[Federal Register: August 24, 2007 (Volume 72, Number 164)]
[Notices]
[Page 48650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au07-76]
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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;
Maria.Ellis@cms.hhs.gov; 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;
Michelle.Atkinson@cms.hhs.gov; 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