Erythropoiesis Stimulating Agents (ESA) – Non-Dialysis CPT code J0881, J0885 with covered DX and modifier


This LCD addresses only the medical necessity of ESAs for conditions other than those included in CMS policies.. Refer to Medicare Claims Processing Manual – Pub. 100-04, Chapter 8, Section 60, for specifics related to use for patients on dialysis. The services subject to this policy are those billed with an “-EC” modifier.
Synthetic supplemental erythropoietin is a biologically engineered protein that stimulates bone marrow to make new red blood cells. The FDA has approved two distinct drugs for use as synthetic erythropoietin substitutes: epoetin alfa (Epogen®, ProCrit®) and darbepoetin alfa (Aranesp®). Epoetin alfa is structurally identical to naturally occurring erythropoietin, while darbepoetin has a few modifications to the molecule. In this LCD, epoetin alfa is referred to as “EPO”, while darbepoetin alfa is referred to as “DPO.”
Most authorities use hemoglobin measurements as a better measure of anemia than hematocrit. However, due to certain coding conventions mainly used in Part A of Medicare, this LCD will express hematocrits as a measure of anemia. Providers may use either hemoglobin or hematocrit determinations for therapeutic decision-making. In general, Medicare considers the hematocrit to be approximately three times the hemoglobin measurement.
Indications and Product Use (EPO or DPO):
  • Symptomatic anemia related to therapy with zidovudine (AZT) in Human Immunodeficiency Virus (HIV)-infected patients (EPO only).
  • Symptomatic anemia related to chronic renal falure (EPO and DPO).
  • Symptomatic anemia due to the effects of concomitantly administered chemotherapy in patients with non-myeloid malignancies (EPO and DPO). National indications are described in NCD 110.21 (CAG 383N) and are not addressed further in this LCD.
  • Anemic patients (Hemoglobin greater than 10, to less than or equal to 12 grams per dL) who are scheduled to undergo elective non-cardiac, non-vascular surgery that are at high risk for perioperative transfusions (significant blood loss anticipated) in order to reduce the need for allogeneic blood transfusions (EPO only).
  • Symptomatic anemic patients with chronic anemia and rheumatoid arthritis (EPO only).
  • Symptomatic anemic patients with anemia related to Myelodysplastic Syndrome (MDS) (EPO only; for DPO, see Indications and Limitations below).
  • Symptomatic anemic patients with anemia related to hepatitis C virus infection (EPO only).
Limitations That Apply to All Indications for EPO and DPO
  • EPO or DPO are never covered when the Hematocrit exceeds 36 percent (with EC modifier).
  • Claims for self-administration of EPO or DPO are not covered under Part B. Claims must be sent to the Durable Medical Equipment Regional Carrier (DMERC) (for Part A Method II and Part B).
  • When anemia is caused by a correctable pathology such as iron or folate deficiencies, hemolysis or an occult or overt blood loss, EPO or DPO are not medically necessary and are not covered.
  • The pretreatment Hematocrit level should be obtained within one week of the initial EPO or DPO injection.
  • Subsequent Hematocrit levels should be obtained within two weeks of the next EPO or DPO administration.
  • The patient may be treated until he no longer needs a transfusion, is no longer symptomatic or the Hematocrit level is greater than 36 percent or the Hemoglobin is greater than 12 (with EC modifier).
  • Dose, dosage frequency, and dose adjustments must not exceed FDA-approved labeling (or equivalent dose over time) and should be titrated to achieve and maintain the lowest hemoglobin level to avoid the need for transfusion and not to exceed 12 g/dl.
  • Medicare considers dosages exceeding 400,000 units per month for EPO or 1,200 mcg per month for DPO to be clinically unlikely and never reasonable and necessary.
