HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-126-015
Topic:
Alpha1-Proteinase Inhibitors
Section:
Injections
Effective Date:
August 26, 2024
Issued Date:
August 26, 2024
Last Revision Date:
June 2024
Annual Review:
June 2024
 
 

Alpha-1 proteinase inhibitors (Aralast NP™, Glassia®, Prolastin-C®, or Zemaira™) are used for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1 proteinase inhibitor (A1-PI), also known as alpha1-antitrypsin deficiency (A1AD).

Policy Position

Alpha-1 proteinase inhibitors (Aralast NP, Glassia, Prolastin-C, or Zemaira) administered intravenously may be considered medically necessary in individuals 18 years of age and older when ALL the following criteria are met: 

  • Individual diagnosed with emphysema due to alpha-1 antitrypsin deficiency; and
  • There is a documented high risk phenotype** resulting in a low serum concentration of alpha-1 antitrypsin (AAT), as evidenced by less than 80 mg per deciliter (mg/dL) (0.8 g/L) by radial immunodiffusion (or less than 50 mg/dL (0.5 g/L) if measured by nephelometry) or less than 11 µM/L (35 % of normal); and
  • ONE of the following is present:
    • Presence of airflow obstruction is evidenced by forced expiratory volume (FEV1) less than or equal to 80% of predicted value, prior to initiation of therapy; or
    • Individual has a rapid decline in lung function as measured by a change in FEV1 greater than 120 ml/year; and
  • The individual is a non-smoker or is a smoker undergoing active smoking cessation therapy; and
  • Must be on standard therapy for chronic obstructive pulmonary disease (COPD) (i.e. inhaled bronchodilators, inhaled steroids) as defined by current clinical guidelines (i.e. the Global Initiative COPD- GOLD guidelines); or
  • Individual has necrotizing panniculitis; and
  • Initial authorization will be for a period of 12 months.

** PiZZ, PiZ, or Pi phenotype (homozygous) or other phenotypes, (PiSZ or PiMS) when associated with serum AAT concentrations of less than 80 mg/dL.  

Reauthorization Criteria

  • Continuation of therapy for AAT inhibitor therapy with Aralast NP, Glassia, Prolastin-C, or Zemaira may be considered medically necessary when ALL the following criteria are met:
    • Individual is currently receiving AAT inhibitor therapy; and
    • Provider attestation of positive clinical response; and
    • Reauthorization will be for a period of 12 months

The use of AAT inhibitor therapy (i.e. Aralast NP, Glassia, Prolastin-C, or Zemaira not meeting the criteria as indicated in this policy is considered not medically necessary.

J0256

J0257

 

 

 

 

 




Safety and effectiveness of alpha-1-proteinase inhibitors in pediatric individuals has not been established.

AAT inhibitor therapy (i.e. Aralast NP, Glassia, Prolastin-C, or Zemaira) may be considered medically necessary for individuals 18 years of age and older when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home.

Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in other than an outpatient facility setting:

  • Member’s home is considered unsuitable for care by the home infusion provider; or
  • Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or
  • Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or
  • Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or
  • Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or 
  • Individual is initiating therapy or re-initiating therapy after a period of at least 6 months with no therapy; or
  • Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

Home health services may be considered medically necessary when utilized for the administration of home infusion therapy and when provided by licensed eligible provider. Each case will be addressed on an individual basis.

The medications identified in this policy will be considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

J0256

J0257

 

 

 

 

 




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 I-151, Site of Care, for more information.


Professional Statements and Societal Positions Guidelines

Global initiative for Chronic Obstructive Lung Disease (GOLD).  Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease.  Bronchodilators – Recommendations 2020.

  • For both beta2-agonists and anticholinergics, long-acting formulations are preferred over short-acting formulations.
  • The combined use of short- or long-acting beta2-agonists and anticholinergics may be considered if symptoms are not improved with single agents.
  • Based on efficacy and side effects inhaled bronchodilators are preferred over oral bronchodilators.
  • Based on evidence of relatively low efficacy and more side effects, treatment with theophylline is not recommended unless other long-term treatment bronchodilators are unavailable or unaffordable.


Covered Diagnosis Codes for Procedure Codes J0256 and J0257 When Reported with  Diagnosis Code E88.01

J43.0

J43.1

J43.2

J43.8

J43.9

J44.0

J44.1

J44.9

J98.2

J98.3

M79.3

 

 

 



Place of Service: Outpatient - Infusion

Evidence-based guidelines support the administration of injectable medications in alternative sites of care such as the non-hospital physician’s office, non-hospital infusion center or in the home.  Administration of the injectable medications subject to this policy at alternate sites of care is based upon the professional judgment of the provider, and takes into account the clinical appropriateness for each individual member. Requests for administration of any dose of the drugs listed in this policy received from a hospital-based facility, physician’s office or specialized infusion center will be assessed for meeting the policy exception criteria based on the clinical documentation provided by the requesting practitioner.



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.