Number: 005
Update

Subject: Biologic Materials To Aid in Osseous Tissue Regeneration

Reviewed: April 8, 2020

Important note

This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical 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 practicing in relevant clinical areas, and other relevant factors).

 Aetna makes no representations and accepts no liability with respect to the content of any external information cited or relied upon in this Bulletin. The discussion, analysis, conclusions and positions reflected in this Bulletin, including any reference to a specific provider, product, process or service by name, trademark, manufacturer, constitute Aetna’s opinion and are made without any intent to defame.

Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information including correction of any factual error. CPBs include references to standard HIPAA compliant code sets to assist with search functions and to facilitate billing and payment for covered services. New and revised codes are added to the CPBs as they are updated. When billing, you must use the most appropriate code as of the effective date of the submission. Unlisted, unspecified and nonspecific codes should be avoided.

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.

The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (for example, will be paid for by Aetna) for a particular member. The member's benefit 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, the Federal government or CMS for Medicare and Medicaid members.

Visit CMS's Coverage Database

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) to reduce or eliminate 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.  

Medical necessity for the use of Biological Materials is based on supporting evidence of infrabony defects without furcations resulting from moderate or severe periodontitis. If the expected clinical benefit cannot be documented, the use of Biologic Materials may not be considered medically necessary.

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; March 17, 2015; April 28, 2016; April 27, 2017; April 26, 2018; April 29, 2019; April 8, 2020
Revised: December 5, 2005; February 22, 2010

The above policy is based on the following references:

¹American Dental Association. CDT 2020 Dental Procedure Codes.*

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 April 24, 2018.

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.

¹³Ramseier C A, Rasperini G, Batia S, Giannobile W V. Advanced reconstructive technologies for periodontal tissue repair. Periodontology 2000. 2012 Jun;59(1):185-202. doi: 10.1111/j.1600-0757.2011.00432. Accessed April 24, 2018.

*Copyright 2019 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.