81 FR 9859 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 27, 2016

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

Federal Register Volume 81, Issue 38 (February 26, 2016)

Page Range		9859-9860
FR Document		2016-04088

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, April 27, 2016. This meeting will specifically focus on obtaining the MEDCAC's recommendations regarding the definition of treatment resistant depression (TRD) as well as to advise CMS on the use of the definition of TRD in the context of coverage with evidence development and treatment outcomes. 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 81 Issue 38 (Friday, February 26, 2016)

[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9859-9860]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3331-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--April 27, 2016

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, April 27, 2016. This meeting 
will specifically focus on obtaining the MEDCAC's recommendations 
regarding the definition of treatment resistant depression (TRD) as 
well as to advise CMS on the use of the definition of TRD in the 
context of coverage with evidence development and treatment outcomes. 
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, 
April 27, 2016 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., EDT, Monday, March 28, 2016. 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., EDT on Monday, March 28, 2016. 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, April 20, 2016.
    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., EDT Friday, April 1, 2016.

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 [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, April 27, 2016, public meeting 
of the Committee. During this meeting, the Committee will discuss 
recommendations regarding the definition of treatment resistant 
depression (TRD) and provide advice to CMS on the use of the definition 
of TRD in the context of coverage with evidence development and 
treatment outcomes. Background information about this topic, including 
panel materials, is available at http://www.cms.gov/

[[Page 9860]]

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 appropriate 
organizations with expertise in TRD clinical research. 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 April 4, 2016. 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: February 18, 2016.
Kate Goodrich,
Director, Center for Clinical Standards and Quality, Centers for 
Medicare & Medicaid Services.
[FR Doc. 2016-04088 Filed 2-25-16; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices 9859

notice on its Web site and informing SUMMARY: This notice announces that a & Medicaid Services, 7500 Security
consumers that contact the company, public meeting of the Medicare Boulevard, Baltimore, MD 21244.
ASUS must provide security-related Evidence Development & Coverage Submission of Presentations and
notifications directly to consumers. For Advisory Committee (MEDCAC) Comments: Presentation materials and
this purpose, ASUS must provide (‘‘Committee’’) will be held on written comments that will be presented
consumers with an opportunity to Wednesday, April 27, 2016. This at the meeting must be submitted via
register an email address, phone meeting will specifically focus on email to MedCACpresentations@
number, device, or other information obtaining the MEDCAC’s cms.hhs.gov or by regular mail to the
during the initial setup or configuration recommendations regarding the contact listed in the FOR FURTHER
of a covered device. definition of treatment resistant INFORMATION CONTACT section of this
Parts V through IX of the proposed depression (TRD) as well as to advise notice by the date specified in the DATES
consent order are reporting and CMS on the use of the definition of TRD section of this notice.
compliance provisions. Part V requires in the context of coverage with evidence FOR FURTHER INFORMATION CONTACT:
ASUS to retain documents relating to its development and treatment outcomes. Maria Ellis, Executive Secretary for
compliance with the order. The order This meeting is open to the public in MEDCAC, Centers for Medicare &
requires that materials relied upon to accordance with the Federal Advisory Medicaid Services, Center for Clinical
