Cochlear Implants for Sensorineural Hearing Loss

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=58 | meeting_date=2011-05-11

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%.

Actions Taken: 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. Webcast of meeting Registration Webinar registration Information about visiting CMS Registrations have closed. Agenda: 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 Directions To Cms: http://www.cms.gov/CMSHeadquarters/05_Driving%20Directions.asp#TopOfPage Issue: 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%. Minutes: Download meeting minutes [PDF, 1.3MB]. Other Material: Transcript 1 Agenda, Roster and Speaker List Presentations Written Comments Panel Voting Questions: 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 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: >40% and ≤50% >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? 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 : >40% and ≤50% >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. 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 ? ≤ 40% > 40 % and ≤ 50%, > 50% and ≤ 60% 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? ≤ 40% > 40 % and ≤ 50% > 50% and ≤ 60% 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? ≤ 40% > 40 % and ≤ 50% > 50% and ≤ 60% 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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 ? ≤ 40% > 40 % and ≤ 50% > 50% and ≤ 60% 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? ≤ 40% > 40 % and ≤ 50% > 50% and ≤ 60% 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? ≤ 40% > 40 % and ≤ 50% > 50% and ≤ 60% 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence What significant evidence gaps exist regarding the clinical criteria of individuals who should receive cochlear implants, either unilateral or bilateral? How confident are you that these conclusions are generalizable to: The Medicare patient population? Community based settings? Download scoresheet [PDF, 97KB] Roster: 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 Speakers List: 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