[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