ModifiedAnthemPolicy 04-203

Biological Materials to Aid in Soft and Osseous Tissue Regeneration

Defines clinical documentation and contract-based coverage requirements for use of biological materials (e.g., PRP, Emdogain, rhBMP, GEM 21S) to aid in periodontal and osseous tissue regeneration in dentistry, whether used alone or with other procedures. Provides criteria for documentation, exclusions when used with certain procedures/sites, and informational CDT codes.

Policy Summary

PayerAnthem

PolicyBiological Materials to Aid in Soft and Osseous Tissue Regeneration

Policy CodePolicy 04-203

Change TypeRevised (annual review noted)

Effective DateJan 1, 2023

Next Review Date

Key ActionSubmit pretreatment periapical radiographs, current 6‑point periodontal charting showing ≥5mm pocket depths, and a letter of rationale specifying the biologic material when requested to support coverage.

SourceLink

POLICY UPDATE CHANGES

Policy marked 'Revised' with last review date 2022-10-26 and publish date 01/01/2023.

3Required documentation items

7Listed exclusions/contexts

3Example CDT codes

Coverage Summary

Background: This policy (Policy #04-203, status: MODIFIED) addresses the use of biologic materials to aid in soft and osseous tissue regeneration in dentistry — a component of dental tissue engineering/regenerative medicine intended to restore, maintain, or improve periodontal and osseous tissue function. Coverage is contract-dependent and based on generally accepted standards of dental care with emphasis on medical/dental necessity and cost-effectiveness.

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Scope summary: Defines clinical documentation and contract-based coverage requirements for use of biological materials (examples: PRP, Emdogain®, rhBMP, GEM 21S®) to aid in periodontal and osseous tissue regeneration, whether used alone or in conjunction with other procedures. Provides criteria for required documentation (radiographs, periodontal charting, letter of rationale), lists contexts where biologic materials may not be considered, and presents informational CDT codes. Effective date: 2023-01-01. Last review date: 2022-10-26. Coverage stance: mixed.

Medical-Necessity Criteria and Documentation Requirements

Documentation / Indications Requirements

When covered by specific group contract, indications for the use of biologic materials must be documented by all of the following:

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"operator":"all",

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{"text":"Pretreatment periapical radiographic images that are of diagnostic quality, properly oriented, identified, and dated current.","threshold":"<= 12 months","note":"Images must be dated and within the currency threshold."},

{"text":"Current, dated periodontal charting (6-point periodontal charting) indicating pocket depths of at least 5 mm.","threshold":">= 5 mm","note":"Charting must document >=5 mm pocket depths at affected sites."},

A letter of rationale explaining the necessity of the regeneration procedure and the type of material being used (examples: platelet rich plasma (PRP), Emdogain®, recombinant human bone morphogenic protein (rhBMP), GEM 21S®, etc.).

]

}

Documentation Required

Provide pretreatment radiographs

Provide pretreatment periapical radiographs that are diagnostic quality, properly oriented, identified, and dated within 12 months.

Pretreatment periapical radiographic images must be current (dated within 12 months).
Images should be of diagnostic quality, properly oriented, and clearly identified.

Documentation Required

Provide periodontal charting

Provide current, dated 6‑point periodontal charting documenting pocket depths of at least 5 mm at the treated sites.

Periodontal charting must be current and dated.
Charting must document pocket depths >= 5 mm for the sites proposed for regenerative therapy.

Documentation Required

Letter of rationale

Provide a letter of rationale explaining the clinical necessity for the regeneration procedure and specifying the biologic material to be used.

Include the indication for regeneration and the specific product or material planned (e.g., PRP, Emdogain®, rhBMP, GEM 21S®).

Exclusions — Contexts Where Biologic Materials Are Not Considered

Exclusions / Not considered

Biologic materials may not be considered when used in the following contexts regardless of specific group plan coverage:

ANY of the following

Soft tissue grafting: When used in conjunction with soft tissue grafting.
Bone grafts: When used in conjunction with bone grafts.
Guided tissue regeneration: When used in conjunction with guided tissue regeneration.
Ridge augmentation: When used in conjunction with ridge augmentation.
Periradicular surgery: When used in conjunction with periradicular surgery.
Extraction sites: When placed within extraction sites.
Other regenerative materials: When utilized with other regenerative materials.

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Denial Risk

Exclusion when combined with certain procedures/sites

Claims for biologic materials may not be considered/covered when used with soft tissue grafting, bone grafts, guided tissue regeneration, ridge augmentation, periradicular surgery, placed within extraction sites, or when utilized with other regenerative materials; document accordingly to avoid denial.

Coding (Informational)

Informational CDT codes (examples)CDT

D3431	Biological 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, per site.
D4266	Guided tissue regeneration - resorbable barrier per site.

Codes listed (CDT codes such as D3431, D4265, D4266) are provided for informational purposes only and do not by themselves determine member coverage. Coverage is contract-dependent; inclusion/exclusion of a code does not guarantee payment. Payer-specific claim adjudication and the member's contract benefits in effect at the time of service apply to determine coverage or non-coverage.

Provider Actions & Submission Guidance

Denial Risk

Exclusion when combined with certain procedures/sites

Operational note: Coverage for biologic materials is contract-dependent. Documentation may be requested to substantiate medical/dental necessity, including pretreatment periapical radiographs dated within 12 months, current 6‑point periodontal charting showing a minimum of 5mm pocket depths, and a letter of rationale specifying the regeneration procedure and the biologic material used (examples: platelet rich plasma (PRP), Emdogain®, recombinant human bone morphogenic protein (rhBMP), GEM 21S®).

Background & Evidence

Background: Biologic materials are used in dental tissue engineering and regenerative medicine as adjunctive regenerative therapy to regenerate damaged periodontal and osseous tissues rather than relying solely on grafts, with the goal to restore, maintain, or improve tissue function. Determination of whether such services are covered is made in accordance with specific plan contract provisions and generally accepted standards of dental practice; a finding of medical or dental necessity does not by itself guarantee that the service is a covered benefit payable by the dental plan.

Evidence and definition

Peer-reviewed studies and guidelines referencedMultiple clinical studies and AAP position/review papers (references 1-13) supporting enamel matrix derivatives, PRP, rhBMP, grafting techniques.

Definition: Generally accepted standards of dental practiceStandards based on credible scientific evidence in peer-reviewed dental literature, specialty society recommendations, views of recognized dentists in the relevant clinical area, and other credible sources.

Policy Summary

PayerAnthem

PolicyBiological Materials to Aid in Soft and Osseous Tissue Regeneration

Policy CodePolicy 04-203

Change TypeRevised (annual review noted)

Effective DateJan 1, 2023

Next Review Date

SourceLink

On This Page

OpenPayer

Biological Materials to Aid in Soft and Osseous Tissue Regeneration

Coverage Summary

Medical-Necessity Criteria and Documentation Requirements

Exclusions — Contexts Where Biologic Materials Are Not Considered

Coding (Informational)

Provider Actions & Submission Guidance

Background & Evidence

Revision History