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September 30, 2015

Submitted electronically via: FFEcomments@cms.hhs.gov

To: Center for Consumer Information and Insurance Oversight (CCIIO)

RE: 2017 Essential Health Benefits (EHB) Benchmark Plans for All 50 States and DC


Dear CCIIO Official and State Insurance Commissioner:

     The American Cochlear Implant Alliance (ACI Alliance) appreciates the opportunity to provide comments regarding the Essential Health Benefits (EHB) benchmark plan pursuant to Section 1302 of the Patient Protection and Affordable Care Act (ACA). The ACI Alliance is a non-profit organization of clinicians, scientists, and educators who work in the field of cochlear implantation, as well as parent and consumer advocates. Our mission is to advance the gift of hearing provided by cochlear implantation through research, advocacy and awareness. We offer comments on the coverage issues involving the statutory EHB category of “rehabilitative and habilitative services and devices,” with an emphasis on coverage for cochlear implantation and intensive post-implantation therapy.

Cochlear implant devices and related services (the “CI” benefit) are critical for adults and children who have severe to profound hearing impairments. A cochlear implant is an electronic medical device designed to restore the ability to perceive sounds and understand speech by individuals with severe to profound hearing loss. Cochlear implants bypass damaged cells in the cochlea and stimulate the remaining nerve fibers directly through the application of electrical current.

While hearing aids help the majority of individuals with hearing loss, even the most advanced hearing aids cannot overcome the hearing difficulties associated with cases of severe to profound hearing impairment. Cochlear implantation is a low incidence intervention; the total number of cochlear implant recipients in the United States in 2009 was estimated at 70,000 children and adults.1

There are stringent standards for who may receive a cochlear implant. Determination of candidacy is made by a team including an otolaryngologist and audiologist specializing in cochlear implantation. Testing for candidacy is completed in “best aided condition,” meaning the patient must be unable to receive sufficient meaningful sound when wearing well-fit and appropriate hearing aids. Therefore, there is no meaningful alternative to CI.

Cochlear implants are covered by over 90% of commercial health plans because the CI benefit is life-changing and cost effective. Typical coverage includes evaluation, surgery, the CI device itself, programming, and habilitation/rehabilitation needed to optimize outcomes with the intervention.

Cochlear implants, coupled with intensive post-implantation therapy, can help young children to acquire speech, language, and literacy skills. Many deaf children who receive cochlear implants are able to attend mainstream schools and perform academically on par with their peer. The CI benefit enables adults who have congenital or acquired severe-to-profound hearing loss to remain self-sufficient and in the workforce. For young adults, the cochlear implant can provide decades of benefit for those seeking to advance their careers or employment options. Seminal research demonstrated that the cost savings to society when a young child receives a cochlear implant exceeds $1 million.2 Cost effectiveness of CI has also been confirmed in adults of all ages.3

ACA Requirements Applicable to All State EHB Benchmark Plans

The ACI Alliance recognizes the need for state benchmark plans to clarify the definition of the habilitation and rehabilitation services and devices EHB, as well as to provide coverage of this EHB category in accordance with federal regulations. Given that appropriate and adequate coverage of the CI benefit could make a critical difference to the lives of individual Americans with severe to profound hearing impairment; the ACI Alliance recommends the following coverage be included in benchmark plans for all 50 states and DC.

Cochlear implantation and intensive post-implantation therapy is covered by the “typical employer plan,” the standard for coverage in the Affordable Care Act. Similarly, coverage of cochlear implants and intensive therapy post-implantation, under the category of habilitative and rehabilitative services and devices, should be clearly defined as a benefit within the benchmark plans of all 50 states and DC, as well as all qualified health plan offered through the marketplace exchange(s).

