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MEDCAC Meeting 5/11/2011 - Cochlear Implants for Sensorineural Hearing Loss

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The Centers for Medicare and Medicaid Services (CMS) has convened this meeting for the panel to review the evidence on health outcomes attributable to unilateral and bilateral cochlear implantation for its beneficiaries.

A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture, analyze, and code sound. Cochlear implant devices are available in single-channel and multi-channel models. The purpose of implanting the device is to provide awareness and identification of sounds and to facilitate communication for persons who are moderately to profoundly hearing impaired.

In 2005, CMS published National Coverage Determination (NCD) for Cochlear Implantation (50.3). This NCD establishes Medicare's criteria for coverage of cochlear implantation. Among other criteria, the patient must derive limited benefit from current means of sound amplification. Limited benefit is defined by test scores of less than or equal to 40% correct in the best-aided listening condition on tape recorded tests of open set sentence recognition.

For those patients who demonstrate hearing test scores of greater than 40% and less than or equal to 60% (and who meet Medicare's other coverage criteria), NCD 50.3 states that cochlear implantation may be covered, but only when the provider is participating in, and patients are enrolled in, either an FDA-approved category B investigational device exemption clinical trial as defined at 42 CFR 405.201, a trial under the Centers for Medicare & Medicaid (CMS) Clinical Trial Policy as defined at section 310.1 of the National Coverage Determinations Manual, or a prospective, controlled comparative trial approved by CMS as consistent with the evidentiary requirements for National Coverage Analyses and meeting specific quality standards. Since the 2005 NCD was published, we are unaware of any new clinical trials that adequately address the impact of cochlear implantation in patients who demonstrate hearing test scores of greater than 40% and less than or equal to 60%.

Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED ON THE CMS WEBSITE PRIOR TO THE MEETING.



March 5, 2011

Posted questions to panel

March 15, 2011

Federal Register notice posted.

May 9, 2011

Posted agenda, roster and speakers list for meeting.

May 9, 2011

Posted presentations [ZIP, 6MB] and written comments [ZIP, 2MB] for May 11 meeting.

May 16, 2011

Posted scoresheet [PDF, 97KB] from meeting.

July 12, 2011

Posted minutes [PDF, 1.3MB] and transcript [PDF, 272KB] from meeting.



Registrations have closed.
Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
May 11, 2011
7:30 AM – 4:30 PM
CMS Auditorium
Clifford Goodman, PhD, Chair
Saty Satya-Murti, MD, Vice Chair
James Rollins, MD, Division Director, Division of Items and Devices, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 – 8:00 AM

Registration

8:00 – 8:15 AM

Opening Remarks— Maria Ellis/James Rollins, MD/Clifford Goodman, PhD

8:15 - 8:35 AM

CMS Presentation & Voting Questions – Susan Miller, MD/ Sarah Meisenberg

8:35 – 8:55 AM

Debara L. Tucci, MD, Professor, Otolaryngology Head and Neck Surgery, Duke University Medical Center

8:55 – 9:15 AM

Teresa A. Zwolan, PhD, Professor and Director, University of Michigan Cochlear Implant Program, University of Michigan Health Systems

9:15 – 10:00 AM

TA Presentation: Mei Chung, PhD, MPH, Assistant Professor of Medicine, Investigator, Institute for Clinical Research and Health Policy Studies, Assistant Director, Tufts Evidence-based Practice Center, Tufts Medical Center and Gowri Raman, MD, MS, Assistant Director, Tufts Evidence-based Practice Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center

10:00 – 10:15 AM

BREAK

10:15 – 11:00 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.

11:00 – 11:15 AM

Open Public Comments

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

11:15 – 12:00 PM

Questions to Presenters

12:00 – 1:00 PM

LUNCH (on your own)

1:00 – 2:00 PM

Initial Open Panel Discussion: Dr. Goodman

2:00 – 3:00 PM

Formal Remarks and Voting Questions

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

3:00 – 4:00 PM

Final Open Panel Discussion: Dr. Goodman

4:00 – 4:30 PM

Closing Remarks/Adjournment: Dr. Rollins & Dr. Goodman

Download meeting minutes [PDF, 1.3MB].

MEDCAC -May 11, 2011 QUESTIONS

Cochlear Implants for Sensorineural Hearing Loss

The questions below all refer to the use of cochlear implant(s) in adults with bilateral sensorineural, moderate to profound hearing loss who demonstrate limited benefit from amplification. Definitions of terms included in these questions are:

  • Limited benefit from amplification is defined by the correct test scores noted in the questions below, obtained with the best aided listening condition on tape or otherwise recorded tests of open-set sentence recognition.
  • Health outcomes include symptom status, functional abilities and health related quality of life. In your discussions please note if your conclusions apply only to specific outcomes or more broadly.

For the voting questions, use the following scale identifying level of confidence - with 1 being the lowest or no confidence and 5 representing a high level of confidence.

1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence
  1. How confident are you that there is adequate evidence to determine whether or not a unilateral (i.e. first) cochlear implant improves health outcomes for adults with hearing loss who have demonstrated a test score of:

    1. >40% and ≤50%
    2. >50% and ≤60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

Discussion for Question 1:

Is there an absolute or relative change in test scores that indicates a clinically meaningful difference in health outcomes for this population?

  1. If the result of Question 1 is at least intermediate (mean vote ≥ 2.5) for either range of correct open set sentence recognition scores noted above, how confident are you that a unilateral (i.e. first) cochlear implant improves health outcomes for adults with hearing loss who have demonstrated a test score of :

    1. >40% and ≤50%
    2. >50% and ≤60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

Discussion for Question 2:

Are there any specific factors, other than test scores (e.g.anatomy, duration of hearing loss, characteristics of facilities/care providers, etc.), that can aid in the identification of those individuals most likely to attain improved health outcomes?

