[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35772-35774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1666-N]


Medicare, Medicaid, and Children's Health Insurance Programs; 
Announcement of the Advisory Panel on Clinical Diagnostic Laboratory 
Tests Meeting on July 18, 2016

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the next public meeting date of the 
Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on 
Monday, July 18, 2016. The purpose of the Panel is to advise the 
Secretary of the Department of Health and Human Services (DHHS) 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 for Monday, 
July 18, 2016 beginning at 9:00 a.m., Eastern Daylight Time (EDT). The 
morning session will be held jointly with the Public Meeting on New and 
Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical 
Laboratory Fee Schedule (CLFS) for Calendar Year (CY) 2017 (the 2016 
Laboratory Public Meeting) (see 81 FR 29863, May 13, 2016 for notice of 
the 2016 Laboratory Public Meeting). During the afternoon session, the 
Panel will deliberate and make recommendations regarding the new and 
reconsidered laboratory codes for CY 2017. The Panel may also hear 
public presentations on additional issues concerning the CY 2017 CLFS 
that are designated in the Panel's charter and specified in the Panel 
meeting agenda for the afternoon session.
    Meeting Registration: The public may attend the Panel meeting in-
person, view via webcast, or listen via teleconference. Beginning 
Monday, June 6, 2016 and ending Friday, July 1, 2016 at 5:00 p.m. EDT, 
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 ``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 Panel meeting 
in-person on July 18, 2016 should not register. No registration is 
required for participants who plan to view the Panel meeting via 
webcast or listen via teleconference. Participants planning to 
attend only the morning session which includes the 2016 Laboratory 
Public Meeting, or both the morning and afternoon sessions, should 
register only once, for the 2016 Laboratory Public Meeting (see 
instructions for registering for the 2016 Laboratory Public Meeting 
at 81 FR 29863). Participants planning to attend only the afternoon 
session of the Panel meeting must register using the above link and 
instructions.

    Presenter Registration and Submission of Presentations and 
Comments: In the morning session only, we are interested in in-person 
presentations concerning the payment methodologies for new or 
reconsidered laboratory codes. The instructions for submitting such 
comments and presentations are also included in 2016 Laboratory Public 
Meeting notice (81 FR 29863). Although these comments and presentations 
will be made during the morning joint session of the 2016 Laboratory 
Public Meeting and Panel Meeting, the Panel may wish to ask follow-up 
questions to presenters at the afternoon session of the Panel Meeting.
    As previously mentioned, additional issues concerning the calendar 
year (CY) 2017 clinical laboratory fee schedule (CLFS) that are 
designated in the Panel's charter and specified in the meeting agenda, 
may also be discussed at the afternoon session of the Panel meeting. 
Any such issues to be discussed will be specified in the Panel meeting 
agenda, to be published approximately 3 weeks before the meeting (A 
preliminary agenda is described in section II. of this notice.) Should 
issues be added to the agenda, we would be interested in public 
comments or presentations related to those issues. The comments and 
presentations should not address issues not specified in the agenda for 
the Panel meeting. The deadline to register to be a presenter and to 
submit written presentations for agenda items for the Panel's afternoon 
session (that is, presentations on issues other than payment for new 
and reconsidered laboratory codes for CY 2017) is 5:00 p.m. EDT July 1, 
2016. 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 Panel meetings 
will be held in the Auditorium of the CMS, Central Office, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850. Alternately, the 
public may either view the Panel meetings via a webcast or listen by 
teleconference. During the scheduled Panel meeting, webcasting is 
accessible online at http://cms.gov/live. Teleconference dial-in 
information will appear on the final Panel 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 Panel 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, July 18, 2016, preceding the morning session of the 2016 
Laboratory Public Meeting, and again at 12:30 p.m. for visitors 
attending only the Panel meeting (afternoon session).
    During the morning session, the Panel, along with the public, will 
hear and pose questions to presenters recommending crosswalks or 
gapfilling for new and reconsidered laboratory codes for calendar year 
(CY) 2017. During the afternoon session, the Panel will deliberate and 
make recommendations to the Secretary of HHS and the Acting 
Administrator of CMS regarding crosswalks or gapfilling for new and 
reconsidered laboratory codes discussed during the morning

[[Page 35773]]

session. The Panel may also hear public presentations (for a total time 
period of no more than one hour) and provide input on other CY 2017 
CLFS issues that are designated in the Panel's charter and specified on 
meeting agenda. Both the morning and afternoon sessions are open to the 
public.

ADDRESSES: Web site: For additional information on the Panel, please 
refer to our Web site at https://www.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(a) 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 (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. 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 Acting Administrator of 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 upcoming new payment system, to be 
based on private payor rates, 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.
    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 Designated Federal 
Official (DFO) or DFO's designee must be present at all meetings.

II. Agenda

    The Agenda for the July 18, 2016, Panel meeting will provide for 
discussion and comment on the following topics as designated in the 
Panel's Charter:
     CY 2017 CLFS new and reconsidered test codes which were 
posted on May 12, 2016, on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html
     Other CY 2017 CLFS issues designated in the Panel's 
charter and further described on our Agenda.
    A detailed Agenda will be posted approximately 3 weeks before the 
meeting, on our Web site at http://cms.gov/Regulations-andGuidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

III. Meeting Attendance

    The Panel's meeting on July 18, 2016, is open to the public. 
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 our 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

[[Page 35774]]

Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Dated: May 25, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-13084 Filed 6-2-16; 8:45 am]
 BILLING CODE 4120-01-P