A heart transplant consists of replacing a diseased heart with a healthy donor heart. Transplantation is used for patients with refractory end-stage cardiac disease.
In the United States, approximately 5.8 million people have heart failure and 300,000 die each year from this condition. The reduction of cardiac output is considered to be severe when systemic circulation cannot meet the body’s needs under minimal exertion. Heart transplantation can potentially improve both survival and quality of life in patients with end-stage heart failure.
Heart failure may be due to a number of differing etiologies, including ischemic heart disease, cardiomyopathy, or congenital heart defects. The leading indication for heart transplant has shifted over time from ischemic to nonischemic cardiomyopathy. During the period 2005 to 2010, the primary causes of heart failure in patients undergoing transplant operations were nonischemic cardiomyopathy (53%) and ischemic cardiomyopathy (38%). Approximately 3% of the heart transplants during this time period were in adults with congenital heart disease.
The demand for heart transplants far exceeds the availability of donor organs, and the length of time patients are on the waiting list for transplants has increased. According to data from the Organ Procurement and Transplantation Network (OPTN), in 2014, a total of 2,655 heart transplants were performed in the United States. As of October 30, 2015, there were 4,207 patients on the waiting list for a heart transplant. Also in recent years, advances in medical and device therapy for patients with advanced heart failure has improved the survival of patients awaiting heart transplantation. The chronic shortage of donor hearts has led to the prioritization of patients awaiting transplantation to ensure greater access for patients most likely to derive benefit. Prioritization criteria are issued by OPTN and fulfilled through a contract with the United Network for Organ Sharing.
From 2005 to 2010, approximately 3% of heart transplants were repeat transplantations. Heart retransplantation raises ethical issues due to the lack of sufficient donor hearts for initial transplants. UNOS does not have separate organ allocation criteria for repeat heart transplant recipients.
Heart transplantation is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA).
Indications for Heart-Lung Transplantation are discussed in another policy.
No 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.
A human heart transplant is considered medically necessary for selected adult and pediatric patients with end-stage heart failure who meet the following criteria below (I) and fall within acceptable guidelines for patient selection below (II), and fall within the highest priority of allocation (III) as indicated below:
I. Patients must meet all of the following criteria:
II. The following indications are to be used as a guideline for patient selection
A. For Adult Patients:
B. For Pediatric Patients:
III. The following indications are to be used as a guideline for priority allocation.
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 the United Network for Organ Sharing (UNOS). Donor thoracic organs are prioritized by UNOS on the basis of recipient medical urgency, distance from donor hospital, and pediatric status. Patients who are most severely ill (status 1A) are given highest priority. Criteria from OPTN for listing status are as follows (Organ Procurement and Transplantation Network, 2015):
A heart transplant should be considered under the members contract transplant benefit.
Coverage is not provided for:
Potential contraindications subject to the judgment of the transplant center:
Policy-specific potential contraindications:
* Some patients may be candidates for combined heart-lung transplantation (see Heart/Lung Transplant medical policy)
Patients must meet the United Network for Organ Sharing (UNOS) guidelines for 1A, 1B, or 2 Status and not currently be Status 7.
A candidate who does not meet the criteria for Status 1A or 1B is listed as Status 2.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
8/1998: Approved by Medical Policy Advisory Committee (MPAC)
5/1/2002: Type of Service and Place of Service deleted
7/21/2005: Review by MPAC: Policy updated; "HIV positivity is not an absoulte contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients."
10/26/2005: Code Reference section updated: HPCS S2152 added; ICD-9 procedure code 00.93 added, 5th digit added to 37.51; ICD-9 Diagnosis code: 398.0, 422.91, 422.92, 422.93, 425.0, 425.3, 425.4, 428.0, 428.1, 428.22, 428.23, 428.32, 428.33, 428.42, 428.43, 428.9, 429.1, 429.3 added
3/27/2006: Coding updated. CPT4 2006 revisions added to policy
12/31/2008: Policy reviewed, prior authorization for evaluation removed
11/23/2009: Policy Description revised to add link to Heart-Lung Transplantation policy, Policy Statement Section revised to add new medically necessary criteria being patients must now meet specific criteria, fall within patient selection ACC guidelines and priority allocation UNOS guidelines, specific medically necessary criteria added, revised ACC guideline information added, revised UNOS priority allocation information added, non-coverage information added, Coding Section revised to add ICD9 procedure codes 37.99 and 39.61 to Covered Codes Table, ICD9 Diagnosis codes 422.91, 422.92, 422.93 replaced incorrect codes 442.91, 442.93, 442.94 on the Covered Codes Table.
02/24/2012: Contraindications moved to the Policy Guidelines section, and the absolute and relative contraindications were combined. Deleted outdated references from the Sources section.
03/31/2013: Policy reviewed; no changes.
04/24/2014: Added the following policy statements: 1) Heart retransplantation after a failed primary heart transplant may be considered medically necessary in patients who meet criteria for heart transplantation. 2) Heart transplantation is considered investigational in all other situations.
02/19/2015: Policy description updated. Policy statement criteria for pediatric patients regarding anatomical and physiological conditions updated to change "natural history or congenital heart disease" to "natural history of congeital heart disease." In the UNOS priority allocation statement, "donor heart organs" changed to "donor thoracic organs." Added the following statement for Status 1A Adult Patients: If criteria a, b, c, and d are not met, such status can be obtained by application to the applicable Regional Review Board. Revised the statement for Status 1A Pediatric Patients to state that a candidate who does not meet the criteria specified in a, b, c, d, or e may be listed as Status 1A if the candidate has a life expectancy without a heart transplant of less than 14 days, such as due to refractory arrhytmia.
08/25/2015: Code Reference section updated to add ICD-10 codes. Removed ICD-9 procedure codes 37.99 and 39.61.
03/04/2016: Policy description updated regarding 2014 and 2015 data for heart transplants. Policy section updated regarding cardiac-specific criteria for adult and pediatric patients. Policy guidelines section updated to list the policy-specific potential contraindications separately from the potential contraindications subject to the judgment of the transplant center. Added medically necessary and investigative definitions.
06/01/2016: Policy number added.
Blue Cross Blue Shield Association policy #7.03.09
This 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.