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Local Chemotherapeutic/Antimicrobial Agents (003)

Number: 003
(Revised)

Subject: Local Delivery of Antimicrobial Agents (LDAs) as Adjunctive Therapy in the Treatment of Adult         Periodontitis

Reviewed: April  8, 2016

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. CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.

Developments in Aetna’s Clinical Policy

New practice guidelines published in 2015 in the Journal of the American Dental Association have prompted Aetna to conclude that the use of local antimicrobial agents in connection with the treatment of periodontitis is experimental and investigational in all clinical settings for purposes of coverage under Aetna plans. Previously, the 2006 “American Academy of Periodontology statement on local delivery of sustained or controlled release antimicrobials as adjunctive therapy in the treatment of periodontitis1 served as the prevailing scientific position of the profession on this treatment.  In 2015, however, the Journal of the American Dental Association published its Evidence-based clinical practice guideline on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts,”2 which concludes with a weak recommendation for one type of local antimicrobial agent and a low level of certainty for others.

Until we are able to update our benefit plans and processes in light of these new clinical standards, we will continue to consider benefits (under plans that list local antimicrobial agents as a covered benefit) for local antimicrobial agents under a transitional policy based on our previous Dental Clinical Policy Bulletin.

Aetna’s Current Clinical Policy

Aetna considers the use of local antimicrobial agents as experimental and investigational for the treatment of periodontal disease in all clinical settings.

Aetna’s Transitional Policy

This transitional policy applies to Aetna plans that specifically list local antimicrobial agents as a covered benefit.

The use of antimicrobial agents will be treated as necessary and appropriate in localized recurrent and/or residual pockets with inflammation identified following the completion and clinical reevaluation of scaling and root planing (SRP). We require a minimum of 4 weeks for adequate response to root planing and scaling before reevaluation.

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. 

Treatment with antimicrobial agents is considered a dental procedure and subject to applicable dental plan provisions.

Specific to Dental-Medical Integration (DMI) program: In the transitional period, the use of LDAs in DMI program members may still 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 with implants – Current and Transitional Policy

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.3

The use of Arestin in this application is considered by Aetna to be experimental and investigational.

Background

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.

The placement of antimicrobial agents into diseased periodontal pockets for extended time periods has been used in clinical practice in a select group of patients.  Four antimicrobial agents/delivery systems have undergone extensive evaluation for clinical safety and efficacy and have been used in clinical practice:

  • 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.

Actisite, 25 percent tetracycline hydrochloride impregnated into an ethylene/vinyl acetate copolymer elastic fiber, must be removed from the pocket(s) at a second visit because the fibers are not biodegradable. 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. Atridox, Periochip and Arestin are biodegradable over a 7- to 10-day period of useful life. 

All four listed products have been utilized in treatment of 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 have also been used in the treatment of an acute periodontal abscess, when the depth of the pocket remains constant.

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 2006 “American Academy of Periodontology statement on local delivery of sustained or controlled release antimicrobials as adjunctive therapy in the treatment of periodontitis” stated that the existing data were insufficient to conclude that adjunctive local antimicrobial agents could reduce the need for surgery or improve long-term tooth retention, or was cost effective. The statement held that clinicians might consider the use of local antimicrobial agents in chronic periodontitis patients as an adjunct to SRP when localized recurrent and/or residual PD greater than or equal to 5mm with inflammation is still present following conventional therapies.

In 2015, the Journal of the American Dental Association published the findings of a multidisciplinary panel convened by the American Dental Association (ADA) Council on Scientific Affairs (CSA.) The CSA presented clinical practice guidelines on the nonsurgical treatment of chronic periodontitis by means of SRP with or without adjuncts on the basis of a systematic review of the evidence.2  For patients with chronic periodontitis, the evidence based review concluded SRP showed a moderate benefit, and the benefits were judged to outweigh potential adverse effects. The guidelines were in favor of SRP as the initial nonsurgical treatment for chronic periodontitis. Regarding adjuncts, however, the strength of recommendations for chlorhexidine chips was deemed to be “weak” and recommendations for doxycycline hyclate gel and minocycline microspheres were listed as “expert opinion for.”  (Note that “expert opinion for” does not imply endorsement but instead signifies that evidence is lacking and the level of certainty in the evidence is low.) 

The ADA CSA evidence-based review could not definitively support the use of these adjuncts in conjunction with or following SRP. Therefore, Aetna’s current clinical policy decision is that locally applied antimicrobials are considered experimental and investigational under Aetna plans.  

Codes4

D4381 — Local Delivery of Antimicrobial Agents via a Controlled-Release Vehicle into Diseased Crevicular Tissue, per Tooth

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). 

Revision dates
Original policy: November 23, 2004
Updated: May 21, 2012; August 12, 2013; June 9, 2014
Revised: December 5, 2005; November 28, 2007; October 13, 2008; September 22, 2009; December 21, 2009; April 25, 2011; October 19, 2015; April 8, 2016

The above policy is based on the following references:

1Task 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 April 7, 2016 from http://www.joponline.org/doi/pdf/10.1902/jop.2006.068001.

2Evidence-based clinical practice guideline on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. JADA 2015:146(7):525-535, http://dx.doi.org/10.1016/j.adaj.2015.01.026

3OraPharma. Valeant Pharmaceuticals North America LLC, Product information sheet Rev. 08/2015.

4CDT 2016 Dental Procedure Codes: 37. Copyright 2016 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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