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by Cochlear Guest Author

A letter from Tony Manna, President of Cochlear Americas

March 17, 2020
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Dear Clinical Partner,

As the situation with coronavirus (COVID-19) continues to evolve, I would like to update you on what Cochlear is doing to care for recipients and to ensure the safety and well-being of all our customers and employees.  

Promoting health for everyone is our priority

Like many of your institutions, I have asked our team to temporarily restrict travel to the support of necessary patient care activities only. Our Denver office and warehouse remain open and our staff is equipped and working remotely as needed. We anticipate that these measures will avoid any service interruptions to you or your patients while simultaneously protecting the health of our team and the local community.

We are here to support you

Understandably, to ensure a safe environment for patients, many hospitals have limited visitor access including manufacturer reps. In cases where you need support from Cochlear, we are introducing new remote options for virtual OR and Clinic Support. Please contact your local Cochlear Clinical or Surgical representative to set up as needed. Many of you were also scheduled to attend an upcoming Osia® System training workshop. We are in the process of converting these workshops to virtual format. Your local Cochlear representative will share the details with you once available.  

We are here to support our recipients

We recognize that many of our recipients are among those most vulnerable to the coronavirus and need to limit potential exposure. Cochlear offers many services online to support them from the safety and convenience of their own homes. These include our recipient portal myCochlear.com, the Cochlear Smart Apps* and new web-based guided support at Cochlear.com. Service requests can be made via phone, chat or online and through Cochlear™ Link we are able to send a programmed processor directly to the recipient to avoid any unnecessary clinic visits. Your local Cochlear representative can provide you further details on each of these programs and tools that can assist you and your patients in getting continued support and services in a remote environment.  

We understand this is a challenging time for everyone. On behalf of everyone at Cochlear, please be safe and let me know if there is anything we can do to help.

Thanks,
Tony
Anthony Manna
President, Cochlear Americas

*The Cochlear Nucleus Smart App and Baha Smart App are available on App Store and Google Play. For compatibility information visit www.cochlear.com/compatibility.

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Cochlear Guest Author

In an effort to keep our content fresh and reflective of a diverse industry, Cochlear Americas features a mix of employees and professional partners to contribute to Cochlear ProNews as Guest Authors.

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calculating at desk

Best Practices – Surgical Approvals, Appeals & Advocacy

June 12, 2019

Reimbursement

By Nicole Craig, Senior Manager of Managed Care and Market Access, Cochlear Americas

Obtaining commercial insurance coverage for implantable hearing solutions can present unfamiliar challenges for your office as this may be a limited portion of your practice.  Although most commercial plans cover cochlear implants (CI) and osseointegrated bone anchored systems (Baha), each plan follows their own medical policies and prior authorization requirements.  In addition, each plan has their own coinsurance, deductibles, and out of pocket maximums based on the member’s benefit coverage.

Luckily, there are some best practices that can be implemented to improve success in navigating the insurance maze. For example, always determine if a prior authorization/precertification is required by the candidate’s health plan for their cochlear implant or osseointegrated bone anchored surgery. If so, obtain that prior authorization/pre-certification in writing where the plan allows. If available it is also a good idea to request a pre-determination.

What is the difference between a prior authorization/ pre-certification and a pre-determination?

A prior authorization (aka pre-certification) is the process to determine if the insurance company finds a service to be medically necessary.  It is mandatory for most plans for CI and Baha procedures, and a lack of prior authorization can result in a denial of coverage and reimbursement. While a prior authorization is never a guarantee of payment or reimbursement for any service, a decision which payers universally reserve the right to make after receiving and reviewing the actual claim details, it does provide some measure of assurance that you have followed the payer’s process and met their requirements.

A pre-determination of benefits is the process to determine that both an individual’s specific benefit coverage and the health plan’s medical necessity criteria is met.  It is a voluntary process, typically performed as a courtesy if available. The pre-determination process helps to avoid misunderstandings about financial liability.

