Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A56538 (Billing and Coding: Allergen Immunotherapy) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A56538: Billing and Coding: Allergen Immunotherapy (Billing and Coding, effective 2025-10-01)
- Covered ICD-10-CM codes
- 128
- 3 groups
- Non-covered ICD-10-CM codes
- 1
- Procedure codes listed
- 11
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| H10.411 | — |
| H10.412 | — |
| H10.413 | — |
| H10.45 | — |
| J30.0 | — |
| J30.1 | — |
| J30.2 | — |
| J30.81 | — |
| J30.89 | — |
| J31.0 | — |
| J45.20 | — |
| J45.30 | — |
| J45.40 | — |
| J45.50 | — |
| T36.0X5A | — |
| T36.0X5D | — |
| T36.0X5S | — |
| T36.1X5A | — |
| T36.1X5D | — |
| T36.1X5S | — |
| T36.4X5A | — |
| T36.4X5D | — |
| T36.4X5S | — |
| T36.8X5A | — |
Procedure codes: 95115, 95117, 95144, 95145, 95146, 95147, 95148, 95149, 95165, 95170, 95180.
Coverage indications, limitations and medical necessity
Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.
History/Background and/or General Information
Allergen Immunotherapy is defined as the repeated administration of specific allergens to individuals with IgE-mediated conditions to provide protection against allergic symptoms and inflammatory reactions associated with natural exposure to these allergens. 1
Allergen immunotherapy should be considered for patients who have discernable evidence of specific IgE antibodies to clinically relevant allergens. The decision to begin allergen immunotherapy may depend on a number of factors, including but not limited to, patient's preference/acceptability, adherence, medication requirements, response to avoidance methods, and the adverse effects of medications. The severity and duration of symptoms should also be considered when evaluating the need for allergen immunotherapy. 1
The presence of IgE antibodies alone does not infer the need for immunotherapy; the presence of IgE antibodies to an allergen must correlate with the patient’s history. 1 For example, the presence of IgE antibodies to an allergen not locally found, with no history of exposure or expectation of exposure, would not be considered clinically relevant.
In order for allergen immunotherapy to be considered medically reasonable and necessary both of the following criteria must be met:
• The allergen(s) to which the patient is allergic must be clinically relevant, and
• Trial of avoidance measures has failed or there is unavoidable exposure to allergy triggers identified in allergy testing. 1
Covered Indications
Conditions for which immunotherapy will be considered medically reasonable and necessary include:
• Allergic rhinitis
• Allergic conjunctivitis
• Allergic asthma 2-9
• Dust mite atopic dermatitis 1,9-11
• Stinging insect hypersensitivity (e.g., bees, hornets, wasps, fire ants) 1-9
Although all treatment regimens must be individualized for a given patient, immunotherapy generally has two phases. A build-up phase and a maintenance phase .
The build-up phase includes the initiation and subsequent increase of applicable antigen concentrations within 8-28 weeks. Usually a single dose increase is administered per visit and visits generally vary from 1-3 times per week. Accelerated timetables, also referred to as rush or cluster immunotherapy, involve giving several injections at increasing doses on a single visit. 1,9
The maintenance phase occurs when the effective therapeutic dose is reached. This dose provides therapeutic effectiveness without significant adverse local or systemic consequences. This dose may not be the initial targeted concentration/dose. The maintenance immunotherapy schedule is generally every 4-8 weeks for venoms and every 2-4 weeks for inhalant allergens. Maintenance immunotherapy generally involves follow-up visits every 6-12 months. 1,2,9
Length of Maintenance Therapy: The duration of all forms of immunotherapy must be individualized. A presumption of failure can be made when, after 12-24 months of therapy, a person does not experience:
• A noticeable decrease of symptoms,
• An increase in tolerance to the offending allergen, and
• A reduction in medication usage.
For many patients, the recommended duration of allergen immunotherapy is 3-5 years. However, the duration of immunotherapy should be individualized based on the benefits sustained from therapy, disease severity, immunotherapy reaction, patient preference and certain antigens in the therapy. 1,2,9
Desensitization is the rapid administration of incremental doses of allergens or medications by which effector cells are rendered less reactive or nonreactive to an IgE-mediated immune response. Tolerance to medications can be achieved through desensitization. 1
Limitations
• Patients should not have substantial comorbid conditions that could increase immunotherapy risk (e.g., severe asthma uncontrolled by pharmacotherapy, significant cardiovascular disease).
