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LDL apheresis has been investigated as a technique to treat patients with familial hypercholesterolemia (FH). FH is a dominantly inherited disorder involving a mutation of the gene that encodes for the specific cell surface receptor responsible for LDL uptake by the cells. The heterozygous form affects about 1 in 500 people. The number of LDL receptors is halved in this condition, resulting in serum LDL-C levels that are approximately 2 to 3 times acceptable levels (i.e., >300 mg/dL). Affected male patients typically develop coronary heart disease in their thirties and forties, while women develop coronary heart disease in their fifties. Heterozygous FH may or may not respond adequately to lipid-lowering drugs.

Homozygous hypercholesterolemia is rare, occurring in only 1 in 1 million subjects. Serum levels of LDL-C may be elevated sixfold (>500 mg/dL), due to the total lack of functioning LDL receptors. Homozygotes develop severe aortic stenosis and coronary heart disease by age 20.  These patients typically do not respond adequately to drug or diet modification therapy. In the past, patients with homozygous FH may have been treated with plasma exchange, but the advent of LDL apheresis provides a more targeted approach by permitting selective removal of LDL from the plasma.

The patient initially undergoes an apheresis procedure to isolate the plasma. The low-density lipoproteins are then selectively removed from the plasma by either immunoadsorption, heparin-induced extracorporeal LDL precipitation (also referred to as HELP), or dextran sulfate adsorption. In immunoadsorption, polyclonal antihuman apoB antibodies from sheep selectively bind and remove LDL. (ApoB is the protein moiety of low-density lipoprotein.) In HELP, LDL and other particles containing apoB are precipitated by heparin at an acidic pH. Dextran sulfate adsorption removes LDL by binding the positively charged apoB to dextran sulfate particles bound to cellulose. LDL apheresis must be distinguished from plasma exchange (also referred to as plasmapheresis). In plasma exchange the plasma is collected during a pheresis procedure, then discarded and replaced with crystalloids. In contrast, LDL apheresis is a selective procedure in which only pathogenic low-density lipoproteins are removed. The plasma is then returned to the patient.

Two lipid apheresis systems have received approval from the U.S. Food and Drug Administration (FDA) for marketing. The Liposorber LA 15® System dextran sulfate system was granted FDA approval in 1996. The heparin-induced extracorporeal LDL precipitation (HELP®) system received FDA approval in 1997.

LDL apheresis may be considered medically necessary in patients with heterozygous familial hypercholesterolemia who have failed a 6-month trial of diet therapy and maximum tolerated combination drug* therapy AND who meet the following FDA-approved indications: (All LDL levels represent the best achievable LDL level after a program of diet and drug therapy.) 

1. Functional hypercholesterolemic heterozygotes with LDL > 300 mg/dL
2. Functional hypercholesterolemic heterozygotes with LDL > 200 mg/dL AND documented coronary artery disease*

LDL apheresis is considered investigational for all other uses, including use in preeclampsia.  

*For definitions of maximum tolerated drug therapy and documented coronary artery disease, please see Policy Guidelines.

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. 

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

9/18/2008: Annual ICD-9 updates effective 10-1-2008 applied

4/6/2009: Policy reviewed, no changes

09/09/2010:  Policy description updated regarding treatment approaches. Policy statement unchanged.

09/28/2011:  Policy reviewed; no changes.

09/27/2012:  Policy reviewed; no changes.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes