Archived Policies - Surgery


Neuralgia Inducing Cavitational Osteonecrosis (NICO)

Number:SUR705.028

Effective Date:01-15-2018

End Date:11-14-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Diagnosis and treatment of neuralgia inducing cavitational osteonecrosis (NICO) are considered experimental, investigational, and/or unproven, including but not limited to:

Ultrasonograph scans and interpretation (e.g., Cavitat™); OR

Surgery, including but not limited to:

1. Debridement, or

2. Scraping, or

3. Curettage, or

4. Any other method of removal of “cavitations”; OR

Bone graft replacement; OR

Any other therapy, including but not limited to:

1. Rinsing “cavitations” with saline and/or colloidal silver; or

2. Administration of chelation therapy and intravenous vitamin C.

Description:

Neuralgia-inducing cavitational osteonecrosis (NICO), also known as Ratner’s bone cavity, was originally described in 1920. The concept of NICO gained notoriety several decades later when it was used to describe a bony lesion(s) associated with symptoms characteristic of trigeminal neuralgia like facial pain. The concept has been expanded to include additional symptoms to include osteomyelitis secondary to bone marrow ischemia, hypercoagulopathies and autoimmunity evidenced by the presence of anticardiolipin antibodies, thrombophilia, hypofibrinolysis and anti-peripheral nerve myelin antibodies. Recently, it was reported that a genetic mutation (endothelial nitric oxide synthase) potentially could be associated with NICO.

Due to its indefinite disease characteristics with unclear etiology and pathogenesis, there have been doubts within the dental community regarding whether NICO is a distinct disease entity. Proponents of NICO, who are primarily “biological dentists”, believe the bony lesion(s) as a newly identified form of avascular osteonecrosis (AO). AO most commonly affects the femur at the hip, but also can affect other bones such as the femur at the knee or the humerus at the shoulder, and is frequently the result of trauma or disease that damages blood supply to an area where there is not a lot of collateral circulation. However, many experts believe the jaw has abundant collateral circulation, and therefore believe AO does not occur there.

While dentists are able to diagnose abscesses, cysts, and other bone lesions with x-rays, NICO cavitations are reported to be difficult to discover and usually missed on most x-rays. Despite the lack of knowledge regarding the actual existence of NICO lesions, aggressive treatment typically includes decortication and curettage of the bony tissues. Patients often require multiple surgical procedures to achieve some pain relief, which can take months to achieve. NICO has a strong tendency to recur and to develop in other jawbone sites. Some patients with long, frustrating histories of pain associated with endodontically treated teeth have been presented the treatment option of tooth extraction followed by periapical curettage in an attempt to alleviate pain. Presently, there are a number of non-odontogenic orofacial pain conditions that may coexist with bony lesions but are unrelated in pathogenesis including but not limited to trigeminal neuralgia (i.e., tic douloureux), atypical odontalgia, myofascial pain. (1)

Regulatory status

Cavitat Medical Technologies, Inc. previously developed the Cavitat Ultrasound Bone Densitometer (Cavitat™) to aid medical professionals in diagnosing NICO. Cavitat™ is a bone sonography imaging system; Cavitat™ (Ultrasonograph) received Food and Drug Administration (FDA) 510(k) approval on February 15, 2002. In the 510(k) approval, the FDA classified the Cavitat™ (Ultrasonograph) as an Extraoral X-Ray Unit. The FDA stated the technological characteristics of the Cavitat™ (Ultrasonograph) are identical to those of a diagnostic pulse-echo ultrasound device, with the exception that the Cavitat™ (Ultrasonograph) measures the signal that passes through the bone rather than the return or echo. (2-3)

Rationale:

This medical policy was created in 2006 and has been updated periodically using the MEDLINE database. The most recent literature review was performed through November 27, 2017.

The clinical significance of neuralgia inducing cavitational osteonecrosis (NICO) has not been established; many etiologies for NICO have been suggested, but none have been substantiated through research and scientific evidence. (4-10) In addition, there is no agreement within the dental community on the clinical significance of these cavitations, and there are no clear diagnostic or treatment criteria that are widely accepted and integrated into clinical practice.