  • Medicare will cover the amount of drug that is reasonable and necessary for the patient’s condition. If a physician must discard the remainder of a vial after administering a portion to a Medicare patient, the Medicare program may cover a small, but reasonable amount of discarded drug, along with the amount administered. Medicare expects this wastage to be minimal. The provider should make an effort to schedule patients in such a way that he can minimize any waste and use the drug most efficiently. Any amount wasted must be clearly documented in the chart with the time, amount of medication wasted and reason for the wastage.
  • The FDA issued several alerts and added “black box” warnings to the product labels. These should be reviewed periodically for updated information. The FDA Web site link is:http://www.fda.gov/cder/drug/infopage/RHE/default.htm.
The indications above apply to all ESA uses in addition to the specific requirements listed below by condition.
EPO And DPO Indications:
Patients with Chronic Renal Insufficiency Not on Dialysis (with EC modifier)
  • Medicare will cover EPO or DPO use for this indication when the anemia is symptomatic, and there is evidence that the anemia is due to chronic renal insufficiency, such as an elevated creatinine level or a reduced creatinine clearance indicative of chronic renal insufficiency.
  • This local policy applies the same CMS requirements (clinical criteria) established for the treatment of ESRD patients on dialysis to the initiation and continuation of EPO or DPO for treatment of the anemia of chronic renal failure for all patients, whether or not “ESRD” and whether or not on dialysis. The pretreatment Hematocrit/Hemoglobin must be obtained within one week of the initial drug injection. Subsequent Hematocrit/Hemoglobin levels must be obtained within two weeks of each succeeding injection. Hematocrit/Hemoglobin (IOM 100-02, Ch.11, §90): CMS instructions for ESRD claims, for both EPO and DPO, require the following:
    • For initiating DPO or EPO, the Hematocrit must be no higher than 30% unless there is medical documentation showing the need, and
    • For continuation of DPO or EPO, the Hematocrit must not be greater than “36 percent”.
Patients with Anemia Due to Cancer Chemotherapy Treatment (with EA modifier)
Patients with Myelodysplastic Syndromes (MDS) (with EC modifier)
Anemia is observed in 90 percent of individuals with MDS; only 10 to 28 percent of MDS patients with anemia respond to exogenous EPO.
  • Medicare will cover EPO use with MDS when all of the following coverage criteria are met:
    • Life expectancy is greater than 3 months.
    • To avoid transfusions.
    • The patient is symptomatic from the anemia (e.g., fatigue, shortness of breath).
    • The chart documents that the bone marrow has been reviewed by the clinician and is consistent with a diagnosis of myelodysplastic syndrome. *
      • If the marrow blast count is greater than 10 percent, no ESA is covered unless the medical records demonstrate the patient’s diagnosis is not leukemia.
*Note: When a definitive diagnosis may be established on a cytological basis, marrow confirmation is not required.
    • The pretreatment Hematocrit level is less than 30 percent.
    • The pretreatment erythropoetin level is less than 500µU/ml (if performed).
    • The patient is classified as Low or Intermediate -1 risk by the International Prognostic Scoring System.
  • The patient may be treated until there is no longer a need for transfusions, until he is no longer symptomatic or the hematocrit level is greater than 36 percent.
  • If, after the first 12 weeks of EPO therapy, there is no improvement evidenced by a sustained increase in hemoglobin to a level 1-2 g/dl greater than the starting hemoglobin or a 50 percent decrease in the transfusion requirement over at least two months, then further treatment will not be covered. Additionally, Medicare will not cover ESA supplemental use for subsequent Hematocrit level greater than 36 percent.
  • Patients whose medical records clearly document a clinical need to administer DPO, rather than EPO, may be treated with DPO in accordance with the same MDS coverage criteria as required for administration of EPO.
EPO Only Indications:
Patients with HIV/Acquired Immune Deficiency
Syndrome (AIDS) Developing Anemia Due to the Drug Zidovudine (AZT)
(with EC modifier)
HIV-infected patients taking AZT develop anemia. It has been observed that this anemia responds to exogenous EPO therapy in individuals who were receiving AZT doses of 4,200 mg or less per week, and whose endogenous levels of EPO are 500 MU/ml or less. Patients with AZT-induced anemia, whose endogenous serum EPO levels are more than 500 MU/ml, do not appear to respond to this therapy.
