Medicare, Medicaid, and Children's Health Insurance Programs; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on July 18, 2016, 35772-35774 [2016-13084]
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Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
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
presentation or to support a
presentation.
Note: 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 45 minutes prior to the convening
of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)
and 41 CFR 102–3).
Dated: May 26, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–13085 Filed 6–2–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1666–N]
Medicare, Medicaid, and Children’s
Health Insurance Programs;
Announcement of the Advisory Panel
on Clinical Diagnostic Laboratory
Tests Meeting on July 18, 2016
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
next public meeting date of the
Advisory Panel on Clinical Diagnostic
Laboratory Tests (the Panel) on Monday,
July 18, 2016. 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) (the Administrator) on
issues related to clinical diagnostic
laboratory tests.
DATES: Meeting Date: The meeting of the
Panel is scheduled for Monday, July 18,
2016 beginning at 9:00 a.m., Eastern
Daylight Time (EDT). The morning
session will be held jointly with the
Public Meeting on New and
Reconsidered Clinical Diagnostic
Laboratory Test Codes for the Clinical
Laboratory Fee Schedule (CLFS) for
Calendar Year (CY) 2017 (the 2016
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SUMMARY:
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Laboratory Public Meeting) (see 81 FR
29863, May 13, 2016 for notice of the
2016 Laboratory Public Meeting).
During the afternoon session, the Panel
will deliberate and make
recommendations regarding the new
and reconsidered laboratory codes for
CY 2017. The Panel may also hear
public presentations on additional
issues concerning the CY 2017 CLFS
that are designated in the Panel’s charter
and specified in the Panel meeting
agenda for the afternoon session.
Meeting Registration: The public may
attend the Panel meeting in-person,
view via webcast, or listen via
teleconference. Beginning Monday, June
6, 2016 and ending Friday, July 1, 2016
at 5:00 p.m. EDT, 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 ‘‘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 Panel meeting in-person on July
18, 2016 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 morning session which
includes the 2016 Laboratory Public Meeting,
or both the morning and afternoon sessions,
should register only once, for the 2016
Laboratory Public Meeting (see instructions
for registering for the 2016 Laboratory Public
Meeting at 81 FR 29863). Participants
planning to attend only the afternoon session
of the Panel meeting must register using the
above link and instructions.
Presenter Registration and
Submission of Presentations and
Comments: In the morning session only,
we are interested in in-person
presentations concerning the payment
methodologies for new or reconsidered
laboratory codes. The instructions for
submitting such comments and
presentations are also included in 2016
Laboratory Public Meeting notice (81 FR
29863). Although these comments and
presentations will be made during the
morning joint session of the 2016
Laboratory Public Meeting and Panel
Meeting, the Panel may wish to ask
follow-up questions to presenters at the
afternoon session of the Panel Meeting.
As previously mentioned, additional
issues concerning the calendar year (CY)
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Fmt 4703
Sfmt 4703
2017 clinical laboratory fee schedule
(CLFS) that are designated in the Panel’s
charter and specified in the meeting
agenda, may also be discussed at the
afternoon session of the Panel meeting.
Any such issues to be discussed will be
specified in the Panel meeting agenda,
to be published approximately 3 weeks
before the meeting (A preliminary
agenda is described in section II. of this
notice.) Should issues be added to the
agenda, we would be interested in
public comments or presentations
related to those issues. The comments
and presentations should not address
issues not specified in the agenda for
the Panel meeting. The deadline to
register to be a presenter and to submit
written presentations for agenda items
for the Panel’s afternoon session (that is,
presentations on issues other than
payment for new and reconsidered
laboratory codes for CY 2017) is 5:00
p.m. EDT July 1, 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.
Meeting Location, Webcast, and
Teleconference: The Panel meetings will
be held in the Auditorium of the CMS,
Central Office, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Alternately, the public may either view
the Panel meetings 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. on Monday, July 18,
2016, preceding the morning session of
the 2016 Laboratory Public Meeting, and
again at 12:30 p.m. for visitors attending
only the Panel meeting (afternoon
session).
During the morning session, the
Panel, along with the public, will hear
and pose questions to presenters
recommending crosswalks or gapfilling
for new and reconsidered laboratory
codes for calendar year (CY) 2017.
During the afternoon session, the Panel
will deliberate and make
recommendations to the Secretary of
HHS and the Acting Administrator of
CMS regarding crosswalks or gapfilling
for new and reconsidered laboratory
codes discussed during the morning
E:\FR\FM\03JNN1.SGM
03JNN1
Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
session. The Panel may also hear public
presentations (for a total time period of
no more than one hour) and provide
input on other CY 2017 CLFS issues that
are designated in the Panel’s charter and
specified on meeting agenda. Both the
morning and afternoon sessions are
open to the public.
