Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:11/01/2019

Policy Number: 0688 Effective Date: Revision Date: 11/20/2009

Policy Name: Intra-oral Appliances for Headaches and Trigeminal Neuralgia

Type of Submission – Check all that apply:

New Policy Revised Policy*

Annual Review – No Revisions Statewide PDL

*All revisions to the pol icy must be highlighted using track changes throughout the document.

Please prov ide a ny clarifying information for the p olicy below:

CPB 0688 Intra-oral Appliances for Headaches and Trigeminal Neuralgia

Clinical content was last revised on 11/20/2009. No additional non-clinical updates were made by Corporate since the last PARP submission.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

Proprietary Revised July 22, 2019

Proprietary

( https://www.aetna.com/)

Intra-oral Appliances for Headachesand Trigeminal Neuralgia

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Number: 0688

*Please see amendment forPennsylvaniaMedicaid

at the end of this CPB.

Aetna considers intra-oral appliances (e.g., the Nociceptive Trigeminal Inhibition-Tension

Suppression System) experimental and investigational for the treatment of headaches and

trigeminal neuralgia because their effectiveness for these indications has not been established.

For policy on intra-oral appliances for TMJ syndrome, see

CPB 0028 - Temporomandibular Disorders (../1_99/0028.html).

See also CPB 0113 - Botulinum Toxin (../100_199/0113.html);

CPB 0132 - Biofeedback (../100_199/0132.html);

CPB 0135 - Acupuncture (../100_199/0135.html);

CPB 0172 - Hyperbaric Oxygen Therapy (HBOT) (../100_199/0172.html);

CPB 0462 - Migraine and Cluster Headache: Nonsurgical Management

(../400_499/0462.html)

CPB 0469 - Transcranial Magnetic Stimulation and Cranial Electrical Stimulation

(../400_499/0469.html)

Last Review

03/12/2019

Effective: 08/06/2004

Next

Review: 07/25/2019

Review

History

Definitions

Additional

Clinical Policy

Bulletin

Notes

www.aetna.com/cpb/medical/data/600_699/0688.html Proprietary 1/8

CPB 0647 - Histamine Desensitization Therapy for Intractable Headaches

(../600_699/0647.html)

; CPB 0707 - Headaches: Invasive Procedures (../700_799/0707.html).

Headache is a common medical complaint and is generally categorized by 1 of 3 syndromes, (i)

migraine headache, (ii) tension-type headache, and (iii) cluster headache. Migraineis

characterizedby attacks of headache, nausea, vomiting, photophobia, phonophobia, and

malaise. Tension-type headache is mild-to-moderate in intensity, bilateral, and non-throbbing

without other associated features. Cluster headache is strictly unilateral, begins quickly without

warning, and reaches maximal intensity within a few minutes. It is usually deep, excruciating,

continuous, and explosive in quality, although occasionally it may be pulsatile and throbbing.

Other headache syndromes may include sinus headache, post-traumatic headache, medication

over-use, and temporomandibular joint (TMJ) dysfunction. The typical headache associated with

TMJ presents as unilateral ear or pre-auricular pain that radiates to the jaw, temple, or neck.

The pain is deep, dull, continuous, and usually worse in the morning. It is typically associated

with a limitation of jaw motion and deviation of the jaw upon opening. Physical examination may

reveal tenderness of the muscles of mastication and, less commonly, clicking of the joint. Many

cases are difficult to distinguish from tension type headaches (Bajwa and Sabahat, 2008).

Pharmacological treatment of headaches is aimed at reversing, aborting, or reducing pain and

the accompanying symptoms of an attack, and to optimize the patient's ability to function

normally. Most attacks of mild migraine can be effectively treated by anti-emetics followed by

analgesics such as aspirin, acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs).

Moderate-to-severe attacks are successfully treated utilizing combinations of ergotamine tartrate,

dihydroergotamine, and triptans with anti-emetics, simple analgesics, NSAIDs, and/or opiates.

For severe migraine headaches, alternative medications include intravenous administration of

neuroleptics such as chlorpromazine (Thorazine) and prochlorperazine (Compazine),

occasionally corticosteroids such as prednisone, hydrocortisone, dexamethasone, and

methylprednisone, and lastly parenteral narcotic analgesics such as meperidine and the nasal

spray butorphanol tartrate (Stadol NS). The acute or abortive therapy of tension-type headache

(TTH) ranges from non-pharmacologic therapies to analgesic medications. The treatment of

headache due to TMJ primarily involves therapy of the joint disorder itself. Most cases can be

treated with local heat, physical therapy, dental hygiene, NSAIDs, and dietary measures (Bajwa

and Sabahat, 2008).

