SUPERSEDED Local Coverage Determination (LCD)

Allergen Immunotherapy

L37800

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

LCD Information

Document Information

LCD ID
L37800

LCD Title
Allergen Immunotherapy

Proposed LCD in Comment Period
N/A

Source Proposed LCD
DL37800

Original Effective Date
For services performed on or after 10/18/2018

Revision Effective Date
For services performed on or after 07/11/2021

Revision Ending Date
03/30/2024

Retirement Date
N/A

Notice Period Start Date
05/27/2021

Notice Period End Date
07/10/2021

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for allergen immunotherapy services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for allergen immunotherapy services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies regarding allergen immunotherapy services may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations

CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
- Chapter 15, Sections 20.2 Physician Expense for Allergy Treatment, 50.4.4.1 Antigens, 60.1 Direct Personal Supervision, and 60.2 Services of Nonphysician Personnel Furnished Incident To Physician's Services
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
CMS IOM Publication 100-04, Medicare Claims Processing Manual,
- Chapter 12, Section 200 Allergy Testing and Immunotherapy
CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDs

Social Security Act (Title XVIII) Standard References

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Coverage Guidance

Coverage Indications, Limitations, and/or 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.^1,9The 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.^1,2,9Desensitization 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 hypersensitivity¹
Urticaria and/or angioedema^1,12,13
Provocation-neutralization therapy
Low-dose subcutaneous therapy based on the Rinkel method^6,12,13
Therapy formulations, such as allergoids or adjuvants¹
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
Multiallergen subcutaneous immunotherapy¹

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; 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

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 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. Patient assessments should include a detailed clinical history, an applicable physical evaluation, and particular laboratory tests. Allergy testing results provide a conclusive diagnosis (e.g., immediate hypersensitivity skin tests, in vitro tests for serum specific IgE). When tests outcomes are positive for select IgE antibodies that align with likely triggers and patient exposure, immunotherapy is recommended; however, the manifestation of specific 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

Many well-designed controlled trials show that allergen immunotherapy is effective for individuals with symptoms of allergic rhinitis/conjunctivitis, allergic asthma and stinging insect hypersensitivity.^2-9 Also, randomized trials demonstrate that allergen immunotherapy inhibits the development of asthma in individuals with allergic rhinitis.¹⁵ Several studies have also shown that aeroallergen immunotherapy may be beneficial for individuals with atopic dermatitis resulting from aeroallergen sensitization to dust mites.^1,9-11

Venom immunotherapy (VIT) is recommended for individuals with a history of a systemic reaction to Hymenoptera stings who demonstrate Hymenoptera-specific IgE antibodies and exhibit large local reactions (LLRs). In this regard, measurements of serum tryptase levels are recommended in individuals with a history of moderate to severe anaphylactic reactions to stings. Studies have shown that greater serum tryptase levels are correlated with recurrent and severe systemic responses (including deadly reactions) to VIT injections, increased failure rates in VIT, and increased relapse rates with discontinuation of VIT. While venom extracts are available for honeybees, yellow jackets, white-faced hornets, yellow hornets, and wasps, there is currently no venom extract available for fire ants. However, literature supports the use of whole-body extract (WBE) to be used as a reagent for diagnostic testing and immunotherapy for fire ant sting allergy.^1,2,9

The provider prescribing immunotherapy should be trained and experienced in prescribing and administering immunotherapy. The prescribing provider must choose the applicable allergen extracts based on the patient’s medical history, allergen exposure history, and the presence of specific IgE antibodies. The prescription must indicate the initial dose, the target maintenance dose, and the immunotherapy schedule.^1,2

Immunotherapy treatments are generally separated into two phases; the build-up phase and the maintenance phase. The build-up phase (also referred to as updosing, induction, or dose-increase) involves gradually giving greater doses 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. While accelerated timetables provide a means of reaching the therapeutic dose sooner, a greater risk of a systemic reaction is possible in some individuals.^1,9