ADDRESSES: Web site: For additional
information on the Panel, please refer to
our Web site at https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonClinical
DiagnosticLaboratoryTests.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:
mstockstill on DSK3G9T082PROD with NOTICES
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 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, 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 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
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21:20 Jun 02, 2016
Jkt 238001
• Other aspects of the upcoming 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.
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. Agenda
The Agenda for the July 18, 2016,
Panel meeting will provide for
discussion and comment on the
following topics as designated in the
Panel’s Charter:
• CY 2017 CLFS new and
reconsidered test codes which were
posted on May 12, 2016, on our Web
site at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
ClinicalLabFeeSched/Laboratory_
Public_Meetings.html
• Other CY 2017 CLFS issues
designated in the Panel’s charter and
further described on our Agenda.
A detailed Agenda will be posted
approximately 3 weeks before the
meeting, on our Web site at https://
cms.gov/Regulations-andGuidance/
Guidance/FACA/AdvisoryPanelon
ClinicalDiagnosticLaboratoryTests.html.
III. Meeting Attendance
The Panel’s meeting on July 18, 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 ‘‘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:
• Persons attending the meeting,
including presenters, must be pre-
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35773
registered 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
at https://cms.gov/Regulations-and
Guidance/Guidance/FACA/Advisory
PanelonClinicalDiagnosticLaboratory
Tests.html.
VIII. Copies of the Charter
The Secretary’s Charter for the
Advisory Panel on Clinical Diagnostic
Laboratory Tests is available on our Web
site at https://cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory
PanelonClinicalDiagnosticLaboratory
Tests.html 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
E:\FR\FM\03JNN1.SGM
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35774
Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: May 25, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–13084 Filed 6–2–16; 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
Title: Migrant and Seasonal Head
Start Study.
OMB No.: New Collection.
Description: The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services, is
proposing an information collection
activity for the Migrant and Seasonal
Head Start (MSHS) Study.
The MSHS Study will describe the
characteristics and experiences of the
children and families who enroll in
MSHS and the practices and services of
the MSHS programs that serve them.
The findings will provide up-to-date
information to the Office of Head Start,
other federal government agencies, local
MSHS programs, and the public. The
study will be the first national MSHS
study to include direct child
assessments, which will provide
information about MSHS children that
programs can use to inform program,
center and classroom practices.
Data collection will involve mail
surveys to selected MSHS center
directors and all MSHS program
directors nationwide about operational
characteristics, program- and centerlevel policies and practices, and
services and resources offered to MSHS
families. The study will also conduct
on-site data collection with children,
parents, teachers, and classrooms in a
nationally-representative sample of
MSHS centers. The on-site data
collection will include classroom
observations, teacher surveys, child
reports and child assessments.
Respondents: MSHS program
directors, center directors, teachers,
assistant teachers, parents, and children.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Program Director survey ..................................................................................
Center Director survey .....................................................................................
Call script for Program Directors .....................................................................
Form for Program Directors to verify key information for selected centers ....
Call script for Center Directors ........................................................................
Call script for On Site Coordinators .................................................................
Classroom sampling form ................................................................................
Child roster form ..............................................................................................
Teacher survey ................................................................................................
Teacher child report .........................................................................................
Assistant Teacher survey ................................................................................
Parent consent form ........................................................................................
Child assessments (preschoolers and older toddlers only) ............................
Parent interview (including Parent child report) ..............................................
Number of
responses per
respondent
53
253
24
24
53
53
53
53
159
159
159
1,018
848
1,018
Average
burden hours
per response
1
1
1
1
1
1
1
3
1
8
1
1
1
1
Estimated
annual
burden hours
0.5
0.5
1
0.5
1
1
0.5
0.25
0.5
0.25
0.25
0.25
0.75
1
27
127
24
12
53
53
27
40
80
318
40
255
636
1,018
mstockstill on DSK3G9T082PROD with NOTICES
Estimated Total Annual Burden Hours: 2,710.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
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Jkt 238001
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
ACF Certifying Officer.
AGENCY:
[FR Doc. 2016–13104 Filed 6–2–16; 8:45 am]
ACTION:
Frm 00042
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[Docket No. FDA–2016–N–0628]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reporting
Associated With New Animal Drug
Applications
Food and Drug Administration,
HHS.
BILLING CODE 4184–22–P
PO 00000
Food and Drug Administration
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.
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35772-35774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13084]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1666-N]
Medicare, Medicaid, and Children's Health Insurance Programs;
Announcement of the Advisory Panel on Clinical Diagnostic Laboratory
Tests Meeting on July 18, 2016
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the next public meeting date of the
Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on
Monday, July 18, 2016. 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)
(the Administrator) on issues related to clinical diagnostic laboratory
tests.
