Autologous HCT may be considered medically necessary as a treatment of systemic sclerosis/scleroderma when ALL of the following criteria are met:
- The individual is less than 60 years of age; and
- Duration of the condition is NOT greater than five (5) years; and
- Modified Rodnan Scale Scores is greater than or equal to 15; and
- History of less than six (6) months treatment with cyclophosphamide; and
- No active gastric antral vascular ectasia.
Autologous HCT for all other autoimmune diseases is considered experimental/investigation and therefore non-covered due to lack of supporting published peer reviewed literature.
Individuals with systemic sclerosis/scleroderma AND internal organ involvement indicated by the following should not be considered for autologous HCT:
- Left ventricular ejection fraction less than 50%; or
- Tricuspid annular plane systolic excursion less than 1.8 cm; or
- Pulmonary artery systolic pressure greater than 40 mm Hg; or
- Mean pulmonary artery pressure greater than 25 mm Hg; or
- Diffusing capacity of carbon monoxide (DLCo) less than 40% of predicted value; or
- Forced vital capacity (FVC) less than 45% of predicted value; or
- Renal: creatinine clearance less than 40 ml/minute.
Autologous HCT performed in individuals with internal organ involvement, as defined above, is considered not medically necessary.