     • Explicitly include coverage of rehabilitative and habilitative services and devices, as required by federal regulations. In establishing the 2017 benchmark health plans, all states must explicitly adopt a rehabilitative and habilitative benefit that complies with the newly-issued federal regulations for this benefit category under the ACA. By recognizing these regulations, every state will be clarifying coverage of this benefit category consistent with the Centers for Medicare and Medicaid Services’ (CMS’) February 27, 2015 final rule (The Rule).4  

      • Adopt the Rule’s definition of rehabilitative and habilitative services and devices as the floor for individual and small employer health insurance plans beginning in 2016. This definition is a floor for coverage and includes both services and devices that may be required to meet this standard. The services and devices covered by the rehabilitation and habilitation benefit should not be limited to certain specific therapies but include a wide array of rehabilitation therapies and devices. These services should be provided based on the individual’s needs, prescribed in consultation with a clinician, and based on the assessment of an interdisciplinary team and resulting care plan.

     • Cover habilitation and rehabilitation by permitting flexibility in benefit design to accommodate those who need additional therapy to achieve medically necessary, therapeutic goals. The benefit should have allowances for extra contracted services and include access to various therapy types;

     • Cover habilitation in a way that allows separate and distinct visit limits from other EHBs. Habilitation visit limits must be based upon medical need and not set at a standardized number (i.e., a child who is deaf and who, through the use of CI, is learning to hear and speak for the first time would need a certain level of habilitation services, as opposed to the adult who regains hearing and will need a different intensity of rehabilitation services than the child). 5 As part of early prevention, at a minimum, habilitation should be made available to children less than three years old with no caps on therapy;

     • Prohibit unreasonable and arbitrary visit and dollar limits on a specific category of benefits resulting in a condition-based exclusion or condition-based limits. Caps on coverage can easily serve as de-facto annual monetary caps on coverage, which violate ACA requirements. In the event that states impose coverage caps based on visit or service limits, the caps should not be arbitrary, but rather, should be grounded in medical necessity and based on clinical and medical evidence. Further, EHB plans that do not include an exceptions process for patients with greater-than-average needs violates the ACA’s plan design requirements that prohibit discrimination based on disability. All EHB plans should, therefore, have an exceptions process in place if they decide to establish arbitrary caps in benefits.

     • Prohibit arbitrary limits on devices which prevent a patient from receiving the accepted and recognized standard of care appropriate for that benefit. For example, limiting a device benefit to one device per year would prevent a child with profound hearing impairment from receiving bilateral cochlear implants, which are now the standard of care for children with profound hearing loss to allow them to develop language that is as close as possible to that of their typically hearing peers. Furthermore, health plans should not set condition-specific medical device exclusions;

     • Cover device maintenance, including replacement batteries and long-term maintenance of external devices even after a device warrantee runs out. With regard to CI, the replacement of processors is a prime example of the need for the coverage of device maintenance;

      • Prohibit discrimination based on an individual’s age, expected length of life, present or predicted disability, degree of medical dependency, quality of life, or other health conditions, such as designing a benefit to exclude services for adults or children who are deaf or hard of hearing. These nondiscrimination protections are included in the ACA statute at Sections 1302 and Section 1557 and form the basis for plan benefit design that is equitable and meets the needs of diverse populations.

     • Prohibit the use of cost-sharing requirements or utilization management techniques that are more restrictive on habilitation and rehabilitation services and devices than they are on all other EHB benefits.

State Specific Examples of Problematic Benchmark Coverage of Cochlear Implantation and Therapy Post Surgery

     • The Virginia 2017 EHB benchmark plan and Ohio 2017 EHB benchmark plan include coverage cochlear implants, but no mention of audiology as an eligible provider for habilitation and/or rehabilitation (i.e., the device is covered but not aural rehabilitation to learn how to function with the device).
This type of incomplete coverage is problematic. Aural rehabilitation in connection with cochlear implantation is a critical service necessary to effectuate the proper functioning of and adaptation to the device. Aural rehabilitation to an individual with cochlear implantation is no different than physical therapy for an individual with a hip replacement. The ACA statute and regulations establishes explicit coverage for rehabilitation and habilitation services and devices and, therefore, aural rehabilitation must be covered under the 2017 EHB packages in Virginia, Ohio, and any other state that seeks to restrict coverage of these services.

