[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3605-3606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00935]



[[Page 3605]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3312-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--March 24, 2015

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 Tuesday, March 24, 2015. 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 molecular pathology tests for the 
estimation of prognosis in common cancers (such as, adenocarcinoma of 
the colon and rectum, breast cancer--invasive duct and lobular cancers, 
non-small cell lung cancers). 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 Tuesday, March 
24, 2015 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., EST, Monday, February 23, 2015. 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 Monday, February 23, 2015. 
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.aspstrOrderBy=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, Tuesday, March 17, 2015.
    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, March 6, 2015.

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), 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 Tuesday, 
March 24, 2015, public meeting of the Committee. During this meeting, 
the Committee will discuss selected molecular pathology tests for the 
estimation of prognosis in common cancers (adenocarcinoma of the colon 
and rectum, breast cancer--invasive duct and lobular cancers, non-small 
cell lung cancers). 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 
molecular pathology tests for the estimation of prognosis in the above 
mentioned common cancers.

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 March 2, 2015. 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 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

[[Page 3606]]

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. 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.

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

    Dated: January 9, 2015.
Patrick Conway,
Deputy Administrator for Innovation and Quality and CMS Chief Medical 
Officer. Centers for Medicare & Medicaid Services.
[FR Doc. 2015-00935 Filed 1-22-15; 8:45 am]
BILLING CODE 4120-01-P