Local Coverage Determination (LCD): Allergy Testing (L31267)

Transcription

1 Local Coverage Determination (LCD): Allergy Testing (L31267) Contractor Information Contractor Name First Coast Service Options, Inc. LCD Information Document Information LCD ID L31267 LCD Title Allergy Testing AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Original Effective Date For services performed on or after 09/30/2010 Revision Effective Date For services performed on or after 01/01/2015 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 08/16/2010 Notice Period End Date N/A

2 UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. CMS National Coverage Policy Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR [b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the Social Security Act. Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub , Medicare Benefit Policy Manual, Chapter 15, Sections 20.2, 80.1 and 80.6 CMS Manual System, Pub , Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Sections and CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 12, Section 200 and Chapter 16, Section 40.7 Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Allergy is a form of exaggerated sensitivity or hypersensitivity to a substance that is either inhaled, ingested, injected, or comes in contact with the skin or eye. The term allergy is used to describe situations where hypersensitivity results from heightened or altered reactivity of the immune system in response to external substances. Allergic or hypersensitivity disorders may be manifested by generalized systemic reactions as well as localized reactions in any part of the body. The reactions may be acute, subacute, or chronic, immediate or delayed, and may be caused by a variety of offending agents; pollen, molds, mites, dust, feathers, animal fur or dander, venoms, foods, drugs, etc. Allergy testing is performed to determine a patient's immunologic sensitivity or reaction to particular allergens for the purpose of identifying the cause of the allergic state, and is based on

3 findings during a complete medical and immunologic history and appropriate physical exam obtained by face-to-face contact with the patient. Allergy testing can be broadly subdivided into two methodologies: A. In vivo testing (skin tests): this testing correlates the performance and evaluation of selective cutaneous and mucous membrane tests with the patient s history, physician examination, and other observations. Percutaneous testing (scratch, puncture, prick) and intracutaneous (intradermal) testing are used to evaluate immunoglobulin E (IgE) mediated hypersensitivity to inhalants, foods, hymenoptera (e.g., bee venom), drugs and/or chemicals. Patch testing to used to differentiate allergic contact dermatitis (ACD) and irritant contact dermatitis (ICD). Photo patch testing is used to evaluate unique allergies resulting from light exposure. Photo tests are performed for the evaluation of photosensitivity disorders. B. In vitro testing (blood serum analysis): immediate hypersensitivity testing by measurement of allergen-specific serum IgE (CPT code 86003). Special clinical situations in which specific IgE immunoassays may be appropriate include the following: Patients with severe dermatographism, ichthyosis or generalized eczema. Patients who cannot be safely withdrawn from medications that interfere with skin testing (such as long-acting antihistamines, tricyclic antidepressants). Uncooperative patients with mental or physical impairments. Evaluation of cross-reactivity between insect venoms (e.g., fire ant, bee, wasp, yellow jacket, hornet).

4 As adjunctive laboratory testing for disease activity of allergic bronchopulmonary aspergillosis and certain parasitic diseases. Patients at increased risk for anaphylactic response from skin testing based on clinical history (e.g., when an unusual allergen is not available as a licensed skin test extract), or who have a history of a previous systemic reaction to skin testing. Patients in whom skin testing was equivocal/inconclusive and in vitro testing is required as a confirmatory test. Limitations In vitro allergy testing is not covered for the following, because it is considered not medically reasonable and necessary: Patients with no contraindications to skin testing Patients being treated successfully for allergies Patients with mild symptoms Patients who have had negative skin testing for the allergy in question In vitro testing is covered when medically reasonable and necessary as a substitute for skin testing; it is not usually necessary in addition to skin testing. Qualitative multi-allergen screen (CPT code 86005) is a non-specific screening test that does not identify a specific antigen, and is not covered. The use of sublingual, intracutaneous, and subcutaneous provocative and neutralization testing and neutralization therapy for food allergies are excluded from Medicare coverage because available evidence does not show that these tests and therapies are effective (CMS Manual System, Pub , Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Section ).

