Medical Policy Bulletin

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Title:

Allergy Immunotherapy

Policy #:

07.00.21c

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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. 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.

Intent

The intent of this policy is to communicate the coverage positions for allergy immunotherapy. For information on policies related to this topic, refer to the Cross References section in this policy.

Description:

The three basic treatments for allergy are avoidance therapy, pharmacologic therapy, and immunotherapy. Complete avoidance of the allergen responsible for inducing the signs and symptoms of the allergy is the most effective treatment for any allergic condition. When avoidance of a specific allergen such as house dust, molds, or pollens is impossible, pharmacologic therapy is initiated (eg, antihistamines, adrenergic agonists, anticholinergics, beta-adrenergic agonists, corticosteroids, cromolyn sodium, methylxanthines). When known allergens are unavoidable and not effectively controlled with pharmacologic agents, allergy immunotherapy may be necessary. Allergy (or allergen) immunotherapy is the repeated administration of specific allergens to an individual with immune globulin E (IgE)-mediated conditions, to provide protection against the allergic symptoms and inflammatory reactions associated with exposure to these allergens. Five years of age is the youngest recommended age to start immunotherapy; however, there is no age limit for receiving immunotherapy. Allergy (or allergen) immunotherapy has been shown in clinical studies to be effective for individuals with allergic rhinitis or conjunctivitis, allergic asthma, and stinging insect hypersensitivity. Aeroallergen immunotherapy is indicated for individuals with inhalant allergen sensitivities due to seasonal pollinosis caused by trees, grasses, and weeds, and in the treatment of mold-, dust-, and mite-induced rhinitis. Venom immunotherapy is indicated for individuals who have a severe systemic anaphylactic reaction after an insect sting and a positive skin test or other documented IgE sensitivity to a specific insect venom. Individuals 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. Animal dander sensitivity (epidermal) may respond to immunotherapy, but it is not routinely recommended to replace the removal of the offending allergen. Individuals who have unavoidable occupational exposures (eg, veterinarians or laboratory workers) may require a trial of immunotherapy. There are usually two phases to immunotherapy: a build-up phase and a maintenance phase. The build-up phase involves an individual receiving therapy injections with increasing small amounts of an antigen. The duration of the build-up phase generally ranges from three to six months and depends on the frequency of the injections, which is progressively increased as tolerated to every four to six weeks. The injections are administered once or twice per week, at least two days apart. The goal of administering a slowly increasing quantity of antigen is to gradually increase the individual's immunity to the offending allergen and to help them develop a degree of tolerance to the antigen. This treatment regimen leads to a lessening of the individual's symptoms and medication requirements. The maintenance phase begins when the therapeutic dose is reached. The effective maintenance dose is different for each individual, depending on their level of allergen sensitivity and their response to the immunotherapy build-up phase. The intervals between injections will be longer and generally range from every two to four weeks, as determined by the allergist or immunologist. Individuals should be evaluated every six to 12 months while on immunotherapy. Clinical improvement is usually attainable within one year. Once the maintenance dose is reached, immunotherapy should continue for three to five years. Cluster immunotherapy involves the administration of two or more injections per visit to achieve a maintenance dose more rapidly than is achieved with conventional schedules. It is a type of rush immunotherapy characterized by giving several allergen injections on the same day. Rush immunotherapy involves incremental doses of an allergen administered at intervals varying from 15 to 30 minutes and 24 hours, until the optimal effect is achieved. Very sensitive individuals may experience various degrees of systemic reaction during this procedure. Physicians frequently premedicate individuals with both an antihistamine or corticosteroid to minimize the risk of systemic reaction. A modified rush method involves subcutaneous allergen injections administered 24 hours apart, and may or may not require a premedication. Allergy or allergen immunotherapy is different from desensitization. Desensitization is a process by which effector cells are rendered less reactive or nonreactive to IgE-mediated immune responses by the rapid administration of incremental doses of an allergenic substance. Rapid desensitization may be used in cases of allergy to insulin, penicillin, and horse serum. In addition, it can be effective for allergies to sulfonamides, cephalosporins, and other commonly used drugs. Desensitization is performed when an individual requires the use of an allergic substance; therefore, physician supervision is required in a hospital setting to monitor the individual's reactions and response to treatment. In some cases, the skin test response to the agent is reduced or is negative after desensitization. Standardized allergen extracts can also be administered under the tongue to allow absorption through the mucosa. This method is known as sublingual immunotherapy. At this time, there is a lack of scientific evidence in the published peer-reviewed medical literature to support the safety and effectiveness of this form of administration. Clinical studies do not show support for the use of allergy immunotherapy for food hypersensitivity (gastrointestinal disturbances, skin eruptions, or shock due to allergic reactions to allergens in food), chronic urticaria (persistent itchy hives for six weeks or more, usually without a known cause), and/or angioedema (the sudden development of painful, itchy swelling or welts that can occur around the eyes and lips or on the hands, feet, and throat).

