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Allergy Immunotherapy
07.00.21k

Policy

MEDICALLY NECESSARY

Allergy immunotherapy is considered medically necessary and, therefore, covered when both of the following criteria are met:
  • An individual has one of the following documented conditions:
    • Allergic asthma
    • Allergic rhinitis and/or conjunctivitis
    • Stinging insect allergy
    • Clinical evidence of an inhalant allergen sensitivity
  • The individual's medical record documents the antigens to be administered, the treatment plan, and the dosage regimen. The regimen must include the starting immunotherapy schedule, target maintenance dose, and immunotherapy schedule.
    • Documentation in the medical record should demonstrate evidence of specific immune globulin E (IgE) antibodies to clinically relevant allergens and that the allergic symptoms warrant the time and risk of allergen immunotherapy.
    • Documentation in the medical record should demonstrate evidence that avoidance or pharmacologic therapy cannot control allergic symptoms or the individual has unacceptable side effects with pharmacologic therapy.
Individuals must be evaluated every 6 to 12 months while receiving allergy immunotherapy for all of the following:
  • To determine efficacy
  • To monitor for the two types of adverse reactions: local and systemic
    • Local reactions are fairly common, and they present as redness and swelling at the injection site.
    • Systemic reactions may include symptoms such as sneezing, nasal congestion, or hives. Anaphylaxis can occur and includes swelling in the throat, wheezing or a sensation of tightness in the chest, nausea, dizziness, or other symptoms that require immediate treatment.
  • To determine whether adjustments in the dosing schedule or allergen content are necessary
  • To ensure compliance

There are two phases of immunotherapy: a build-up phase and a maintenance phase. 

The build-up phase involves an individual receiving therapy injections with increasing small amounts of an antigen over approximately 3 to 6 months until a therapeutic dose is reached. A single dose of antigen is administered one to three times per week. Rush or cluster therapies use accelerated timetables to achieve the target dose and involve giving several injections at increasing doses on a single visit.


The maintenance phase begins when the therapeutic dose is reached and the individual no longer has significant adverse local or systemic reactions. The intervals between injections will be longer and generally range from every 2 to 4 weeks for inhalant allergens and every 4 to 8 weeks for venom allergens. Once the maintenance dose is reached, immunotherapy should continue for 3 to 5 years. Individuals should be evaluated every 6 to 12 months while receiving maintenance immunotherapy.

Professional services for the supervision of preparation and provision of single or multiple antigens for allergen immunotherapy (CPT code: 95165) are considered medically necessary and, therefore, covered as follows:
  • Up to 120 doses or units during the first year, including the build-up phase of immunotherapy.​
  • Up to 90 doses or units during the 12 months' period for each of the successive maintenance phases of allergy immunotherapy.
When documentation in the medical records support that allergy immunotherapy is being administered in the first year, including the build-up phase, claims submitted for professional services for the supervision of preparation and provision of single or multiple antigens for allergen immunotherapy (CPT code: 95165) are eligible to be adjusted for up to 120 doses or units.

The US Food and Drug Administration (FDA)-approved sublingual extract tablets may be covered under applicable pharmacy benefits. These sublingual allergen formulations (e.g., tablet preparation, delivery route) are not covered under the medical benefits of the Company's products.

NOT MEDICALLY NECESSARY

Allergy immunotherapy is considered not medically necessary and, therefore, not covered if, after 1 year in the maintenance phase, the individual does not experience any of the following signs of improvement, when all other reasonable factors have been ruled out:
  • A noticeable decrease of symptoms
  • An increase in tolerance to the offending allergen
  • A reduction in medication usage
EXPERIMENTAL/INVESTIGATIONAL

The use of allergy immunotherapy is considered experimental/investigational and, therefore, not covered for (not an all-inclusive list) food hypersensitivity (gastrointestinal disturbances, skin eruptions, or shock due to allergic reactions to allergens in food), chronic urticaria (persistent itchy hives for 6 weeks or more, usually without a known cause), and/or angioedema (the sudden development of painful, itchy swelling or welts that can occur around the eyes and lips or on the hands, feet, and throat) because the efficacy of this therapy cannot be established by review of the available published peer-reviewed literature.

Sublingual immunotherapy prepared, administered, and delivered through a drop formulation is considered experimental/investigational and, therefore, not covered because the effectiveness of this therapy has not been established by review of the available published peer-reviewed literature.

