MEDICAL POLICY
POLICY TITLE
LOW-DENSITY LIPID APHERESIS
POLICY NUMBER
MP-4.011
Original Issue Date (Created):
July 1, 2002
Most Recent Review Date
(Revised):
December 18, 2007
Effective Date:
September 15, 2008- RETIRED
I.
DESCRIPTION/BACKGROUND
Low-density lipoprotein apheresis describes a variety of technologies used to acutely
remove low-density lipoprotein (LDL) from the plasma. The patient initially undergoes an
apheresis procedure to isolate the plasma. The LDL is then selectively removed from the
plasma. The plasma is then returned to the patient.
LDL apheresis has been investigated as a technique to treat patients with familial
hypercholesteremia (FH). FH is an inherited disorder involving a mutation of the gene that
encodes the cell surface receptor responsible for LDL uptake by cells. The number of LDL
receptors is halved in this condition, resulting in serum LDL cholesterol levels that are two
to three times above normal (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 affects one in five hundred people, and may or
may not respond adequately to lipid lowering drugs.
Homozygous hypercholesteremia is rare, occurring in only one in one million persons.
Serum levels of LDL-C may be elevated six-fold (> 500 mg/dl), due to the total lack of
functioning LDL receptors. Homozygotes develop severe aortic stenosis and coronary
heart disease by age twenty. 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 Liposorber LA15® system, and the heparin-induced extracorporeal LDL precipitation
(HELP®) system are two examples of U.S. Food and Drug Administration (FDA)
approved apheresis systems.
II.
DEFINITIONS
ALLELE refers to one of two or more different genes containing specific inheritable
characteristics that occupy corresponding positions (loci) on paired chromosomes.
HETEROZYGOUS refers to having two different alleles at corresponding loci on homologous
chromosomes.
Page 1
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
LOW-DENSITY LIPID APHERESIS
POLICY NUMBER
MP-4.011
HOMOZYGOUS refers to having two identical alleles at corresponding loci on homologous
chromosomes.
PLASMA refers to the watery straw-colored fluid part of the lymph and the blood in which
the leukocytes, erthrocytes, and platelets are suspended. Plasma is made up of water,
electrolytes, proteins, glucose, fats, bilirubin, and gases, and is essential for carrying the
cellular elements of the body through the circulation, transporting nutrients, maintaining
the acid-base balance of the body, and transporting wastes from the tissue.
III.
POLICY
LDL apheresis may be considered medically necessary in patients with homozygous
familial hypercholesterolemia as an alternative to plasmapheresis.
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 FDAapproved indications (all LDL levels represent the best achievable LDL level after a
program of diet and drug therapy):
1. Functional hypercholesterolemic heterozygotes with LDL greater than or equal to 300
mg/dl;
2. Functional hypercholesterolemic heterozygotes with LDL greater than or equal to 200
mg/dl AND documented coronary artery disease.**
*Maximum tolerated drug therapy is defined as a trial of drugs from at least two 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.
Cross-reference
MP-4.024 Plasmapheresis (Plasma Exchange)
IV.
EXCLUSIONS
LDL apheresis for all indications not addressed in the policy is considered investigational,
as there is insufficient evidence to support a conclusion concerning the health outcomes or
benefits associated with this procedure.
Page 2
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
LOW-DENSITY LIPID APHERESIS
POLICY NUMBER
MP-4.011
V.
BENEFIT VARIATIONS
The existence of this medical policy does not mean that this service is a covered benefit
under the member's contract. Benefit determinations should be based in all cases on the
applicable contract language. Medical policies do not constitute a description of benefits.
A member’s individual or group customer benefits govern which services are covered,
which are excluded, and which are subject to benefit limits and which require
preauthorization. Members and providers should consult the member’s benefit information
or contact Capital for benefit information.
VI.
DISCLAIMER
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute
medical advice and are subject to change. Treating providers are solely responsible for medical advice and
treatment of members. Members should discuss any medical policy related to their coverage or condition
with their provider and consult their benefit information to determine if the service is covered. If there is a
discrepancy between this medical policy and a member’s benefit information, the benefit information will
govern. Capital considers the information contained in this medical policy to be proprietary and it may only
be disseminated as permitted by law.
VII. REFERENCES
BCBSA 1999 TEC Assessment; Tab 3.
Highmark Medicare Services Local Coverage Determination (LCD) S-11K: Pheresis
Therapy (Apheresis). Effective 08/15/06. [Website]:
http://www.highmarkmedicareservices.com/policy/partb/s1/s11k.html Accessed
September 10, 2007.
Mosby’s Medical, Nursing, & Allied Health Dictionary, 6th edition.
Ramunni A, Giancipoli G, Guerriero S et al. LDL-apheresis accelerates the recovery of
nonarteritic acute anterior ischemic optic neuropathy. Ther Apher Dial 2005; 9(1): 538.
Taber’s Cyclopedic Medical Dictionary, 19th edition.
Thompson J, Thompson PD. A systematic review of LDL apheresis in the treatment of
cardiovascular disease. Atherosclerosis 2006; 189(1): 31-9. Epub 2006 Mar 20.
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage
Insurance Company® and Keystone Health Plan® Central. Independent licensees of the Blue Cross and Blue Shield
Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider
relations for all companies.
Page 3
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
LOW-DENSITY LIPID APHERESIS
POLICY NUMBER
MP-4.011
VIII. PRODUCT VARIATIONS
[N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
[N] CHIP POS
[N] Indemnity
[N] PPO
[N] SpecialCare
[N] HMO
[N] POS
[N] CHIP HMO
[N] FEP HMO
[Y] SeniorBlue*
[N] FEP PPO
[Y] SeniorBlue PPO*
* Refer to Highmark Medicare Services Local Coverage Determination (LCD) S-11K
Pheresis Therapy (Apheresis) as Medicare does not require 6 months of failed drug
treatment prior to therapy.
IX.
POLICY HISTORY
Mp 4.011
CAC 5/25/04
CAC 7/26/05
CAC 6/27/06
CAC 6/26/07
CAC 11/27/07
Policy approved for retirement effective 9/15/2008.
Information added into Policy 4.024.
Page 4
[Note: Final page is signature page and is kept on file, but not issued with Policy.]