Code Description of CPT code 95115, 95117, 95144, 95145, 95146, 95147, 95148, 95149, 95165, 95170
95115 – Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection
95117 – 2 or more injections
Allergen immunotherapy is performed to treat seasonal allergies, such as allergies to pollen from grasses, weeds, and trees or to treat indoor perennial allergies, such as allergies to dust mites, pet dander, and molds. Following separately reportable allergy testing to identify the specific allergen(s), an allergen immunotherapy schedule is developed consisting of two phases, the build-up phase and the maintenance phase. During the build-up phase, small but increasing doses of the allergen extract(s) are administered by injection, usually into the upper arm, one, two or three times a week. The build-up phase usually lasts for 3 to 6 months. During the maintenance phase, monthly injections are given for a period of 3 to 5 years. An allergist or outside supplier formulates and provides the allergenic extract for the patient and bills separately for the supply of the allergenic extract. Another physician or other qualified health care professional administers the allergenic extract and observes the patient for a period of time following each injection. Use code 95115 per encounter for a single injection and 95117 for a single encounter where two or more injections are given.
95144 – Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy, single dose vial(s) (specify number of vials)
An allergist or other supplier prepares or supervises the preparation of single dose vials of antigens for allergen immunotherapy. Using results obtained from separately reportable allergy testing services, the correct dose of the allergen is formulated and provided to the patient in single dose vials. A single dose vial provides the correct formulation for a single injection of the antigen. The total number of single dose vials that are needed for a course of immunotherapy are prepared and the physician reports code 95144 for each single dose vial supplied. The allergist typically administers the first dose which is reported separately and observes the patient for adverse effects. The patient then takes the single dose vials to another physician who administers the remaining doses.
95145 – Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); single stinging insect venom
95146 – 2 single stinging insect venoms
95147 – 3 single stinging insect venoms
95148 – 4 single stinging insect venoms
95149 – 5 single stinging insect venoms
An allergist or other supplier prepares or supervises the preparation of multiple dose vials of antigens for one or more stinging insects to be used for allergen immunotherapy. Using results obtained from separately reportable allergy testing services, the correct dose of one or more stinging insect allergens is formulated and provided to the patient in multiple dose vials. A multiple dose vial provides the correct formulation for a specific number of injections of the antigen. The total number of doses that are needed for a course of immunotherapy are prepared and the physician reports a single code for each multiple dose vial supplied. The allergist typically administers the first dose which is reported separately and observes the patient for adverse effects. The patient then takes the multiple dose vials and another physician administers the remaining doses. Use code 95145 when the allergist or other supplier prepares or supervises the preparation of a single stinging insect venom, code 95146 for 2 single stinging insect venoms, code 95147 for 3 single stinging insect venoms, 95148 for 4 single stinging insect venoms, and 95149 for 5 single stinging insect venoms.
95165 – Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)
95170 – whole body extract of biting insect or other arthropod (specify number of doses)
An allergist or other supplier prepares or supervises the preparation of multiple dose vials of antigens for allergen immunotherapy. Using results obtained from separately reportable allergy testing services, the correct dose of the allergen is formulated and provided to the patient in multiple dose vials. A multiple dose vial provides the correct formulation for a specific number of injections of the antigen. The multiple dose vials that are needed for a course of immunotherapy are prepared and the physician reports code 95165 for each multiple dose vial of a single or multiple antigens supplied or code 95170 for a whole body extract of a biting insect or other arthropod and specifies the number of doses in each vial. The allergist typically administers the first dose which is reported separately and observes the patient for adverse effects. The patient then takes the multiple dose vials to another physician who administers the remaining doses.
95180 – Rapid desensitization procedure, each hour (eg, insulin, penicillin, equine serum)
A patient who has experienced a hypersensitivity reaction to an essential or life-saving drug such as insulin, penicillin, other antibiotics, or equine or other serums undergoes a rapid desensitization procedure so that the required drug can be administered. Desensitization involves administration of the essential drug in a very small dose initially and then increasing the dose incrementally over several hours until the target dose is reached. The initial dose may be as little as one ten-thousandth of the target dose. As each subsequent dose is administered, the patient is carefully monitored for adverse effects. The physician provides a written report of the rapid desensitization procedure.
95199 – Unlisted allergy/clinical immunologic service or procedure
Coverage Indications, Limitations, and/or Medical Necessity
Allergen Immunotherapy is defined as the repeated administration of specific allergens to patients with IgE-mediated conditions for the purpose of providing protection against allergic symptoms and inflammatory reactions associated with natural exposure to these allergens.
Allergen immunotherapy should be considered for patients who have demonstrable evidence of specific IgE antibodies to clinically relevant allergens. The decision to begin allergen immunotherapy might depend on a number of factors, including but not limited to patient’s preference/acceptability, adherence, medication requirements, response to avoidance, and the adverse effects of medications.
The presence of IgE antibodies alone does not infer the need for immunotherapy. For example the presence of IgE antibodies to an allergen not locally found, with no history or exposure or expectation of exposure, would not be considered to be clinically relevant.
