ph-0243
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Epoetin alfa: Epogen®; Procrit®; Retacrit™

Policy Number: PH-0243

Subcutaneous/Intravenous

*NON-DIALYSIS*

 

Last Review Date: 05/03/2021

Date of Origin: 10/17/2008

Dates Reviewed: 11/2008, 06/2009, 12/2009, 09/2010, 12/2010, 02/2011, 03/2011, 06/2011, 08/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 10/2012, 12/2012, 03/2013, 05/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 04/2017, 8/2017, 11/2017, 12/2017, 05/2018, 06/2018, 04/2019, 04/2020, 05/2021

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization
  • Coverage will be provided for 45 days and may be renewed unless otherwise specified.
    • Reduction of Allogeneic Blood Transfusions in Elective, Non-Cardiac, Non-Vascular Surgery: Coverage may not be renewed.
  1. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC Unit]:

  • 2,000 U/mL single-dose vial: 3 vials per week
  • 3,000 U/mL single-dose vial: 3 vials per week
  • 4,000 U/ml single-dose vial: 3 vials per week
  • 10,000 U/mL single-dose vial: 3 vials per week
  • 10,000 U/mL 2 mL multi-dose vial: 3 vials per week
  • 20,000 U/mL multi-dose vial: 3 vials per week
  • 40,000 U/mL single-dose vial: 1 vial per week

B.  Max Units (per dose and over time) [HCPCS Unit]:

  • MDS: 120 billable units every 7 days
  • Surgery patients: 600 billable units every 15 days
  • All other indications: 60 billable units every 7 days
  1. Initial Approval Criteria1-3,6,7

    Coverage is provided in the following conditions:

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

   Universal Criteria 1-3,5,8

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

   Anemia Secondary to Myelodysplastic Syndrome (MDS) ‡ 4,6

  • Endogenous serum erythropoietin level of ≤ 500 mUnits/mL; AND
  • Patient has lower risk disease (i.e., defined as IPSS-R [Very Low, Low, Intermediate], IPSS [Low/Intermediate-1], WPSS [Very Low, Low, Intermediate]); AND
  • Patient has symptomatic anemia

   Anemia Secondary to Myeloproliferative Neoplasms (MPN) - Myelofibrosis ‡ 4,7

  • Endogenous serum erythropoietin level of < 500 mUnits/mL

   Anemia Secondary to Chemotherapy Treatment † 1-5

  • Patient is at least 5 years of age; AND
  • Patient is receiving concomitant myelosuppressive chemotherapy; AND
  • Patient’s chemotherapy is not intended to cure their disease (i.e., palliative treatment); AND
  • There are a minimum of two additional months of planned chemotherapy

   Anemia Secondary to Chronic Kidney Disease (Non-Dialysis Patients) † Ф 1-3,8

  • Patient is at least 1 month of age

   Anemia Secondary to Zidovudine-Treated, HIV-Infected Patients † Ф 1-3

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

   Reduction of Allogeneic Blood Transfusions in Elective, Non-Cardiac, Non-Vascular Surgery † 1-3

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

FDA approved indication(s); Compendia recommended indication(s); Ф Orphan Drug –  applicable to Procrit/Epogen only

  1. Renewal Criteria 1-3,6,7

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria identified in section III; AND
  • Previous dose was administered within the past 60 days; AND
  • Anemia response compared to pretreatment baseline; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe cardiovascular events (stroke, myocardial infarction, congestive heart failure, thromboembolism, etc.), uncontrolled hypertension, increased risk of tumor progression/ recurrence in patients with cancer, seizures, pure red cell aplasia, serious allergic reactions (anaphylaxis, angioedema, bronchospasm, etc.), severe cutaneous reactions (erythema multiforme, Stevens-Johnson Syndrome [SJS]/Toxic Epidermal Necrolysis [TEN], etc.), “gasping syndrome” (central nervous system depression, metabolic acidosis, gasping respirations) due to benzyl alcohol preservative, etc.; AND

Anemia Secondary to Myelodysplastic Syndrome (MDS):

  • Hemoglobin (Hb) <12 g/dL and/or Hematocrit (Hct) <36%

Anemia Secondary to Myeloproliferative Neoplasms - Myelofibrosis

  • Hemoglobin (Hb) <10 g/dL and/or Hematocrit (Hct) <30%

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

  • Coverage may not be renewed.

