HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-3-030
Topic:
Allergy Immunotherapy
Section:
Injections
Effective Date:
April 29, 2024
Issued Date:
April 29, 2024
Last Revision Date:
March 2024
Annual Review:
January 2024
 
 

Allergy immunotherapy or subcutaneous immunotherapy (SCIT) (also known as desensitization, hyposensitization, allergy injection therapy, or allergy shots), is the repeated administration of specific allergens to individuals with immune globulin E (IgE)-mediated conditions. The aim is to modify or stop the allergy by reducing the strength of the IgE response. Five (5) years of age is the youngest recommended age to start immunotherapy; however, there is no upper age limit for receiving immunotherapy.

Policy Position

Allergy immunotherapy may be considered medically necessary when the following criteria are met:

  • An individual has ANY of the following conditions:
    • Asthma; or
    • Allergic rhinitis; or
    • Allergic conjunctivitis; or
    • Stinging insect allergy (hymenoptera – bees, hornets, wasps, fire ants); or
    • Clinical evidence of an inhalant allergen sensitivity; and
  • Individual meets ALL of the following criteria:
    • Documented skin test and/or serologic evidence of IgE-mediated antibody to a potent extract of the allergen IgE test; and
    • Avoidance or pharmacologic therapy cannot control allergic symptoms or individual has unacceptable side effects with pharmacologic therapy; and
    • The individual's medical record documents the antigens to be administered, the treatment plan, and the dosage regimen. The regimen must include the starting immunotherapy schedule, target maintenance dose, and immunotherapy schedule.

Individuals must be evaluated every six (6) to 12 months while receiving allergy immunotherapy for ALL of the following indications:

  • To determine efficacy; and
  • To determine whether adjustments in the dosing schedule or allergen content are necessary; and
  • To ensure compliance; and
  • To monitor for the two (2) types of adverse reactions: local (i.e., redness and swelling at the injection site) and systemic (i. e., sneezing, nasal congestion, or hives).

Allergy immunotherapy is considered not medically necessary after one (1) year in the maintenance phase if ANY of the following signs of improvement is not experienced, when all other reasonable factors have been ruled out:

  • A noticeable decrease of symptoms; or
  • An increase in tolerance to the offending allergen; or
  • A reduction in medication usage.

Allergy immunotherapy not meeting the criteria as listed is considered not medically necessary.

95115

95117

95120

95125

95130

95131

95132

95133

95134

95144

95145

95146

95147

95148

95149

95165

95170

95180

 

 

 




Supervision of preparation and provision of single or multiple antigens for allergen immunotherapy may be considered medically necessary for a cumulative total of 150 doses/units per benefit period for the first year, including the build-up phase. 

Supervision of preparation and provision of single or multiple antigens for allergen immunotherapy may be considered medically necessary for a cumulative total of 120 doses/units per benefit period after the first year as maintenance therapy.

A dose/unit of antigen is defined as one (1)-cc aliquot from a multi-dose vial.

Supervision of preparation and provision of single or multiple antigens for allergen immunotherapy represents single or multiple-dose vials of non-venom antigens. Common practice for mixing a multi-dose vial of antigens is to prepare a ten (10)-cc vial then remove one (1)-cc doses. Reimbursement may be made up to a maximum of ten (10) doses per vial.

95165

 

 

 

 

 

 




Allergy immunotherapy for the following is considered experimental/investigational and, therefore, non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature:

  • Food Allergy [excluding FDA approved medications (e.g., peanut Arachis hypogaea allergen powder-dnfp (Palforzia), etc.]; and
  • Chronic Urticaria; and
  • Angioedema; and
  • Sublingual immunotherapy (SLIT) administered as drop formulation.

95115

95117

95120

95125

95130

95131

95132

95133

95134

95144

95145

95146

95147

95148

95149

95165

95170

95180

 

 

 




NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.


Related Policies

Refer to Medical Policy Z-27, Eligible Providers and Supervision Guidelines, for additional information.

Refer to Pharmacy Policy J-694, Sublingual Immunotherapy, for additional information.


Covered Diagnosis Codes for Procedure Codes 95115, 95117, 95120, 95125, 95130, 95131, 95132, 95133, 95134, 95144, 95145, 95146, 95147, 95148, 95149, 95165, 95170, 95180

E905.3

H10.10

H10.11

H10.12

H10.13

H10.44

H10.45

J30.0

J30.1

J30.2

J30.81

J30.89

J30.9

J45.20

J45.21

J45.30

J45.31

J45.40

J45.41

J45.50

J45.51

J45.901

J45.902

J45.909

J45.991

J45.998

J82.81

J82.82

J82.89

T63.421A

T63.421D

T63.421S

T63.441A

T63.441D

T63.441S

T63.451A

T63.451D

T63.451S

T63.461A

T63.461D

T63.461S

T78.40XA

T78.40XD

T78.40XS

T78.49XA

T78.49XD

T78.49XS

Z51.6

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Allergy Immunotherapy is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.