Oct-Nov 00 Part A Bulletin - Medicare

LOCAL AND FOCUSED MEDICAL REVIEW POLICIES
Q0136: Non-ESRD Epoetin (Procrit)
Policy Number
Q0136
Contractor Name
First Coast Service Options, Inc.
Contractor Number
090
Contractor Type
Intermediary
LMRP Title
Non-ESRD Epoetin (Procrit)
AMA CPT Copyright Statement
CPT codes, descriptions, and other data only are
copyright 1998 American Medical Association (or such
other date of publication of CPT). All Rights Reserved.
Applicable FARS/DFARS Apply.
HCFA National Coverage Policy
Program transmittal AB-99-59
Hospital Manual – Sections 230.B4, E205C
Intermediary Manual – Section 3168D, 3922
Primary Geographic Jurisdiction
Florida
Secondary Geographic Jurisdiction
N/A
HCFA Region
Region IV
HCFA Consortium
Southern
Policy Effective Date
11/15/2000
Revision Effective Date
N/A
Revision Ending Effective Date
N/A
Policy Ending Date
N/A
LMRP Description
Erythropoietin is a glycoprotein which stimulates red
blood cell production. It is produced in the kidneys and
stimulates the division and differentiation of committed
erythroid progenitors in the bone marrow.
Indications and Limitations of Coverage
and/or Medical Necessity
Florida Medicare considers Epogen [EPO] to be medically
necessary for the treatment of certain conditions including:
(1) Anemia induced by the drug Zidovudine (AZT)
- EPO is indicated in HIV infected patients to elevate
or maintain the red blood cell level as manifested by
an increase in the hemoglobin and/or hematocrit and
to decrease the need for transfusions.
- EPO therapy is indicated for the patients with
endogenous serum erythropoietin levels ≤ 500m units/ml
and are receiving a dose of AZT ≤ 4200 mg/wk.
- The initial recommended starting dose is 100 u/kg as
an IV or SC injection 3 times weekly for 8 weeks. If
after 8 weeks of therapy, the patient’s hematocrit has
not increased or transfusion requirements have not
decreased, then the dose of EPO can be increased by
50 to 100 u/kg 3 times weekly. If patients have not
responded satisfactorily to a 300 u/kg dose 3 times
weekly, it is unlikely that the patient will respond to
higher doses, and therefore, the EPO should be
discontinued.
- The maintenance dose is titrated to maintain the
response based on factors such as zidovudine dose
and presence of intercurrent infectious or
inflammatory episodes.
- If the hematocrit exceeds 40%, the EPO should be
stopped until the hematocrit drops to 36%. When
resuming treatment, the EPO dose should be reduced
by 25%, then titrate to maintain desired hematocrit.
*EPO is not indicated for patients with an endogenous
serum erythropoietin level of >500 mu/ml or treatment of
anemia in HIV-infected patients due to factors such as iron or
folate deficiencies, hemolysis or gastrointestinal bleeding.
(2) Anemia in cancer patients receiving chemotherapy for
nonmyeloid malignancies
- The use of EPO has been shown to be effective in
treatment of anemia in patients with malignancies
where anemia is due to the effect of concomitantly
administered chemotherapy. EPO should be
discontinued when the patient is no longer receiving
chemotherapy.
- EPO is indicated to decrease the need for transfusions
in patients who will be receiving concomitant
chemotherapy for a minimum of two months.
- EPO is indicated for patients who had chemotherapy
for a non-myeloid malignancy within the past year
and presents post-chemo with anemia (i.e.,
permanent damage resulting from chemo).
Documentation should support that the anemia was a
result of a chemotherapy agent.
- EPO therapy is indicated for patients with a serum
erythropoietin level of ≤ 500 mu/ml.
- The recommended starting dose is 150 units/kg 3
times weekly. If after 8 weeks the patient is not
responding (increase HGB & HCT or decrease
transfusion requirements), the dose may be increased
up to 300 u/kg 3 times weekly. If patient has not
responded satisfactorily to a 300 u/kg dose 3 times
weekly, (defined as increase in HGB by 2g or
decrease in transfusion requirements), it is unlikely
that the patient will respond to higher doses. If the
hematocrit exceeds 40%, the EPO should be stopped
until the hematocrit drops to 36%. When resuming
treatment, the EPO dose should be reduced by 25%,
then titrate to maintain desired hematocrit.
(3) Anemia associated with myelodysplastic syndrome (MDS)
- EPO therapy is indicated for patients with a serum
erythropoietin level below 500 mu/ml.
- Same dosage as cancer patients on chemotherapy.
- The patient presents with variable clinical features
depending on the MDS classification and the degree
of disordered hematopoiesis with anemia. Common
50 The Florida Medicare A Bulletin
October/November 2000