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Complimentary and alternative therapies for headaches include acupuncture, aromatherapy,

biofeedback, Bowen technique (remedial therapy tool to manage pain), chiropractic, cranial

electrical stimulation, hyperbaric oxygen therapy, hypnotherapy, massage, nutrition, reflexology,

Reiki, spinal/osteopathic manipulation, transcranial magnetic stimulation, and yoga although the

effectiveness of many of these approaches has not been established. Recently, it has been

suggested that intra-oral dental appliances that are used to reduce the intensity and the amount

of jaw muscle activity may be beneficial in preventing headaches.

Advocates of intra-oral appliances for preventing headaches believe that stimulation of the

trigeminal nerve through increased cervical as well as mandibular muscle activities (e.g.,

clenching or grinding the teeth), which can occur when the patient is awake or asleep, may

trigger headaches. Intra-oral appliances are thought to aid in controlling clenching and grinding

of the teeth, thus, decreasing the possibility of over-stimulating the trigeminal nerve system.

These intra-oral dental appliances are pre-fabricated in different configurations covering all or

some of either the upper or lower dentition.

An example of an intra-oral device for the prevention of headaches is the Nociceptive Trigeminal

Inhibition - tension suppression system (NTI-tss, NTI-TSS, Inc., Mishawaka, IN). It was

developed and patented by James P. Boyd, DDS. While the Standard NTI-tss device can be

worn indefinitely (while sleeping), the NTI-tss Daytime device is recommended for patients with

migraine (in addition to the use of the Standard device) for 4 to 8 weeks during waking hours.

The inch-wide device is made of clear plastic and fits over 2 front teeth -- usually but not always

the top teeth. It keeps the back teeth from coming together and thus prevents clenching. The

NTI-tss is sold in a kit form, and dentists can mold and custom-fit the device to patients’ teeth in

approximately 1 hour.

The NTI-tss was cleared by the Food and Drug Administration (FDA) through 510(k) premarket

notification in June 2001 for the prevention of medically diagnosed migraine headaches as well

as migraine associated with tension-type headaches, and for the prevention of bruxism and

TMJ. Thus, the manufacturer was not required to submit to the FDA the evidence of efficacy that

is necessary to support a premarket approval application (PMA).

Staplemann and Turk (2011) has commented that, since its FDA clearance, controversy has

persisted concerning the therapeutic benefits and potential dangers of use of NTI-tss.

Staplemann and Turk (2011) state that the manufacturer recommends that the appliance be

utilized for the treatment of bruxism, temporomandibular disorders and headaches. The authors

stated that articles in both the lay press and the dental literature have reported the positive

effects associated with the use of the NTI-tss device. The authors note that other researchers,

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however, have raised doubts about the appliance; warning of the potential for adverse events

such as appliance aspiration, ingestion and permanent occlusal changes after prolonged and

unmonitored use.

Lamey et al (1996) studied t he relationship between the nocturnal wearing of an acrylic

appliance of 2 mm thickness covering all occlusal surfaces of the teeth (2 appliance designs)

and the frequency of migraine attacks in 19 patients who had migraine with or without aura. One

design covered the maxillary occlusal surfaces of the dentition while the other design contacted

the palatal mucosa only and was free of the occlusion. Treatment outcome was expressed as

the number of migraine attacks per week per patient. The occlusal cover appliance reduced the

number of attacks on average to about 40 % of that normally experienced. The improvement

was most marked in those who had frequent migraine attacks (i.e., 2 attacks per week on a

regular basis). The authors concluded that acrylic appliance therapy is of value in migraine

sufferers who have attacks on waking but the appliance design has to involve covering of the

occlusal surfaces of all of the teeth (Note: the NTI-tss only covers the front 2 teeth). The

drawbacks of this study were that it was a non-randomized study with a small sample size and

no long-term follow-up.

