Apheresis
Apheresis (also known as pheresis or therapeutic pheresis) is a medical procedure utilizing specialized equipment to remove selected blood constituents (plasma, leukocytes, platelets, or cells) from whole blood. The remainder is re-transfused into the person from whom the blood was taken.

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).

Extracorporeal immunoadsorption (ECI)
Extracorporeal immunoadsorption (ECI), using Protein A columns, selectively removes circulating immune complexes (CIC) and immunoglobulins (IgG) from patients in whom these substances are associated with their diseases. The technique involves pumping the patient's anticoagulated venous blood through a cell separator from which 1-3 liters of plasma are collected and perfused over adsorbent columns, after which the plasma rejoins the separated, unprocessed cells and is retransfused to the patient.

Apheresis (NCD 110.14)
Apheresis (36511-36514) is covered for the following indications:

1. Plasma exchange for acquired myasthenia gravis.
2. Leukapheresis in the treatment of leukemia.
3. Plasmapheresis in the treatment of primary macroglobulinemia (Waldenstrom).
4. Apheresis in the treatment of hyperglobulinemias, including (but not limited to) multiple myelomas, cryoglobulinemia, and hyperviscosity syndromes.
5. Plasmapheresis or plasma exchange as a last resort treatment of thrombotic thrombocytopenic purpura (TTP). 
6. Plasmapheresis or plasma exchange in the last resort treatment of life-threatening rheumatoid vasculitis.
7. Plasma perfusion of charcoal filters for treatment of pruritis of cholestatic liver disease. 
8. Plasma exchange in the treatment of Goodpasture’s Syndrome.
9. Plasma exchange in the treatment of glomerulonephritis associated with antiglomerular basement membrane antibodies and advancing renal failure or pulmonary hemorrhage. 
10. Apheresis in the treatment of chronic relapsing polyneuropathy for patients with severe or life-threatening symptoms who have failed to respond to conventional therapy. 
11. Apheresis in the treatment of life-threatening scleroderma and polymyositis, when the patient is unresponsive to conventional therapy. 
12. Treatment of Guillian-Barre Syndrome.
13. Systemic Lupus Erythematosus (SLE), life-threatening, as a treatment of last resort when conventional therapy has failed to prevent clinical deterioration.

Any service reported not meeting the above guidelines on this policy will be denied as not medically necessary. Effective January 26, 2009, a provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Extracorporeal Immunoadsorption (ECI) Using Protein A Columns (20.5)
Protein A column immunoadsorption apheresis (36515) is covered for the following indications:

1. Treatment of idiopathic thrombocytopenia purpura (ITP).
2. Treatment of rheumatoid arthritis (RA) for patients who meet the following criteria:
   • Patient has severe RA. Patient disease is active, having >5 swollen joints, >20 tender joints, and morning stiffness >60 minutes; or
   • Patient has failed an adequate course of a minimum of 3 Disease Modifying Anti-Rheumatic Drugs (DMARDs). Failure does not include intolerance.

Other uses of these columns are currently considered to be investigational and, therefore, not reasonable and necessary. A provider can bill the member for the denied service.

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 non-physician services are furnished under the direct, personal supervision of a physician.

Documentation Requirements

Documentation must support a history pertinent to the indications of this policy, the medical necessity of this treatment, and the frequency of treatment.

Documentation for apheresis services reported as provided in the inpatient or outpatient hospital setting must support that the reporting physician was intermittently monitoring the patient during the apheresis treatment, adjusting the apheresis concentrations as necessary, writing orders based on the patient’s condition as warranted, and was immediately available for an emergency or change in the patient’s condition throughout the entire procedure.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Apheresis/pheresis services are billed on a per visit basis. An Evaluation and Management (E&M) visit (99211-99215)(99231-99233) may be reported only if there is a separately identifiable E&M service performed which extends beyond the evaluation and management portion of a typical apheresis/pheresis service. If the provider is billing an E&M visit code in addition to the apheresis/pheresis service, it may be appropriate to use the modifier -25.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Online Manual Pub. 100-3, Chapter 1, Sections 20.5, 110.14

CMS Online Manual Pub. 100-4, Chapter 4, Section 231.9

The following conditions are eligible for codes 36511-36514:

The following conditions are eligible for code 36515: