82 FR 6560 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-March 22, 2017

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

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range		6560-6561
FR Document		2017-01043

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, March 22, 2017. This meeting will specifically focus on obtaining the MEDCAC's recommendations regarding what health outcomes in studies for heart failure treatment technologies should be of interest to CMS. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)

[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6560-6561]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01043]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3339-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--March 22, 2017

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

ACTION: Notice of meeting.

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

SUMMARY: This notice announces that a public meeting of the Medicare 
Evidence Development & Coverage Advisory Committee (MEDCAC) 
(``Committee'') will be held on Wednesday, March 22, 2017. This meeting 
will specifically focus on obtaining the MEDCAC's recommendations 
regarding what health outcomes in studies for heart failure treatment 
technologies should be of interest to CMS. This meeting is open to the 
public in accordance with the Federal Advisory Committee Act (5 U.S.C. 
App. 2, section 10(a)).

DATES: 
    Meeting Date: The public meeting will be held on Wednesday, March 
22, 2017 from 7:30 a.m. until 4:30 p.m., Eastern Daylight Time (EDT).
    Deadline for Submission of Written Comments: Written comments must 
be received at the address specified in the ADDRESSES section of this 
notice by 5:00 p.m., Eastern Standard Time (EST), Tuesday, February 21, 
2017. Once submitted, all comments are final.
    Deadlines for Speaker Registration and Presentation Materials: The 
deadline to register to be a speaker and to submit PowerPoint 
presentation materials and writings that will be used in support of an 
oral presentation is 5:00 p.m., EST on Tuesday, February 21, 2017. 
Speakers may register by phone or via email by contacting the person 
listed in the FOR FURTHER INFORMATION CONTACT section of this notice. 
Presentation materials must be received at the address specified in the 
ADDRESSES section of this notice.
    Deadline for All Other Attendees Registration: Individuals may 
register online at http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone by contacting the 
person listed in the FOR FURTHER INFORMATION CONTACT section of this 
notice by 5:00 p.m. EDT, Wednesday, March 15, 2017.
    We will be broadcasting the meeting live via Webcast at http://www.cms.gov/live/.
    Deadline for Submitting a Request for Special Accommodations: 
Persons attending the meeting who are hearing or visually impaired, or 
have a condition that requires special assistance or accommodations, 
are asked to contact the Executive Secretary as specified in the FOR 
FURTHER INFORMATION CONTACT section of this notice no later than 5:00 
p.m., EST Friday, March 3, 2017.

ADDRESSES: 
    Meeting Location: The meeting will be held in the main auditorium 
of the Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244.
    Submission of Presentations and Comments: Presentation materials 
and written comments that will be presented at the meeting must be 
submitted via email to [email protected] or by regular 
mail to the contact listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice by the date specified in the DATES section of 
this notice.

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for 
MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical 
Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 
Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone 
(410-786-0309) or via email at Ma[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    MEDCAC, formerly known as the Medicare Coverage Advisory Committee 
(MCAC), is advisory in nature, with all final coverage decisions 
resting with CMS. MEDCAC is used to supplement CMS' internal expertise. 
Accordingly, the advice rendered by the MEDCAC is most useful when it 
results from a process of full scientific inquiry and thoughtful 
discussion, in an open forum, with careful framing of recommendations 
and clear identification of the basis of those recommendations. MEDCAC 
members are valued for their background, education, and expertise in a 
wide variety of scientific, clinical, and other related fields. (For 
more information on MCAC, see the MEDCAC Charter (http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf) and 
the CMS Guidance Document, Factors CMS Considers in Referring Topics to 
the MEDCAC (http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10)).

II. Meeting Topic and Format

    This notice announces the Wednesday, March 22, 2017, public meeting 
of the Committee. During this meeting, the Committee will discuss 
recommendations regarding what health outcomes in studies for heart 
failure treatment technologies should be of interest to CMS. Background 
information about this topic, including panel materials, is available 
at http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. We will no longer be providing 
paper copies of the handouts for the meeting. Electronic copies of all 
the meeting materials will be on the CMS Web site no later than 2 
business days before the meeting. We encourage the participation of 
organizations with expertise in what