Home administration of allergy immunotherapy is considered experimental/investigational and, therefore, not covered because the effectiveness of this therapy has not been established by review of the available published peer-reviewed literature.

VIAL PREPARATION OF NON-VENOM ANTIGENS

Current Procedural Terminology (CPT) antigen codes 95144 to 95149 and 95170 are for a single dosage. When billing these codes, health care professionals must specify the number of doses provided.

CPT code 95165 represents the preparation of the maintenance concentrate vial. This preparation is the highest concentration of a vaccine (antigen extract) that is projected to be the therapeutically effective dose. As in the case of venoms, some nonvenom antigens cannot be mixed together (i.e., they must be prepared in separate vials). An example of this is mold and pollen. Therefore, some individuals will be injected at one time from one vial (which contains all of the appropriate antigens in one mixture), while other individuals will be injected at one time from more than one vial.

SUPPLY OF ANTIGENS

Reimbursement may be made for a reasonable supply of antigens. To reflect industry standards and guidelines, a reasonable supply of a specific antigen is considered to be no more than a 12-month supply.

Maintenance concentrate vials of vaccine are not to be shared. Individual maintenance concentrate vials of vaccine must be prepared for each individual.

SUPPLY OF VENOM EXTRACT
​
There is no maximum limitation on venom (stinging) extract.

BILLING REQUIREMENTS

The appropriate CPT codes must be used when submitting claims for the preparation and provision of an antigen or venom by a health care professional who may or may not be providing the actual immunotherapy injection.
  • A multiplier can be used with the appropriate code range. A multiplier (number of units) is representative of the number of doses prepared and provided, not the number of vials.
Single-dose vials of antigen (CPT code 95144) must be billed only if the physician is supervising, preparing, and providing the antigen to be injected by someone other than the physician. However, if code 95144 is reported in conjunction with an injection code (95115 or 95117), reimbursement for code 95144 is included in the reimbursement for code 95165.

An office visit evaluation and management (E&M) code must not be billed when administering immunotherapy injections unless it refers to a separately identifiable medical problem and service. In this case, the E&M code must have Modifier 25 (Significant, Separately Identifiable Evaluation and Management Service by the Same Physician on the Same Day of the Procedure or Other Service) appended to indicate that a significant, separately identifiable E&M service was performed on the same day as the immunotherapy service.

During the conduction of professional services for the supervision of preparation and provision of single or multiple antigens for allergen immunotherapy, units/doses being prepared should approximate the expected number of units/doses the individual is to receive during a given timeframe. If an individual's doses are adjusted (e.g., because of individual reaction), and the antigen provided is actually more or fewer doses than originally anticipated, a health care provider must make no change in the number of doses for which they bill. The number of doses anticipated at the time of the antigen preparation is the number of doses to be billed. A health care provider is to identify the number of doses scheduled when the vial is provided. This means that in cases where the individual actually gets more doses than originally anticipated (because dose amounts were decreased during treatment), and in cases where the individual gets fewer doses (because dose amounts were increased), no change is to be made in the billing. This is applicable to nonvenom and venom antigens.

Subsequent dilutions of the maintenance concentrate are not eligible for reimbursement as preparations (CPT code 95165). For example, taking a 1-cc aliquot from the maintenance concentrate vial and mixing it with 9-cc of dilutant in a new multidose does not constitute a new preparation.

In a diluted vial, there are no associated allergen costs because they have already been billed in preparation of the initial vial. Do not bill for preparation of dilutions of antigen.

If it is medically necessary, a provider may bill for preparation of more than one multidose vial.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Failure to respond to allergy immunotherapy may be due to various factors. The following factors should be ruled out, prior to stopping allergy immunotherapy:
  • Inadequate dose of allergen in the allergy vaccine
  • Missing allergens not identified during the allergy evaluation
  • High levels of allergen in the environment (i.e., inadequate environmental control)
To avoid wrongful injections to an individual, the specific components should be mixed once with the preparation of individually prepared patient-labeled vials. The off-the-board method involves repeated mixing on every injection visit that is withdrawn from different stock solutions. For safety reasons and to avoid cross-mixing of allergens removed from the manufacturer’s extract, the cross-mixing of antigens in the syringe (off-the-board) is not recommended by the American Academy of Allergy Asthma & Immunology (AAAAI) and the Joint Council of Allergy, Asthma and Immunology (JCAAI).

STORAGE

Allergen immunotherapy extracts should be stored at 4°C to reduce the rate of potency loss.