5 Allergen-specific IgG and IgG subclasses measured by using immunoabsorption assays and IgG and IgG subclass antibody tests for food allergy/delayed food allergic symptoms or intolerance to specific foods (eg., CPT code 86001) are considered experimental and investigational, as there is insufficient evidence in the published peer-reviewed scientific literature to support the diagnostic value of these tests. The following tests are considered experimental and investigational for allergy testing as they have not been proven to be effective. These tests are not appropriate for the evaluation and/or management of IgE-mediated allergic reactions. Antigen leukocyte cellular antibody (ALCAT) automated food allergy testing Applied kinesiology or Nambudripad s allergy elimination test (NAET (i.e., muscle strength testing or measurement after allergen ingestion) Candidiasis test Chemical analysis of body tissues (e.g., hair) Chlorinated pesticides (serum) Complement (total or components) C-reactive protein Cytokine and cytokine receptor assay Cytotoxic testing for food, environmental or clinical ecological allergy testing (Bryans Test, ACT)

6 Electrodermal testing or electro-acupuncture ELISA/Act qualitative antibody testing Food immune complex assay (FICA) Ingestion challenge food testing for diagnosing rheumatoid arthritis, depression, or respiratory disorders not associated with anaphylaxis or similar systemic reactions Immune complex assay Iridology Leukocyte histamine release test (LHRT)/basophil histamine release test Lymphocytes (B or T subsets) Lymphocyte function assay Lymphocyte Response Assay (LRA) by ELISA/ACT and Lymphocyte Mitogen Response Assays (LMRA) by ELISA/Act Mediator release test (MRT)

7 Testing for multiple chemical sensitivity syndrome (a.k.a., idiopathic environmental intolerance (IEI), clinical ecological illness, clinical ecology, environmental illness, chemical AIDS, environmental/chemical hypersensitivity disease, total allergy syndrome, cerebral allergy, 20th century disease) Testing of specific Immunoglobulin (IgG) (e.g., by Radioallergosorbent (RAST) or Enzyme-linked immunosorbent assay (ELISA) Testing of total serum IgG, immunoglobulin A (IgA) and immunoglobulin M (IgM) Prausnitz-Kustner or P-K testing - passive cutaneous transfer test Pulse test (pulse response test, reaginic pulse test) Rebuck skin window test Sage Complement Antigen Test Measurements of total IgE levels (CPT code Gammaglobulin[immunoglobulin]; IgE) are not appropriate in most general allergy testing which is performed to determine a patient s immunologic sensitivity or reaction to particular allergens for the purpose of identifying the cause of the allergic state. It would not be expected that total serum IgE levels would be billed unless evidence exists for allergic bronchopulmonary Asperigillosis (ABPA), select immunodeficiencies, such as the syndrome of hyper-ige, eczematous dermatitis, atopic dermatitis in children and recurrent pyogenic infections, or in the evaluation for omalizumab therapy. Serial, repeat testing of total IgE will be subject to medical review.

8 Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient 021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient 073x Clinic - Freestanding 085x Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes Laboratory - Immunology 0924 Other Diagnostic Services - Allergy Test CPT/HCPCS Codes Group 1 Paragraph: CPT Codes that SUPPORT Medical Necessity NOTE: Per CR 8572, beginning in CY 2014, payment for most laboratory tests (except for molecular pathology tests) will be packaged under the OPPS, therefore the clinical laboratory tests listed below, for TOB 13X (outpatient hospital), are packaged in this setting. Group 1 Codes: ALLERGEN SPECIFIC IGE; QUANTITATIVE OR SEMIQUANTITATIVE, EACH ALLERGEN