Policy

MEDICALLY NECESSARY Allergy immunotherapy is considered medically necessary and, therefore, covered when both of the following criteria are met: An individual has one of the following documented conditions: Allergic asthma Allergic rhinitis and/or conjunctivitis Stinging insect allergy Clinical evidence of an inhalant allergen sensitivity The individual's medical record documents the antigens to be administered and treatment plan and dosage regimen. The regimen must include the starting immunotherapy schedule, target maintenance dose, and the immunotherapy schedule. Documentation in the medical record should demonstrate evidence of specific immune globulin E (IgE) antibodies to clinical relevant allergens and that the allergic symptoms warrant the time and risk of allergen immunotherapy. Individuals must be evaluated every six to 12 months while receiving allergy immunotherapy for all of the following: To determine efficacy To monitor for the two types of adverse reactions: local and systemic Local reactions are fairly common, and they present as redness and swelling at the injection site. Systemic reactions may include symptoms such as sneezing, nasal congestion, or hives. Anaphylaxis can occur and include swelling in the throat, wheezing or a sensation of tightness in the chest, nausea, dizziness, or other symptoms that require immediate treatment. To determine whether adjustments in the dosing schedule or allergen content are necessary To ensure compliance NOT MEDICALLY NECESSARY Allergy immunotherapy is considered not medically necessary and, therefore, not covered if, after one year in the maintenance phase, the individual does not experience any of the following signs of improvement, when all other reasonable factors have been ruled out: A noticeable decrease of symptoms An increase in tolerance to the offending allergen A reduction in medication usage EXPERIMENTAL/INVESTIGATIONAL The use of allergy immunotherapy is considered experimental/investigational and, therefore, not covered for food hypersensitivity (gastrointestinal disturbances, skin eruptions, or shock due to allergic reactions to allergens in food), chronic urticaria (persistent itchy hives for six weeks or more, usually without a known cause), and/or angioedema (the sudden development of painful, itchy swelling or welts that can occur around the eyes and lips or on the hands, feet, and throat) because the efficacy of this therapy cannot be established by review of the available published peer-reviewed literature. Sublingual immunotherapy is considered experimental/investigational and, therefore, not covered as the efficacy of this therapy has not been established by review of the available published peer-reviewed literature. VIAL PREPARATION OF NON-VENOM ANTIGENS Current Procedural Terminology (CPT) antigen codes 95144 to 95149 and 95170 are for a single dosage. When billing these codes, health care professionals must specify the number of doses provided. CPT code 95165 represents the preparation of the maintenance concentrate vial. This preparation is the highest concentration of a vaccine (antigen extract) that is projected to be the therapeutically effective dose. As in the case of venoms, some non-venom antigens cannot be mixed together (ie, they must be prepared in separate vials). An example of this is mold and pollen. Therefore, some individuals will be injected at one time from one vial (which contains all of the appropriate antigens in one mixture), while other individuals will be injected at one time from more than one vial. A billable unit dose of antigen taken from the maintenance concentrate vial is defined as a 1-cc aliquot. Reimbursement of CPT code 95165 is for the preparation of this maintenance concentrate vial and is based upon the number of 1-cc maintenance concentrate aliquots it contains. This does not mean that a health care professional must remove 1-cc aliquot doses from the maintenance concentrate vial. It means that the practice expenses payable for the preparation of a 10-cc vial remain the same irrespective of the size or number of aliquots removed from the vial. Therefore, a health care professional may not bill this vial preparation code for more than 10 doses per vial. (Note that this code does not include the injection of antigen[s]; the injection of antigen[s] is separately billable.) When a multidose maintenance concentrate vial contains less than 10-cc, a health care professional should bill for the number of 1-cc aliquots that may be removed from the vial. That is, an health care professional may bill up to a maximum of 10 doses per multidose vial but should bill for fewer than 10 doses per vial when there is less than 10-cc in the vial. The following are billing examples: If a 10-cc multidose vial is filled to 6-cc with maintenance concentrate, a health care professional may bill for six doses because six 1-cc aliquots may be removed from the prepared maintenance concentrate vial. If