HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-122-023
Topic:
Heart Transplant
Section:
Surgery
Effective Date:
October 1, 2023
Issued Date:
October 1, 2023
Last Revision Date:
September 2023
Annual Review:
December 2022
 
 

A heart transplant and re-transplant consists of replacing a diseased heart with a healthy donor heart. Transplantation is used for individuals with refractory end-stage cardiac disease.

Policy Position

Human heart transplantation may be considered medically necessary for select adults and children with end-stage heart failure when the following individual selection criteria are met:

  • Adult Individuals 18 years or older
    • Accepted indications for cardiac transplantation
      • Hemodynamic compromise due to heart failure demonstrated by ANY of the following:
        • Circulatory support, mechanical; or
        • Maximal oxygen consumption (Vo2) less than 10 mL/kg/min with achievement of anaerobic metabolism; or
        • Refractory cardiogenic shock; or
        • Documented dependence on intravenous inotropic support to maintain adequate organ perfusion; or
      • Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty; or
      • Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities.
    • Probable indications for cardiac transplantation
      • Maximal Vo2 less than 14 mL/kg/min and major limitation of the individual's activities; or
      • Recurrent unstable ischemia not amenable to bypass surgery or angioplasty; or
      • Instability of fluid balance/renal function not due to individual noncompliance with a regimen of weight monitoring, flexible use of diuretic drugs, and salt restriction.
    • Inadequate indications for cardiac transplantation unless other factors as listed above are present:
      • Ejection fraction less than 20 percent; or
      • History of functional class III or IV symptoms of heart failure; or
      • Previous ventricular arrhythmias; or
      • Maximal Vo2 greater than 15 mL/kg/min.
  • Pediatric Individuals 17 years or younger
    • Individuals with heart failure with persistent symptoms at rest who require ONE or MORE of the following:
      • Circulatory support, mechanical; or
      • Infusion of intravenous inotropic agents, continuous; or
      • Ventilator support, mechanical; or
    • Individuals with heart disease with symptoms of heart failure who do not meet the above criteria but who have at least ONE of the following:
      • Anatomic and physiologic conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
      • Anatomic and physiologic conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction; or
      • Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease; or
      • Restrictive cardiomyopathy with reactive pulmonary hypertension; or
      • Severe limitation of exercise and activity (if measurable, such individuals would have a maximum Vo2 less than percent predicted for age and sex); or
      • Near sudden death and/or life-threatening arrhythmias, untreatable with medications or an implantable defibrillator; or
      • Reactive pulmonary hypertension and risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future.

Heart re-transplantation after a failed primary heart transplant may be considered medically necessary in individuals who meet criteria for heart transplantation. 

Heart transplantation or re-transplantation not meeting the criteria as indicated in this policy is considered not medically necessary.

In addition to the above criteria and subject to the discretion of the transplant center, a Hepatitis C Virus (HCV) positive donor organ may be considered an acceptable organ option for an HCV negative adult recipient 18 years of age or older.

33940

33944

33945

 

 

 

 




General Criteria

Potential contraindications for solid organ transplant subject to the judgment of the transplant center include the following:

  • Known current malignancy, including metastatic cancer; or
  • Recent malignancy with a high risk of recurrence; or
  • Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
  • Other irreversible end-stage diseases not attributed to heart or lung disease; or
  • History of cancer with a moderate risk of recurrence; or
  • Systemic disease that could be exacerbated by immunosuppression; or
  • Psychosocial conditions or chemical dependency affecting the ability to adhere to therapy.

Policy-specific potential contraindications include:

  • Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance greater than six (6) Wood units, or transpulmonary gradient greater than or equal to 16 mm/Hg despite treatment; or
  • Severe pulmonary disease, despite optimal medical therapy, not expected to improve with heart transplantation

Pediatric individuals must meet the United Network for Organ Sharing (UNOS) guidelines for status one A or one B (1A, 1B), or status two (2). Adult individuals must meet the United Network for Organ Sharing (UNOS) guidelines for status. One (1), two (2), three (3) or four (4).

Cardiac-Specific Criteria

Specific criteria for prioritizing donor thoracic organs for transplant are provided by the Organ Procurement and Transplantation Network (OPTN) and implemented through a contract with UNOS. Donor thoracic organs are prioritized by UNOS on the basis of recipient medical urgency, distance from donor hospital, and pediatric status. Individuals who are most severely ill (Adults status 1 or Pediatrics status 1A) are given the highest priority. The following factors are considered in assessing the severity of illness: reliance on continuous mechanical ventilation, infusion of intravenous inotropes, and/or dependency on mechanical circulatory support (i.e., total artificial heart, intra-aortic balloon pump, extracorporeal membrane oxygenator, ventricular assist device).

Additional criteria, which are considered in pediatric individuals, include diagnosis of an OPTN-approved congenital heart disease diagnosis, presence of ductal dependent pulmonary or systemic circulation, and diagnosis of hypertrophic or restrictive cardiomyopathy while less than one (1-) year-old. Of note, pediatric heart transplant candidates who remain on the waiting list at the time of their 18th birthday without receiving a transplant continue to qualify for medical urgency status based on the pediatric criteria.


Professional Statements and Societal Positions Guidelines

American College of Cardiology Foundation and American Heart Association-2017

Guidelines from the American College of Cardiology Foundation and American Heart Association were updated in 2017. Evaluation for heart transplantation was recommended for [individuals] in whom heart failure is assessed as refractory based on New York Heart Association functional class III or IV (stage D) for heart failure after previous guideline-directed medical therapy, use of devices such as an implantable cardioverter defibrillator or a cardiac resynchronization therapy device, or surgical management.

European Society of Cardiology-2016

The European Society of Cardiology (2016) guidelines on the diagnosis and treatment of acute and chronic heart failure recommended considering heart transplantation for [individuals] with end-stage heart failure with severe symptoms, poor prognosis, and no alternative treatment options. Active infection, severe peripheral arterial or cerebrovascular ischemia, pharmacologically irreversible pulmonary hypertension, cancer, renal insufficiency, systemic disease with multi-organ involvement, pre-transplant body mass index greater than 35 kg/m2, current alcohol or drug abuse, and insufficient social support to achieve compliant care in the outpatient setting were considered relative contraindications for heart transplantation.


Covered Diagnosis Codes for Procedure Codes 33940, 33944, 33945

I25.110

I25.111

I25.118

I25.119

I25.2

I25.3

I25.41

I25.42

I25.5

I25.6

I25.700

I25.701

I25.708

I25.709

I25.710

I25.711

I25.718

I25.719

I25.720

I25.721

I25.728

I25.729

I25.730

I25.731

I25.738

I25.739

I25.750

I25.751

I25.758

I25.759

I25.760

I25.761

I25.768

I25.769

I25.790

I25.791

I25.798

I25.799

I25.810

I25.811

I25.812

I25.82

I25.83

I25.84

I25.89

I25.89

I25.9

I47.0

I47.20

I47.29

I47.9

I49.01

I49.02

I50.1

I50.20

I50.21

I50.22

I50.23

I50.30

I50.31

I50.32

I50.33

I50.40

I50.41

I50.42

I50.43

I50.9

R57.0

T86.22

 



Place of Service: Inpatient

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



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.