9 PERCUTANEOUS TESTS (SCRATCH, PUNCTURE, PRICK) WITH ALLERGENIC EXTRACTS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT, SPECIFY NUMBER OF TESTS ALLERGY TESTING, ANY COMBINATION OF PERCUTANEOUS (SCRATCH, PUNCTURE, PRICK) AND INTRACUTANEOUS (INTRADERMAL), SEQUENTIAL AND INCREMENTAL, WITH VENOMS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT, SPECIFY NUMBER OF TESTS ALLERGY TESTING, ANY COMBINATION OF PERCUTANEOUS (SCRATCH, PUNCTURE, PRICK) AND INTRACUTANEOUS (INTRADERMAL), SEQUENTIAL AND INCREMENTAL, WITH DRUGS OR BIOLOGICALS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT, SPECIFY NUMBER OF TESTS INTRACUTANEOUS (INTRADERMAL) TESTS WITH ALLERGENIC EXTRACTS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT, SPECIFY NUMBER OF TESTS INTRACUTANEOUS (INTRADERMAL) TESTS, SEQUENTIAL AND INCREMENTAL, WITH ALLERGENIC EXTRACTS FOR AIRBORNE ALLERGENS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT, SPECIFY NUMBER OF TESTS INTRACUTANEOUS (INTRADERMAL) TESTS WITH ALLERGENIC EXTRACTS, DELAYED TYPE REACTION, INCLUDING READING, SPECIFY NUMBER OF TESTS PATCH OR APPLICATION TEST(S) (SPECIFY NUMBER OF TESTS) PHOTO PATCH TEST(S) (SPECIFY NUMBER OF TESTS) PHOTO TESTS OPHTHALMIC MUCOUS MEMBRANE TESTS Group 2 Paragraph: CPT Codes that DO NOT Support Medical Necessity *86343 Leukocyte histamine release test (LHR) G0461 Immunohistochemistry or immunocytochemistry, per specimen; first single or multiplex antibody stain *Services which are also listed in the FCSO LCD for Noncovered Services Group 2 Codes: IMMUNOASSAY FOR ANALYTE OTHER THAN INFECTIOUS AGENT ANTIBODY OR INFECTIOUS AGENT ANTIGEN; QUALITATIVE OR SEMIQUANTITATIVE, MULTIPLE STEP METHOD VOLATILES (EG, ACETIC ANHYDRIDE, DIETHYLETHER) ALLERGEN SPECIFIC IGG QUANTITATIVE OR SEMIQUANTITATIVE, EACH ALLERGEN

10 ALLERGEN SPECIFIC IGE; QUALITATIVE, MULTIALLERGEN SCREEN (DIPSTICK, PADDLE, OR DISK) C-REACTIVE PROTEIN; COMPLEMENT; ANTIGEN, EACH COMPONENT COMPLEMENT; FUNCTIONAL ACTIVITY, EACH COMPONENT COMPLEMENT; TOTAL HEMOLYTIC (CH50) IMMUNE COMPLEX ASSAY SKIN TEST; CANDIDA ANTIBODY; CANDIDA IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH ADDITIONAL SINGLE ANTIBODY STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; INITIAL SINGLE ANTIBODY STAIN PROCEDURE IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH MULTIPLEX ANTIBODY STAIN PROCEDURE IMMUNOFLUORESCENT STUDY, EACH ANTIBODY; DIRECT METHOD DIRECT NASAL MUCOUS MEMBRANE TEST MUSCLE TESTING, MANUAL (SEPARATE PROCEDURE) WITH REPORT; EXTREMITY (EXCLUDING HAND) OR TRUNK MUSCLE TESTING, MANUAL (SEPARATE PROCEDURE) WITH REPORT; HAND, WITH OR WITHOUT COMPARISON WITH NORMAL SIDE MUSCLE TESTING, MANUAL (SEPARATE PROCEDURE) WITH REPORT; TOTAL EVALUATION OF BODY, EXCLUDING HANDS MUSCLE TESTING, MANUAL (SEPARATE PROCEDURE) WITH REPORT; TOTAL EVALUATION OF BODY, INCLUDING HANDS ICD-9 Codes that Support Medical Necessity Group 1 Paragraph: The following ICD-9-CM codes apply only to CPT code 86003: Group 1 Codes: ACUTE ATOPIC CONJUNCTIVITIS OTHER CHRONIC ALLERGIC CONJUNCTIVITIS ALLERGIC RHINITIS DUE TO POLLEN ALLERGIC RHINITIS DUE TO FOOD ALLERGIC RHINITIS, DUE TO ANIMAL (CAT) (DOG) HAIR AND DANDER ALLERGIC RHINITIS DUE TO OTHER ALLERGEN ALLERGIC RHINITIS CAUSE UNSPECIFIED EXTRINSIC ASTHMA UNSPECIFIED EXTRINSIC ASTHMA WITH STATUS ASTHMATICUS EXTRINSIC ASTHMA WITH (ACUTE) EXACERBATION

