GRT) .........
US$1,495
2,990
5,980
8,970
11,960
17,940
1 Gross register tonnage in cubic feet, as
shown in Lloyd’s Register of Shipping.
[FR Doc. 2016–19785 Filed 8–18–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1680–N]
Medicare Program; Announcement of
the Advisory Panel on Clinical
Diagnostic Laboratory Tests Meeting
on September 12, 2016
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
next meeting date of the Advisory Panel
on Clinical Diagnostic Laboratory Tests
(the Panel) on Monday, September 12,
2016. The purpose of the Panel is to
advise the Secretary of the Department
of Health and Human Services (HHS)
(the Secretary) and the Acting
Administrator of the Centers for
Medicare & Medicaid Services (CMS)
(the Acting Administrator) on issues
related to clinical diagnostic laboratory
tests. The Panel will address Clinical
Laboratory Fee Schedule issues relevant
to the June 23, 2016 final rule entitled
‘‘Medicare Program; Medicare Clinical
Diagnostic Laboratory Tests Payment
System’’ (81 FR 41035 through 41101),
which are designated in the Panel’s
charter and outlined in the agenda.
DATES: Meeting Date: The meeting of the
Panel is scheduled to take place at
CMS’s headquarters in Baltimore,
Maryland on Monday, September 12,
2016 beginning at 9:00 a.m. and ending
at 4:30 p.m., Eastern Daylight Time
(e.d.t.). The times listed in this notice
are Eastern Daylight Time (EDT) and are
approximate times except that the
meeting will not begin before the posted
time.
Meeting Registration: The public may
attend the meeting in-person, view via
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:08 Aug 18, 2016
Jkt 238001
webcast, or listen via teleconference.
Beginning Friday, August 19, 2016 and
ending Friday, September 2, 2016 at
5:00 p.m. e.d.t., registration to attend the
meeting in-person may be completed
on-line at https://cms.gov/Regulationsand-Guidance/Guidance/FACA/
AdvisoryPanelonClinical
DiagnosticLaboratoryTests.html. On this
Web page, under ‘‘Related Links,’’
double-click the ‘‘Clinical Diagnostic
Laboratory Tests FACA Panel Meeting
Registration’’ link and enter the required
information. All the following
information must be submitted when
registering:
• Name.
• Company name.
• Address.
• Email addresses.
Note: Participants who do not plan to
attend the meeting in-person on
September 12, 2016 should not register.
No registration is required for
participants who plan to view the
meeting via webcast or listen via
teleconference.
Presenter Registration and
Submission of Presentations and
Comments: We are interested in
submitted comments or in-person
presentations at the meeting concerning
the issues described in the
SUPPLEMENTARY INFORMATION section of
this notice and clarified in the agenda
to be published approximately 2 weeks
before the meeting. The comments and
presentations should not address issues
not before the Panel. The deadline to
register to be a presenter and to submit
written presentations for the meeting is
5:00 p.m. e.d.t., Friday, September 2,
2016. Presenters may register by email
by contacting the person listed in the
FOR FURTHER INFORMATION CONTACT
section of this notice. Presentations
should be sent via email to the same
person’s email address.
ADDRESSES: Meeting Location and
Webcast: The meeting will be held in
the Auditorium, CMS Central Office,
7500 Security Boulevard, Woodlawn,
Maryland 21244–1850. Alternately, the
public may either view the meeting via
a webcast at https://cms.gov/live.
Web site and Teleconference: For
teleconference dial-in information, the
final meeting agenda, and additional
information on the Panel, please refer to
our Web site at https://cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelon
ClinicalDiagnosticLaboratoryTests.html.
FOR FURTHER INFORMATION CONTACT:
Glenn C. McGuirk, Designated Federal
Official (DFO), Center for Medicare,
Division of Ambulatory Services, CMS,
7500 Security Boulevard, Mail Stop C4–
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
55461
01–26, Baltimore, MD 21244, 410–786–
5723, email CDLTPanel@cms.hhs.gov or
Glenn.McGuirk@cms.hhs.gov. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145.
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
of the Protecting Access to Medicare Act
of 2014 (PAMA) (Pub. L. 113–93,
enacted 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 (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, clinical
laboratory researchers, and individuals
with expertise in laboratory science or
health economics.