The maintenance phase occurs when the effective therapeutic dose is reached. This dose provides therapeutic efficiency 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. If clinical improvement is not achieved after 1 year of maintenance immunotherapy, potential reasons for lack of effectiveness should be investigated and if no reasons are discovered, cessation of immunotherapy should be contemplated and other therapy possibilities should be explored. For many patients, the recommended duration of immunotherapy is 3-5 years. However, the duration of immunotherapy should be personalized based on the benefits sustained from therapy, disease severity, immunotherapy reaction, patient preference, and certain antigens in the therapy.^1,2,9

Generally, the initial dose is 1,000 to 10,000-fold less than the maintenance dose. The maintenance dose is usually 500-2,000 allergy units (AU) (e.g., for dust mites) or 1,000-4,000 bioequivalent allergy units (BAU) (e.g., for grass or cat) for standardized allergen extracts. For non-standardized extracts, a recommended dose is 3,000-5,000 protein nitrogen units (PNU) or 0.5 mL of a 1:100 or 1:200 weight/volume dilution of manufacturer’s extract. If the main allergen concentration for the extract is available, a maintenance dose of 5-20 micrograms (µg) of the major allergen is recommended for inhalant allergens and 100 µg for Hymenoptera venoms.^1,2

Desensitization involves 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. Desensitization can involve IgE-mediated or other immune mechanisms. A positive skin test response to the allergens might lessen or actually convert to a negative response in some situations after desensitization. Tolerance to medications can be achieved through desensitization.

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.⁶ The preferred location for such administration is the prescribing physician's office. However, patients can receive immunotherapy at another health care facility if the physician and staff at that location are trained and equipped to recognize and manage immunotherapy 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. Regardless of the location, allergen immunotherapy should be administered under the direct supervision of an appropriately trained physician, qualified nurse practitioner or physician assistant in a facility with the proper equipment, medications, and personnel to treat anaphylaxis.^1,9

The risk of severe systemic reactions is low with allergen immunotherapy that is administered appropriately; however, life-threatening and fatal reactions do happen. Studies have shown that severe responses following allergen immunotherapy occur in less than 1% of patients receiving conventional immunotherapy, but occur in about 34% of patients receiving rush (e.g., accelerated timetable) immunotherapy.¹

Limitations for Immunotherapy

Immunotherapy injections should be withheld if the patient presents with an acute asthma exacerbation; allergen immunotherapy should not be initiated unless the patient’s asthma is stable with pharmacotherapy as patients with severe or uncontrolled asthma are at a greater risk for systemic reactions to immunotherapy injections.Regarding inhalant and venom allergen immunotherapy, individual evaluations of risk versus benefit must be made for individuals on beta-blockers and angiotensin-converting enzyme (ACE) inhibitor medications.^1,2,9

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

Methods of Immunotherapy not Supported in the Literature

In addition to the subcutaneous route, allergen extracts can be given by various methods. However, there are currently no FDA-approved formulations for a non-injection immunotherapy extract. In this regard, the quality of evidence in the literature does not support the following methods of immunotherapy: Oral and sublingual immunotherapy (SLIT) for food hypersensitivity, multiallergen subcutaneous immunotherapy (SCIT), neutralization-provocation therapy, low-dose subcutaneous therapy based on the Rinkel method, intranasal, intra-bronchial, intralymphatic, and epicutaneous. Further research is needed to clarify the utility and efficacy of these methods.^1,6,12,13

Conditions not Supported in the Literature for Immunotherapy

The quality of evidence in the literature is lacking in support of allergen immunotherapy for food hypersensitivity, cockroach hypersensitivity, chronic urticaria and/or angioedema, and therefore, is not recommended.^1,12,13 The use of therapy formulations, such as allergoids and adjuvants is also not supported in the literature.¹

Analysis of Evidence (Rationale for Determination)

Allergen immunotherapy, also known as allergy shots involves the repeated administration of allergen extracts to individuals with IgE-mediated conditions to decrease symptoms and improve quality of life during subsequent natural allergen exposure. Allergen immunotherapy consists of administering increasingly greater doses of specific allergens to individuals who have shown immunologic sensitivity or reaction to a particular allergen through allergy testing.

