Clinical Policy Title: Allergy testing

Transcription

1 Clinical Policy Title: Allergy testing Clinical Policy Number: Effective Date: June 1, 2014 Initial Review Date: December 18, 2013 Most Recent Review Date: January 20, 2016 Next Review Date: January 2017 Policy contains: In vivo and in vitro tests. Food, inhalant, contact, insect venom, and drug allergies. Related policies: None. ABOUT THIS POLICY Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers the use of allergy testing to be clinically proven and therefore, medically necessary, when all of the following criteria are met: Clinically significant symptoms documented in allergy-focused history. Tests are performed by allergists, otorhinolaryngologists (ENT), or pulmonologists. 1

2 In vivo allergy tests Test Skin scratch, prick, or puncture: Up to 70 tests/year. Additional 70 tests, if initial results negative. Skin endpoint titration (SET) Skin patch Indication(s) Suspected IgE-mediated allergy to: Foods. Stinging insect venom. Specific drugs. Patients highly allergic to stinging insect venom: Determination of starting dose for testing or immunotherapy. Testing in facility equipped to manage anaphylaxis. Suspected contact allergy. Photo-patch Suspected contact photo-sensitization. Drug bronchial challenge Suspected IgE-mediated drug hypersensitivity: With suggestive history. Drug is required for treatment. No effective alternative available. Limitations: Tests not covered due to insufficient evidence: Sublingual provocation and neutralization for food allergies. Allergen-specific IgG. Testing and desensitization for poison ivy, oak, or sumac. Applied kinesiology. Body chemical analysis. Candida hypersensitivity syndrome. Conjunctival challenge. Cytotoxic food test. Electrodermal acupuncture. Food-specific IgG. Vega. Facial thermography. Hair analysis. 2

3 Iridology In vitro: o Histamine release or leukocyte histamine release. o Lymphocyte proliferation. There are in vitro tests that are covered, specifically allergen specific IgE. This testing is limited to that which is determined to be medically necessary on a case by case basis. Alternative covered services: None Background Allergies: acquired, rapid, usually predictable, and exaggerated immune system responses to otherwise harmless environmental substances or allergens that are ingested, inhaled, or contacted. Most allergic reactions, such as hay fever or hypersensitivity to animal dander are relatively mild and non-life threatening, although accompanied by unpleasant symptoms (sneezing, eye irritation, or itching). Others, such as anaphylaxis or severe asthma attacks, may be much more serious. Allergy tests include skin patches or prick tests with candidate allergens, tests involving cell types or chemicals that mediate hypersensitivity reactions (basophils, lymphocytes, or histamines) and blood tests (serum or allergenspecific immunoglobulin E). Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on December 24, Search terms were: allergy and diagnosis. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. 3

4 Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Available reviews cover all types of allergies in people of all ages, and generally concur that allergy testing should follow an allergy-focused history. Cost-effective testing strategies should begin with in vivo tests and progress to in vitro, only when initial results are negative or equivocal. The research literature on allergy testing is restricted to diagnostic accuracy studies. No reviews covered randomized controlled trials (RCTs) or other study types documenting improved outcomes with testing. Reviews concur on those tests supported by insufficient evidence (limitations, above). Policy updates: None Summary of clinical evidence: Citation Content, Methods, Recommendations UK National Institute for Clinical Excellence (NICE) (2011) Food allergies in children and young people Published meta-analyses, March years presenting with: o Atopic eczema. o Anaphylaxis. o Urticaria. o Rhinitis. o Conjunctivitis. o Asthma. o Gastrointestinal symptoms. o Oral allergy syndrome. 19 years at higher risk of food allergy: o Existing atopic diseases (asthma, atopic eczema, or allergic rhinitis). o First degree relative (parent or sibling) with food allergy/other atopic disease. 4

5 Citation Content, Methods, Recommendations Boyce (2010) Cost analysis: skin prick and IgE blood analysis to confirm food allergy is associated with cost-effectiveness ratio below threshold of 20,000/quality adjusted life years (QALY) gained: robust result with high probability of costeffectiveness for skin-prick option. Based on results of allergy-focused history, offer skin-prick test and/or blood tests for specific IgE antibodies to suspected foods and co-allergens. Skin-prick only at facilities equipped to deal with anaphylaxis. If non-ige mediated allergy suspected: try allergen elimination for 2 6 weeks and reintroduce after trial; consult with appropriately trained dietician. Tests not recommended: o Vega. o Hair. o Applied kinesiology. o Serum-specific IgG. Diagnosis and management of food allergies Recommended tests: o Symptom recognition and history. o Physical exam. o Skin prick test. o Total serum immunoglobulin E (IgE). o Allergen-specific IgE. o Atropy patch test. o Food elimination diets. o Oral food challenges. Tests not recommended: o Intradermal tests. o Basophil/histamine release or activation. o Lymphocyte stimulation. o Facial thermography. o Gastric juice analysis. o Endoscopic allergen provocation. o Hair analysis. o Applied kinesthesiology. o Provocation neutralization. o Allergen-specific IgG4. o Cytotoxicity assays. o Electrodermal test. o Mediator release assay. 5