More dilute concentrations of allergen immunotherapy extracts (diluted >1:10 vol/vol) are more sensitive to the effects of temperature and lose potency more rapidly than more concentrated allergen immunotherapy extracts. The expiration date for more dilute concentrations should reflect this shorter shelf life.

In determining the allergen immunotherapy extract expiration date, consideration must be given to the fact that the rate of potency loss over time is influenced by a number of factors separately and collectively, including 1) storage temperature, 2) presence of stabilizers and bactericidal agents, 3) concentration, 4) presence of proteolytic enzymes, and 5) volume of the storage vial.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, allergy immunotherapy is covered under the medical benefits of most of the Company’s products when medical necessity criteria in the medical policy are met. However, services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

Description

The three basic treatments for allergy are avoidance therapy, pharmacologic therapy, and immunotherapy. Complete avoidance of the allergen responsible for inducing the signs and symptoms of the allergy is the most effective treatment for any allergic condition. When avoidance of a specific allergen such as house dust, molds, or pollens is impossible, pharmacologic therapy is initiated (e.g., antihistamines, adrenergic agonists, anticholinergics, beta-adrenergic agonists, corticosteroids, cromolyn sodium, methylxanthines). When known allergens are unavoidable and not effectively controlled with pharmacologic agents, allergy immunotherapy may be necessary.

ALLERGY IMMUNOTHERAPY

Allergy (or allergen) immunotherapy or subcutaneous immunotherapy (SCIT) is the repeated administration of specific allergens to an individual with immune globulin E (IgE)–mediated conditions, to provide long-lasting protection against the allergic symptoms and inflammatory reactions associated with exposure to these allergens. In an individual with allergy, allergen challenge leads to a cascade of biological events resulting in clinical manifestation of allergy. For example, immune effector cells such as mast cells and basophils release chemical mediators (e.g., histamine) that are responsible for symptoms of allergy such as itching and sneezing. Administration of allergy immunotherapy yields a decrease in mast cell and basophil activity and degranulation, as well as the generation of specific regulatory T and B cells, suppression of allergen-specific effector T cells, decrease in tissue granulocytes, and other important systemic changes. The effect is a gradual lessening of the immune response upon subsequent allergen challenge.

Allergy (or allergen) immunotherapy has been shown in clinical studies to be effective for individuals with allergic rhinitis or conjunctivitis, allergic asthma, and stinging insect hypersensitivity. Aeroallergen immunotherapy is indicated for individuals with inhalant allergen sensitivities due to seasonal pollinosis caused by trees, grasses, and weeds, and in the treatment of mold-, dust-, and mite-induced rhinitis. According to the American Academy of Allergy, Asthma & Immunology (AAAAI), 5 years of age is the youngest recommended age to start immunotherapy; however, there is no upper age limit for receiving immunotherapy.

Venom immunotherapy is indicated for individuals who have a severe systemic anaphylactic reaction after an insect sting and a positive skin test or other documented IgE sensitivity to a specific insect venom. Individuals with delayed systemic reactions with symptoms of anaphylaxis or serum sickness and with a positive skin test or presence of venom-specific IgE by in vitro testing are also recommended for treatment.

Animal dander sensitivity (epidermal) may respond to immunotherapy, but immunotherapy is not routinely recommended to replace removal of the offending allergen. Individuals who have unavoidable occupational exposures (e.g., veterinarians or laboratory workers) may require a trial of immunotherapy.

There are usually two phases of immunotherapy: a build-up phase and a maintenance phase.

The build-up phase involves an individual receiving therapy injections with increasing small amounts of an antigen. The duration of the build-up phase generally ranges from 3 to 6 months and depends on the frequency of the injections, which is progressively increased as tolerated to every 4 to 6 weeks. The injections are administered once or twice per week, at least two days apart. The goal of administering a slowly increasing quantity of antigen is to gradually increase the individual's immunity to the offending allergen and to help the individual develop a degree of tolerance to the antigen. This treatment regimen leads to a lessening of the individual's symptoms and medication requirements.

The maintenance phase begins when the therapeutic dose is reached. The effective maintenance dose is different for each individual, depending on the level of allergen sensitivity and response to the immunotherapy build-up phase. The intervals between injections will be longer and generally range from every 2 to 4 weeks, as determined by the allergist or immunologist. Individuals should be evaluated every 6 to 12 months while on immunotherapy. Clinical improvement is usually attainable within 1 year. Once the maintenance dose is reached, immunotherapy should continue for 3 to 5 years.

