Coverage Policies

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.

Apheresis, Cytopheresis, Plasmapheresis and Plasma Exchange are covered when determined to be medically necessary under QualChoice criteria in this policy. Red Cell Pheresis is covered for sickle cell crisis; all other forms of apheresis require preauthorization.

Apheresis is a medical procedure utilizing special equipment to remove selected blood constituents (plasma, leukocytes, platelets, or cells) from whole blood.  The remainder is then re-infused into the person from whom the blood was taken. Plasmapheresis and Plasma Exchange are variants of this procedure.

QualChoice considers Red cell apheresis to be:

1) Covered for acute sickle cell crisis without prior authorization.

2) Any other indications require preauthorization.

QualChoice/QCA considers Plasmapheresis (PP) or plasma exchange (PE) medically necessary for the following indications (ICD codes in parentheses):

    1.        Severe (grades 3-5) Guillain Barre` syndrome (G61.0) (consistent with guidelines from the American Academy of Neurology, it is generally considered medically necessary to initiate PE within 2 weeks of onset of neuropathic symptoms for ambulant individuals and within 4 weeks of symptom onset for non-ambulant individuals).

    2.        Chronic relapsing polyneuropathy (G61.81) (chronic inflammatory demyelinating polyneuropathy (CIDP)) with severe or life threatening symptoms, in persons who have failed to respond to conventional therapy.

    3.        Treatment of Thrombotic Thrombocytopenic Purpura (TTP) (M31.1)

    4.        HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome of pregnancy (O14.10-O14.23), in persons who are not getting better within 5 days after delivery.

    5.        Glomerulonephritis associated with Anti-glomerular basement membrane antibodies and advancing renal failure or pulmonary hemorrhage (N01.0 – N01.9, N03.8).

    6.        Goodpasture`s syndrome (M31.0).

    7.        Hyperglobulinemias (D89.0 – D89.2, D47.2, C88.0), (including (but not limited to) multiple myelomas (C90.00, C90.02), Cryoglobulinemia (D89.1), primary (Waldenstrom`s) Macroglobulinemia (C88.0) or other hyper viscosity syndromes (C88.2, D89.0 - D89.2).

    8.        Myasthenia gravis (G70.00-G70.01), in persons with any of the following:

• Acute, short-term benefit is critical because of a sudden worsening of symptoms (such as in impending respiratory crisis)
• Needs rapid improvement of strength before surgery or irradiation
• Requires chronic intermittent treatment because of failure to respond to all other treatments;

    9.        Last resort treatment of life threatening rheumatoid vasculitis (M05.00-M05.09, M05.20-M05.29);

 10.        Pruritus from Cholestatic liver disease (plasma perfusion of charcoal filters) (K74.3-K74.5).

 11.        Scleroderma (M34.0-M34.9) and Polymyositis (M33.20-
M33.29), in persons who are unresponsive to conventional therapy;

 12.        Last resort treatment of life threatening systemic lupus erythematosus (SLE) (M32.0-M32.9) when conventional therapy has failed to prevent clinical deterioration

 13.        Refsum`s disease (G60.1).

 14.        Severe hypercholesterolemia (E78.0) in persons refractory to diet and maximum drug therapy who are homozygous for familial hypercholesterolemia (LDL apheresis, also known as heparin-induced extracorporeal LDL precipitation [HELP] or Dextra Sulfate adsorption) with LDL levels > 500 mg/dL, or persons heterozygous for familial hypercholesterolemia with LDL levels > 300 mg/dl or > 200 mg/dL with documented history of coronary artery disease. (For this policy, maximum drug therapy is defined as a 6-month trial of diet plus maximum tolerated combination drug therapy (defined as a trial of drugs from at least 2 separate classes of Hypolipidemic agents such as bile acid sequestrants, HMG-CoA reductase inhibitors, fibric acid derivatives, or niacin/nicotinic acids). Documented history of coronary artery disease is defined as a history of myocardial infarction, coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, alternative revascularization procedure, or angina with coronary artery disease documented by stress test. The frequency of LDL apheresis that is considered medically necessary varies, but typically averages about once every 2 weeks to obtain an intrapheresis level of low density lipoprotein cholesterol (LDL-C) of 120 mg/dl or less. It may be considered medically necessary to treat individuals with homozygous familial hypercholesterolemia more frequently).

