[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44011-44012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3251-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--September 21, 2011

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, September 21, 2011. 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 the currently available evidence regarding 
antivascular endothelial growth factor (anti-VEGF) treatment of 
diabetic macular edema (DME). 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, 
September 21, 2011 from 7:30 a.m. until 4:30 p.m., Daylight Saving Time 
(D.S.T.).
    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. D.S.T., Monday, August 22, 2011. 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 p.m., D.S.T. on Monday, August 22, 2011. 
Speakers may register by phone or via e-mail 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. D.S.T., Friday, September 16, 2011.
    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 
p.m., D.S.T. Friday, September 2, 2011.

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 e-mail 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, Office of 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 e-mail 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 September 
21, 2011, public meeting of the Committee. During this meeting, the 
Committee will discuss the currently available evidence regarding 
antivascular endothelial growth factor (anti-VEGF) treatment of 
diabetic macular edema (DME). 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&. 
CMS 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 the treatment of diabetic retinopathy (DR) and DME.

II. Meeting Format

    This meeting is open to the public. The agenda for the day of the 
meeting offers two opportunities for the public to participate as 
either a registered scheduled speaker or an unscheduled speaker. The 
Committee will hear oral presentations from the registered scheduled 
speakers 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, CMS 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 August 25, 2011. 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

[[Page 44012]]

their competitors) of any items or services being discussed.
    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 open public session for any unscheduled speaker 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 
e-mail address. You will receive a registration confirmation with 
instructions for your arrival at the CMS complex or you will be 
notified 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 brought 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: July 18, 2011.
Patrick Conway,
CMS Chief Medical Officer and Director, Office of Clinical Standards 
and Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-18562 Filed 7-21-11; 8:45 am]
BILLING CODE 4120-01-P