Best practices:

  • When scheduling surgery, allocate enough time to allow for a response from the health plan
    • Prior authorizations typically take 15-30 days for a response from health plan
    • Pre-determinations can take up to 30 days on average
  • If prior authorization is treated as a separate process by the plan, submit the pre-determination first. Benefit coverage always supersedes medical necessity or prior authorization approval when payers evaluate services for reimbursement
  • Submit both surgery and device codes on the authorization or pre-determinationNucleus 7
  • Many plans have the ability to submit approval requests online if you are submitting them on your own
  • Always verify procedural requirements for the approval process with the health plan
  • End of year response times from health plans may be delayed.  Keep this in mind when scheduling patients and setting expectations for patients trying to optimize benefits by the end of the calendar year

What should you do if you get a denial?

When this happens, be sure to initiate the appeal.  The appeal process will vary by health plan but typically the process is outlined in the benefit handbook. As a provider, you can contribute to your patient appeal process by providing your clinical expertise. Providers should request a peer-to-peer review when available and always be sure to appeal to all levels available. Many health plans will offer three levels of appeals. Once you determine the denial reason and understand the appeal options, be sure to provide supporting documentation such as:

  • Clinical history of the patient which should include:
    • Causes of patient hearing loss
    • Length of patient’s hearing loss
    • Severity of hearing loss
    • Specific treatments tried and failed
  • FDA product approval or clearance letter (available by request through Cochlear)
  • Appeal letter to address why technology is beneficial to patient and medically necessary
  • Scientific evidence supporting the use of the technology and its applicability to your clinical recommendations for the patient’s treatment plan

Cochlear has sample appeal letters to help with crafting your appeal response. Be sure to write the letters specific to each patient and health plan denial.  Cochlear also has a variety of clinical articles to support clinical effectiveness of CI and Baha systems and are available when requested.

If an appeal is filed via fax or mail, your medical biller should follow-up within 15 days of filing to ensure that the appeal was received and to verify status.  Always maintain a “paper trail,” collecting reference numbers for every call, appeal document tracking numbers, and documenting all conversations with representatives, ensuring that names and employee ID’s are documented.

In some cases, the patient may be able to speak to their employer about offering coverage for a CI or Baha system. If employer is self-funded, the human resources department may be willing to remove the exclusions of the implantable hearing solutions or make an exception for the patient.

How are health plan medical policies developed?

Health plans develop medical policies to assist with the administration of the health benefits. The policies serve as a guideline for determining whether health services are covered, medically necessary, and fall within the health plan benefit category of covered services. Medical policies are regularly reviewed by the health plan and updated as needed. Health plans have a medical policy review process where they will review new clinical evidence about the clinical effectiveness of a procedure or technology. During the review process providers have the opportunity to review draft polices and provide comments, feedback or pertinent references to assist with the development or updating of medical policies. The volume of exception request and appeals generated through the prior authorization/pre-certification and/or the pre-determination processes can have significant impact on the timing and outcome of payer policy reviews.

How can you help improve coverage for your patients?

  • Let the Health Plan know there is a problem
    • Be sure to submit all cases for approval
    • Go all the way through the appeals process
  • The approval process not only impacts individual access, it can also prompt plans to consider changes in health plan policy, especially when a given plan routinely receives similar requests.
  • Medical policies are regularly reviewed by the health plan and updated as needed. Health plans have a medical policy review process where they will review new clinical evidence about the clinical effectiveness of a procedure or technology.
  • During the review process providers have the opportunity to review draft polices and provide comments, feedback or pertinent references to assist with the development or updating of medical policies.
  • Successful change in policy will make the process easier and less administratively burdensome for all, making services available to more patients.

How can Cochlear help?

Let Cochlear assist your practice with the authorization process.  A division of Cochlear Americas, OMS (Otologic Management Service) is a dedicated team of reimbursement specialists who are available, at no-cost, to help healthcare providers and candidates obtain the necessary insurance approval or to support appeals where coverage has been denied for Cochlear’s Nucleus® Cochlear Implants or Baha® Systems for medically qualified candidates.