11 ASTHMA UNSPECIFIED ASTHMA UNSPECIFIED TYPE WITH STATUS ASTHMATICUS ASTHMA UNSPECIFIED WITH (ACUTE) EXACERBATION OTHER ATOPIC DERMATITIS AND RELATED CONDITIONS CONTACT DERMATITIS AND OTHER ECZEMA UNSPECIFIED CAUSE DERMATITIS DUE TO DRUGS AND MEDICINES TAKEN INTERNALLY DERMATITIS DUE TO FOOD TAKEN INTERNALLY DERMATITIS DUE TO OTHER SPECIFIED SUBSTANCES TAKEN INTERNALLY DERMATITIS DUE TO UNSPECIFIED SUBSTANCE TAKEN INTERNALLY ALLERGIC URTICARIA DERMATOGRAPHIC URTICARIA OTHER SPECIFIED URTICARIA UNSPECIFIED URTICARIA RASH AND OTHER NONSPECIFIC SKIN ERUPTION TOXIC EFFECT OF VENOM TOXIC EFFECT OF LATEX OTHER ANAPHYLACTIC REACTION ANGIONEUROTIC EDEMA NOT ELSEWHERE CLASSIFIED UNSPECIFIED ADVERSE EFFECT OF UNSPECIFIED DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE UNSPECIFIED ADVERSE EFFECT OF ANESTHESIA OTHER DRUG ALLERGY UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE ALLERGY UNSPECIFIED NOT ELSEWHERE CLASSIFIED ANAPHYLACTIC REACTION DUE TO UNSPECIFIED FOOD ANAPHYLACTIC REACTION DUE TO PEANUTS ANAPHYLACTIC REACTION DUE TO CRUSTACEANS ANAPHYLACTIC REACTION DUE TO FRUITS AND VEGETABLES ANAPHYLACTIC REACTION DUE TO TREE NUTS AND SEEDS ANAPHYLACTIC REACTION DUE TO FISH ANAPHYLACTIC REACTION DUE TO FOOD ADDITIVES ANAPHYLACTIC REACTION DUE TO MILK PRODUCTS ANAPHYLACTIC REACTION DUE TO EGGS ANAPHYLACTIC REACTION DUE TO OTHER SPECIFIED FOOD V15.09* PERSONAL HISTORY OF OTHER ALLERGY OTHER THAN TO MEDICINAL AGENTS Group 1 Medical Necessity ICD-9 Codes Asterisk Explanation: ** ICD-9-CM code V15.09 should be used as a secondary code only and should not be billed as the primary diagnosis. Group 2 Paragraph: The following ICD-9-CM codes apply only to CPT codes *95004, 95017, 95018, 95024, 95027, and 95028:

12 Group 2 Codes: ACUTE ATOPIC CONJUNCTIVITIS OTHER CHRONIC ALLERGIC CONJUNCTIVITIS CHRONIC RHINITIS ALLERGIC RHINITIS DUE TO POLLEN ALLERGIC RHINITIS DUE TO FOOD ALLERGIC RHINITIS, DUE TO ANIMAL (CAT) (DOG) HAIR AND DANDER ALLERGIC RHINITIS DUE TO OTHER ALLERGEN ALLERGIC RHINITIS CAUSE UNSPECIFIED EXTRINSIC ASTHMA UNSPECIFIED EXTRINSIC ASTHMA WITH STATUS ASTHMATICUS EXTRINSIC ASTHMA WITH (ACUTE) EXACERBATION OTHER ATOPIC DERMATITIS AND RELATED CONDITIONS 693.1* DERMATITIS DUE TO FOOD TAKEN INTERNALLY UNSPECIFIED PRURITIC DISORDER ALLERGIC URTICARIA OTHER SPECIFIED URTICARIA TOXIC EFFECT OF VENOM TOXIC EFFECT OF LATEX OTHER ANAPHYLACTIC REACTION ANGIONEUROTIC EDEMA NOT ELSEWHERE CLASSIFIED UNSPECIFIED ADVERSE EFFECT OF UNSPECIFIED DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE OTHER DRUG ALLERGY UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE ALLERGY UNSPECIFIED NOT ELSEWHERE CLASSIFIED SHOCK DUE TO ANESTHESIA NOT ELSEWHERE CLASSIFIED * ANAPHYLACTIC REACTION DUE TO UNSPECIFIED FOOD * ANAPHYLACTIC REACTION DUE TO PEANUTS * ANAPHYLACTIC REACTION DUE TO CRUSTACEANS * ANAPHYLACTIC REACTION DUE TO FRUITS AND VEGETABLES * ANAPHYLACTIC REACTION DUE TO TREE NUTS AND SEEDS * ANAPHYLACTIC REACTION DUE TO FISH * ANAPHYLACTIC REACTION DUE TO FOOD ADDITIVES * ANAPHYLACTIC REACTION DUE TO MILK PRODUCTS * ANAPHYLACTIC REACTION DUE TO EGGS * ANAPHYLACTIC REACTION DUE TO OTHER SPECIFIED FOOD 995.7* OTHER ADVERSE FOOD REACTIONS NOT ELSEWHERE CLASSIFIED V14.0* PERSONAL HISTORY OF ALLERGY TO PENICILLIN V14.1* PERSONAL HISTORY OF ALLERGY TO OTHER ANTIBIOTIC AGENT