Patients with Anemia Due to Rheumatoid Arthritis (with EC modifier)
EPO has been shown to increase hematocrit levels and decrease transfusion requirements in patients with anemia related to rheumatoid arthritis.
  • Medicare will cover EPO use for this indication in order to avoid transfusions when the patient is symptomatic from the anemia and the pretreatment Hematocrit level is less than 30.
  • The pretreatment Hematocrit level should be obtained within one week of the initial EPO injection.
  • Subsequent Hematocrit levels should be obtained within two weeks of the next EPO injection.
  • The patient may be treated until the hematocrit level reaches a target between 30 and 36 Medicare will not cover EPO supplemental use for subsequent Hematocrit level greater than 36 percent.
  • If, after the first 12 weeks of EPO therapy, there is no improvement evidenced by a sustained increase in Hematocrit to a level of at least 30 percent (at least five percentage points higher) or a 50 percent decrease in the transfusion requirement in that period, then further treatment will not be covered.
Patients with Anemia Due to Management of Hepatitis C (with EC modifier)
EPO is indicated for the treatment of anemia in patients with hepatitis C virus infection who are being treated with the combination of ribivirin and interferon alpha or ribivirin and peginterferon alfa. The recommended dosage for treating the resulting anemia is 40,000 units of EPO once weekly, subcutaneously.
  • Subsequent Hematocrit levels should be obtained weekly to monitor effectiveness and need to continue EPO therapy.
Preoperative Use (with EC modifier)
Preoperative EPO usage is medically reasonable and necessary for treatment of preoperative anemia in a select target patient population. Medicare will cover EPO use for this indication when the patient meets all of the following coverage criteria.
  • Patient is scheduled to undergo non-cardiac, non-vascular surgery.
  • Patient has preoperative anemia with a pretreatment Hemoglobin level between 10 and 12 mg/dl.
  • Patient is not a candidate for autologous blood transfusion, or autologous transfusion is not available.
  • Patient is expected to lose more than two units of blood during the surgery.
  • Patient has received an appropriate preoperative workup revealing his anemia appears to be of chronic disease and is likely to be responsive to EPO administration. A pretreatment Hemoglobin level should be obtained within one week of initial EPO injection.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
Drug Wastage
Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good-faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug, and made good-faith efforts to minimize the unused portion of the drug in how it is supplied, the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Coding and billing instructions can be referenced in the attached article. Refer to national policy:Medicare Claims Processing Pub. 100-04, Chapter 17, Section 40.
Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP). Reference to national policy: Medicare Claims Processing Manual, Pub. 100-04, Chapter 17, Section 100.2.9.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 18X, 21X, 22X, 23X, 85X
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.
0450, 0634, 0635, 0636
CPT/HCPCS Codes
Note:
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and CMS require the use of short CPT descriptors in LCDs published on the Web.
J0881
Injection, darbepoetin alfa, 1 mcg (non ESRD)
J0885
Injection, epoetin alfa, per 1000 units (non ESRD)
Modifier Definitions:
  • EA: ESA, anemia, chemo-induced.
  • EB: ESA, anemia, radio-induced.
  • EC: ESA, anemia, non-chemo/radio-induced.
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Treatment of Non-Dialysis-Related Anemias With DPO:
Medicare is establishing the following limited coverage for HCPCS code J0881:
Covered for:
238.72*
Low grade myelodysplastic syndrome lesions
238.73*
High grade myelodysplastic syndrome lesions
238.74*
Myelodysplastic syndrome with 5q deletion
238.75*
Myelodysplastic syndrome, unspecified
Note: Use diagnosis codes 238.72, 238.73, 238.74 and 238.75 only when there is a documented clinical need to use DPO rather than EPO.
285.21*
Anemia in chronic kidney disease
Note: When using 285.21*, the medical records must reflect patient is not on dialysis.
