evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
 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
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
B.  Hemoperfusion   This is a process which removes substances from the blood using a charcoal or resin artificial kidney.  When used in the treatment of life threatening drug overdose, hemoperfusion is a covered service for patients with or without renal failure.  Hemoperfus ion generally requires a physician to be present to initiate treatment and to be present in the hospital or an adjacent medical office during the entire procedure, as changes may be sudden.  Special staff training and equipment are required.   Develop charges for hemoperfusion in the same manner as for any new or unusual service. One or two treatments are usually all that is necessary to remove the toxic compound; document additional treatments.  Hemoperfusion may be performed concurrently with dialysis, and in those cases payment for the hemoperfusion reflects only the additional care rendered over and above the care given with dialysis.  The effects of using hemoperfusion to improve the results of chronic hemodialysis are not known.  Therefore, hemoperfusion is not a covered service when used to improve the results of hemodialysis.  In addition, it has not been demonstrated that the use of hemoperfusion in conjunction with deferoxamine (DFO), in treating symptomatic patients with iron overload, is efficacious.  There is also a paucity of data regarding its efficacy in treating asymptomatic patients with iron overload.  Therefore, hemoperfus ion used in conjunction with DFO in treating patients with iron overload is not a covered service; i.e., it is not considered reasonable and necessary within the meaning of 1862(a)(1) of the Act.   However, the use of hemoperfusion in conjunction with DFO for the treatment of patients with aluminum toxicity has been demonstrated to be clinically efficacious and is therefore regarded as a covered service.
(Medicare National Coverage Determinations Manual)
of the Act.   However, the use of hemoperfusion in conjunction with DFO for the treatment of patients with aluminum toxicity has been demonstrated to be clinically efficacious and is therefore regarded as a covered service.   C.  Hemofiltration  This is a process which removes fluid, electrolytes and other low molecular weight toxic substances from the blood by filtration through hollow artificial membranes and may be routinely performed in 3 weekly sessions.  Hemofiltration (which is also known as diafiltration) is a covered procedure under Medicare and is a safe and effective technique for the treatment of ESRD patients and an alternative to peritoneal dialysis and hemodialysis.  In contrast to both hemodialysis and peritoneal dialysis treatments which eliminate dissolved substances via diffusion across semipermeable membranes, hemofiltration mimics the filtration process of the normal kidney.  The technique requires an arteriovenous access.  Hemofiltration may be performed either in facility or a t home.  The procedure is most advantageous when applied to high-risk unstable patients, such as older patients with cardiovascular diseases or diabetes, because there are fewer side effects such as hypotension, hypertension or volume overload.  110.16 - Nonselective (Random) Transfusions and Living Related Donor Specific Transfusions (DST) in Kidney Transplantation  (Rev. 1, 10-03-03) CIM 35 -71
(Medicare National Coverage Determinations Manual)
Transplant surgeons have established a definite correlation in both cadaver and living-related kidney transplantation between pretransplant transfusions of blood into the recipient and the success of graft retention.  These pretransplant transfusions are covered under Medicare without a specific limitation on the number of transfusions, subject to the normal Medicare blood deductible provisions.  Where blood is given directly to the transplant patient; e.g., in the case of donor specific transfusions, the blood is considered replaced for purposes of the blood deductible provisions.  (See the Medicare General Information, Eligibility, and Entitlement Manual, Chapter 3, Deductibles, Coinsurance Amounts, and Payment Limitations, 20.5.4.)  110.17  Anti -Cancer Chemotherapy for Colorectal Cancer (Effective January 28, 2005)  (Rev. 173, Issued: 09-04- 14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Oxaliplatin (Eloxatin ), irinotecan (Camptosar), cetuximab (Erbitux), and bevacizumab (Avastin) are anti -cancer chemotherapeutic agents approved by the Food and Drug Administration (FDA) for the treatment of colorectal cancer.  Anti -cancer chemotherapeutic agents are eligible for coverage when used in accordance with FDA -approved labeling (see section 1861(t)(2)(B) of the Social Security Act (the Act)), when the off-label use is supported in one of the authoritative drug compendia listed in section 1861( t)(2)(B)(ii)(I) of the Act, or when the A/B MAC determines an off- label use is medically accepted based on guidance provided by the Secretary (section 1861(t)(2)(B)(ii)(II).  B. Nationally Covered Indications
