04-14273. 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.

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 [e-mail].

FOR FURTHER INFORMATION CONTACT:

Rana Hogarth, [phone]. You may also send inquires about this meeting via e-mail to [e-mail].

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 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 [e-mail]. 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.