Archive
API

MEDCAC Meeting

Physician-supervised behavioral interventions for patients with symptomatic coronary artery disease

01/25/2005

Expand All | Collapse All

Issue

Coronary artery disease (CAD) is of great concern to patients and health care providers and the major cause of illness and death in this country.

Aging populations and advances in life-saving treatment technologies have lead to an increase in the number of patients living with CAD and needing disease management and follow-up care, sometimes in the form of coordinated services. CMS has received documents regarding physician-supervised behavioral interventions including diet, exercise, counseling and stress reduction and the impact of these interventions on health outcomes of patients with CAD.

CMS is referring the issue of physician-supervised behavioral interventions for patients with symptomatic coronary artery disease to the Medicare Coverage Advisory Committee (MCAC).   The MCAC will review and evaluate the evidence related to the benefits and risks of physician-supervised interventions for patients with symptomatic coronary artery disease.

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

Actions Taken

December 15, 2004

A Medicare Coverage Advisory Committee meeting will be held on Tuesday, January 25, 2005 from 7:30 a.m. until 4:30 p.m. EST at the Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244. The Committee will review the evidence related to the benefits and risks of physician supervised behavioral interventions for patients with symptomatic coronary artery disease. The meeting was announced in the Federal Register [PDF, 36KB] on November 26, 2004. Questions to be addressed to the MCAC panel will be posted soon.

December 20, 2004

Release of Questions to be addressed to the MCAC panel. Due to the late posting of the questions, the dealine for receiving public comments has been extended to COB January 10, 2005. Individuals wishing to make scheduled public comments should ensure that their presentations focus on these questions.

January 21, 2005

March 21, 2005

Posted Minutes.

Agenda

Federal Register Notice
Medicare Coverage Advisory Committee
January 25, 2005
7:30 AM - 4:30 PM
CMS Auditorium
Agenda

Ronald M. Davis, MD, Chairperson
Barbara J. McNeil, MD, PhD, Vice-Chairperson
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Michelle Atkinson, Executive Secretary

7:30 - 8:00 AM

Registration

8:00 - 8:15 AM

Opening Remarks: M. Atkinson/ S. Phurrough, MD, MPA/R. Davis, MD

8:15 - 8:20 AM

Presentation of the Voting Questions: Clay Farris, MPH

8:20 - 9:00 AM

Presentation of the TA: Dr. Alex Clark
University of Alberta Evidence-Based Practice Center

9:00 - 9:45 AM

Dean Ornish, M.D.
Founder & President, Preventive Medicine Research Institute

9:45 - 10:20 AM

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.

10:20 - 10:35 AM

BREAK

10:35 - 10:50 AM

Scheduled Public Comments (Continued)

10:50 - 11:30 AM

Questions to Presenters

11:30 - 12:00 PM

Open Public Comments

12:00 - 1:00PM

LUNCH (on your own)

1:00 - 3:15 PM

Open Panel Deliberations: Dr. Davis

3:15 - 4:15 PM

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

4:15 - 4:30 PM

Closing Remarks / Adjournment: M Atkinson /Dr. Phurrough

4:30 PM

ADJOURN

Minutes

Download Minutes [PDF, 21KB]

Panel Voting Questions

Medicare Coverage Advisory Committee - Evaluative Questions

Physician-supervised Behavioral Interventions for Symptomatic Coronary Artery Disease

1. How well does the evidence address the effectiveness of physician-supervised behavioral interventions for patients with symptomatic coronary artery disease as compared to usual medical/surgical management?
* 1 - Poorly    * 2    * 3 - Reasonably Well    * 4    * 5 - Very Well
1    2    3    4    5
 