6 Citation Content, Methods, Recommendations Lieberman (2010) Diagnosis and management of anaphylaxis Diagnosis: o History. o Evaluation of signs and symptoms. o Skin-prick. o Food challenge. o In vitro IgE. Schneider Chaffen (2010) Diagnosing and managing common food allergies Diagnostic accuracy studies, 9/2009. Eighteen prospective studies (N = 2806); generally fair quality. No significant (NS) differences, skin-prick vs. food challenge or serum foodspecific IgE. Conclusions hindered by lack of uniform diagnostic criteria. Hayes (2009) Diagnosis of respiratory allergy, in vitro: quantitative in vitro assay for allergen-specific IgE Fair-to-good evidence for agreement with skin testing in patients referred to allergy clinic. No evidence for impact on decision making in clinic, in primary care, or on patient outcomes. Hayes (2009a) Allergy testing, in vivo Remaining questions re: most effective skin tests. Evidence ratings: (A) for skin-prick/puncture, suspected inhalant; (B) intradermal, suspected inhalant; (C) skin-prick+ history/physical, suspected food; (D) intradermal, suspected food (high rate of false-positive reactions). Lewis (2008) Cost-effectiveness of diagnostic evaluation of inhalant allergies Three approaches to suspected IgE-mediated inhalant allergies: o Modified quantitative. o Intra-dermal dilution. o In vitro. Modified quantitative most effective and least costly. May not be generalized to all laboratories. 6

7 Glossary Anaphylaxis A rapid and severe life-threatening allergic reaction most often caused by insect bites, foods, and medications. It may occur on first or subsequent exposures to allergens and is treated by epinephrine injection, along with fluids and other supportive measures. At some point in life, percent of people will experience anaphylaxis. Asthma A common chronic disease in which swelling of the airways causes wheezing, shortness of breath, and coughing. Some cases of asthma have allergic components, such as reactions to inhaled pollen, dust mites, molds, or animal dander. Atopy or atopic disease A predisposition to unusual hypersensitivity reactions, which may include hereditary contributors and a tendency to be hyper-allergic. A patient may experience multiple allergies, including hay fever, asthma, and/or food allergies. Atopy is characterized by: eczema (atopic dermatitis), allergic rhinitis (hay fever), allergic conjunctivitis (inflammation of eye mucous membranes), and allergy-induced asthma. Immunoglobulin E (IgE) A class of antibody involved in immunity to parasites and in allergic reactions, such as allergic asthma, rhinitis, and food allergies. It also mediates anaphylaxis and may be involved in the immune response to cancer. IgE-mediated allergies are usually acute and of rapid onset; non-ige-mediated are generally non-acute and delayed. In vitro In glass testing conducted in the laboratory (e.g., blood tests), in contrast to in vivo or in life tests, conducted directly on the patient (e.g., skin patch or prick tests). References Professional society guidelines/other: Centre for Clinical Practice. Food allergy in children and young people in primary care and community settings. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011 (Clinical guideline no 116). Hayes, Inc. Allergy testing for diagnosis of respiratory allergy in vitro. Lansdale: Hayes, Inc., Hayes, Inc. Allergy testing, in vivo. Lansdale: Hayes, Inc. 2009a. Peer-reviewed references: Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Part 1. Ann Allergy Asthma Immunol.2008a; 100(3 Suppl 3):S Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. 7

8 Part 2. Ann Allergy Asthma Immunol.2008a; 100(3 Suppl 3):S 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. J Allergy Clin Immunol.2010; 126(6 Suppl):S1-58. Centre for Clinical Practice. Food allergy in children and young people in primary care and community settings. London (UK): National Institute for Health and Clinical Excellence (NICE); 2011 (Clinical guideline no 116). Hayes, Inc. Allergy testing for diagnosis of respiratory allergy in vitro. Lansdale: Hayes, Inc., Hayes, Inc. Allergy testing, in vivo. Lansdale: Hayes, Inc. 2009a. Lewis AF, Franzese C, Stringer SP. Diagnostic evaluation of inhalant allergies: a cost-effectiveness analysis. Am J Rhinol.2008/22(3): Lieberman P, Nicklas RA, Oppenheimer J, et al. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol. 2010; 126(3): Schneider Chaffen JJ, Newberry SJ, Riedl MA, et al.. Diagnosing and Managing common food allergies: a systematic review. JAMA.2010; 303(18): Clinical trials: Searched clinicaltrials.gov on December 24, 2015, using the term allergy diagnosis; 840 studies identified on a wide range of allergies, including food and drugs. CMS National Coverage Determinations (NCDs): Centers for Medicare & Medicaid Services. National coverage determination (NCD) for food allergy testing and treatment (110.11). Effective 10/31/1988. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. 8

9 CPT Code Description Comments Allergen specific IgE; quantitative or semiquantitative, each allergen Allergen specific IgE; qualitative, multiallergen screen (dipstick, paddle, or disk) Intra-dermal scratch/prick Serial endpoint titration 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 tests(s) (specify number of tests) Photo patch test(s) (specify number of tests Inhalation bronchial challenge testing (not including necessary pulmonary function tests); with histamine, methacholine, or similar compounds Inhalation bronchial challenge testing (not including necessary pulmonary function tests); with antigens or gases, specify ICD-10 Code Description Comments No codes HCPCS Level II No codes Description Comments 9