Two studies comparing the NTI-tss splint with a standard stabilization splint in the treatment of

TMJ have been published (Magnusson et al, 2004; Jokstad et al, 2005). Results obtained by

Magnusson favored the use of a stabilization splint over the NTI splint. In addition, 1 subject

treated with the NTI-tss splint exhibited an impaired occlusion at the 6-month follow-up. Jokstad

found no differences between a standard stabilization splint versus the NTI splint regarding TMJ

treatment efficacy over a 3-month period. Both comparative studies were small and neither

focused on migraine as an outcome measure. Further studies are needed to determine the

effects of the NTI-tss splint on the treatment of headaches, including migraine, as well as

possible long-term side effects.

Stapelmann and Turp (2008) conducted a systematic review to evaluate the currently available

evidence regarding the efficacy and safety of the NTI-tss splint. The authors found that 9 of 68

relevant publications reported about the results of five different randomized controlled trials

(RCTs). Two RCTs concentrated on electromyographic (EMG) investigations in patients with

temporomandibular disorders (TMDs) and concomitant bruxism (citing Baad-Hansen, et al.,

2007) or with bruxism alone (citing an unpublished PhD thesis by Kavakli, 2006). The authors

stated that, in both of these studies, compared to an occlusal stabilization splint the NTI-tss

device showed significant reduction of EMG activity. The authors stated that 2 RCTs focused

exclusively on TMD patients; in one trial (citing Magnusson, et al., 2004), a stabilization

appliance led to greater improvement than an NTI-tss device, while in the other study (citing

Jokstad, et al., 2005) no difference was found. The authors identified one RCT evaluating the

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use of the NTI-tss device in headache and migraine (citing Shankland, 2002); in this study,

patients with tension-type headache or migraine responded more favorably to the NTI-tss splint

than to a bleaching tray. NTI-tss-induced complications related predominantly to single teeth or

to the occlusion. The authors concluded that the evidence from RCTs suggests that the NTI-tss

device may be successfully used for the management of bruxism and TMDs. The authors noted,

however, in order to avoid potential unwanted effects, the device should be chosen only if certain

a patient will be compliant with follow-up appointments. The authors stated that the NTI-tss bite

splint may be justified when a reduction of jaw closer muscle activity (e.g., jaw clenching or tooth

grinding) is desired, or as an emergency device in patients with acute temporomandibular pain

and, possibly, restricted jaw opening. Commenting on the systematic evidence review by

Stapelmann and Turp, Bender (2011) stated that the inability to design a double blind study

involving intra-oral appliances creates limitations to the quality of the findings. Differing inclusion

criteria, small sample sizes and the lack of standardized diagnostic criteria also limited the

quality of the included evidence. Bender (2011) also noted that the literature is not conclusive as

to the role of EMG activity and its relevance to pain.

UpToDate reviews on “Overview of chronic daily headache” (Garza and Schwedt, 2013a),

“Chronic migraine” (Garza and Schwedt, 2013b), “Tension-type headache in adults: Preventive

treatment” (Taylor, 2013), and “Trigeminal neuralgia” (Bajwa et al, 2013) do not mention the use

of intra-oral appliances as therapeutic options.

There is insufficient data on the effectiveness of oral appliances in the treatment of headaches.

Randomized controlled studies are needed to determine the effectiveness of oral appliances in

the treatment of headache.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

CPT codes not covered for indications listed in the CPB:

21110 Application of interdental fixation device for conditions other than fracture or

dislocation, includes removal

HCPCS codes not covered for indications listed in the CPB:

D7880 Occlusal orthotic device, by report

D8210 Removable appliance therapy

D9940 Occlusal guard, by report

www.aetna.com/cpb/medical/data/600_699/0688.html Proprietary 5/8

:

G43.001 - G43.919 Migraine

G44.001 - G44.89 Other headache syndromes

G50.0 Trigeminal neuralgia

G97.1 Other reaction to spinal and lumbar puncture [headache due to lumbar puncture]

R51 Headache

Code Code Description

1. Lamey PJ, Steele JG, Aitchison T. Migraine: The effect of acrylic appliance design on

clinical response. Br Dent J. 1996;180(4):137-140.

2. Horne M. Treating headaches. A conceptual framework. Aust Fam Physician.

1998;27(7):579-586.

3. Long L, Huntley A, Ernst E. Which complementary and alternative therapies benefit which

conditions? A survey of the opinions of 223 professional organizations. Complement Ther

Med. 2001;9(3):178-185.

