Currentmedical mutual - ohioPolicy N/A

Epoetin alfa products (Epogen, Procrit, Retacrit) non-dialysis

Prior authorization policy for medical-benefit epoetin alfa products (HCPCS J0885, Q5106) for multiple anemia indications (MDS, MPN/myelofibrosis, chemotherapy-induced, CKD non-dialysis and dialysis, zidovudine-associated, preoperative transfusion reduction, etc.). Defines initial and renewal clinical criteria, dosing/administration, unit limits, coding, NDCs and prior authorization/billing rules.

Policy Summary

Payermedical mutual - ohio

PolicyEpoetin alfa products (Epogen, Procrit, Retacrit) non-dialysis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for J0885 and Q5106 and document labs (within 30 days), iron studies or IV iron use, hemoglobin/hematocrit, and other required diagnostic coding per policy.

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

MultipleCovered Indications (count)

J0885,Q5106Prior Authorization HCPCS

45dInitial auth duration

120/600/60Max billable units (MDS/Surg/Other)

Coverage Summary

Policy applies to medical-benefit epoetin alfa products Epogen, Procrit, and Retacrit for multiple anemia indications (non-dialysis and specified uses). Prior authorization is required for medical-benefit HCPCS codes J0885 and Q5106. Approvals are contingent on meeting the policy's specified initial and renewal clinical criteria, laboratory confirmation (including iron studies), demonstration of adequate iron status or IV iron use, and exclusion of other causes of anemia.

Key thresholds & quick facts

Hemoglobin — initiation< 10 g/dL (unless otherwise specified)

Hematocrit — initiation< 30% (unless otherwise specified)

Ferritin (iron adequacy)≥ 100 ng/mL

Transferrin saturation (TSAT)≥ 20%

Serum erythropoietin (MDS) — primary threshold≤ 500 mU/mL

Serum erythropoietin (MDS) — alternative< 200 mU/mL

Renewal — previous dose recencyPrevious dose administered within the past 60 days

Initial authorization duration45 days

Max billable units — MDS120 billable units every 7 days

Max billable units — Surgery (preoperative)600 billable units every 15 days

Max billable units — All other indications60 billable units every 7 days

Billable unit equivalence1 billable unit = 1,000 units (HCPCS J0885, Q5106)

Initial Therapy Criteria

Initial Approval Criteria

Coverage is recommended when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age (unless otherwise specified)
Initiation of therapy Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30% (unless otherwise specified)Hb < 10 g/dL; Hct < 30%

Universal Criteria

Lab values are obtained within 30 days of the date of administration (unless otherwise indicated)within 30 days
Iron status
- Patient has adequate iron stores as demonstrated by serum ferritin ≥ 100 ng/mL and transferrin saturation (TSAT) ≥ 20% (measured within the previous 3 months for renewal)ferritin ≥ 100 ng/mL; TSAT ≥ 20%
  measured within previous 3 months for renewal
- Patient is receiving concurrent intravenous iron
Other causes of anemia (e.g. hemolysis, bleeding, vitamin deficiency, etc.) have been ruled out
Patient does not have uncontrolled hypertension

Indication-specific branches (one must apply)

Anemia due to Myelodysplastic Syndromes (MDS)
- Patient has symptomatic anemia
- Serum erythropoietin ≤ 500 mU/mL (unless otherwise specified)≤ 500 mU/mL
- Patient has lower risk disease (defined as IPSS-R Very Low, Low, Intermediate)
- Cytogenetics / use
  - Used as a single agent for del(5q) mutation (excluding use in patients with cytogenetic abnormality involving chromosome 7)

Renewal / Continuation Therapy Criteria

Renewal Criteria

Prior authorization may be renewed when ALL of the following are met:

ALL of the following

Patient continues to meet universal and other indication-specific relevant criteria identified in Initial Approval
Refer to Initial Approval
Duration of authorization has not been exceeded (refer to Length of Authorization)refer to Section I
Initial 45 days; renewals every 45 days
Previous dose was administered within the past 60 dayswithin 60 days
Disease response with treatment as defined by improvement in anemia compared to pretreatment baselineresponse per indication
Examples: MDS response definition provided in policy
Absence of unacceptable toxicity from the drug (examples listed)
Examples include severe cardiovascular events, uncontrolled HTN, seizures, PRCA, severe allergic reactions, severe cutaneous reactions, gasping syndrome

Indication-specific renewal thresholds

MDS
- Hemoglobin (Hb) < 12 g/dL and/or Hematocrit (Hct) < 36%Hb < 12 g/dL; Hct < 36%
MPN / Myelofibrosis
- Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30%Hb < 10 g/dL; Hct < 30%
Chemotherapy-induced anemia
- Refer to Initial Approval criteria (age was met initially)
Chronic Kidney Disease (Non-ESRD) Renewal thresholds

Exclusions and Contraindications

Exclusions and contraindications include: uncontrolled hypertension (must be absent for coverage) and failure to rule out other causes of anemia (e.g., hemolysis, bleeding, vitamin deficiency). Cytogenetic guidance excludes use as single-agent for del(5q) when there is a cytogenetic abnormality involving chromosome 7. ESRD/dialysis ESA codes (Q4081, Q5105) do not require prior authorization per policy and are handled separately. Include only explicit exclusions stated in the policy; no other exclusions are inferred.

