(Medicare Benefit Policy Manual)

The statute provides that EPO is covered for the treatment of anemia for patients with chronic renal failure who are on dialysis.  Coverage is available regardless of whether the drug is administered by the patient or the patients caregiver.  EPO is a bio logically engineered protein which stimulates the bone marrow to make new red blood cells.  NOTE:   Non -ESRD patients who are receiving EPO to treat anemia induced by other conditions such as chemotherapy or the drug zidovudine (commonly called AZT) must meet the coverage requirements in 50 .  EPO is covered for the treatment of anemia for patients with chronic renal failure who are on dialysis when:   It is administered in the renal dialysis facility; or    It is self -administered in the home by any dialysis patient (or patient caregiver) who is determined competent to use the drug and meets the other conditions detailed below.  NOTE:   Payment may not be made for EPO under the incident to provision when EPO is administered in the renal dialysis facility.   Also, in the office setting, reimbursement will be made for the administration charge only for non- ESRD patients receiving EPO.  50.5.2.1 - Requirements for Medicare Coverage for EPO  (Rev. 1, 10-01-03) B3-2049.5  Medicare covers EPO and items related to its administration for dialysis patients who use EPO in the home when the following conditions are met:  A.  Patient Care Plan  A dialysis patient who uses EPO in the home must have a current care plan (a copy of which must be maintained by the designated backup facility for Method II patients) for monitoring home use of EPO that includes the following:  1. Review of diet and fluid intake for aberrations as indicated by hyperkalemia and elevated blood pressure secondary to volume overload;  2. Review of medications to ensure adequate provision of supplemental iron;  3. Ongoing evaluations of hematocrit and iron stores;  4. Reevaluation of the dialysis prescription taking into account the patients increased appetite and red blood cell volume;  5. Method for physician and facility (including backup facility for Method II patients) follow-up on blood tests and a mechanism (such as a patient log) for keeping the physician informed of the results;  6. Training of the patient to identify the signs and symptoms of hypotension and hypertension; and  7. The decrease or discontinuance of EPO if hypertension is uncontrollable.  B.  Patient Selection   The dialysis facility, or the physician responsible for all dialysis- related services furnished to the patient, must make a comprehensive assessment that includes the following:  1. Preselection Monitoring   The patients hematocrit (or hemoglobin), serum iron, transferrin saturation, serum ferritin, and blood pressure must be measured.  2 Conditions the Patient Must Meet   The assessment must find that the patient meets the following conditions:  a. Is a dialysis patient;  b. Has a hematocrit (or comparable hemoglobin level) that is as follows:   For a patient who is initiating EPO treatment, no higher than 30 percent unless there is medical documentation showing the need for EPO despite a hematocrit (or comparable hemoglobin level) higher than 30 percent.  Patients with severe angina, severe pulmonary distress, or severe hypotension may require EPO to prevent adverse symptoms even if they have higher hematocrit or hemoglobin level s.   For a patient who has been receiving EPO from the facility or the physician, between 30 and 36 percent.   c. Is under the care of:    A physician who is responsible for all dialysis -related services and who prescribes the EPO and follows the drug labeling instructions when monitoring the EPO home therapy; and    A renal dialysis facility that establishes the plan of care and monitors the progress of the home EPO therapy.   3. The assessment must find that the patient or a caregiver meets the following conditions:    Is trained by the facility to inject EPO and is capable of carrying out the procedure;    Is capable of reading and understanding the drug labeling; and    Is trained in, and capable of observing, aseptic techniques.  4. Care and Storage of Drug  The assessment must find that EPO can be stored in the patients residence under refrigeration and that the patient is aware of the potential hazard of a childs having access to the drug and syringes.   C.  Responsibilities of Physician or Dialysis Facility   The patients physician or dialysis facility must:    Develop a protocol that follows the drug label instructions;    Make the protocol available to the patient to ensure safe and effective home use of EPO;    Through the amounts prescribed, ensure that the drug on hand at any time does not exceed a 2- month supply;    Maintain adequate records to allow quality assurance for review by the Network and State Survey Agencies. For Method II patients, current records must be provided to and maintained by the designated backup facility; and   The dialysis facility must submit claims for EPO, if the facility provides it.   See the Medicare Claims Processing Manual, Chapter 11, End Stage Renal Disease, for instructions for billing and processing claims for EPO under Method 1 and Method 2.  Note that hematocrit readings are required on claims.  It is expected that the ESRD f acility or hospital outpatient department will maintain the following information in each patients medical record to permit the review of the medical necessity of EPO.   1. Diagnostic coding;  2. Most recent creatinine prior to initiation of EPO therapy;  3. Date of most recent creatinine prior to initiation of EPO therapy;  4. Most recent hematocrit (HCT) prior to initiation of EPO therapy;  5. Date of most recent hematocrit (HCT) prior to initiation of EPO therapy;  6. Dosage in units/kg;  7. Weight in kgs; and 8. Number of units administered.   50.5.2.2 - Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use  (Rev. 1, 10- 01-03) PM-AB-99-59, Dated 8/1/99  This instruction pertains exclusively to the preoperative surgical indication of the drug Procrit, in which it is administered to specific patients prior to surgery to reduce risk of transfusion.  