Multiple evidence-based practice guidelines and appropriate use criteria are available for allergen immunotherapy. Many well-designed controlled studies have shown that immunotherapy is effective for pollen, animal allergens, dust mites, mold/fungi, and Hymenoptera hypersensitivity. Also, aeroallergen immunotherapy is recommended for individuals with atopic dermatitis resulting from aeroallergen sensitization to dust mites. In addition, venom immunotherapy (VIT) is recommended for individuals with a history of a systemic reaction to Hymenoptera stings who demonstrate Hymenoptera-specific IgE antibodies and exhibit large local reactions (LLRs). Measurements of serum tryptase levels are also recommended for these individuals as increased serum tryptase levels are correlated with recurrent and severe systemic responses (including deadly reactions) to VIT injections, increased failure rates in VIT, and increased relapse rates with discontinuation of VIT. Also, the use of whole-body extract (WBE) is recommended for fire ant sting allergy as venom extracts are not currently available for fire ants.

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. Patient assessments should include a detailed clinical history, an applicable physical evaluation, and particular laboratory tests. Evidence-based guidelines recommend immunotherapy when allergy testing results are positive for select IgE antibodies that align with likely triggers and patient exposure. 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.

Per evidence-based guidelines, the provider prescribing immunotherapy should be trained and experienced in prescribing and administering immunotherapy. The prescribing provider must choose the applicable allergen extracts based on the patient’s medical history, allergen exposure history, and the presence of specific IgE antibodies. The prescription must indicate the initial dose, the target maintenance dose, and the immunotherapy schedule.

Evidence-based guidelines recommend that immunotherapy be administered in a setting that permits the prompt recognition and management of adverse reaction. The preferred location for such administration is the prescribing physician's office. However, patients can receive immunotherapy at another health care facility if the physician and staff at that location are trained and equipped to recognize and manage immunotherapy 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 as immunotherapy may have severe unpredictable systemic and local reactions within the first 30 minutes following the injection. Regardless of the location, allergen immunotherapy should be administered under the direct supervision of an appropriately trained physician, qualified nurse practitioner or physician assistant in a facility with the proper equipment, medications, and personnel to treat anaphylaxis.

Evidence-based guidelines support the following limitations for allergen immunotherapy: 1) Patients should not have substantial comorbid conditions that could increase immunotherapy risk (e.g., severe asthma uncontrolled by pharmacotherapy, significant cardiovascular disease); 2) 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; 3) Patients should be able to cooperate during therapy; and 4) 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.

The quality of evidence in the literature does not support the following methods of immunotherapy: 1) oral and sublingual immunotherapy (SLIT) for food hypersensitivity; 2) multiallergen subcutaneous immunotherapy (SCIT); 3) neutralization-provocation therapy; 4) low-dose subcutaneous therapy based on the Rinkel method; 5) intranasal; 6) intra-bronchial; 7) intralymphatic; and 8) epicutaneous. Further research is needed to clarify the utility and efficacy of these methods. Also, the quality of evidence in the literature is lacking in support of allergen immunotherapy for the following conditions: a) food hypersensitivity; b) cockroach hypersensitivity; and c) chronic urticaria and/or angioedema. In addition, the use of therapy formulations, such as allergoids and adjuvants is also not supported in the literature.

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Associated Information

Please refer to the related Local Coverage Article: Billing and Coding: Allergen Immunotherapy, A57678, for documentation requirements, utilization parameters and all coding information as applicable.

