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Local Coverage Determination (LCD)

Allergy Skin Testing

L33417

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33417
Original ICD-9 LCD ID
Not Applicable
LCD Title
Allergy Skin Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33417
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 04/15/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
04/13/2017
Notice Period End Date
05/28/2017

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Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(1)(D) Investigational or Experimental

Title XVIII of the Social Security Act, §1862(a)(6) Personal Comfort Items

Title XVIII of the Social Security Act, §1862(a)(7) excludes routine physical examinations

42 Code of Federal Regulations §410.20 Physicians' Services

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2 Determining Self-Administration of Drug or Biological and §50.4.4.1 Antigens

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.9 Antigens Prepared for Sublingual Administration, §110.11 Food Allergy Testing and Treatment, §110.12 Challenge Ingestion Food Testing and §110.13 Cytotoxic Food Tests

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Allergy skin testing is a clinical procedure that is used to evaluate an immunologic response to allergenic material. The need for testing and interpretation of test findings must be correlated with signs and symptoms of possible allergies as determined by a complete history and physical examination of the patient. The number and type of antigens used for testing must be chosen judiciously given the patient’s presentation and the tester’s clinical judgment.

Allergy testing is covered when a patient presents with clinically significant allergic history or symptoms that are not controllable by empiric conservative therapy. For Medicare to cover allergy testing, all of the following criteria must be met:

  • Testing must correlate specifically to the patient’s history and physical findings.
  • The test technique and/or allergens tested must have proven efficacy demonstrated through scientifically valid medical studies published in peer-reviewed literature.
  • Allergy testing must be performed on patients whose environment provides the reasonable probability of exposure to the specific antigen tested.

Percutaneous testing is the usual preferred method for allergy testing. Medicare covers percutaneous (scratch, prick or puncture) testing when documented IgE-mediated reactions occur to any of the following:

  • Inhalants
  • Foods
  • Hymenoptera (stinging insects)
  • Specific drugs (penicillins and macromolecular agents)

In selected patients, intradermal testing for the same antigen may be necessary to test persons whose percutaneous test was negative. For intradermal testing, the clinician should narrow the area of investigation so that the minimal number of skin tests necessary for diagnosis is performed. Medicare covers intradermal (intracutaneous) testing when documented IgE-mediated reactions occur to any of the following:

  • Inhalants
  • Hymenoptera (stinging insects)
  • Specific drugs (penicillins and macromolecular agents)

Retesting with the same antigen(s) should rarely be necessary within a 3-year period. Exceptions include young children with negative skin tests, or older children and adults with negative skin tests in the face of persistent symptoms. Routine repetition of skin tests is not indicated (i.e., annually). If under specific circumstances, extensive repeat testing is required within a 3-year period, those circumstances must be clearly documented in the medical record including an explanation as to why the original testing is unacceptable.

Percutaneous testing for food allergens is covered for patients with a clinical presentation suggestive of significant IgE mediated food allergy. Such patients will have presented with signs and symptoms of such conditions as angioedema, urticaria or anaphylaxis after ingestion of specific foods. Testing for food allergies in patients who present with significant respiratory symptoms alone may be required in certain instances.

The following allergy testing is non-covered by Medicare:

  •  Provocative and neutralization testing and neutralization therapy of food allergies (sublingual, intracutaneous and subcutaneous) are excluded from Medicare coverage because available evidence does not show these tests and therapies are effective
  • Qualitative multiallergen screens have insufficient literature demonstrating clear-cut clinical utility and are, therefore, non-covered
  • Late reactions occurring with allergenic extracts are of unclear clinical significance and are, therefore, non-covered
  • Intradermal testing for food allergens
  • Food allergen testing for patients who present with respiratory symptoms other than wheezing and asthma
  • Food allergen testing for patients who present with gastrointestinal symptoms suggestive of food intolerance
  • Skin endpoint testing
  • Allergy testing for antigens for which no clinical efficacy is documented in peer-reviewed literature. Such antigens include but are not limited to the following:
    • Grain mill dust (pollen grains of cereals/related crops are large; they do not become airborne)
    • Tobacco smoke (no component has ever been shown to be a respiratory allergen)
    • Orris root (almost never used in cosmetics these days; test adds nothing to evaluation)
    • Dandelion (non-allergenic; no pollen produced)
    • Marigold (non-allergenic; no airborne pollen produced)
    • Honeysuckle (non-allergenic; non-significant airborne pollen produced)

Allergy testing for certain antigens is covered only when performed on patients whose environment provides the reasonable probability of their exposure to antigens tested. Such antigens include, but are not limited to the following:

  • Tobacco leaf for tobacco workers
  • Pyrethrum for florists (non-allergenic; found in some insecticides; cross-reacts strongly with ragweed)
  • Golden rod for florists (pollen not carried by wind)
  • Soybean dust for workers in food processing plants
  • Wool for patients exposed to sheep or unprocessed wool (processed wool is non-allergenic)
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
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

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N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

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N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

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

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

  • Documentation supporting medical necessity should be legible, maintained in the patient’s medical record, and made available to A/B MAC upon request.

