Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

QualChoice maintains a national network of Centers of Excellence for members who require transplantation.

Heart transplants and long term Ventricular Assist Devices (VADs) require prior authorization. Transplants, long term VADs and transplant related services are covered only when performed at a transplant center previously approved by QualChoice.

Heart Transplant

1.    Human cadaver heart transplant is considered medically necessary and is covered for patients with end-stage heart disease that limits prognosis for survival over 2 years or severely limits daily quality of life despite optimal medical and other surgical therapy and have one or more of the following conditions:

·         Presence of an implanted ventricular assist device

·         End stage dilated cardiomyopathy refractory to medical therapy

·         Ischemic cardiomyopathy refractory to medical therapy and not amenable to revascularization procedures

·         Ventricular tachyarrhythmias refractory to all accepted therapeutic modalities

·         Valvular heart disease

·         Myocarditis

·         Congenital heart disease

·         Non-ischemic cardiomyopathy refractory to medical therapy

2.    The recipient must have a suitable psychological profile and social support system.

Ventricular Assist Devices (“bridge to transplant” or “destination”)

QualChoice considers a Food and Drug Administration (FDA)-approved ventricular assist device (VAD) medically necessary for any of the following FDA-approved indications:

1.    As a bridge to transplant for members who are awaiting heart transplantation and the device has received FDA approval for a bridge to transplant indication (e.g., HeartMate 3 left ventricular assist system (LVAS)); or

2.    As destination therapy when all of the following criteria are met:

a)    The device has received FDA approval for a destination therapy indication (e.g., HeartMate II LVAD, HeartWare HVAD); and

b)    Member has New York Heart Association (NYHA) Class IV end-stage ventricular heart failure and is not a candidate for heart transplant; and

c)    Member has failed to respond to optimal medical management (including beta-blockers, and angiotensin-converting enzyme (ACE) inhibitors if tolerated) for at least 45 of the last 60 days, or has been balloon pump dependent for 7 days, or has been IV inotrope dependent for 14 days; and

d)    Has a left ventricular ejection fraction (LVEF) less than 25 %; and

e)    Has demonstrated functional limitation with a peak oxygen consumption of less than or equal to 14 ml/kg/min.  (Note: This criterion may be waived in persons who are balloon pump or intravenous inotrope dependent or are otherwise unable to perform exercise stress testing).

Codes Used In This BI:

1)    QualChoice will not cover a heart transplant for a member with any of the following:

a)    Acute illness or clinically unstable

b)    An active infectious process or untreatable infection

c)    Active malignancy within the past two years with the exception of basal cell and squamous cell carcinoma of the skin

d)    History of adenocarcinoma or epithelial origin carcinoma within the past five years

e)    Any systemic process with a high probability of recurring in the transplanted heart (e.g., amyloidosis)

f)      Severe pulmonary hypertension

g)    Active tobacco use within the last six months

h)    Alcohol or drug abuse or dependence within the last six months

i)      Peripheral or cerebrovascular disease not amenable to surgical correction

j)      Diabetes mellitus with end-organ damage (e.g., neuropathy, nephropathy, proliferative retinopathy)

k)    Severe pulmonary disease (for criteria for heart-lung transplant, see BIXXX)

l)      Human immunodeficiency virus (HIV) infection unless ALL of the following are met:

i)      CD4 count greater than 200 cells/mm3

ii)     Undetectable HIV-1 RNA

iii)    Stable anti-retroviral therapy for > three months

iv)   Absence of serious complications associated with or secondary to HIV disease (e.g., opportunistic infection, neoplasm, encephalopathy)

m)  Unresolved psychosocial concerns or history of noncompliance with medical management

n)    Body Mass Index (BMI) ≥30 kg/m2 or percent ideal body weight (PIBW) > 140%

o)    Irreversible renal dysfunction with serum creatinine >3 mg/dl.

2)    Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart is considered investigational and is not covered.

Heart transplantation may be life-saving, but it also consumes an extremely scarce resource.  It is therefore critical that heart transplant recipients be patients who are most likely to gain the most benefit from the procedure.  Similarly, the long term use of ventricular assist devices needs to be reserved for patients most likely to benefit from this technology.

1)    Mehra MR et al.  Listing criteria for Heart Transplantation:  International Society for Heart and Lung Transplantation Guidelines for the Care of Cardiac Transplant Candidates—2006.  J Heart Lunt Transplant 2006; 25: 1024-42.

2)    Mudge GH, Goldstein S, Addonizio LJ et al. 24th Bethesda Conference: Cardiac transplantation. Task Force 3: Recipient guidelines/prioritization. J Am Coll Cardiol 1993; 22(1):21-31.

Addendum:

Effective 03/01/2019: Added criteria for VAD as bridge to transplant or destination therapy.