[[Page 6561]]

health outcomes in studies for heart failure treatment technologies 
should be of interest to CMS. This meeting is open to the public. The 
Committee will hear oral presentations from the public for 
approximately 45 minutes. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak 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. The contact person will 
notify interested persons regarding their request to speak by February 
27, 2017. Your comments should focus on issues specific to the list of 
topics that we have proposed to the Committee. The list of research 
topics to be discussed at the meeting will be available on the 
following Web site prior to the meeting: http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. 
We require that you declare at the meeting whether you have any 
financial involvement with manufacturers (or their competitors) of any 
items or services being discussed. Speakers presenting at the MEDCAC 
meeting should include a full disclosure slide as their second slide in 
their presentation for financial interests (for example, type of 
financial association--consultant, research support, advisory board, 
and an indication of level, such as minor association <$10,000 or major 
association >$10,000) as well as intellectual conflicts of interest 
(for example, involvement in a federal or nonfederal advisory committee 
that has discussed the issue) that may pertain in any way to the 
subject of this meeting. If you are representing an organization, we 
require that you also disclose conflict of interest information for 
that organization. If you do not have a PowerPoint presentation, you 
will need to present the full disclosure information requested 
previously at the beginning of your statement to the Committee.
    The Committee will deliberate openly on the topics under 
consideration. Interested persons may observe the deliberations, but 
the Committee will not hear further comments during this time except at 
the request of the chairperson. The Committee will also allow a 15-
minute unscheduled open public session for any attendee to address 
issues specific to the topics under consideration. At the conclusion of 
the day, the members will vote and the Committee will make its 
recommendation(s) to CMS.

III. Registration Instructions

    CMS' Coverage and Analysis Group is coordinating meeting 
registration. While there is no registration fee, individuals must 
register to attend. You may register online at http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone by contacting 
the person listed in the FOR FURTHER INFORMATION CONTACT section of 
this notice by the deadline listed in the DATES section of this notice. 
Please provide your full name (as it appears on your state-issued 
driver's license), address, organization, telephone number(s), fax 
number, and email address. You will receive a registration confirmation 
with instructions for your arrival at the CMS complex or you will be 
notified that the seating capacity has been reached.

IV. Security, Building, and Parking Guidelines

    This meeting will be held in a federal government building; 
therefore, federal security measures are applicable. The Real ID Act, 
enacted in 2005, establishes minimum standards for the issuance of 
state-issued driver's licenses and identification (ID) cards. It 
prohibits Federal agencies from accepting an official driver's license 
or ID card from a state unless the Department of Homeland Security 
determines that the state meets these standards. Beginning October 
2015, photo IDs (such as a valid driver's license) issued by a state or 
territory not in compliance with the Real ID Act will not be accepted 
as identification to enter Federal buildings. Visitors from these 
states/territories will need to provide alternative proof of 
identification (such as a valid passport) to gain entrance into CMS 
buildings. The current list of states from which a Federal agency may 
accept driver's licenses for an official purpose is found at http://www.dhs.gov/real-id-enforcement-brief. We recommend that confirmed 
registrants arrive reasonably early, but no earlier than 45 minutes 
prior to the start of the meeting, to allow additional time to clear 
security. Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.
     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means, 
of all persons entering the building. We note that all items brought 
into CMS, whether personal or for the purpose of presentation or to 
support a presentation, are subject to inspection. We cannot assume 
responsibility for coordinating the receipt, transfer, transport, 
storage, set-up, safety, or timely arrival of any personal belongings 
or items used for presentation or to support a presentation.

    Note: Individuals who are not registered in advance will not be 
permitted to enter the building and will be unable to attend the 
meeting. The public may not enter the building earlier than 45 
minutes prior to the convening of the meeting.

    All visitors must be escorted in areas other than the lower and 
first floor levels in the Central Building.

V. Collection of Information

    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. Chapter 35).

    Authority: 5 U.S.C. App. 2, section 10(a).

    Dated: January 10, 2017.
Kate Goodrich,
Director, Center for Clinical Standards and Quality, Centers for 
Medicare & Medicaid Services.
[FR Doc. 2017-01043 Filed 1-18-17; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6561

