|
CPT codes,
descriptions and other data only are copyright 2007 American Medical
Association (or such other date of publication of CPT). All Rights
Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology,
(CDT) (including procedure codes, nomenclature, descriptors and other data
contained therein) is copyright by the American Dental Association. © 2002,
2004 American Dental Association. All rights reserved. Applicable
FARS/DFARS apply.
|
|
Title XVIII of the
Social Security Act, Section 1862(a)(1)(A). This
section excludes coverage for items or services that are not reasonable and
necessary for the diagnosis or treatment of illness or injury or to improve
the functioning of a malformed body member.
Title XVIII of the Social Security Act, Section 1833 (e). This section
prohibits Medicare payment for any claim that lacks the necessary
information to process the claim.
Title XVIII of the Social Security Act, section 1861 (s). These sections
outline coverage for drugs and biologicals and services and supplies.
|
|
CMS National Coverage Policy References
Title XVIII of the
Social Security Act, Section 1862(a)(1)(A). This
section excludes coverage for items or services that are not reasonable
and necessary for the diagnosis or treatment of illness or injury or to
improve the functioning of a malformed body member.
Title XVIII of the Social Security Act, Section 1833 (e). This section
prohibits Medicare payment for any claim that lacks the necessary
information to process the claim.
Title XVIII of the Social Security Act, section 1861 (s). These sections
outline coverage for drugs and biologicals and services and supplies
|
Ferrlecit and Venofer are first line treatment for iron deficiency anemia
when furnished intravenously in patients undergoing chronic hemodialysis
and are receiving supplemental erythropoietin.
The primary cause of anemia in patients with chronic renal failure is
insufficient production of erythropoietin (EPO) by the diseased kidney.
Additional factors that may cause or contribute to the anemia include iron
deficiency. Iron deficiency in hemodialysis patients may be due to several
reasons including substantial losses of blood from frequent blood tests,
blood remaining in the dialysis tubing and dialyzer, gastrointestinal blood
losses, and increases in the rate of erythropoiesis on epoetin (i.e.,
Epoetin Alfa, recombinant human erythropoietin) therapy.
Iron is a critical structural component of hemoglobin, a key protein found
in normal red blood cells (RBCs), which transport oxygen throughout the
body. Additionally, iron is necessary for metabolism and synthesis of DNA
and various enzymatic processes. The total body iron content of an adult
ranges from 2 to 4 grams. Approximately 2/3 is in hemoglobin and 1/3 in
reticuloendothelial storage (bone marrow, spleen, liver) and ferritin.
Administration of exogenous erythropoietin in the hemodialysis patients
increases red blood cell production and iron utilization. This, along with
blood losses in the hemodialysis patient, may lead to absolute or
functional iron deficiency. Absolute iron deficiency in chronic renal
failure patients has been defined as a TSAT level <20% and serum
ferritin level <100ng.ml. In contrast, functional iron deficiency
results when there is a need for a greater amount of iron to support
hemoglobin synthesis, than can be released from iron stores in reticuloendothelial
cells. As a result, the TSAT decreases to levels consistent with iron
deficiency, while the serum ferritin value remains within normal (or
elevated) range.
The National Kidney Foundation Dialysis Outcome Quality Initiative (K-DOQI)
Clinical Practice Guideline for Treatment of Anemia of Chronic Renal
Failure recommends the target hematocrit (hemoglobin) should be 33%
(11g/dl) for Epo therapy; sufficient iron should be administered to
maintain a TSAT of 20% or greater and a serum ferritin level of 100ng/ml or
greater, to achieve and maintain a target hct/hgb in conjunction with EPO
use.
Clinical management of iron deficiency in ESRD patients involves treating
patients with iron replacement products while they undergo dialysis. IV
iron is infused directly into the bloodstream in a form that is readily
available to the bone marrow for RBC synthesis.
Ferrlecit
Ferrlecit (sodium ferric gluconate complex in sucrose) is a stable
macromolecular complex consisting of mono- and di-nuclear iron (III) oxide
hydrates which are directly and covalently bonded to saccharates. It is
approved as a first line treatment for iron deficiency anemia in renal
hemodialysis patients on supplemental recombinant human erythropoietin.
