Allergy refers to conditions in which immune responses to environmental antigens cause tissue inflammation and organ dysfunction.

Allergen immunotherapy consists of the parenteral administration of allergenic extracts as antigens at periodic intervals, usually on an increasing dosage scale to a dosage which is maintained as maintenance therapy.

Prerequisites for Covered Immunotherapy: Patients selected for immunotherapy should have significant life threatening symptomatology (e.g., anaphylaxis) or a chronic allergic state (e.g., allergic rhinitis, asthma) which has not responded to conservative measures such as environmental control or judicious use of pharmacologic agents.

Immunotherapy is indicated for significant underlying diseases with demonstration of IgE-mediated sensitivity to relevant allergens as defined by skin testing or appropriate in vitro laboratory measurements, along with a clinical history that correlates with these laboratory findings.

Immunotherapy has been shown to be effective in stinging insect hypersensitivity, inhalant allergies, and allergic asthma. It has not been shown to be effective for food allergies and nonallergic rhinitis. Desensitization, not immunotherapy, is the procedure of choice for drug allergies.

Administration of a high dose of allergen (e.g., 1:100 to 1:30 weight/volume or the highest dose tolerated) is the ultimate goal for immunotherapy. It would be expected to see increasing concentrations before maximum or maintenance dosage is attained.

Continued, indefinite submaximal dose immunotherapy is not considered effective and is not covered. Very low dose immunotherapy has not been shown to be effective and therefore not covered.

Length of Therapy: The duration of all forms of immunotherapy must be individualized. A presumption of failure can be made when, after 12 months of therapy, a person does not experience a noticeable decrease of symptoms, does not demonstrate an increase in tolerance to the offending allergen and there is not a reduction in medication usage. Treatment will not be reimbursed long term when there is no apparent clinical benefit.

Place of Service: Codes 95115, 95117, and 95144 are allowed only in an office setting. Codes 95145-95170 are allowed in the office and a skilled nursing facility.

An evaluation and management (E/M) service is allowed when billed on the same date of service as allergen immunotherapy (codes 95115, 95117, 95144-95180) only when it is a significantly separate service. Modifier 25 may be reported with medical care (e.g. visits, consults) to identify it as significant and separately identifiable from the other service(s) provided on the same day. When modifier 25 is reported, the patient’s records must clearly document that separately identifiable medical care was rendered.

Allergen immunotherapy will not be covered for the following antigens: newsprint, tobacco smoke, dandelion, orris root, phenol, formalin, alcohol, sugar, yeast, grain mill dust, pyrethrum, marigold, soybean dust, honeysuckle, wool, fiberglass, green tea, or chalk.

Whole body extract of biting insect or other arthropod is only indicated for use for fire ant allergy.
 
Any service reported not meeting the above guidelines on this policy will be denied as not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Reasons for Noncoverage

Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation.

Documentation Requirements

The patient's medical record must document the medical necessity of services performed for each date of service submitted on a claim, and documentation must be available upon request.

The patient’s medical record must confirm that allergen immunotherapy is clinically reasonable and necessary as determined by the standard of care developed by specialty societies. The medical record must show that indications for immunotherapy were determined by appropriate diagnostic procedures coordinated with clinical judgement and knowledge of the natural history of allergic diseases.

The number of vials or doses prepared and the injection schedule must be documented in the chart when immunotherapy is being provided.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

• For allergen immunotherapy purposes a dose describes the amount of antigen(s) administered in a single injection from a multi-dose vial.
• Codes 95115-95117 describe the professional allergenic extract administration (Injection only). Code 95144 describes the allergist’s preparation and provision of single-dose vials for administration by another physician.
• Codes 95145-95170 represent the antigen preparation (Preparation only).
• Codes 95120-95134 describe complete service codes for the combined supply of antigen AND allergy injection provided during a SINGLE encounter. Complete service codes are NOT covered. See the component-billing sample.
• Code 95165 includes single OR multiple antigens.

Codes 95115–95117

• Report one code 95115 or 95117 per date of service (DOS).
• Do NOT report code 95115 and 95117 on the same DOS.
• Do NOT report code 95115 and 95117 if the antigen is self-administered by the patient.

Code 95144

• To report code 95144, designate the number of single-dose vials prepared and provided.
• Code 95144 indicates ONLY single-dose vials.
• Code 95144 may only be used when a physician prepares an extract to be injected by another entity.

