MEDCAC Meeting

Transmyocardial revascularization (TMR) / Percutaneous Myocardial Revascularization (PMR)

07/14/2004

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Issue

The Medicare Coverage Advisory Committee (MCAC) will discuss and make recommendations concerning the quality of the evidence and related issues for the use of transmyocardial revascularization (TMR) and percutaneious myocardial revascularization (PMR) for treatment of severe angina.   TMR is a surgical technique that uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached due to diseased or clogged arteries; PMR is a subset of this technique which is less invasive and is used as a late or last resort to relieve symptoms of severe angina in patients suffering ischemic heart disease who are not amenable to direct coronary revascularization interventions such as angioplasty, stenting, or open coronary bypass.  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

May 30, 2004

Federal Register Notice announcing this MCAC is published. The public meeting will be held on Wednesday, July 14, 2004 from 7:30 a.m. until 3:30 p.m. e.d.t., at the Holiday Inn Inner Harbor, 301 West Lombard Street, Baltimore, MD 21201.

June 15, 2004

Additional information is available including the panel questions, Federal Register Notice and instructions for public commenters. Additional information will be posted closer to the day of the meeting.

June 23, 2004

The technology assessment [PDF, 901KB] that will be presented to the panel is now available. Due to the late posting of the assessment, the deadline for receiving public comments has been extended to close of business on June 30, 2004.

June 29, 2004

We have corrected an error in the questions [PDF, 47KB] we posted to our website. We have also defined the term "validity" in the 2nd question.

July 1, 2004

CMS has received a request from the TMR/PMR MCAC panel to add an additional question to address net health benefit. This question is now question #3 [PDF, 47KB]. We have extended the deadline to submit a presentation to no later than July 7, 2004.

September 10, 2004

The minutes and transcript [PDF, 638KB] from the July 14, 2004 MCAC meeting are now available for viewing.

Agenda

Medicare Coverage Advisory Committee
July 14, 2004
7:30 AM - 4:30 PM
Holiday Inn Inner Harbor
Agenda

Ronald M. Davis, MD, Chairperson
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Michelle L. Atkinson, Executive Secretary

8:00 - 8:05 AM

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

8:05 - 8:15 AM

CMS Presentation of Request and Voting Questions: Lori Paserchia, MD

8:15 - 8:50 AM

AHRQ Presentation of Technology Assessment: Deborah Zarin, MD

8:50 - 10:20 AM

Scheduled Public Comments
  • STS, Cardiogenesis, PLC, Edwards Lifesciences
    • T. Bruce Ferguson Jr, MD
    • Keith A. Horvath, MD
    • Robert A. Guyton, MD
    • Richard L. Popp, MD
  • ACC
    • Julius M. Gardin, MD, FACC
  • Kurt E. Wehberg, MD, CV Surgical Associates, P.A.
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 - 10:30AM

BREAK

10:30 - 11:00AM

Questions to Presenters

11:00 - 11:30AM

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


11:30 - 12:30PM

LUNCH


12:30 - 4:15 PM

Open Panel Deliberations: Dr. Davis
  • Formal Remarks and Vote on TMR/ PMR
    Prior to voting, the Chairperson will ask each panel member to state his or her position on the voting question.

4:15 - 4:30 PM

Closing Remarks / Adjournment: M. Atkinson /Dr. Phurrough

4:30 PM

ADJOURN

Minutes

MEETING MINUTES
OF THE
CENTERS FOR MEDICARE AND MEDICAID SERVICES
MEDICARE COVERAGE ADVISORY COMMITTEE

July 14, 2004

Holiday Inn Inner Harbor
Lombard and Howard Street
Baltimore, Maryland


Medicare Coverage Advisory Committee

July 14, 2004

Attendees

Ronald M. Davis, M.D.
Chairperson

Barbara J. McNeil, M.D., Ph.D.
Vice-Chairperson

Michelle Atkinson
Executive Secretary

Voting Members
Edgar R. Black, M.D.
Steven N. Goodman, M.D., M.H.S., Ph.D.
David J. Cohen, M.D., M.Sc.
Lishan Aklog, M.D.

