Subject:
Fluency Enhancing Devices for Stuttering
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
Fluency enhancing devices are generally small two-part electronic devices consisting of an earpiece or headphones, and an auditory processing unit, sometimes worn around the waist or attached to the earpiece itself. Different types of fluency enhancing devices perform one or a combination of the following functions:
- Device provides delayed auditory feedback (DAF), in which the user’s voice is transmitted to his/her earpiece with a fraction of a second delay (e.g., SpeechEasy, Kay Facilitator, Pocket Speech Lab);
- Device provides a “frequency shifted auditory feedback” (FAF); device that shifts the pitch of the user’s voice up or down in the earpiece/headphones (e.g. SpeechEasy, Pocket Speech Lab);
- Masking device that produces a sine wave (signal mimicking the user’s vocal cord vibration) in the earpiece (e.g., Kay Facilitator, Pocket Speech Lab, Edinburgh Masker);
- Device that works on an auditory feedback mechanism (neither delayed nor masking) from one’s own vocal cord vibration (e.g., Fluency Master).
The SpeechEasy, the Kay Facilitator, and the Pocket Speech Lab are examples of fluency enhancing devices that are capable of performing a combination of the above-mentioned functions (e.g. DAF/ FAF for the SpeechEasy, DAF/masking for the Facilitator, DAF/FAF/masking for the Pocket Speech Lab).
It is unclear how these devices help stuttering, but various theories attribute stuttering to an auditory-somatic integration deficit for which these devices compensate.
The U.S. Food and Drug Administration web site lists devices that have received 510(k) clearance for marketing as an anti-stammering device. Note that devices in this product category (i.e., KTH) are Class I, 510(k) exempt devices (i.e., a premarket notification application and FDA clearance is not required before marketing the device in the US). Although some manufacturers have voluntarily submitted product information through the 510(k) clearance process, it is not a requirement for these devices and therefore, devices other than those listed may be commercially available.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. The use of fluency enhancing devices in the management of stuttering is considered investigational.
[INFORMATIONAL NOTE: There is insufficient evidence in the published, peer-reviewed medical literature to support the clinical efficacy and treatment durability of fluency enhancing devices in the management of stuttering.]
2. Fluency enhancing devices are electronic communication aids and are not considered prosthetic devices for speech.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL or DME jurisdiction JA for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
Fluency Enhancing Devices for Stuttering
Edinburgh Masker
Facilitator
Fluency Master
KayPentax Facilitator
Kay Facilitator
Pocket Speech Lab
Speech Easy
Stuttering, Fluency Enhancing Devices for
References:
1. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Fluency enhancing devices for stuttering. Updated: 03/29/07.
2. The National Stuttering Association’s position on the Speech Easy and other assistive devices. Published on the web on 02/16/05. [Available at: http://www.nsastutter.org/search/dsp_results.php?tbl=material&mixid=328 (last accessed 09/08/08]
3. Electronic devices used in conjunction with stuttering treatment. The Stuttering Foundation of America. [Available at: http://oldsite.stutteringhelp.org/electdev.htm (accessed 10/11/05).]
4. SpeechEasy: How they work. [Available at: http://www.speecheasy.com/devices_howtheywork.html 10/10/05).]
5. Stuttering Treatment: How does the Fluency Master work? [Available at: http://www.stutteringcontrol.com/fnwork.htm (accessed 10/11/05).]
6. Casa Futura Technologies / Pocket Speech Lab. [Available at: http://www.casafuturatech.com/ (accessed 10/10/05).]
7. KayPentax Facilitator, Model 3500. [Available at: http://kayelemetrics.com/Product%20Info/3500/3500appsec1.htm (accessed 10/11/05).]
8. Armson J, Kiefte M, Mason J, et al. The effect of SpeechEasy on stuttering frequency in laboratory conditions. J Fluency Disord. 2006;31(2):137-52.
9. O'Donnell JJ, Armson J, Kiefte M. The effectiveness of SpeechEasy during situations of daily living. J Fluency Disord. 2008;33(2):99-119.
10. Pollard R, Ellis JB, Finan D, et al. Effects of the SpeechEasy on objective and perceived aspects of stuttering: a 6-month, phase I clinical trial in naturalistic environments. J Speech Lang Hear Res. 2009 Apr;52(2):516-33.
11. Gallop RF, Runyan CM. Long-term effectiveness of the SpeechEasy fluency-enhancement device. J Fluency Disord. 2012 Dec;37(4):334-43.
12. Foundas AL, Mock JR, Corey DM, et al. The SpeechEasy device in stuttering and nonstuttering adults: fluency effects while speaking and reading. Brain Lang. 2013 Aug;126(2):141-50.
13. Andade CR, Juste FS. Systematic review of delayed auditory feedback effectiveness for stuttering reduction. J Soc Bras Fonoaudiol. 2011;23(2):187-91.
14. National Institute of Deafness and other Communication Disorders (NIDCD). Stuttering. NIH Pub. No. 10-4232. Updated March 2010. Available at: http://www.nidcd.nih.gov/health/voice/pages/stutter.aspx (accessed 11/03/2014)
15. UpToDate. Evaluation and treatment of speech and language disorders in children, Literature review current through August 2016. Topic last updated April 22, 2015.
16. Ritto AP, Juste FS, Stuart A, et al. Randomized clinical trial: the use of SpeechEasy in stuttering treatment. Int J Lang Commun Disord. 2016 Jun 8 [Epub ahead of print]
17. Baxter S, Johnson M, Blank L, et al. Non-pharmacological treatments for stuttering in children and adults: a systematic review and evaluation of clinical effectiveness, and exploration of barriers to successful outcomes. Health Technol Assess. 2016 Jan;20(2):1-302.
18. Carter J, Mucher K. Evaluation and treatment of speech and language disorders in children. In: UpToDate, Duryea TK, Augustyn M, Torchia MM (Eds), UpToDate, Waltham, MA (Accessed on July 20, 2020).
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |