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 ½ 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.
