Archived Policies - Surgery


Neuralgia Inducing Cavitational Osteonecrosis (NICO)

Number:SUR705.028

Effective Date:07-01-2008

End Date:07-31-2013

Coverage:

This policy is no longer scheduled for routine literature review and update.

Diagnosis and treatment of neuralgia inducing cavitational osteonecrosis (NICO) are considered experimental, investigational, and 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:

Within the dental community, there are two schools of thought on the existence and importance of neuralgia inducing cavitational osteonecrosis (NICO).  The proponents of NICO, who are primarily “biological dentists”, believe it is 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.

NICO lesions, or cavitations, can be either dead, hollow areas in the jaw bone, or holes filled with dead bone and bone marrow.  These cavitations are believed to be the cause of facial pain, neuralgia, and headache, as well as pains and diseases located far from the mouth.  Because these cavitations have no blood circulation, medications and other remedies cannot permeate the lesions, and the only recommended treatment is surgical removal of cavitational lesions by curettage of bony tissues.  The excised material is biopsied to confirm the presence of inflammation or infection.  NICO is believed to be a problem of chemical toxins and not bacterial infection, so antibiotics are thought to be of little value.  Instead, some practitioners rinse the cavity with saline or colloidal silver and administer chelation therapy or intravenous vitamin C.

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.  Cavitat Medical Technologies, Inc. has developed the Cavitat Ultrasound Bone Densitometer (CAVITAT™) to aid medical professionals in diagnosing NICO.  On their web site, Cavitat Medical Technologies, Inc. claims that the CAVITAT™ is the world’s leading technology in bone sonography imaging systems; reportedly CAVITAT™ imaging precisely identifies cavitational porosity in the jawbone.  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. Positive regions represent alveolar regions that attenuate ultrasound signals.

Rationale:

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.  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.  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.

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:

NOTE:  On their web site, Cavitat Medical Technologies, Inc. states that the “American Medical Association has assigned a CPT coding number 76977 for CAVITAT™ scans and interpretations.” The AMA assigned 76977 in 1998 to be used for billing of bone mineral density tests in peripheral sites such as the wrist, fingers, or heel, primarily as a portable screening tool; the CAVITAT™ received FDA 510K approval in February 2002.  Also, CPT code 76977 is for ultrasound bone density measurement and interpretation, peripheral site(s), any method.  The 510K approval for CAVITAT™ specifies that the CAVITAT™ is substantially equivalent to the MYSONO™, which is a general ultrasound device that is used for general ultrasound imaging purposes. 

NOTE:  Some dentists believe NICO can cause illnesses that are remote from the mouth, including symptoms typical of arthritis, heart disease, and other bodily pain.  Therefore, diagnosis codes given may vary widely.


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 or changed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

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.

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. 

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.

NICO Lesions (Neuralgia-Inducing Cavitational Osteonecrosis).  American Association of Endodontists Position Statement, 211 E. Chicago Ave., Suite 1100, Chicago, IL.  1996.  <http://www.aae.org> Accessed November, 2005.

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.

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.

Woda, A., and P. Pionchon.  A unified concept of idiopathic orofacial pain: pathophysiologic features.  Journal of Orofacial Pain (2000 Summer) 14(3):196-212.

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.

Dodes, D.D.S., John E.  A critical look at cavitational osteopathosis, NICO, and “biological dentistry”.  <http://quackwatch.com>  Accessed on November 9, 2005.

“Welcome to CAVITAT Medical Technologies, Inc. Evidence-Based Imaging.”  <http://www.cavitatmedtech.homestead.com.> Accessed on November 10, 2005.

“Avascular necrosis of the bone.” <http://www.merck.com> Accessed November 18, 2005.

510K Premarket Notification Database.  510K Number K011147.  Federal Drug Administration – Center for Devices and Radiologic Health. (2002 February 15) <http://www.fda.gov>  Accessed November 14, 2005.

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

NICO—Neuralgia-Inducing Cavitational Osteonecrosis.  http://www.facial-neuralgia.org  Accessed on November 16, 2005.

Shankland, Wesley E.  NICO and Cavitations.  <http://www.drshankland.com>   Accessed on November 16, 2005.

Policy History:

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

Archived Document(s):

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