81 FR 55461 - Medicare Program; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on September 12, 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 161 (August 19, 2016)

Page Range		55461-55462
FR Document		2016-19848

This notice announces the next meeting date of the Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday, September 12, 2016. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (HHS) (the Secretary) and the Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Acting Administrator) on issues related to clinical diagnostic laboratory tests. The Panel will address Clinical Laboratory Fee Schedule issues relevant to the June 23, 2016 final rule entitled ``Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System'' (81 FR 41035 through 41101), which are designated in the Panel's charter and outlined in the agenda.

Federal Register, Volume 81 Issue 161 (Friday, August 19, 2016)

[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55461-55462]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19848]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1680-N]


Medicare Program; Announcement of the Advisory Panel on Clinical 
Diagnostic Laboratory Tests Meeting on September 12, 2016

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, 
September 12, 2016. The purpose of the Panel is to advise the Secretary 
of the Department of Health and Human Services (HHS) (the Secretary) 
and the Acting Administrator of the Centers for Medicare & Medicaid 
Services (CMS) (the Acting Administrator) on issues related to clinical 
diagnostic laboratory tests. The Panel will address Clinical Laboratory 
Fee Schedule issues relevant to the June 23, 2016 final rule entitled 
``Medicare Program; Medicare Clinical Diagnostic Laboratory Tests 
Payment System'' (81 FR 41035 through 41101), which are designated in 
the Panel's charter and outlined in the agenda.

DATES: Meeting Date: The meeting of the Panel is scheduled to take 
place at CMS's headquarters in Baltimore, Maryland on Monday, September 
12, 2016 beginning at 9:00 a.m. and ending at 4:30 p.m., Eastern 
Daylight Time (e.d.t.). The times listed in this notice are Eastern 
Daylight Time (EDT) and are approximate times except that the meeting 
will not begin before the posted time.
    Meeting Registration: The public may attend the meeting in-person, 
view via webcast, or listen via teleconference. Beginning Friday, 
August 19, 2016 and ending Friday, September 2, 2016 at 5:00 p.m. 
e.d.t., 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 September 12, 2016 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. e.d.t., Friday, September 2, 
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.

ADDRESSES: Meeting Location and Webcast: The meeting will be held in 
the Auditorium, CMS Central Office, 7500 Security Boulevard, Woodlawn, 
Maryland 21244-1850. Alternately, the public may either view the 
meeting via a webcast at http://cms.gov/live.
    Web site and Teleconference: For teleconference dial-in 
information, the final meeting agenda, and 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 Acting 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, 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. Subsequent public meetings for the Panel were 
held on October 19, 2015 (80 FR 59782) and July 18, 2016 (81 FR 35772). 
Recommendations from Panel meetings are posted on the CMS Web site 
listed in the ADDRESSES section of this notice.

[[Page 55462]]

    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. Meeting Format and Agenda

    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, September 
12, 2016. Following the opening remarks, the Panel will hear oral 
presentations from the public for no more than 1 hour during each of 
two sessions, one session in the morning and one session in the 
afternoon. During session one, registered persons from the public may 
present recommendations on payment options for routine chemistry tests 
that are currently paid as Automated Test Panels (ATPs) following 
implementation of the new payment system for clinical diagnostic 
laboratory tests on January 1, 2018. During session two, registered 
persons from the public may present recommendations on the application 
process for Advanced Diagnostic Laboratory Tests (ADLTs).
    The agenda for the September 12, 2016, meeting will provide for 
discussion and comment on specified CLFS issues relevant to the final 
rule, CMS-1621-F entitled, ``Medicare Program; Medicare Clinical 
Diagnostic Laboratory Tests Payment System,'' which are designated in 
the Panel's charter. Specifically, the Panel will discuss the following 
issues:
     Payment for routine chemistry tests that are currently 
paid as ATPs following implementation of the new payment system for 
clinical diagnostic laboratory tests on January 1, 2018.
     The application process for ADLTs.
    A detailed agenda will be posted approximately 2 weeks before the 
meeting, on the CMS Web site listed in the ADDRESSES section of this 
notice.

III. Meeting Attendance

    The Panel's meeting on September 12, 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 DATES 
section of this notice under ``Meeting Registration.'' 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 as specified in the ADDRESSES section of this notice.

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 as 
specified in the ADDRESSES section of this notice 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: August 4, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-19848 Filed 8-18-16; 8:45 am]
 BILLING CODE 4120-01-P