The Panel will provide input and
recommendations to the Secretary and
the Acting Administrator of the Centers
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;
• The factors used in determining
coverage and payment processes for
new clinical diagnostic laboratory tests;
and
• Other aspects of the new payment
system, to be based on private payor
rates, 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 public meetings
for the Panel were held on October 19,
2015 (80 FR 59782) and July 18, 2016
(81 FR 35772). Recommendations from
Panel meetings are posted on the CMS
Web site listed in the ADDRESSES section
of this notice.
E:\FR\FM\19AUN1.SGM
19AUN1
55462
Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
The Panel charter provides that panel
meetings will be held up to four times
annually. The Panel consists of 15
individuals and a Chair. The Panel
Chair facilitates the meeting and the
Designated Federal Official (DFO) or
DFO’s designee must be present at all
meetings.
II. Meeting Format and Agenda
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. on
Monday, September 12, 2016. Following
the opening remarks, the Panel will hear
oral presentations from the public for no
more than 1 hour during each of two
sessions, one session in the morning
and one session in the afternoon. During
session one, registered persons from the
public may present recommendations
on payment options for routine
chemistry tests that are currently paid as
Automated Test Panels (ATPs)
following implementation of the new
payment system for clinical diagnostic
laboratory tests on January 1, 2018.
During session two, registered persons
from the public may present
recommendations on the application
process for Advanced Diagnostic
Laboratory Tests (ADLTs).
The agenda for the September 12,
2016, meeting will provide for
discussion and comment on specified
CLFS issues relevant to the final rule,
CMS–1621–F entitled, ‘‘Medicare
Program; Medicare Clinical Diagnostic
Laboratory Tests Payment System,’’
which are designated in the Panel’s
charter. Specifically, the Panel will
discuss the following issues:
• Payment for routine chemistry tests
that are currently paid as ATPs
following implementation of the new
payment system for clinical diagnostic
laboratory tests on January 1, 2018.
• The application process for ADLTs.
A detailed agenda will be posted
approximately 2 weeks before the
meeting, on the CMS Web site listed in
the ADDRESSES section of this notice.
mstockstill on DSK3G9T082PROD with NOTICES
III. Meeting Attendance
The Panel’s meeting on September 12,
2016, 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 DATES section of this
notice under ‘‘Meeting Registration.’’ A
confirmation email will be sent to the
registrants shortly after completing the
registration process.
VerDate Sep<11>2014
18:08 Aug 18, 2016
Jkt 238001
IV. Security, Building, and Parking
Guidelines
The following are the security,
building, and parking guidelines:
• 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
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 our Web site
as specified in the ADDRESSES section of
this notice.
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 as specified in the
ADDRESSES section of this notice or you
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.
IX. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: August 4, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–19848 Filed 8–18–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0370]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Medical
Devices; Foreign Letters of Approval
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 September
19, 2016.
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 0910–0264. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@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:
Export of Medical Devices; Foreign
Letters of Approval—OMB Control
Number 0910–0264—Extension
Section 801(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
E:\FR\FM\19AUN1.SGM
19AUN1
Agencies
[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55461-55462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19848]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1680-N]
Medicare Program; Announcement of the Advisory Panel on Clinical
Diagnostic Laboratory Tests Meeting on September 12, 2016
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the next meeting date of the Advisory
Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday,
September 12, 2016. The purpose of the Panel is to advise the Secretary
of the Department of Health and Human Services (HHS) (the Secretary)
and the Acting Administrator of the Centers for Medicare & Medicaid
Services (CMS) (the Acting Administrator) on issues related to clinical
diagnostic laboratory tests. The Panel will address Clinical Laboratory
Fee Schedule issues relevant to the June 23, 2016 final rule entitled
``Medicare Program; Medicare Clinical Diagnostic Laboratory Tests
Payment System'' (81 FR 41035 through 41101), which are designated in
the Panel's charter and outlined in the agenda.
DATES: Meeting Date: The meeting of the Panel is scheduled to take
place at CMS's headquarters in Baltimore, Maryland on Monday, September
12, 2016 beginning at 9:00 a.m. and ending at 4:30 p.m., Eastern
Daylight Time (e.d.t.). The times listed in this notice are Eastern
Daylight Time (EDT) and are approximate times except that the meeting
will not begin before the posted time.