     • In Iowa for coverage year 2015 a health care insurance plan by Coventry is offered through the marketplace exchange that only covers cochlear implantation in terms of the “prosthetic device.” The plan does not provide coverage of the implantation surgery and does not provide coverage of the subsequent clinical follow-up needed during aftercare including audiology and speech language pathology. In order to correct this 2015 coverage policy concern going forward, we request that included in the Iowa 2017 EHB benchmark plan, is explicit coverage of cochlear implantation in terms of not only the prosthetic device, but also the implantation surgery, and subsequent clinical follow-up needed during aftercare including audiology and speech language pathology.

     •The Georgia 2017 EHB benchmark plan, explicitly mentions coverage for cochlear implantation; however, candidate criteria as outlined in benchmark plan is likely to adversely impact children in need of cochlear implantation and associated therapy post surgery.6 The candidate criteria included in the Georgia 2017 EHB benchmark plan is not in line with current FDA recipient criteria and this is of concern. The FDA guidelines for children have evolved significantly since FDA expanded the indication in the 1990s. Indications for implantation include both pure tone averages (generally severe to profound hearing loss) and failure of progression of language skills. There are children who would not meet the requirements of the state’s 2017 benchmark plan if restricted only to profoundly deaf individuals. The plan coverage is 15 years behind best practice. There are very few examples of plans using the profound criteria for children up to 17 years of age. We respectfully request that the Georgia EHB benchmark plan adopt the current FDA criteria established in 2000.

The cost of late implantation is significant, both at the individual and the societal level. Numerous studies have demonstrated that late cochlear implantation in pre-lingually deafened children (after age 4 years) results in poorer speech and language skills than those implanted by age 2 years. The language centers in the developing brain must receive auditory input (acoustic or electric) early in development to allow for development of spoken language. The societal direct and indirect costs have been estimated at $1.2M per pre-lingually deaf child.

A motivated family who wishes to pursue cochlear implantation for their child who is failing to develop language normally due to hearing loss should have the opportunity to do so. The EBH 2017 plan would result in a cohort of children who fail to receive the auditory stimulation early enough to develop spoken language because their hearing loss “wasn’t severe enough” despite failure to progress developmentally.

The EHB 2017 plan also fails to recognize that hearing is not just the ability to detect tones but also understanding what is said. Consequently, there is an older group of children that would also be excluded from implantation based on the EHB 2017 plans restriction to profound loss only. Children between 2 and 17 years 11 months can participate in spoken language testing. In the best aided condition, children with moderate to profound loss and word understanding scores of less than 30% or lack of progress in development of auditory/speech skills should be considered for implantation.

With regard to adults, the EHB 2017 plan provides coverage for implantation only for severe to profound sensorineural hearing loss. The current FDA criteria also include criteria for word understanding scores. These scores are determined on sentence testing in the best aided condition and allow implantation for ≤50% in the ear to be implanted and ≤60% in the contralateral ear. These speech scores have changed dramatically since cochlear implants were first introduced and reflect our understanding of the impact of the technology in patients’ lives.

FDA Cochlear Implant Candidate Criteria

The FDA cochlear implant candidacy criteria for children was updated in 2000 to cover patients 25 months to 17 years 11 months with severe to profound hearing loss. The criteria are listed below as well as chart summarizing the historical changes. The expansion in 2000 to include children older than 24 months with severe to profound hearing loss was made because of the extensive literature demonstrating that waiting until the child is over age 17 results in much poorer outcomes because of brain plasticity. There is a window for developing language, both listening and speaking, for children with hearing loss. If that window is missed, it is extremely difficult for a child to progress. If the child has a severe to profound hearing loss, (s)he is unlikely to be able to hear all of the parts of spoken language—even with the most powerful hearing aids.

Providing auditory access at an early age is cost effective over the long term. Providing cochlear implants at the age allowed by FDA provides a means to restore hearing. When combined with an appropriate habilitation program, children are generally able to attend mainstream schools and most develop reading skills that are equivalent or close to those of their typically hearing peers.

