Original Effective Date: June 1, 2019
Last Updated: March 15, 2020
Updates Effective May 1, 2020 (For Allergy Testing)

Purpose:
This policy provides guidelines for appropriately billing for allergy services, including allergy testing and allergy immunotherapy.

Scope:
Products included:

• NJ FamilyCare/Medicaid Plan
• Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP)

Definitions:
Allergy Testing: Allergy (or allergen) testing can be broadly subdivided into in vivo and in vitro methodologies. In vivo methodologies include skin allergy testing (e.g., skin prick testing, skin scratch testing, intradermal testing, skin patch testing, and skin endpoint titration), bronchial provocation tests, and food challenges. In vitro allergy tests include various techniques to test the blood for the presence of specific IgE antibodies to a particular antigen (e.g., ELISA and RAST tests), and leukocyte histamine release test (LHRT). LHRT may also be referred to as basophil histamine release test.

Allergy Immunotherapy:Allergy (or allergen) immunotherapy or subcutaneous immunotherapy (SCIT) is the repeated administration of specific allergens to an individual with immune globulin E (IgE)--mediated conditions, to provide protection against the allergic symptoms and inflammatory reactions associated with exposure to these allergens.

CPT Code 95004: Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests

CPT Code 95165: Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)

Allergy Testing Policy:
The number and type of antigens used for CPT 95004 must be chosen judiciously given the patient’s presentation, history, physical findings, clinical judgment and exist in the patient’s environment with a reasonable probability of exposure. The number of tests required may vary widely from patient to patient, depending on the patient’s history. Rarely are more than forty (40) percutaneous tests required.Ⅰ

Prior to performance of allergy testing, there must be evidence in the medical records that a history has been obtained, indicating the possible presence of allergy.

• This history should support that attempts to narrow the area of investigation were taken so that the minimal number of necessary skin tests might deliver a diagnosis
• The history should support that the selection of antigens was based on the patient specific history and physician examination ⅠⅠ

Horizon NJ Health will reimburse the following:

• CPT code 95004, with each test billed as one (1) unit of service
• Allergy testing will only be reimbursed for Allergists, Immunologists or Otolaryngologists or their nurse practitioners or physician assistants working under the direction of one of the above

Allergy Testing Limitations:

• It would not be expected that all patients would receive the same tests or the same number of sensitivity tests
• Retesting with the same antigen(s) should rarely be necessary within a three (3) year period
• Routine repetition of skin tests is not indicated (e.g., annually)
• CPT 95004 is only eligible for reimbursement consideration when performed by Allergists, Immunologists or Otolaryngologists or their nurse practitioners or physician assistants working under the direction of one of the above

Allergy Immunotherapy Policy:
CPT code 95165 represents the preparation of the maintenance concentrate vial. This preparation is the highest concentration of a vaccine (antigen extract) that is projected to be the therapeutically effective dose. As in the case of venoms, some non-venom antigens cannot be mixed together (i.e., they must be prepared in separate vials). An example of this is mold and pollen. Therefore, some individuals will be injected at one time from one vial (which contains all of the appropriate antigens in one mixture), while other individuals will be injected at one time from more than one vial. A billable unit dose of antigen taken from the maintenance concentrate vial is defined as a 1-cc aliquot. Reimbursement of CPT code 95165 is for the preparation of this maintenance concentrate vial and is based upon the number of 1-cc maintenance concentrate aliquots it contains.

Horizon NJ Health will reimburse the following:

• Injection portion from the applicable rendering provider (CPT 95115-95117)
• Antigen and preparation (CPT 95144-95170) is only eligible for reimbursement consideration when performed by Allergists, Immunologists or Otolaryngologists or their nurse practitioners or physician assistants working under the direction of one of the above
• Up to one hundred and twenty (120) units of CPT code 95165 from a certified provider, per member, for the initial rolling calendar year of treatment
• Up to sixty (60) units of CPT code 95165 from a certified provider, per member, for the subsequent rolling year(s) for maintenance therapy
  • Horizon will not pay past two (2) years of maintenance therapy without supporting documentation
  • Continued maintenance will be contingent upon accepted standards of six to twelve (6-12) month follow-up after the initiation of immunotherapy
  • No more than ten (10) doses (1-cc aliquot) of CPT 95165 per vial up to one hundred and twenty (120) units for the initial rolling calendar year of treatment
  • No more than ten (10) doses (1-cc aliquot) of CPT 95165 per vial up to sixty (60) units for the subsequent rolling year(s) for maintenance therapy