a 5-cc multidose vial is completely filled, a health care professional may bill for five doses for this prepared maintenance concentrate vial. If a health care professional removes 0.5 cc aliquots from a 10-cc prepared maintenance concentrate vial for 20 doses from one vial, they may only bill for 10 doses. If a health care professional prepares two 10-cc maintenance concentrate vials, they may bill for 20 doses; however, they may remove aliquots of any amount from those vials. For example, a health care professional may remove 0.5 cc aliquots from one vial, and 1 cc aliquots from the other vial, but may bill no more than 20 doses. If a health care professional prepares a 20-cc maintenance concentrate vial, they may bill for 20 doses, because the practice expense is calculated based on the health care professional removing 1 cc aliquots from one vial. If a health care professional removes 2 cc aliquots from this vial, thus getting only 10 doses, they may nonetheless bill for 20 doses because 20 doses reflects the actual practice expense of preparing the vial. If a health care professional prepares a 5-cc maintenance concentrate vial, they may bill for five doses, based on the way that the practice expense component is calculated. However, if an health care professional removes 10 0.5-cc aliquots from the vial, they may still bill only five doses because the practice expense of preparing the vial is the same, regardless of the number of additional doses that are removed from the vial. ALLERGY INJECTIONS AND VISIT SERVICES ON THE SAME DAY Evaluation and management (E&Ms) billed on the same day as an allergy injection (CPT code 95115 or 95117) will not be reimbursed, unless the E&M represents another separately identifiable service. SUPPLY OF ANTIGENS Reimbursement may be made for a reasonable supply of antigens. To reflect industry standards and guidelines, a reasonable supply of a specific antigen is considered to be no more than a 12-month supply. Maintenance concentrate vials of vaccine are not to be shared. Individual maintenance concentrate vials of vaccine must be prepared for each individual. SUPPLY OF VENOM EXTRACT There is no maximum limitation on venom (stinging) extract. BILLING REQUIREMENTS The appropriate CPT codes must be used when submitting claims for the preparation and provision of an antigen or venom by an health care professional who may or may not be providing the actual immunotherapy injection. A multiplier can be used with the appropriate code range. A multiplier (number of units) is representative of the number of doses prepared and provided, not the number of vials. Single-dose vials of antigen (CPT code 95144) must be billed only if the physician is supervising, preparing, and providing the antigen to be injected by someone other than the physician. However, if code 95144 is reported in conjunction with an injection code (95115 or 95117), reimbursement for code 95144 is included in the reimbursement for code 95165. An office visit evaluation and management (E&M) code must not be billed when administering immunotherapy injections unless it refers to a separately identifiable medical problem and service. In this case, the E&M code must have Modifier 25 (Significant, Separately Identifiable Evaluation and Management Service by the Same Physician on the Same Day of the Procedure or Other Service) appended to indicate that a significant, separately identifiable E&M service was performed on the same day as the immunotherapy service. If an individual's doses are adjusted (eg, because of individual reaction), and the antigen provided is actually more or fewer doses than originally anticipated, a health care provider must make no change in the number of doses for which they bill. The number of doses anticipated at the time of the antigen preparation is the number of doses to be billed. A health care provider is to identify the number of doses scheduled when the vial is provided. This means that in cases where the individual actually gets more doses than originally anticipated (because dose amounts were decreased during treatment), and in cases where the individual gets fewer doses (because dose amounts were increased), no change is to be made in the billing. This is applicable to non-venom and venom antigens. Subsequent dilutions of the maintenance concentrate are not eligible for reimbursement as preparations (CPT code 95165). For example, taking a 1-cc aliquot from the maintenance concentrate vial and mixing it with 9 cc of dilutant in a new multidose does not constitute a new preparation. In a diluted vial, there are no associated allergen costs, because they have already been billed in preparation of the initial vial. Do not bill for preparation of dilutions of antigen. If it is medically necessary, a provider may bill for preparation of more than one multidose vial. Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. 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