285.3*
Antineoplastic chemotherapy induced anemia
Note: Dual diagnosis requirement: Use 285.3* as the primary diagnosis to indicate symptomatic anemia associated with cancer chemotherapy. See V58.11 or V67.2 below for secondary diagnoses.
V58.11*
Encounter for antineoplastic chemotherapy
Note: Use V58.11* to represent a non-myeloid malignancy actively receiving chemotherapy that is causing the symptomatic anemia. This is a secondary diagnosis in the dual diagnosis requirement for 285.3.Non-myeloid malignancy ICD-9-CM codes are no longer required but still recommended on claim.
V67.2*
Follow-up examination, following chemotherapy
Note: Use V67.2* to represent chemotherapy received within the previous three months for a non-myeloid malignancy caused symptomatic anemia. This is a secondary diagnosis in the dual diagnosis requirement for 285.3. Non-myeloid malignancy ICD-9-CM codes are no longer required but still recommended on claim.
Treatment of Non-Dialysis-Related Anemias With EPO:
Medicare is establishing the following limited coverage for HCPCS code J0885:
Covered for:
042
Human immunodeficiency virus (HIV) disease
070.70–070.71
Unspecified viral hepatitis C
238.72*
Low grade myelodysplastic syndrome lesions
238.73*
High grade myelodysplastic syndrome lesions
238.74*
Myelodysplastic syndrome with 5q deletion
238.75*
Myelodysplastic syndrome, unspecified
Note: Diagnosis codes 238.72, 238.73, 238.74 and 238.75 must only be used to represent patients meeting the specified MDS indications listed in this LCD.
285.21*
Anemia in chronic kidney disease
Note: When using 285.21*, the medical records must reflect patient is not on dialysis.
285.3 *
Antineoplastic chemotherapy induced anemia
Note: Dual diagnosis requirement: Use 285.3* as the primary diagnosis to indicate symptomatic anemia associated with cancer chemotherapy. See V58.11 or V67.2 below for secondary diagnoses.
714.0
Rheumatoid arthritis
998.11*
Hemorrhage complicating a procedure
Note: By using diagnosis code 998.11, the medical records must reflect the labeled indication for using EPO as a perioperative adjuvant.
V58.11*
Encounter for antineoplastic chemotherapy
Note: Use V58.11* to represent a non-myeloid malignancy actively receiving chemotherapy that is causing the symptomatic anemia. This is a secondary diagnosis in the dual diagnosis requirementfor 285.3. Non-myeloid malignancy ICD-9-CM codes are no longer required but still recommended on claim.
V67.2*
Follow-up examination, following chemotherapy
Note: Use V67.2* to represent chemotherapy received within the previous three months for a non-myeloid malignancy caused symptomatic anemia. This is a secondary diagnosis in the dual diagnosis requirement for 285.3. Non-myeloid malignancy ICD-9-CM codes are no longer required but still recommended on claim.
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
The following ICD-9-CM codes are non-covered (per Change Request 5818) when billed for non-ESRD ESA services(J0881 or J0885) and the EC modifier:
205.00–205.02
Myeloid leukemia, acute
205.10–205.12
Myeloid leukemia, chronic
205.20–205.22
Myeloid leukemia, subacute
205.30-205.32
Myeloid leukemia, myeloid sarcoma
205.80–205.82
Other myeloid leukemia
205.90–205.92
Unspecified leukemia
207.00–207.02
Other specified leukemia
207.10–207.12
Other specified leukemia
207.20–207.22
Other specified leukemia
207.80–207.82
Other specified leukemia
280.0–280.9
Iron deficiency anemias
281.1–281.3
Other deficiency anemias
282.0
Hereditary spherocytosis
282.2
Anemias due to disorders of glutathione metabolism
282.9
Hereditary hemolytic anemia, unspecified
283.0
Autoimmune hemolytic anemias
283.10
Non-autoimmune hemolytic anemia, unspecified
283.19
Other non-autoimmune hemolytic anemias
283.2
Hemoglobinuria due to hemolysis from external causes
283.9
Acquired hemolytic anemia, unspecified
285.1
Acute posthemorrhagic anemia
V49.89*
Other specified conditions influencing health status
Note: Use V49.89* to represent non-covered conditions listed below in the “Diagnoses That DO NOT support Medical Necessity” section.