12-24 Months
Profound SNHL (sensorineural hearing loss) bilaterally
Lack of progress in the development of auditory skills
No medical contraindications
High motivation and appropriate expectations from family

25 months to 17 years 11 months
Severe to profound (sensorineural hearing loss) bilaterally
MLNT scores of 30% or less in best-aided condition (children 25 months to 4 years 11 months)
LNT scores of 30% or less in best-aided condition (children 5 years to 17 years 11 months)
Lack of progress in the development of auditory skills
No medical contraindications
High motivation and appropriate expectations (both child when appropriate and family) 

The ACI Alliance appreciates the opportunity to provide comments on this important topic. Should you have further questions regarding this information, please visit www.ACIAlliance.org or contact Donna Sorkin, Executive Director via email at: DSorkin@acialliance.org.

Thank you for your consideration of our comments.

Sincerely,

Donna Sorkin
Executive Director
American Cochlear Implant Alliance

 

1 iData Research Inc., US Market for Hearing Aids and Audiology Devices, 2010.
2 Cheng et al. Cost-utility of the cochlear implant in children, JAMA 2000 Aug;204(7):851-6.
3 Francis HW. Impact of cochlear implants on the functional health of older adults, Larynoscope 2002 (Aug; 112(8Pt1):1482-8.
4 Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016 – Final Rule, 80 Fed. Reg. 10811, 10871 (February 27, 2015). Available at: http://www.gpo.gov/fdsys/pkg/FR-2015-02- 27/pdf/2015-03751.pdf. 
5 The amount and duration of therapy required will vary depending upon the age of the individual receiving the cochlear implant, the individual’s amount of residual hearing at the time of the implant, the individual’s ear anatomy, and other complicating health factors such as cognitive impairment, blindness, or Cerebral Palsy, to name a few conditions that are known to occur with deafness. Clinicians must have the ability to set the amount of benefit provided; arbitrary limits set by the plan could prohibit the individual from receiving meaningful benefit from the intervention, and could severely limit the cost-effectiveness of the intervention.
6 Per the Georgia 2017 EHB benchmark plan, Certificate of Coverage Humana Employers Health Plan of Georgia, pages 50-51: Additional covered expenses, we will pay benefits for covered expenses incurred by you based upon the location of the services and the type of provider for: Cochlear implants, when approved by us, for a covered person: - 18 years of age or older with bilateral severe to profound sensorineural deafness; or - 12 months through 17 years of age with profound bilateral sensorineural deafness. Replacement or upgrade of a cochlear implant and its external components may be a covered expense if: - The existing device malfunctions and cannot be repaired; - Replacement is due to a change in the covered person's condition that makes the present device non-functional; or - The replacement or upgrade is not for cosmetic purposes.


 

September 30, 2015

Submitted electronically via: FFEcomments@cms.hhs.gov

To: Center for Consumer Information and Insurance Oversight (CCIIO)
RE: Georgia’s 2017 Essential Health Benefits (EHB) Benchmark Health Plan


Dear CCIIO Official and State Insurance Commissioner:

      Thank you for the opportunity to comment on Georgia’s 2017 Essential Health
Benefits (EHB) benchmark plan of the Patient Protection and Affordable Care Act (ACA).
I would like to offer comments on the coverage issues involving the EHB category of
“rehabilitative and habilitative services and devices,” with an emphasis on coverage for
cochlear implantation and associated therapy post implantation.

 I. ACA Requirements Applicable to All State EHB Benchmark Plans

In establishing the 2017 benchmark health plans, all states must explicitly adopt a
rehabilitative and habilitative benefit that complies with the newly-issued federal
regulations for this benefit category under the ACA. By recognizing these regulations,
every state will be clarifying coverage of this benefit category consistent with the
Centers for Medicare and Medicaid Services’ (CMS’) February 27, 2015 final rule (The
Rule).1

Specifically, under this federal regulation, every state’s EHB plan must:
     • Explicitly include coverage of rehabilitative and habilitative devices, as required by
federal regulations.

     • Adopt the Rule’s definition of rehabilitative and habilitative services and devices as
the floor for individual and small employer health insurance plans beginning in 2016.
This definition is a floor for coverage and includes both services and devices that may
be required to meet this standard. The services and devices covered by the
rehabilitation and habilitation benefit should not be limited to certain specific therapies
but include a wide array of rehabilitation therapies and devices. These
services should be provided based on the individual’s needs, prescribed in
consultation with a clinician, and based on the assessment of an interdisciplinary team
and resulting care plan.

