Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Allergy Immunotherapy

Policy #:07.00.21i

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

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, the treatment plan, and the dosage regimen. The regimen must include the starting immunotherapy schedule, target maintenance dose, and immunotherapy schedule.
    • Documentation in the medical record should demonstrate evidence of specific immune globulin E (IgE) antibodies to clinically relevant allergens and that the allergic symptoms warrant the time and risk of allergen immunotherapy.
    • Documentation in the medical record should demonstrate evidence that avoidance or pharmacologic therapy cannot control allergic symptoms or the individual has unacceptable side effects with pharmacologic therapy.

Individuals must be evaluated every 6 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 includes 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

Professional services for the supervision of preparation and provision of single or multiple antigens for allergen immunotherapy (CPT code: 95165) are considered medically necessary and, therefore, covered as follows:
  • Up to one hundred and twenty (120) doses or units during the escalation phase (i.e., the initial year), which constitute the first twelve months' period of allergy immunotherapy.
  • Up to ninety (90) doses or units during the twelve months' period for each of the successive maintenance phases of allergy immunotherapy.

When documentation in the medical records support that allergy immunotherapy is being administered in the escalation phase, (i.e., the initial year), claims submitted for professional services for the supervision of preparation and provision of single or multiple antigens for allergen immunotherapy (CPT code: 95165) are eligible to be adjusted for up to one hundred and twenty (120) doses or units.

The FDA approved sublingual extract tablets may be covered under applicable pharmacy benefits. These sublingual allergen formulations (i.e. tablet preparation and delivery route etc.) are not covered under the medical benefits of the Company's products.

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 (not an all-inclusive list) 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 prepared, administered, and delivered through a drop formulation is considered experimental/investigational and, therefore, not covered because the effectiveness of this therapy has not been established by review of the available published peer-reviewed literature.

Home administration of allergy immunotherapy is considered experimental/investigational and, therefore, not covered because the effectiveness 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 (i.e., 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, a 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 a 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 services (E&Ms) billed on the same day as an allergy injection (CPT code 95115 or 95117) are not eligible for separate reimbursement, 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 a 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.

During the conduction of professional services for the supervision of preparation and provision of single or multiple antigens for allergen immunotherapy, units/doses being prepared should approximate the expected number of units/doses the individual is to receive during a given timeframe. If an individual's doses are adjusted (e.g., 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 (i.e., 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).

STORAGE

Allergen immunotherapy extracts should be stored at 4 degrees Celsius (C) to reduce the rate of potency loss.

More dilute concentrations of allergen immunotherapy extracts (diluted greater than 1:10 vol/vol) are more sensitive to the effects of temperature and lose potency more rapidly than more concentrated allergen immunotherapy extracts. The expiration date for more dilute concentrations should reflect this shorter shelf life.

In determining the allergen immunotherapy extract expiration date, consideration must be given to the fact that the rate of potency loss over time is influenced by a number of factors separately and collectively, including 1) storage temperature, 2) presence of stabilizers and bactericidal agents, 3) concentration, 4) presence of proteolytic enzymes, and 5) volume of the storage vial.

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.

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 (e.g., 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 IMMUNOTHERAPY

Allergy (or allergen) immunotherapy or subcutaneous immunotherapy (SCIT) is the repeated administration of specific allergens to an individual with immune globulin E (IgE)--mediated conditions, to provide long-lasting protection against the allergic symptoms and inflammatory reactions associated with exposure to these allergens. In an individual with allergy, allergen challenge leads to a cascade of biological events resulting in clinical manifestation of allergy. For example, immune effector cells such as mast cells and basophils release chemical mediators (e.g., histamine) that are responsible for symptoms of allergy such as itching and sneezing. Administration of allergy immunotherapy yields a decrease in mast cell and basophil activity and degranulation, as well as the generation of specific regulatory T and B cells, suppression of allergen-specific effector T cells, decrease in tissue granulocytes, and other important systemic changes. The effect is a gradual lessening of the immune response upon subsequent allergen challenge.

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. According to the American Academy of Allergy, Asthma & Immunology (AAAAI), five years of age is the youngest recommended age to start immunotherapy; however, there is no upper age limit for receiving immunotherapy.

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 immunotherapy is not routinely recommended to replace removal of the offending allergen. Individuals who have unavoidable occupational exposures (e.g., veterinarians or laboratory workers) may require a trial of immunotherapy.

