ModifiedAlliance HealthPolicy 1N-2

Allergy Immunotherapy

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Defines NC Medicaid coverage, prior approval expectations, and clinical criteria for allergy immunotherapy and rapid desensitization for beneficiaries enrolled in NC Medicaid.

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ModifiedAlliance HealthPolicy 1N-2

Allergy Immunotherapy

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Defines NC Medicaid coverage, prior approval expectations, and clinical criteria for allergy immunotherapy and rapid desensitization for beneficiaries enrolled in NC Medicaid.

Policy Summary

PayerAlliance Health

PolicyAllergy Immunotherapy

Policy CodePolicy 1N-2

Change TypeUnit limit and definition updatesadded definitions

Effective Date

Last ReviewFeb 1, 2025

Next Review Date

Key ActionBill antigen supply and administration separately and follow updated CPT unit limits (e.g., 95180 = 6 units/day; 95144–95149 and 95170 = 10 units/day; 95165 capped at 180 units/365 days with max 10 doses per 10 mL vial).

SourceLink

POLICY UPDATE CHANGES

Unit limitations for multiple CPT codes were changed (e.g., 95180 from 12 to 6 units per date of service; several 9514x and 95170 from 1 to 10 units per date of service).

Definitions were added for Rapid Desensitization and Hymenoptera Sensitivity.

Changed volume unit label from cc to mL to match current practices.

NCApplicable state

No PAPrior authorization

695180 max units/day

1095144/45–49/70 max units/day

180/365d95165 limit

18 listedNon-covered antigens

Coverage and Medical Necessity Criteria

Initial/Standard Immunotherapy

Covered when ALL of the following are met:

Standard Allergy Immunotherapy Coverage: 1) The hypersensitivity cannot be managed by medications or allergen avoidance; 2) Triggering allergens determined by appropriate skin testing or blood tests per Policy 1N-1 (Allergy Testing); 3) The beneficiary has clinically significant allergic symptoms or a chronic allergic state caused by one of: (a) hymenoptera sensitivity; (b) inhalants; (c) allergic (extrinsic) asthma; (d) allergic rhinitis or conjunctivitis; or (e) dust mite atopic dermatitis.

See Policy 1N-1 for testing requirements.

General Coverage Criteria

Covered when ALL general medical necessity criteria are met:

General Medical Necessity: a) The procedure, product, or service is individualized, specific, and consistent with the beneficiary's symptoms or confirmed diagnosis and not in excess of the beneficiary's needs; b) It can be safely furnished and no equally effective and more conservative or less costly treatment is available statewide; c) It is furnished in a manner not primarily intended for the convenience of the beneficiary, the beneficiary's caretaker, or the provider.

These are general Medicaid medical necessity requirements.

Rapid Desensitization

Rapid desensitization is covered when ANY one of the following is present:

Rapid Desensitization Coverage: a) Hymenoptera sensitivity; b) Presence of IgE antibodies to a medically necessary drug for which substitution with an alternative medicine is not an effective option; c) Moderate to severe allergic rhinitis requiring treatment during or immediately before the season of the affecting allergy.

Any one criterion suffices for coverage of rapid desensitization.

Covered Rapid Desensitization

Medicaid covers rapid desensitization when ANY one of the following is met:

Covered Rapid Desensitization: a) Hymenoptera sensitivity; b) Presence of IgE antibodies to a medically necessary drug for which substitution is not an effective option; c) Moderate to severe allergic rhinitis requiring treatment during or immediately before the season of the affecting allergy.any one of a-c

From Medicaid additional criteria for rapid desensitization.

Duration/Continuation Criteria

Continuation of allergy immunotherapy is covered only when ALL of the following apply:

Continuation therapy effectiveness: a) Noticeable decrease of symptoms; b) Demonstrated increase in tolerance to the offending allergen; c) Reduction in medication usage and documented clinical benefit.all required

Treatment beyond two years is not covered if any of these are absent.

Coverage with documentation and coding conditions

Covered when billing and documentation requirements are met and code/unit limits are followed:

Documentation and coding requirements: Health record documents medical necessity, that triggering allergens were determined by appropriate diagnostic testing, any reactions to injections, continuing evaluation of treatment effectiveness, and the number of vials/doses prepared with the injection schedule; supply (preparation) and administration must be billed separately using distinct CPT codes.

Supports medical necessity and claim adjudication.