13 V14.2* PERSONAL HISTORY OF ALLERGY TO SULFONAMIDES V14.3* PERSONAL HISTORY OF ALLERGY TO OTHER ANTI-INFECTIVE AGENT V14.7* PERSONAL HISTORY OF ALLERGY TO SERUM OR VACCINE PERSONAL HISTORY OF ALLERGY TO OTHER SPECIFIED MEDICINAL V14.8* AGENTS V15.01* PERSONAL HISTORY OF ALLERGY TO PEANUTS V15.02* PERSONAL HISTORY OF ALLERGY TO MILK PRODUCTS V15.03* PERSONAL HISTORY OF ALLERGY TO EGGS V15.04* PERSONAL HISTORY OF ALLERGY TO SEAFOOD V15.05* PERSONAL HISTORY OF ALLERGY TO OTHER FOODS V15.06* ALLERGY TO INSECTS AND ARACHNIDS Group 2 Medical Necessity ICD-9 Codes Asterisk Explanation: **ICD-9-CM codes that apply for CPT code for food allergy testing. **ICD-9-CM V codes should be used as a secondary code only and should not be billed as the primary diagnosis. Group 3 Paragraph: The following ICD-9-CM codes apply only to CPT codes 95044, and 95056: Group 3 Codes: OTHER ATOPIC DERMATITIS AND RELATED CONDITIONS CONTACT DERMATITIS AND OTHER ECZEMA DUE TO DETERGENTS CONTACT DERMATITIS AND OTHER ECZEMA DUE TO OILS AND GREASES CONTACT DERMATITIS AND OTHER ECZEMA DUE TO SOLVENTS CONTACT DERMATITIS AND OTHER ECZEMA DUE TO DRUGS AND MEDICINES IN CONTACT WITH SKIN CONTACT DERMATITIS AND OTHER ECZEMA DUE TO OTHER CHEMICAL PRODUCTS CONTACT DERMATITIS AND OTHER ECZEMA DUE TO FOOD IN CONTACT WITH SKIN CONTACT DERMATITIS AND OTHER ECZEMA DUE TO PLANTS (EXCEPT FOOD) DERMATITIS DUE TO COSMETICS DERMATITIS DUE TO METALS CONTACT DERMATITIS AND OTHER ECZEMA DUE TO OTHER SPECIFIED AGENTS CONTACT DERMATITIS AND OTHER ECZEMA UNSPECIFIED CAUSE Group 4 Paragraph: The following ICD-9-CM codes apply only to CPT code 95060: Group 4 Codes: ACUTE ATOPIC CONJUNCTIVITIS OTHER CHRONIC ALLERGIC CONJUNCTIVITIS

