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MEDCAC Meeting

Percutaneous Transluminal Angioplasty (PTA) and Stenting of the Renal Arteries

07/18/2007

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Issue

The Centers for Medicare and Medicaid Services (CMS) has internally generated a national coverage analysis (NCA) in order to examine the best treatment for patients with atherosclerotic renal artery stenosis (ARAS) and develop a national coverage determination (NCD) for PTA and stenting of the renal arteries.

Currently, Medicare covers percutaneous transluminal angioplasty (PTA) of the renal arteries “for patients in whom there is an inadequate response to a thorough medical management of symptoms and for whom surgery is the likely alternative. The PTA for this group of patients is an alternative to surgery, not simply an addition to medical management” (Medicare NCD Manual, 20.7 B1).  Medicare coverage of renal artery stenting is at the discretion of local Medicare contractors.

In 2006, the Agency for Healthcare Research and Quality (AHRQ) issued a report summarizing the evidence evaluating the effect and safety of angioplasty with stent placements and medical therapies in the treatment of atherosclerotic renal artery stenosis (ARAS) [link to http://effectivehealthcare.ahrq.gov/synthesize/reports/execSummary.cfm?Topic=42]. The National Institutes of Health (NIH) has sponsored the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial to examine which patients with ARAS would benefit from angioplasty with stent placement versus aggressive medical therapy. Due to the recent increase in concern regarding renal artery PTA and stenting and external questions regarding Medicare’s impact on current research and utilization of these procedures, we are initiating this reconsideration. 

Actions Taken

May 3, 2007

Announced MedCAC meeting July 18, 2007.

May 30, 2007

Posted Federal Register Notice [PDF, 95KB] and Questions [PDF, 65KB] to panel.

July 11, 2007

Posted roster and agenda.

July 20, 2007

Posted scoresheet [PDF, 84KB] from meeting.

August 17, 2007

Posted minutes [PDF, 33KB] and transcript [PDF, 644KB].

Agenda

Federal Register Notice
Agenda
Medicare Coverage Advisory Committee
July 18, 2007
7:30 AM - 4:30 PM
CMS Auditorium

Alan Garber, M.D., PhD Chair
Alex Krist, MD, Vice Chair
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Michelle Atkinson, Executive Secretary

7:30 - 8:00 AM

Registration

8:00 - 8:15AM

Opening Remarks—M. Atkinson / S. Phurrough, MD, MPA/ Alan Garber, MD

8:15 - 8:25 AM

CMS Presentation Voting Questions - Sarah McClain, MHS

8:25 - 9:10 AM

TA Presentation: Ethan Balk, MD, MPH, Institute for Clinical Research and Health Policy Studies

9:10 - 9:25 AM

Christopher J. Cooper, MD, Department of Medicine, University of Toledo

9:25 -9:40 AM

Lance D. Dworkin, MD, Brown Medical School
Rhode Island Hospital

9:40 - 10:10AM

Thomas A. Sos, MD, Professor and Vice Chair of Radiology
Director, Peripheral Arterial Disease, Cornell Vascular New York Presbyterian Hospital, Weill Medical College

10:10 - 10:40AM

Stuart L. Linas, MD, Professor of Medicine
Chief of Nephrology, Denver Health Medical Center
University of Colorado

10:40 - 11:25AM

Scheduled Public Comments
(Refer to Speaker List)

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Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

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11:25- 11: 35AM

Open Public Comments

Public Attendees who wish to address the panel will be given that opportunity

11:35 - 12:35 PM

LUNCH (on your own)

12:35 - 1:35 PM

Questions to Presenters

1:35 - 2:45 PM

Initial Open Panel Discussion: Dr. Garber

2:45 - 3:30 PM

Formal Remarks and Voting Questions

The Chairperson will ask each panel member to state his or her position on the voting questions

3:30 - 4:25 PM

Final Open Panel Discussion: Dr. Garber

4:25 - 4:30 PM

Closing Remarks / Adjournment: Dr. Phurrough, Dr. Garber

4:30 PM

ADJOURN

Minutes

Download meeting minutes [PDF, 33KB]

Panel Voting Questions

Download Questions [PDF, 65KB] to panel.

Download scoresheet [PDF, 84KB].

Contact Information

Other Material

Roster

July 18, 2007
Medicare Evidence Development & Coverage Advisory Committee

Alan M. Garber, M.D, Ph.D.
Director, Center for Primary Care and Outcomes Research
Stanford University

Alexander H. Krist, MD
Family Physician
Fairfax Family Practice Center

Chaim Charytan, MD
Renal Division
New York Hospital Medical Center of Queens

A. Mark Fendrick, MD
Professor, Internal Medicine and
Health Management Policy
The University of Michigan

Carole Redding Flamm, MD, MPH
Senior Medical Director
Office of Clinical Affairs
Blue Cross Blue Shield Association

William Lewis, MD
Clinical Chief of Cardiology
MetroHealth Medical Center
Heart & Vascular Center

Bernard Lo, MD
Professor of Medicine
University of California San Francisco

William H. Maisel, MD, MPH
Cardiovascular Division
Beth Israel Deaconess Medical Center
Harvard Medical School

Barry D. Pressman, MD
Chair, Department of Imaging
Cedars Sinai Medical Center

Robert S. Schwartz, MD
Medical Director
Minnesota Cardiovascular Research Institute

Sanford J. Schwartz, MD
Professor of Medicine, Health Management & Economics
University of Pennsylvania

Mark Slaughter, MD
Director, Cardiac Surgery
Advocate Christ Medical Center

Industry Representative

Michael J. Lacey M.Sc.
Director, Reimbursement and Health Economics
Acusphere, Inc

Consumer Representative

Linda A. Bergthold, PhD
Independent Healthcare Consultant

Guests

Matthew S. Edwards, MD
Asst Professor of Surgery and Public Health Sciences
Department of General Surgery, Vascular Surgery Section
Wake Forest University School of Medicine Winston-Salem, NC

Stephen C. Textor, MD
Professor of Medicine
Division of Nephrology and Hypertension
Mayo Clinic

CMS Liaison

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group

Michelle Atkinson
Coverage and Analysis Group

Associated NCA

Associated Technology Assessment

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