• Patients on beta-blockers and/or angiotensin-converting enzyme (ACE) inhibitor medications must have individualized assessments of risk versus benefit prior to receiving inhalant or venom allergen immunotherapy.
• Patients should be able to cooperate during therapy.
• Please refer to the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.4.1 Antigens for additional limitations.
• Please refer to the CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual , Chapter 1, Part 2 Sections 110.9 Antigens Prepared for Sublingual Administration and 110.11 Food Allergy Testing and Treatment for additional limitations.
Allergen immunotherapy is not considered medically reasonable and necessary for :
• Food hypersensitivity 1,12-14
• Cockroach hypersensitivity 1
• Urticaria and/or angioedema 1,12,13
• Provocation-neutralization therapy 1,13
• Low-dose subcutaneous therapy based on the Rinkel method 6,12,13
• Therapy formulations, such as allergoids or adjuvants 1
• The following routes of administration 6,12,13 :
• Oral or sublingual for food immunotherapy
• Epicutaneous immunotherapy
• Intralymphatic immunotherapy
• Intranasal immunotherapy
• Sublingual Immunotherapy
• Immunotherapy for Hymenoptera venom sensitivity using whole-body extracts, with the exception of fire ant extracts. 1,2,9
Place of Services (POS)
Immunotherapy may have severe unpredictable systemic and local reactions within the first 30 minutes following the injection. It is recommended that immunotherapy be administered in a setting that permits the prompt recognition and management of adverse reactions, particularly anaphylaxis. It is recommended that patients wait at the physician's office/medical clinic for at least 30 minutes after the immunotherapy injection. 1,6,9
Home administration of allergen immunotherapy should only be considered in rare and exceptional cases when the benefits of immunotherapy clearly outweigh the risks. Frequent or routine home immunotherapy is not considered appropriate under any circumstances. If this method is utilized, informed consent should be attained from the patient and the individual administering the injection must be trained and equipped to recognize and manage immunotherapy reactions, particularly anaphylaxis. 1
Provider Qualifications
Services will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.
Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
Summary of evidence (opening)
A literature search was conducted using the following key words: allergens; allergen immunotherapy; practice guidelines; practice parameters; meta-analysis; systematic review; allergic rhinitis; seasonal allergic rhinitis; allergic conjunctivitis; allergic asthma; inhalant allergies; routes of immunotherapy administration; subcutaneous immunotherapy; allergen-specific immunotherapy, atopic dermatitis; acute and chronic urticaria; skin rash; food allergies; stinging insect allergy; Hymenoptera; anaphylaxis.
Evidence-Based Guidelines
A Joint Task Force represented by the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology (JCAAI) has provided an updated practice parameter for allergen immunotherapy. 1 Also, the European Academy of Allergy and Clinical Immunology (EAACI) and the AAAAI provided an updated, comprehensive consensus report which includes the mechanisms of allergy immunotherapy and its use in clinical practice. 6 In addition, the AAAAI and the ACAAI have provided a practice parameter update for stinging insect hypersensitivity. 2
Allergen immunotherapy is defined as the repeated administration of specific allergens to individuals with IgE-mediated conditions to provide protection against allergic symptoms and inflammatory reactions associated with natural exposure to these allergens. Immunotherapy is effective for pollen, animal allergens, dust mites, mold/fungi, and Hymenoptera hypersensitivity. Allergen immunotherapy should be considered for patients who have discernable evidence of specific IgE antibodies to these allergens. 1
The contractor cites 21 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2015-10-01
- Current revision effective
- 2024-03-31
- MCD version
- 57
The contractor lists 2 National Coverage Determinations as related: NCD 110.11 Food Allergy Testing and Treatment, NCD 110.9 Antigens Prepared for Sublingual Administration. Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.
Other related documents: A59574 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Novitas Solutions, Inc. hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L36240 cover?
Allergen Immunotherapy is defined as the repeated administration of specific allergens to individuals with IgE-mediated conditions to provide protection against allergic symptoms and inflammatory reactions associated with natural exposure to these allergens. 1 The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L36240 apply to?
Novitas Solutions, Inc. applies it to Medicare claims in AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L36240?
The companion billing and coding article A56538 lists 128 ICD-10-CM codes in 3 groups that support medical necessity and 1 that do not; the first 24 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L36240?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.