Subject: Local Delivery of Antimicrobial Agents (LDAs) via a Controlled-Release Vehicle Into Diseased Crevicular Tissue, Per Tooth, by Report. Use of Controlled Release of Antimicrobial Agents as Adjunctive Therapy in the Treatment of Adult Periodontitis
Reviewed: October 19, 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, excluded and 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 will consider the use of antimicrobial agents for coverage in localized recurrent and/or residual pockets with inflammation identified following the completion and clinical reevaluation of scaling and root planing (SRP). Our policy requires a minimum of 4 weeks for adequate response to root planing and scaling before reevaluation. Treatment with antimicrobial agents is considered a dental procedure and subject to applicable dental plan provisions.
We will determine necessity and appropriateness through review of corresponding diagnostics, and a rationale, if necessary. Need for local antimicrobial agents will be determined based upon the number of teeth treated versus the need for alternate periodontal therapy (for example, periodontal surgery).
If there are multiple sites of recurrent and/or residual pockets with inflammation following periodontal scaling and root planing, other more extensive periodontal treatment modalities (for example, surgery) may be more appropriate.
The placement of antimicrobial agents into diseased periodontal pockets for extended time periods is acceptable clinical practice in a select group of patients.
At present,four antimicrobial agents/delivery systems have been shown to be clinically safe and efficacious:
- Actisite® -fibers
- Atridox® -injectables
- Arestin® -microspheres using a syringe delivery system for sulcular placement
- PerioChip® -chips
The active agents in each product are antimicrobials and are effective against a broad spectrum of crevicular microbial flora.
These agents/delivery systems, have been used for a number of years:
• Actisite, 25 percent tetracycline hydrochloride impregnated into an ethylene/vinyl acetate copolymer elastic fiber, has been used in clinical practice for more than 5 years.
• Atridox, 10 percent doxycycline hyclate, was approved by the FDA for clinical use in September 1998.
• PerioChip, 2.5 mg of chlorhexidine gluconate in a hydrolyzed gelatin base, was approved by the FDA for clinical use in May 1998.
• Arestin, 1 mg minocycline HCl microspheres, was approved by the FDA for clinical use in May 2001.
Actisite fibers must be removed from the pocket(s) at a second visit because the fibers are not biodegradable. The other three agents are biodegradable over a 7- to 10-day period of useful life.
Adult periodontitis is routinely treated with plaque control, periodontal SRP and, as required, various surgical procedures. Active periodontal therapy is followed by supportive periodontal therapy, approximately 3 to 4 months after active treatment.
At this time, all four listed products are indicated for treatment in active and recurrent and/or residual pockets with inflammation. An active site is usually described as a periodontal pocket, 5 millimeters or greater, that shows clinical signs of inflammation, bleeding, suppuration, increasing pocket depth and/or increasing attachment loss. If there are multiple sites of recurrent and/or residual inflammation after periodontal scaling and root planing has been completed, more extensive periodontal therapeutic modalities (for example, surgery) may need to be appropriately employed. The use of subgingivally placed chemotherapeutic agents may also be indicated as an adjunct to periodontal maintenance therapy when localized recurrent and/or residual sites with inflammation are found. Antimicrobial agents may also be used in the treatment of an acute periodontal abscess, when the depth of the pocket remains constant.
The use of antimicrobial agents may be indicated after the initial phase of periodontal therapy. Thorough SRP is highly effective in the treatment of chronic periodontitis and is the standard approach to non-surgical periodontal therapy. In most cases the majority of sites will respond and require no additional adjunctive or aggressive therapy.
The success of the overall periodontal treatment performed during the initial phase should be assessed in 4 to 6 weeks following treatment. If limited refractory periodontitis is confined to one or a few isolated sites, the use of these agents may be indicated. If a generalized pattern of nonresponsive periodontitis is found, a more comprehensive intervention of surgical resection and regeneration may be the appropriate treatment of choice, subject to individual clinical circumstances.
Specific to DMI program: Because additional studies are needed regarding the effectiveness of LDAs in special populations (for example, those who are medically compromised,) the use of LDAs in DMI (Dental-Medical Integration) program members may be considered for coverage concurrently with scaling and root planing.
However, if there are multiple sites with pocketing and/or inflammation, other more extensive periodontal treatment modalities (for example, surgery) may be more appropriate.
Antimicrobial agents and implants
The use of the antimicrobial agent Arestin has not been clinically tested for use in the regeneration of alveolar bone, either in preparation for or in conjunction with the placement of endosseous dental implants or in the treatment of failing implants.6 The use of Arestin in this application is considered by Aetna to be experimental and/or still under clinical investigation, and therefore is excluded from coverage.
D4381 -- Localized delivery of antimicrobial agents via a controlled-release vehicle into diseased crevicular tissue, per tooth, by report.
FDA-approved subgingival delivery devices containing antimicrobial medication(s) are inserted into periodontal pockets to suppress the pathogenic microbiota. These devices slowly release the pharmacological agent so they can remain at the intended site of action in a therapeutic concentration for a sufficient length of time.4
Aetna supports the nomenclature and descriptor as stated in the Current Dental Terminology (CDT), Code on Dental Procedures and Nomenclature as published by the American Dental Association.4 As the code specifically references a per-tooth application, and does not reference a tray-delivery method (such as the Perio Protect® system), or the adjunctive use of a specialized technology (such as the utilization of lasers), benefits for delivery techniques, methods and/or specialized technology will not be considered for other than the service as defined by the CDT code (please see above).
Original policy:November 23, 2004
Updated: May 21, 2012; August 12,2013; June 9, 2014; October 19, 2015
Revised: December 5, 2005; November 28, 2007; October 13, 2008; September 22, 2009; December 21, 2009; April 25, 2011
The above policy is based on the following references:
1 Paquette, David W. Minocycline microspheres: a complementary medical-mechanical model for the treatment of chronic periodontitis. Compendium. May 2002; Volume 23: No. 5 (Suppl):3.
2 Killoy,W.J. Assessing the effectiveness of locally delivered chlorhexidine: in the treatment of periodontitis. Journal of the American Dental Association. April 1999; Volume 130(4):567:570.
3 Practical Procedures and Aesthetic Dentistry, Volume 14, No. 2, Mar 2002.
4 American Dental Association. CDT 2015 Dental Procedure Codes: 37.*
5 Parameter on systemic conditions affected by periodontal diseases. Journal of Periodontology. May 2000; Volume 71 No. 71:847-883.
6 Prescribing Information for Arestin (minocycline hydrochloride) Microshperes, 1 mg, OraPharma, Inc., 04/05 R3.
7 Task force on Local Delivery of Antimicrobials as Adjunct Therapy, approved Board of Trustees of the American Academy of Periodontology. (May 2006). American academy of periodontology statement on local delivery of sustained or controlled release antimicrobials as adjunctive therapy in the treatment of periodontitis. Retrieved June 5, 2015, from http://www.joponline.org/doi/pdf/10.1902/jop.2006.068001.
* 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.