- NOTE:
- See Medicare Advantage Medical Policy Bulletin I-7 for information regarding Epoetin alfa not being administered as home dialysis.
For any item to be covered, it must:
be eligible for a defined benefit category;
be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and
meet all other applicable statutory and regulatory requirements.
For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.
For an item to be covered, a written signed and dated order must be received by the supplier. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.
Indications and Limitations of Coverage
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.)
The patient is on dialysis which is being administered as Method II home dialysis.
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.
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:
Measurement of the patient's hematocrit (or hemoglobin), serum iron, transferrin saturation, serum ferritin, and blood pressure,
Assurance that the patient or a caregiver who assists the patient is:
Trained by the facility to inject EPO and is capable of carrying out the procedure,
Capable of reading and understanding the drug labeling, and
Trained in, and capable of observing, aseptic techniques,
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.
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.
For patients who are being treated with EPO, the hematocrit is between 30 and 36% (or comparable hemoglobin level).
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:
Review of diet and fluid intake for aberrations as indicated by hyperkalemia and elevated blood pressure secondary to volume overload;
Review of medications to ensure adequate provision of supplemental iron;
Ongoing evaluations of hematocrit and iron stores;
Re-evaluation of the dialysis prescription taking into account the patient's increased appetite and red blood cell volume;
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;
Training of the patient to identify the signs and symptoms of hypotension and hypertension; and
The decrease or discontinuance of EPO if hypertension is uncontrollable.
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.
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.
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 not medically necessary.
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.
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 not medically necessary. 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 not medically necessary. Claims for EPO for Method II home dialysis patients that are not submitted by the home dialysis supplier will be denied as not medically necessary. 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.
Reasons for Noncoverage
Payment for services will be denied as not medically necessary when used for indications other than those listed in the "Indications and Limitations of Coverage" section of this policy or when coverage criteria are not met. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.
Documentation Requirements
Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.
An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.
The order must indicate the dose and frequency of administration. A new order is needed if there is a change in the dose or frequency of administration.
The most recent hematocrit value prior to the From date on the claim should be reported in the narrative field of the electronic record.
If additional information is requested for patients with hematocrits in excess of 36%, and if the goal is to maintain the hematocrit at greater than 36%, the supplier must submit documentation (e.g., diagnosis, patient symptoms, etc.) supporting the medical necessity for the higher target hematocrit. If additional documentation is requested and if the goal is to maintain the hematocrit between 30-36%, the supplier must submit a copy of the flow sheet/log for the past 3 months documenting hematocrit dates and dates of EPO order changes.
GY and KX Modifiers
GY - Item or service statutorily excluded or does not meet the definition of any Medicare benefit
KX - Requirements specified in the medical policy have been met
On all claims for EPO, a KX modifier must be added to codes for EPO if all coverage criteria (#1-9 above) are met. If the hematocrit prior to initiation of EPO therapy is greater than or equal to 31%, or if other coverage criteria are not met, the KX modifier must not be used.
If all the criteria are not met, the GY modifier must be added to the EPO code.
Claim lines billed without a GY or KX modifier will be rejected as missing information.
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.