80 FR 47491 - Medicare, Medicaid, and Children's Health Insurance Programs; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 152 (August 7, 2015)

Page Range		47491-47492
FR Document		2015-19498

This notice announces 15 membership appointments to the Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and the first meeting date for the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on issues related to clinical diagnostic laboratory tests. The membership appointments are for 3 years. This notice also announces the first meeting date of the Panel on Wednesday, August 26, 2015.

Federal Register, Volume 80 Issue 152 (Friday, August 7, 2015)

[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Notices]
[Pages 47491-47492]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-19498]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1641-N]

Medicare, Medicaid, and Children's Health Insurance Programs;
Membership and Meeting Announcement for the Advisory Panel on Clinical
Diagnostic Laboratory Tests

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces 15 membership appointments to the
Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and
the first meeting date for the Panel. The purpose of the Panel is to
advise the Secretary of the Department of Health and Human Services
(DHHS) (the Secretary) and the Administrator of the Centers for
Medicare & Medicaid Services (CMS) (the Administrator) on issues
related to clinical diagnostic laboratory tests. The membership
appointments are for 3 years. This notice also announces the first
meeting date of the Panel on Wednesday, August 26, 2015.

DATES: Meeting Date: The first meeting of the Panel is scheduled to
take place at CMS's headquarters in Baltimore, MD on Wednesday, August
26, 2015 beginning at 9:00 a.m., Eastern Daylight Time (EDT). The Panel
will specifically recommend crosswalks for new laboratory codes,
recommend an appropriate coding structure for drugs of abuse testing,
and recommend crosswalks for such drugs of abuse testing.

Meeting Registration

The public may attend the meeting in-person, view via webcast, or
listen via teleconference. Beginning Friday, August 7, 2015 and ending
Friday, August 14, 2015 at 5:00 p.m. EDT, registration to attend the
meeting in-person may be completed online at http://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.
Postal address.
Email address.

Note: Participants who do not plan to attend the meeting in-
person on August 26, 2015, 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 presentations at the
meeting concerning the issues described in the SUMMARY section of this
notice. The comments and presentations should not duplicate those that
were provided at the Annual Clinical Laboratory Public Meeting on July
16, 2015, or submitted through the comment process provided subsequent
to the Annual Clinical Laboratory Public Meeting. The deadline to
register to be a presenter and to submit written presentations for the
meeting is 5:00 p.m. EDT, Monday, August 17, 2015. Presenters may
register by phone or via 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.
For reconsidered and new test codes, presenters should address all
of the following items:
Reconsidered or new test code(s) and descriptor.
Test purpose and method.
Costs.
Charges.
A recommendation with rationale for one of the two methods
(crosswalking or gapfilling) for determining payment for new tests, or
a recommendation with rationale for changing the basis or payment
amount, as applicable, for reconsidered tests.
Additionally, the presenters should provide the data on which their
recommendations are based.
When registering, individuals who want to make a presentation must
also specify for which new test codes they will be presenting comments.
A confirmation will be sent upon receipt of the registration.
Presenters must register by the date specified in the ``Meeting
Registration'' section of this notice.

Meeting Location, Webcast, and Teleconference

The meetings will be held in the Auditorium, CMS Central Office,
7500 Security Boulevard, Woodlawn, Maryland 21244-1850. Alternately,
the public may either view the meetings via a webcast or listen by
teleconference. During the scheduled meeting, webcasting is accessible
online at http://cms.gov/live. Teleconference dial-in information will
appear on the final meeting agenda, which will be posted on the CMS Web
site when available at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

Meeting Format

This meeting is open to the public. The onsite check-in for
visitors will be held from 8:30 a.m. to 9:00 a.m. EDT on Wednesday,
August 26, 2015, followed by opening remarks. Following the opening
remarks, the Panel will hear oral presentations from the public for no
more than 1 hour during two sessions. During the first session,
registered persons from the public may present recommendations for
crosswalks for new laboratory codes for the CY 2016 CLFS. During the
second session, registered persons from the public may present
recommendations for drugs of abuse testing and crosswalks. Time
allotted for each presentation may be limited. If the number of
registrants requesting to present is greater than can be reasonably
accommodated during the scheduled open public hearing session, we may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. We will accept written presentations from those
who were unable to present due to time constraints.