  2. How confident are you in the validity of the scientific data on the following outcomes with respect to physician supervised behavioral interventions for patients with symptomatic coronary artery disease?
1 - No confidence
  2
   3 - Moderate Confidence
    4
     5 -High Confidence 		3. How likely is it that physician-supervised behavioral interventions for patients with symptomatic coronary artery disease will positively affect the following outcomes when compared to usual medical/surgical management?
1 - Not Likely
  2
   3 - Reasonable Likely
    4
     5 - Very likely
Cardiac event incl. angina 1    2    3    4    5 1    2    3    4    5
Long-term Survival 1    2    3    4    5 1    2    3    4    5
Short-term Survival 1    2    3    4    5 1    2    3    4    5
QOL 1    2    3    4    5 1    2    3    4    5
 
4. How confident are you that physician-supervised behavioral interventions will produce a clinically important net health benefit in the treatment of patients with symptomatic coronary artery disease?
*1 - No confidence    *2   *3 - Moderate Confidence    *4   *5 -High Confidence
 
5. Based on the scientific evidence presented, how likely is it that the results of physician-supervised behavioral interventions for patients with symptomatic coronary artery disease can be generalized to:
* 1 - Not Likely    * 2    * 3 - Reasonably Likely     * 4    * 5 - Very Likely
    a. The Medicare population (aged 65+): 1 2 3 4 5
    b. Providers (facilities/ physicians) in community practice: 1 2 3 4 5
 

Glossary:

Physician supervised behavioral interventions: A comprehensive program utilizing several modalities that may include nutrition counseling, exercise, stress reduction, group therapy, etc.
Symptomatic coronary artery disease. Includes but is not limited to Angina, Myocardial Infarction, Coronary Heart Disease, etc
Validity. CMS uses "validity" here as defined by Meinert, "Validity, in the context of a treatment difference, refers to the extent to which that difference can be reasonablyattributed to a treatment assignment." (Meinert CL. Clinical Trials, Overview. In: Redmond CK, Colton T, eds. Biostatistics in clinical trials. Wiley and Sons, 2001.pp. 37-51). This encompasses all issues of methodologic framework, study design, observed results, biological rationale, etc.
Net health benefit. Balance between risks and benefits including complications of surgery

Contact Information

Other Material

Roster

Ronald M. Davis, MD
Director, Center for Health Promotion &
Disease Prevention, Henry Ford Health System
Detroit, MI

Barbara J. McNeil, MD, PhD
Department of Health Care Policy
Harvard Medical School
Boston, MA

Rita F. Redberg, MD, MSc
University of California, San Francisco Medical Center
Division of Cardiology
San Francisco, CA

Norman Daniels, PhD
Harvard School of Public Health
Department of Population and International Health
Boston, MA

Clifford Goodman, PhD
Senior Scientist
The Lewin Group
Falls Church, VA

Anne B. Curtis, MD
Division of Cardiology,
Department of Medicine,
University of Florida
Health Science Center
Gainesville, FL

Tracy R. Gordy, MD
Austin, TX

Paul H. Barrett, Jr.
Kaiser Permante
Clinical Research Unit
Aurora, CO

Tammy L. Born, DO
Owner and Chief Medical Officer
Born Clinic
Grand Rapids, MI

Mary W.L. Lee, PharmD., BCPS, FCCP
Dean, Chicago College of Pharmacy
Downers Grove, IL

William F. Owen, Jr., MD
Professor of Medicine
Duke University of Medicine
Durham, NC

Mark Slaughter, MD
Cardiothoracic & Vascular Surgical Associates, S.C.
Oak Lawn, IL

Industry Rep
Patricia L. Garvey, PhD
Corporate Vice President
Regulatory, Quality and Clinical Affairs
Edwards Lifesciences Corporation
Irvine, CA

Consumer Rep
Charles J. Queenan, III
Independent Management Consultant
McLean, VA

Guest
Christina Biesemeier, MS, RD,LDN,FADA
Assistant Director, Nutrition Services
Vanderbilt University Medical Center
Nashville, TN

William H. Herman, MD, MPH
Department of Internal Medicine
Division of Metabolism, Endocrinology & Diabetes
Ann Arbor, MI

Pamela Snider, ND
Associate Dean
Naturopathic Medicine Program
Bastyr University
Kenmore, WA

Associated NCA

Associated Technology Assessment

Submit Feedback/Ask a Question