Meeting Registration: The public may attend the meeting in-person,
view via webcast, or listen via teleconference. Beginning Friday,
August 19, 2016 and ending Friday, September 2, 2016 at 5:00 p.m.
e.d.t., registration to attend the meeting in-person may be completed
on-line at https://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. On this Web
page, under ``Related Links,'' double-click the ``Clinical Diagnostic
Laboratory Tests FACA Panel Meeting Registration'' link and enter the
required information. All the following information must be submitted
when registering:
Name.
Company name.
Address.
Email addresses.
Note: Participants who do not plan to attend the meeting in-person
on September 12, 2016 should not register. No registration is required
for participants who plan to view the meeting via webcast or listen via
teleconference.
Presenter Registration and Submission of Presentations and
Comments: We are interested in submitted comments or in-person
presentations at the meeting concerning the issues described in the
SUPPLEMENTARY INFORMATION section of this notice and clarified in the
agenda to be published approximately 2 weeks before the meeting. The
comments and presentations should not address issues not before the
Panel. The deadline to register to be a presenter and to submit written
presentations for the meeting is 5:00 p.m. e.d.t., Friday, September 2,
2016. Presenters may register by email by contacting the person listed
in the FOR FURTHER INFORMATION CONTACT section of this notice.
Presentations should be sent via email to the same person's email
address.
ADDRESSES: Meeting Location and Webcast: The meeting will be held in
the Auditorium, CMS Central Office, 7500 Security Boulevard, Woodlawn,
Maryland 21244-1850. Alternately, the public may either view the
meeting via a webcast at https://cms.gov/live.
Web site and Teleconference: For teleconference dial-in
information, the final meeting agenda, and additional information on
the Panel, please refer to our Web site at https://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal
Official (DFO), Center for Medicare, Division of Ambulatory Services,
CMS, 7500 Security Boulevard, Mail Stop C4-01-26, Baltimore, MD 21244,
410-786-5723, email CDLTPanel@cms.hhs.gov or Glenn.McGuirk@cms.hhs.gov.
Press inquiries are handled through the CMS Press Office at (202) 690-
6145.
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 of the Protecting
Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted 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 (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, clinical laboratory researchers, and
individuals with expertise in laboratory science or health economics.
The Panel will provide input and recommendations to the Secretary
and the Acting Administrator of the Centers 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;
The factors used in determining coverage and payment
processes for new clinical diagnostic laboratory tests; and
Other aspects of the new payment system, to be based on
private payor rates, 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 public meetings for the Panel were
held on October 19, 2015 (80 FR 59782) and July 18, 2016 (81 FR 35772).
Recommendations from Panel meetings are posted on the CMS Web site
listed in the ADDRESSES section of this notice.
[[Page 55462]]
The Panel charter provides that panel meetings will be held up to
four times annually. The Panel consists of 15 individuals and a Chair.
The Panel Chair facilitates the meeting and the Designated Federal
Official (DFO) or DFO's designee must be present at all meetings.
II. Meeting Format and Agenda
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. on Monday, September
12, 2016. Following the opening remarks, the Panel will hear oral
presentations from the public for no more than 1 hour during each of
two sessions, one session in the morning and one session in the
afternoon. During session one, registered persons from the public may
present recommendations on payment options for routine chemistry tests
that are currently paid as Automated Test Panels (ATPs) following
implementation of the new payment system for clinical diagnostic
laboratory tests on January 1, 2018. During session two, registered
persons from the public may present recommendations on the application
process for Advanced Diagnostic Laboratory Tests (ADLTs).
The agenda for the September 12, 2016, meeting will provide for
discussion and comment on specified CLFS issues relevant to the final
rule, CMS-1621-F entitled, ``Medicare Program; Medicare Clinical
Diagnostic Laboratory Tests Payment System,'' which are designated in
the Panel's charter. Specifically, the Panel will discuss the following
issues:
Payment for routine chemistry tests that are currently
paid as ATPs following implementation of the new payment system for
clinical diagnostic laboratory tests on January 1, 2018.
The application process for ADLTs.
A detailed agenda will be posted approximately 2 weeks before the
meeting, on the CMS Web site listed in the ADDRESSES section of this
notice.
III. Meeting Attendance
The Panel's meeting on September 12, 2016, 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 DATES
section of this notice under ``Meeting Registration.'' 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:
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 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 our
Web site as specified in the ADDRESSES section of this notice.
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 as
specified in the ADDRESSES section of this notice or you 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.
IX. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
Dated: August 4, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-19848 Filed 8-18-16; 8:45 am]
BILLING CODE 4120-01-P