Continuation of Medicare Expansion Study
The ACI Alliance multi-center study for CMS continued through 2017. It is hoped that this study will provide outcomes data that may result in a decision by CMS to expand CI candidacy for Medicare beneficiaries. Nine additional study sites were added in 2017 to boost enrollment, bringing the site total to 19 across the US; one additional site is awaiting IRB approval. A total of 28 subjects had received a CI as part of the study by December 2017, up from 18 at the end of 2016. Patient outcomes are demonstrating important improvement for this population that is equivalent to the under 65 population, though the numbers of enrolled study patients remains lower than expected.
ACI Alliance Study of Medicare Candidacy Expands
Ten sites were initially included in the Evaluation of Revised Indications (ERID) for Cochlear Implant Candidacy for the Adult CMS study. Recently, we asked Medicare to approve expansion of the study to include 10 additional sites as it was believed this would increase access to the study for potential recipients. Medicare approved this request, bringing the total number of sites to 20. New sites were selected based on geographical location access to potential subjects based on the number of Medicare recipients implanted last year at the clinic site, and clinical trial experience. The 20 study sites are below.
Evaluation of Revised Indications (ERID) for
Cochlear Implant Candidacy for the Adult CMS
ClinicalTrials.gov Number: NCT02075229
ACI Alliance is accepting applications for Cochlear Implant Centers to be added to the ongoing Centers for Medicare and Medicaid Services (CMS) Coverage with Evidence Development (CED) study titled “A Proposal to Evaluate Revised Indications for Cochlear Implant Candidacy for the Adult CMS Population”. Potentially, the results of this trial may provide sufficient evidence of clinical utility that a future National Coverage Determination (NCD) on this topic will provide for the expansion of the current coverage of cochlear implantation.
Candidates for the study must meet the following criteria:
- Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids, as defined by a score that falls between 40 and 60% correct on AzBio sentences in their best aided condition when stimuli are presented in quiet at a level of 60 dB A;
- Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation;
- Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system;
- No contraindications to surgery; and
- The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling.
Participating CI Centers’ responsibilities include:
- Obtainment of site-specific IRB approval for participation in the study.
- Self-designation as a study sponsor, meaning financial assistance is not provided for IRB-related expenses.
- Data collection and submission of findings to the data coordination center (via fax or email). Test intervals include preoperatively and 6 and 12 months post-operatively. It is estimated that approximately 30 -60 minutes of additional time will be required at each of these appointments if a subject is enrolled in the study.
What expenses will be covered?
- Payment for the device and costs related to surgery are reimbursed at the local Medicare rate. Billing for surgery will require use of a modifier to indicate the patient has been enrolled in a Medicare CED.
- Payment for audiological services (pre-operative testing and post-operative programming and evaluation) are billed using standard CPT codes. Such billing covers all of the time spent with the patient (i.e., CPT 92626, Evaluation of Auditory Rehabilitation Status should include all of the time spent with the patient to perform necessary testing at the pre, 6 and 12 month intervals).
Additional information regarding CED studies, in general, may be found here:
Thank you for your interest. Please contact Terry Zwolan Ph.D. (firstname.lastname@example.org), Craig Buchman M.D. (BuchmanC@ent.wustl.edu), or Donna Sorkin (DSorkin@acialliance.org) if you have questions. For previously published content on this topic, view the article below.
Applications to participate as a study site were due by October 10, 2016.
Medicare Expansion Study
Study Underway to Examine Expansion of Medicare Criteria for Cochlear Implants in Adults Age 65 and Older
By Donna Sorkin and Teresa Zwolan
At present, candidacy criteria for cochlear implantation followed by the Centers for Medicare and Medicaid Services (CMS) are more stringent than the FDA guidelines typically followed by most health insurance plans. As a consequence, many older adults do not have access to the benefits of cochlear implants (CI) that could help them remain active, engaged and healthy.
The American Cochlear Implant Alliance is conducting a CMS-approved study to evaluate expansion of CI candidacy to include adults with better pre-operative speech recognition skills, bringing CMS criteria more in line with those of the FDA and traditional insurers. Ten CI centers across the country are taking part in this study. Although study participants must have the surgery and specific follow-up appointments at one of the ten study sites, some follow-up may occur at centers closer to the study participant’s home, and patients may transfer to a CI center closer to their home after the first year.
If you are of Medicare age, using hearing aids, and still having difficulty hearing, or if you have been evaluated and told that you have too much hearing for a cochlear implant under Medicare’s more stringent criteria, we encourage you to learn more about this study. Research has found that CI recipients who had more residual hearing and shorter periods of deafness at the time of cochlear implantation tend to have better outcomes.
For More Information
For additional information and to check on your eligibility to receive a cochlear implant as part of the study, please contact Donna Sorkin, email@example.com or visit https://clinicaltrials.gov/ct2/show/NCT02075229.
Overview Information on this study can also be found in past issues of the ACI Alliance e-magazine, which can be accessed freely in the Member Center area of the website:
August 2013 Issue
February 2014 Issue
February 2015 Issue
July 2015 Issue
March 2016 Issue
Cochlear Implant Center Study Sites
Johns Hopkins, New York University, University of Iowa, University of Miami, University of Michigan, University of North Carolina, University of Southern California, Vanderbilt, University of Washington (Seattle), Washington University (St. Louis)
Zwolan T, Henion K, Segel P, Runge C. The role of age on cochlear implant performance, use, and health utility: a multicenter clinical trial. Otol Neurotol, 2014 Oct;35(9).
Clark JH, Yeagle J, Arbaje AI, Lin FR, Niparko JK, Francis HW Cochlear implant rehabilitation in older adults: literature review and proposal for a conceptual framework. J Am Geriatr Soc. 2012 Oct;60(10):1936-45.
Green K, et al. Predictors of audiological performance following cochlear implantation in adults, Cochlear Implants International, 2007.
Agency for Healthcare Research and Quality. Technology Assessment: Effect of cochlear implants in adults with sensorineural hearing loss. 2011. http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id80TA.pdf
Reprinted with permission from Hearing Loss Association of America. This content appeared in Hearing Loss magazine, March/April 2015.