55462 Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices

The Panel charter provides that panel IV. Security, Building, and Parking review by the Office of Management and
meetings will be held up to four times Guidelines Budget under the authority of the
annually. The Panel consists of 15 The following are the security, Paperwork Reduction Act of 1995 (44
individuals and a Chair. The Panel building, and parking guidelines: U.S.C. 3501 et seq.).
Chair facilitates the meeting and the • Persons attending the meeting, Dated: August 4, 2016.
Designated Federal Official (DFO) or including presenters, must be pre- Andrew M. Slavitt,
DFO’s designee must be present at all registered and on the attendance list by Acting Administrator, Centers for Medicare
meetings. the prescribed date. & Medicaid Services.
II. Meeting Format and Agenda • Individuals who are not pre- [FR Doc. 2016–19848 Filed 8–18–16; 8:45 am]
registered in advance may not be BILLING CODE 4120–01–P
This meeting is open to the public. permitted to enter the building and may
The on-site check-in for visitors will be be unable to attend the meeting.
held from 8:30 a.m. to 9:00 a.m. on • Attendees must present a DEPARTMENT OF HEALTH AND
Monday, September 12, 2016. Following government-issued photo identification HUMAN SERVICES
the opening remarks, the Panel will hear to the Federal Protective Service or
oral presentations from the public for no Guard Service personnel before entering Food and Drug Administration
more than 1 hour during each of two the building. Without a current, valid
sessions, one session in the morning [Docket No. FDA–2013–N–0370]
photo ID, persons may not be permitted
and one session in the afternoon. During entry to the building. Agency Information Collection
session one, registered persons from the • Security measures include Activities; Submission for Office of
public may present recommendations inspection of vehicles, inside and out, at Management and Budget Review;
on payment options for routine the entrance to the grounds. Comment Request; Export of Medical
chemistry tests that are currently paid as • All persons entering the building Devices; Foreign Letters of Approval
Automated Test Panels (ATPs) must pass through a metal detector.
following implementation of the new • All items brought into CMS AGENCY: Food and Drug Administration,
payment system for clinical diagnostic including personal items, for example, HHS.
laboratory tests on January 1, 2018. laptops and cell phones are subject to ACTION: Notice.
During session two, registered persons physical inspection.
from the public may present • The public may enter the building SUMMARY: The Food and Drug
recommendations on the application 30 to 45 minutes before the meeting Administration (FDA) is announcing
process for Advanced Diagnostic convenes each day. that a proposed collection of
Laboratory Tests (ADLTs). • All visitors must be escorted in information has been submitted to the
The agenda for the September 12, areas other than the lower and first-floor Office of Management and Budget
2016, meeting will provide for levels in the Central Building. (OMB) for review and clearance under
discussion and comment on specified • The main-entrance guards will the Paperwork Reduction Act of 1995.
CLFS issues relevant to the final rule, issue parking permits and instructions DATES: Fax written comments on the
CMS–1621–F entitled, ‘‘Medicare upon arrival at the building. collection of information by September
Program; Medicare Clinical Diagnostic 19, 2016.
V. Special Accommodations
Laboratory Tests Payment System,’’ ADDRESSES: To ensure that comments on
which are designated in the Panel’s Individuals requiring special the information collection are received,
charter. Specifically, the Panel will accommodations must include the OMB recommends that written
discuss the following issues: request for these services during comments be faxed to the Office of
• Payment for routine chemistry tests registration. Information and Regulatory Affairs,
that are currently paid as ATPs VI. Panel Recommendations and OMB, Attn: FDA Desk Officer, FAX:
following implementation of the new Discussions 202–395–7285, or emailed to oira_
payment system for clinical diagnostic submission@omb.eop.gov. All
The Panel’s recommendations will be comments should be identified with the
laboratory tests on January 1, 2018. posted after the meeting on our Web site
• The application process for ADLTs. as specified in the ADDRESSES section of
OMB control number 0910–0264. Also
A detailed agenda will be posted include the FDA docket number found
this notice. in brackets in the heading of this
approximately 2 weeks before the
meeting, on the CMS Web site listed in VIII. Copies of the Charter document.
the ADDRESSES section of this notice. The Secretary’s Charter for the FOR FURTHER INFORMATION CONTACT: FDA
III. Meeting Attendance Advisory Panel on Clinical Diagnostic PRA Staff, Office of Operations, Food
Laboratory Tests is available on the and Drug Administration, Three White
The Panel’s meeting on September 12, CMS Web site as specified in the Flint North 10A–12M, 11601
2016, is open to the public. Priority will ADDRESSES section of this notice or you Landsdown St., North Bethesda, MD
be given to those who pre-register and may obtain a copy of the charter by 20852, PRAStaff@fda.hhs.gov.
attendance may be limited based on the submitting a request to the contact listed SUPPLEMENTARY INFORMATION: In
number of registrants and the space in the FOR FURTHER INFORMATION compliance with 44 U.S.C. 3507, FDA
available. CONTACT section of this notice. has submitted the following proposed
Persons wishing to attend this
mstockstill on DSK3G9T082PROD with NOTICES

collection of information to OMB for
meeting, which is located on federal IX. Collection of Information
review and clearance.
property, must register by following the Requirements
instructions in the DATES section of this This document does not impose Export of Medical Devices; Foreign
notice under ‘‘Meeting Registration.’’ A information collection requirements, Letters of Approval—OMB Control
confirmation email will be sent to the that is, reporting, recordkeeping or Number 0910–0264—Extension
registrants shortly after completing the third-party disclosure requirements. Section 801(e)(2) of the Federal Food,
registration process. Consequently, there is no need for Drug, and Cosmetic Act (the FD&C Act)

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Document Created: 2016-08-19 01:35:01
Document Modified: 2016-08-19 01:35:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		81 FR 55461

81 FR 55461 - Medicare Program; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on September 12, 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 161 (August 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services