SUPERSEDED Local Coverage Determination (LCD)

Allergy Immunotherapy

L32553

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Proposed LCD
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L32553
Original ICD-9 LCD ID
Not Applicable
LCD Title
Allergy Immunotherapy
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/27/2022
Revision Ending Date
11/01/2023
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Publication 100-02, Medicare Benefit Manual, Chapter 15: Section

    20.2 Physician Expense for Allergy Treatment


CMS Publication 100-02, Medicare Benefit Manual, Chapter 15: Section

    50.4.4.1 Payment for Antigens


CMS Publication 100-03, Medicare National Coverage Decisions Manual, Chapter 1:

    110.9 Antigens Prepared for Sublingual Administration


CMS Publication 100-03, Medicare National Coverage Decisions Manual, Chapter 1:

    110.11 Food Allergy Testing and Treatment

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 12

    200 Allergy Testing and Immunotherapy

CMS Transmittal No. 1770, Publication 100 – 04, Medicare Claims Processing Manual, Change Request #6520, July 10, 2009, Medicare contractor annual update of the international classification of diseases, ninth revision, clinical modification (ICD-9-CM).

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract:

Allergen immunotherapy is defined as the repeated administration of specific allergens to patients with IgE-mediated conditions, for the purpose of providing protection against the allergic symptoms and inflammatory reactions associated with natural exposure to these allergens.

Immunotherapy (hyposensitization) may extend over a period of years, usually on an increasing dosage scale. This is followed by a build-up of tolerance to the antigen (as evidenced by the markedly higher doses that can be administered) and a decline in the symptoms and medication requirements of the patient. Indications for immunotherapy are determined by diagnostic testing appropriate to the individual needs of each patient and his/her clinical history of allergic diseases.

Allergen immunotherapy should be differentiated from the process of desensitization, which usually applies to the rapid progressive administration of an allergenic substance to render effector cells less reactive.

The technique of allergen immunotherapy should also be differentiated from unproven techniques such as neutralization-provocation therapy. Optimal dosing for sublingual swallow and oral immunotherapies is under clinical investigation in the United States but remain investigational at this time.

This LCD documents CGS indications and limitations of coverage for these procedures

Indications:

Indications for immunotherapy are determined by appropriate diagnostic procedures coordinated with clinical judgment and knowledge of the natural history of allergic diseases.

Controlled studies have shown that allergen immunotherapy is effective for patients with allergic rhinitis or conjunctivitis, allergic asthma, and stinging insect hypersensitivity.

Allergen immunotherapy is indicated for patients who show demonstrable evidence of specific IgE antibodies to clinically relevant allergens and whose allergic symptoms warrant the time and risk of allergen immunotherapy. The necessity of initiating allergen immunotherapy may also depend on the degree to which symptoms can be reduced by medication, the amount and type of medication required to control symptoms, and whether appropriate avoidance is possible.

Allergen immunotherapy is indicated for patients with a diagnosis of allergic asthma, allergic conjunctivitis, allergic rhinitis, or stinging insect hypersensitivity depending on the results of allergy testing (immediate hypersensitivity skin tests or in vitro tests for specific IgE). There is limited data indicating that it may be effective in atopic dermatitis when this condition is associated with aeroallergen sensitivity. Immunotherapy should not be given to patients with negative results for specific IgE antibodies or those with positive test results for specific IgE antibodies that do not correlate with suspected triggers, clinical symptoms, or exposure. Immunotherapy is effective for pollen, mold, animal allergens, cockroach, and dust mite.

Venom immunotherapy is indicated for patients who have anaphylaxis after an insect sting and a positive skin test or other documented IgE sensitivity to specific insect venom. Patients 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.

Rapid desensitization is indicated in cases of allergy to insulin, penicillin and horse serum, as well as sulfonamides, cephalosporins and other commonly used drugs. In patients with a positive history of reaction and with documented skin test reactivity, every effort should be made to avoid the use of these substances. When circumstances require the use of one of these substances, the patient will have to be desensitized. Full-dose therapy should be initiated immediately after reactions (treated and controlled), requiring strict physician monitoring in a setting with continuous monitoring of vital signs and cardio-respiratory status. In most cases, this can be performed in a physician’s office if a physician trained to treat anaphylaxis is physically present for the entire duration. In cases where the initial reaction was severe, desensitization should be performed in the ambulatory care department of a hospital.

