[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59782-59784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25162]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1657-N]
Medicare, Medicaid, and Children's Health Insurance Programs;
Announcement of the Advisory Panel on Clinical Diagnostic Laboratory
Tests Meeting on October 19, 2015
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the next meeting date of the Advisory
Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday,
October 19, 2015. 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.
DATES: Meeting Date: The meeting of the Panel is scheduled to take
place at CMS's headquarters in Baltimore, MD on Monday, October 19,
2015. beginning at 9:00 a.m., Eastern Daylight Time (EDT). The Panel
will address issues relating to the CY 2016 clinical laboratory fee
schedule (CLFS) preliminary determinations of new and
[[Page 59783]]
reconsidered test codes, as well as provide input on other CY2016 CLFS
issues that are designated in the Panel's charter.
Meeting Registration:
The public may attend the meeting in-person, view via webcast, or
listen via teleconference. Beginning Friday, October 2, 2015, and
ending Tuesday, October 13, 2015 at 5:00 p.m. EDT, registration to
attend the meeting in-person may be completed on-line 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.
Address.
Email addresses.
Note: Participants who do not plan to attend the meeting in-
person on October 19, 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 person presentations
at the meeting concerning the issues described in the SUPPLEMENTARY
INFORMATION section of this notice and clarified in the agenda to be
published approximately 2 weeks before the meeting. The comments and
presentations should not address issues not before the Panel. The
deadline to register to be a presenter and to submit written
presentations for the meeting is 5:00 p.m. EDT, Tuesday, October 13,
2015. 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 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 on-site check-in for
visitors will be held from 8:30 a.m. to 9:00 a.m. on Monday, October
19, 2015. Following the opening remarks, the Panel will address any
issues relating to the CY 2016 CLFS preliminary determinations of new
and reconsidered test codes, as well as provide input on other CY 2016
CLFS issues that are designated in the Panel's charter. The Panel will
hear oral presentations from the public for no more than 1 hour during
each of two sessions. During session one, registered persons from the
public may present recommendations on preliminary determinations of new
and reconsidered codes for the CY 2016 CLFS. During session two,
registered persons from the public may present recommendations on CLFS
issues that are designated in the Panel's charter and outlined in the
Agenda.
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 [email protected] or [email protected].
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 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 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 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;
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.
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), CMS 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 DFO or DFO's designee
must be present at all meetings.
II. Agenda
The Agenda for the October 19, 2015, meeting will provide for
discussion and comment on the following topics as designated in the
Panel's Charter:
CY 2016 CLFS preliminary determinations of new and
reconsidered test codes which were posted on September 25, 2015 on our
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html.
Other CY 2016 CLFS issues designated in the Panel's
charter and further described on our Agenda.
A detailed Agenda will be posted approximately 2 weeks before the
meeting, on the CMS Web site at http://cms.gov/Regulations-andGuidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.
III. Meeting Attendance
The Panel's meeting on October 19, 2015, is open to the public;
however,
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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 after the meeting on our
Web site at http://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 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.
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: September 29, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-25162 Filed 10-1-15; 8:45 am]
BILLING CODE 4120-01-P