Cluster immunotherapy involves the administration of two or more injections per visit to achieve a maintenance dose more rapidly than is achieved with conventional schedules. This type of rush immunotherapy is achieved by giving several allergen injections on the same day.

Rush immunotherapy involves incremental doses of an allergen administered at intervals varying from 15 to 30 minutes and 24 hours, until the optimal effect is achieved. Very sensitive individuals may experience various degrees of systemic reaction during this procedure. Physicians frequently premedicate individuals with an antihistamine or corticosteroid to minimize the risk of systemic reaction. A modified rush method involves subcutaneous allergen injections administered 24 hours apart, and may or may not require a premedication.

Allergy or allergen immunotherapy is different from desensitization. Desensitization is a process by which effector cells are rendered less reactive or nonreactive to IgE-mediated immune responses by the rapid administration of incremental doses of an allergenic substance. By contrast, allergy immunotherapy is often thought to describe a state of incomplete desensitization, as complete desensitization is rarely accomplished with allergy immunotherapy. Rapid desensitization may be used in cases of allergy to insulin, penicillin, and horse serum. In addition, it can be effective for allergies to sulfonamides, cephalosporins, and other commonly used drugs. Desensitization is performed when an individual requires the use of an allergic substance; therefore, physician supervision is required in a hospital setting to monitor the individual's reactions and response to treatment. In some cases, the skin test response to the agent is reduced or is negative after desensitization.

According to the parameters developed by the Joint Task Force on Practice Parameters, representing the AAAAI; the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology: "Immunotherapy is effective for the treatment of allergic rhinitis, allergic conjunctivitis, allergic asthma, and stinging insect hypersensitivity. Therefore immunotherapy merits consideration in patients with these disorders as a possible treatment option."

HOME-BASED SUBCUTANEOUS ALLERGY IMMUNOTHERAPY

According to guidelines from the AAAAI, subcutaneous allergen immunotherapy should be administered in a medical facility with trained staff and medical equipment capable of recognizing and treating anaphylaxis. Under rare circumstances, when the benefit of allergen immunotherapy clearly outweighs the risk of withholding immunotherapy (e.g., individuals with a history of venom-induced anaphylaxis living in a remote region), at-home administration of allergen immunotherapy should be considered on an individual basis. Furthermore, AAAAI emphasizes that frequent or routine prescription of home immunotherapy is not appropriate under any circumstances.

There are a limited number of studies of home-based allergy immunotherapy. The largest is a prospective study by Hurst et al. (1999). A major limitation of the study is that it was limited to otolaryngic allergy practices; the generalizability of the results to primary care practices is uncertain.

PREPARATION AND PROVISION OF ANTIGENS FOR SUBCUTANEOUS ALLERGY IMMUNOTHERAPY

The preparation of antigens for allergy injections, but not the injection itself, is billed under Current Procedural Terminology (CPT) code 95165. CPT Code 95165 (with the narrative: Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens [specify number of doses]),represents preparation of vials of nonvenom antigens. As in the case of venoms, some nonvenom antigens cannot be mixed together, i.e., they must be prepared in separate vials. An example of this is mold and pollen. Therefore, some individuals will receive the injection at one time from one vial—containing in one mixture all of the appropriate antigens—while other individuals will receive the injection at one time from more than one vial. 

 PROFESSIONAL SERVICE FOR INJECTION ADMINISTRATION FOR ALLERGY IMMUNOTHERAPY

According to the ACAAI, for a majority of individuals in clinical need of allergy immunotherapy, an injection may be given once a week for about 30 weeks, after which injections can be administered every 2 weeks. Eventually, injections can be given every 4 weeks. The duration of therapy may be 3 to 5 years.

SUBLINGUAL IMMUNOTHERAPY

Standardized allergen extracts can also be administered under the tongue to allow absorption through the mucosa. This method is known as sublingual immunotherapy. Several types of allergen preparations have been studied in sublingual immunotherapy (SLIT), including sublingual allergen tablets (SLIT-tablets) and sublingual aqueous or glycerinated liquid allergen extracts, which are referred to as SLIT-drops. In April 2014, the US Food and Drug Administration (FDA) approved the first sublingual allergen extract tablets for treatment of pollen-induced allergic rhinitis with or without conjunctivitis. However, the other main SLIT preparation, drop constructs, are being studied in United States clinical trials. In the United States, phase I studies on safety and tolerability have been carried out with ragweed, grass, house dust mite, and cat glycerinated extracts. There are several fundamental issues with SLIT-drops that require further study before clinicians can be confident that SLIT-drops using available products represent an effective alternative to SCIT. Of primary importance is the question of effective dose. At this time, there is a lack of scientific evidence in the published peer-reviewed medical literature to support the safety and effectiveness of SLIT-drops.