Sources of Information

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Bibliography

Cox L, Nelson H, Lockey R, Calabria C, et al. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol. January 2011;127(1 Suppl):S1-55. doi:10.1016/j.jaci.2010.09.034.
Golden DB, Demain J, Freeman T, et al. Stinging insect hypersensitivity: A practice parameter update 2016. Ann Allergy Asthma Immunol. 2017;118(1):28-54. doi:10.1016/j.anai.2016.10.031.
Lin SY, Azar A, Suarez-Cuervo C, et al. The Role of Immunotherapy in the Treatment of Asthma. Comparative Effectiveness Review No. 196 (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No.290-2015-00006-I). AHRQ Publication No. 17(18)-EHC029-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2018. doi:10.23970/AHRQEPCCER196.
Lin SY, Erekosima N, Suarez-Cuervo C, et al. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. Report No.: 13-EHC061-EF. https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/asthma-immunotherapy-2010_research-protocol.pdf. Accessed August 11, 2020.
Brozek JL, Bousquet J, Baena-Cagnani CE, et al. Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010;126(3):466-76. doi:10.1016/j.jaci.2010.06.047.
Burks AW, Calderon MA, Casale T, et al. Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report. J Allergy Clin Immunol. May 2013;131(5):1288-1296. doi:10.1016/j.jaci.2013.01.049.
Calderón MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S. Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane Database of Syst Rev. January 2007;(1). Art. No.CD001936. doi:10.1002/14651858.CD001936.pub2.
Calderón MA, Casale TB, Togias A, Bousquet J, Durham SR, Demoly P. Allergen-specific immunotherapy for respiratory allergies: from meta-analysis to registration and beyond. J Allergy Clin Immunol. 2011;127(1):30-38. doi:10.1016/j.jaci.2010.08.024.
Moote W, Kim H, Ellis AK. Allergen-specific immunotherapy. Allergy Asthma Clin Immunol. 2018;14(Suppl 2):53. doi:10.1186/s13223-018-0282-5.
Bae JM, Choi YY, Park CO, Chung KY, Lee KH. Efficacy of allergen-specific immunotherapy for atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials. J Allergy Clin Immunol. 2013;132(1):110-117. doi:10.1016/j.jaci.2013.02.044.
Lee J, Park CO, Lee KH. Specific immunotherapy in atopic dermatitis. Allergy Asthma Immunol Res. 2015;7(3):221-229. doi:10.4168/aair.2015.7.3.221.
Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014;133(5):1270-1277. doi:10.1016/j.jaci.2014.02.036.
Sampson HA, Aceves S, Bock SA, et al. Joint Task Force on Practice Parameters, Food allergy: a practice parameter update-2014. J Allergy Clin Immunol. 2014;134(5):1016-1025. doi:10.1016/j.jaci.2014.05.013.
Boyce JA, Assa'ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. J Am Acad Dermatol. 2011;64(1):175-192. doi:10.1016/j.jaad.2010.11.020.
Mortuaire G, Michel J, Papon JF, et al. Specific immunotherapy in allergic rhinitis. Eur Ann Otorhinolaryngol Head Neck Dis. 2017;134(4):253-258. doi:10.1016/j.anorl.2017.06.005.

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
07/11/2021	R3	LCD posted for notice on 5/27/2021 to become effective 07/11/2021. Proposed LCD posted for comment on 01/14/2021.	Creation of Uniform LCDs With Other MAC Jurisdiction
10/15/2019	R2	Revision Number: 2 Publication: November 2019 Connection LCR B2019-031 Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes,” “Revenue Codes,” “CPT/HCPCS Codes,” “ICD-10 Codes that Support Medical Necessity,” “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. In addition, The Social Security Act and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.	Other (Revision based on CR 10901)
02/19/2019	R1	Revision Number: 1 Publication: March 2019 Connection LCR B2019-010 Explanation of Revision: Based on a Change Request 10951, the LCD was revised to update the IOM Citation in the “CMS National Coverage Policy” section of the LCD. CMS IOM Publication 100-09, Chapter 5 was removed and CMS IOM Publication 100-04, Chapter 23, Section 20.9 was added. The effective date of this revision is for claims processed on or after 02/19/2019, for dates of service on and after 12/11/2018. In addition, based on CR 10901, the “CMS National Coverage Policy”, “Limitations”, and “Provider Qualifications” sections of the LCD were revised to update the section number for Pub. 100-08, Chapter 13 from 13.5.1 to 13.5.4. The effective date of this revision is for claims processed on or after 01/08/2019, for dates of service on or after 09/26/2018.	Other (Revisions based on Change Requests 10951 and 10901)

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NCDs
110.9 - Antigens Prepared for Sublingual Administration
110.11 - Food Allergy Testing and Treatment

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Allergen Immunotherapy

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