Unit limits: Providers must follow unit limits per CPT: 95115 (1 unit per date of service when only one injection given); 95117 (1 unit per date of service when two or more injections given); 95180 (rapid desensitization billed as one hour equals one unit; testing limitation 6 units per date of service); 95144/95145–95149/95170 (preparation codes limited to 10 units per date of service); 95165 (billable unit defined as 1 mL, limited to 10 doses per 10 mL vial and 180 units per 365 days).

Unit limits effective per Attachment A and Billing Units section.

Non-covered coding: Codes describing combined supply and administration (complete service codes) are not covered; the supply (preparation) of antigen(s) and the administration of antigen(s) must be billed separately. Examples include non-covered codes listed in Attachment A (e.g., 95120, 95125, 95130–95134).

Medicaid excludes services that are unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice. For beneficiaries under age 21, EPSDT allows exceeding policy limits only when provider documentation demonstrates the service is medically necessary to correct or ameliorate a condition and meets EPSDT criteria; EPSDT does not require coverage for services that are unsafe, ineffective, or experimental/investigational.

Allergy immunotherapy is explicitly not covered for intrinsic (non-allergic) asthma, food allergy, angioedema, chronic urticaria, migraine headaches, or non-allergic vasomotor rhinitis. The policy also lists multiple specific non-covered antigens (for example: newsprint, tobacco smoke, dandelion, orris root, phenol, formalin, alcohol, sugar, yeast, grain mill dust, pyrethrum, marigold, soybean dust, honeysuckle, wool, fiberglass, green tea, and chalk) and excludes allergen-proof supplies (mattresses, casings, pillows, etc.).

Procedure codes that describe a combined supply of antigen and allergy injection provided during a single encounter are not covered. The policy directs providers to Attachment A, Section C, 4 for the specific list of non-covered combined-supply codes and states that supply and administration must be billed separately.

The policy identifies specific CPT codes that represent the complete service (combined supply + administration) as non-covered. Examples are shown in Attachment A where complete-service codes (e.g., mappings listed in the non-covered codes section) are not payable; providers must bill the supply (preparation) and the administration as separate CPT codes.

Services, procedures, or products that are not individualized, not specific or consistent with the beneficiary’s symptoms or confirmed diagnosis, provided in excess of the beneficiary’s needs, unsafe, or where an equally effective, more conservative, or less costly statewide option exists, are considered not medically necessary and may be denied.

Medicaid will not cover services that are experimental, investigational, part of a clinical trial, duplicate another provider’s service, or when the beneficiary fails to meet eligibility or the policy’s specified criteria. Coverage requires that the service meet general medical necessity standards: be individualized, safe to furnish, and not primarily for convenience.

Billing, Codes, and Unit Limits

Combined supply procedure codesCPTNot Covered

No codes listed

Billing modifiers/instructionsModifier

Modifier 25

Append to office visit code to indicate separately identifiable service when billed with an allergy injection.

Covered CPT Codes with unit limitationsCPTCovered

95115	Administration of antigen(s) by injection; testing limitation 1 unit per date of service
95117	Administration of antigen(s) by injection; testing limitation 1 unit per date of service
95180	Allergy treatments (rapid desensitization); testing limitation 6 units per date of service
95144	Preparation of antigen(s); testing limitation 10 units per date of service
95145	Preparation of antigen(s); testing limitation 10 units per date of service
95146	Preparation of antigen(s); testing limitation 10 units per date of service
95147	Preparation of antigen(s); testing limitation 10 units per date of service
95148	Preparation of antigen(s); testing limitation 10 units per date of service
95149	Preparation of antigen(s); testing limitation 10 units per date of service
95165	Preparation/supervision for build-up and maintenance concentrate vial; testing limitation 180 units per 365 days; reimbursement based on mL per vial and max 10 doses per 10 mL vial

1–10 of 11

1/2

Non-Covered/Combined Supply Procedure CodesCPTNot Covered

95120	Non-covered when used as combined supply+administration (listed in Non-Covered Codes)
95125	Non-covered (listed under non-covered codes mapping)
95130	Non-covered (listed under non-covered codes mapping)
95131	Non-covered (listed under non-covered codes mapping)
95132	Non-covered (listed under non-covered codes mapping)
95133	Non-covered (listed under non-covered codes mapping)
95134	Non-covered (listed under non-covered codes mapping)