(Medicare National Coverage Determinations Manual)
Pursuant to this national coverage determination (NCD), the off- label use of clinical items and services, including the use of the studied drugs oxaliplatin, irinotecan, cetuximab, or bevacizumab, are covered in specific clinical trials identified by the C enters for Medicare & Medicaid Services (CMS).  The clinical trials identified by CMS for coverage of clinical items and services are sponsored by the National Cancer Institute (NCI) and study the use of one or more off-label uses of these four drugs in colorectal cancer and in other cancer types.  The list of identified trials is on the CMS Web site at: http://www.cms.hhs.gov/coverage/download/id90b.pdf.  C. Other  This policy does not alter Medicare coverage for items and services that may be covered or non-covered according to the existing national coverage policy for Routine Costs in a Clinical Trial (NCD Manual section 310.1).  Routine costs will continue to be c overed as well as other items and services provided as a result of coverage of these specific trials in this policy.  The basic requirements for enrollment in a trial remain unchanged.  The existing requirements for coverage of oxaliplatin, irinotecan, cetuximab,  bevacizumab, or other anticancer chemotherapeutic agents for FDA -approved indications or for indications listed in an approved compendium are not modified.  A/B MACs shall continue to make reasonable and necessary coverage determinations under section 1861(t)(2)(B)(ii)(II) of the Act based on guidance provided by the Secretary for medically accepted uses of off-label indications of oxaliplatin, irinotecan, cetuximab, bevacizumab, or other anticancer chemotherapeutic agents provided outside of the identified clinical trials appearing on the CMS website noted above.  110.18 - Aprepitant for Chemotherapy -Induced Emesis  A. General
(Medicare National Coverage Determinations Manual)
Chemotherapy-induced nausea and vomiting (CINV) can range from mild to severe, with the most severe cases resulting in dehydration, malnutrition, metabolic imbalances, and potential withdrawal from future chemotherapy treatments.  The incidence and severit y of CINV are influenced by the specific chemotherapeutic agent(s) used; dosage, schedule and route of administration; and drug combinations. Patient specific risk factors such as gender, age, history of motion sickness, and prior `exposure to chemotherapeutic agents can also have an effect on CINV incidence and severity.  Progress has been made in reducing CINV, although it can still be hard to control symptoms that occur more than a day after chemotherapy, during repeat cycles of chemotherapy, and when chemotherapy is given on more than one day or in very high doses. No single antiemetic agent is completely effective in all patients. As noted above, many factors influence the incidence and severity of CINV, with the specific chemotherapeutic agent as the primary factor to consider when deciding which antiemetic to administer.  Aprepitant (Emend) is the first Food and Drug Administration-approved drug of its type. Aprepitant has been proposed to function in combination with other oral antiemetics for a spec ified population of Medicare patients receiving highly emetogenic chemotherapy and/or moderately emetogenic chemotherapy.  CMS is defining highly emetogenic chemotherapy and moderately emetogenic chemotherapy as those anticancer agents so designated in at least two of three guidelines published by the National Comprehensive Cancer Network (NCCN), American Society of Clinical O ncology (ASCO), and European Society of Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC).  The inclusive examples are: NCCN plus ASCO, NCCN plus ESMO/MASCC, or ASCO plus ESMO/MASCC.   B. Nationally Covered Indications   Effective for services performed between April 4, 2005, and May 28, 2013, the Centers for Medicare & Medicaid Services makes the following determinations regarding the use of aprepitant in the treatment of reducing chemotherapy -induced emesis:
(Medicare National Coverage Determinations Manual)
Effective for services performed between April 4, 2005, and May 28, 2013, the Centers for Medicare & Medicaid Services makes the following determinations regarding the use of aprepitant in the treatment of reducing chemotherapy -induced emesis:   The evidence is adequate to conclude that the use of the oral antiemetic three- drug combination of oral aprepitant (Emend), an oral 5HT3 antagonist, and oral dexamethasone is reasonable and necessary for a specified patient population.  