CMS Liaison
Steve Phurrough, M.D., M.P.A..

Consumer Representative
Charles J. Queenan, III

Industry Representative
Michael Lacey, M.Sc.

Guest Panelists
Joel Cooper, M.D.
Eric A. Rose, M.D.

Wednesday, July 14, 2004, 8:07 a.m.

The Medicare Coverage Advisory Committee met on July 14, 2004, to discuss and make recommendations concerning the quality of the evidence and related issues for the use of transmyocardial revascularization (TMR), TMR + coronary artery bypass grafting (CABG) and percutaneous myocardial revascularization (PMR) to treat severe angina.

The meeting began with a reading of the conflict of interest statement and introduction of the Committee.

CMS Presentation of Request and Voting/Discussion Questions. A CMS representative presented the panel with information on Medicare coverage policy related to the technologies, FDA label information, and presented the questions that the panel would be asked to vote upon at the conclusion of this meeting.

Following this presentation, Dr. Davis informed the panel and the public that the format of the questions and voting procedure had changed from prior MCAC meetings.

AHRQ Presentation of Technology Assessment Dr. Deborah Zarin presented a summary of the evidence review conducted by the Duke University Evidence-Based Practice Center. Following her presentation, the panel was given the opportunity to ask questions.

Requestor’s Presentation. Representatives from Society of Thoracic Surgeons, Cardiogenesis, PLC, and Edwards Lifesciences presented the panel with information on the STS database, clinical results from treatment with TMR, results and analyses of different randomized and observational studies, asserting that the use of TMR alone or as an adjunct to CABG, is of favorable clinical significance and does lead to better health outcomes when compared to CABG alone. It was also argued that PMR, although the evidence concerning its use is not as strong as that of TMR, does show promise and further studies are warranted. Following these presentations, the panel engaged in lengthy questions of the presenters.

A representative from the American College of Cardiology addressed the panel, stating ACC’s position that use of TMR plus CABG would produce a clinically important net health benefit for selected patients with chronic refractory angina, and that the data would be applicable to the Medicare population. Concerning PMR, the ACC’s position is that the emerging body of evidence suggests that in selected individuals there is a moderate degree of confidence that this is a helpful technique; however, there does not seem to be any mortality benefit currently shown either in the short term or the long term, and they await further data.

A community cardiothoracic surgeon presented the panel with a clinical study addressing 30-day outcomes of TMR plus CABG, concluding that TMR plus CABG as compared to CABG alone in very carefully selected patients is associated with a reduced intensive care unit stay, postoperative lengths of stay, postoperative atrial fibrillation, and may also provide a benefit for operative survival, as well as rehospitalizations.

The panel posed questions to the ACC representative and the community cardiothoracic surgeon.

Open Public Comments. Four speakers addressed the panel, including three Medicare beneficiaries who had received TMR. All three noted the significant positive change the treatment had made in their cases.

The fourth speaker was the director and chief research analyst of ECRI, who highlighted some of the points made in the ECRI report that was provided to the panel.

Open Panel Discussion. Following a lunch break, the panel engaged in a general discussion, followed by discussion specific to each of the three categories, TMR alone, TMR plus CABG, and PMR, prior to voting on each therapy.

Final Remarks and Vote.

The panel voted on the following questions:

TMR.

Question 1. For TMR alone, how well does the evidence address the effectiveness of TMR in the treatment of chronic refractory angina in study patients for whom other methods of revascularization are contraindicated? Four voting members indicated a moderate effectiveness (level 3) and one voting member indicated a moderate to complete effectiveness (level 4).

Question 2a. How confident are you in the validity of the scientific data for this outcome, concerning:

Short-term mortality? Two voting members indicated a moderate confidence (level 3), and three voting members indicated a moderate to complete confidence (level 4).

Long-term survival? One voting member indicated none to moderate confidence (level 2) and four voting members indicated moderate confidence (level 3).

