(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   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.   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  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  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   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:   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   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.