HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-123-017
Topic:
Lung and Lobar Lung Transplantation
Section:
Surgery
Effective Date:
November 27, 2017
Issued Date:
September 17, 2018
Last Revision Date:
September 2018
Annual Review:
September 2018
 
 

Lung transplantation (single or double)
Lung transplantation involves either single-lung or double-lung replacement. One or both lungs are transplanted from a donor with pronounced brain death into the chest cavity of the recipient.

Lobar lung transplant
A lobar lung transplant refers to the transplant of a lobe excised from the donor's lung that is sized appropriately for the recipient's thoracic dimensions. Lobar lung transplant donors are primarily living related donors, with one lobe obtained from each of two donors in cases where a bilateral transplant is required.

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

Lung transplantation (single or double) may be considered medically necessary for carefully selected adults and children with irreversible, progressively disabling, end-stage pulmonary disease including, but not limited to any ONE of the conditions listed below:

  • Bronchiectasis
  • Pulmonary fibrosis
  • Alpha-1 antitrypsin deficiency
  • Primary pulmonary hypertension
  • Cystic fibrosis (both lungs to be transplanted)
  • Bronchopulmonary dysplasia
  • Idiopathic pulmonary fibrosis
  • Chemotherapy induced restrictive pulmonary disease
  • Sarcoidosis
  • Silicosis
  • Scleroderma
  • Lupus
  • CREST
  • Lymphangiomyomatosis
  • Emphysema
  • Kartageners
  • Eosinophilic granuloma
  • Bronchiolitis obliterans
  • Recurrent pulmonary embolism
  • Pulmonary hypertension due to cardiac disease
  • Chronic obstructive pulmonary disease
  • Eisenmenger's syndrome
  • Interstitial pulmonary fibrosis
  • Thromboembolic disease
  • Bronchoalveolar carcinoma of the lung that is restricted to the lung without sign of spread to mediastinal nodes or other distant sites
  • Post inflammatory fibrosis
  • Graft vs. Host disease or failed primary lung graft

Patient Selection Criteria
In addition, the following patient selection criteria apply:

  •  Medical therapy has been ineffective or unavailable; and
  • Substantial limitation to daily living activities; and
  • Ambulatory with rehabilitation potential; and
  • Adequate cardiac function without significant coronary artery disease; and
  • Acceptable nutritional status; and
  • Satisfactory psychosocial profile and emotional support; and
  • Patients must meet United Network for Organ Sharing (UNOS) guidelines for lung allocation score (LAS) greater than zero

Lung and lobar lung transplantation for all other conditions or for patients presenting with any absolute contraindication will be considered not medically necessary.

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Lobar lung transplant
Lobar lung transplantation may be considered medically necessary for adults and children with endstage pulmonary disease including, but not limited to any ONE of the conditions listed below:

  • Bilateral bronchiectasis
  • Alpha-1 antitrypsin deficiency
  • Primary pulmonary hypertension
  • Post- inflammatory pulmonary fibrosis
  • Cystic fibrosis (both lungs to be transplanted)
  • Bronchopulmonary dysplasia
  • Idiopathic pulmonary fibrosis
  • Sarcoidosis
  • Scleroderma
  • Lymphangiomyomatosis
  • Emphysema 
  • Eosinophilic granuloma
  • Bronchiolitis obliterans
  • Recurrent pulmonary embolism
  • Pulmonary hypertension due to cardiac disease
  • Chronic obstructive pulmonary disease
  • Eisenmenger's syndrome
  • Interstitial pulmonary fibrosis

Patient Selection Criteria
In addition, the following patient selection criteria apply:

  • Medical therapy has been ineffective or unavailable; and
  • Substantial limitation to daily living activities; and
  • Ambulatory with rehabilitation potential; and
  • Adequate cardiac function without significant coronary artery disease; and
  • Acceptable nutritional status; and
  • Satisfactory psychosocial profile and emotional support; and
  • Patients must meet UNOS guidelines for lung allocation score (LAS) greater than zero.

Lung and lobar lung transplantation for all other conditions will be considered not medically necessary.

S2060

S2061




Absolute contraindications for transplant recipients include, but are not limited to, the following:

  • Metastatic cancer; or
  • Ongoing or recurring infections that are not effectively treated; or
  • Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery; or
  • Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured; or
  • Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations; or
  • Potential complications from immunosuppressive medications are unacceptable to the patient; or
  • Psychosocial conditions or chemical dependency affecting ability to adhere to therapy; or
  • AIDS (diagnosis based on CDC definition of CD4 count, 200cells/mm3) unless the following are noted:
    • CD4 count greater than 200 cells/mm³ for greater than six (6) months; and
    • HIV-1 RNA undetectable; and
    • On stable anti-retroviral therapy greater than three (3) months; and
    • No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi's sarcoma or other neoplasm); and
    • Meeting all other criteria for lung and lobar transplantation.

Lung and lobar lung transplantation for patients presenting with any absolute contraindication will be considered not medically necessary.


Relative contraindications for lung and lobar transplantation include, but are not limited to, the following:

  • History of cancer with a moderate risk of recurrence; or
  • Systemic disease that could be exacerbated by immunosuppression; or
  • Psychosocial conditions or chemical dependence affecting the ability to adhere to therapy; or
  • Coronary artery disease not amenable to percutaneous intervention or bypass grafting, or associated with significant impairment of left ventricular function; or
  • Colonization with highly resistant or highly virulent bacteria, fungi or mycobacteria.

Lung and lobar transplantation for patients presenting with a relative contraindication will be reviewed on a case-by-case basis.


Retransplantation in individuals with graft failure of an initial lung or lobar transplant, due to either technical reasons or hyperacute rejection may be considered medically necessary.

Retransplantation in individuals with chronic rejection or recurrent disease may be considered medically necessary when the individual meets the indications and limitations of coverage.

Retransplantation in individuals with bronchiolitis obliterans may be considered medically necessary as it is associated with chronic lung transplant rejection, and thus, may be the etiology of a request for lung retransplantation.

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Selected candidates may be eligible for multi-organ transplant. In each case, the candidate should meet all of the indications and limitations of coverage for the individual transplant.

Refer to medical policy S-125 Heart/Lung Transplantation for additional information.


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Place of Service: Inpatient



The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees 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.