14 ICD-9 Codes that DO NOT Support Medical Necessity Paragraph: The following ICD-9-CM codes are noncovered for procedure codes 86005, 86160, 86161, 86162: Codes: CONTACT DERMATITIS AND OTHER ECZEMA DUE TO FOOD IN CONTACT WITH SKIN DERMATITIS DUE TO FOOD TAKEN INTERNALLY ANAPHYLACTIC REACTION DUE TO UNSPECIFIED FOOD - ANAPHYLACTIC REACTION DUE TO OTHER SPECIFIED FOOD OTHER ADVERSE FOOD REACTIONS NOT ELSEWHERE CLASSIFIED General Information Associated Information Documentation Requirements Medical record documentation (e.g., history & physical, office/progress notes, procedure report, test results) must include the following information, and be available upon request: A complete medical and immunologic history and appropriate physical exam obtained by face-to-face contact with the patient. The medical necessity for performing the test. The test methodology used. The measurement (in mm) of reaction sizes of both wheal and erythema response (in vivo testing).

15 The medical necessity for the use of in vitro testing if used, instead of in vivo methods. The quantitative result (in kiu/l) for specific IgE testing (in vitro testing). The interpretation of the test results and how the results of the test will be used in the patient s plan of care. Per 42 CFR , all diagnostic tests must be ordered by the physician/nonphysician practitioner who is treating the patient, that is, the physician/nonphysician practitioner who furnishes a consultation or treats a patient for a specific medical problem and who uses the results in the management of the patient s specific medical problem. Tests not ordered by the physician/nonphysician practitioner who is treating the patient are not reasonable and necessary. Providers should not submit additional information with the claim. Information may be requested separately with an additional documentation request (ADR) letter. Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity. It would not be expected that all patients would receive the same tests or the same number of sensitivity tests. The number of tests performed must be judicious and related to the history, physical findings and clinical judgment specific to each individual patient. In vitro testing is covered when medically reasonable and necessary as a substitute for skin testing; it is not usually necessary in addition to skin testing. In vitro testing (CPT code 86003) will be covered for only thirty (30) units per year for medically reasonable and necessary indications as outlined in this LCD. Services exceeding this parameter will be considered not medically necessary. It would not be expected that more than twenty (20) units be reported for percutaneous testing per year for food sensitivity (CPT code 95004). It would not be expected that more than forty (40) units be reported for intracutaneous (intradermal) testing (CPT code 95024) per year for a patient. It would not be expected that more than forty (40) units be reported for intracutaneous (intradermal), sequential and incremental testing (CPT code 95027) per year for a patient.

16 When photo patch test(s) (CPT code 95052) are performed (same antigen/same session) with patch or application test(s) (CPT code 95044), only the photo patch tests should be reported. In the event photo tests (CPT code 95056) are performed with patch or application test(s) (CPT code 95044), only the photo tests should be reported. Sources of Information and Basis for Decision Contact dermatitis: a practice parameter. (2006). The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI), 100, S1-S38. Food allergy: a practice parameter. (2006). The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI), 96, S1-S68. Other Contractor(s) LCDs Practice parameters for allergy diagnostic testing: An updated practice parameter. (2008). The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI), 100(3), S1-S148. Retrieved on August 31, 2009 from Wang, J., Godbold, J., & Sampson, H. (2008). Correlation of serum allergy (IgE) tests performed by different assay systems. J Allergy Clin Immunol, 121, Wood, R., Segall, N., Ahlstedt, S., & Williams, P. (2007). Accuracy of IgE antibody laboratory results. Ann Allergy, Asthma & Immunol, 99, U.S. Department of Health and Human Services. (2008) National asthma education and prevention program guidelines implementation panel report 3-Guidelines for the diagnosis and management of asthma, (NIH Publication No ), 1-44 (Retrieved on November 10, 2009 from on November 10. Revision History Information Please note: Most Revision History entries effective on or before 01/24/2013 display with a Revision History Number of "R1" at the bottom of this table. However, there may be LCDs where these entries will display as a separate and distinct row. Revision History Date Revision History Number Revision History Explanation Reason(s) for Change