Clinical studies do not show support for the use of allergy immunotherapy for food hypersensitivity (gastrointestinal disturbances, skin eruptions, or shock due to allergic reactions to allergens in food), chronic urticaria (persistent itchy hives for six weeks or more, usually without a known cause), and/or angioedema (the sudden development of painful, itchy swelling or welts that can occur around the eyes and lips or on the hands, feet, and throat).

References

Abbas AK, Lichtman AH, Pillai S. Hypersensitivity. In: Abbas AK, Lichtman AH, Pillai S. Basic Immunology: Functions and Disorders of the Immune System. 4th Ed. Philadelphia, PA: Elsevier Saunders; 2014: 207-223.

Akdis M. Allergen immunotherapy for allergic disease: Therapeutic mechanisms. [UpToDate Web site]. 9/01/2020. Updated: 08/13/2024. Available at: https://www.uptodate.com/contents/allergen-immunotherapy-for-allergic-disease-therapeutic-mechanisms?search=allergen immunotherapy&source=search_result&selectedTitle=1~69&usage_type=default&display_rank=1 [via subscription only]. Accessed May 15, 2025.

American Academy of Allergy, Asthma & Immunology (AAAAI). Allergy Shots (Immunotherapy). [AAAAI Web site]. 11/13/2023. Available at: https://www.aaaai.org/conditions-and-treatments/library/allergy-library/allergy-shots-(immunotherapy). Accessed May 15, 2025.


American Academy of Allergy, Asthma & Immunology (AAAAI). Immunotherapy can provide lasting relief. [AAAAI Web site]. 12/27/2023. Available at: https://www.aaaai.org/tools-for-the-public/conditions-library/allergies/immunotherapy-can-provide-lasting-relief. Accessed 05/22/2025.

American College of Allergy, Asthma & Immunology (ACAAI). Allergy Shots. [ACAAI Web site]. 12/28/2017. Available at: https://acaai.org/?s=allergy+shots. Accessed May 15, 2025.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Publication 100-04: Medicare claims processing. Transmittal 504. Allergy testing and immunotherapy. [CMS Web site]. Original: 03/11/05. (Revised: 12/19/2024). Available at: http://www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed May 15, 2025.

Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network (MLN). MLN Matters. Use of professional society practice parameters in properly providing allergen immunotherapy to Medicare beneficiaries. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNGenInfo. Accessed May 15, 2025.

Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: A practice parameter third update. J Allergy Clin Immunol. 2011;127(1 Suppl):S1-S55.

Cox L, Aaronson D, Casale T et al. Allergy immunotherapy safety: location matters! J Allergy Clin Immunol: In Practice. 2013;1:455-457.

Creticos PS. Subcutaneous immunotherapy for allergic disease: indications and efficacy. [UpToDate Web site]. 08/26/2019. Updated: 01/30/2025. Available at: https://www.uptodate.com/contents/subcutaneous-immunotherapy-for-allergic-disease-indications-and-efficacy?search=allergen immunotherapy&source=search_result&selectedTitle=2~69&usage_type=default&display_rank=2 [via subscription only]. Accessed May 15, 2025.

Department of Health and Human Services: Office of Inspector General. October 2002 (OEI-09-00-00530). MEDICARE ANTIGEN PREPARATION. Available at:
http://oig.hhs.gov/oei/reports/oei-09-00-00530.pdf. Accessed May 15, 2025.

Greenhawt M, Oppenheimer J, Nelson M, et al. Sublingual immunotherapy: A focused allergen immunotherapy practice parameter update. Ann Allergy Asthma Immunol. 2017;118:276-282.

Hurst DS, Gordon BR, Fornadley JA, Hunsaker DH. Safety of home-based and office allergy immunotherapy: A multicenter prospective study. Otolaryngol Head Neck Surg.1999;121(5):553-561.

James C, Bernstein D. Allergen immunotherapy: an updated review of safety. Curr Opin Allergy Clin Immunol. 2017;17(1):55-59.

Li JT, Lockey RF, Bernstein IL, et al. Allergen immunotherapy: A practice parameter. Ann Allergy Asthma Immunol. 2003;90:S1-40.

