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NON-MEDICAL
NECESSITY COVERAGE AND PAYMENT RULES
Epoetin (EPO) (J0882, J0886) and items related to its administration are
covered when all of the following criteria are met. (In this policy, the
term EPO applies to both epoetin alfa and darbepoetin alfa.)
1) The patient is on dialysis which is being administered as Method II home
dialysis.
2) The EPO is self administered in the home by the patient (or patient
caregiver) who is determined by the physician or back-up dialysis facility
to be competent to use the drug and to be capable of understanding and
implementing a plan of care.
3) Prior to initiation of home EPO therapy, the back-up dialysis facility
or the physician responsible for all dialysis-related services furnished to
the patient has made a comprehensive assessment that includes the
following:
a) Measurement of the patient's hematocrit (or hemoglobin), serum iron,
transferrin saturation, serum ferritin, and blood pressure,
b) Assurance that the patient or a caregiver who assists the patient is:
i) Trained by the facility to inject EPO and is capable of carrying out the
procedure,
ii) Capable of reading and understanding the drug labeling, and
iii) Trained in, and capable of observing, aseptic techniques,
c) Assurance that the EPO can be stored in the patient's residence under
refrigeration and that the patient is aware of the potential hazard of a
child having access to the drug and syringes.
4) The patient has anemia and the most recent hematocrit prior to
initiating EPO treatment was 30% or less (or hemoglobin level was less than
10.1 gm% [gm/dl] or less) Unless there is medical documentation showing the
need for EPO treatment despite a hematocrit of 31% or higher (or hemoglobin
is 10.2 gm% or higher. For example, 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 levels.
5) For patients who are being treated with EPO, the hematocrit is between
30 and 36% (or comparable hemoglobin level).
6) The patient is under the care of a back-up dialysis facility which has a
written care plan for monitoring home use of EPO which includes the
following:
a) Review of diet and fluid intake for aberrations as indicated by hyperkalemia
and elevated blood pressure secondary to volume overload;
b) Review of medications to ensure adequate provision of supplemental iron;
c) Ongoing evaluations of hematocrit and iron stores;
d) Re-evaluation of the dialysis prescription taking into account the
patient's increased appetite and red blood cell volume;
e) A method for the physician and back-up dialysis facility to follow-up on
blood tests and a mechanism (such as a patient log) for keeping the
physician informed of the results;
f) Training of the patient to identify the signs and symptoms of
hypotension and hypertension; and
g) The decrease or discontinuance of EPO if hypertension is uncontrollable.
7) The patient is under the care of a physician who is responsible for all
dialysis-related services and who orders the EPO and follows the drug
labeling instructions when monitoring the EPO home therapy.
8) The patient’s physician or back-up dialysis facility develops a protocol
that follows the drug label instructions, makes the protocol available to
the patient to ensure safe and effective home use of EPO.
9) The back-up dialysis facility maintains adequate records to allow
quality assurance for review by the network and State survey agencies.
If all of the above criteria are not met, the EPO will be denied as
noncovered.
The patient's dialysis physician or facility must maintain a flow sheet or
log recording the dates and results of hematocrit tests, iron studies, and
the EPO prescription with dates of change. This information must be
available upon request.
Supplies (e.g., syringe, needle, alcohol) used for the administration of
EPO are included in the allowance for the EPO. These supplies must not be
billed separately.
The EPO must be supplied by the Method II supplier of home dialysis
equipment and supplies. The amount of EPO that the patient has on hand must
be limited to a two-month supply.
EPO that is self-administered by a patient (or caregiver) is billed to the
DME MAC. The only claims that are eligible for coverage are those for
patients who are on Method II home dialysis and that are submitted by the
dialysis supplier. Therefore, claims for codes J0882 and J0886 that are
submitted for home administration of EPO by patients who are on
facility-based dialysis or Method I home dialysis will be denied as
noncovered. Claims for codes J0885 and J0881 that are submitted for home
administration of EPO by patients who are not on dialysis will be denied as
noncovered. Claims for EPO for Method II home dialysis patients that are
not submitted by the home dialysis supplier will be denied as noncovered.
EPO that is not self-administered by a patient (or caregiver) is billed
either to the Medicare intermediary or the local carrier. If a Method II
home dialysis patient is in a Part A covered stay in a SNF and the Method
II supplier provides EPO, it is separately payable from the SNF
consolidated billing reimbursement. The Method II supplier should submit
the claim to the DME MAC.
CODING GUIDELINES
Codes J0882 and J0886 may only be used on claims for EPO administered to
patients who are on dialysis. EPO administered to patients who are not on
dialysis must be billed with codes J0885 and J0881.
Code Q4081 (Injection, epoetin alfa, 100 units, for ESRD on dialysis) is
invalid for claim submission.
One unit of service of epoetin alfa is reported for each 1000 units
dispensed. For example if 20,000 units are dispensed, bill 20 units. If the
dose dispensed is not an even multiple of 1,000, rounded down for 1-499
units (e.g. 20,400 units dispensed = 20 units billed), round up for 500-999
units (e.g. 20,500 units dispensed = 21 units billed). One unit of service
for darbepoetin alfa is 1 mcg. Similar rounding rules apply.
Suppliers should contact the Statistical Analysis Durable Medical Equipment
Regional Carrier (SADMERC) for guidance on the correct coding of these
items.
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