Medicare Program; Rechartering and Appointment of New Members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
| Published date | 28 June 2019 |
| Record Number | 2019-13900 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 84 Issue 125 (Friday, June 28, 2019)
[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Notices]
[Pages 31070-31071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13900]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1728-N]
Medicare Program; Rechartering and Appointment of New Members to
the Medicare 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 the rechartering and appointment of
seven new members to the Medicare Advisory Panel on Clinical Diagnostic
Laboratory Tests (the CDLT Panel). The purpose of the CDLT Panel is to
advise the Secretary of the Department of Health and Human Services and
the Administrator of the Centers for Medicare & Medicaid Services on
issues related to clinical diagnostic laboratory tests.
DATES:
Recharter Dates: The charter for the CDLT Panel will expire on
April 26, 2021 (2 years from the date the charter was filed).
New CDLT Panel Member Appointment Dates: The term period for the
new CDLT Panel members is July 1, 2019 through June 30, 2022.
FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, Ph.D., Designated
Federal Official (DFO), (410) 786-3434 or email at
[email protected].
Press inquiries are handled through the CMS Press Office at (202)
690-6145.
For additional information on the CDLT Panel, please refer to the
CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
SUPPLEMENTARY INFORMATION:
I. Background
The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
(CDLT Panel) 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 CDLT 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. Individuals may
include molecular pathologists, researchers, and individuals with
expertise in laboratory science or health economics.
The CDLT Panel will provide information 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 (CDLTs), including
whether to use ``cross walking'' or ``gap filling'' processes to
determine payment for a specific new test;
The factors used in determining coverage and payment
processes for new CDLTs; and
Other aspects of the new payment system under section
1834A of the Act.
A notice announcing the establishment of the CDLT 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 CDLT Panel along with the first public meeting date
for the CDLT Panel, which was held on August 26, 2015. Subsequent
meetings of the CDLT Panel and membership appointments were also
announced in the Federal Register.
The CDLT Panel charter provides that CDLT Panel meetings will be
held up to 4 times annually and the CDLT Panel shall consist of up to
15 individuals appointed by the Secretary's or CMS Administrator's
designee to serve a term of up to 3 years. Members may serve after the
expiration of his or her term until a successor has been sworn-in. A
CDLT Panel member selected to replace another CDLT Panel member who has
resigned prior to the end of his or her term shall serve for the
balance of the original CDLT Panel members' term.
II. Provisions of the Notice
A notice requesting nominations to the CDLT Panel was published in
the September 29, 2017 Federal Register (82 FR 45590 through 45592). In
that notice, we stated that nominations would be accepted on a
continuous basis. Since the last CDLT Panel meeting, which was held
July 16 through 17, 2018, the Secretary's designee approved membership
(term period: July 1, 2019 through June 30, 2022) of the following new
panel members (parenthetical denotes nomination source(s)):
Maria Arcila, MD (Memorial Sloan Kettering Cancer Center);
Karen Carroll, MD, FIDSA (Infectious Diseases Society of
America);
Lydia Contis, MD (University of Pittsburgh School of
Medicine);
Elizabeth Harris, MD (Humana, Inc.);
Kevin Krock, Ph.D. (Precision Diagnostics);
Elaine Lyon, Ph.D. (Association for Molecular
Pathologists);
Heather Shappell, MS, CGC (National Society of Genetic
Counselors);
Current CDLT Panel members (parenthetical denotes nomination
source(s):
Vickie Baselski, Ph.D. (American Society of Microbiology);
Aaron Bossler, M.D., Ph.D. (Association for Molecular
Pathologists);
Pranil Chandra, D.O. (Association for Molecular
Pathologists);
William Clarke, Ph.D., M.B.A., DABCC, FACB (American
Association of Clinical Chemistry);
Stanley R. Hamilton, M.D. (Alliance of Dedicated Cancer
Centers; College of
[[Page 31071]]
American Pathologists; National Association of Medical Examiners; MD
Anderson Cancer Center);
Kimberley Hanson, MD, MHS, FIDSA (Infectious Diseases
Society of America);
Michele M. Schoonmaker, Ph.D. (Advanced Medical Technology
Association);
Terms have expired (or will expire during Calendar Year (CY) 2019)
for the following CDLT Panel members (parenthetical denotes nomination
source(s)):
Geoffrey Baird, M.D., Ph.D. (Seattle Children's Hospital);
Raju Kucherlapati, Ph.D. (Coalition of 21st Century
Medicine);
Bryan A. Loy, M.D., M.B.A. (Humana, Inc.);
Gail Marcus, Ph.D., M.B.A., M.S.E. (Self-Nomination);
Carl Morrison, M.D., D.V.M. (The United States Congress;
Roswell Park Cancer Center);
Rebecca Sutphen, M.D. (Self- Nomination; Informed Medical
Decisions);
III. Copies of the Charter
The Secretary's Charter for the Medicare Advisory Panel on CDLTs is
available on the CMS website at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. Also, copies of
the charter can be obtained by submitting a request to the contact
listed in the For Further Information Contact section of this notice.
IV. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, 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.) is not required.
Dated: June 11, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-13900 Filed 6-27-19; 8:45 am]
BILLING CODE 4120-01-P