Morbidity? Two voting members indicated a moderate confidence (level 3) and three voting members indicated a moderate to complete confidence (level 4).

Quality of life? Four voting members indicated a moderate confidence (level 3) and one voting member indicated a moderate to complete confidence (level 4).

Question 2b. How likely is it that TMR will improve this outcome compared to usual care:

Short-term care? Four voting members indicated not likely (level 1) and one voting member indicated not likely to reasonably likely (level 2).

Long-term survival? Four voting members indicated not likely (level 1) and one voting member indicated not likely to reasonably likely (level 2).

Morbidity? Two voting members indicated a reasonably likelihood (level 3), two voting members indicated a reasonable to complete likelihood (level 4), and one voting member indicated a complete likelihood (level 5).

Quality of life? Three voting members indicated a reasonable likelihood (level 3) and two voting members indicated a reasonable to complete likelihood (level 4).

Question 3. One voting member indicated no to moderate confidence (level 2), two voting members indicated moderate confidence (level 3), and two voting members indicated moderate to high confidence (level 4).

Question 4. Based on the literature presented, how likely is it that the results of TMR in the treatment of chronic medically refractory angina can be generalized to:

The Medicare population (aged 65+)? Two voting members indicated a reasonable to very likely likelihood (level 4) and three voting members indicated a very likely likelihood.

Providers (facilities/physicians) in community practice? Three voting members indicated none to reasonably likelihood (level 2), one voting member indicated a reasonable likelihood (level 3), and one voting member indicated a reasonable to very likely likelihood (level 4).

TMR + CABG

Before voting on these questions, the panel stated that their responses would be addressed to modified forms of questions 1 and 3, as follows:

Question 1. How well does the evidence address the effectiveness of TMR plus CABG in the treatment of chronic refractory angina in study patients for whom complete revascularization cannot be obtained by conventional means, i.e., CABG or PCI? Two voting members indicated limited confidence (level 1), one voting member indicated limited to moderate confidence (level 2), and two voting members indicated moderate confidence (level 3).

Question 2b. How confident are you in the validity of the scientific data for this outcome:

Short-term mortality? Three panel members indicate no to moderate confidence (level 2), and two voting members indicated moderate confidence (level 3).

Long-term survival? One voting member indicated no confidence (level 1), two voting members indicated no to moderate confidence (level 2), and two voting members indicated moderate confidence (level 3).

Morbidity? One voting member indicated no confidence (level 1), three voting members indicated moderate confidence (level 3), and one voting member indicated moderate to complete confidence (level 4).

Quality of life? Two voting members indicated no to moderate confidence (level 2), two voting members indicated moderate confidence (level 3), and one voting member indicated moderate to high confidence (level 4).

Question 2b. How likely is it that TMR plus CABG will improve this outcome compared to usual care:

Short-term mortality? Four voting members indicated none to reasonable likelihood (level 2), and one voting member indicated reasonable to very likely likelihood (level 4).

Long-term survival? Three voting members indicated not likely (level 1), one voting member indicated none to reasonable likelihood (level 2), and one voting member indicated reasonable likelihood (level 3).

Morbidity? Four voting members indicated none to reasonable likelihood (level 2), and one voting member indicated reasonable likelihood (level 3).

Quality of life? One voting member indicated not likely (level 1), three voting members indicated none to reasonable likelihood (level 2), and one voting member indicated reasonable likelihood (level 3).

Question 3. How confident are you that TMR plus CABG will produce a clinically important net health benefit in the treatment of chronic refractory angina in study patients, in study patients for whom complete revascularization cannot be obtained by conventional means, i.e., CABG or PCI? One voting member indicated no confidence (level 1), three voting members indicated no to moderate confidence (level 2), and one voting member indicated moderate to high confidence (level 4).

Question 4. Based on the literature presented, how likely is it that the results of TMR plus CABG in the treatment of chronic refractory angina can to be generalized to:

The Medicare population (aged 65 +)? Three voting members indicated reasonable likelihood (level 3), and two voting members indicated reasonable to very likely likelihood (level 5).