Covered CPT CodesCPTCovered

95115	Administration of antigen(s) by injection — one unit billed when only one injection is given on the same day
95117	Administration of antigen(s) by injection — one unit billed when two or more injections are given on the same day
95180	Allergy treatments — rapid desensitization billed as one hour equals one unit
95165	Preparation of antigen(s) — supervision of preparation and provision of the build-up and maintenance concentrate vial; billable unit dose defined as 1 mL aliquot; limited to 10 doses per 10 mL vial

Duration of therapy — continuation rules

Coverage limitTreatment beyond 2 years is not covered when any of the following are true: no noticeable decrease of symptoms; no demonstrated increase in tolerance to the offending allergen; no reduction in medication usage; or no documented clinical benefit.

Individualization requirementAllergy immunotherapy must be individualized, specific, and consistent with the beneficiary's symptoms or confirmed diagnosis.

Documentation requiredOngoing evaluation of effectiveness must be documented to justify continuation beyond two years.

Decision triggerIf any one of the effectiveness criteria is absent, continuation beyond two years is not covered.

CPT 95165 billable unit definition

Provider Responsibilities, Documentation, and Billing Practices

Note

Prior Approval

Medicaid shall not require prior approval for Allergy Immunotherapy.

Note

EPSDT and Prior Approval

If the service, product, or procedure requires prior approval, the fact that the beneficiary is under 21 years of age does NOT eliminate the requirement for prior approval. Follow NCTracks and EPSDT guidance for additional details.

Billing Rule

Claims and Billing Compliance

Provider(s) shall comply with NCTracks, Medicaid bulletins, fee schedules, NC Medicaid clinical coverage policies, and other relevant guidance for coverage and reimbursement. Refer to the NCTracks Provider Claims and Billing Assistance Guide and applicable Medicaid bulletins for operational details.

Definitions and Terminology

Rapid Desensitization — definition

DefinitionAn accelerated allergy treatment that increases doses over a short period of time allowing for several months of build-up to be completed in one day.

PurposeUsed to complete build-up more rapidly than traditional immunotherapy schedules.

ContextCovered by Medicaid under specified criteria when rapid desensitization indications are met.

Hymenoptera Sensitivity — definition

DefinitionAn allergic reaction to the venom of stinging insects, including wasps, hornets, bees, and fire ants.

Clinical relevanceHymenoptera sensitivity is a covered indication for rapid desensitization under Medicaid additional criteria.

Background and Clinical Context

Allergy immunotherapy reduces sensitivity to triggering allergens by administering gradually increasing doses (build-up) followed by maintenance injections at intervals (commonly every two to six weeks) and may be continued for several years when clinically indicated. Rapid desensitization is an accelerated approach that increases doses over a short period so that months of build-up can be completed in a single day; indications include allergic rhinitis, allergic asthma, and Hymenoptera sensitivity when allergens are confirmed by appropriate testing.

Policy Summary

PayerAlliance Health

PolicyAllergy Immunotherapy

Policy CodePolicy 1N-2

Change TypeUnit limit and definition updatesadded definitions

Effective Date

Last ReviewFeb 1, 2025

Next Review Date

SourceLink

On This Page

Must bill supply and administration separately.

Billable unit definition (95165)One billable unit equals a 1 mL (cubic centimeter) aliquot of antigen; providers may not bill for more than 10 doses per 10 mL vial.

Annual/period limit (95165)Testing limitations: 95165 limited to 180 units per 365 days.

Vial-level billing constraintMaximum billing of 10 doses per 10 mL vial applies to both venom and non-venom antigens.

Administration and treatment unit rules

95115 billing ruleBill 1 unit when only one injection is given on the same day of service.

95117 billing ruleBill 1 unit when two or more injections are given on the same day of service.

95180 billing ruleRapid desensitization (95180) is billed as one unit per hour (testing limitation: 6 units per date of service).

Maximum billable doses per vial (95165)

Maximum doses per vialProviders may not bill for more than 10 doses per 10 mL vial when using CPT 95165.

Applies to venom and non-venomThe 10-per-10 mL vial maximum applies to both venom and non-venom antigen codes.

Billing consequenceBilling more than 10 doses per 10 mL vial may trigger reimbursement denial or adjustment.

Billable unit size for CPT 95165

Unit size for 95165A billable unit dose for CPT 95165 is defined as a 1 mL (cubic centimeter) aliquot.

