Subject: Biologic Materials To Aid in Osseous Tissue Regeneration
Reviewed: March 17, 2015
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 refer to 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.
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.
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. Studies have also shown EMD to be of benefit in periodontal soft tissue grafting for coronally advanced flaps and connective tissue grafts.
D4265 -- Biologic materials to aid in soft and osseous tissue regeneration.
Original policy: September 13, 2004
Updated: November 28, 2007; December 29, 2008; May 23, 2011; May 21, 2012; August 12, 2013; March 13, 2014; March 17, 2015
Revised: December 5, 2005; February 22, 2010
The above policy is based on the following references:
1American Dental Association. CDT 2015 Dental Procedure Codes: 34.*
2American Academy of Periodontology. AAP Position Paper: The Potential Role of Growth and Differentiation Factors in Periodontal Regeneration, 1996, 445-451.
3American Academy of Periodontology. AAP Position Paper: Periodontal Regeneration. J Periodontol, 2005; 76: 9, 1601-1622.
4Hoang AM, Oates TW, Cochran DL. In vitro wound healing responses to enamel matrix derivative. J Periodontol. 2000; 71: 8, 1270-1277.
5A 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.
6Patton 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.
7Castellanos T., A, et al. Enamel matrix derivative and coronal flaps to cover marginal tissue recession. Journal of Periodontology. Jan 2006. Vol 77 No 1:7-14.
8Rosperini G, et al. Clinical and histologic evaluation of human gingival recession treated with a subepithelial connective tissue graft and enamel matrix derivative (Emodgain) : a case report. Int J Periodontics Restorative Dent. 2000;20:269-275.
9Sota S, et al. Treatment of Miller class IIIrecessions with enamel matric derivative (Emdogain) in combination with subepithelial connective tissue grafting. Int J Periodontics Restorative Dent. 2006;26(1):71-77.
10Berlucchi I, et al. Enamel matric proteins (Emdogain) in combination with coronally advanced flap or subepithelial connective tissue graft in the treatment of shallow gingival recessions. Int J Periodontics Restoratie Dent. 2002;22(6):583-593.
11Abbos I, et al. Surgical treatment of gingival recessions using Emdogain gel: clinical procedure and case reports. Int J Periodontics Restorative Dent. 2003;23:607-613.
12Camio J, et al. Histological evaluation of 4 cases of root coverage following a connective tissue graft combined with an enamel matrix derivative preparation. J Periodontal. 2002;73:1534-1543.
*Copyright 2014 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.