Applicable Codes

Prior authorization required HCPCS (Medical benefit)HCPCSCovered

J0885	Injection, epoetin alfa, (for non-ESRD use), 1000 units; 1 billable unit = 1,000 units
Q5106	Injection, epoetin alfa-epbx, biosimilar, (Retacrit) (for non-ESRD use), 1000 units; 1 billable unit = 1,000 units

HCPCS not requiring prior auth (ESRD on dialysis)HCPCS

Q4081	ESA code for ESRD on dialysis (does not require prior authorization per policy)
Q5105	ESA code for ESRD on dialysis (does not require prior authorization per policy)

Covered ICD-10 diagnosis codesICD-10Covered

C93.10	Chronic myelomonocytic leukemia, not having achieved remission
C94.40	Acute panmyelosis with myelofibrosis not having achieved remission
C94.41	Acute panmyelosis with myelofibrosis in remission
C94.42	Acute panmyelosis with myelofibrosis in relapse
C94.6	Myelodysplastic disease, not classified
D46.0	Refractory anemia without ring sideroblasts, so stated
D46.1	Refractory anemia with ring sideroblasts
D46.20	Refractory anemia with excess of blasts, unspecified
D46.21	Refractory anemia with excess of blasts 1
D46.4	Refractory anemia, unspecified

1–10 of 35

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Provider Actions & Billing Impact

Prior Authorization

Prior authorization required

Prior authorization is required for medical‑benefit epoetin alfa HCPCS codes J0885 and Q5106. Requests will be authorized initially for 45 days, with renewals every 45 days thereafter unless otherwise specified (the policy also notes a 180‑day prior approval processing statement elsewhere). Nurse reviewers may authorize when submitted documentation meets policy criteria; requests that do not meet criteria will be forwarded to a physician reviewer.

J0885
Q5106
Initial authorization duration: 45 days

Documentation Required

Required clinical documentation

Document laboratory and clinical data to support the request. Labs must be obtained within 30 days of administration. Required assessments include iron studies (serum ferritin and TSAT) or documentation of concurrent IV iron; hemoglobin and hematocrit values; and serum erythropoietin level when indicated by the indication-specific criteria. The policy also requires dual diagnosis coding for certain indications (see examples).

Preoperative example: D63.8 or D64.9 AND Z41.8
CKD (non‑dialysis) example: D63.1 AND one of I12.9, I13.0, I13.10, N18.30, N18.31, N18.32, N18.4, N18.5

Billing Rule

Unit limits / maximum billable units

Unit limits vary by indication; billing is per HCPCS billable unit where 1 billable unit = 1,000 units. For myelodysplastic syndromes (MDS) the limit is 120 billable units every 7 days. For elective surgery patients the limit is 600 billable units every 15 days. For all other indications the limit is 60 billable units every 7 days.

MDS: 120 units every 7 days
Surgery patients: 600 units every 15 days
All other indications: 60 units every 7 days

Denial Risk

Edits and claim adjudication

Claims submitted with HCPCS codes J0885 and Q5106 will edit with Remark Code M3M or M4M and will be adjudicated in accordance with the corporate medical policy. Participating providers are required to write off charges for services denied as not medically necessary.

J0885
Q5106

Billing Rule

Dual coding requirements for specific indications

Certain indications require dual ICD-10 coding on the claim. Preoperative use must be billed with a diagnosis of D63.8 or D64.9 paired with Z41.8. Anemia due to chronic kidney disease (non‑dialysis) must be billed with D63.1 paired with one of the specified CKD codes.

Preoperative: D63.8 or D64.9 AND Z41.8
CKD non-dialysis: D63.1 AND one of I12.9, I13.0, I13.10, N18.30, N18.31, N18.32, N18.4, N18.5

Clinical Evidence & References

Referenced evidence sources: package inserts — Procrit Apr 2024, Epogen Dec 2024, Retacrit Jun 2024; guidance sources — NCCN Compendia 2026 and KDIGO 2026. No trial-level metrics were provided in the brief; metric_cards are not used.

Background

Background: This policy governs medical-benefit epoetin alfa products (Epogen, Procrit, Retacrit) for non-dialysis and other specified anemia indications. Prior authorization is recommended/required for medical-benefit coverage of these products. Approvals are contingent on meeting initial and renewal clinical criteria, laboratory confirmation (including iron studies and hemoglobin/hematocrit values), demonstration of iron adequacy or IV iron use, and exclusion of other causes of anemia. The policy includes scope details and references Medicare NCD/LCD documents (NCD 110.21 and example LCDs) without reproducing full Medicare determination text.

