CurrentDelta Dental of OhioPolicy 282.28.v2

Clinical Criteria for Hydroxyapatite Regeneration

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Clinical and medical-necessity criteria for hydroxyapatite regeneration, including qualifying indications, documentation requirements, and circumstances that may result in benefit disapproval.

Policy Summary

PayerDelta Dental of Ohio

PolicyClinical Criteria for Hydroxyapatite Regeneration

Policy CodePolicy 282.28.v2

Change TypeNo material change

Effective DateJun 21, 2025

Next Review DateN/A

Key ActionSubmit the applicable dental-record information with the claim, including the P11-4 medicament used, clinical and radiographic examination findings, and treatment plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

D2991Applicable dental procedure code

Age 4+Minimum age for incipient non-cavitated lesions

5 minutesMinimum application time

30 minutesPost-application restriction

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CurrentDelta Dental of OhioPolicy 282.28.v2

Clinical Criteria for Hydroxyapatite Regeneration

Customize your policy alerts

Sign up for deltadentalofohio Policy 282.28.v2 alerts

Get alerted when Policy 282.28.v2 changes without checking for updates manually.

Monitor payer policy activity

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Clinical and medical-necessity criteria for hydroxyapatite regeneration, including qualifying indications, documentation requirements, and circumstances that may result in benefit disapproval.

Policy Summary

PayerDelta Dental of Ohio

PolicyClinical Criteria for Hydroxyapatite Regeneration

Policy CodePolicy 282.28.v2

Change TypeNo material change

Effective DateJun 21, 2025

Next Review DateN/A

Key ActionSubmit the applicable dental-record information with the claim, including the P11-4 medicament used, clinical and radiographic examination findings, and treatment plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

D2991Applicable dental procedure code

Age 4+Minimum age for incipient non-cavitated lesions

5 minutesMinimum application time

30 minutesPost-application restriction

Typical repeat-treatment frequency

Curodont Repair Fluoride PlusQualifying medicament

Hydroxyapatite Regeneration Overview

Hydroxyapatite regeneration is a noninvasive approach for managing early carious lesions without removing tooth structure. The procedure uses a medicament intended to support regeneration of hydroxyapatite in the affected area and is primarily associated with initial, non-cavitated lesions, including smooth-surface or white-spot lesions following fixed multibracket orthodontic treatment. When a member’s plan requires review, the dental record must document a generally accepted indication and support medical necessity and clinical appropriateness.

Medical Necessity and Clinical Appropriateness

Qualifying indications

Considered medically necessary and clinically appropriate when the dental record documents a generally accepted indication, including one of the following:

Incipient non-cavitated carious lesion: An incipient non-cavitated carious lesion is present and the patient is age 4 or older.Age 4 or older
Initial smooth-surface caries is present, including white-spot lesions following orthodontic fixed multibracket treatment.

Potential disapproval circumstances

Depending on clinical circumstances, application may be considered not medically necessary, inadvisable, or deficient in clinical quality when any of the following applies:

Disqualifying clinical or treatment circumstances

Inappropriate tooth or lesion: The medicament is applied to a tooth with no evidence of a carious lesion, a cavitated carious lesion, a restoration present or needed, a hopeless periodontal, endodontic, or structural prognosis, a primary tooth where natural exfoliation is imminent, or a tooth planned for extraction.
Protocol failure: The approved medicament application protocol is not followed.
Unsupported material: A material not clinically reported to promote hydroxyapatite regeneration is used.
Allergy:

Plan-specific and individual considerations

Coverage determinations must also account for applicable plan, regulatory, and patient-specific circumstances.

Plan and individual circumstances: Apply any dental benefit program criteria defining medical necessity, eligibility, or limits on the number of hydroxyapatite regeneration medicament applications covered per tooth or time period.

Consider individual patient characteristics, including age, comorbidities, complications, progress of treatment, psychosocial situation, and home environment, as well as the ability of available local dental services to meet the patient's specific needs. Federal or state statutes or regulations, dental plan contract provisions, claim-processing policies, and other mandated requirements may take precedence over these clinical criteria.

Benefits may be disapproved when hydroxyapatite regeneration medicament is applied to a tooth with no evidence of a carious lesion, a cavitated carious lesion, or a restoration present or needed. Disapproval may also apply when the tooth has a hopeless periodontal, endodontic, or structural prognosis, is a primary tooth nearing natural exfoliation, or is planned for extraction.

Hydroxyapatite regeneration may be considered not medically necessary or clinically inappropriate when applied to the same tooth on the same date of service as a direct or indirect restoration. The same consideration applies when the medicament is applied to a tooth surface previously treated with silver diamine fluoride.

Depending on the clinical circumstances, treatment may be considered not medically necessary, inadvisable, or deficient in clinical quality when the qualifying indication is absent, the approved medicament application protocol is not followed, or a material not clinically reported to promote hydroxyapatite regeneration is used. Treatment may also be disapproved when the patient is allergic to the hydroxyapatite regeneration material or another agent used in treatment.