Desensitization may need to be repeated if future circumstances require an additional course of the offending allergen. Rapid desensitization in the form of rush immunotherapy may also be appropriate for venom, pollen, dust mite, mold and dander.

Standardized dust mite extracts appear effective for immunotherapy. Other environmental allergens (e.g., kapok, jute, feathers, and unstandardized house dust extracts) are of questionable value in immunotherapy, however, and generally should not be used.

Animal dander sensitivity (epidermal) may respond to immunotherapy. While removal of the offending allergen is recommended, this is often not possible or there may be occupational or other sources of exposure. Therefore, a trial of immunotherapy may be warranted.

Allergen-induced asthma is an indication for immunotherapy along the guidelines for allergic rhinitis when there is a poor response to environmental control or pharmacologic treatment.

Limitations:

Allergen immunotherapy is divided into codes that describe the injection only and codes that describe the preparation of the antigen to be delivered for injection by a different physician.

SUPPLY OF ANTIGEN

Payment may be made for a reasonable supply of antigens that have been prepared for a particular patient when:

  • The antigens are prepared by a physician who is a doctor of medicine or osteopathy; and
  • The physician who prepared the antigens has examined the patient and has determined a plan of treatment and a dosage regimen.

Antigens must be administered in accordance with the plan of treatment and by a doctor of medicine or osteopathy or by a properly instructed person under the supervision of the doctor.
Effective January 1, 2001, the Centers for Medicare and Medicaid Services (CMS) revised the regulation limiting the supply of antigens that can be prepared by a physician for a particular patient at one time. The limitation is changed from a 12-week supply to a 12-month supply. This regulation is revised with the stipulation that it is a physician's responsibility to furnish only a supply that would remain stable and potent over the time period for which they are administered.

TREATMENT SCHEDULES

The starting dose of an allergenic extract and the progression of the dose must be individualized for each patient. The Immunotherapy build-up schedule entails administration of gradually increasing doses during a period of approximately 14 to 28 weeks. In conventional schedules a single dose increase is given on each visit, and the visit frequency can vary from 1 to 3 times a week. Accelerated schedules such as rush or cluster immunotherapy entail administration of several injections at increasing doses on a single visit. Accelerated schedules offer the advantage of achieving the therapeutic dose earlier but might be associated with increased risk of systemic reaction in some patients.

LENGTH OF 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.

Treatment will not be reimbursed after a 2-year period when there is no apparent clinical benefit.

The major risk of allergen immunotherapy is anaphylaxis. Allergen immunotherapy should, therefore, be administered under the supervision of an appropriately trained physician who can recognize early symptoms and signs of anaphylaxis and administer emergency medications where necessary. In addition, immunotherapy should be administered only in facilities equipped to treat anaphylaxis.

It may be appropriate to permit patient self-administration at home for the rare patient with life-threatening anaphylaxis who cannot receive immunotherapy in a health care facility (e.g., venom immunotherapy for a patient living in a remote area)). This requires very careful consideration of potential benefits and risks and should be made on an individual patient basis with appropriate informed consent.

The following services are considered investigational and will not be covered.

  • Desensitization with commercially available extracts of poison ivy, poison oak, or poison sumac.
  • Desensitization for hymenoptera sensitivity using whole body extracts, with the exception of venom extracts and fire ant extracts.
  • Desensitization with bacterial vaccine (BAC: bacterial, antigen complex, streptococcus vaccine, staphylo-strepto vaccine, serobacterin, staphylococcus phage lysate).
  • Food allergenic extract immunotherapy.
  • Intracutaneous desensitization (Rinkel Injection Therapy, RIT).
  • Neutralization therapy (intradermal and subcutaneous).
  • Repository emulsion therapy.
  • Sublingual desensitization.
  • Sublingual provocative therapy.
  • Urine autoinjection (autogenous urine immunotherapy).
  • Allergen immunotherapy for the management of skin and mucous membrane disease such as urticaria, and Candida vulvovaginitis.