Code 95165

• To report code 95165, designate the number of doses.
• Code 95165 does NOT include antigen administration.
• To report for antigen preparation and administration, use component billing. (Samples below)
• If a multi-dose vial contains less than 10cc, report the number of 1 cc aliquots that may be removed from the vial up to a maximum of 10 doses per multi-dose vial.
• If medically necessary, physicians may bill for preparation of more than one multi-dose vial.

Code 95165 Billing Exceptions

If the antigens, i.e. mold and pollen, cannot be mixed together, the practice expense (PE) for mixing a multi-dose vial of antigens will be calculated based on the following observed practice method:

• Physicians usually prepare a 10 cc vial and remove aliquots with a volume of 1 cc.
• 10, 1 cc aliquot doses equal the entire PE component for the service.
• Size or number of aliquots removed do NOT alter the PE for the service.

Code 95165 Billing Samples

• To bill a 10 cc multi-dose vial filled to 6cc with antigen, submit code 95165 with 6 in the days/units field.
• If a physician removes ½ cc aliquots from a 10cc multi-dose vial for a total of 2 doses, submit code 95165 with 10 in the days/unit field. (Billing for more than 10 doses represents an overpayment for the practice expense vial preparation.)
• If a physician prepares two 10cc multi-dose vials, submit code 95165 with 20 in the days/unit field. (The number of aliquots removed from the vials does NOT change the number of doses billed.)

Codes  95144-95170 Component Billing

• Services for codes 95144-95170 represent a single dose.
• To bill, specify number of doses in the days/units field.
• Use a code below the venom treatment number ONLY for “catch up” purposes.
• If a physician prepares the allergen and administers the injection on the same date of service, report the appropriate injection code (codes 95115-95117) AND the appropriate preparation code (codes 95145-95170).
• Do NOT report code 95144 AND an injection code (codes 95115-95117).

Code 95144 Billing Samples

Sample 1:

• Allergist reports code 95144 and 2 in the days/units field to indicate preparation of 2 single-dose vials of extract.
• Primary care reports code 95117 and 1 in the days/units field to indicate the administration of 2 or more injections.

Sample 2: Component Billing:
Allergist prepares a 10-dose vial and develops a schedule to administer one dose per encounter over a predetermined period of time.

• Report code 95145 with 10 in the days/units field for the preparation.
• Report code 95115 for one injection.

Sample 3:
Allergist prepares a 10-dose vial and develops a schedule for the patient to self-administer the injections.

• Report code 95145 with 10 in the days/units field for the preparation. Do NOT bill an injection code.

Sample 4:
Allergist prepares a 10-dose vial for non-stinging insect venom and administers one injection.

• Report code 95165 with 10 in the days/units field for the preparation.
• Report code 95115 for one injection.

Venom Doses and Catch-Up Billing

Since physicians prepare most venom doses in separate vials, a respective dose of code 95146-95149 represents a portion of two, three, four or five venoms. Therefore, if a patient receives two-venom, three-venom, four-venom or five-venom therapy, physicians should allow the highest possible venom level.

In multi-venom therapy the physician provides a portion of each venom amount. Due to patient reaction, venom administration may not remain synchronized and dosage adjustments must be made. If the physician makes an adjustment, he must synchronize the preparation to the highest-level venom as soon as possible.

Sample: A physician prepares ten doses of code 95148 in two vials. One contains 10 doses of three-vespid mix and another contains 10 doses of wasp venom. Because of dose adjustment, the three-vespid mix covers 15 doses. The physician must prepare 5 doses of code 95145 for the “catch-up.”

• Report code 95148 with 10 in the days/units field for a patient in four-venom therapy.
• Report code 95145 with 5 in the days/units field.

Treatment Boards

To report treatment boards, use the antigen preparation vial codes (95145-95149, 95165 and 95170) AND the component billing method. Use code 95165 in place of 95144 to bill for other than stinging/biting insects.

Sample: Allergist prepares a 10-dose vial for non-stinging allergen and administers one injection.

• Report code 95165 with 10 in the days/units field for the preparation.
• Report code 95115 for one injection.

Code 95170

Applies ONLY to fire ant extract.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Online Manual Pub. 100-4, Chapter 12, Section 200

Use of these codes does not guarantee reimbursement. The patient's medical record must document that the coverage criteria in this policy have been met.

Covered diagnosis codes for procedure codes 95115, 95117, 95144-95165

Covered diagnosis codes for procedure codes 95115, 95117 and 95170

Covered diagnosis codes for procedure codes 95180