prepare the assessments required by Committee Act (5 U.S.C. App. 2, section Standards and Quality, Coverage and
Part III be retained for a three-year 10(a)). Analysis Group, S3–02–01, 7500
period, and that all other documents DATES: Meeting Date: The public Security Boulevard, Baltimore, MD
related to compliance with the order be meeting will be held on Wednesday, 21244 or contact Ms. Ellis by phone
retained for a five-year period. Part VI April 27, 2016 from 7:30 a.m. until 4:30 (410–786–0309) or via email at
requires dissemination of the order now p.m., Eastern Daylight Time (EDT). Maria.Ellis@cms.hhs.gov.
and in the future to all current and Deadline for Submission of Written SUPPLEMENTARY INFORMATION:
future subsidiaries, current and future Comments: Written comments must be
principals, officers, directors, and received at the address specified in the I. Background
managers, and to all current and future ADDRESSES section of this notice by 5:00 MEDCAC, formerly known as the
employees, agents, and representatives p.m., EDT, Monday, March 28, 2016. Medicare Coverage Advisory Committee
having supervisory responsibilities Once submitted, all comments are final. (MCAC), is advisory in nature, with all
relating to the subject matter of the Deadlines for Speaker Registration final coverage decisions resting with
order. Part VII ensures notification to and Presentation Materials: The CMS. MEDCAC is used to supplement
the FTC of changes in corporate status. deadline to register to be a speaker and CMS’ internal expertise. Accordingly,
Part VIII mandates that ASUS submit a to submit PowerPoint presentation the advice rendered by the MEDCAC is
compliance report to the FTC within 60 materials and writings that will be used most useful when it results from a
days, and periodically thereafter as in support of an oral presentation is 5:00 process of full scientific inquiry and
requested. Part IX is a provision p.m., EDT on Monday, March 28, 2016. thoughtful discussion, in an open
‘‘sunsetting’’ the order after (20) years, Speakers may register by phone or via forum, with careful framing of
with certain exceptions. email by contacting the person listed in recommendations and clear
The purpose of this analysis is to the FOR FURTHER INFORMATION CONTACT identification of the basis of those
facilitate public comment on the section of this notice. Presentation recommendations. MEDCAC members
proposed consent order. It is not materials must be received at the are valued for their background,
intended to constitute an official address specified in the ADDRESSES education, and expertise in a wide
interpretation of the proposed section of this notice. variety of scientific, clinical, and other
complaint or consent order or to modify Deadline for All Other Attendees related fields. (For more information on
the consent order’s terms in any way. Registration: Individuals may register MCAC, see the MEDCAC Charter
By direction of the Commission. online at http://www.cms.gov/apps/ (http://www.cms.gov/Regulations-and-
Donald S. Clark, events/upcomingevents.asp?strOrder Guidance/Guidance/FACA/Downloads/
Secretary.
By=1&type=3 or by phone by contacting medcaccharter.pdf) and the CMS
the person listed in the FOR FURTHER Guidance Document, Factors CMS
[FR Doc. 2016–04190 Filed 2–25–16; 8:45 am]
INFORMATION CONTACT section of this Considers in Referring Topics to the
BILLING CODE 6750–01–P
notice by 5:00 p.m. EDT, Wednesday, MEDCAC (http://www.cms.gov/
April 20, 2016. medicare-coverage-database/details/
We will be broadcasting the meeting medicare-coverage-document-
DEPARTMENT OF HEALTH AND live via Webcast at http://www.cms.gov/ details.aspx?MCDId=10)).
HUMAN SERVICES live/.
Deadline for Submitting a Request for II. Meeting Topic and Format
Centers for Medicare & Medicaid Special Accommodations: Persons This notice announces the
Services attending the meeting who are hearing Wednesday, April 27, 2016, public
or visually impaired, or have a meeting of the Committee. During this
[CMS–3331–N] condition that requires special meeting, the Committee will discuss
assistance or accommodations, are recommendations regarding the
Medicare Program; Meeting of the asked to contact the Executive Secretary
mstockstill on DSK4VPTVN1PROD with NOTICES

