Editor's note: We're pleased to present a special section on candidacy criteria updates and economic considerations for cochlear implantation.
In recent years, numerous studies touting the benefits of cochlear implant (CI) in non-traditional populations have emerged in the literature. The benefits of short electrode arrays in patients with profound high-frequency hearing loss and word understanding of <60 percent in the ear to be implanted and up to 80 percent in the contralateral ear are well documented.1 Individuals who exceed FDA-approved candidacy on sentence materials but struggle with individual words are sometimes implanted off-label with positive outcomes.2 Patients with asymmetric hearing loss (AHL) or even single-sided deafness (SSD), where only one ear meets the traditional FDA-approved candidacy criteria of ≤50 percent sentence understanding in the ear to be implanted, have been shown to derive substantial benefit from CIs,3,4 and the FDA has recently approved this new indication. Better understanding of the factors that improve outcomes (e.g., residual hearing, shorter duration of severe-to-profound hearing loss, and consistent use of appropriate amplification) has prioritized the emphasis on early intervention. Increasing access to CI for those who are most likely to demonstrate the greatest benefit is a primary focus of implant programs, CI manufacturers, and advocacy groups.
Despite these advances, Medicare beneficiaries remain firmly entrenched amid unyielding barriers to access. While the candidacy criteria for most patient populations continue to expand, buoyed by strong clinical data underscoring the benefits of CI for speech recognition and quality of life even in older adults,5 virtually no progress has been made for Medicare beneficiaries since 2005.
ILLUSTRATING THE DISPARITY
Consider the following scenario: An adult patient presents with a 25-year history of progressive bilateral sensorineural hearing loss (SNHL) that has reached a moderate-to-profound degree with fair unaided word recognition ability. He has consistently used appropriate hearing aids, but finds it increasingly challenging to converse in a crowded room or in a group. He has begun to withdraw from social events that he usually enjoys because it's simply too exhausting and frustrating to hear in those settings. He utilizes assistive devices, such as a remote microphone and a captioned phone, but feels limited by his hearing and is interested in options other than hearing aids.
During a CI evaluation, it is determined that he meets the FDA criteria for CI (Table 1) using AzBio Sentence materials presented in quiet. Further consideration of his results highlights that in the absence of context (i.e., CNC Words) his understanding decreases, which may support his claims of significant listening effort and fatigue. It is also clear that his ability to understand in noise is somewhat poorer than in quiet.
Most CI clinicians would recognize this patient as a classic CI candidate. However, the final consideration must be his primary health insurance. If this patient has a commercial payer or even a Medicare Advantage plan, his providers could submit his case to the payer for pre-authorization and reasonably expect approval. But for patients with Medicare Part B, unless they have the financial means to pay out of pocket for the CI, the appointment would conclude with the disappointing recommendation to continue wearing hearing aids because the speech recognition scores do not align with Medicare's coverage guidelines.
The disparity highlighted by this hypothetical case is not unusual, and most CI providers have likely experienced the challenge of counseling patients who are struggling significantly and would likely benefit from CI but do not meet Medicare's coverage policy.
In a recent review of our large academic medical center's CI program (excluding patients with SSD), we found that although a majority (Fig. 1) of those who underwent a CI evaluation over a limited time frame were Medicare beneficiaries, this group demonstrated the lowest “hit rate” for CI candidacy (Fig. 2). In other words, although Medicare beneficiaries in this sample were the largest group perceiving enough difficulty to be evaluated for a CI, they were the least likely to have access to one, mostly due to Medicare's restrictive criteria.
UNDERSTANDING MEDICARE NUANCES
Medicare is the federal health insurance program created in 1965 for people ages 65 and over, regardless of income, medical history, or health status, and for people under age 65 with a long-term disability. It consists of four parts: A-inpatient services; B-outpatient services; C-Medicare Advantage, which includes coverage of Part A, B, and sometimes D benefits by a private health insurance company; and D-outpatient prescription drugs.