Interpretation noteDefinition of 1 mL unit does not require that exactly 1 mL be removed from the vial but establishes the unit for billing purposes.

Coding separationPreparation (95165) must be billed separately from administration; both services require documentation.

Comply with federal, state, and local laws, HIPAA, and record retention requirements.
Follow NC Medicaid clinical policies, provider manuals, implementation updates, and bulletins.
See Attachment A: Claims-Related Information for code-specific billing rules.

Billing Rule

Billing Unit Requirements for Allergy Immunotherapy

Providers must follow specific billing unit rules when submitting claims for allergy immunotherapy. Billing must reflect the service actually rendered and adhere to code-specific unit definitions and limits.

Administration by injection: CPT 95115 = 1 unit when only one injection is given on the same day; CPT 95117 = 1 unit when two or more injections are given on the same day.
Allergy treatments: CPT 95180 (rapid desensitization) = bill by time (one hour = one unit).
Preparation of antigen(s): CPT 95165 = 1 mL aliquot defined as one billable unit dose; providers may not bill for more than 10 doses per 10 mL vial for vial-preparation codes (applies to venom and non-venom).
Preparation codes 95144–95149 and 95170 have testing limitations of 10 units per date of service where specified; 95165 has testing limitation of 180 units per 365 days as listed in Attachment A.

Denial Risk

Denial Triggers

Services that are not medically necessary, not individualized or consistent with the beneficiary's symptoms, unsafe, duplicative, experimental/investigational, or when a more conservative and equally effective treatment is available statewide may be denied. Claims that exceed unit limits, combine supply and administration into a single code, or do not meet documentation requirements are also subject to denial or adjustment.

Denial triggers include: beneficiary not eligible (Section 2.0), not meeting Section 3.0 criteria, duplicate services, experimental/investigational services, or lack of clinical benefit for treatment beyond two years.
Billing-specific denial risks: billing supply and administration together using a single CPT code (see Attachment A), billing more than allowed doses per vial for 95165, or exceeding listed testing limitations for preparation/administration codes.

Billing Rule

Separate Billing for Preparation and Administration

The supply (preparation) of antigen(s) and the administration of the antigen(s) must be billed separately. Use distinct CPT codes for preparation (supply) and for administration and document both services in the medical record.

Do not bill a combined supply-and-administration complete-service code; separate CPT codes for preparation (e.g., 95165, 95144–95149, 95170) and administration (e.g., 95115, 95117) are required.
Billing the combined supply-and-administration service using a single CPT code will result in non-coverage or denial.

Documentation Required

Compliance Requirements and Documentation

Provider(s) shall follow applicable modifier guidelines and maintain documentation that supports medical necessity, clinical indications, injection reactions, ongoing effectiveness evaluations, and the number of vials and doses prepared and administered. Providers must also adhere to all applicable agreements, laws, HIPAA, and record retention requirements.

Follow applicable modifier guidelines when reporting services.
Health record must confirm medical necessity, document diagnostic determination of triggering allergens (per Policy 1N-1), record injection reactions, and document ongoing treatment effectiveness and vial/dose counts.
Retain records in accordance with state and federal requirements to support claims and clinical decisions.

Testing requirementTriggering allergen must be documented by appropriate testing per Policy 1N-1.

Rapid desensitization — Medicaid additional coverage criteria

Medicaid covered reasonsRapid desensitization is covered when any one of the following is present: hymenoptera sensitivity; presence of IgE antibodies to a medically necessary drug for which substitution is not effective; or moderate to severe allergic rhinitis requiring treatment during or immediately before the allergy season.

Any-one criterionOnly one of the listed criteria (a–c) needs to be met for coverage of rapid desensitization under Medicaid additional criteria.

Relation to testingAllergen or antibody presence must be documented as clinically appropriate per policy and testing guidance.

Rapid Desensitization — revision note

Policy updateDefinitions for Rapid Desensitization were added to Section 1.1 effective 02/01/2025.

Location of full wordingFull definition text appears in Section 1.1 of the policy (revision noted 02/01/2025).

Revision noteSee Revision Information in Attachment A for effective dates and related changes.

Hymenoptera Sensitivity — revision note

Policy updateDefinitions for Hymenoptera Sensitivity were added to Section 1.1 effective 02/01/2025.

Location of full wordingFull definition text appears in Section 1.1 of the policy (revision noted 02/01/2025).

Revision noteSee Revision Information in Attachment A for effective dates and related changes.