Required medical record documentation

Record must include complete medical and immunologic history, face-to-face physical exam, medical necessity rationale, test methodology, measurement of reaction sizes (mm) for in vivo testing, quantitative result (kIU/L) for specific IgE testing, interpretation and how results will be used in the care plan, periodic clinical evaluation of treatment benefits, and clinical re-evaluation at 3-5 years to determine need for continuing immunotherapy.

• Measurement of reaction sizes (wheal and erythema) in millimeters for in vivo testing
• Quantitative specific IgE results reported in kIU/L for in vitro testing
• Documentation of test interpretation and how results inform the patient's care plan
• Periodic clinical evaluation of treatment benefits; consider alternative therapy if no benefit within 12–24 months
• Clinical re-evaluation at 3–5 years to determine need for continuing immunotherapy

State-specific unit limitations

Unit limitations for allergy testing and treatment are determined by state-specific guidelines in the provider fee schedule. If state-specific guidance is not available, CMS Medicaid/Medicare NCCI MUE limits are applied.

• See state provider fee schedule for specific unit limits
• If no state rules, apply CMS NCCI MUE limits

Photo tests/patch test reporting

When patch/photo testing are performed in the same session, follow the reporting rule: if photo patch tests (95052) are performed with patch/application tests (95044) in the same session, report only the photo patch tests; if photo tests (95056) are performed with patch/application tests (95044), report only the photo tests.

• Affected codes: 95052, 95044, 95056

Ingestion challenge unit

Ingestion challenge testing is allowed once per patient encounter regardless of the number of items tested. Report the initial 120 minutes with CPT 95076 and each additional 60 minutes with CPT 95079 (each additional 60 minutes reported separately in addition to the primary procedure).

• Affected codes: 95076, 95079
• One allowed service per patient encounter; 95076 = initial 120 minutes; 95079 = each additional 60 minutes (report separately)

Immunotherapy administration setting and supervision

Allergen immunotherapy should be administered under the supervision of an appropriately trained physician in facilities equipped to recognize and treat anaphylaxis. Personnel preparing extracts must demonstrate aseptic technique and documented competency, with training, written testing, annual media-fill/glove fingertip testing, and maintenance of training records.

• Affected codes: 95115, 95117, 95144, 95165, 95180
• Facility readiness and ability to treat anaphylaxis required
• Personnel must meet aseptic technique and competency testing requirements and maintain training records

Total serum IgE testing limitations

Total serum IgE testing (CPT 82785) is not appropriate for most general allergy evaluations and should only be billed for specific indications such as allergic bronchopulmonary aspergillosis (ABPA), select immunodeficiencies (e.g., hyper-IgE syndromes), or when evaluating for omalizumab; serial repeat testing is subject to medical review.

• Affected code: 82785
• Reserve for ABPA, select immunodeficiencies, IgE myeloma/pemphigoid, or omalizumab evaluation
• Serial/repeat total IgE testing will be medically reviewed

Evaluation and management billing with immunotherapy

Evaluation and management (E/M) services may be separately reimbursed on the same day as allergen immunotherapy only when a significant, separately identifiable E/M service is performed and documented.

• Document the separately identifiable E/M service to support same-day reimbursement

Immunotherapy extract preparation oversight

Antigens must be prepared by clinical staff directly overseen by the physician who examined the patient and who has training and expertise in allergen immunotherapy. Training and competency expectations reference the AAAAI Allergen Immunotherapy Extract Preparation Instructional Guide and include demonstrated aseptic technique, written testing, annual media-fill or equivalent testing, gloved fingertip/thumb sampling, and maintenance of training and assessment records.

• Oversight requirement: physician who examined the patient must directly oversee antigen preparation
• Reference: AAAAI Allergen Immunotherapy Extract Preparation Instructional Guide for training expectations
• Personnel expectations include written test, annual media-fill, gloved fingertip testing, and retained training/assessment records

Refer sublingual immunotherapy to pharmacy benefit

Non-FDA approved sublingual immunotherapy (sublingual provocative therapy) is referenced to the pharmacy benefit for coverage criteria and is considered non-FDA approved per policy revisions.

• Refer non-FDA approved SLIT formulations to the pharmacy benefit
• Only FDA-approved SLIT products are recommended per AAAAI/AAAI guidance