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

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=39 | meeting_date=2007-07-18

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) ********************************************************************************** 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. ********************************************************************************** 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 Associated Nca: Percutaneous Transluminal Angioplasty (PTA) and Stenting of the Renal Arteries (CAG-00085R4) 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. Minutes: Download meeting minutes [PDF, 33KB] Other Material: Transcript 1 Panel Voting Questions: Download Questions [PDF, 65KB] to panel. Download scoresheet [PDF, 84KB]. 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