Medicare is a defined benefit program, which means that a device must fall within a specific benefit category as a prerequisite for Medicare coverage. In October 1986,6 the Centers for Medicare and Medicaid Services (CMS) first approved coverage of CI for adult Medicare beneficiaries within the benefit category of prosthetic devices under section 1861(s)(8) of the Social Security Act. In 2005, they revised the National Coverage Determination (NCD)6,7 with guidelines that remain in effect today:
The evidence is adequate to conclude that cochlear implantation is reasonable and necessary for treatment of bilateral pre- or post-linguistic sensorineural moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification. Limited benefit from amplification is defined by test scores of ≤40 percent correct in the best-aided listening condition on tape-recorded tests of open-set sentence cognition.
Furthermore, the candidate must demonstrate the following: cognitive ability to use auditory clues and willingness to undergo an extended program of rehabilitation, freedom from middle ear infection, an accessible cochlear lumen that is structurally suited for implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system, and no contraindications to surgery. The device must be used in accordance with FDA-approved labeling.
The evidence is sufficient to conclude that a CI is reasonable and necessary for individuals with hearing test scores of >40 and ≤60 percent only when the provider is participating and patients are enrolled in either an FDA-approved category B IDE clinical trial, a trial under the CMS Clinical Trial Policy, or a prospective controlled comparative trial approved by CMS as consistent with the evidentiary requirements for National Coverage Analyses and meet specific quality standards.
Medicare requires providers enrolled in its program to adhere to the prescribed coverage policy. As such, when a clinical team identifies a potential candidate for CI, there is no pre-authorization process. Rather, the patient is scheduled for surgery, then Medicare is billed and later pays the claim. Deviations from accepted protocols are only retrospectively identified during an audit process. Thus, centers should not interpret payment on a claim as confirmation of approval by CMS.
In the case of Medicare Advantage plans, the Medicare program essentially pays the private health insurance company's premiums at a rate equal to the per-person benefit if they were enrolled directly in Parts A and B. Medicare Advantage plans may cover supplemental benefits not covered by Medicare, such as eyeglasses, dental services, and hearing aids,8 and may determine coverage for CI following their own policies. As such, CI programs may submit cases for individual review and pre-authorization, and do not have to be bound by the restrictive CMS guidelines. Because Medicare Advantage plans may determine how benefits are distributed, as with commercial payers, even off-label cases may sometimes be approved.
ADVOCATING FOR CHANGE
Expansion of candidacy criteria for Part B Medicare beneficiaries is widely advocated by CI providers. Zhang and Coelho9 specifically considered benefit derived from CI by 54 patients >60 years old. Recipients were divided into three groups: (1) those who met CMS criteria (<40%) in quiet for both word and sentence materials, (2) those who met CMS criteria for sentences in noise (+5 SNR), and (3) those who met CMS criteria for sentences in noise (+5 SNR) and CNC Words. The authors found that those patients who qualified using sentences in noise improved by an average of 20 percent in sentence understanding, while those who qualified based on their word understanding improved by an average of 42 percent. They concluded that restrictive CMS criteria exclude numerous patients who could benefit from CI and that the criteria should be updated. Similarly, Mudery, et al.,10 examined the outcomes of 15 patients with sentence understanding of >40 percent in quiet but <40 percent in noise, and concluded that testing in noise is essential to capturing appropriate candidates, and speech understanding for these individuals has significantly improved.
As of December 2018, five clinical trials, for which candidates may be enrolled using scores of up to 60 percent, were registered with the aim to collect sufficient evidence of clinical utility that a future NCD on this topic will provide for the expansion of the current coverage of cochlear implantation.7 While clinicians and patients alike hope that CI access among Medicare beneficiaries will continue to increase, it's also necessary to consider the impact that increasing volumes could have on practices in terms of providing adequate management of patients.
CI services tend to be more frequently provided by CI centers based in hospitals as opposed to independent practices, but this model is evolving. From appropriate identification of candidates to provision of surgical intervention and post-operative programming services, increasing volumes have the potential to introduce significant strain on programs that are not always self-sufficient—unless the economic impact of serving Medicare beneficiaries is proactively considered. Managing a fiscally responsible CI program depends on reasonable contracted pricing, strategic appointment scheduling and clinical protocols, and minimizing non-billable hours.