health outcomes in studies for heart III. Registration Instructions entering the building. We note that all
failure treatment technologies should be CMS’ Coverage and Analysis Group is items brought into CMS, whether
of interest to CMS. This meeting is open coordinating meeting registration. While personal or for the purpose of
to the public. The Committee will hear there is no registration fee, individuals presentation or to support a
oral presentations from the public for must register to attend. You may register presentation, are subject to inspection.
approximately 45 minutes. Time online at http://www.cms.gov/apps/ We cannot assume responsibility for
allotted for each presentation may be events/upcomingevents.asp?strOrder coordinating the receipt, transfer,
limited. If the number of registrants By=1&type=3 or by phone by contacting transport, storage, set-up, safety, or
requesting to speak is greater than can the person listed in the FOR FURTHER timely arrival of any personal
be reasonably accommodated during the INFORMATION CONTACT section of this
belongings or items used for
scheduled open public hearing session, notice by the deadline listed in the presentation or to support a
we may conduct a lottery to determine DATES section of this notice. Please
presentation.
the speakers for the scheduled open provide your full name (as it appears on Note: Individuals who are not registered in
public hearing session. The contact your state-issued driver’s license), advance will not be permitted to enter the
person will notify interested persons address, organization, telephone building and will be unable to attend the
regarding their request to speak by number(s), fax number, and email meeting. The public may not enter the
February 27, 2017. Your comments building earlier than 45 minutes prior to the
address. You will receive a registration convening of the meeting.
should focus on issues specific to the confirmation with instructions for your
list of topics that we have proposed to arrival at the CMS complex or you will All visitors must be escorted in areas
the Committee. The list of research be notified that the seating capacity has other than the lower and first floor
topics to be discussed at the meeting been reached. levels in the Central Building.
will be available on the following Web
site prior to the meeting: http:// IV. Security, Building, and Parking V. Collection of Information
www.cms.gov/medicare-coverage- Guidelines This document does not impose
database/indexes/medcac-meetings- This meeting will be held in a federal information collection requirements,
index.aspx?bc=BAAAAAAAAAAA&. government building; therefore, federal that is, reporting, recordkeeping or
We require that you declare at the security measures are applicable. The third-party disclosure requirements.
meeting whether you have any financial Real ID Act, enacted in 2005, establishes Consequently, there is no need for
involvement with manufacturers (or minimum standards for the issuance of review by the Office of Management and
their competitors) of any items or state-issued driver’s licenses and Budget under the authority of the
services being discussed. Speakers identification (ID) cards. It prohibits Paperwork Reduction Act of 1995 (44
presenting at the MEDCAC meeting Federal agencies from accepting an U.S.C. Chapter 35).
should include a full disclosure slide as official driver’s license or ID card from Authority: 5 U.S.C. App. 2, section 10(a).
their second slide in their presentation a state unless the Department of
for financial interests (for example, type Dated: January 10, 2017.
Homeland Security determines that the
of financial association—consultant, Kate Goodrich,
state meets these standards. Beginning
research support, advisory board, and October 2015, photo IDs (such as a valid Director, Center for Clinical Standards and
an indication of level, such as minor Quality, Centers for Medicare & Medicaid
driver’s license) issued by a state or Services.
association <$10,000 or major territory not in compliance with the
association >$10,000) as well as [FR Doc. 2017–01043 Filed 1–18–17; 8:45 am]
Real ID Act will not be accepted as
intellectual conflicts of interest (for identification to enter Federal buildings. BILLING CODE 4120–01–P
example, involvement in a federal or Visitors from these states/territories will
nonfederal advisory committee that has need to provide alternative proof of
discussed the issue) that may pertain in DEPARTMENT OF HEALTH AND
identification (such as a valid passport) HUMAN SERVICES
any way to the subject of this meeting. to gain entrance into CMS buildings.
If you are representing an organization, The current list of states from which a Food and Drug Administration
we require that you also disclose Federal agency may accept driver’s
conflict of interest information for that licenses for an official purpose is found [Docket No. FDA–2008–D–0394]
organization. If you do not have a at http://www.dhs.gov/real-id-
PowerPoint presentation, you will need Regulation of Intentionally Altered
enforcement-brief. We recommend that
to present the full disclosure Genomic DNA in Animals; Draft
confirmed registrants arrive reasonably
information requested previously at the Guidance for Industry; Availability
early, but no earlier than 45 minutes
beginning of your statement to the prior to the start of the meeting, to allow AGENCY: Food and Drug Administration,
Committee. additional time to clear security. HHS.
The Committee will deliberate openly Security measures include the ACTION: Notice of availability.
on the topics under consideration. following:
Interested persons may observe the • Presentation of government-issued SUMMARY: The Food and Drug
deliberations, but the Committee will photographic identification to the Administration (FDA or Agency) is
not hear further comments during this Federal Protective Service or Guard announcing the availability of a draft
time except at the request of the Service personnel. guidance for industry (GFI) #187
chairperson. The Committee will also • Inspection of vehicle’s interior and entitled ‘‘Regulation of Intentionally
mstockstill on DSK3G9T082PROD with NOTICES

allow a 15-minute unscheduled open exterior (this includes engine and trunk Altered Genomic DNA in Animals.’’
public session for any attendee to inspection) at the entrance to the This draft guidance revises GFI #187
address issues specific to the topics grounds. Parking permits and entitled ‘‘Regulation of Genetically
under consideration. At the conclusion instructions will be issued after the Engineered Animals Containing
of the day, the members will vote and vehicle inspection. Heritable Recombinant DNA
the Committee will make its • Inspection, via metal detector or Constructs’’ (current GFI #187). Current
recommendation(s) to CMS. other applicable means, of all persons GFI #187 clarifies FDA’s requirements

VerDate Sep<11>2014 21:20 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1

Document Created: 2018-02-01 15:16:27
Document Modified: 2018-02-01 15:16:27

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 of meeting.
Dates		Meeting Date: The public meeting will be held on Wednesday, March 22, 2017 from 7:30 a.m. until 4:30 p.m., Eastern Daylight Time (EDT).
Contact		Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via email at [email protected]
FR Citation		82 FR 6560

82 FR 6560 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-March 22, 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 82, Issue 12 (January 19, 2017)

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