CMS has defined the patient population for which the use of the oral antiemetic three -drug combination of oral aprepitant (Emend), an oral 5HT3 antagonist, and oral dexamethasone is reasonable and necessary as only those patients who are receiving one or more of the follow ing anti -cancer chemotherapeutic agents:    Carmustine   Cisplatin   Cyclophosphamide   Dacarbazine   Mechlorethamine   Streptozocin   Doxorubicin   Epirubicin  Lomustine   Effective for services performed on or after May 29, 2013, the oral three -drug regimen of oral aprepitant, an oral 5HT 3 antagonist and oral dexamethasone is reasonable and necessary for beneficiaries receiving, either singularly or in combination with other drugs the following anticancer chemotherapeutic agents:    Alemtuzumab   Azacitidine   Bendamustine   Carboplatin  Carmustine   Cisplatin   Clofarabine   Cyclophosphamide   Cytarabine   Dacarbazine   Daunorubicin   Doxorubicin   Epirubicin  Idarubicin   Ifosfamide   Irinotecan   Lomustine   Mechlorethamine   Oxaliplatin   Streptozocin   The oral three drug regimen must be administered immediately before and within 48 hours after the administration of these chemotherapeutic agents.   C. Nationally Noncovered Indications
(Medicare National Coverage Determinations Manual)
C. Nationally Noncovered Indications   The evidence is adequate to conclude that aprepitant cannot function alone as a full replacement for intravenously administered antiemetic agents for patients who are receiving highly emetogenic chemotherapy and/or moderately emetogenic chemotherapy.  Medi care does not cover under Part B for oral antiemetic drugs in antiemetic drug combination regimens that are administered in part, via an oral route and in part, via an intravenous route.  Medicare does not cover under Part B aprepitant when it is used alone for anticancer chemotherapy related nausea and vomiting.   D. Other   A/B MACs may determine coverage for other all -oral three -drug antiemesis regimens of aprepitant or any other FDA approved oral NK -1 antagonist in combination with an oral 5HT3 antagonist and oral dexamethasone with the chemotherapeutic agents listed above, or any other anticancer chemotherapeutic agents that are FDA approved and are defined as highly or moderately emetogenic.   (Last reviewed May 2013.)   110.19  Abarelix for the Treatment of Prostate Cancer (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective January 1, 2021, the Centers for Medicare & Medicaid Services determined that no national coverage determination  (NCD)  is appropriate  at this time for Abarelix  for the Treatment  of Prostate  Cancer. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act.   110.20 - Blood Brain Barrier Osmotic Disruption for Treatment of Brain Tumors (Effective March 20, 2007)  (Rev. 67, Issued:  04- 06-07; Effective Date:  03 -20-07; Implementation Date:  05 -07-07)  A. General   The blood brain barrier (BBB) of the central nervous system is characterized by tight junctions between vascular endothelial cells, which prevent or impede various naturally occurring and synthetic substances (including anti -cancer drugs) from entering bra in tissue.  The BBB may be partly responsible for the poor efficacy of chemotherapy for malignant primary or metastatic brain tumors.
(Medicare National Coverage Determinations Manual)
The BBBD is the disruption of the tight junctions between the endothelial cells that line the capillaries in the brain accomplished by osmotic disruption, bradykinin or irradiation.  Theoretically, disruption of the BBB may, in the treatment of brain tumor s, increase the concentration of chemotherapy drugs delivered to the tumor and may prolong the drug- tumor contact time.   Osmotic disruption of the BBB is the most common technique used.  Chemotherapeutic agents are given in conjunction with barrier disruption.  The BBBD process includes all items and services necessary to perform the procedure, including hospitalization, monitoring, and repeated imaging procedures.   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   Effective for services performed on and after March 20, 2007, the Centers for Medicare & Medicaid Services determines that the use of osmotic BBBD is not reasonable and necessary when it is used as part of a treatment regimen for brain tumors.   D. Other  This NCD does not alter in any manner the coverage of anti- cancer chemotherapy.   (This NCD last reviewed March 2007.)  110.21  - Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions  (Rev. 173, Issued: 09-04- 14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Erythropoiesis stimulating agents (ESAs) stimulate the bone marrow to make more red blood cells and are United States Food and Drug Administration (FDA) approved for use in reducing the need for blood transfusion in patients with specific clinical indications.  The FDA has issued alerts and warnings for ESAs administered for a number of clinical conditions, including cancer.  Published studies report a higher risk of serious and life-threatening events associated with oncologic uses of ESAs.  B. Nationally Covered Indications  ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia is only reasonable and necessary under the following specified conditions:   The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is <10 g/dL (or the hematocrit is <30%).