     • The EBH plan should not impose arbitrary caps on coverage. Caps on coverage can
easily serve as de-facto annual monetary caps on coverage, which violate ACA
requirements. In the event that states impose coverage caps based on visit or service
limits, the caps should not be arbitrary, but rather, should be grounded in medical
necessity and based on clinical and medical evidence. Further, EHB plans that do not
include an exceptions process for patients with greater-than-average needs violates
the ACA’s plan design requirements that prohibit discrimination based on disability.
All EHB plans should, therefore, have an exceptions process in place if they decide to
establish arbitrary caps in benefits.

     • Not discriminate based on an individual’s age, expected length of life, present or
predicted disability, degree of medical dependency, quality of life, or other health
conditions. These nondiscrimination protections are included in the ACA statute at
Sections 1302 and Section 1557 and form the basis for plan benefit design that is
equitable and meets the needs of diverse populations.

     II. Coverage of Cochlear Implantation and Therapy Post Surgery

     I applaud the explicit mention of coverage for cochlear implantation in the
Georgia 2017 EHB benchmark plan. However, the candidate criteria as outlined in 2017
EHB benchmark plan is likely to adversely impact children and adults in need of
cochlear implantation and associated therapy post surgery. The candidate criteria
included in the EHB plan is not in line with current FDA recipient criteria and this is of
concern.

     The FDA guidelines for children have evolved significantly since FDA expanded
the indication in the 1990s. Indications for implantation include both pure tone
averages (generally severe to profound hearing loss) AND failure of progression of
language skills. There are children who would not meet the requirements of the EHB
2017 plan if restricted only to profoundly deaf individuals.

     The cost of late implantation is significant, both at the individual and the societal
level. Numerous studies have demonstrated that late cochlear implantation in prelingually
deafened children (after age 4 years) results in poorer speech and language
skills than those implanted by age 2 years. The language centers in the developing brain
must receive auditory input (acoustic or electric) early in development to allow for
development of spoken language. The societal direct and indirects costs have been
estimated at $1.2M per pre-lingually deaf child.

     Any motivated family who wishes to pursue cochlear implantation for their child
who is failing to develop language normally due to hearing loss should have the
opportunity to do so. The EBH 2017 plan would result in a cohort of children who fail to
receive the auditory stimulation early enough to develop spoken language because their
hearing loss “wasn’t severe enough” despite failure to progress developmentally.
The EHB 2017 plan also fails to recognize that hearing is not just the ability to
detect tones but also understanding what is said. Consequently, there is an older group
of children that would also be excluded from implantation based on the EHB 2017
plan’s restriction to profound loss only. Children between 2 and 17 years 11 months can
participate in spoken language testing. In the best aided condition, children with
moderate to profound loss and word understanding scores of less than 30% or lack of
progress in development of auditory/speech skills should be considered for
implantation.

      With regard to adults, the EHB 2017 plan provides coverage for implantation
only for severe to profound sensorineural hearing loss. The current FDA criteria also
include criteria for word understanding scores. These scores are determined on
sentence testing in the best aided condition and allow implantation for ≤50% in the ear
to be implanted and ≤60% in the contralateral ear. These speech scores have changed
dramatically since cochlear implants were first introduced and reflect our
understanding of the impact of the technology in patients’ lives.

     As the neurotologist at the state’s medical college and director of the cochlear
implant program for the Medical College, I strongly encourage you to expand the
criteria for cochlear implant coverage and (re)habilitative services in the EHB 2017.
Should you have any questions please feel free to contact me directly at smowry@GRU.edu
or via telephone at (706) 721-6100.

Sincerely,

Sarah Mowry, MD
Assistant Professor
Department of Otolaryngology
Director of the Hearing and Balance Center
Georgia Regents University/Augusta University

1. Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016 – Final
Rule
, 80 Fed. Reg. 10811, 10871 (February 27, 2015). Available at: http://www.gpo.gov/fdsys/pkg/FR-2015-
02-27/pdf/2015-03751.pdf.

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