 15.        Hemolytic uremic syndrome (D59.3), when due to autoantibody to factor H or due to complement factor mutatons.

 16.        Moderate to severe active rheumatoid arthritis (M05.00-M06.9) in adults with longstanding disease who have failed or are intolerant of disease-modifying anti-rheumatic drugs (DMARD’s).

 17.        Renal transplantation (Z94.0) from live donor with ABO incompatibility or positive cross-match, where a suitable non-reactive live or cadaveric donor is unavailable.

 18.        Acute, severe attack of relapsing remitting multiple sclerosis (G35) when ALL of the following criteria are met:

• Clinically definite or laboratory-supported definite MS
• No history of a progressive form of the disease
• Acute neurological deficit of major proportion, manifest by coma, aphasia, acute severe cognitive dysfunction, hemiplegia, or paraplegia
• No or minimal pre-attach neurological deficit in the affected area
• Failure of at least five days of treatment with high-dose corticosteroids

QualChoice considers therapeutic apheresis for white blood cells (Leukapheresis) medically necessary for acute debulking only in members with leukemia (C90.10-C90.12, C91.00-C95.92).

QualChoice considers therapeutic apheresis for red blood cells medically necessary for sickle cell disease (D57.00-D57.02, D57.211-D57.219, D57.411-D57.419, or D57.811-D57.819).

QualChoice considers therapeutic apheresis for platelets medically necessary for essential Thrombocythemia (D47.3) when platelet count is greater than 1,000,000.

Codes Used In This BI:

36511       Therapeutic apheresis; for white blood cells

36512       for red blood cells

36513       for platelets

36514       for Plasmapheresis

36515       with extracorporeal Immunoadsorption and plasma reinfusion

36516       with extracorporeal adsorption or filtration and plasma reinfusion          

QualChoice/QCA considers PP/PE experimental and investigational for all other indications, including the following conditions because the medical literature does not support the value of PP/PE for these indications:

1. Necrobiotic Xanogranulomatous skin disorder;
2. Amyotrophic lateral sclerosis;
3. Psoriasis;
4. Chronic fatigue syndrome;
5. Regional enteritis;
6. Acute pancreatitis related to hyperlipidemia;
7. Raynaud`s phenomenon;
8. Paraneoplastic syndromes including Eaton-Lambert syndrome and Paraproteinemic polyneuropathy;
9. Parkinson`s disease;
10. Lupus nephritis;
11. Hashimoto`s encephalopathy.

1. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda (MD): U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung and Blood Institute; 2001. Available at: http://www.nhlbi.nih.gov/guidelines/cholesterol/
   atp3_rpt.htm.
2. U.S. Food and Drug Administration, Center for Devices and Radiologic Health. H.E.L.P. (Heparin-induced Extracorporeal Lipoprotein Precipitation) System. Summary of Safety and Effectiveness Data. PMA No. P940016. Rockville, MD: CDER; September 17, 1997. Available at:  http://www.fda.gov/cdrh/pmasep97.html.
3. U.S. Food and Drug Administration, Center for Devices and Radiologic Health. Liposorber LA-15 System. Summary of Safety and Effectiveness Data. PMA No. P910018. Rockville, MD: CDER; February 21, 1996. Available at: http://www.fda.gov/cdrh/pmafeb96.html. 
4. Hughes RA, Wijdicks EFM , Barohn R, et al. Practice parameter: Immunotherapy for Guillain-Barré syndrome. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2003; 61(6):736-740. Available at:  http://www.neurology.org/cgi/content/abstract/61/6/736.
5. Medicare NCDs 100-3 located at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=110.14&ncd_version=1&show=all
6. Cortese I, Chaudhry V, et al.  Evidence-based guideline update:  Plasmapheresis in neurologic disorders.  Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology  Accessed 09/23/2013 at: http://www.neurology.org/content/76/3/294.full.pdf
7. Szczepiorkowski ZM, Winters JL, et al.  Guidelines on the use of therapeutic apheresis in clinical practice—evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis.  J Clin Apher 2010; 25(3):83-177.