Low-Density Lipid (LDL) apheresis may be considered medically necessary for ALL of the following indications:
- Patients with homozygous familial hypercholesterolemia as an alternative to plasmapheresis; and
- Patients with heterozygous familial hypercholesterolemia who have failed a six (6) month trial of diet therapy, and maximum tolerated combination drug therapy(*), and who meet the following FDA-approved indications:
- Functional hypercholesterolemic heterozygotes with LDL cholesterol greater than300 mg/dl without coronary artery disease; or
- Functional hypercholesterolemic heterozygotes with LDL cholesterol greater than 200 mg/dl and documented coronary artery disease.
*Maximum tolerated drug therapy is defined as a trial of drugs from at least two (2) separate classes of hypolipidemic agents such as bile acid sequestrants, HMG-CoA reductase inhibitors, fibric acid derivatives, or Niacin/Nicotinic acids.
Documented coronary artery disease includes a history of myocardial infarction, coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or alternative revascularization procedure, or progressive angina documented by exercise or non-exercise stress test.
All other indications will be denied as not medically necessary.