[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Page 48650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3193-N]


Town Hall Meeting Regarding the Effect of Coverage and Payment on 
Clinical Research Study Participation and Retention, September 20, 2007

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

ACTION: Notice of Town Hall Meeting.

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SUMMARY: This notice announces a Town Hall meeting to allow interested 
parties to provide individual advice and recommendations to Centers for 
Medicare and Medicaid Services (CMS) regarding the impacts of health 
insurance coverage, and payment for items, and services in clinical 
research studies on the generalizability and validity of study results 
and findings to guide decision-making.

DATES: Meeting Date: The public meeting will be held on September 20, 
2007 from 1 p.m. until 4 p.m., D.S.T.
    Registration and Special Accommodations Deadlines: For security 
reasons, individuals wishing to attend this meeting must register by 5 
p.m., D.S.T. on September 13, 2007. Persons attending the meeting who 
are hearing or visually impaired, or have a condition that requires 
special assistance or accommodations, are asked to notify Michelle 
Atkinson as specified in the FOR FURTHER INFORMATION CONTACT section, 
by 5 p.m. D.S.T. on September 13, 2007.

ADDRESSES: Meeting Location: The meeting will be held in the main 
auditorium of the Centers for Medicare & Medicaid Services, 7500 
Security Blvd, Baltimore, MD 21244.
    Registration: Register by contacting Maria Ellis (410-786-0309; 
[email protected]; Centers for Medicare & Medicaid Services, 
OCSQ-Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard, 
Baltimore, MD 21244). You may access up-to-date information on this 
meeting at http://www.cms.hhs.gov/center/coverage.asp. Please use this 
site to access the system that will permit you to submit written 
comments.

FOR FURTHER INFORMATION CONTACT: Michelle Atkinson, 410-786-2881; 
[email protected]; Centers for Medicare & Medicaid 
Services, OCSQ-Coverage and Analysis Group, C1-09-06, 7500 Security 
Boulevard, Baltimore, MD 21244.

SUPPLEMENTARY INFORMATION:

I. Meeting Topic

    In May 2007, CMS entered into an interagency agreement with the 
Agency for Healthcare Research and Quality (AHRQ) to work with the Duke 
Evidence-Based Practice Center to develop a White Paper that will 
assist CMS in our decisions regarding payment policy, especially the 
timing of initiating coverage, for new therapeutic agents. The Duke 
Evidence-Based Practice Center has assembled a panel for this project. 
The agenda for the town hall meeting is as follows:
     Review the planned methodology.
     Advise the investigators at the Duke Center for Clinical 
Health Policy Research regarding key informants.
     Provide critical input on content of the conference calls, 
topics for discussion, and direction for the literature search.
    Background information about this topic, including instructions for 
submitting written comments, is available on the Internet at http://www.cms.hhs.gov/center/coverage/asp. This meeting will specifically 
discuss the following issues:
     How do payment policies by CMS and other third-party 
payers affect enrollment into clinical trials?
     How do payment policies by CMS and other third-party 
payers affect randomization and blinding within clinical trials?
     What is the summary impact of this effect?
     Does the timing of third-party payment in the clinical 
trial process impact the development of better evidence?
     Do differing payment structures within clinical trials 
affect the resulting evidence?
    All interested parties are invited to attend or participate via 
teleconference. The perspectives expressed during this meeting and in 
writing will assist the Duke Center for Clinical Health Policy Research 
in drafting the White Paper.

II. Registration Instructions

    The CMS Coverage and Analysis Group is coordinating meeting 
registration. While there is no registration fee, individuals must 
register to attend. Register by contacting Maria Ellis at the address 
by the dates specified in the ADDRESSES and DATES sections of the 
notice, respectively. Please provide your name, address, organization, 
telephone and fax numbers, and e-mail address.
    You will receive a registration confirmation with instructions for 
your arrival at the CMS complex. You will be notified if the seating 
capacity has been reached.

III. Security, Building, and Parking Guidelines

    This meeting will be held in a Federal government building; 
therefore, Federal security measures are applicable. In planning your 
arrival time, we recommend allowing additional time to clear security.
    In order to gain access to the building and grounds, individuals 
must present photographic identification to the Federal Protective 
Service or Guard Service personnel before being allowed entrance. 
Security measures also include inspection of vehicles, inside and out, 
at the entrance to the grounds. In addition, all individuals entering 
the building must pass through a metal detector. All items brought to 
CMS, whether personal or for the purpose of demonstration or to support 
a demonstration, 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 demonstration or to support a demonstration.
    Parking permits and instructions will be issued upon arrival.

    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: Medicare--Supplementary Medical Insurance Program.

    Dated: August 9, 2007.
Herb B. Kuhn,
Acting Deputy Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E7-16581 Filed 8-23-07; 8:45 am]
BILLING CODE 4120-01-P