As experts in medical insurance advocacy, OMS has an extensive knowledge of health insurance plans. With over 56 years combined industry experience, representatives understand that not all insurance policies are the same. OMS partners with candidates and healthcare providers to provide navigational support of the health insurance maze.

For more information on services provided by OMS, visit our webpage or contact via email at OMS@Cochlear.com.

About our guest author:

Nicole Craig is the Senior Manager of Managed Care and Market Access for Cochlear Americas. She oversees OMS and managed care contracting for Cochlear’s external DME replacement parts and accessories.

© Cochlear Limited 2019. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.
Information provided by Cochlear Americas regarding insurance coverage or reimbursement is provided as guidance only and is not intended as reimbursement or legal advice. Cochlear Americas makes no representation or warranty regarding such information or its completeness, accuracy, fitness for a particular purpose, or that following such guidance will result in any form of coverage or reimbursement from any insurer. Information presented is subject to change at any time. To be sure that you have the most current and applicable information available for your unique circumstances, please consult your own experts and seek your own legal advice regarding your reimbursement needs. In all cases, products or services billed must be medically necessary, actually performed and appropriately documented in the medical record.
pediatric cochlear implant

Cochlear receives FDA approval to lower the age of pediatric cochlear implantation to 9 months

March 19, 2020

Approval underscores necessity of earlier cochlear implantation for better hearing, speech and language outcomes in children born deaf

By Renee Oehlerking, Senior Public Relations Manager – Cochlear Americas

Centennial, Colo. (March 18, 2020) — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval to lower the age of cochlear implantation from 12 months to 9 months for children with bilateral, profound sensorineural hearing loss. This approval ensures children born deaf have earlier access to a cochlear implant which can provide them with the hearing capabilities to develop speech and language at a trajectory similar to their hearing peers.

Cochlear implants have been FDA approved for use in children since 1990 with CochlearTM Nucleus® Implants obtaining the first approval. Decades of research and current surgical and clinical practice underscore the efficacy of earlier implantation to achieve their personal best language and speech outcomes.1-13 The research and support in practice by trained hearing health professionals provided the foundation to approve the indication be lowered to 9 months, along with the considerable developments in technology and evolving speech coding strategies in modern day cochlear implant devices.

“Cochlear implants are one of the most revolutionary and effective modern-day implantable solutions that can restore hearing to children and adults with significant hearing loss,” said J. Thomas Roland Jr., MD, Co-Director, Cochlear Implant Center, and Chair, Department of Otolaryngology – Head and Neck Surgery, NYU Langone Health. “Through our diligent research and years of treating children with hearing loss, we know the earlier a child receives access to sound the sooner they can develop speech and language that will transform their future. It is important that children born deaf have access to cochlear implants as soon as possible to give them the tools to hear and participate in their life to the fullest extent.”

According to the American Academy of Pediatrics, an estimated three in 1,000 infants are born in the U.S. each year with moderate, severe or profound hearing loss.14 Additionally, hearing loss is the most common congenital condition in the U.S.14 Hearing loss has a major impact on a child’s life, including speech and language development, literacy, mental health, social and cognitive functioning, educational achievement, employment and socio-economic opportunity.3 Research shows that children with a severe-to-profound hearing loss who receive cochlear implants early achieve better speech recognition than children who continue to use hearing aids, underscoring the importance to not delay access to cochlear implants because doing so can have lingering developmental consequences.3,4

“Earlier implantation ultimately provides children with access to critical auditory input that has been proven to enhance their development of speech and language,” said Christine Menapace, MA, Vice President, Clinical Affairs, Cochlear Americas. “We hope this approval changes the pathway and access to care for families who desire cochlear implantation so full advantage can be taken of the critical period of language development in a young child.”