Patients who are mentally or physically unable to communicate clearly with the allergist and those with a history of noncompliance are not good candidates for allergy immunotherapy.

Medicare will not cover antigens provided for sublingual administration. This type of therapy has not been proven safe and effective.

Immunotherapy with whole-body extracts of biting insects or other arthropod (95170) is covered only for fire ant extracts.

Evaluation and management codes are separately reimbursable on the same day as allergen immunotherapy only when a significant, separately identifiable service is performed. 

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

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Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. CGS is not responsible for the continuing viability of Web site addresses listed below.

Adkinson: Middleton's Allergy: Principles and Practice, 6th ed.2003.

Allergen Immunotherapy: A practice parameter. The Joint Council of Allergy, Asthma, and Immunology, 1996;98:1001-1011.

Allergen Immunotherapy: A practice parameter. Ann Allergy Asthma Immunol.90(suppl):SI-S40.

Allergen Immunotherapy: A practice parameter second update. J Allergy Clin Immunol. 2007;120:S25-85.

Department of Health and Human Services. Office of Inspector General. Immunotherapy for Medicare Beneficiaries. February 2006.

Lawlor GJ, Fischer TJ, Adelman DC. Manual of Allergy and Immunology, Third Edition. Little Brown and Company. Boston, MA. 1995.

Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/27/2022 R14

R14
Revision Effective: 10/27/2022
Revision Explanation: Annual review, no changes were made.

10/21/2022: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/21/2021 R13

R13
Revision Effective: 10/21/2021
Revision Explanation: Annual review, no changes were made.

10/15/2021: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
11/07/2019 R12

R12
Revision Effective: N/A
Revision Explanation: Annual review, no changes made.

10/07/2020: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
11/07/2019 R11

Annual Review

  • Other (R11
    Revision Effective: 11/07/2019
    Revision Explanation: Annual Review, Removed other comments from Coverage Indications, Limitations and/or Medical Necessity and Associated Information based on TDL 190550. Added to A56424-Billing and Coding: Allergy Immunotherapy

    10/29/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
    )
09/19/2019 R10

R10
Revision Effective: 09/19/2019
Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901.

09/19/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (New Template)
03/28/2019 R9

R9
Revision Effective: 03/28/2019
Revision Explanation: removed all coding and billing information from policy into article for Billing and Coding for Allergy Immunotherapy A56424 that can be found below in related article section. Coding information was removed based on CR10901.

03/22/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Removed Coding into article)
10/01/2015 R8

R8
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

10/30/2018:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Other (Annual Review)
10/01/2015 R7

R7
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

  • Other (Annual review)
10/01/2015 R6 R6
Revision Effective: N/A
Revision Explanation: annual review no changes made.
  • Other (Annual Review)
10/01/2015 R5 R5
Revision Effective: 10/01/2015
Revision Explanation: Added J30.81 to group 1 and T88.6XXA to group 3 ICD-10 codes support medical necessity.
  • Reconsideration Request
10/01/2015 R4 R4
Revision Effective: 10/01/2015
Revision Explanation: group 2 had a typographical error T63.422D shold have been T63.421D
  • Typographical Error
10/01/2015 R3 R3
Revision Effective: 10/01/2015
Revision Explanation: Icd-10 code in range T63.421-T63.464 have been added with the 7th character 'D' in group one. Also added J45.21, J45.22, J45.31, J45.32, J45.41, J45.42, J45.51, and J45.52 in group one
  • Reconsideration Request
10/01/2015 R2 R2
Revision Effective: N/A
Revision Explanation: Annual review no changes made.
  • Other (Annual Review)
10/01/2015 R1 R1
Revision Effective: N/A
Revision Explanation: Accepted revenue code description changes.
  • Other (Revenue code description changes)
N/A

Associated Documents

Attachments
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Related Local Coverage Documents
Articles
A56424 - Billing and Coding: Allergy Immunotherapy
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
10/27/2023 11/02/2023 - N/A Currently in Effect View
10/21/2022 10/27/2022 - 11/01/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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