Medicare Claims Processing Manual. Chapter 12 - Physicians/Nonphysician Practitioners (Rev. 13012, 12-19-24). Available at:
http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c12.pdf. Accessed May 15, 2025.


Novitas Solutions, Inc. Local Coverage Article. A56538: Billing and Coding: Allergen Immunotherapy [Novitas Solutions Web site]. Original 05/16/2019 (Revised: 09/28/2022). Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=56538&ver=24. Accessed May 12, 2025.

 
Novitas Solutions, Inc. Local Coverage Article. A56558: Billing and Coding: Allergy Testing. [Novitas Solutions Web site]. Original: 05/16/2019. (Revised: 01/01/2025) Available at https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=56558&ver=75&bc=0. Accessed May 15, 2025.


Novitas Solutions, Inc. Local Coverage Determination (LCD).L36240: Allergen Immunotherapy. [Novitas Solutions Web site]. Original: 10/01/2015. (Revised: 03/31/2024) Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36240&ver=57&contractorName=6&contractorNumber=all&updatePeriod=1082&sortBy=updated&bc=13. Accessed May 15, 2025.

Novitas Solutions, Inc. Local Coverage Determination (LCD). L36241: Allergy Testing. [Novitas Solutions Web site]. Original: 10/01/2015. (Revised: 07/11/2021) Available at https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36241&ver=98&keyword=L36241&keywordType=any&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=name&contractorName=6&sortBy=relevance&bc=1. Accessed May 15, 2025.


Novitas Solutions, Inc. LCD Reference Article. A59575: Response to Comments: Allergen Immunotherapy.[Novitas Solutions Web site]. 02/15/2024. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=59574&ver=4&keyword=A59574&keywordType=any&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=name&contractorName=6&sortBy=relevance&bc=1. Accessed May 15, 2025.​

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

 95115, 95117, 95120, 95125, 95130, 95131, 95132, 95133, 95134, 95144, 95145, 95146, 95147, 95148, 95149, 95165, 95170, 95180

EXPERIMENTAL/INVESTIGATIONAL

 THE FOLLOWING CODE IS USED TO REPRESENT SUBLINGUAL IMMUNOTHERAPY THROUGH A DROP FORMULATION:

 95199
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.
HCPCS Level II Code Number(s)
EXPERIMENTAL/INVESTIGATIONAL

G0069 Professional services for the administration of subcutaneous immunotherapy or other subcutaneous infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes​

G0089 Professional services, initial visit, for the administration of subcutaneous immunotherapy or other subcutaneous infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes​
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

Revisions From 07.00.21k:
​10/20​/2025
This policy will become effective 10/20/2025.

The intent of the policy remains unchanged. Policy language has been revised to Misspelled Wordfurt​her clarify the phases of immunotherapy by:

  • Adding the build-up phase
  • Deleting the escalation phase

The following information has been deleted from this policy:

1cc aliquot requirement


Revisions From 07.00.21j:

​The policy has been reviewed and reissued to communicate the Company’s continuing position on Allergy Immunotherapy.​​
​05/01/2024


​The policy has been reviewed and reissued to communicate the Company’s continuing position on Allergy Immunotherapy.​​
10/04/2023
​​This policy has been reissued in accordance with the Company's annual review process.​
11/16/2022

​The policy has been reviewed and reissued to communicate the Company’s continuing position on Allergy Immunotherapy.​
04/21/2021The policy has been reviewed and reissued to communicate the Company’s continuing position on Allergy Immunotherapy.​
​01/01/2021
​This policy has been identified for the CPT code update, effective 01/01/2021.​ Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time. 

The following CPT narrative has been revised in this policy:

G0069

The following CPT code has been added to this policy:

G0089

Revisions From 07.00.21i:
02/12/2020The policy has been reviewed and reissued to communicate the Company’s continuing position on allergy immunotherapy.
03/11/2019This version of the policy will become effective 03/11/2019. Policy has been updated to communicate the continued coverage of allergy immunotherapy and to provide additional relevant scientific background information.

Revisions From 07.00.21h:
01/01/2019This version of the policy will become effective 01/01/2019. The following HCPCS code has been added to the policy: G0069.

Revisions From 07.00.21g:
11/21/2018This policy has been reissued in accordance with the Company's annual review process.

Effective 10/05/2017 this policy has been updated to the new policy template format.
10/20/2025
10/20/2025
07.00.21
Medical Policy Bulletin
Commercial
No
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.