[Federal Register: June 25, 2004 (Volume 69, Number 122)]
[Notices]
[Page 35650-35651]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn04-93]
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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 Rana.Hogarth@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Rana Hogarth, (410) 786-2112. You may
also send inquires about this meeting via e-mail to MEllis@cms.hhs.gov.
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
Mellis@cms.hhs.gov. 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