[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12256-12257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06147]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1725-N]
Medicare Program; Meeting Announcement for 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 next public meeting dates for the
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the
Panel) on Monday, July 22, 2019 and Tuesday, July 23, 2019. The purpose
of the 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: Meeting Dates: The meeting of the Panel is scheduled for Monday,
July 22, 2019 from 8:00 a.m. to 4:30 p.m., Eastern Daylight Time
(E.D.T.) and Tuesday, July 23, 2019, from 8:00 a.m. to 4:30 p.m.,
E.D.T. The Panel is also expected to participate in the Clinical
Laboratory Fee Schedule (CLFS) Annual Public Meeting for Calendar Year
(CY) 2020 on June 24, 2019 in order to gather information and ask
questions to presenters. Notice of the CLFS Annual Public Meeting for
CY 2020 is published elsewhere in this issue of the Federal Register.
Deadline for Registration: The public may attend the Panel meeting
in person, view via webcast or listen via teleconference. Beginning
Monday, April 8, 2019 and ending Monday, July 1, 2019 at 5:00 p.m.
E.D.T., registration to attend the Panel meeting in person may be
completed online at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. On this web
page, under ``Panel Meetings,'' click the ``Register for July 22
through 23, 2019 Panel Meeting'' link and enter the required
information. We refer readers to Section IV. of this notice for
additional details related to meeting registration.
Webinar, Webcast, and Teleconference Information: Teleconference
dial-in instructions, and related webcast and webinar details will be
posted on the meeting agenda, which will be available on the CMS
website approximately 2 weeks prior to the meeting at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. A preliminary
agenda is described in Section II. of this notice.
ADDRESSES: The Panel meeting will be held in the auditorium of the
Centers for Medicare & Medicaid Services (CMS), Central Building, 7500
Security Boulevard, Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, Ph.D., (410) 786-
3434, email [email protected]. Press inquiries are handled through
the CMS Press Office at (202) 690-6145. For additional information on
the Panel, 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
(the 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 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, which may include the
development, validation, performance, and application of such 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 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.
[[Page 12257]]
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.
II. Agenda
The Agenda for the July 22 and 23, 2019 Panel meeting will provide
for discussion and comment on the following topics as designated in the
Panel's charter:
Calendar Year (CY) 2020 Clinical Laboratory Fee Schedule
(CLFS) new and reconsidered test codes, which will be posted on the CMS
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html.
Other CY 2020 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 website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. The Panel will
make recommendations to the Secretary and the Administrator of CMS
regarding crosswalking and gapfilling for new and reconsidered
laboratory tests discussed during the CLFS Annual Public Meeting for CY
2020. The Panel will also provide input on other CY 2020 CLFS issues
that are designated in the Panel's charter and specified on the meeting
agenda.
III. Meeting Participation
This meeting is open to the public. As noted previously, the public
may participate in the meeting on-site, via teleconference, webcast,
and webinar. The on-site check-in for visitors will be held from 7:30
a.m. to 8:00 a.m. E.D.T.
IV. Registration Instructions
Beginning Monday, April 8, 2019 and ending Monday, July 1, 2019 at
5:00 p.m. E.D.T., registration to attend the Panel Meeting in person
may be completed online at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. On
this web page, under ``Panel Meetings,'' click the ``Register for July
22 through July 23, 2019 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 July 22 or 23, 2019 should not register. No registration is
required for participants who plan to view the Panel meeting via
webcast or listen via teleconference.
V. Security, Building, and Parking Guidelines
The meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, we recommend allowing additional time to clear security.
We suggest that you arrive at the CMS campus and parking facilities
between 7:00 a.m. and 8:00 a.m. E.D.T., so that you will be able to
arrive promptly at the meeting by 8:00 a.m. E.D.T. Individuals who are
not registered in advance will not be permitted to enter the building
and will be unable to attend the meeting. We note that the public may
not enter the CMS building earlier than 7:15 a.m. E.D.T. (45 minutes
before the convening of the meeting).
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel. Persons without proper identification may be denied access
to the building.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of demonstration or to support a
demonstration, are subject to inspection. 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 demonstration or to support a demonstration.
VI. Panel Recommendations and Discussions
The Panel's recommendations will be posted approximately 2 weeks
after the meeting on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
VII. Special Accommodations
Individuals requiring special accommodations must include the
request for these services during registration.
VIII. Copies of the Charter
The Secretary's Charter for the Medicare Advisory Panel on Clinical
Diagnostic Laboratory Tests is available on the CMS website 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.
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: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-06147 Filed 3-29-19; 8:45 am]
BILLING CODE 4120-01-P