(Medicare National Coverage Determinations Manual)

110.7 - Blood Transfusions  (Rev. 1, 10- 03-03) CIM 45 -27  Blood transfusions are used to restore blood volume after hemorrhage, to improve the oxygen carrying capacity of blood in severe anemia, and to combat shock in acute hemolytic anemia.   A.  Definitions   1. Homologous Blood Transfusion  Homologous blood transfusion is the infusion of blood or blood components that have been collected from the general public.  2. Autologous Blood Transfusion  An autologous blood transfusion is the precollection and subsequent infusion of a patients own blood.  3. Donor Directed Blood Transfusion  A donor directed blood transfusion is the infusion of blood or blood components that have been precollected from a specific individual(s) other than the patient and subsequently infused into the specific patient for whom the blood is designated.  For example, patient Bs brother predeposits his blood for use by patient B during upcoming surgery.  4.  Perioperative Blood Salvage   Perioperative blood salvage is the collection and reinfusion of blood lost during and immediately after surgery.   B.  Policy Governing Transfusions   For Medicare coverage purposes, it is important to distinguish between a transfusion itself and preoperative blood services; e.g., collection, processing, storage.  Medically necessary transfusion of blood, regardless of the type, may generally be a covered service under both Part A and Part B of Medicare.  Coverage does not make a distinction between the transfusion of homologous, autologous, or donor-directed blood. With respect to the coverage of the services associated with the preoperative collection, processing, and storage of autologous and donor-directed blood, the following policies apply.  1. Hospital Part A and B Coverage and Payment  Under 1862(a)(14) of the Act, nonphysician services furnished to hospital patients are covered and paid for as hospital services.  As provided in 1886  of the Act, under the prospective payment system (PPS), the diagnosis related group (DRG) payment to the hospital includes all covered blood and blood processing expenses, whether or not the blood is eventually used.  In a situation where the hospital operates its own blood collection activities, rather than using an independent blood supplier, the costs incurred to collect autologous or donor-directed blood are recorded in the whole blood and packed red blood cells cos t center.  Because the blood has been replaced, Medicare does not recognize a charge for the blood itself.  Under PPS, the DRG payment is intended to pay for all covered blood and blood services, whether or not the blood is eventually used.  Under its provider agreement, a hospital is required to furnish or arrange for all covered services furnished to hospital patients.  Medicare payment is made to the hospital, under PPS or cost reimbursement, for covered inpatient and outpatient services, and it is intended to reflect payment for all costs of furnishing those services.   2.  Nonhospital Part B Coverage  Under Part B, to be eligible for separate coverage, a service must fit the definition of one of the services authorized by 1832 of the Act. These services are defined in 42 CFR  410.10 and do not include a separate category for a suppliers services associated with blood donation services, either autologous or donor-directed. That is, the collection, processing, and storage of blood for later transfusion into the beneficiary is not reco gnized as a separate service under Part B.  Therefore, there is no avenue through which a blood supplier can receive direct payment under Part B for blood donation services.  C.  Perioperative Blood Salvage  When the perioperative blood salvage process is used in surgery on a hospital patient, payment made to the hospital (under PPS or through cost reimbursement) for the procedure in which that process is used is intended to encompass payment for all costs relating to that process.  110.8 - Blood Platelet Transfusions  (Rev. 1, 10-03-03) CIM 35 -30  Blood platelet transplants are safe and effective for the correction of thrombocytopenia and other blood defects.  It is covered under Medicare when treatment is reasonable and necessary for the individual patient.   110.8.1 Stem Cell Transplantation (RETIRED)  (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04-10-23)    Effective January 27, 2016 NCD 110.8.1 is retired and incorporated into NCD 110.23.  110.9 - Antigens Prepared for Sublingual Administration  (Rev. 1, 10-03-03) CIM 45 -28  For antigens provided to patients on or after November 17, 1996, Medicare does not cover such antigens if they are to be administered sublingually, i.e., by placing drops under the patients tongue.  This kind of allergy therapy has not been proven to be safe and effective.  Antigens are covered only if they are administered by injection.  110.10 - Intravenous Iron Therapy  (Rev. 1, 10-03-03) CIM 45 -29  Iron deficiency is a common condition in end stage renal disease (ESRD) patients undergoing hemodialysis.  