It does not affect Medicare policies related to other Food and Drug Administration (FDA) approved uses of Procrit.  It is not a national coverage decision .  Procrit as Preventive Service   The A/B MAC (B) may determine that Procrit is covered for individuals who:   1. Are undergoing hip or knee surgery   2. Have an anemia with a hemoglobin between 10 and 13 mg/dL;   3. Are not a candidate for autologous blood transfusion;   4. Are expected to lose more than 2 units of blood; and  5. Have had a workup so that their anemia appears to be that of chronic disease.  The preoperative use of Procrit may be afforded to these individuals when A/B MACs (B), exercising their discretion, determine that this treatment is reasonable and necessary.  In other cases, Procrit is considered a preventive service and therefore not covered.   50.5.3 - Oral Anti -Cancer Drugs  (Rev. 1, 10- 01-03) A3-3112.4.B.5, HO -230.4.B.5  Effective January 1, 1994, Medicare Part B coverage is extended to include oral anti -cancer drugs that are prescribed as anti -cancer chemotherapeutic agents providing they have the same active ingredients and are used for the same indications as anti -cancer chemotherapeutic agents which would be covered if they were not self -administered and they were furnished incident to a physicians service as drugs and biologicals.  For an oral anti -cancer drug to be covered under Part B, it must:    Be prescribed by a physician or other practitioner licensed under State law to prescribe such drugs as anti-cancer chemotherapeutic agents;    Be a drug or biological that has been approved by the Food and Drug Administration (FDA);    Have the same active ingredients as a non -self-administrable anti- cancer chemotherapeutic drug or biological that is covered when furnished incident to a physicians service.  The oral anti -cancer drug and the non- self-administrable drug must have the same  chemical/generic name as indicated by the FDAs Approved Drug Products (Orange Book), Physicians Desk Reference (PDR), or an authoritative drug compendium;    Be used for the same indications, including unlabeled uses, as the non- self-administrable version of the drug; and    Be reasonable and necessary for the individual patient.  50.5.4 - Oral Anti -Nausea (Anti-Emetic) Drugs  (Rev. 185, Issued: 04- 15-14, Effective: 05 -29-13, Implementation: 07- 07-14)  Effective January 1, 1998, Medicare also covers self -administered anti- emetics, which are necessary for the administration and absorption of the anti -neoplastic chemotherapeutic agents when a high likelihood of vomiting exists.  The anti -emetic drug is cov ered as a necessary means for administration of the anti -neoplastic chemotherapeutic agents.  Oral drugs prescribed for use with the primary drug, which enhance the anti-neoplastic effect of the primary drug or permit the patient to tolerate the primary an ti-neoplastic drug in higher doses for longer periods, are not covered.  Self -administered anti- emetics to reduce the side effects of nausea and vomiting brought on by the primary drug are not included beyond the administration necessary to achieve drug absorption.  Section 1861(s)(2) of the Social Security Act extends coverage to oral anti -emetic drugs that are used as full replacement for intravenous dosage forms of a cancer regimen under the following conditions:    Coverage is provided only for oral drugs approved by the Food and Drug Administration (FDA) for use as anti -emetics;    The oral anti -emetic must either be administered by the treating physician or in accordance with a written order from the physician as part of a cancer chemotherapy regimen;    Oral anti -emetic drugs administered with a particular chemotherapy treatment must be initiated within 2 hours of the administration of the chemotherapeutic agent and may be continued for a period not to exceed 48 hours from that time;    The oral anti -emetic drugs provided must be used as a full therapeutic replacement for the intravenous anti -emetic drugs that would have otherwise been administered at the time of the chemotherapy treatment.   Only drugs pursuant to a physicians order at the time of the chemotherapy treatment qualify for this benefit.  The dispensed number of dosage units may not exceed a loading dose administered within two hours of the treatment, plus a supply of additional dosage units not to exceed 48 hours of therapy.   Oral drugs that are not approved by the FDA for use as anti -emetics and which are used by treating physicians adjunctively in a manner incidental to cancer chemotherapy are not covered by this benefit and are not reimbursable within the scope of this benef it.  It is recognized that a limited number of patients will fail on oral anti- emetic drugs. Intravenous anti -emetics may be covered (subject to the rules of medical necessity) when furnished to patients who fail on oral anti-emetic therapy.   More than one oral anti emetic drug may be prescribed and may be covered for concurrent use if needed to fully replace the intravenous drugs that otherwise would be given.  See the Medicare National Coverage Determinations Manual, Publication 100-03, Chapter 1, Section 110.18, for detailed coverage criteria.  50.5.5 - Hemophilia Clotting Factors  (Rev. 1, 10-01-03) A3-3112.4.B.2, HO-230.4.B.2  Section 1861(s)(2)(I) of the Act provides Medicare coverage of blood clotting factors for hemophilia patients competent to use such factors to control bleeding without medical supervision, and items related to the administration of such factors.  Hemophilia, a blood disorder characterized by prolonged coagulation time, is caused by deficiency of a factor in plasma necessary for blood to clot.  For purposes of Medicare Part B coverage, hemophilia encompasses the following conditions:   Factor VIII deficiency (classic hemophilia);    Factor IX deficiency (also termed plasma thromboplastin component (PTC) or Christmas factor deficiency); and    Von Willebrands disease.