[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Notices]
[Pages 47491-47492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1641-N]


Medicare, Medicaid, and Children's Health Insurance Programs; 
Membership and Meeting Announcement for the 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 15 membership appointments to the 
Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and 
the first meeting date for the Panel. 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. The membership 
appointments are for 3 years. This notice also announces the first 
meeting date of the Panel on Wednesday, August 26, 2015.

DATES: Meeting Date: The first meeting of the Panel is scheduled to 
take place at CMS's headquarters in Baltimore, MD on Wednesday, August 
26, 2015 beginning at 9:00 a.m., Eastern Daylight Time (EDT). The Panel 
will specifically recommend crosswalks for new laboratory codes, 
recommend an appropriate coding structure for drugs of abuse testing, 
and recommend crosswalks for such drugs of abuse testing.

Meeting Registration

    The public may attend the meeting in-person, view via webcast, or 
listen via teleconference. Beginning Friday, August 7, 2015 and ending 
Friday, August 14, 2015 at 5:00 p.m. EDT, registration to attend the 
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.
     Postal address.
     Email address.

    Note:  Participants who do not plan to attend the meeting in-
person on August 26, 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 presentations at the 
meeting concerning the issues described in the SUMMARY section of this 
notice. The comments and presentations should not duplicate those that 
were provided at the Annual Clinical Laboratory Public Meeting on July 
16, 2015, or submitted through the comment process provided subsequent 
to the Annual Clinical Laboratory Public Meeting. The deadline to 
register to be a presenter and to submit written presentations for the 
meeting is 5:00 p.m. EDT, Monday, August 17, 2015. Presenters may 
register by phone or via 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.
    For reconsidered and new test codes, presenters should address all 
of the following items:
     Reconsidered or new test code(s) and descriptor.
     Test purpose and method.
     Costs.
     Charges.
     A recommendation with rationale for one of the two methods 
(crosswalking or gapfilling) for determining payment for new tests, or 
a recommendation with rationale for changing the basis or payment 
amount, as applicable, for reconsidered tests.
    Additionally, the presenters should provide the data on which their 
recommendations are based.
    When registering, individuals who want to make a presentation must 
also specify for which new test codes they will be presenting comments. 
A confirmation will be sent upon receipt of the registration. 
Presenters must register by the date specified in the ``Meeting 
Registration'' section of this notice.

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 onsite check-in for 
visitors will be held from 8:30 a.m. to 9:00 a.m. EDT on Wednesday, 
August 26, 2015, followed by opening remarks. Following the opening 
remarks, the Panel will hear oral presentations from the public for no 
more than 1 hour during two sessions. During the first session, 
registered persons from the public may present recommendations for 
crosswalks for new laboratory codes for the CY 2016 CLFS. During the 
second session, registered persons from the public may present 
recommendations for drugs of abuse testing and crosswalks. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to present is greater than can be reasonably 
accommodated during the scheduled open public hearing session, we may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. We will accept written presentations from those 
who were unable to present due to time constraints.

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]. 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

[[Page 47492]]

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 representatives of clinical laboratories, 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, 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.
    The Panel charter provides that panel meetings will be held up to 
four times annually. The Panel will consist of up to 15 individuals and 
a Chair. The Panel Chair will facilitate meetings and the DFO or DFO's 
designee must be present at all meetings. Meetings will be open to the 
public except as determined otherwise by the Secretary or other 
official to whom the authority has been delegated in accordance with 
the Sunshine Act of 1976 (5 U.S.C. 552b(c)) and FACA. Notice of all 
meetings will be published in the Federal Register as required by 
applicable laws and Departmental regulations. Meetings will be 
conducted, and records of the proceedings kept, as required by 
applicable laws and Departmental regulations.
    In order to conduct the business of the Panel, a quorum is 
required. A quorum exists when a majority of currently appointed 
members is present at full Panel or subcommittee meetings or is 
participating in conference calls.

II. Provisions of This Notice

    We published a notice in the Federal Register on October 27, 2014, 
entitled ``Medicare, Medicaid, and Children's Health Insurance 
Programs; Advisory Panel on Clinical Diagnostic Laboratory Tests and 
Request for Nominations'' (79 FR 63919 through 63920). The notice 
solicited nominations for up to 15 members and a Chair to serve on this 
Panel. This notice announces 16 new members to the Panel. Their 
appointments are for 3-year terms beginning July 1, 2015.
    The Panel will consist of the following members and a Chair:

 Steve Phurrough M.D., Panel Chair, CMS Medical Officer
 Geoffrey Baird, M.D., Ph.D.
 Vickie Baselski, Ph.D.
 Stephen N. Bauer, M.D.
 William Clarke, Ph.D., M.B.A., DABCC, FACB
 Judith Davis, M.S.
 Stanley R. Hamilton, M.D.
 Curtis A. Hanson, M.D.
 Kandice Kottke-Marchant, M.D., Ph.D.
 Raju Kucherlapati, Ph.D.
 Bryan A. Loy, M.D., M.B.A.
 Gail Marcus, M.S.E., M.B.A.
 Carl Morrison, M.D., D.V.M.
 Victoria M. Pratt, Ph.D., FACMG
 Michele M. Schoonmaker, Ph.D.
 Rebecca Sutphen, M.D.

III. Meeting Attendance

    The first meeting (August 26, 2015) is open to the public; however, 
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 to our Web site after 
the meeting.

VII. 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.

VIII. 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: August 3, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-19498 Filed 8-6-15; 8:45 am]
BILLING CODE 4120-01-P