Utilization Guidelines

  • The selection of antigens should be individualized and based on specific details obtained and documented within the history and physical examination.
Sources of Information
N/A
Bibliography

Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: An updated practice parameter. Annals of Allergy, Asthma and Immunology. 2008;100(3 Suppl 3):S1-S148.

Boyce JA, Assa'ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: Report of the NIAID-sponsored expert panel. The Journal of Allergy and Clinical Immunology. 2010;126(6):S1-S58.

Burks W. Clinical manifestations of food allergy: An overview. UptoDate; 2015.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
04/15/2021 R13

Under CMS National Coverage Policy corrected headings for regulations 42 Code of Federal Regulations §410.20 Physicians’ Services and CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2 Determining Self-Administration of Drug or Biological. Formatting, punctuation and typographical errors were corrected throughout the LCD.

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.
  • Provider Education/Guidance
10/10/2019 R12

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Under CMS National Coverage Policy all regulations regarding billing and coding have been moved into the related Billing and Coding: Allergy Skin Testing A56559 article and removed from the LCD. Under Associated Information subheading Documentation Requirements removed the second bullet point. Under subheading Utilization Guidelines added the verbiage “and based on specific details obtained and documented within” to the first bullet point and removed the second bullet point. Formatting, punctuation and typographical errors were corrected throughout the LCD. 

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.
  • Provider Education/Guidance
05/16/2019 R11

All coding located in the Coding Information section has been moved into the related Billing and Coding: Allergy Skin Testing A56559 article and removed from the LCD. Formatting, punctuation and typographical errors were corrected throughout the LCD. 

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.
  • Provider Education/Guidance
03/07/2019 R10

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the policy.

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.
  • Provider Education/Guidance
  • Typographical Error
04/12/2018 R9

Under Associated Information-Utilization Guidelines deleted bullets 3-6 due to current MUE edits being published on the Medicare Coverage Database. This revision is effective for dates of service on or after 1/1/18. 

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.
  • Provider Education/Guidance
04/12/2018 R8

Under Bibliography revisions were made to the sources to reflect AMA citation guidelines.
  • Other (Under Bibliography revisions were made to the sources to reflect AMA citation guidelines.
    )
02/26/2018 R7 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
11/16/2017 R6

Under Coverage Indications, Limitations and/or Medical Necessity added “If under specific circumstances, extensive repeat testing is required within a three-year period, those circumstances must be clearly documented in the medical record including an explanation as to why the original testing is unacceptable” in the fifth paragraph. In the sixth paragraph, added the following verbiage, "...IgE mediated..." and deleted “Testing for food allergies in patients who present with wheezing is occasionally required” and replaced it with “Testing for food allergies in patients who present with significant respiratory symptoms alone may be required in certain instances.”

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.
  • Provider Education/Guidance
  • Reconsideration Request
05/29/2017 R5 No revisions were made as there were no comments received from the provider community.
  • Provider Education/Guidance
10/01/2016 R4 Under ICD-10 Codes That Support Medical Necessity-Groups 1, 2, and 3: Codes added Z51.6*. Under Group 1, 2, and 3: Medical Necessity ICD-10 Codes Asterisk Explanation added verbiage regarding Z51.6*. Under ICD-10 Codes That Support Medical Necessity: Group 3 added K52.29. Under ICD-10 Codes That Support Medical Necessity: Group 3 deleted K52.2. This revision is due to the Annual ICD-10 Code Update.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
07/25/2016 R3 Under Associated Information- Utilization Guidelines changed 20 to 30 tests per year under the 5th bullet and changed 10 to 12 tests per year under the 6th bullet.
  • Provider Education/Guidance
01/22/2016 R2 Under Coverage Indications, Limitations and/or Medical Necessity in the second paragraph added “a patient presents with” and removed the word “exist”. Added the word “documented” to ….IgE-mediated reactions occur….

Under CPT/HCPCS Codes removed the statement from all paragraph sections “Note Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Center for Medicare & Medicaid Services (CMS) require the use of the short descriptors in policies published on the Web”.

Under ICD-10 Codes that Support Medical Necessity, Group I Paragraph removed the statement “Note: Providers should continue to submit ICD-10-CM diagnosis codes without decimals on their claim forms and electronic claims” as it is not relevant to the policy.
  • Provider Education/Guidance
  • Public Education/Guidance
  • Typographical Error
  • Other (Annual Validation)
10/01/2015 R1 Under CMS National Coverage Policy added citation 42 Code of Federal Regulations, §410.20, Physician's Services.
  • Provider Education/Guidance
  • Automated Edits to Enforce Reasonable & Necessary Requirements
N/A

Associated Documents

Attachments
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Public Versions
Updated On Effective Dates Status
04/05/2021 04/15/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Allergy Skin Testing

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