While many early intervention factors contribute to a child succeeding with a cochlear implant, cochlear implants provide improved: auditory awareness of sounds at levels within the normal range of hearing15; speech understanding, sound clarity and language skills15; hearing in noise16; quality of life16; and educational outcomes.17 Up to 80 percent of children who received cochlear implants younger than 12 months of age demonstrate receptive vocabulary knowledge within the normal range by school entry, and 81 percent of children who receive cochlear implants early attend mainstream schools.13,18

“When we got the news that our daughter failed her newborn hearing screening and was diagnosed with profound hearing loss at birth, it gutted us. We had never met a deaf person before our daughter and did not know what life would look like raising a child with hearing loss,” said Christy Keane, mother to Nucleus Cochlear Implant recipient, Charly, and social media influencer focused on motherhood and children with hearing loss. “Thankfully, we had an amazing care team who helped us understand all of the possibilities on this journey, and we decided to have Charly implanted at 10 months of age. Now, nearly 3 years old, Charly receives speech therapy every day in school and we work together at home on her listening and language skills. Thanks to all the early intervention factors we provided her, Charly is on track developmentally and we’re so excited to see what her future will bring.”

In the United States, the Cochlear Nucleus Implant System is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss bilaterally.* This FDA approval is extended to all current Cochlear Nucleus Implant models, as well as all models developed in the future by Cochlear. Cochlear implants are typically covered for children by Medicaid and most insurance plans.** For more information on implantable hearing solutions for children with hearing loss, visit IWantYouToHear.com. For more clinical information on the longitudinal outcomes of cochlear implantation for children with hearing impairment, visit: www.outcomes.nal.gov.au/key-findings.

About Cochlear Limited (ASX: COH)

Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$180 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.

Since 1981, Cochlear has provided more than 600,000 implantable devices, helping people of all ages, in more than 180 countries, to hear.