In most traditional service delivery models, significant unbillable hours are absorbed by highly trained audiologists, sometimes adding up to multiple weeks per year in larger CI programs. Having more Medicare beneficiaries qualify for CI may further call for a reconsideration of traditional service delivery models and a renewed advocacy for more appropriate coding options and adequate reimbursement to improve service efficiency and access while incentivizing providers to offer programming services.
COST CONTAINMENT IN MEDICARE
The Medicare program will also be considering the economic impact of expanding CI services. Medicare reimbursed a total of 69 cochlear implants in the fiscal year 1987, the first year after CI was added to a defined benefit category.11 By 2016, Medicare received claims for approximately 3,600 CIs (52 times more than 30 years prior). In the last decade alone, the number of CI procedures increased by 124.6 percent.12
Today, nearly 60 million people are enrolled Medicare beneficiaries (approximately two-thirds traditional Medicare and one-third Medicare Advantage).13 According to the World Health Organization, approximately one-third of adults over the age of 65 are affected by disabling hearing loss (defined as hearing loss of >40 dB in the better ear).14 One could extrapolate these data to conclude that there may be up to 20 million Medicare beneficiaries with disabling hearing loss, including approximately 13 million under the traditional Medicare program. It is unclear how many of these individuals have moderate sloping to profound hearing loss and may be experiencing limited benefit from hearing aids, but some of these beneficiaries can be expected to be CI candidates.
Given that Medicare covers 3,600 CIs per year12 and approximately 10 percent of CI candidates have a CI,15 we could reasonably expect that at least 36,000 Medicare beneficiaries could benefit from CI per year using conservative (FDA labeling) candidacy criteria, which would hypothetically lead to over $1 billion in charges to the Medicare program if full utilization were achieved.
In 2017, Medicare spending accounted for 15 percent of total federal spending and 20 percent of total health care spending.8 As the population ages, the number of enrolled beneficiaries is expected to grow exponentially (Fig. 3). Between 2010 and 2050, the 65-plus population is expected to double from about 40 million to 84 million people.16 As a result, legislators are constantly reconsidering how to contain costs in a program that is expected to incur increasingly higher expenses. Between 2010 and 2015, the overall program spending growth rate fell from 9.0 percent to 4.4 percent, even as the baby boomer generation started aging into Medicare in 2011. Spending increases per beneficiary similarly declined, averaging 1.4 percent down from 7.4 percent.16 It is important to note that if the program is succeeding in cutting costs, it is likely due at least in part to reduction of Medicare payments to providers (Table 2) or restrictions on provided services.
CONSIDERATIONS FOR ADVOCACY
Clearly, Medicare reimbursement for CI is not as lucrative as commercial payers. Just as CMS is under strain to manage its budget, health care administrators are similarly challenged to maintain positive margins. Thus, procedures that fail to cover incurred costs are viewed less favorably. It is critically important to recognize that increased access to CI for Medicare beneficiaries will come not only from expanded candidacy criteria but also from reimbursement commensurate with the cost of providing the service and realigning service delivery to maximize efficiency. While expanding candidacy is justifiable from a comparative clinical effectiveness standpoint and providing best possible outcomes is ethically and morally defensible, advocacy for CMS coverage of CI cannot only focus on clinical criteria but must also demand commensurate reimbursement to ensure that providing the technology is viable for clinicians.
A 1989 report in the New England Journal of Medicine11 offered two principal explanations for the failure of CIs to be used more widely: “The first is that clinicians rejected implantation on the grounds that the outcomes remained uncertain and the method of selecting patients problematic; [the second] points to a much stronger financial disincentive—one that discouraged most hospitals from establishing a service of cochlear implantation and encouraged hospitals that did offer such a service to ration the availability of the device to elderly patients.”
The concerns during the early days of cochlear implantation are not so different from the issues we face today. First, advocacy surrounding the issue of CI candidacy for Medicare beneficiaries must be addressed, and candidacy ought to be expanded to eliminate the disparity in access compared with non-Medicare patients. And second, which is just as important, consideration must be given to the financial implications of such expansion on the Medicare program as well as on the CI centers that must be compelled to offer these services. Advocacy efforts must not exclude consideration of appropriate reimbursement for CI services, otherwise access will continue to be unnecessarily limited.
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