[Federal Register Volume 69, Number 122 (Friday, June 25, 2004)]
[Notices]
[Pages 35650-35651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14273]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3134-N]


Medicare Program; Town Hall Meeting on Potential Facility 
Qualifications for Expanded Coverage of Percutaneous Transluminal 
Angioplasty for Carotid Stenting Procedures

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

ACTION: Notice of meeting.

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SUMMARY: This notice announces a Town Hall meeting to discuss potential 
facility qualifications and requirements to ensure that expanded 
Medicare coverage of Percutaneous Transluminal Angioplasty (PTA) for 
carotid stenting procedures would be safe, reasonable and necessary. 
Topics to be addressed include, but are not limited to, the degree of 
facility experience required, types of provider training programs to be 
developed and the rigor of these programs, supporting staff and 
specialty requirements, and specific stipulations that must be in place 
to ensure the correct use of this procedure in the appropriate patient 
population. Interventional radiologists, radiologists, neurological 
surgeons, cardiologists, neuro-radiologists, interventional 
cardiologists, interventional neurologists, vascular surgeons, 
neurologists, and other interested individuals are invited to this 
meeting to present their individual views on carotid stenting 
procedures. The opinions and alternatives provided during this meeting 
will assist us as we evaluate our policy on carotid stenting procedures 
for high-risk patients. The meeting is open to the public, but 
attendance is limited to space available.

DATES: The Town Hall meeting will be held on Tuesday August 17, 2004 at 
8:30 a.m., e.s.t.

ADDRESSES: The Town Hall meeting will be held in the auditorium at the 
Centers for Medicare and Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244.
    Written Questions or Statements: Interested persons may send 
written comments by mail or electronically. We will accept written 
testimony, questions, or other statements, not to exceed 2-3 single-
spaced, typed pages prior to, or within 14 days after the meeting. This 
time frame will allow us sufficient time for serious consideration and 
review of the submitted materials. Send written testimony, questions, 
or other statements to Rana Hogarth, OCSQ/CAG, C1-09-06, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850 or to [email protected].

FOR FURTHER INFORMATION CONTACT: Rana Hogarth, (410) 786-2112. You may 
also send inquires about this meeting via e-mail to [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Medicare currently covers Percutaneous Transluminal Angioplasty of 
the Carotid Artery Concurrent with Stenting (CAG-00085N) in the context 
of Food and Drug Administration (FDA) approved Category B 
Investigational Device Exemption (IDE) Clinical Trials. Performance of 
Percutaneous Transluminal Angioplasty in the carotid artery used to 
treat obstructive lesions outside of these clinical trials is 
noncovered. Currently, Medicare is considering opening a National 
Coverage Determination to review coverage of carotid stenting 
procedures outside of the clinical trial setting. It is important that 
we establish facility qualifications and experience requirements that 
will ensure that carotid stenting procedures are performed in a manner 
which is safe, reasonable and necessary, and that would ensure 
beneficiaries needed pre- and post-procedure care.

II. Meeting Format

    The initial portion of the meeting will be designed to elicit 
information on the appropriate experience requirements for facilities 
intending to offer carotid stenting procedures, suggestions for 
developing training programs, the rigor of these programs, and specific 
stipulations or limitations that must be in place to ensure appropriate 
use of this procedure. The remainder of the

[[Page 35651]]

meeting will be reserved for questions from interested persons.
    Time for participants to make a statement will be limited according 
to the number of registered participants. Therefore, individuals who 
wish to make a statement must contact the individuals identified in the 
FOR FURTHER INFORMATION CONTACT section of this notice as soon as 
possible to register. Comments from individuals not registered will be 
heard after scheduled statements only, if time permits.
    Written submissions will also be accepted.

III. Registration Instructions

    The Coverage and Analysis Group is coordinating meeting 
registration. While there is no registration fee, individuals must 
register to attend. You may register by contacting Maria Ellis at 410-
786-0309, mailing address: Coverage and Analysis Group, OCSQ; Centers 
for Medicare & Medicaid Services; 7500 Security Boulevard; Mailstop: 
C1-09-06; Baltimore, Maryland 21244, or by e-mail at 
[email protected]. Please provide your name, address, telephone 
number, and, if available, e-mail address and fax number.
    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.
    Because this meeting will be located on Federal property, for 
security reasons, any persons wishing to attend this meeting must 
register by close of business on August 10, 2004. In order to gain 
access to the building and grounds, participants must show to the 
Federal Protective Service or guard service personnel government-issued 
photo identification and a copy of their registration confirmation. 
Individuals who have not registered in advance will not be allowed to 
enter the building to attend the meeting.
    Individuals requiring sign language interpretation or other special 
accommodations must provide that information upon registering for the 
meeting.

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

    Dated: June 17, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. 04-14273 Filed 6-24-04; 8:45 am]
BILLING CODE 4120-01-P