Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 27, 2016, 9859-9860 [2016-04088]

Download as PDF Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices notice on its Web site and informing consumers that contact the company, ASUS must provide security-related notifications directly to consumers. For this purpose, ASUS must provide consumers with an opportunity to register an email address, phone number, device, or other information during the initial setup or configuration of a covered device. Parts V through IX of the proposed consent order are reporting and compliance provisions. Part V requires ASUS to retain documents relating to its compliance with the order. The order requires that materials relied upon to prepare the assessments required by Part III be retained for a three-year period, and that all other documents related to compliance with the order be retained for a five-year period. Part VI requires dissemination of the order now and in the future to all current and future subsidiaries, current and future principals, officers, directors, and managers, and to all current and future employees, agents, and representatives having supervisory responsibilities relating to the subject matter of the order. Part VII ensures notification to the FTC of changes in corporate status. Part VIII mandates that ASUS submit a compliance report to the FTC within 60 days, and periodically thereafter as requested. Part IX is a provision ‘‘sunsetting’’ the order after (20) years, with certain exceptions. The purpose of this analysis is to facilitate public comment on the proposed consent order. It is not intended to constitute an official interpretation of the proposed complaint or consent order or to modify the consent order’s terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2016–04190 Filed 2–25–16; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services mstockstill on DSK4VPTVN1PROD with NOTICES [CMS–3331–N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—April 27, 2016 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. AGENCY: VerDate Sep<11>2014 20:41 Feb 25, 2016 Jkt 238001 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?strOrder By=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 SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 9859 & 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 MedCACpresentations@ cms.hhs.gov 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 Maria.Ellis@cms.hhs.gov. 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-andGuidance/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-documentdetails.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/ E:\FR\FM\26FEN1.SGM 26FEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 9860 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices 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 VerDate Sep<11>2014 20:41 Feb 25, 2016 Jkt 238001 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?strOrder By=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-idenforcement-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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 • 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10407] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION: Notice. The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect SUMMARY: E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9859-9860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 MedCACpresentations@cms.hhs.gov 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 Maria.Ellis@cms.hhs.gov.

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