[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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,

[[Page 59784]]

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