CMS Pub. 100-03, ch. 1, § 110.14

CIM 35-60

A. General

Apheresis (also known as pheresis or therapeutic pheresis) is a medical procedure utilizing specialized

equipment to remove selected blood constituents (plasma, leukocytes, plataelets, or cells) from whole blood.

The remainder is retransfused into the person from whom the blood was taken.

For purposes of Medicare coverage, apheresis is defined as an autologous procedure, i.e., blood is taken

from the patient, processed, and returned to the patient as part of a continuous procedure (as distinguished

from the procedure in which a patient donates blood preoperatively and is transfused with the donated blood

at a later date).

B. Indications

Apheresis is covered for the following indications:

• Plasma exchange for acquired myasthenia gravis;

• Leukaphersis in the treatment of leukemia;

• Plasmapheresis in the treatment of primary macroglobulinemia (Waldenstrom);

• Treatment of hyperglobulinemias, including (but not limited to) multiple myelomas,

cryoglobulinemia and hyperviscosity syndromes;

• Plasmapheresis or plasma exchange as a last resort treatment of thromobotic thrombocytopenic

purpura (TTP);

• Plasmapheresis or plasma exchange in the last resort treatment of life threatening rheumatoid

vasculitis;

• Plasma perfusion of charcoal filters for treatment of pruritis of cholestatic liver disease;

• Plasma exchange in the treatment of Goodpasture’s Syndrome;

• Plasma exchange in the treatment of glomerulonephritis associated with antiglomerular basement

membrane antibodies and advancing renal failure or pulmonary hemorrhage;

• Treatment of chronic relapsing polyneuropathy for patients with severe or life threatening symptoms

who have failed to respond to conventional therapy;

• Treatment of life threatening scleroderma and polymyositis when the patient is unresponsive to

conventional therapy;

• Treatment of Guillain-Barre Syndrome; and

• Treatment of last resort for life threatening systemic lupus erythematosus (SLE) when conventional

therapy has failed to prevent clinical deterioration.

C. Settings

Apheresis is covered only when performed in a hospital setting (either inpatient or outpatient); or in a

nonhospital setting, e.g., a physician directed clinic when the following conditions are met:

• A physician (or a number of physicians) is present to perform medical services and to respond to

medical emergencies at all times during patient care hours;

• Each patient is under the care of a physician; and

• All nonphysician services are furnished under the direct, personal supervision of a physician.