ADDRESSES: Web site: For additional information on the Panel, please
refer to our Web site at http://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 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

[[Page 47492]]

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 representatives of clinical laboratories, 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 Administrator, 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 under section
1834A of the Act.
The Panel charter provides that panel meetings will be held up to
four times annually. The Panel will consist of up to 15 individuals and
a Chair. The Panel Chair will facilitate meetings and the DFO or DFO's
designee must be present at all meetings. Meetings will be open to the
public except as determined otherwise by the Secretary or other
official to whom the authority has been delegated in accordance with
the Sunshine Act of 1976 (5 U.S.C. 552b(c)) and FACA. Notice of all
meetings will be published in the Federal Register as required by
applicable laws and Departmental regulations. Meetings will be
conducted, and records of the proceedings kept, as required by
applicable laws and Departmental regulations.
In order to conduct the business of the Panel, a quorum is
required. A quorum exists when a majority of currently appointed
members is present at full Panel or subcommittee meetings or is
participating in conference calls.

II. Provisions of This Notice

We published a notice in the Federal Register on October 27, 2014,
entitled ``Medicare, Medicaid, and Children's Health Insurance
Programs; Advisory Panel on Clinical Diagnostic Laboratory Tests and
Request for Nominations'' (79 FR 63919 through 63920). The notice
solicited nominations for up to 15 members and a Chair to serve on this
Panel. This notice announces 16 new members to the Panel. Their
appointments are for 3-year terms beginning July 1, 2015.
The Panel will consist of the following members and a Chair:

Steve Phurrough M.D., Panel Chair, CMS Medical Officer
Geoffrey Baird, M.D., Ph.D.
Vickie Baselski, Ph.D.
Stephen N. Bauer, M.D.
William Clarke, Ph.D., M.B.A., DABCC, FACB
Judith Davis, M.S.
Stanley R. Hamilton, M.D.
Curtis A. Hanson, M.D.
Kandice Kottke-Marchant, M.D., Ph.D.
Raju Kucherlapati, Ph.D.
Bryan A. Loy, M.D., M.B.A.
Gail Marcus, M.S.E., M.B.A.
Carl Morrison, M.D., D.V.M.
Victoria M. Pratt, Ph.D., FACMG
Michele M. Schoonmaker, Ph.D.
Rebecca Sutphen, M.D.

III. Meeting Attendance

The first meeting (August 26, 2015) is open to the public; however,
attendance is limited to space available. 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 to our Web site after
the meeting.

VII. 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 http://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.

VIII. 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 3, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-19498 Filed 8-6-15; 8:45 am]
BILLING CODE 4120-01-P

Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Notices 47491

Board of Governors of the Federal Reserve double-click the ‘‘Clinical Diagnostic Meeting Location, Webcast, and
System, August 4, 2015. Laboratory Tests FACA Panel Meeting Teleconference
Michael J. Lewandowski, Registration’’ link and enter the required The meetings will be held in the
Associate Secretary of the Board. information. All the following Auditorium, CMS Central Office, 7500
[FR Doc. 2015–19380 Filed 8–6–15; 8:45 am] information must be submitted when Security Boulevard, Woodlawn,
BILLING CODE 6210–01–P registering: Maryland 21244–1850. Alternately, the
• Name. public may either view the meetings via
• Company name. a webcast or listen by teleconference.
DEPARTMENT OF HEALTH AND • Postal address. During the scheduled meeting,
HUMAN SERVICES • Email address. webcasting is accessible online at http://
Note: Participants who do not plan to
cms.gov/live. Teleconference dial-in
Centers for Medicare & Medicaid attend the meeting in-person on August 26, information will appear on the final
Services 2015, should not register. No registration is meeting agenda, which will be posted
required for participants who plan to view on the CMS Web site when available at
[CMS–1641–N]
the meeting via webcast or listen via http://cms.gov/Regulations-and-
Medicare, Medicaid, and Children’s teleconference. Guidance/Guidance/FACA/
Health Insurance Programs; AdvisoryPanelonClinical
Presenter Registration and Submission DiagnosticLaboratoryTests.html.
Membership and Meeting
of Presentations and Comments
Announcement for the Advisory Panel Meeting Format
on Clinical Diagnostic Laboratory We are interested in submitted This meeting is open to the public.
Tests comments or in presentations at the The onsite check-in for visitors will be
meeting concerning the issues described held from 8:30 a.m. to 9:00 a.m. EDT on
AGENCY: Centers for Medicare & in the SUMMARY section of this notice.
Medicaid Services (CMS), HHS. Wednesday, August 26, 2015, followed
The comments and presentations should by opening remarks. Following the
ACTION: Notice. not duplicate those that were provided opening remarks, the Panel will hear
at the Annual Clinical Laboratory Public oral presentations from the public for no
SUMMARY: This notice announces 15 Meeting on July 16, 2015, or submitted
membership appointments to the more than 1 hour during two sessions.
through the comment process provided During the first session, registered
Advisory Panel on Clinical Diagnostic subsequent to the Annual Clinical
Laboratory Tests (the Panel) and the first persons from the public may present
Laboratory Public Meeting. The recommendations for crosswalks for
meeting date for the Panel. The purpose deadline to register to be a presenter and
of the Panel is to advise the Secretary of new laboratory codes for the CY 2016
to submit written presentations for the CLFS. During the second session,
the Department of Health and Human meeting is 5:00 p.m. EDT, Monday,
Services (DHHS) (the Secretary) and the registered persons from the public may
August 17, 2015. Presenters may register present recommendations for drugs of
Administrator of the Centers for by phone or via email by contacting the
Medicare & Medicaid Services (CMS) abuse testing and crosswalks. Time
person listed in the FOR FURTHER allotted for each presentation may be
(the Administrator) on issues related to
INFORMATION CONTACT section of this limited. If the number of registrants
clinical diagnostic laboratory tests. The
notice. Presentations should be sent via requesting to present is greater than can
membership appointments are for 3
email to the same person’s email be reasonably accommodated during the
years. This notice also announces the
address. scheduled open public hearing session,
first meeting date of the Panel on
For reconsidered and new test codes, we may conduct a lottery to determine
Wednesday, August 26, 2015.
presenters should address all of the the speakers for the scheduled open
DATES: Meeting Date: The first meeting following items: public hearing session. We will accept
of the Panel is scheduled to take place • Reconsidered or new test code(s) written presentations from those who
at CMS’s headquarters in Baltimore, MD and descriptor. were unable to present due to time
on Wednesday, August 26, 2015
• Test purpose and method. constraints.
beginning at 9:00 a.m., Eastern Daylight
Time (EDT). The Panel will specifically • Costs. ADDRESSES: Web site: For additional
recommend crosswalks for new • Charges. information on the Panel, please refer to
laboratory codes, recommend an • A recommendation with rationale our Web site at http://cms.gov/
appropriate coding structure for drugs of for one of the two methods Regulations-and-Guidance/Guidance/
abuse testing, and recommend (crosswalking or gapfilling) for FACA/AdvisoryPanelonClinical
crosswalks for such drugs of abuse determining payment for new tests, or a DiagnosticLaboratoryTests.html.
testing. recommendation with rationale for FOR FURTHER INFORMATION CONTACT:
changing the basis or payment amount, Glenn C. McGuirk, Designated Federal
Meeting Registration as applicable, for reconsidered tests. Official (DFO), Center for Medicare,
The public may attend the meeting in- Additionally, the presenters should Division of Ambulatory Services, CMS,
person, view via webcast, or listen via provide the data on which their 7500 Security Boulevard, Mail Stop C4–
teleconference. Beginning Friday, recommendations are based. 01–26, Baltimore, MD 21244, 410–786–
August 7, 2015 and ending Friday, When registering, individuals who 5723, email Glenn.McGuirk@
August 14, 2015 at 5:00 p.m. EDT, want to make a presentation must also cms.hhs.gov. Press inquiries are handled
tkelley on DSK3SPTVN1PROD with NOTICES

registration to attend the meeting in- specify for which new test codes they through the CMS Press Office at (202)
person may be completed online at will be presenting comments. A 690–6145.
http://cms.gov/Regulations-and- confirmation will be sent upon receipt SUPPLEMENTARY INFORMATION:
Guidance/Guidance/FACA/ of the registration. Presenters must
AdvisoryPanelonClinical register by the date specified in the I. Background
DiagnosticLaboratoryTests.html. On this ‘‘Meeting Registration’’ section of this The Advisory Panel on Clinical
Web page, under ‘‘Related Links,’’ notice. Diagnostic Laboratory Tests is

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Document Created: 2015-12-15 10:56:26
Document Modified: 2015-12-15 10:56:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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 [email protected] Press inquiries are handled through the CMS Press Office at (202) 690-6145.
FR Citation		80 FR 47491

80 FR 47491 - Medicare, Medicaid, and Children's Health Insurance Programs; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 152 (August 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services