[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 27993-27995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12831]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3363-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--August 22, 2018

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

ACTION: Notice of meeting.

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SUMMARY: This notice announces that a public meeting of the Medicare 
Evidence Development & Coverage Advisory Committee (MEDCAC) 
(``Committee'') will be held on Wednesday, August 22, 2018. This 
meeting will focus on the state of evidence on Chimeric Antigen 
Receptor (CAR) T-cell therapies that are approved by the Food and Drug 
Administration (FDA). We are seeking the MEDCAC's recommendations 
regarding collection of patient reported outcomes (PRO) in cancer 
clinical studies. The MEDCAC will specifically focus on appraisal of 
evidence-based PRO assessments to provide information that impacts 
patients, their providers, and caregivers after a CAR T-cell therapy 
intervention for the patient's cancer. This meeting is open to the 
public in accordance with the Federal Advisory Committee Act.

DATES: 
    Meeting Date: The public meeting will be held on Wednesday, August 
22, 2018 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, July 16, 2018. Once submitted, all 
comments are final.
    Deadlines for Speaker Registration and Presentation Materials: The

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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, July 16, 2018. 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, August 15, 2018.
    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, August 3, 2018.

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, August 22, 2018, public 
meeting of the Committee. This meeting will focus on the state of 
evidence on CAR-T cell therapies that are approved by the FDA. We are 
seeking the MEDCAC's recommendations regarding collection of PRO in 
cancer clinical studies. The MEDCAC will specifically focus on 
appraisal of evidence-based PRO assessments to provide information that 
impacts patients, their providers, and caregivers after a CAR T-cell 
therapy intervention for the patient's cancer. 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 website no later than 2 business 
days before the meeting. We encourage the participation of 
organizations with expertise in the appraisal of the state of evidence 
for patient reported outcomes, development of patient reported health 
outcome measures, and use of patient reported health outcome 
assessments in cancer clinical trials. 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 July 23, 
2018. 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 website 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

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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: June 4, 2018.
Kate Goodrich,
Director, Center for Clinical Standards and Quality, Chief Medical 
Officer, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-12831 Filed 6-14-18; 8:45 am]
 BILLING CODE 4120-01-P