Procedure and Treatment Parameters

Applicable Dental Procedure CodeCPT

D2991

application of hydroxyapatite regeneration medicament - per tooth

Patient age for incipient non-cavitated carious lesions

Minimum ageAge 4 or older

Qualifying lesionIncipient non-cavitated carious lesion

Additional qualifying indicationInitial smooth-surface caries, including white-spot lesions following orthodontic fixed multibracket treatment

Medicament application duration

Minimum application timeAt least five minutes

Application site preparationThe tooth is isolated and dried after prophylaxis; two percent sodium hypochlorite and phosphoric acid etch are applied before the medicament

Documentation and Disapproval Risks

Documentation Required

Submit examination and P11-4 documentation

When medical necessity or clinical appropriateness is reviewed, submit the applicable dental-record information with the claim. The record should support a thorough clinical and radiographic examination, an appropriate treatment plan, and use of a self-assembling peptide P11-4 medicament.

Describe the self-assembling peptide P11-4 medicament used.
Include applicable clinical and radiographic examination information and the treatment plan.

Documentation Required

Document any alternative material

If an agent other than Curodont Repair Fluoride Plus is reported for D2991, submit a detailed explanation supporting the reported hydroxyapatite regeneration treatment.

Identify the material used.
Describe the specific procedure performed.
Document tooth-surface preparation.

Clinical Terms

Noncavitated carious lesion

Surface integrityThe carious surface appears macroscopically intact

CavitationThere is no clinical evidence of cavitation

Clinical classificationThe lesion is distinguished from a cavitated lesion by visual or tactile assessment of surface integrity

Cavitated carious lesion

Surface integrityThe carious lesion surface is not macroscopically intact

Distinct discontinuityThe lesion has a distinct discontinuity or break in surface integrity

Usual determination

Policy Summary

PayerDelta Dental of Ohio

PolicyClinical Criteria for Hydroxyapatite Regeneration

Policy CodePolicy 282.28.v2

Change TypeNo material change

Effective DateJun 21, 2025

Next Review DateN/A

Key ActionSubmit the applicable dental-record information with the claim, including the P11-4 medicament used, clinical and radiographic examination findings, and treatment plan.

SourceLink

On This Page

The patient is allergic to the hydroxyapatite regeneration material or another agent used in treatment.

Conflicting treatment: The medicament is applied to the same tooth and on the same date of service as a direct or indirect restoration, or to a tooth surface previously treated with silver diamine fluoride.

Hydroxyapatite regeneration medicament

Post-treatment restriction

Restriction periodThirty minutes after medicament application

Do not eatThe patient should not eat during the restriction period

Do not drink or rinseThe patient should not drink or rinse during the restriction period

Repeat treatment frequency

Typical frequencyOnce or twice a year

More active cariesOnce or twice every six months may be recommended

Treatment contextRepeat treatment follows hydroxyapatite regeneration medicament application

Describe the topical application likely to produce hydroxyapatite regeneration consistent with the D2991 descriptor.

Note

Provide additional clinical information when requested

Delta Dental of Ohio may request additional clinical information relevant to the patient’s care when needed to make a coverage decision. Be prepared to provide the requested information.

Documentation Required

Document a qualifying indication

When the member’s dental plan requires a medical-necessity and clinical-appropriateness determination, the dental record must document a generally accepted indication for performing hydroxyapatite regeneration.

Incipient non-cavitated carious lesions in patients age 4 or older.
Initial smooth-surface caries, including white-spot lesions following orthodontic fixed multibracket treatment.

Denial Risk

Verify tooth and lesion suitability

Benefits may be disapproved when the medicament is applied to an inappropriate tooth or lesion, including a tooth with no evidence of a carious lesion, a cavitated carious lesion, or a restoration present or needed.

Hopeless periodontal, endodontic, or structural prognosis.
Primary tooth where natural exfoliation is imminent.
Tooth planned for extraction.

Denial Risk

Follow the approved application protocol

Failure to follow the approved medicament application protocol may result in disapproval based on lack of medical necessity or clinical appropriateness.

Denial Risk

Use and document a qualifying material

Use of a material not clinically reported to promote hydroxyapatite regeneration, or use of an agent other than Curodont Repair Fluoride Plus without the required detailed explanation, may result in disapproval.

For an alternative agent, document the material, specific procedure, tooth-surface preparation, and topical application.
The reported treatment must be consistent with the D2991 procedure code nomenclature and descriptor.

Denial Risk

Check for allergy or contraindication

Treatment may be disapproved when the patient is allergic to the hydroxyapatite regeneration material or another agent used in treatment. Verify allergies and contraindications before application.

Denial Risk

Avoid conflicting same-tooth treatment

Hydroxyapatite regeneration applied to the same tooth on the same date of service as a direct or indirect restoration, or to a tooth surface previously treated with silver diamine fluoride, may be considered not medically necessary or clinically inappropriate.

Check for same-tooth restoration treatment on the date of service.
Check whether the tooth surface was previously treated with silver diamine fluoride.

Cavitation is usually determined using visual or tactile means

Caries diagnosis

Primary and secondary lesionsAccessible primary and secondary cavitated and noncavitated carious lesions are diagnosed using this approach

Examination methodVisual-tactile examination

Classification methodUsed in conjunction with an accepted caries classification system