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Subject: Biologic materials to aid in soft and osseous tissue regeneration
Reviewed: August 16, 2023
This Clinical Policy Bulletin determines 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 the 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 an opinion by Aetna 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.
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) 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. Biologic Materials include Emdogain, bone morphogenic proteins BMP-2, and GEM-21. The FDA has approved Emdogain only for the treatment of vertical osseous defects. There are no long- term well- controlled studies that support the Biologic Materials currently on the market have an added clinical advantage when done in conjunction with periradicular surgery, either alone or with osseus grafting materials and barrier membranes (GTR).
D3431 - Biologic Materials to Aid in Soft and Osseous Tissue Regeneration in Conjunction with Periradicular Surgery
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; April 28, 2016; April 27, 2017; April 26, 2018; April 29, 2019; April 8, 2020; November 5, 2021; October 12, 2022; August 16, 2023
Revised: December 5, 2005; February 22, 2010
The above policy is based on the following references:
American Dental Association. CDT 2023 Dental Procedure Codes.
Copyright 2023 American Dental Association. All rights reserved.
Kwon,T.; Lamster, I.; Levin, L. Current Concepts in the Management of Periodontitis, International Dental Journal, 2021, 6:462-476.
Mercado, F.; Hamlet, S.; Ivanovski, S. Subepithelial connective tissue graft with or without enamel matrix derivative for the treatment of multiple Class III-IV recessions in lower anterior teeth: A 3-year randomized clinical trial. J. Periodontol. 2020, 9:473–483.
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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Health benefits and health insurance plans contain exclusions and limitations.