definition of treatment resistant
Medicare Evidence Development and as specified in the FOR FURTHER depression (TRD) and provide advice to
Coverage Advisory Committee—April INFORMATION CONTACT section of this CMS on the use of the definition of TRD
27, 2016 notice no later than 5:00 p.m., EDT in the context of coverage with evidence
Friday, April 1, 2016. development and treatment outcomes.
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS. ADDRESSES: Meeting Location: The Background information about this
meeting will be held in the main topic, including panel materials, is
ACTION: Notice of meeting.
auditorium of the Centers for Medicare available at http://www.cms.gov/

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9860 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices

medicare-coverage-database/indexes/ chairperson. The Committee will also • Inspection of vehicle’s interior and
medcac-meetings-index.aspx?bc= allow a 15-minute unscheduled open exterior (this includes engine and trunk
BAAAAAAAAAAA&. We will no longer public session for any attendee to inspection) at the entrance to the
be providing paper copies of the address issues specific to the topics grounds. Parking permits and
handouts for the meeting. Electronic under consideration. At the conclusion instructions will be issued after the
copies of all the meeting materials will of the day, the members will vote and vehicle inspection.
be on the CMS Web site no later than the Committee will make its • Inspection, via metal detector or
2 business days before the meeting. We recommendation(s) to CMS. other applicable means, of all persons
encourage the participation of III. Registration Instructions entering the building. We note that all
appropriate organizations with expertise items brought into CMS, whether
in TRD clinical research. This meeting CMS’ Coverage and Analysis Group is personal or for the purpose of
is open to the public. The Committee coordinating meeting registration. While presentation or to support a
will hear oral presentations from the there is no registration fee, individuals presentation, are subject to inspection.
public for approximately 45 minutes. must register to attend. You may register We cannot assume responsibility for
Time allotted for each presentation may online at http://www.cms.gov/apps/ coordinating the receipt, transfer,
be limited. If the number of registrants events/upcomingevents.asp?strOrder transport, storage, set-up, safety, or
requesting to speak is greater than can By=1&type=3 or by phone by contacting timely arrival of any personal
be reasonably accommodated during the the person listed in the FOR FURTHER belongings or items used for
scheduled open public hearing session, INFORMATION CONTACT section of this presentation or to support a
we may conduct a lottery to determine notice by the deadline listed in the presentation.
the speakers for the scheduled open DATES section of this notice. Please Note: Individuals who are not
public hearing session. The contact provide your full name (as it appears on registered in advance will not be
person will notify interested persons your state-issued driver’s license), permitted to enter the building and will
regarding their request to speak by April address, organization, telephone be unable to attend the meeting. The
4, 2016. Your comments should focus number(s), fax number, and email public may not enter the building earlier
on issues specific to the list of topics address. You will receive a registration than 45 minutes prior to the convening
that we have proposed to the confirmation with instructions for your of the meeting.
Committee. The list of research topics to arrival at the CMS complex or you will All visitors must be escorted in areas
be discussed at the meeting will be be notified that the seating capacity has other than the lower and first floor
been reached.
available on the following Web site levels in the Central Building.
prior to the meeting: http://www.cms. IV. Security, Building, and Parking
V. Collection of Information
gov/medicare-coverage-database/ Guidelines
indexes/medcac-meetings-index.aspx This meeting will be held in a federal This document does not impose
?bc=BAAAAAAAAAAA&. We require government building; therefore, federal information collection requirements,
that you declare at the meeting whether security measures are applicable. The that is, reporting, recordkeeping or
you have any financial involvement Real ID Act, enacted in 2005, establishes third-party disclosure requirements.
with manufacturers (or their minimum standards for the issuance of Consequently, there is no need for
competitors) of any items or services state-issued driver’s licenses and review by the Office of Management and
being discussed. Speakers presenting at identification (ID) cards. It prohibits Budget under the authority of the
the MEDCAC meeting should include a Federal agencies from accepting an Paperwork Reduction Act of 1995 (44
full disclosure slide as their second official driver’s license or ID card from U.S.C. Chapter 35).
slide in their presentation for financial a state unless the Department of Authority: 5 U.S.C. App. 2, section 10(a).
interests (for example, type of financial Homeland Security determines that the Dated: February 18, 2016.
association—consultant, research state meets these standards. Beginning
support, advisory board, and an Kate Goodrich,
October 2015, photo IDs (such as a valid Director, Center for Clinical Standards and
indication of level, such as minor driver’s license) issued by a state or
association < $10,000 or major Quality, Centers for Medicare & Medicaid
territory not in compliance with the Services.
association > $10,000) as well as Real ID Act will not be accepted as [FR Doc. 2016–04088 Filed 2–25–16; 8:45 am]
intellectual conflicts of interest (for identification to enter Federal buildings.
example, involvement in a federal or BILLING CODE 4120–01–P
Visitors from these states/territories will
nonfederal advisory committee that has need to provide alternative proof of
discussed the issue) that may pertain in identification (such as a valid passport) DEPARTMENT OF HEALTH AND
any way to the subject of this meeting. to gain entrance into CMS buildings. HUMAN SERVICES
If you are representing an organization, The current list of states from which a
we require that you also disclose Federal agency may accept driver’s Centers for Medicare & Medicaid
conflict of interest information for that licenses for an official purpose is found Services
organization. If you do not have a at http://www.dhs.gov/real-id-
PowerPoint presentation, you will need [Document Identifiers: CMS–10407]
enforcement-brief. We recommend that
to present the full disclosure confirmed registrants arrive reasonably
information requested previously at the Agency Information Collection
early, but no earlier than 45 minutes Activities: Submission for OMB
beginning of your statement to the
mstockstill on DSK4VPTVN1PROD with NOTICES

prior to the start of the meeting, to allow Review; Comment Request
Committee. additional time to clear security.
The Committee will deliberate openly Security measures include the ACTION: Notice.
on the topics under consideration. following:
Interested persons may observe the • Presentation of government-issued SUMMARY: The Centers for Medicare &
deliberations, but the Committee will photographic identification to the Medicaid Services (CMS) is announcing
not hear further comments during this Federal Protective Service or Guard an opportunity for the public to
time except at the request of the Service personnel. comment on CMS’ intention to collect

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Document Created: 2018-02-02 14:36:50
Document Modified: 2018-02-02 14:36:50

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, April 27, 2016 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		81 FR 9859

81 FR 9859 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 27, 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 38 (February 26, 2016)

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