Providers (facilities/physicians) in community practice? Three voting members indicated no to reasonable likelihood (level 2), one voting member indicated reasonable likelihood (level 3), and one voting member indicated very likely (level 5).

PMR

Question 1. How well does the evidence address the effectiveness of PMR in the treatment of chronic refractory angina in study patients for whom other methods of revascularization are contraindicated? Two voting members indicated limited (level 1), one voting member indicated limited to moderate (level 2), one voting member indicated moderate (level 3), and one voting member indicated moderate to complete (level 4).

Question 2a. How confident are you in the validity of the scientific data for this outcome:

Short-term mortality? Two voting members indicated no to moderate confidence (level 2), one voting member indicated moderate confidence (level 3), and two voting members indicated moderate to high confidence (level 4).

Long-term survival? One voting member indicated no confidence (level 1), and four voting members indicated no to moderate confidence (level 2).

Morbidity? Four voting members indicated no to moderate confidence (level 2), and one member indicated moderate confidence (level 3).

Quality of life? The voting members were unanimous indicating no to moderate confidence (level 2).

Question 2b. How likely is it that PMR will improve this outcome compared to usual care:

Short-term mortality? The voting members were unanimous indicating not likely (level 1).

Long-term survival? The voting members were unanimous indicating not likely (level 1).

Morbidity? Four voting members indicated not likely to reasonable likelihood (level 2), and one voting member indicated reasonable likelihood (level 3).

Quality of life? The voting members were unanimous indicating not likely to reasonable likelihood (level 2).

Question 3. How confident are you that PMR will produce a clinically important net health benefit in the treatment of chronic refractory angina in study patients for whom other conventional methods of revascularization are contraindicated? Two voting members indicated no confidence (level 1) and three voting members indicated no to moderate confidence (level 2).

Question 4. Based on the literature presented, how likely is it that the results of PMR in the treatment of chronic medically refractory angina can be generalized to:

The Medicare population aged 65 and older? Three voting members indicated reasonably likely (level 3) and two voting members indicated reasonably to very likely (level 4).

Providers (facilities/physicians) in community practice? Four voting members indicated not likely to reasonably likely (level 2) and one voting member indicated reasonably likely (level 3).

Adjournment. The meeting adjourned at 3:25 p.m.

I certify that I attended the meeting
of the Executive Committee on
July 14, 2004, and that these
minutes accurately reflect what
transpired.
_________________________________
Michelle Atkinson
Executive Secretary, MCAC, CMS

I approve the minutes of this meeting
as recorded in this summary.
______________________________
Ronald M. Davis, M.D.
Chairperson

Panel Voting Questions

Download Questions [PDF, 47KB].

Contact Information

Roster

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

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

Voting Members
Edgar Roy Black, MD
Vice President, Chief Medical Officer
Blue Cross Blue Shield
Rochester, NY

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

Lishan Aklog, MD
Department of Cardiothoracic Surgery
Mount Sinai Medical Center
New York, NY

Steven N. Goodman, MD, MHS, PhD
Depart of Oncology,
Division of Biostatistics
John Hopkins School of Medicine
Baltimore, MD

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

David J. Cohen, MD, MSc
Cardiovascular Division
Beth Israel Deaconess Medical Center
Boston, MA

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

Industry Representative:
Michael Lacey, MSc
Director Health Economics and Outcomes Research
Boston Scientific
Boston, MA

Non-Voting Guest Panelists
Joel Cooper, MD
Washington University
St. Louis, MO

Eric A. Rose, MD
Professor and Chairman,
Department of Surgery,
Associate Dean for Translational Research
Columbia University Medical Center
New York, NY

CMS Liaison
Steve Phurrough,
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Baltimore, MD

Executive Secretary
Michelle Atkinson
Centers for Medicare & Medicaid Services
Baltimore, MD

Associated NCA

Associated Technology Assessment