www.cochlear.com/us

###

References

  1. Waltzman SB, Roland JT Jr. Cochlear implantation in children younger than 12 months. Pediatrics. 2005; 116(4): 487-493.
  2. Cuda D, Murri A, Guerzoni L, Fabrizi E, Mariani V. Pre-school children have better spoken language when early implanted. Int J Pediatr Otorhinolaryngol. 2014; 78(8):1327-1331.
  3. Ching T, Dillon H, Marmane V, Hou S, Day J, Seeto M, Crowe K, Street L, Thomson J, Van Buynder P, Zhang V, Wong A, Burns L, Flynn C, Cupples L, Cowan R, Leigh G, Sjahalam-King J and Yeh A. Outcomes of early-and late-identified children at 3 years of age: Findings from a prospective population-based study. Ear Hear. 2013; 34(5): 535-552.
  4. Leigh J, Dettman S, Dowell R. Evidence-based guidelines for recommending cochlear implantation for young children: Audiological criteria and optimizing age at implantation. Int J Aud 2016; 55:S9-S18.
  5. Cosetti M and Roland J. Cochlear implantation in the very young child: issues unique to the under-1 population. Trends Amplif. 2010 Mar; 14(1): 46-57.
  6. Holt R and Svirsky M. An exploratory look at pediatric cochlear implantation: is earliest always best? Ear Hear. 2008 Aug; 29(4):492-511.
  7. Roland J, Cosetti M, Wang K, Immerman S, Waltzman S. Cochlear implantation in the very young child: Long-term safety and efficacy. Laryngoscope. 2009; 119(11): 2205-2210.
  8. Holman MA, Carlson ML, Driscoll CL, Grim KJ, Peterson RS, Sladen DP, Flick RP. Cochlear implantation in children 12 months of age and younger. Otol Neurotol. 2013; 34(2):251-258.
  9. Dettman SJ, Pinder D, Briggs RJ, Dowell RC, Leigh JR. Communication development in children who receive the cochlear implant younger than 12 months: Risks versus benefits. Ear Hear. 2007; 28(2 Suppl):11S-18S.
  10. Ching TY, Dillon H, Day J, Crowe K, Close L, Chisholm K, Hopkins T. Early language outcomes of children with cochlear implants: interim findings of the NAL study on longitudinal outcomes of children with hearing impairment. Cochlear Implants Int. 2009;10 Suppl 1:2832.
  11. Colletti L. Long-term follow-up of infants (4-11 months) fitted with cochlear implants. Acta Otolaryngol. 2009 Apr; 129(4):361-6.
  12. Nicholas J and Geers, A. Spoken language benefits of extending cochlear implant candidacy below 12 months of age. Otol Neurotol. 2013; 34:532-538.
  13. Dettman SJ, Dowell RC, Choo D, Arnott W, Abrahams Y, Davis A, Dornan D, Leigh J, Constantinescu G, Cowan R, Briggs RJ. Long-term communication outcomes for children receiving cochlear implants younger than 12 months: A multicenter study. Otol Neurotol. 2016 Feb; 37(2): e82-95.
  14. Program to Enhance the Health & Development of Infants and Children (PEHD​IC)​ [Internet]. American Academy of Pediatrics; c2020 [cited 10 Feb 2020]. Available from: https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/PEHDIC/Pages/Early-Hearing-Detection-and-Intervention.aspx. 
  15. Novak MA, Firszt JB, Rotz LA, et al. Cochlear implants in infants and toddlers. Ann Otol Rhino Laryngol Suppl 2000;185:46-49.
  16. Hirschfelder A, Gräbel S, Olze H. The impact of cochlear implantation on quality of life: The role of audiologic performance and variables. Otolaryngol Head Neck Surg. 2008 Mar;138(3): 357-362.
  17. Wyatt JR, Niparko JK, Rothman M, deLissovoy G. Cost Utility of the Multichannel Cochlear Implant in 258 Profoundly Deaf Individuals. Laryngoscope.1996;106:816–821.
  18. Semenov, YR, Yeh, ST, Seshamani, M, Wang, N-Y, Tobey, EA, Eisenberg, LS, Quittner, AL, Frick, KD, Niparko, JK, CDaCI

Investigative Team. Age-Dependent Cost-Utility of Pediatric Cochlear Implantation. Ear Hear. 2013;34(4):402-412.

* In the United States, the cochlear implant system is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss bilaterally. In Canada, the cochlear implant system is intended for use in children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss bilaterally.

** Payer coverage policies may not align with new indications. Exceptions for coverage should be sought through the prior authorization process. Contact your insurance company or local Hearing Implant Specialist to determine your eligibility for coverage.

Dr. Roland is an advisor for Cochlear.

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©Cochlear Limited 2024. All rights reserved. ACE, Advance Off-Stylet, AOS, Ardium, AutoNRT, Autosensitivity, Baha, Baha SoftWear, BCDrive, Beam, Bring Back the Beat, Button, Carina, Cochlear, 科利耳, コクレア, 코클리어, Cochlear SoftWear, Contour, コントゥア, Contour Advance, Custom Sound, DermaLock, Freedom, Hear now. And always, Hugfit, Human Design, Hybrid, Invisible Hearing, Kanso, LowPro, MET, MP3000, myCochlear, mySmartSound, NRT, Nucleus, Osia, Outcome Focused Fitting, Off-Stylet, Piezo Power, Profile, Slimline, SmartSound, Softip, SoundArc, True Wireless, the elliptical logo, Vistafix, Whisper, WindShield and Xidium are either trademarks or registered trademarks of the Cochlear group of companies. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

 

This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

 

Cochlear ProNews is monitored Monday through Friday, excluding some holidays. Questions and inquiries submitted over the weekends or holidays may see a delay in response. For immediate assistance please contact us directly. You are solely responsible for your interactions with other members of our Websites. Cochlear reserves the right, but has no obligation, to monitor disputes or communications between you and other members of our Websites. For a full list of Cochlear’s terms of use, click here.