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Heart/lung transplantation 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. Heart/lung transplant refers to the transplantation of one or both lungs and heart from a single cadaver donor.
Combined heart/lung transplantation is intended to prolong survival and improve function in patients with end-stage cardiac and pulmonary diseases. Most recipients have Eisenmenger syndrome (37%), followed by idiopathic pulmonary artery hypertension (28%) and cystic fibrosis (14%). Eisenmenger syndrome is a form of congenital heart disease in which systemic-to-pulmonary shunting leads to pulmonary vascular resistance. Eventually, pulmonary hypertension may lead to a reversal of the intracardiac shunting and inadequate peripheral oxygenation, or cyanosis.
However, the total number of patients with Eisenmenger syndrome has been declining in recent years, as a result of corrective surgical techniques and improved medical management of pulmonary hypertension. Heart/lung transplants have not increased appreciably for other indications either, as it has become more common to transplant a single or double lung and maximize medical therapy for heart failure, rather than perform a combined transplant. In these, patient survival rates are similar to lung transplant rates. Bronchiolitis obliterans syndrome is a major complication; 1-, 5-, and 10-year patient survival rates are 68%, 50%, and 40%, respectively.
In 2014, 24 individuals received heart/lung transplants in the United States. As of the end of October 2015, there were 49 patients on the waiting list for heart/lung transplants.
POLICYNo benefits will be provided for a covered transplant procedure unless the Member receives prior authorization through case management from Blue Cross & Blue Shield of Mississippi.
Heart/lung transplantation is medically necessary for carefully selected patients with end-stage cardiac and pulmonary disease including, but not limited to, one of the following diagnoses:
Heart/lung retransplantation after a failed primary heart/lung transplant may be considered medically necessary in patients who meet criteria for heart/lung transplantation.
Heart/lung transplantation is considered investigational in all other situations.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Potential contraindications subject to the judgment of the transplant center:
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 (LAS), 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. Status 1A is described below.
Adult Patients (18 years of age or older)
(a) Mechanical circulatory support that includes at least one of the following:
(b) Continuous mechanical ventilation
(c) Requires continuous infusion of a single high-dose intravenous or multiple intravenous inotropes, and requires continuous hemodynamic monitoring of left ventricular filling pressures.
A patient has one of the following devices or therapies in place (with or without being admitted to the listing transplant center hospital):
(a) Mechanical circulatory support that includes at least one of the following:
(b) Mechanical circulatory support and there is medical evidence of significant device-related complications including, but not limited to, thromboembolism, device infection, mechanical failure, or life-threatening ventricular arrhythmias.
A patient who does not meet Status 1A or 1B is listed as Status 2.
A candidate listed as status 1B meets at least one of the following criteria:
Status 7 patients are considered temporarily unsuitable to receive a thoracic organ transplant.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC)
5/1/2002: Type of Service and Place of Service deleted
7/21/2005: Reviewed by MPAC: "HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients."
10/17/2005: Code Reference table updated: codes: 33930, 33960 description revised, 33933 added; diagnosis codes 277.0-277.01, 416.2 deleted, 277.02, 416.0, 491.20, 491.22, 493.20, 493.21, 493.22 added; ICD-9 procedure 00.93 added.
3/28/2006: Coding updated: CPT4 2006 revisions added to policy
12/31/2008: Policy reviewed, prior authorization for evaluation removed.
02/24/2012: Policy statement revised to add "with severe heart failure" to the second bullet point. Deleted the following from the policy statement: HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients. Contraindications moved to the Policy Guidelines section, and the absolute and relative contraindications were combined. Deleted outdated references from the Sources section.
03/13/2013: Policy reviewed; no changes.
04/07/2014: Policy statement updated to add "Heart/lung retransplantation after a failed primary heart/lung transplant may be considered medically necessary in patients who meet criteria for heart/lung transplantation." Added statement that heart/lung transplantation in all other situations is considered investigational.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 33946, 33947, 33948, 33949, 33951, 33952, 33953, 33954, 33955, 33956, 33957, 33958, 33959, 33962, 33963, 33964, 33965, 33966, 33969, 33984, 33985, 33986, 33987, 33988, and 33989.
01/14/2015: Policy reviewed; description updated regarding Eisenmeger syndrome. Policy statements unchanged.
08/25/2015: Code Reference section updated for ICD-10.
03/04/2016: Policy description updated with 2014 and 2015 data. Policy statements unchanged. Policy guidelines updated regarding cardiac-specific criteria for adult and pediatric patients. Added medically necessary and investigative definitions. Removed deleted CPT code 33960 from the Code Reference section.
06/01/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy #7.03.08
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.