(Medicare National Coverage Determinations Manual)
 The starting dose for ESA treatment is the recommended FDA label starting dose, no more than 150 U/kg/3 times weekly for epoetin and 2.25 mcg/kg/1 time weekly for darbepoetin alpha. Equivalent doses may be given over other approved time periods.   Maintenance of ESA therapy is the starting dose if the hemoglobin level remains below 10g/dL (or hematocrit is <30%) 4 weeks after initiation of therapy and the rise in hemoglobin is >1g/dL (hematocrit >3%);    For patients whose hemoglobin rises <1g/dl (hematocrit rise <3%) compared to pretreatment baseline over 4 weeks of treatment and whose hemoglobin level remains <10g/dL after the 4 weeks of treatment (or the hematocrit is <30%), the recommended FDA label st arting dose may be increased once by 25%. Continued use of the drug is not reasonable and necessary if the hemoglobin rises <1g/dl (hematocrit rise <3%) compared to pretreatment baseline by 8 weeks of treatment.   Continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin >1g/dl (hematocrit >3%) over 2 weeks of treatment unless the hemoglobin remains below or subsequently falls to <10g/dL (or the hematocrit is <30%). Continuation and reinstitution of ESA therapy must include a dose reduction of 25% from the previously administered dose.   ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.  C. Nationally Non -Covered Indications   ESA treatment is not reasonable and necessary for beneficiaries with certain clinical conditions, either because of a deleterious effect of the ESA on their underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use. These conditions include:    Any anemia in cancer or cancer treatment patients due to folate deficiency, B -12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis;
(Medicare National Coverage Determinations Manual)
 Any anemia in cancer or cancer treatment patients due to folate deficiency, B -12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis;    The anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML), or erythroid cancers;    The anemia of cancer not related to cancer treatment;    Any anemia associated only with radiotherapy;    Prophylactic use to prevent chemotherapy -induced anemia;    Prophylactic use to reduce tumor hypoxia;    Patients with erythropoietin -type resistance due to neutralizing antibodies; and    Anemia due to cancer treatment if patients have uncontrolled hypertension.   D. Other  Local A/B MACs may continue to make reasonable and necessary determinations on all other uses of ESAs not specified in this National Coverage Determination.   See the Medicare Benefit Policy Manual, chapter 11, section 90 and chapter 15, section 50.5.2 for coverage of ESAs for end -stage renal disease- related anemia.   110.22 - Autologous Cellular Immunotherapy Treatment (Effective June 30, 2011)  (Rev. 140, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11)  A. General   Prostate cancer is the most common non- cutaneous cancer in men in the United States.  In 2009, an estimated 192,280 new cases of prostate cancer were diagnosed and an estimated 27,360 deaths were reported.  The National Cancer Institute states that prostat e cancer is predominantly a cancer of older men; the median age at diagnosis is 72 years.  Once the patient has castration -resistant, metastatic prostate cancer the median survival is generally less than two years.  In 2010 the Food and Drug Administration (FDA) approved sipuleucel -T (PROVENGE; APC8015), for patients with castration -resistant, metastatic prostate cancer.  The posited mechanism of action, immunotherapy, is different from that of anti -cancer chemotherapy such as docetaxel.  This is the first immunotherapy for prostate cancer to receive FDA approval.