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Health Coverage
Clinical Policy Bulletins
Dental - Clinical Policy Bulletins
Number: 003 Subject: Local Delivery of Antimicrobial Agents 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: November 28, 2007 Important Note This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. We have reached these conclusions based upon 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, and 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 consult the member's benefits plan to determine if there are any exclusions or other benefits 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 (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 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. Policy The use of antimicrobial agents will be considered for coverage if used as an adjunct to or concurrently with active periodontal therapy. This will include the adjunctive use of local antimicrobial agents at the time of scaling and root planing (SRP). “Active therapy” is defined broadly to include scaling and root planing and periodontal surgery.Treatment with antimicrobial agents is considered a dental procedure and subject to applicable dental plan provisions. Necessity and appropriateness will be determined 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). A single application will be considered on the same tooth/teeth in a 12-month period on a per-tooth basis regardless of how many “sites” (for example, buccal and lingual pockets) per tooth are treated. Background 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 --Actisite®, Atridox™, Arestin™ and PerioChip® -- have been shown to be clinically safe and efficacious. These systems are used as injectables (Atridox), fibers (Actisite), microspheres using a syringe delivery system for sulcular placement (Arestin), and chips (PerioChip). 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, has been used in clinical practice for over five 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 scaling and root planing, 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 refractory sites of adult periodontitis. 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 active or refractory disease after periodontal scaling and root planing has been completed, other more extensive periodontal therapeutic modalities (for example, surgery) may be more appropriately employed. The use of subgingivally placed chemotherapeutic agents may also be indicated as an adjunct to periodontal maintenance therapy when localized recurrent active sites 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 during the initial phase of periodontal therapy with scaling and root planing.Periodontal scaling and root planing alone may be adequate to resolve periodontal disease for patients diagnosed with Case Types I and II periodontal conditions (see below). 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 the active periodontitis is confined to one or a few sites, the use of these agents may be indicated. If a more general pattern of nonresponsive periodontitis is found, a more comprehensive intervention of surgical resection and regeneration may be appropriate alternative treatments of choice, subject to individual clinical circumstances. 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. Codes4 D4381 -- Localized delivery of antimicrobial agents via a controlled-release vehicle into diseased crevicular tissue, per tooth, by report.Revision Dates Original policy: November 23, 2004Updated Revised: December 5, 2005; November 28, 2007 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. Current Dental Terminology, CDT 2007-2008: 26.* 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, 1mg, OraPharma, Inc., 04/05 R3.
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. Copyright 2001 - 2007 Aetna Inc. |
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