ModifiedAnthemPolicy 03-401

Biological Materials to Aid in Soft Tissue and Osseous Tissue Regeneration (Endodontic)

Governs the documentation, clinical indications, and coding guidance for use of biological materials to aid in soft and bone tissue regeneration in dental care when covered by group contract; applies to dental providers evaluating or performing regenerative adjunctive therapy for periodontal defects and dental implants.

Policy Summary

PayerAnthem

PolicyBiological Materials to Aid in Soft Tissue and Osseous Tissue Regeneration (Endodontic)

Policy CodePolicy 03-401

Change TypeNo material clinical or coverage changes

Effective Date01/01/2024

Next Review Date

Key ActionWhen covered by the member's group contract, document pretreatment diagnostic periapical radiographs, current 6-point periodontal charting showing ≥5 mm pocket depths, and a letter of rationale.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5mmminimum pocket depth

12 monthsmax age of radiograph

D4265, D3431example CDT codes

03-401document id

Coverage Criteria

Indications / Documentation for Coverage

Covered when ALL of the following documentation and clinical findings are present and coverage is allowed by the member's group contract

Documentation and clinical criteria: 1) Pretreatment periapical radiographic images that are diagnostic quality, properly oriented, identified, and dated within 12 months; 2) Current, dated 6-point periodontal charting (as described by AAP/ADA) indicating a minimum of 5 mm pocket depths; 3) A letter of rationale explaining the necessity of the regeneration procedure and the type of biological material being used may be requested (examples: platelet rich plasma [PRP], Emdogain, recombinant human bone morphogenic protein [rhBMP], Gem-21S).

Applies only when covered by specific group contract; documentation may be requested prior to coverage determination.

Concomitant Use Exclusions

Not considered when used in conjunction with the following (regardless of specific group plan coverage)

Disallowed conjoint uses: Use of biological materials may not be considered when used in conjunction with soft tissue grafting, bone grafts, guided tissue regeneration, ridge augmentation, periradicular surgery, placed within extraction sites, or when utilized with other regenerative materials.

Policy Summary

PayerAnthem

PolicyBiological Materials to Aid in Soft Tissue and Osseous Tissue Regeneration (Endodontic)

Policy CodePolicy 03-401

Change TypeNo material clinical or coverage changes

Effective Date01/01/2024

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

This exclusion applies regardless of specific group plan coverage.

The policy specifies that the use of biological materials may not be considered for coverage when they are used in conjunction with certain other procedures. Examples of these disallowed conjoint uses include: soft tissue grafting, bone grafts, guided tissue regeneration, ridge augmentation, periradicular surgery, placement within extraction sites, or use together with other regenerative materials. This exclusion applies regardless of specific group plan coverage and should be confirmed against the member's contract prior to benefit determination.

A determination that a procedure is medically or dentally necessary does not by itself guarantee that the service is a covered benefit or that payment will be made. Federal and state law and the member's contract language take precedence, and plan contract provisions govern benefit eligibility and payment. Providers should verify coverage with the member's plan and understand that policy guidance does not override contractual limitations.

Coding and Clinical Thresholds

CDT example codesCPT

D3431	Biologic materials to aid in soft and osseous tissue regeneration in conjunction with periradicular surgery
D4265	Biological material to aid in soft and osseous tissue regeneration, per site

ICD-10 CM Diagnoses (reference)ICD-10

See CDT code book

ICD-10 CM Diagnoses for Dental Diseases and Conditions: See the current CDT code book for details

inv-06: Periodontal pocket depth — numeric threshold

Minimum documented periodontal pocket depth>= 5 mm (documented on current, dated 6-point periodontal charting)

Charting standard6-point periodontal charting as described by AAP and ADA

Documentation timeframe relevanceCharting must be current and dated when submitted for coverage consideration

inv-07: Age of pretreatment radiograph — numeric threshold

Maximum age of pretreatment periapical radiograph<= 12 months (radiographs must be diagnostic quality, properly oriented, identified, and dated)

Image requirementsPretreatment periapical radiographic images must be of diagnostic quality, properly oriented, and identified

Use-caseRadiographs are required when biologic materials are covered by specific group contract and may be requested for coverage determination

Provider Actions and Documentation Requirements

Note

Documentation may be requested

Documentation may be requested to support coverage when indicated by the member's specific group contract. Examples of documentation that may be required include diagnostic imaging, periodontal charting, and other records relevant to the indication for biologic materials.

Pretreatment periapical radiographs (diagnostic quality, properly oriented, identified and dated; current within 12 months).
Current, dated 6‑point periodontal charting (AAP/ADA method) showing a minimum of 5 mm pocket depths where applicable.

Denial Risk

Provider alert — documentation and denial risk

Providers should be aware that lack of required documentation may result in claim denial or request for additional information. Ensure all requested records are submitted with the claim or during prior authorization to avoid processing delays.

Failure to provide pretreatment periapical radiographs dated within 12 months.
Missing or incomplete 6‑point periodontal charting.
Absence of a letter of rationale when requested explaining medical necessity and the specific biologic material to be used.

Documentation Required

Required documentation

Required documentation — when biologic materials are covered by the group contract, submit the following items as applicable to establish medical necessity. Additional documentation may be requested by the plan.

Pretreatment periapical radiographs (diagnostic quality, oriented, identified, and dated; current within 12 months).
Current, dated 6‑point periodontal charting per AAP/ADA showing ≥ 5 mm pocket depths where indicated.
Letter of rationale explaining the need for the regenerative procedure and naming the biologic material(s) proposed (examples: platelet rich plasma [PRP], Emdogain, recombinant human bone morphogenic protein [rhBMP], Gem‑21S).
Documentation that biologic materials are not being used in conjunction with excluded procedures when coverage restricts such combinations (e.g., soft tissue grafting, bone grafts, guided tissue regeneration, ridge augmentation, periradicular surgery, placement within extraction sites, or combined with other regenerative materials).

Denial Risk

Documentation triggers for denial

Documentation triggers for denial — the plan may deny coverage when required records are incomplete, missing, or demonstrate exclusionary use. Review and submit complete documentation to reduce denial risk.

No pretreatment periapical radiographs or radiographs older than 12 months.
Incomplete or absent 6‑point periodontal charting or charting that does not document the required pocket depths.
No letter of rationale when requested or rationale that does not support medical necessity for the specific biologic material.
Evidence that the biologic material is being used in conjunction with procedures excluded by the group contract (see list above).

Background

Tissue engineering, also called regenerative medicine, focuses on regenerating damaged tissues by developing biological substitutes that restore, maintain, or improve tissue function rather than relying solely on grafts. In dentistry, adjunctive regenerative biological materials are used to support regeneration of periodontal defects around natural teeth and, more recently, dental implants. Because benefit determination is subject to contractual requirements, the plan reviews use of these materials to ensure services meet accepted standards of dental care and applicable contract provisions before coverage is approved.

Definitions

inv-13: Tissue engineering / regenerative medicine — definition entry

DefinitionTissue engineering / regenerative medicine: a process by which damaged tissues are regenerated rather than using grafts by developing biological substitutes that restore, maintain, or improve tissue function.

Dental applicationIn dentistry, adjunctive regenerative biological materials are used to treat periodontal defects of natural teeth and dental implants.

Examples of biologic materialsExamples may include platelet rich plasma (PRP), Emdogain, recombinant human bone morphogenic protein (rhBMP), Gem-21S.