Billing and Coding: Allergy Immunotherapy

This article gives guidance for billing, coding, and other guidelines in
relation to local coverage policy L32553-Allergy Immunotherapy.



**_Definitions_**

  * For allergen immunotherapy purposes a dose describes the amount of antigen(s) administered in a single injection from a multi-dose vial.
  * CPT codes 95115-95117 describe the professional allergenic extract administration. (Injection only)
CPT code 95144 describes the allergist's preparation and provision of single-
dose vials for administration by another physician.

  * CPT codes 95145-95170 represent the antigen preparation. (Preparation only)
  * CPT codes 95120-95134 describe complete service codes for the combined supply of antigen AND allergy injection provided during a SINGLE encounter. Medicare does NOT cover complete service codes. See the component-billing sample.
  * CPT code 95165 includes single OR multiple antigens.

  
  
**_CPT codes 95115 - 95117_**

    * Bill one CPT code 95115 or 95117 per date of service (DOS) and 1 unit in Box 24-G, days or units field.
    * Do NOT bill CPT code 95115 and 95117 on the same DOS.



  * Do NOT bill CPT code 95115 and 95117 if the antigen is self-administered by the patient.

  
  
**_Code 95144_**

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

  
  
**_CPT Code 95165_**

  * To bill CPT code 95165, designate the number of doses.
  * CPT code 95165 does NOT include antigen administration.
  * To bill for antigen preparation and administration, use component billing.(Samples below)
  * If a multi-dose vial contains less than 10cc, bill 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.

  
  
  
**_CPT code 95165 Billing Exceptions_**  
  
If the antigens, i.e. mold and pollen, cannot be mixed together, CGS
calculates the practice expense (PE) for mixing a multi-dose vial of antigens
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.

  
  
**_CPT code 95165 Billing Samples_**

  * To bill a 10 cc multi-dose vial filled to 6cc with antigen, submit CPT code 95165 with 6 in the days/units field.
  * If a physician removes 12 cc aliquots from a 10cc multi-dose vial for a total of 2 doses, submit CPT code 96165 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 CPT 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.)

  
  
**_CPT codes 95144-95170 Component Billing_**

  * Services for CPT 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, bill the appropriate injection code (CPT codes 95115-95117) AND the appropriate preparation code (CPT codes 95145-95170).
  * Do NOT bill CPT code 95144 AND an injection code (CPT codes 95115-95117).

  
  
**_CPT code 95144 Billing Samples_**  
  
 **Sample 1:**

  * Allergist bills CPT code 95144 and 2 in the days/units field to indicate preparation of 2 single-dose vials of extract.
  * Primary care bills CPT 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.

  * Bill CPT code 95145 with 10 in the days/units field for the preparation.
  * Bill CPT 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.

  * Bill CPT 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.

  * Bill CPT code 95165 with 10 in the days/units field for the preparation.
  * Bill CPT code 95115 for one injection.

  
  
**_Venom Doses and Catch-Up Billing_**  
  
Since physicians prepare most venom doses in separate vials, a respective dose
of CPT code 95146-95149 represents a portion of two, three, four or five
venoms. Medicare built savings into the reimbursement for the higher venom
codes. 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 CPT 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 CPT code 95145 for the "catch-up."

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

  
  
  
**_Treatment Boards_**  
  
To report treatment boards, use the antigen preparation vial CPT codes
(95145-95149, 95165 and 95170) AND the component billing method. Use CPT 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.

  * Bill CPT code 95165 with 10 in the days/units field for the preparation.
  * Bill CPT code 95115 for one injection.

  
  
**_CPT Code 95170_**  
  
Applies ONLY to fire ant extract  
  
 **_Evaluation and Management (E/M) Services and Immunotherapy_**  
  
To identify a significant, separately identifiable visit service above and
beyond the allergen immunotherapy service provided, select the appropriate E/M
code and append with Modifier 25.  
  