In order for immunotherapy to be considered reasonable and necessary there must be:
- Clinical relevance
- Trial of avoidance or unavoidable exposure to allergy triggers identified in allergy testing
- Adherence to medical regimens which is clearly documented in the medical record
- Stable pharmacotherapy for certain conditions, such as asthma
Medical documentation should demonstrate the decision to begin immunotherapy. Without clear cut reasoning documented, these services will be denied.
In 2010, a Joint Task Force on Practice Parameters for Allergen Immunology issued guidelines. The Task Force included American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI), and the Joint Council of Allergy, Asthma and Immunology. As these guidelines were peer reviewed, incorporated, and invited reviewers, they are felt to be the state of the art in allergen immunotherapy. The indications set out in this LCD often will reflect the principals set out in the Practice Parameters when Medicare guidelines allow.
INDICATIONS:
Conditions for which immunotherapy is effective include:
- Allergic rhinitis,
Allergic conjunctivitis,
Allergic asthma and
Stinging insect hypersensitivity
Please note: Atopic dermatitis secondary to aeroallergen has been reported to be influenced by immunotherapy. (These rare issues will be reviewed through the appeals process with documentation review.)
Immunotherapy has two phases. A build-up phase and a maintenance phase.
The build-up phase includes the initiation and subsequent rise of applicable antigen concentrations. Documentation of this phase should include the initial concentration, any changes/delay of progress and the reasoning for such delays, and the target concentration.
Injections usually occur 1-3 times per week and can take anywhere from 8-28 weeks to achieve a maintenance dose.
Since it should be rare that injections would be administered less frequent than the dosing intervals above, providers should expect denials when reporting these services less frequently. These less frequent services will need to be reviewed through the appeals process with documentation as to why the frequency was not met, i.e. hospitalizations, illness, acute asthma events which would preclude the continuation of the build-up phase.
Various techniques such as cluster immunotherapy and rush immunotherapy are also included in the build-up phase and should be documented as such in the medical records. These techniques are noted to have more frequent injections in the build-up phase.
The maintenance phase occurs when the effective therapeutic dose is reached. This dose is defined as the dose that provides therapeutic efficacy without significant adverse local or systemic reactions. This dose may not be the initial target concentration but documentation should clearly show why the target concentration is not being used. All references to the therapeutic effective dose should be referenced to the maintenance concentrate and should be noted as a volume-to-volume dilution (e.g., 1:100 vol/vol dilution of maintenance concentrate).
Although all treatment regimens have to be individualized for a given patient, acceptable maintenance dose concentrations are generally as the following:
For standard allergen extracts:
500 to 2,000 allergy units (AU; e.g. for dust mite): or
1,000-4,000 bioequivalent allergy units (BAU; e.g. for grass or cat).
For non-standardized extracts:
a suggested maintenance dose is 3,000-5,000 protein nitrogen units (PNU) or 0.5ml of a 1:100 or 1:200 wt/vol dilution of manufacturer’s extract;
non-standard extracts are noted to be estimates and will need to be individualized.
For major known allergen concentration of the extract:
a range between 5 and 20 micrograms of major allergen is the recommended maintenance dose for inhalant allergens and 100 micrograms for Hymenoptra venon.
Documentation of the extracts being used should include concentrations, even if an estimate is used for non-standard extracts. Significant sub-therapeutic dosing in a maintenance manner will be considered not reasonable and necessary. Table IX and X in the Guidelines outline probable effective dose ranges. Sub-therapeutic dosing would be considered to be below these levels.
Providers of Immunotherapy: The physician prescribing immunotherapy should be trained and experienced in prescribing and administering immunotherapy. Should any Medicare entity (MAC, RA, ZPIC, OIG or DOJ) request documentation of training this information must be made available. Medicare expects practitioners’ documented training to be commensurate with the degree to which his or her practice is related to allergy testing and immunotherapy.
Allergen Supply: The Medicare Benefit Manual, Pub. 100-02, Chapter 15, section 50.4.4.1 outlines the benefit for the supply of antigen use in immunotherapy.
Hence, if an auxiliary staff member, such as a registered nurse or technician, prepares the antigens, the physician must provide direct supervision of the services for the employee to bill CPT code 95165 incident-to the physician based on Medicare incident-to-rules.
The preparation of allergen extract should have direct supervision of any employee.
Definition of qualified non-physician practitioner (NPP) must meet incident-to guidelines. For services to qualify as incident-to:
The NPP must be licensed or certified to provide professional health care services in the state where the physician practice is located.
Generally, the NPP must be a full-time, part-time or leased employee of the physician or physician group practice. (In limited cases, the NPP may be an independent contractor of the physician or physician group practice.)
The NPP must provide services as an integral part of-and-incident-to the physician’s services.
The NPP must provide such services under the direct supervision of the physician.
Direct supervision does not mean that the physician must be in the same room when the staff person prepares the antigens. The physician must be present in the office suite and immediately available to provide direction and assistance through the time the staff person is performing the service. The supervision physician should be documented. The physician must have examined the patient and determined a plan of treatment and a dosage regimen.
