Notification



Notification Issue Date:



Medical Policy Bulletin


Title:In Vivo Allergy Sensitivity Testing

Policy #:07.00.05g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Percutaneous (scratch, puncture, prick) and intracutaneous (intradermal) allergy testing are considered medically necessary and, therefore, covered for the diagnosis, evaluation, and treatment of allergies when there are signs and symptoms or a diagnosis suggestive of an allergy (e.g., a history of hypersensitivity to animals, food, pollen, dust mites, mold, grass, insect venoms; or asthma, allergic rhinitis, urticaria) with the following limitations:
  • A cumulative total of 70 percutaneous (scratch, puncture, or prick) allergy tests are eligible for reimbursement per calendar year.
  • A cumulative total of 40 intracutaneous allergy tests (which usually follow negative scratch, puncture, or prick tests) are eligible for reimbursement per calendar year.

Serial endpoint titration (SET) testing (e.g., intradermal dilutional testing [IDT]) is considered medically necessary and, therefore, covered for the diagnosis, evaluation, and treatment of allergies with a cumulative total of 80 tests being eligible for reimbursement per calendar year.

In vivo allergy sensitivity testing in excess of the above limits is considered not medically necessary and, therefore, not covered.

The following allergy tests are considered medically necessary and, therefore, covered for the diagnosis, evaluation, and treatment of allergies but are not subject to the maximum calendar year test limitation:
  • Patch testing
  • Photo patch testing
  • Mucous membrane testing (e.g., the direct nasal mucous membrane test)
  • Bronchial inhalation challenges
  • Food ingestion challenges

EXPERIMENTAL/INVESTIGATIONAL

All other allergy testing such as, but not limited to, sublingual testing (antigens prepared for sublingual administration), provocative testing (e.g., the Rinkel test), and the Rebuck skin window test is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this testing cannot be established by review of the available peer-reviewed published literature.

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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, in vivo allergy sensitivity testing is covered under the medical benefit for 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.

BILLING GUIDELINES

If percutaneous or intracutaneous (intradermal) sequential and incremental injections and single injection tests are performed on the same date of service, both the sequential and incremental injection and single injection test codes may be reported if the tests are different allergens or different dilutions of the same allergen.

The unit of service to report is the number of separate injections. Do not report both a single injection test and a sequential and incremental injection test for the same dilution of an allergen. For example, if the single injection test for an antigen is positive and the provider proceeds to sequential and incremental injection tests, with three additional different dilutions of the same antigen, the provider may report one unit of service for the single injection test code and three units of service for the sequential and incremental test code.

Serial endpoint titration (SET) testing (e.g., intradermal dilutional testing [IDT]) is reported and reimbursed on a per allergen basis.

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

Description

An allergy is defined as an acquired hypersensitivity to a substance (allergen) that does not normally cause a reaction. It is essentially a disorder of the immune system that results in an antibody-antigen reaction. The most common manifestations of allergy involve the respiratory tract or the skin. Allergic conditions can cause manifestations such as, but not limited to, eczema, allergic rhinitis, hay fever, bronchial asthma, and urticaria (hives). Severe reaction, such as an anaphylactic response, can result in dyspnea, violent cough, chest constriction, cyanosis, fever, pulse variations, convulsions, and/or collapse.

As the majority of clinically significant environmental, food, and medication allergies are mediated by an IgE antibody immune system response, allergy testing aims to identify an IgE specific response to the allergen in question through in vivo or in vitro methods. In vivo allergy tests are those that are performed directly on the individual, in contrast to using an individual's serum sample as is characteristic of in vitro tests.

In vivo allergy testing is performed to determine an individual's sensitivity to particular allergens and the degree of the reaction. This testing will provide recommendations for changes in the home/work environment and/or evaluate the necessity of medications and/or immunotherapy to control the reactions. Skin prick testing is the most commonly performed allergy sensitivity test, although the following cutaneous and mucous membrane tests may also be included in an allergy evaluation:
  • Skin scratch testing
  • Skin patch testing
  • Intradermal testing
  • Bronchial inhalation challenges
  • Food ingestion challenges
  • Mucous membrane testing
  • Serial endpoint titration (SET) testing (e.g., intradermal dilutional testing [IDT])

In vivo allergy tests must be interpreted in the context of each individual’s specific clinical history; the diagnosis of an allergic disorder cannot be based solely on the result of an in vivo sensitivity test. Allergy is a dynamic physiologic response with multiple contributing variables, including, but not limited to, presence of allergen-specific IgE. While most individuals who experience symptoms of hypersensitivity upon allergen exposure show measurable levels of allergen-specific IgE, some sensitized individuals may be asymptomatic upon exposure to the allergen of interest. Skin tests and other in vivo tests are important and recommended in the identification of allergy, but it should be noted that alone they are not sufficient to diagnose allergy.

SKIN TESTING

Skin tests (prick, scratch, patch, intradermal) accurately measure an individual's response to certain allergens. A small amount of solution containing different allergens is used. The professional provider either injects or applies the solution to the skin and evaluates the skin reaction. Photo patch testing includes exposing the skin to a dose of ultraviolet light that is sufficient to produce an inflammatory redness of the skin. If the test is positive, a more severe reaction develops at the patch site than on the surrounding skin.

BRONCHIAL INHALATION CHALLENGES

Bronchial inhalation challenges are used to determine if an individual has hyper-responsive airways when skin testing sensitivity results are not consistent with an individual's history. Histamine, methacholine, or allergens may be administered in increasing increments until a response is produced.