A MedLine search on the terms NICO, cavitational, and osteonecrosis located several articles, some of which were authored or co-authored by one particular dentist who is a proponent of NICO; none of the articles report randomized, controlled studies on the diagnosis and/or treatment of NICO. The biopsies that have reportedly confirmed a diagnosis of NICO are performed on tissue that has been tested after-the-fact following invasive surgery. Further, the available literature suggests that only one specific pathologist has confirmed the NICO diagnosis on biopsy. In addition, an FDA 510(k) approval of the Cavitat™ only addresses the safety and not the effectiveness of the device. (2) In the 510(k) approval the FDA states, “The clinical significance and correlation of the Cavitat™ (Ultrasonograph) images, including column height and color grading, has not been established for specific osseous pathology, or normal bone. Positive images represent alveolar regions that attenuate ultrasound signals.”

Sciubba (2009) reported that NICO remains controversial. (11) Changing etiologic concepts have led to confusion as well as the significant departures from the concept first defined by Ratner, which served as the basis for explaining the pain syndrome with features of trigeminal neuralgia. Since the earliest publications on the subject by Bouquot and colleagues there have been many challenges and counterclaims to the concept introduced, with a discussion of these included. Finally, absence of any form of research design and approval by institutional review panels remains a weakness in terms of acceptance of the information provided in the literature said to support the stated etiology of this entity.

Glueck et al. (2010) believed that the T-786C mutation of the endothelial nitric oxide synthase (eNOS) gene affecting nitric oxide (NO) production was associated with NICO.(12) In this small, non-randomized study, 22 NICO patients, not having taken bisphosphonates, mutations affecting NO production (eNOS T-786C, stromelysin 5A6A) were measured by polymerase chain reaction; and 2healthy normal control subjects were matched per case by race and gender.According to the authors, the results showed homozygosity for the mutant eNOS allele was present in 6 out of 22 patients (27 %) with NICO compared with 0 out of 44 (0 %) race- and gender-matched control subjects; heterozygosity was present in 8 patients (36 %) versus 15 control subjects (34 %); and the wild-type normal genotype was present in 9 patients (36 %) versus 29 controls (66 %) (p = 0.0008). The mutant eNOS T-786C allele was more common in cases (20 out of 44 [45 %]) than in control subjects (15 out of 88 [17 %]) (p = 0.0005). The distribution of the stromelysin 5A6A genotype in cases did not differ from control subjects (p = 0.13).The authors concluded thatthe eNOS T-786C polymorphism affecting NO production was associated with NICO, may contribute to the pathogenesis of NICO, and may open therapeutic approaches to treatment of NICO through provision of L-arginine, the amino-acid precursor of NO.

Klassner and Epstein (2011) reviewed the literature for NICO, andstatedthe following:"the etiology, pathogenesis and treatment of NICO are speculative and not well defined, and the reported bone changes may represent variations of normal changes. (13) As a result, one can argue that the symptoms of chronic pain attributed to NICO are better explained by established concepts of neuropathic pain; thus, they should be approached medically and not managed surgically." The authors concluded: "Without a confirmed clinical diagnosis of localized bone pathosis, aggressive and invasive procedures are not warranted. Such interventions may have no effect or may even worsen the pain by increasing sensitization of the central nervous system."

Practice Guidelines and Position Statements

The American Association of Endodontists (AAE) published a 2012 Position Statement on NICO lesions which states they "cannot condone surgical interventions intended to treat suspected NICO lesions. Even when a NICO lesion is suspected to be associated with an endodontically treated tooth, no surgical procedures should be performed until orofacial pain specialists confirm the diagnosis. It is also recommended that the treatment be performed and followed up by the orofacial pain specialists. In addition, the practice of recommending the extraction of endodontically treated teeth for the prevention of NICO, or any other disease, is unethical and should be reported immediately to the appropriate stated board of dentistry.” (1)

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov did not identify any ongoing or unpublished trials that would likely influence this medical policy.

Summary of Evidence

To date, there is inadequate published peer reviewed literature to permit scientific conclusions regarding the diagnosis and treatment of neuralgia inducing cavitational osteonecrosis (NICO). Well-conducted long-term randomized controlled trials (RCTs) with sufficiently large sample sizes are needed to draw conclusions on the impact to health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

21025, 21026, 21030, 21040, 21046, 21047, 21048, 21049, 21210, 21215, 76977, 76999

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. NICO Lesions (Neuralgia-Inducing Cavitational Osteonecrosis). American Association of Endodontists Position Statement (2012). Available at <http://www.aae.org> (accessed - 2017 November 15).