Place of Administration: Immunotherapy may have severe unpredictable systemic and local reactions within the first 30 minutes post injection. It is recommended that immunotherapy be administered in a setting that permits the prompt recognition and management of adverse reaction. The preferred location for such administration is the prescribing physician’s office. However, the patients can receive immunotherapy at another health care facility if the physician and staff at that location are trained and equipped to recognize and manage immunotherapy reactions, particularly anaphylaxis. It is recommended that patients wait at the physician’s office/medical clinic for at least 30 minutes after the immunotherapy injection.
Medicare payment for maintenance antigens administered by a trained individual in the patient’s home is permitted by regulation. In such cases the patient’s medical record must include information about the training and competence of the administering individual, especially training for emergency management of adverse reactions to immunotherapy injections (e.g. recognition of anaphylaxis and administration of rescue medications such as epinephrine). Such information must be made available to Medicare for review if requested.
Maintenance Dose Interval: The frequency of maintenance dosing can be variable depending on the extract used. During the first year, frequency may vary from subsequent years. The Task Force notes for some antigens, the maintenance dose could be every 4-8 weeks. However, the frequency should be at least every two weeks for this dosing.
Follow-up Care: During maintenance therapy, follow up visits to assess progress or lack of progress should be done at least every 6-12 months. This documentation must be available upon request.
Length of Maintenance Therapy: The duration of all forms of immunotherapy must be individualized. A presumption of failure can be made when, after 12-24 months of therapy, a person does not experience:
a noticeable decrease of symptoms,
an increase in tolerance to the offending allergen, and
a reduction in medication usage.
For many patients, the recommended duration of allergen immunotherapy is 3-5 years. However, the duration of immunotherapy should be individualized based on the clinical response, disease severity, immunotherapy reaction, patient preference and certain antigens in the therapy.
Limitations:
Treatment will not be reimbursed after a 2 year period when there is no apparent clinical benefit as noted above.
Allergen immunotherapy is not indicated and is considered investigational for:
Food hypersensitivity
Urticaria and angioedema
Therapy with allergoids or adjuvants
Therapy Via Other administration:
Oral or sublingual food immunotherapy
Epicutaneous immunotherapy
Intralymphatic immunotherapy
Intranasal immunotherapy
Sublingual Immunotherapy
Desensitization with commercially available extracts of poison ivy, poison oak, or poison sumac,
Desensitization for hymenoptera sensitivity using whole body extracts, with the exception of fire ant extracts
Desensitization with bacterial vaccine (BAC: bacterial, antigen complex, streptococcus vaccine, staphylo-streptovaccine, serobacterin, staphylococcus phage lysate)
Food allergenic extract immunotherapy
Intracutaneous desensitization (Rinkel Injection Therapy, RIT)
Intracutaneous titration
Neutralization therapy (intradermal and subcutaneous)
Repository emulsion therapy
Sublingual desensitization
Sublingual provocative therapy
Urine autoinjection (autogenous, urine immunotherapy)
Allergen immunotherapy for the management of skin and mucous membrane disease such as atopic dermatitis (rare exceptions as noted above reviewed in the appeals process), urticarial, and Candida vulvovaginitis
Intranasal immunotherapy
Postmortem examination for IgE antibodies to identify allergens responsible for lethal anaphylaxis (post mortem work is not covered by Medicare)
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.
11x – Hospital Inpatient (Including Medicare Part A)
12x – Hospital Inpatient (Medicare Part B only)
13x – Hospital Outpatient
21x – Skilled Nursing – Inpatient (Including Medicare Part A)
22x – Skilled Nursing – Inpatient (Medicare Part B only)
23x – Skilled Nursing – Outpatient
71x – Clinic – Rural Health
73x – Clinic – Freestanding
77x – Clinic – Federally Qualified Health Center (FQHC)
85x – Critical Access Hospital
Revenue Codes
Revenue codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC. Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.
Please note that not all revenue codes apply to every type of bill code. Providers are encouraged to refer to the FISS revenue code file for allowable bill types. Similarly, not all revenue codes apply to each CPT/HCPCS code. Providers are encouraged to refer to the FISS HCPCS file for allowable revenue codes.
All revenue codes billed on the inpatient claim for the dates of service in question may be subject to review.
0510 – Clinic – General Classification
0517 – Clinic – Family Practice Clinic
0519 – Clinic – Other Clinic
0520 – Freestanding Clinic – General Classification
0521 – Freestanding Clinic – Clinic Visit by Member to RHC/FQHC
0522 – Freestanding Clinic – Home Visit by RHC/FQHC Practitioner
0523 – Freestanding Clinic – Family Practice Clinic
0524 – Freestanding Clinic – Visit by RHC/FQHC Practitioner to a Member in a SNF or Skilled Swing Bed in a Covered Part A Stay
0525 – Freestanding Clinic – Visit by RHC/FQHC Practitioner to a Member in a SNF (not in a Covered Part A Stay) or NF or ICF MR or Other Residential Facility
0528 – Freestanding Clinic – Visit by RHC/FQHC Practitioner to Other non-RHC/FQHC site (e.g. Scene of Accident)
0529 – Freestanding Clinic – Other Freestanding Clinic
0982 – Professional Fees – Outpatient Services
0983 – Professional Fees – Clinic