FOOD INGESTION CHALLENGES

Food ingestion challenges help diagnose allergies to food. The individual ingests the food to which sensitivity is suspected and is observed and evaluated for allergy symptoms. The individual must undergo a risk evaluation determination to find the food challenge category that describes their risk level (i.e., low risk or high risk). Risk evaluation decisions are based on the same types of data that are evaluated in the early food allergy diagnosis process (e.g., penicillin skin test [PST] results, patient history). Once a risk category is determined, the decision regarding what the most appropriate setting (office, hospital, or short procedure unit) for the oral food challenge is can be made.

For the individual in the low risk category, the settings where injections for allergen immunotherapy are administered should suffice for oral food challenges.

If the challenge is considered high risk (e.g., the individual is asthmatic, the individual has had a previous severe reaction), the challenge should be performed in a more controlled setting where additional interventions to support and reverse anaphylactic shock are available, such as a hospital or short procedure unit.

MUCOUS MEMBRANE TESTING

Conjunctival or nasal challenge testing involves the direct administration of the allergen to the mucosa, to test for suspected localized eye allergy or nasal allergy, respectively. The individual is observed and evaluated for allergy symptoms.

SET TESTING

SET testing is used in conjunction with immunotherapy to determine a starting point for an individual's sensitivity from an immune globulin E (IgE) standpoint for the allergen (antigen) in question. This procedure involves injecting a series of a very small amount of antigen into the individual's arm. Each injection bump, which is called a wheal, is then measured and recorded in millimeters. The size of the wheal helps the professional provider determine an individual's sensitivity to the allergen and what dosage is needed to safely begin the desensitization process. Generally, it takes three tests (dilutions) per allergen to determine the serial endpoint.

PROVOCATIVE TESTING

Provocative testing (e.g., the Rinkel test) determines the presence of allergy to foods, inhalants, and environmental chemicals and involves exposing the individual to test doses of substances that are administered intradermally, subcutaneously, or sublingually with the goal of either producing or preventing subjective symptoms. The Rebuck skin window test involves scraping the individual's skin, applying a suspected allergen on the scraped area, and measuring the reaction to the allergen. There is insufficient evidence to support the effectiveness of sublingual testing (antigens prepared for sublingual administration), provocative testing (e.g., the Rinkel test), and the Rebuck skin window test for the diagnosis and treatment of allergy.
References


Abbas AK, Lichtman AH, Pillai S. Introduction to the immune system. In: Abbas AK, Lichtman AH, Pillai S. Basic Immunology: Functions and Disorders of the Immune System. 4th edition. Philadelphia PA: Elsevier Saunders, 2009: p1-22.

Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy, Asthma, Immunol. 2008;100(3): s1-s22.

Boyce JA, Assa'ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States. J Allergy Clin Immunol. 2010;126(6 0):S1–S58.

Fonacier L, Bernstein DI, Pacheco K, et al. Contact dermatitis: a practice parameter - update 2015. J Allergy Clin Immunol Pract. 2015;3(3S):S1-S39.

Kowal K, DuBuske L. Overview of skin testing for allergic disease. [UpToDate Web site]. 10/14/2016. Available at: https://www.uptodate.com/contents/overview-of-skin-testing-for-allergic-disease/print?search=in%20vivo%20allergy%20tests&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2. Accessed January 11, 2019.

Krouse JH, Mabry RL. Skin testing for inhalant allergy 2003: Current strategies. Otolaryngol Head Neck Surg. 2003;129(4 Suppl):S33-S49.

Novitas Solutions, Inc. Local Coverage Determination (LCD). L36241: Allergy Testing. [Novitas Solutions Web site]. Original: (Revised: ) Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36241&ver=57&Keyword=in+vitro+allergy+test&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=SAD%7cEd&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAA& . Accessed January 3, 2019.

Sampson HA, Aceves S, Bock SA, et al. Food allergy: a practice parameter update - 2014. J Allergy Clin Immunol. 2014;134(5):1016-1025.





Coding

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

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


THE FOLLOWING TYPE OF PERCUTANEOUS ALLERGY TESTING IS SUBJECT TO A CUMULATIVE MAXIMUM LIMITATION OF 70 PERCUTANEOUS TESTS PER CALENDAR YEAR:

95004

THE FOLLOWING TYPES OF INTRACUTANEOUS ALLERGY TESTING ARE SUBJECT TO A CUMULATIVE MAXIMUM LIMITATION OF 40 INTRACUTANEOUS TESTS PER CALENDAR YEAR:

95024, 95028

THE FOLLOWING TYPES OF SERIAL ENDPOINT TITRATION (SET) TESTING ARE SUBJECT TO A CUMULATIVE MAXIMUM LIMITATION OF 80 TESTS PER CALENDAR YEAR:

95017, 95018, 95027

THE FOLLOWING TYPES OF TESTING ARE NOT SUBJECT TO ALLERGY TEST LIMITATIONS:

95044, 95052, 95056, 95060, 95065, 95070, 95071, 95076, 95079


EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT SUBLINGUAL TESTING (ANTIGENS PREPARED FOR SUBLINGUAL ADMINISTRATION), PROVOCATIVE TESTING (EG, THE RINKEL TEST), OR THE REBUCK SKIN WINDOW TEST:

95199



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions for 07.00.05g:
02/25/2019This version of the policy will become effective 02/25/2019. The intent of this policy remains unchanged, but the policy has been updated to add further scientific background information.

Revisions for 07.00.05f:
11/22/2017This policy has undergone a routine review, and no revisions have been made.


Version Effective Date: 02/25/2019
Version Issued Date: 02/25/2019
Version Reissued Date: N/A

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.