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[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13059-13061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04288]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3283-N]

Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--May 1, 2013

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, May 1, 2013. The Committee 
generally provides advice and recommendations concerning the adequacy 
of scientific evidence needed to determine whether certain medical 
items and services can be covered under the Medicare statute. This 
meeting will focus on selected genetic tests for cancer diagnosis (for 
cancers of unknown primary site and for cervical cytology findings of 
uncertain clinical significance). 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, May 
1, 2013 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 p.m., EDT, Monday, March 25, 2013. Once submitted, all 
comments are final.
    Deadlines for Speaker Registration and Presentation Materials: The

[[Page 13060]]

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, April 1, 2013. 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 p.m. EDT, Wednesday, April 24, 2013.
    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 12, 2013.

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), provides advice and recommendations to CMS regarding clinical 
issues. (For more information on MCAC, see the December 14, 1998 
Federal Register (63 FR 68780). This notice announces the Wednesday, 
May 1, 2013, public meeting of the Committee. During this meeting, the 
Committee will discuss selected genetic tests for cancer diagnosis (for 
cancers of unknown primary site and for cervical cytology findings of 
uncertain clinical significance).
    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 appropriate organizations with expertise in selected 
genetic tests for cancer diagnosis.

II. Meeting Format

    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 1, 2013. 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 must 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) 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, fax number(s), 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. 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.

[[Page 13061]]

     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.

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

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: February 13, 2013.
Patrick Conway,
CMS Chief Medical Officer and Director, Center for Clinical Standards 
and Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-04288 Filed 2-25-13; 8:45 am]
BILLING CODE 4120-01-P
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