DATES: Meeting Date: The meeting of the Panel is scheduled for Monday,
July 18, 2016 beginning at 9:00 a.m., Eastern Daylight Time (EDT). The
morning session will be held jointly with the Public Meeting on New and
Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical
Laboratory Fee Schedule (CLFS) for Calendar Year (CY) 2017 (the 2016
Laboratory Public Meeting) (see 81 FR 29863, May 13, 2016 for notice of
the 2016 Laboratory Public Meeting). During the afternoon session, the
Panel will deliberate and make recommendations regarding the new and
reconsidered laboratory codes for CY 2017. The Panel may also hear
public presentations on additional issues concerning the CY 2017 CLFS
that are designated in the Panel's charter and specified in the Panel
meeting agenda for the afternoon session.
Meeting Registration: The public may attend the Panel meeting in-
person, view via webcast, or listen via teleconference. Beginning
Monday, June 6, 2016 and ending Friday, July 1, 2016 at 5:00 p.m. EDT,
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 ``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 Panel meeting
in-person on July 18, 2016 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 morning session which includes the 2016 Laboratory
Public Meeting, or both the morning and afternoon sessions, should
register only once, for the 2016 Laboratory Public Meeting (see
instructions for registering for the 2016 Laboratory Public Meeting
at 81 FR 29863). Participants planning to attend only the afternoon
session of the Panel meeting must register using the above link and
instructions.
Presenter Registration and Submission of Presentations and
Comments: In the morning session only, we are interested in in-person
presentations concerning the payment methodologies for new or
reconsidered laboratory codes. The instructions for submitting such
comments and presentations are also included in 2016 Laboratory Public
Meeting notice (81 FR 29863). Although these comments and presentations
will be made during the morning joint session of the 2016 Laboratory
Public Meeting and Panel Meeting, the Panel may wish to ask follow-up
questions to presenters at the afternoon session of the Panel Meeting.
As previously mentioned, additional issues concerning the calendar
year (CY) 2017 clinical laboratory fee schedule (CLFS) that are
designated in the Panel's charter and specified in the meeting agenda,
may also be discussed at the afternoon session of the Panel meeting.
Any such issues to be discussed will be specified in the Panel meeting
agenda, to be published approximately 3 weeks before the meeting (A
preliminary agenda is described in section II. of this notice.) Should
issues be added to the agenda, we would be interested in public
comments or presentations related to those issues. The comments and
presentations should not address issues not specified in the agenda for
the Panel meeting. The deadline to register to be a presenter and to
submit written presentations for agenda items for the Panel's afternoon
session (that is, presentations on issues other than payment for new
and reconsidered laboratory codes for CY 2017) is 5:00 p.m. EDT July 1,
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.
Meeting Location, Webcast, and Teleconference: The Panel meetings
will be held in the Auditorium of the CMS, Central Office, 7500
Security Boulevard, Baltimore, Maryland 21244-1850. Alternately, the
public may either view the Panel meetings 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. on
Monday, July 18, 2016, preceding the morning session of the 2016
Laboratory Public Meeting, and again at 12:30 p.m. for visitors
attending only the Panel meeting (afternoon session).
During the morning session, the Panel, along with the public, will
hear and pose questions to presenters recommending crosswalks or
gapfilling for new and reconsidered laboratory codes for calendar year
(CY) 2017. During the afternoon session, the Panel will deliberate and
make recommendations to the Secretary of HHS and the Acting
Administrator of CMS regarding crosswalks or gapfilling for new and
reconsidered laboratory codes discussed during the morning
[[Page 35773]]
session. The Panel may also hear public presentations (for a total time
period of no more than one hour) and provide input on other CY 2017
CLFS issues that are designated in the Panel's charter and specified on
meeting agenda. Both the morning and afternoon sessions are open to the
public.
ADDRESSES: Web site: For additional information on the Panel, please
refer to our Web site at https://www.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(a) 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 (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, 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 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 upcoming 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.
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. Agenda
The Agenda for the July 18, 2016, Panel meeting will provide for
discussion and comment on the following topics as designated in the
Panel's Charter:
CY 2017 CLFS new and reconsidered test codes which were
posted on May 12, 2016, on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html
Other CY 2017 CLFS issues designated in the Panel's
charter and further described on our Agenda.
A detailed Agenda will be posted approximately 3 weeks before the
meeting, on our Web site at https://cms.gov/Regulations-andGuidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
III. Meeting Attendance
The Panel's meeting on July 18, 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 ``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:
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 at https://cms.gov/Regulations-andGuidance/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 our Web site at https://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html 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
[[Page 35774]]
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
Dated: May 25, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-13084 Filed 6-2-16; 8:45 am]
BILLING CODE 4120-01-P