2. FDA – CAVITAT™ (K011147) – Medical Devices. U. S. Food and Drug Administration. Available at < https://www.accessdata.fda.gov > (accessed – 2017 November 21).

3. "Welcome to CAVITAT Medical Technologies, Inc. Evidence-Based Imaging." <http://www.cavitatmedtech.homestead.com> (accessed – 2005 November 10).

4. Bouquot JE, Roberts, AM, Person P, et al. Neuralgia-inducing cavitational osteonecrosis (NICO) Osteomyelitis in 224 jawbone samples from patients with facial neuralgia. Oral Surg Oral Med Oral Pathol. Mar 1992; 73(3):307-19. PMID 1545963

5. Bouquot JE and J Christian. Long-term effects of jawbone curettage on the pain of facial neuralgia. J Oral Maxillofac Surg. Apr 1995; 53(4):387-97; discussion 397-9. PMID 7699492

6. Gruppo R, Glueck CJ, McMahon RE, et al. The pathophysiology of alveolar osteonecrosis of the jaw: anticardiolipin antibodies, thrombophilia, and hypofibrinolysis. J Lab Clin Med. May 1996; 127(5):481-8. PMID 8621985

7. Glueck CJ, McMahon RE, Bouquot JE, et al. Heterozygosity for the Leiden mutation of the factor V gene, a common pathoetiology for osteonecrosis of the jaw, with thrombophilia augmented by exogenous estrogens. J Lab Clin Med. Nov 1997; 130(5): 540-3. PMID 9390643

8. Adams WR, Spolnik KJ, Bouquot JE. Maxillofacial osteonecrosis in a patient with multiple “idiopathic” facial pains. J Oral Pathol Med. Oct 1999; 28(9):423-32. PMID 10535367

9. Woda A and P Pionchon. A unified concept of idiopathic orofacial pain: pathophysiologic features. J Orofac Pain. Summer 2000; 14(3):196-212. PMID 11203755

10. Bouquot JE and RE McMahon. Charlatans in dentistry: ethics of the NICO wars. Comment in Quackery and fraud [J AM Coll Dent. 2004]. J Am Coll Dent. 2003; 70(3):38-41. PMID 14977380

11. Sciubba JJ. Neuralgia-inducing cavitational osteonecrosis: a status report. Oral Dis. Jul 2009; 15(5):309-12. PMID 19371400

12. Glueck CJ, McMahon RE, Bouquot JE, et al. T-786C polymorphism of the endothelial nitric oxide synthase gene and neuralgia-inducing cavitational osteonecrosis of the jaws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. Apr 2010; 109(4):548-553. PMID 20185342

13. Klassser GD and JB Epstein. Neuralgia-inducing cavitational osteonecrosis: a possible diagnosis for an orofacial pain complaint? J AM Dent Assoc. Jun 2011; 142(6):651-653. PMID 21628686.

14. Merck Manual - “Avascular necrosis of the bone.” <https://www.merckmanuals.com> (accessed – 2005 November 18).

15. Imbeau, J. Introduction to through-transmission alveolar ultrasonography (TAU) in dental medicine. Cranio. Apr 2005; 23(2):100-12. PMID 15898566

16. NICO - Neuralgia-Inducing Cavitational Osteonecrosis. Available at <http://www.facial-neuralgia.org> (accessed – 2005 November 16).

17. Shankland, Wesley E. NICO and Cavitations. Available at < http://www.tmj-facialpain.com> (accessed – 2015 July 30).

Policy History:

Date Reason
1/15/2018 Document updated with literature review. Coverage unchanged.
8/1/2016 Reviewed. No changes.
10/15/2015 Document updated with literature review. Coverage unchanged.
12/15/2014 Reviewed. No changes.
8/1/2013 Literature reviewed. No change.
7/1/2008 Revised/updated entire document. This policy is no longer scheduled for routine literature review and update.
2/1/2006 New medical document

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