[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Notices]
[Pages 27705-27707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1669-N]


Medicare Program; Rechartering, Membership, and Announcement of 
the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on 
August 1, 2017

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

ACTION: Notice.

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SUMMARY: This notice announces the rechartering of the Advisory Panel 
on Clinical Diagnostic Laboratory Tests (the Panel), designation of a 
new chairperson to the Panel, and the next public meeting date for the 
Panel on Tuesday, August 1, 2017. 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) 
on issues related to clinical diagnostic laboratory tests (CDLTs). The 
Panel will make recommendations to the Secretary and the Administrator 
regarding crosswalking and gapfilling for new and reconsidered 
laboratory codes that are discussed during the Public Meeting Regarding 
New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year (CY) 2018 (2017 CLFS 
Public Meeting), and provide input on other CY 2018 CLFS issues that 
are designated in the Panel's charter and specified on meeting agenda. 
The Secretary approved the rechartering of the Panel on April 25, 2017 
for a 2-year period effective through April 25, 2019.

DATES: Meeting Date: The meeting of the Panel is scheduled for Tuesday, 
August 1, 2017, from 9:00 a.m. to 5:00 p.m., Eastern Daylight Savings 
Time (E.D.T.). We note that the Panel will also attend the 2017 CLFS 
Public Meeting and will gather information and ask questions to 
presenters if they choose. Notice of the 2017 CLFS Public Meeting is 
published elsewhere in this issue of the Federal Register. As we also 
indicate in that notice, in the event the 2017 CLFS Public Meeting 
needs to extend to August 1, 2017, the 2017 CLFS Public Meeting will 
begin at 9:00 a.m., E.D.T. and the Panel Meeting will convene 
immediately following the conclusion of that meeting.
    Meeting Registration: The public may attend the Panel Meeting in 
person, view via webcast, or listen via teleconference. Beginning 
Monday, June 19, 2017 and ending Friday, July 14, 2017 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 August 1, 2017 
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 August 1, 2017 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 2017 CLFS Public Meeting (on July 31, 2017), or both the 2017 
CLFS Public Meeting and the Panel Meeting (on August 1, 2017), should 
register only once for the 2017 CLFS Public Meeting. We refer readers 
to the Public Meeting Regarding New and Reconsidered Clinical 
Diagnostic Laboratory Test Codes for the CLFS for CY 2018 notice 
published elsewhere in this issue of the Federal Register for 
instructions on registering. Participants planning to attend only the 
Panel Meeting (August 1, 2017) must register using the above link and 
instructions. Comments and presentations on new and reconsidered CDLTs 
will be made during the 2017 CLFS Public Meeting (on July 31, 2017). We 
note that here because the Panel will address crosswalking and 
gapfilling for new and reconsidered laboratory codes that are discussed 
during 2017 CLFS Public Meeting and may wish to ask follow-up questions 
to presenters at the Panel Meeting (on August 1, 2017).
    Issues concerning the CY 2018 CLFS that are designated in the 
Panel's charter and specified in the meeting agenda will be discussed 
at the Panel Meeting. The deadline to register to be a presenter and to 
submit written presentations for agenda items during the Panel Meeting 
(that is, presentations on issues other than payment for new and 
reconsidered

[[Page 27706]]

CDLTs considered at the 2017 CLFS Public Meeting) is Friday, July 14, 
2017. Issues to be discussed will be specified in the Panel Meeting 
agenda, to be published approximately 2 weeks before the meeting (a 
preliminary agenda is described in Section II. of this notice). 
Comments and presentations should not address issues not specified in 
the agenda for the Panel Meeting. If issues are added to the agenda, we 
would be interested in public comments or presentations related to 
those additional issues. Commenters and presenters may register via 
email to the designated CLFS-dedicated email box listed in the FOR 
FURTHER INFORMATION CONTACT section of this notice. Presentations 
should be sent via email to the same email address.
    Meeting Location, Webcast, and Teleconference: The Panel Meeting 
will be held in the Auditorium of the CMS, Central Office, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850. Alternately, the 
public may view the Panel Meeting 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. 
E.D.T. on Monday, July 31, 2017, preceding the 2017 CLFS Public 
Meeting, and again at 8:30 a.m. to 9:00 a.m. E.D.T. on August 1, 2017 
for visitors attending only the Panel Meeting.
    During the 2017 CLFS Public Meeting, the public, along with the 
Panel, will hear and pose questions to presenters concerning 
crosswalking and gapfilling for new and reconsidered CDLTs for calendar 
year CY 2018. Following the opening remarks of the Panel Meeting, the 
Panel will address any issues relating to the CY 2018 CLFS new and 
reconsidered laboratory codes, including making recommendations to the 
Secretary of HHS and the Administrator of CMS regarding crosswalking 
and gapfilling for new and reconsidered laboratory codes discussed 
during the CLFS Public Meeting. The Panel will also provide input on 
other CY 2018 CLFS issues that are designated in the Panel's charter 
and specified on the meeting agenda. The Panel will hear oral 
presentations from the public for a total time period of no more than 1 
hour.

FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal 
Official (DFO), 410-786-5723, email [email protected]. Press 
inquiries are handled through the CMS Press Office at (202) 690-6145. 
For additional information on the Panel, please refer to the CMS Web 
site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

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 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. 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 Center 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; and
     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. Since the last meeting, the 
Secretary approved re-chartering of the Panel on April 25, 2017. The 
new charter is effective through April 25, 2019 and may be found on the 
CMS Web site at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. Karen Nakano, 
M.D. has been designated as the new Panel Chair after the retirement of 
the former Panel Chair.
    The Panel charter provides that Panel meetings will be held up to 4 
times annually and the Panel Chair will serve for a period of 3 years, 
which may be extended at the discretion of the CMS Administrator or his 
or her duly appointed designee. Additionally, 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 August 1, 2017, Panel Meeting will provide for 
discussion and comment on the following topics as designated in the 
Panel's charter:
     CY 2018 CLFS new and reconsidered test codes, to be posted 
on June 16, 2017, on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html.
     Other CY 2018 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 Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

III. Meeting Attendance

    The Panel's meeting on August 1, 2017 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:

[[Page 27707]]

     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 (ID) 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 the 
CMS Web site at https://www.cms.gov/Regulations-and-Guidance/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 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.

    Dated: June 2, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-12545 Filed 6-15-17; 8:45 am]
 BILLING CODE 4120-01-P