Iron is a critical structural component of hemoglobin, a key protein found in normal red blood cells (RBCs) that transports oxygen.  Without this important building block, anemic patients experience difficulty in restoring adequate, healthy RBCs that improve hematocrit levels.  Clinical management of iron deficiency involves treating patients with iron replacement products while they undergo hemodialysis.  Body iron stores can be supplemented with either oral or intravenous (IV) iron products.  The available evidence suggests that the mode of intravenous administration is perhaps the most effective treatment for iron deficiency in hemodialysis patients.  Unlike oral iron products which must be absorbed through the GI tract, IV iron products are infused directly into the bloodstream in a form that is readily available to the bone marrow for RBC synthesis, resulting in an earlier correction of iron deficie ncy and anemia.   Effective December 1, 2000, Medicare covers sodium ferric gluconate complex in sucrose injection as a first line treatment of iron deficiency anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.  Effective October 1, 2001, Medicare also covers iron sucrose injection as a first line treatment of iron deficiency anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.  110.11 - Food Allergy Testing and Treatment  (Rev. 1, 10-03-03) CIM 50 -53  Not Covered  Effective October 31, 1988, sublingual intracutaneous and subcutaneous provocative and neutralization testing and neutralization therapy for food allergies are excluded from Medicare coverage because available evidence does not show that these tests and therapies are effective.  This exclusion was published as a Final Notice in the Federal Register on September 29, 1988.  110.12 - Challenge Ingestion Food Testing  (Rev. 1, 10-03-03) CIM 50 -22  Challenge ingestion food testing is a safe and effective technique in the diagnosis of food allergies.  This procedure is covered when it is used on an outpatient basis if it is reasonable and necessary for the individual patient.  Challenge ingestion food testing has not been proven to be effective in the diagnosis of rheumatoid arthritis, depression, or respiratory disorders.  Accordingly, its use in the diagnosis of these conditions is not reasonable and necessary within the meani ng of 1862(a)(1) of the Act, and no program payment is made for this procedure when it is so used.  110.13 - Cytotoxic Food Tests  (Rev. 1, 10-03-03) CIM 50 -2  Not Covered   Prior to August 5, 1985, Medicare covered cytotoxic food tests as an adjunct to in vivo clinical allergy tests in complex food allergy problems.  Effective August 5, 1985, cytotoxic leukocyte tests for food allergies are excluded from Medicare coverage because available evidence does not show that these tests are safe and effective.  This exclusion was published as a CMS Ruling in the Federal Register on July 5, 1985.    110.14 - Apheresis (Therapeutic Pheresis)  (Rev. 1, 10- 03-03) 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 per son 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 dona tes 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 Goodpastures 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.   110.15 - Ultrafiltration, Hemoperfusion and Hemofiltration  (Rev. 1, 10- 03-03) CIM 35 -38  A.  Ultrafiltration   This is a process for removing excess fluid from the blood through the dialysis membrane by means of pressure.  It is not a substitute for dialysis.  Ultrafiltration is utilized in cases where excess fluid cannot be removed easily during the regular course  of hemodialysis.  When it is performed, it is commonly done during the first hour or two of each hemodialysis on patients who, e.g., have refractory edema.  Ultrafiltration is a covered procedure under the Medicare program (effective for services performe d on and after September 1, 1979)   Predialysis Ultrafiltration   While this procedure requires additional staff care, the facility dialysis rate is intended to cover the full range of complicated and uncomplicated nonacute dialysis treatments.  Therefore, no additional facility charge is recognized for predialysis ultra filtration.  The physicians role in ultrafiltration varies with the stability of the patients condition.  In unstable patients, the physician may need to be present at the initiation of dialysis, and available either in -house or in close proximity to monitor the patient carefully.  In patients who are relatively stable, but who seem to accumulate excessive weight gain, the procedure requires only a modest increase in physician involvement over routine outpatient hemodialysis.  Occasionally, medical complications may occur which require that ultrafiltration be performed separate from the dialysis treatment, and in these cases an additional charge can be recognized.  However, the claim must be documented as to why the ultrafiltrat ion could not have been performed at the same time as the dialysis.   B.  Hemoperfusion