There are usually two phases of 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 the individual 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 the level of allergen sensitivity and 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 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. By contrast, allergy immunotherapy is often thought to describe a state of incomplete desensitization, as complete desensitization is rarely accomplished with allergy immunotherapy. 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.

According to the parameters developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology: "Immunotherapy is effective for the treatment of allergic rhinitis, allergic conjunctivitis, allergic asthma, and stinging insect hypersensitivity. Therefore immunotherapy merits consideration in patients with these disorders as a possible treatment option."

HOME-BASED SUBCUTANEOUS ALLERGY IMMUNOTHERAPY

According to guidelines from the American Academy of Asthma, Allergy and Immunotherapy (AAAAI), subcutaneous allergen immunotherapy should be administered in a medical facility with trained staff and medical equipment capable of recognizing and treating anaphylaxis. Under rare circumstances, when the benefit of allergen immunotherapy clearly outweighs the risk of withholding immunotherapy (e.g., individuals with a history of venom-induced anaphylaxis living in a remote region), at-home administration of allergen immunotherapy should be considered on an individual basis. Furthermore, AAAAI emphasizes that frequent or routine prescription of home immunotherapy is not appropriate under any circumstances.

There are a limited number of studies of home-based allergy immunotherapy. The largest is a prospective study by Hurst, et al. (1999). A major limitation of the study is that it was limited to otolaryngic allergy practices; the generalizability of the results to primary care practices is uncertain.

PREPARATION AND PROVISION OF ANTIGENS FOR SUBCUTANEOUS ALLERGY IMMUNOTHERAPY

The preparation of antigens for allergy injections, but not the injection itself, is billed under Current Procedural Terminology (CPT) code 95165. CPT Code 95165, (with the narrative: Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens [specify number of doses]),represents preparation of vials of non-venom antigens. As in the case of venoms, some non-venom antigens cannot be mixed together, i.e., 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 – containing in one mixture all of the appropriate antigens – while other individuals will be injected at one time from more than one vial. In establishing the practice expense component for mixing a multidose vial of antigens, Medicare, as reported in a detailed publication entitled Medicare Antigen Preparation, by the Office of Inspector General (Department of Health and Human Services), observed that the most common practice was to prepare a 10 cubic centimeter (cc) vial. Medicare also observed that the most common use was to remove aliquots with a volume of 1 cc. As explained in Medicare Claims Processing Manual,Chapter 12, Medicare based its practice expense (PE) computations for CPT code 95165 on the aforementioned factors. Therefore, per Medicare, a provider’s removing 10 1-cc aliquot captures the entire PE component for the services represented by CPT code 95165, since practice expense payable for the preparation of a vial remains the same regardless of the size or number of aliquots removed from it.

PROFESSIONAL SERVICE FOR INJECTION ADMINISTRATION FOR ALLERGY IMMUNOTHERAPY

According to ACAAI, for a majority of individuals in clinical need of allergy immunotherapy, an injection may be given once a week for about 30 weeks, after which injections can be administered every two weeks. Eventually, injections can be given every four weeks. The duration of therapy may be three to five years.

SUBLINGUAL IMMUNOTHERAPY

Standardized allergen extracts can also be administered under the tongue to allow absorption through the mucosa. This method is known as sublingual immunotherapy. Several types of allergen preparations have been studied in sublingual immunotherapy (SLIT), including sublingual allergen tablets (SLIT-tablets) and sublingual aqueous or glycerinated liquid allergen extracts, which are referred to as SLIT-drops. In April 2014, the U.S. Food and Drug Administration (FDA) approved the first sublingual allergen extract tablets for treatment of pollen-induced allergic rhinitis with or without conjunctivitis. However, the other main SLIT preparation, drop constructs, are being studied in United States clinical trials. In the United States, phase I studies on safety and tolerability have been carried out with ragweed, grass, house dust mite, and cat glycerinated extracts. There are several fundamental issues with SLIT-drops that require further study before clinicians can be confident that SLIT-drops using available products represent an effective alternative to subcutaneous immunotherapy (SCIT). Of primary importance is the question of effective dose. At this time, there is a lack of scientific evidence in the published peer-reviewed medical literature to support the safety and effectiveness of SLIT-drops.

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).
References


Abbas AK, Lichtman AH, Pillai S. Hypersensitivity. In: Abbas AK, Lichtman AH, Pillai S. Basic Immunology: Functions and Disorders of the Immune System. 4th Ed. Philadelphia, PA: Elsevier Saunders; 2014: 207-223.

Akdis M. Allergen immunotherapy for allergic disease: Therapeutic mechanisms. [UpToDate Web site]. 9/24/2018. Available at:https://www.uptodate.com/contents/allergen-immunotherapy-for-allergic-disease-therapeutic-mechanisms?search=allergen%20immunotherapy&source=search_result&selectedTitle=1~69&usage_type=default&display_rank=1 [via subscription only]. Accessed January 18, 2019.

American Academy of Allergy, Asthma & Immunology (AAAAI). Allergy Shots (Immunotherapy). [AAAAI Web site]. Available at: https://www.aaaai.org/conditions-and-treatments/library/allergy-library/allergy-shots-(immunotherapy). Accessed January 16, 2019.

American College of Allergy, Asthma & Immunology (ACAAI). Allergy Shots. [ACAAI Web site]. 12/28/2017. Available at:
http://www.acaai.org/allergist/allergies/treatment/allergy-immunotherapy-shots/pages/default.aspx. Accessed January 16, 2019.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Publication 100-04: Medicare claims processing. Transmittal 504. Allergy testing and immunotherapy. [CMS Web site]. Original: 03/11/05. (Revised: 11/30/18). Available at: http://www.cms.gov/manuals/downloads/clm104c12.pdf. Accessed January 16, 2019.

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 January 16, 2019.

Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: A practice parameter third update. J Allergy Clin Immunol.2011;127(1 Suppl):S1-S55.

Cox L, Aaronson D, Casale T et al. Allergy immunotherapy safety: location matters! J Allergy Clin Immunol: In Practice. 2013;1:455-457.

Creticos PS. Subcutaneous immunotherapy for allergic disease: indications and efficacy. [UpToDate Web site]. 06/02/2017. Available at: https://www.uptodate.com/contents/subcutaneous-immunotherapy-for-allergic-disease-indications-and-efficacy?search=allergen%20immunotherapy&source=search_result&selectedTitle=2~69&usage_type=default&display_rank=2 [via subscription only]. Accessed January 18, 2019.

Department of Health and Human Services: Office of Inspector General. October 2002 (OEI-09-00-00530). MEDICARE ANTIGEN PREPARATION. Available at:
http://oig.hhs.gov/oei/reports/oei-09-00-00530.pdf. Accessed January 18, 2019.

Greenhawt M, Oppenheimer J, Nelson M, et al. Sublingual immunotherapy: A focused allergen immunotherapy practice parameter update. Ann Allergy Asthma Immunol.2017;118:276-282.

Hurst DS, Gordon BR, Fornadley JA, Hunsaker DH. Safety of home-based and office allergy immunotherapy: A multicenter prospective study. Otolaryngol Head Neck Surg.1999;121(5):553-561.

James C, Bernstein D. Allergen immunotherapy: an updated review of safety. Curr Opin Allergy Clin Immunol. 2017 February ; 17(1): 55–59.

Li JT, Lockey RF, Bernstein IL, et al. Allergen immunotherapy: A practice parameter. Ann Allergy Asthma Immunol.2003;90:S1-40.

Medicare Claims Processing Manual. Chapter 12 - Physicians/Nonphysician Practitioners
(Rev. 2914, 03-25-14). Available at:
http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c12.pdf. Accessed January 18, 2019.





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

95115, 95117, 95120, 95125, 95130, 95131, 95132, 95133, 95134, 95144, 95145, 95146, 95147, 95148, 95149, 95165, 95170, 95180


EXPERIMENTAL/INVESTIGATIONAL
THE FOLLOWING CODE IS USED TO REPRESENT SUBLINGUAL IMMUNOTHERAPY THROUGH A DROP FORMULATION: 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)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.


HCPCS Level II Code Number(s)



EXPERIMENTAL/INVESTIGATIONAL

G0069 Professional services for the administration of subcutaneous immunotherapy for each infusion drug administration calendar day in the individual's home, each 15 minutes


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions for 07.00.21i
03/11/2019This version of the policy will become effective 03/11/2019. Policy has been updated to communicate the continued coverage of allergy immunotherapy and to provide additional relevant scientific background information.

Revisions for 07.00.21h
01/01/2019This version of the policy will become effective 01/01/2019. The following HCPCS code has been added to the policy: G0069.

Revisions for 07.00.21g
11/21/2018This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 03/11/2019
Version Issued Date: 03/11/2019
Version Reissued Date: N/A

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