17 01/01/2015 R6 01/01/2014 R5 01/01/2014 R4 Revision Number: 5 Publication: December 2014 Connection LCRA Explanation of Revision: Annual 2015 HCPCS Update. Under the CPT Codes that DO NOT Support Medical Necessity section of the LCD, HCPCS code G0461 was deleted and replaced with CPT code CPT codes and with descriptors were added. In addition, the descriptor was revised for CPT code The effective date of this revision is based on date of service Revision Number: 4 Publication: October 2014 Connection LCRA Explanation of Revision: Based on CR 8572, the following verbiage was added under the CPT/HCPCS Codes section of the LCD: beginning in CY 2014, payment for most laboratory tests (except for molecular pathology tests) will be packaged under the OPPS, therefore the clinical laboratory tests listed below, for TOB 13X (outpatient hospital), are packaged in this setting. The effective date of this revision is based on date of service. THE FOLLOWING IS A CORRECTION TO REVISION NUMBERS: 2 & 3 Explanation of revision: Annual 2014 HCPCS Update and CR Under the CPT Codes that DO NOT Support Medical Necessity section of the LCD, CPT code with descriptor was deleted and replaced with HCPCS code G0461 with descriptor. In addition, the asterisk was removed from CPT code as it is no longer listed in the Noncovered Services LCD. This revision is not related to the Annual 2014 HCPCS updates. The effective date of this revision is based on date of service. Revisions Due To CPT/HCPCS Code Changes Provider Education/Guidance Other

18 01/01/2014 R3 01/01/2014 R2 01/01/2013 R1 Revision Number: 3 Publication: January 2014 Connection LCR A Explanation of revision: Annual 2014 HCPCS Update and CR Under the CPT Codes that DO NOT Support Medical Necessity section of the LCD, CPT code with descriptor was deleted and replaced with HCPCS code G0461 with descriptor. In addition, CPT code was removed as it is no longer listed in the Noncovered Services LCD. This revision is not related to the Annual 2014 HCPCS updates. The effective date of this revision is based on date of service. Revision Number: 3 Publication: January 2014 Connection LCR A Explanation of revision: Annual 2014 HCPCS Update. Under the CPT Codes that DO NOT Support Medical Necessity section of the LCD, CPT code with descriptor was added. The effective date of this revision is based on date of service. Revision Number:2 Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2013 Original Effective Date:01/01/2013 LCR A December 2012 Connection Explanation of revision: Annual 2013 HCPCS Update. Under sections CPT/HCPCS Codes and ICD-9 Codes that Support Medical Necessity CPT codes and were deleted and replaced with codes and Under section CPT/HCPCS Codes CPT codes 95004, 95024, and descriptors were revised. The effective date of this revision is based on date of service. Other Revisions Due To CPT/HCPCS Code Changes HCPCS Addition/Deletion Narrative Change

19 Revision Number: 1 Start Date of Comment Period:N/A Start Date of Notice Period:10/01/2011 Revised Effective Date:10/01/2011 LCR A September 2011 Connection Explanation of Revision: Annual 2012 ICD-9-CM Update. Revised descriptor for diagnosis code range for CPT codes 86003, 86005, 86160, 86161, 86162, and Revised descriptor for diagnosis code for CPT codes 86003, 95004, 95010, 95015, 95024, 95027, and The effective date of this revision is based on date of service. Revision Number Original Start Date of Comment Period:05/28/2010 Start Date of Notice Period:08/16/2010 Original Effective Date 09/30/2010 LCR A August 2010 Bulletin 8/1/ The description for Bill Type Code 12 was changed 8/1/ The description for Bill Type Code 13 was changed 8/1/ The description for Bill Type Code 21 was changed 8/1/ The description for Bill Type Code 22 was changed 8/1/ The description for Bill Type Code 23 was changed 8/1/ The description for Bill Type Code 73 was changed 8/1/ The description for Bill Type Code 85 was changed 8/1/ The description for Revenue code 0302 was changed 8/1/ The description for Revenue code 0924 was changed

20 11/21/ For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group 2 08/27/ This policy was updated by the ICD Annual Update. 11/21/ For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: descriptor was changed in Group 2 11/25/ For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group descriptor was changed in Group 2 11/25/ The following CPT/HCPCS codes were deleted:

