Archived Policies - Surgery
Neuralgia Inducing Cavitational Osteonecrosis (NICO)
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.
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. ticdouloureux), atypical odontalgia, myofascial pain. (1)
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 U.S. Food and Drug Administration (FDA) 510K approval on February 15, 2002. In the 510K 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)
The clinical significance of NICO has not been established; many etiologies for NICO have been suggested, but none have been substantiated through research and scientific evidence. (3-10) 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 eight articles, six 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 510K approval of the CAVITAT™ only addresses the safety and not the effectiveness of the device. (11) In the 510K 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.”
The diagnosis and treatment of NICO is not supported by a coverage position of the Centers for Medicare and Medicaid Services (CMS) or other authoritative guidelines.
An updated MedLine literature review was conducted through May 2008. Diagnosis and treatment of NICO is not supported by evidence in the peer-reviewed medical literature that demonstrates an improvement in net health outcome and/or permits conclusions on the effect on health outcomes.
Sciubba (2009) reported that NICO remains controversial. (12) 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.
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)
A search of peer reviewed literature through June 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
A MedLine literature review was conducted through June 2015. Diagnosis and treatment of NICO is not supported by evidence in the peer-reviewed medical literature to demonstrate an improvement in net health outcomes therefore it remains experimental, investigational and/or unproven.
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.
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.
The following codes may be applicable to this Medical policy and may not be all inclusive.
21025, 21026, 21030, 21040, 21046, 21047, 21048, 21049, 21210, 21215, 76977, 76999
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
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>.
1. NICO Lesions (Neuralgia-Inducing Cavitational Osteonecrosis). American Association of Endodontists Position Statement, 211 E. Chicago Ave., Suite 1100, Chicago, IL. 2012. <http://www.aae.org> Accessed July 29 2015.
2. "Welcome to CAVITAT Medical Technologies, Inc. Evidence-Based Imaging." <http: //www.cavitatmedtech.homestead.com.> Accessed on November 10, 2005. (Disabled- verified July 31 2015).
3. Bouquot, J.E., Roberts, A.M., et al. Neuralgia-inducing cavitational osteonecrosis (NICO) Osteomyelitis in 224 jawbone samples from patients with facial neuralgia [see comments]. Oral Surgery, Oral Medicine, and Oral Pathology (1992 March) 73(3):307-19.
4. Bouquot, J.E., and J. Christian. Long-term effects of jawbone curettage on the pain of facial neuralgia. Journal of Oral and Maxillofacial Surgery (1995 April) 53(4):387-97; discussion 397-9.
5. Bouquot, J.E., Gruppo, R., et al. The pathophysiology of alveolar osteonecrosis of the jaw: anticardiolipin antibodies, thrombophilia, and hypofibrinolysis. Journal of Laboratory and Clinical Medicine (1996 May) 127(5):481-8.
6. Bouquot, J.E., Glueck, C.J., 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. Journal of Laboratory and Clinical Medicine (1997 November) 130(5): 540-3.
7. Bouquot, J.E., Adams, W.R., et al. Maxillofacial osteonecrosis in a patient with multiple “idiopathic” facial pains. Journal of Oral Pathology and Medicine (1999 October) 28(9):423-32.
8. Woda, A., and P. Pionchon. A unified concept of idiopathic orofacial pain: pathophysiologic features. Journal of Orofacial Pain (2000 Summer) 14(3):196-212.
9. Bouquot, J.E. and R.E. McMahon. Charlatans in dentistry: ethics of the NICO wars. Comment in Journal of the American College of Dentists (2003) 70(3):38-41. Dodes, D.D.S., John E., and Marvin Schissel, D.D.S. Cavitational Osteopathosis, NICO, and “Biological Dentistry”. <http://www.quackwatch.org> Accessed on April13, 2005.
10. Dodes, D.D.S., John E. A critical look at cavitational osteopathosis, NICO, and “biological dentistry”. <http://quackwatch.com> Accessed on July 30 2015.
11. Sciubba JJ., Neuralgia-inducing cavitational osteonecrosis: a status report. Oral Dis.2009, Jul;15(5):309-12, Epub 2009 April, Accessed July 2013.
12. “Avascular necrosis of the bone.” <http://www.merck.com> Accessed November 18, 2005.
13. 510K Premarket Notification Database. 510K Number K011147. Federal Drug Administration – Center for Devices and Radiologic Health. (2002 February 15) <http://www.fda.gov> Accessed July 30 2015.
14. Imbeau, J. Introduction to through-transmission alveolar ultrasonography (TAU) in dental medicine. Cranio (2005 April) 23(2):100-12.
15. NICO—Neuralgia-Inducing Cavitational Osteonecrosis. http://www.facial-neuralgia.org Accessed on November 16, 2005.
16. Shankland, Wesley E. NICO and Cavitations. < http://www.tmj-facialpain.com> Accessed on July 30 2015.
|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|
|Title:||Effective Date:||End Date:|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||01-15-2018||11-14-2018|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||08-01-2016||01-14-2018|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||10-15-2015||07-31-2016|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||12-15-2014||10-14-2015|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||08-01-2013||12-14-2014|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||07-01-2008||07-31-2013|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||05-03-2006||06-30-2008|
|Neuralgia Inducing Cavitational Osteonecrosis (NICO)||02-01-2006||05-02-2006|