Billing Requirements:

• Initial supply of serum under CPT 95165 shall be billed with a -GD Modifier
• Providers shall bill Modifier -32, with CPT 95165, when the serum is to be home administered
• If billing for the initial serum supply and home administration, both the -GD and -32 Modifiers are required on the claim

Evaluation and Management (E&M) Services:
An office visit E&M code must not be billed when administering immunotherapy injections unless it refers to a separately identifiable medical problem and service. In this case, the E&M code must have Modifier -25 (Significant, Separately Identifiable Evaluation and Management Service by the Same Physician on the Same Day of the Procedure or Other Service) appended to indicate that a significant, separately identifiable E&M service was performed on the same day as the immunotherapy service. (Documentation must be submitted to support the use of the modifier)

Procedure:
Horizon NJ Health shall reimburse for allergy testing (CPT code 95004) when billed by one of the following specialties: Allergists, Immunologists or Otolaryngologists or their nurse practitioners or physician assistants working under the direction of one of the above. All other specialties shall be denied.

Horizon NJ Health shall limit CPT code 95165 in the initial rolling calendar year to one hundred and twenty (120) units. (Days 1-365). Horizon NJ Health shall limit CPT code 95165 after the initial rolling calendar year to sixty (60) units for maintenance therapy for two (2) years post initial rolling year. (Days 366-1,095). Lastly, Horizon NJ Health shall deny ALL claims after the 1,096th day for CPT code 95165.

Horizon NJ Health shall deny any Evaluation and Management (E/M) code billed with allergy immunotherapy that does not include modifier -25. (E/M codes: 99201, 99202, 99203, 99203, 99204, 99205, 99211, 99212, 99213, 99214 and 99215)

Limitations and Exclusions:
While reimbursement is considered, payment determination is subject to, but not limited to:

• Benefit Limitations
• The terms of any applicable provider participation agreement;
• Routine claim editing logic, including but not limited to incidental or mutually exclusive logic;
• Medical necessity; and
• Applicable law, regulatory guidance, government mandates, and the terms of the Managed Care Contract between Horizon NJ Health and the New Jersey Department of Human Services, Division of Medical Assistance and Health Services.

References:
1. Billing and Coding Guidelines for Allergy Testing & Allergy Immunotherapy
https://downloads.cms.gov/medicare-coverage-database/lcd_attachments/34597_20/L34597_ALRG001_BCG.pdf

2. Medicare Claims Processing Manual: Chapter 12 - Physicians/Nonphysician Practitioners
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c12.pdf

3. Local Coverage Determination (LCD): Allergy Testing (L36241)
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36241&ver=82&name=331*1&UpdatePeriod=833&bc=AAAAEAAAgAAA&

4. Local Coverage Determination (LCD): Allergen Immunotherapy (L36240)
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36240&ver=45&name=331*1&UpdatePeriod=833&bc=AAAAEAAAgAAA&

5. Local Coverage Article: Billing and Coding: Allergy Testing (A56558)
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=56558&ver=7&LCDId=35408&name=331*1&UpdatePeriod=833&bc=AAAAEAAAAAAA&

6. Local Coverage Article: Billing and Coding: Allergen Immunotherapy (A56538)
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=56558&ver=13&LCDId=35408&name=331*1&UpdatePeriod=833&bc=AAAAEAAAQAAA&

7. Department of Health and Human Services, Medicare Antigen Preparation, 2002
https://oig.hhs.gov/oei/reports/oei-09-00-00530.pdf

8. Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: a practice parameter third update. Allergy Clin Immunol 2011; 127:S1

9. Calderón MA, Cox L, Casale TB, et al. Multiple-allergen and single-allergen immunotherapy strategies in polysensitized patients: looking at the published evidence. J Allergy Clin Immunol 2012; 129:929

10. Larenas-Linnemann DE, Gupta P, Mithani S, Ponda P. Survey on immunotherapy practice patterns: dose, dose adjustments, and duration. Ann Allergy Asthma Immunol 2012; 108:373

11. Rosman Y, Confino-Cohen R, Goldberg A. Venom Immunotherapy in High-Risk Patients: The Advantage of the Rush Build-Up Protocol. Int Arch Allergy Immunol 2017; 174:45

Ⅰ https://services3.horizon-bcbsnj.com/hcm/MedPol2.nsf

ⅠⅠhttps://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36241&ver=78&name=331*1&UpdatePeriod=833&bc=AAAAEAAAAAAA&