Biologic Materials To Aid in Osseous Tissue Regeneration (005)

Number: 005
(Update)

Subject: Biologic Materials To Aid in Osseous Tissue Regeneration

Reviewed: March 13, 2014

Important Note

This Clinical Policy Bulletin explains how we determine whether certain services or supplies are medically necessary. We made these decisions based on a review of currently available clinical information including:

  • Clinical outcome studies in the peer-reviewed published medical and dental literature
  • Regulatory status of the technology
  • Evidence-based guidelines of public health and health research agencies
  • Evidence-based guidelines and positions of leading national health professional organizations
  • Views of physicians and dentists practicing in relevant clinical areas
  • Other relevant factors

We expressly reserve the right to revise these conclusions as clinical information changes, and welcome further relevant information.

Each benefits plan defines which services are covered, which are excluded and which are subject to dollar caps or other limits. Members and their dentists will need to consult the member's benefits plan to determine if any exclusions or other benefits limitations apply to this service or supply. The conclusion that a particular service or supply is medically necessary does not guarantee that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that we consider medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members.

Policy

We consider this surgical procedure to be dental-in-nature (DIN) oral surgery. Coverage may be available for DIN oral surgery procedures under either medical or dental plans.

Background

Enamel matrix derivative (EMD) contains a variety of hydrophobic enamel matrix proteins and is extracted from the developing embryonic enamel of porcine teeth. EMD is associated with the formation of acellular cementum and has been shown to stimulate periodontal regeneration. Studies have demonstrated the regeneration of buccal dehiscences with regeneration of cementum, periodontal ligament and alveolar bone to the extent of mimicking natural process of development.

EMD is U.S. Food and Drug Administration (FDA)-approved for use in vertical osseous defects. It is indicated as an adjunct to periodontal surgery for topical application onto exposed root surfaces to treat infrabony defects without furcations resulting from loss of tooth support due to moderate or severe periodontitis. It is indicated for use either alone or in combination with autografts, allografts, xenografts or guided tissue regeneration (GTR), and in membranes with one-, two- or three-walled vertical osseous defects.

Code1

D4265 -- Biologic materials to aid in soft and osseous tissue regeneration.

Revision Dates

Original policy: September 13, 2004
Updated: November 28, 2007; December 29, 2008; May 23, 2011; May 21, 2012; August 12, 2013; March 13, 2014
Revised: December 5, 2005; February 22, 2010

The above policy is based on the following references:

1 American Dental Association. Current Dental Terminology, CDT 2014:34.*

2 American Academy of Periodontology. AAP Position Paper: The Potential Role of Growth and Differentiation Factors in Periodontal Regeneration, 1996, 445-451.

3 American Academy of Periodontology. AAP Position Paper: Periodontal Regeneration. J Periodontol, 2005; 76: 9, 1601-1622.

4 Hoang AM, Oates TW, Cochran DL. In vitro wound healing responses to enamel matrix derivative. J Periodontol. 2000; 71: 8, 1270-1277.

5 A clinical comparison of bovine-derived xenograft used alone and in combination with EMD for the treatment of periodontal osseous defects in humans. J Periodontol. 2002; 71: 423-432.

6 Patton LL, Epstein JB, Kerr AR. Adjunctive techniques for oral cancer examination and lesion diagnosis: a systematic review of the literature. J Am Dent Assoc. 2008 Jul;139(7):896-905; quiz 993. Accessed December 21, 2009 from http://www.ncbi.nlm.nih.gov/pubmed/18594075.

*Copyright 2013 American Dental Association. All rights reserved.

Property of Aetna. All rights reserved. Dental Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical/dental advice. This Dental 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 health care professionals are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating health care professionals are solely responsible for medical/dental advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

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  • Aetna Dental Clinical Policy Bulletins (DCPBs) are developed to assist in administering plan benefits and do not constitute dental advice. Treating providers are solely responsible for dental advice and treatment of members. Members should discuss any Dental Clinical Policy Bulletin (DCPB) related to their coverage or condition with their treating provider.
  • While the Dental Clinical Policy Bulletins (DCPBs) are developed to assist in administering plan benefits, they do not constitute a description of plan benefits. The Dental Clinical Policy Bulletins (DCPBs) describe Aetna's current determinations of whether certain services or supplies are medically necessary, based upon a review of available clinical information. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. Aetna's conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Aetna). Your benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State or the Federal government.
  • Please note also that Dental Clinical Policy Bulletins (DCPBs) are regularly updated and are therefore subject to change.
  • Since Dental Clinical Policy Bulletins (DCPBs) can be highly technical and are designed to be used by our professional staff in making clinical determinations in connection with coverage decisions, members should review these Bulletins with their providers so they may fully understand our policies.
  • Under certain plans, if more than one service can be used to treat a covered person's dental condition, Aetna may decide to authorize coverage only for a less costly covered service provided that certain terms are met.
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