Failure to respond to allergy immunotherapy may be due to various factors. The following factors should be ruled out, prior to stopping allergy immunotherapy: Inadequate dose of allergen in the allergy vaccine Missing allergens not identified during the allergy evaluation High levels of allergen in the environment (ie, inadequate environmental control) To avoid wrongful injections to an individual, the specific components should be mixed once with the preparation of individually prepared patient-labeled vials. The off-the-board method involves repeated mixing on every injection visit that is withdrawn from different stock solutions. For safety reasons and to avoid cross-mixing of allergens removed from the manufacturer’s extract, the cross-mixing of antigens in the syringe (off-the-board) is not recommended by the American Academy of Allergy Asthma & Immunology (AAAAI) and the Joint Council of Allergy, Asthma and Immunology (JCAAI). BENEFIT APPLICATION Subject to the terms and conditions of the applicable benefit contract, allergy immunotherapy is covered under the medical benefits of 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. Therefore, they are not eligible for reimbursement consideration. MEDICARE This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

References

American Academy of Allergy Asthma & Immunology (AAAAI). Tips to remember: What are “allergy shots?" [AAAAI Web site]. 2009. Available at: http://www.aaaai.org/patients/publicedmat/tips/whatareallergyshots.stm. Accessed November 24, 2009. Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Publication 100-04: Medicare claims processing. Transmittal 504. Allergy testing and immunotherapy. [CMS Web site]. 03/11/05. Available at: http://www.cms.hhs.gov/Transmittals/Downloads/R504CP.pdf. Accessed November 24, 2009. Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network (MLN). MLN Matters. Use of professional society practice parameters in properly providing allergen immunotherapy to Medicare beneficiaries. Available at: http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0812.pdf. Accessed November 24, 2009. Li JT, Lockey RF, Bernstein L, Portnoy JM, Nicklas RA. Allergen immunotherapy: a practice parameter. Ann Allergy Asthma Immunol (serial online). [Joint Council of Allergy, Asthma and Immunology Web site]. 2003;90:1-40. Available at: http://www.jcaai.readyportal.net/file_depot/0-10000000/20000-30000/27387/folder/63948/Allergen_immunotherapy_practice_parameter_2003-90-S1-540.pdf. Accessed November 24, 2009.

Coding Table

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.

Code System	Code Number(s) and Narrative(s)
CPT	TO REPORT ALLERGY IMMUNOTHERAPY, USE THE FOLLOWING CODES 95120, 95125, 95144, 95165 TO REPORT THE PROFESSIONAL SERVICE FOR INJECTION ADMINISTRATION, USE THE FOLLOWING CODES 95115, 95117 TO REPORT VENOM (STINGING) IMMUNOTHERAPY, USE THE FOLLOWING CODES 95130, 95131, 95132, 95133, 95134, 95145, 95146, 95147, 95148, 95149, 95170, 95180 TO REPORT THE EXPERIMENTAL/INVESTIGATIONAL SERVICE SUBLINGUAL IMMUNOTHERAPY, USE THE FOLLOWING CODE 95199
ICD Procedure	N/A
ICD Diagnosis	N/A
HCPCS Level II	N/A
Revenue Codes	N/A

Cross References

Version Effective Date: 02/05/2010