21 95010 was deleted from Group was deleted from Group 1 Associated Documents Attachments Comment Summary (5/28/10-7/11/10) (a comment and response document) code guide eff 1/1/13 Related Local Coverage Documents N/A Related National Coverage Documents N/A Public Version(s) Updated on 12/12/2014 with effective dates 01/01/ N/A Updated on 10/13/2014 with effective dates 01/01/ /31/2014 Updated on 07/01/2014 with effective dates 01/01/ N/A Updated on 01/14/2014 with effective dates 01/01/ N/A Updated on 12/19/2013 with effective dates 01/01/ N/A Updated on 12/13/2013 with effective dates 01/01/ N/A Updated on 12/18/2012 with effective dates 01/01/ /31/2013 FIRST COAST SERVICE OPTIONS LOCAL COVERAGE DETERMINATION CODING GUIDELINES Contractor s Determination Number A86003 LCD Database ID Number L31267 Contractor Name First Coast Service Options, Inc. Contractor Number Florida Puerto Rico/Virgin Islands

22 LCD Title Allergy Testing Coding Guidelines In vitro testing is covered when medically reasonable and necessary as a substitute for skin testing; it is not usually necessary in addition to skin testing. When photo patch test(s) (CPT code 95052) are performed (same antigen/same session) with patch or application test(s) (CPT code 95044), only the photo patch tests should be reported. In the event photo tests (CPT code 95056) are performed with patch or application test(s) (CPT code 95044), only the photo tests should be reported. Per the Centers for Medicare and Medicaid Services (CMS) National Correct Coding Initiative (NCCI) Policy Manual for Medicare Services, Chapter 11 ( 1. If percutaneous or intracutaneous (intradermal) single test (CPT codes or 95024) and "sequential and incremental" tests (CPT codes, 95017, 95018, or 95027) are performed on the same date of service, both the "sequential and incremental" test and single test codes may be reported if the tests are for different allergens or different dilutions of the same allergen. The unit of service to report is the number of separate tests. A single test and a sequential and incremental test for the same dilution of an allergen should not be reported separately on the same date of service. For example, if the single test for an antigen is positive and the physician proceeds to sequential and incremental tests with three additional different dilutions of the same antigen, the physician may report one unit of service for the single test code and three units of service for the sequential and incremental test code. 2. Photo patch tests (CPT code 95052) consist of applying a patch(s) containing allergenic substance(s) to the skin and exposing the skin to light. Physicians should not unbundle this service by reporting both CPT code (patch or application tests) plus CPT code (photo tests) rather than CPT code Evaluation and management (E&M) codes reported with allergy testing or allergy immunotherapy are appropriate only if a significant, separately identifiable service is performed. Obtaining informed consent is included in the immunotherapy service and should not be reported with an E&M code. If E&M services are reported, modifier 25 should be utilized. 4. Allergy testing is not performed on the same day as allergy immunotherapy in standard medical practice. These codes should not be reported together for the same date of service. Additionally, testing is an integral component of rapid desensitization kits (CPT code 95180) and is not separately reportable. Comments This LCD does not directly address the following allergy tests: CPT code Inhalation bronchial challenge testing (not including necessary pulmonary function tests); with histamine, methacholine, or similar compounds CPT code Inhalation bronchial challenge testing (not including necessary pulmonary function tests); with antigens or gases, specify

23 *CPT code Ingestion challenge test (sequential and incremental ingestion of test items, eg, food, drug or other substance such as metabisulfite) *CPT code is covered when it is used on an outpatient basis if it is reasonable and necessary for the individual patient. Challenge ingestion food testing has not been proven to be effective in the diagnosis of rheumatoid arthritis, depression, or respiratory disorders. Accordingly, its use in the diagnosis of these conditions is not reasonable and necessary within the meaning of 1862(a)(1) of the Act, and no program payment is made for this procedure when it is so used (CMS Manual System, Pub , Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Section ). It is expected that the services represented by the above CPT codes would be performed based on findings during a complete medical and immunologic history and appropriate physical exam obtained by face-to-face contact with the patient, and in accordance with current standards of care. Revision History Date Revision 01/01/ Annual 2013 HCPCS Update. Under the section Coding Guidelines CPT codes and were deleted and replaced with codes and The effective date of this revision is based on date of service. 09/30/2010 Original Document formatted: 12/17/2012 (MB/et)