3a.     How confident are you that there is adequate evidence to demonstrate whether or not the use of bilateral cochlear implants as compared to a unilateral cochlear implant improves health outcomes?
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

3b.      If the result of Question 3a is at least intermediate (mean vote ≥ 2.5), how confident are you that the use of bilateral cochlear implants as compared to a unilateral cochlear implant improves health outcomes?
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

If the answer to question 3b is at least intermediate (mean vote ≥ 2.5), continue on to questions 4-9.

  1. How confident are you that there is adequate evidence to determine whether or not a sequential bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below ?

    1. ≤ 40%
    2. > 40 % and ≤ 50%,
    3. > 50% and ≤ 60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence
  1. If the answer to question 4 is at least intermediate (mean vote ≥ 2.5) in any of the ranges noted, how confident are you that a sequential bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

    1. ≤ 40%
    2. > 40 % and ≤ 50%
    3. > 50% and ≤ 60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence
  1. How confident are you that there is adequate evidence to determine whether or not a simultaneous bilateral cochlear implantation as compared to a unilateralcochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

    1. ≤ 40%
    2. > 40 % and ≤ 50%
    3. > 50% and ≤ 60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence
  1. If the answer to question 6 is at least intermediate (mean vote ≥ 2.5) in any of the ranges noted, how confident are you that a simultaneous bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss with test scores in the ranges below ?

    1. ≤ 40%
    2. > 40 % and ≤ 50%
    3. > 50% and ≤ 60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence
  1. How confident are you that there is adequate evidence to determine whether or not a simultaneous bilateral cochlear implantation as compared to a sequential cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

    1. ≤ 40%
    2. > 40 % and ≤ 50%
    3. > 50% and ≤ 60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence
  1. If the answer to question 8 is at least intermediate (mean vote ≥ 2.5) in any of the ranges noted, how confident are you that a simultaneous bilateral cochlear implantation as compared to a sequential cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score in the ranges below?

    1. ≤ 40%
    2. > 40 % and ≤ 50%
    3. > 50% and ≤ 60%
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

  1. What significant evidence gaps exist regarding the clinical criteria of individuals who should receive cochlear implants, either unilateral or bilateral?
  1. How confident are you that these conclusions are generalizable to:

    1. The Medicare patient population?
    2. Community based settings?

Download scoresheet [PDF, 97KB]

MEDCAC Roster
May 11, 2011

Clifford Goodman, PhD CHAIR
Senior Vice President
The Lewin Group

Saty Satya-Murti, MD, FAAN VICE CHAIR
Health Policy Consultant

Phyllis Atkinson, RN, MS, GNP-BC, WCC
Gerontological Nurse Practitioner
Co-Owner, Advanced Geriatric Education & Consulting, LLC

Wayne Chen, MD
Medical Director of Managed Carev AIDS Healthcare Foundation (AHF)

Catherine (Eng) Chan, MD, FACPv Medical Director
On Lok Lifeways
On Lok Senior Health Services

Marie Griffin, MD, MPH
Professor of Preventative Medicine
Vanderbilt University, School of Medicine

Paula E. Hartman-Stein, PhD
Clinical Psychologist & Consultant
Center for Healthy Aging

Alvin Mushlin, MD, ScM
Chairman, Department of Public Health
Weill Cornell Medical College

Ralph Sacco, MD, MS
University of Miami
Miller School of Medicine
Clinical Research Building

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

Teresa A. Zwolan, PhD
Professor and Director
University of Michigan Cochlear Implant Program

CMS Liaison

James Rollins, MD
Director
Division of Items and Devices
Coverage and Analysis Group

Executive Secretary Maria Ellis
Coverage and Analysis Group

Elaine M. Scorza, MSN, RN, APRN, CRNC
Senior Certified Medical Auditor & Coder
Department of Psychiatry
Instructor
Rush University College of Nursing
Rush University Medical Center

Robert L. Steinbrook, MD
Adjunct Associate Professor of
Medicine and Community and Family Medicine
Dartmouth Medical School

Industry Representative

G. Gregory Raab, PhD
Health Policy Consultant
Raab Associates

Guest Panel Members

John K. Niparko, MD
George T. Nager Professor &
Interim Director
The Johns Hopkins University
School of Medicine
The Johns Hopkins Outpatient Center
Department of Otolaryngology, Head & Neck Surgery

Paul R. Rao PhD, CCC, CPHQ, FACHE
2011 President
American Speech-Language-Hearing Association
Vice President
Inpatient Operations & Compliance
National Rehabilitation Hospital

Invited Guest Speakers

Debara L. Tucci, MD
Professor
Otolaryngology Head and Neck Surgery
Duke University Medical Center

Medicare Evidence Development & Coverage Advisory Committee
May 11, 2011

SPEAKER LIST

*7 MINUTES PER SPEAKER*

  • Jill B. Firszt, PhD, Associate Professor, Washington University School of Medicine - Representing: American Academy of Audiology
  • Craig A. Buchman, MD, FACS, Professor and Vice Chairman for Clinical Affairs Chief, Otology, Neurotology, Skull Base Surgery, Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill - Representing: American Neurotology Society
  • Rene’ H. Gifford, PhD, Assistant Professor, Vanderbilt University, Director, Cochlear Implant Program, Associate Director, Pediatric Audiology, Vanderbilt Bill Wilkerson Center, Department of Hearing and Speech Sciences
  • Richard S. Tyler, PhD, Audiologist, Director of Audiology and Professor, Department of Otolaryngology, Head and Neck Surgery and Department of Communication Sciences and Disorders, University of Iowa - Representing: American Speech-Language-Hearing Association - No Powerpoint Presentation
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