Venofer
Venofer (iron sucrose) is a complex of polynuclear iron (III)-hydroxide
cores surrounded by non-covalently-bound sucrose molecules. It is approved
for use in replenishing iron in patients receiving erythropoietin and
undergoing chronic hemodialysis.
Indications:
Ferrlecit
Ferrlecit is used for treatment of iron deficiency anemia in patients
undergoing chronic hemodialysis who are receiving supplemental
erythropoietin therapy. Ferrlecit represents a first line therapy option
for these patients and can be used for both repletion and continued
therapy.
Inclusion criteria:
- Ferritin <100 ng/mL or TSAT <20%;
hemoglobin <10 g/dL or hematocrit<32%.
- Most patients require at least 1.0 gram of
Ferrlecit administered as 125 mg—the highest approved single dose of
any IV iron—over 8 sessions to achieve a favorable Hgb or Hct
response. Patients may continue to require therapy with Ferrlecit at
the lowest dose (between 25 mg and 125 mg per week) necessary to
maintain target levels of Hgb, Hct, and laboratory parameters of iron
storage within acceptable limits.
- Ferrlecit is administered at sequential
dialysis sessions by infusion or by slow IV injection during the
dialysis session itself.
Venofer
Venofer is indicated in the treatment of iron deficiency anemia in patients
undergoing chronic hemodialysis who are receiving supplemental
erythropoietin therapy.
Inclusion criteria:
- Ferritin <100 ng/mL or TSAT <20%;
hemoglobin <10 g/dL or hematocrit<32%.
- The recommended dosage of Venofer for the
repletion treatment of iron deficiency in hemodialysis patients is 5
ml of iron sucrose (100 mg of elemental iron) delivered intravenously
during the dialysis session. Most patients will require a minimum
cumulative dose of 1000 mg of elemental iron, administered over 10
sequential dialysis sessions, to achieve a favorable hemoglobin or
hematocrit response. Patients may continue to require therapy with
Venofer or other intravenous iron preparations at the lowest dose
necessary to maintain target levels of hemoglobin, hematocrit and
laboratory parameters of iron storage within acceptable limits.
Frequency of dosing should be no more than 3 times weekly.
- Iron sucrose must only be administered
intravenously (directly into the dialysis line) either by slow
injection or by infusion.
Limitations:
Ferrlecit
Ferrlecit is contraindicated in patients with:
- Evidence of iron overload
- Anemias not associated with iron
deficiency
- Known hypersensitivity to Ferrlecit or any
of its inactive components
Dosages in excess of iron needs may lead to accumulation of iron in iron
storage sites and hemosidrosis. Periodic monitoring of laboratory
parameters of iron storage levels may assist in recognition of iron
accumulation.
Venofer
Venofer is contraindicated in patients with:
- Evidence of iron overload
- Anemia not caused by iron deficiency
- Known hypersensitivity to Venofer or any
of its inactive components
Dosages of venofer in excess of iron needs may lead to accumulation of iron
in storage sites leading to hemosiderosis. Periodic monitoring of iron
parameters such as serum ferritin and transferrin saturation may assist in
recognizing iron accumulation.
Test dose administration of either Venofer or Ferrlecit during first-time
administration is not necessary.
IV iron may be continued at a maintenance dose of not more frequently than
one time a week so long as the iron saturation level does not exceed 50% or
the ferritin exceed 800ng/ml. IV iron should be held (per DOQI guidelines)
if the iron saturation is greater than 50% or the ferritin is greater than
800ng/ml.
The National Kidney Foundation Dialysis Outcome Quality Initiative (K-DOQI)
Clinical Practice Guideline for Treatment of Anemia of Chronic Renal
Failure recommends the target hematocrit (hemoglobin) should be 33%
(11g/dl) for Epo therapy; sufficient iron should be administered to
maintain a TSAT of 20% or greater and a serum ferritin level of 100ng/ml or
greater, to achieve and maintain a target hct/hgb in conjunction with EPO
use.
Reasons for Denial:
Lack of evidence the hemodialysis patient is receiving supplemental
Erythropoietin therapy.
Failure to support iron deficiency anemia.
Failure to comply with the indications and limitations of this LCD.
|