4. Mauskop A. Alternative therapies in headache. Is there a role? Med Clin North

Am. 2001;85(4):1077-1084.

5. Primack D, Cohen JR. The NTI-Tension Suppression System for migraine. American

Council for Headache Education (ACHE) Articles. Mt. Royal, NJ: ACHE; 2004.

6. Shankland WE. Nociceptive trigeminal inhibition--tension suppression system: A method of

preventing migraine and tension headaches. Compend Contin Educ Dent. 2002;23(2):105­

108, 110, 112-113.

7. Milanov I, Bogdanova D. Trigemino-cervical reflex in patients with headache.

Cephalalgia. 2003;23(1):35-38.

8. Bajwa ZH, Sabahat A. Approach to the patient with headache syndromes other than

migraine. UpToDate [online serial]. Waltham, MA: UpToDate;2008.

9. Turp JC, Komine F, Hugger A. Efficacy of stabilization splints for the management of

patients with masticatory muscle pain: A qualitative systematic review. Clin Oral Investig

2004;8:179.

10. Magnusson T, Adiels AM, Nilsson HL, et al. Treatment effect on signs and symptoms of

temporomandibular disorders--comparison between stabilisation splint and a new type of

splint (NTI). A pilot study. Swed Dent J. 2004;28(1):11-20.

www.aetna.com/cpb/medical/data/600_699/0688.html Proprietary 6/8

11. Baad-Hansen L, Jadidi F, Castrillon E, et al. Effect of a nociceptive trigeminal inhibitory

splint on electromyographic activity in jaw closing muscles during sleep. J Oral Rehabil.

2007;34(2):105-111.

12. Jokstad A, Mo A, Krogstad BS. Clinical comparison between two different splint designs for

temporomandibular disorder therapy. Acta Odontol Scand. 2005;63(4):218-226.

13. Kavakli Y. Polisomnografi ile teşhis edilen uyku bruksizmli hastaların tedavisinde iki farklı

apareyin etkinliğinin değerlendirilmesi [Evaluation of effectiveness of two different

appliances in treatment of patients with sleep bruxism diagnosed with polysomnography].

PhD Thesis. Ankara, Turkey: Hacettepe University, Health Sciences Institute; 2006, as cited

in Stapelmann H, Türp JC. The NTI-tss device for the therapy of bruxism,

temporomandibular disorders, and headache - where do we stand? A qualitative systematic

review of the literature. BMC Oral Health. 2008;8:22.

14. Wright EF, Jundt JS. The NTI appliance for TMD and headache therapy. Tex Dent J.

2006;123(12):1118-24.

15. Blumenfeld A. The NTI appliance for TMD and headache therapy. Tex Dent J.

2007;124(4):356.

16. Bender SD. The NTI appliance for TMD and headache therapy. Tex Dent J.

2007;124(4):357-358.

17. King M. The discussion about the NTI. Tex Dent J. 2007;124(6):566.

18. Stapelmann H, Türp JC. The NTI-tss device for the therapy of bruxism, temporomandibular

disorders, and headache - where do we stand? A qualitative systematic review of the

literature. BMC Oral Health. 2008;8:22.

19. Bender S. The Nociceptive Trigeminal Inhibition tension suppression system (NTI-tss)

device may be successfully used for the management of bruxism and temporomandibular

disorders. Clinical Summary. Systematic Reviews. ADA Center for Evidence-based

Dentistry. Chicago, IL: American Dental Association; November 10, 2011.

20. Garza I, Schwedt, TJ. Overview of chronic daily headache. UpToDate [serial online].

Waltham, MA: UpToDate; reviewed June 2013a.

21. Garza I, Schwedt, TJ. Chronic migraine. UpToDate [serial online]. Waltham, MA:

UpToDate; reviewed June 2013b.

22. Taylor FR. Tension-type headache in adults: Preventive treatment. UpToDate [serial online].

Waltham, MA: UpToDate; reviewed June 2013.

23. Bajwa ZH, Ho CC, Khan SA. Trigeminal neuralgia. UpToDate [serial online]. Waltham, MA:

UpToDate; reviewed June 2013.

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and

constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or

program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any

results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna

or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be

updated and therefore is subject to change.

Copyright © 2001-2019 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical PolicyBulletin Number: 0688 Intra-

oral Appliances for Headaches and Trigeminal Neuralgia

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania annual 11/01/2019

Proprietary