01-2941. Medicare Program; Meetings of the Medical Devices and Prosthetics Panel and the Executive Committee of the Medicare Coverage Advisory Committee; February 21 and 22, 2001

AGENCY:

Health Care Financing Administration (HCFA), HHS.

ACTION:

Notice of meetings.

SUMMARY:

This notice announces public meetings of the Medical Devices and Prosthetics Panel (the Panel) and the Executive Committee (EC) of the Medicare Coverage Advisory Committee (MCAC). The Panel and the EC will provide advice and recommendations to HCFA about clinical issues.

On Wednesday, February 21, 2001, the Panel will hear and discuss presentations from interested persons regarding ambulatory blood pressure monitoring for the diagnosis and treatment of hypertension. On Thursday, February 22, 2001, the meeting of the EC will be to discuss comments received on the March 1, 2000, interim recommendations for evaluating effectiveness of the MCAC process. It will also ratify or comment on the recommendations of the Medical and Surgical Procedures Panel meeting that took place on October 17 and 18, 2000 regarding both electrostimulation for the treatment of chronic wounds and sacral nerve stimulation for the treatment of incontinence.

Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)).

DATES:

The Meetings: The meetings will be held on Wednesday, February 21, and Thursday, February 22, 2001, respectively, from 8 a.m. until 4 p.m., E.S.T.

Deadline for Presentation Notification and Comments: February 14, 2001, 5 p.m., E.S.T.

Special Accommodations: Persons attending the meetings who are hearing-or visually-impaired, and/or have a condition that requires special assistance/accommodations, are asked to notify the respective Executive Secretaries by February 14, 2001.

ADDRESSES:

The Meetings: The meetings will be held at the Baltimore Convention Center, Rooms 327 and 328 (for both days), One West Pratt Street, Baltimore, MD 21201.

Presentations and Comments: Submit formal presentations and written comments for the Panel's discussion on ambulatory blood pressure monitoring for the diagnosis and treatment of hypertension to Patricia M. Brocato-Simons, Executive Secretary, Office of Clinical Standards and Quality, Health Care Financing Administration, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850.

Submit formal presentations and written comments for the EC's discussions on interim recommendations for evaluating effectiveness of the MCAC process, or on electrostimulation for the treatment of chronic wounds and sacral nerve stimulation for the treatment of incontinence to Constance A. Conrad, Executive Secretary, Office of Clinical Standards and Quality, Health Care Financing Administration, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850.

Website: You may access up-to-date information on this meeting at www.hcfa.gov/​quality/​8b.htm.

Hotline: You may access up-to-date information on this meeting on the HCFA Advisory Committee Information Hotline, 1-877-449-5659 (toll free) or in the Baltimore area [phone].

FOR FURTHER INFORMATION CONTACT:

Patricia M. Brocato-Simons, Executive Secretary for the Panel, at 410-786-0261, or Constance A. Conrad, Executive Secretary for the EC, at 410-786-4631.

SUPPLEMENTARY INFORMATION:

On August 13, 1999, we published a notice (64 FR 44231) to describe the Medicare Coverage Advisory Committee (MCAC), which provides advice and recommendations to us about clinical issues. This notice announces the following public meetings of the Medical Devices and Prosthetics Panel (the Panel) and the Executive Committee (EC) of the MCAC:

The Medical Devices and Prosthetics Panel and Invited Guests

Harold Sox, Jr., M.D.; Ronald Davis, M.D.; Willarda Edwards, M.D.; John Hinton, D.O., M.P.H.; Anne Roberts, M.D.; Karl Matuszewski, M.S., PharmD; Thomas Strax, M.D.; Wade Aubry, M.D.; Rory Cooper, Ph.D.; and Eileen Helzner, M.D. In addition, two invitees will attend the Panel meeting and lend their respective expertise to the deliberations: Kenneth Brin, M.D., M.P.H, a current member of the Medical and Surgical Procedures Panel, with a specialty in the field of cardiology, will serve as a temporary, voting member of the Panel; and Parker Staples, M.D., the Carrier Medical Director for the State of Rhode Island, will serve as a temporary, non-voting guest of the Panel.

Topic of the Meeting

On Wednesday, February 21, 2001, the Panel will hear and discuss presentations from interested persons regarding ambulatory blood pressure monitoring for the diagnosis and treatment of hypertension.

The EC Members:

Alan M. Garber, M.D.; Michael D. Maves, M.D.; Daisy Alford-Smith, M.D.; Joe Johnson, D.C.; Harold Sox, M.D.; Ronald Davis, M.D.; Frank Papatheofanis, M.D., Ph.D.; John Ferguson, M.D.; Robert Murray, J.D., Ph.D.; Thomas Holohan, M.D., M.B.A.; Leslie Francis, Ph.D., J.D.; Robert Brook, M.D., Linda Bergthold; and Randel Richner, M.P.H.

Topic of the Meeting

On Thursday, February 22, 2001, the EC will hear and discuss presentations from interested persons regarding comments received on interim recommendations for evaluating effectiveness of the MCAC process. The guidelines were developed on March 1, 2000, for the purpose of providing guidance to the specialty panels. It will also ratify or comment on recommendations regarding electrostimulation for the treatment of chronic wounds and sacral nerve stimulation, discussed by the Medical and Surgical Procedures Panel on October 17 and 18, 2000.

Procedure and Agenda

The meetings are open to the public. Oral presentations will be heard from the public for approximately 2.5 hours each meeting day. However, the number and duration of each oral presentation may be limited in recognition of the time available. If you wish to make formal presentations, you must notify the respective Executive Secretaries listed in the FOR FURTHER INFORMATION CONTACT section of this notice, and submit the following by the Deadline for Presentations and Comments date listed in the DATES section of this notice: a brief statement of the general nature of the evidence or arguments you wish to present, the names and addresses of proposed participants, and an estimate of the time required to make the presentation. A written copy of your presentation will be provided to each Panel or EC member prior to offering your public comments. We will request that you declare at the meetings whether or not you have any financial involvement with manufacturers of any items or services being discussed (or with their respective competitors).

After HCFA presentations, the public will be asked to make its presentations to the Panel (February 21) or the EC (February 22). After public presentations, the Panel or the EC will deliberate openly on the topic. Interested persons may observe the deliberations, but the Panel or the EC will not hear further comments during this time except at the request of the chairpersons. Each day, there will be approximately a 30-minute open public session for any attendee to address issues specific to the topic. At the conclusion of each day, the respective members will vote, and the Panel or the EC will make its recommendations.

Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).

(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: January 26, 2001.

Jeffrey L. Kang,

Director, Office of Clinical Standards and Quality, Health Care, Financing Administration