Diagnoses That DO NOT Support Medical Necessity
As outlined in the CMS Change Request (CR) 5818:
  • Any anemia in cancer or cancer treatment patients due to bone marrow fibrosis.
  • Anemia of cancer not related to cancer treatment.
  • Prophylactic use to prevent chemotherapy-induced anemia.
  • Prophylactic use to reduce tumor hypoxia.
  • Patients with erythropoietin-type resistance due to neutralizing antibodies.
  • Anemia due to cancer treatment if patients have uncontrolled hypertension.
All other diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
The patient’s medical record must contain:
  • The pretreatment Hematocrit level obtained within one week of the initial EPO or DPO injection.
  • Subsequent Hematocrit levels obtained within two weeks of the next EPO or DPO injection.
  • Patient’s weight in kilograms.
  • Patient’s starting dose per kilogram.
  • Occult blood loss has been excluded.
  • Serum iron, transferrin saturation, and serum ferritin.
For patients treated with EPO for the treatment of anemia due to MDS, the above requirements and following information should be included in the patient’s record:
  • Erythropoietin level, if obtained.
  • Bone marrow biopsy or aspiration report demonstrating a diagnosis of myelodysplasia.
Note: When a definitive diagnosis may be established on a cytological basis, marrow confirmation is not required.
  • The start date at the beginning of the 12-week trial period.
  • Evidence that the anemia is significantly responsive to EPO therapy at the end of the trial.
  • Evidence that the fatigue is significantly impacting activities of daily living.
For drug-induced anemia in HIV-infected patients or chemotherapy-induced anemia, the agent(s) used to treat the underlying condition causing the anemia must be included in the patient’s record. For AIDS- or chemotherapy-induced anemia, the above requirements and following information should be included in the patient’s record:
  • Most recent Hematocrit or Hemoglobin level prior to initiation of chemotherapy.
For preoperative patients, the following information must be included in the patient’s record:
  • Documentation verifying the patient is scheduled to undergo elective non-cardiac, non-vascular surgery when billing diagnosis code 998.11.
  • Documentation to support an anemia.
  • An explanation as to why the patient is not a candidate for autologous blood transfusion.
  • Documentation to support an anemia of chronic disease (this could include lab reports, slide interpretations, etc.).
For the treatment of anemia in patients with hepatitis C virus infection that are being treated with the combination of ribivirin and interferon alpha or ribivirin and peginterferon alfa, the following information must be included in the patient’s record:
  • Documentation of which ribivirin combination (interferon alpha or peginterferon alfa) therapy patient is receiving and duration.
  • Weekly Hematocrit levels and the patient’s response to EPO and continued therapy.
  • Patient’s dosage and route of administration.
Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record, regardless of whether the JW modifier will be used in billing for the drug/biological, with:
  • Date and time.
  • Amount of medication wasted.
  • Reason for the wastage.
Appendices
N/A
Utilization Guidelines
Medicare considers dosages exceeding 400,000 units per month for EPO or 1,200 mcg per month for DPO to be clinically unlikely and never reasonable and necessary.
If, after the first 12 weeks of EPO therapy, there is no improvement evidenced by a sustained increase in hemoglobin to a level 1-2 g/dl greater than the starting hemoglobin or a 50 percent decrease in the transfusion requirement over at least two months, then further treatment will not be covered. Additionally, Medicare will not cover ESA supplemental use for subsequent Hematocrit level greater than 36 percent.
Medicare will not cover ESA supplemental use for subsequent Hematocrit levels greater than 36 percent (with EC modifier).
Notice: This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.

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