Definitions

Billable unit (definition)1 billable unit = 1,000 units for J0885 and Q5106

No response (ESA) — definitionLack of ≥1.5 g/dL rise in hemoglobin OR lack of a decrease in RBC transfusion requirement (within 6-8 weeks when treated with ESAs)

Revision History

2026-01Last reviewLatest

Policy last reviewed (document references and guidelines accessed January 2026; internal last_review date 2026-01).

2007-07-30Medicare determination (NCD)

National Coverage Determination (NCD 110.21) for Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions effective 2007-07-30.

Medicare determination (LCD examples)

Local Coverage Articles listed as examples for ESA billing/coding: A58982, A56462, A56795 (contractor-specific LCD/Local Coverage Article references).

Policy Summary

Payermedical mutual - ohio

PolicyEpoetin alfa products (Epogen, Procrit, Retacrit) non-dialysis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for J0885 and Q5106 and document labs (within 30 days), iron studies or IV iron use, hemoglobin/hematocrit, and other required diagnostic coding per policy.

On This Page

Patient does not have del(5q) mutation

Patient has ring sideroblasts < 15% (or < 5% with an SF3B1 mutation) AND used as a single agent; OR used in combination with lenalidomide or a G-CSFring sideroblasts <15% (or <5% with SF3B1)

Prior therapy failure

Patient had no response (despite adequate iron stores) to or relapse after an ESA aloneNo response per definition
No response = lack of ≥1.5 g/dL rise in Hb or lack of decrease in RBC transfusion within 6-8 weeks (ESA)
Patient had no response to or relapse after luspatercept
luspatercept response window 3-6 months

MDS alternate branch

Patient has ring sideroblasts ≥15% (or ≥5% with SF3B1), AND used as single agent, AND had no response to or relapse after luspaterceptring sideroblasts ≥15% (or ≥5% with SF3B1)
Serum erythropoietin < 200 mU/mL< 200 mU/mL
Used in combination with a G-CSF and had no response to or relapse after luspatercept

Anemia due to Myeloproliferative Neoplasms (MPN) / Myelofibrosis

Patient has myelofibrosis-associated anemia with serum erythropoietin level of < 500 mU/mL< 500 mU/mL
ANY of the following
- Patient has splenomegaly and constitutional symptoms currently controlled on a JAK inhibitor AND used in combination with a JAK inhibitor
- Patient has no splenomegaly or constitutional symptoms AND used as a single agent

Anemia Due To Chemotherapy Treatment

Patient is at least 5 years of age≥ 5 years
Anemia due to concomitant myelosuppressive chemotherapy for a non-myeloid malignancy
Patient is receiving chemotherapy that is not intended to cure their disease (i.e., palliative treatment) (patients not undergoing palliative treatment who refuse transfusions may be reviewed case-by-case)
There are a minimum of two additional months of planned chemotherapy≥ 2 months planned

Anemia Due To Chronic Kidney Disease (Non-Dialysis)

Patient is at least 1 month of age≥ 1 month

Anemia Secondary to Chronic Kidney Disease (dialysis patients)

Patient is at least 1 month of age≥ 1 month
Patient does not have end stage renal disease (ESRD) or stage 5 chronic kidney diseasenot ESRD or stage 5 CKD

Anemia Due To Zidovudine in HIV (Procrit/Epogen only)

Patient is at least 8 months of age≥ 8 months
Endogenous serum erythropoietin level of ≤ 500 mUnits/mL≤ 500 mU/mL
Patient is receiving zidovudine administered at ≤ 4200 mg/week≤ 4200 mg/week

Reduction of Allogeneic Blood Transfusions in Elective, Non-Cardiac, Non-Vascular Surgery

Hemoglobin (Hb) >10 g/dL and ≤ 13 g/dL and/or Hematocrit (Hct) > 30% and ≤ 39%Hb >10 and ≤13 g/dL; Hct >30% and ≤39%
Patient is at high-risk of blood-loss from elective, non-cardiac, non-vascular surgery
Patient is unwilling or unable to participate in an autologous blood donation program prior to surgery

Pediatric patients: Hemoglobin (Hb) < 12 g/dL and/or Hematocrit (Hct) < 36%Peds Hb <12 g/dL; Hct <36%

Adult patients: Hemoglobin (Hb) < 11 g/dL and/or Hematocrit (Hct) < 33%Adult Hb <11 g/dL; Hct <33%

Zidovudine-associated anemia renewal

Hemoglobin (Hb) < 12 g/dL and/or Hematocrit (Hct) < 36%Hb <12 g/dL; Hct <36%
Patient is receiving zidovudine administered at ≤ 4200 mg/week≤ 4200 mg/week