Medical Policy: 07.03.08
Original Effective Date: November 2009
Reviewed: November 2020
Revised: November 2016
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
A combined heart/lung transplant is intended to prolong survival and improve function in patients with end-stage cardiopulmonary or pulmonary disease. The transplant involves a coordinated triple operative procedure consisting of procurement of a donor heart-lung block, excision of the heart and lungs of the recipient, and implantation of the heart and lungs into the recipient.
A heart/lung transplant refers to the transplantation of one or both lungs and heart from a single cadaver donor.
When the candidate is eligible to receive a heart in accordance with United Network for Organ Sharing (UNOS) guidelines for cardiac transplantation, the lung(s) shall be allocated to the heart/lung candidate from the same donor. When the candidate is eligible to receive a lung in accordance with the UNOS Lung Allocation System, the heart shall be allocated to the heart/lung candidate from the same donor "if no suitable Status 1A isolated heart candidates are eligible to receive the heart" (Organ Procurement and Transplantation Network ).
In 2014, the International Society for Heart and Lung Transplantation updated its consensus-based guidelines on the selection of lung transplant recipients. These guidelines made the following statements about lung transplantation:
"Lung transplantation should be considered for adults with chronic, end-stage lung disease who meet all the following general criteria:
For combined heart/lung transplant, the guidelines have stated that patients with irreversible myocardial dysfunction or irreparable congenital defects in conjunction with intrinsic lung disease or severe pulmonary arterial hypertension are appropriate candidates for heart/lung transplantation. The guidelines also mentioned that isolated bilateral lung transplantation is associated with comparable or better outcomes in most patients with pulmonary hypertension associated with right ventricular failure.
Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA).
The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.
Prior approval is required.
Heart/lung transplantation may be considered medically necessary for carefully selected patients with end-stage cardiac and pulmonary disease including, but not limited to, one of the following diagnoses:
Except as defined above, candidates for heart/lung transplant should meet the following general criteria:
The evaluation of a transplant candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.
The United Network for Organ Sharing (UNOS) believes that asymptomatic HIV-positive patients should not necessarily be excluded for candidacy for organ transplantation, stating, “A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy.” In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that the presence of AIDS could be considered a contraindication to kidney transplant unless the following criteria were present. These criteria may be extrapolated to other potential organ transplants:
It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.
UNOS prioritizes donor thoracic organs according to the severity of illness with those patients who are most severely ill (status 1A) given highest priority in allocation of the available organs as follows:
A patient is admitted to the listing transplant center hospital and has at least one of the following devices or therapies in place:
A patient has at least 1 of the following devices or therapies in place:
Patient meets at least one of the following criteria:
Note: A patient who does not meet the criteria above may be listed as Status 1A if the patient has a life expectancy without a heart transplant of less than 14 days, such as due to refractory arrhythmia.
Patient meets at least one of the following criteria:
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 upon the pediatric criteria.
Heart/lung retransplantation after a failed primary heart/lung transplant may be considered medically necessary in patients who meet criteria for heart/lung transplantation.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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