**General Guidelines for Claims submitted to Part A or Part B MAC:**

Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to
billing Medicare. For services requiring a referring/ordering physician, the
name and NPI of the referring/ordering physician must be reported on the
claim. A claim submitted without a valid ICD-10-CM diagnosis code will be
returned to the provider as an incomplete claim under Section 1833(e) of the
Social Security Act. The diagnosis code(s) must best describe the patient's
condition for which the service was performed. For diagnostic tests, report
the result of the test if known; otherwise the symptoms prompting the
performance of the test should be reported.



**Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines**

An ABN may be used for services which are likely to be non-covered, whether
for medical necessity or for other reasons. Refer to CMS Publication 100-04,
Medicare Claims Processing Manual, Chapter 30, for complete instructions.

Effective from April 1, 2010, non-covered services should be billed with
modifier -GA, -GX, -GY, or -GZ, as appropriate.

The -GA modifier ("Waiver of Liability Statement Issued as Required by Payer
Policy") should be used when physicians, practitioners, or suppliers want to
indicate that they anticipate that Medicare will deny a specific service as
not reasonable and necessary and they do have an ABN signed by the beneficiary
on file. Modifier GA applies only when services will be denied under
reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e),
or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC
systems will automatically deny services billed with modifier GA. An ABN, Form
CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts
responsibility for payment. The -GA modifier may also be used on assigned
claims when a patient refuses to sign the ABN and the latter is properly
witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the
date of the ABN is required.



Modifier GX ("Notice of Liability Issued, Voluntary Under Payer Policy")
should be used when the beneficiary has signed an ABN, and a denial is
anticipated based on provisions other than medical necessity, such as
statutory exclusions of coverage or technical issues. An ABN is not required
for these denials, but if non-covered services are reported with modifier GX,
will automatically be denied services.



The -GZ modifier should be used when physicians, practitioners, or suppliers
want to indicate that they expect that Medicare will deny an item or service
as not reasonable and necessary and they have not had an ABN signed by the
beneficiary. If the service is statutorily non-covered, or without a benefit
category, submit the appropriate CPT/HCPCS code with the -GY modifier. An ABN
is not required for these denials, and the limitation of liability does not
apply for beneficiaries. Services with modifier GY will automatically deny.

**Documentation Requirements**

The patient's medical record should include but is not limited to:

  * The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit,
  * Relevant medical history
  * Results of pertinent tests/procedures
  * Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed.)

The patient's medical record must contain documentation that fully supports
the medical necessity for services included within this LCD. (See "Indications
and Limitations of Coverage.") This documentation includes, but is not limited
to, relevant medical history, physical examination, and results of pertinent
diagnostic tests or procedures.  
  
Include in the record the following information: Medical history, examination,
and results of diagnostic testing (including allergy testing) upon which the
need for the treatment is based.  
  
A plan of treatment and dosage regimen must be documented in the patient's
medical record. The record should be prepared so that the data regarding
injection and responses can be appreciated in a logical and sequential sense.  
  
When an evaluation and management service is billed on the same day as
allergen immunotherapy (by the same physician) a separately identifiable
service must be documented in the medical record.  
  
Documentation must support the use of the code (e.g., number of venoms, number
of vials).  
  
Documentation must be available to Medicare upon request.  
  



**Other Comments:  
  
** For claims submitted to the Part A MAC: this coverage determination also
applies within states outside the primary geographic jurisdiction with
facilities that have nominated CGS to process their claims.  
  
Bill type codes only apply to providers who bill these services to the Part A
MAC. Bill type codes do not apply to physicians, other professionals and
suppliers who bill these services to the carrier or Part B MAC.  
  
For dates of service prior to April 1, 2010, FQHC services should be reported
with bill type 73X. For dates of service on or after April 1, 2010, bill type
77X should be used to report FQHC services Limitation of liability and refund
requirements apply when denials are likely, whether based on medical necessity
or other coverage reasons. The provider/supplier must notify the beneficiary
in writing, prior to rendering the service, if the provider/supplier is aware
that the test, item or procedure may not be covered by Medicare. The
limitation of liability and refund requirements do not apply when the test,
item or procedure is statutorily excluded, has no Medicare benefit category or
is rendered for screening purposes.