HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-143-004
Topic:
Inhalation Products for the Management of Cystic Fibrosis
Section:
Injections
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
May 2018
Annual Review:
May 2018
 
 

Tobramycin (Tobi®, Bethkis®, Kitabis™ Pak), an inhaled aminoglycoside antibacterial, is indicated for the management of Cystic Fibrosis (CF) in individuals with Pseudomonas aeruginosa.

Dornase alfa (Pulmozyme®) is a recombinant DNase enzyme indicated in individuals in conjunction with standard therapies for the management of CF to improve pulmonary function.

Aztreonam (Cayston®), an inhaled monobactam antibacterial, is indicated to improve respiratory symptoms in CF in individuals with Pseudomonas aeruginosa.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

The use of Tobramycin, inhaled product, may be considered medically necessary for the management of CF when ALL of the following criteria are met: 

  • The individual is six years of age or older; and
  • The individual tests positive for Pseudomonas aeruginosa; and
  • The individual is not colonized with Burkholderia cepacia.

The use of Tobramycin, inhaled product, for any other indication is considered experimental/investigational and therefore, non-covered. There is a lack of clinical data to support its effectiveness and safety in other conditions.

J7682

J7685

 

 

 

 

 


The use of dornase alfa (Pulmozyme), inhaled product, may be considered medically necessary for the management of CF when used in conjunction with standard therapies to improve pulmonary function (i.e. chest physiotherapy, bronchodilators, antibiotics, anti-inflammatory therapy). 

The use of dornase alfa (Pulmozyme), inhaled product, for any other indication is considered experimental/investigational and therefore, non-covered. There is a lack of clinical data to support its effectiveness and safety in other conditions.

J7639

 

 

 

 

 

 


The use of aztreonam (Cayston), inhaled product, may be considered medically necessary to improve respiratory symptoms in individuals with CF when ALL of the following criteria are met:

  • The individual is seven (7) years of age or older; and
  • The individual tests positive for Psuedomonas aeruginosa; and
  • The individual is not colonized with Burkholderia cepacia.

The use of aztreonam (Cayston), inhaled product, for any other indication is considered experimental/investigational and therefore, non-covered. There is a lack of clinical data to support its effectiveness and safety in other conditions.

J3490

 

 

 

 

 

 


NOTE: 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.

Related Policies

Refer to Pharmacy Policy Bulletin J-430 for more information on inhaled antibiotics for CF. 

Refer to Medical Policy Bulletin E-32 for more information on nebulizers for administration of inhaled antibiotics for CF.


Covered Diagnosis Codes for J7682, J7685, and J7639

E84.0

E84.11

E84.19

E84.8

E84.9

 

 


Place of Service: Inpatient/Outpatient

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

The use of Tobramycin, aztreonam (Cayston), and dornase alfa (Pulmozyme), inhaled products, 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


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



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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.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.




    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.