Anemia Secondary to Chemotherapy Treatment

  • Refer to Section III for criteria (age was met initially)

Anemia Secondary to Zidovudine Treated, HIV-Infected Patients:

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

Anemia Secondary to Chronic Kidney Disease:

  • Pediatric patients: Hemoglobin (Hb) < 12 g/dL and/or Hematocrit (Hct) < 36%
  • Adults: Hemoglobin (Hb) < 11 g/dL and/or Hematocrit (Hct) < 33%

* Intravenous iron supplementation may be taken into account when evaluating iron status

  • Functional iron deficiency (i.e., adequate iron stores with an insufficient supply of available iron) may occur in patients with chronic diseases, cancer, and/or in those currently receiving ESAs.
  • Iron is not generally recommended in anemic patients with a Ferritin >500 ng/mL
  • Anemic patients with a Ferritin ≤500 ng/mL AND TSAT <50% may derive benefit from IV iron therapy in conjunction with ESA
  1. Dosage/Administration 1-3,24,28

Indication

Dose

Anemia due to CKD – non-dialysis§

  • Adult patients: 50-100 units/kg intravenously or subcutaneously three times weekly
  • Pediatric patients: 50 units/kg intravenously or subcutaneously three times weekly

Anemia due to HIV on zidovudine§

  • 100 units/kg intravenously or subcutaneously three times weekly
  • May titrate up to 300 units/kg per dose

Anemia due to chemotherapy§

  • Adult patients: 150 units/kg subcutaneously three times weekly or 40,000 units subcutaneously once weekly
    • May titrate up to 300 units/kg subcutaneously three times weekly or 60,000 units subcutaneously once weekly
  • Pediatric patients (5-18 years): 600 units/kg intravenously once weekly
    • May titrate up to 900 units/kg intravenously once weekly

Perioperative use

  • 300 units/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery (15 days total)

-OR-

  • 600 units/kg/dose subcutaneously on days 21, 14, and 7 before surgery plus 1 dose on the day of surgery (4 total doses)

Anemia due to MDS§

  • 40,000 to 60,000 units subcutaneously once to twice weekly

Anemia due to myeloproliferative neoplasms (MPN)§

  • 10,000 units subcutaneously three times weekly
  • May increase dose to 20,000 units subcutaneously three times weekly

Most commonly initiated dose

40,000 units weekly

§

  • For patients with CKD,
  • Dose increases of 25% can be considered if after 4 weeks of initial therapy the hemoglobin has increased less than 1 g/dL and the current hemoglobin level is less than the indication specific level noted above.
  • Dose decreases of 25% or more can be considered if the hemoglobin rises rapidly by more than 1 g/dL in any 2-week period.
  • Dose and frequency requested are the minimum necessary for the patient to avoid RBC transfusions.
  • Avoid frequent dose adjustments. Do not increase the dose more frequently than once every 4 weeks; decreases can occur more frequently.
  • If patients fail to respond over a 12-week dose escalation period, further doses increases are unlikely to improve response and discontinuation of therapy should be considered.
  • For patients with MDS:
  • After 3 to 4 months of therapy, if there is no response as measured by at least a 1.5 g/dL increase in hemoglobin or a decrease in RBC transfusions, discontinuation of therapy should be considered.
  • For patients with MPN:
  • After 3 months of therapy, if there is no response as measured by at least a 2 g/dL increase in hemoglobin or a decrease in RBC transfusions, discontinuation of therapy should be considered.
  • For patients on Cancer Chemotherapy
  • After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue therapy.
  • For zidovudine treated HIV infected patients
  • If the patient fails to respond after 8 weeks of therapy, increase dose by approximately 50-100 U/kg at 4- to 8- week intervals until the hemoglobin reaches levels needed to avoid transfusion or max dose of 300 U/kg is reached.
  • If the hemoglobin exceeds the indication specific level noted above, withhold therapy and resume therapy once level declines to <11 g/dL, at a dose 25% below the previous dose.

  1. Billing Code/Availability Information

HCPCS code:

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

NDC:

Brand

HCPCS

Strength

MDV or SDV

MDV Size

NDC

Epogen

J0885

2,000 U/mL

SDV

55513-0126

Epogen

J0885

3,000 U/mL

SDV

55513-0267

Epogen

J0885

4,000 U/mL

SDV

55513-0148

Epogen

J0885

10,000 U/mL

SDV

55513-0144

Epogen

J0885

10,000 U/mL

MDV

2 mL

55513-0283

Epogen

J0885

20,000 U/mL

MDV

1 mL

55513-0478

Procrit

J0885

2,000 U/mL

SDV

59676-0302

Procrit

J0885

3,000 U/mL

SDV

59676-0303

Procrit

J0885

4,000 U/mL

SDV

59676-0304

Procrit

J0885

10,000 U/mL

SDV

59676-0310

Procrit

J0885

10,000 U/mL

MDV

2 mL

59676-0312

Procrit

J0885

20,000 U/mL

MDV

1 mL

59676-0320

Procrit

J0885

40,000 U/mL

SDV

59676-0340

Retacrit

Q5106

2,000 U/mL

SDV

00069-1305

Retacrit

Q5106

3,000 U/mL

SDV

00069-1306

Retacrit

Q5106

4,000 U/mL

SDV

00069-1307

Retacrit

Q5106

10,000 U/mL

SDV

00069-1308

Retacrit

Q5106

10,000 U/mL

MDV

2 mL

00069-1318

Retacrit

Q5106

20,000 U/mL

MDV

1 mL

00069-1311

Retacrit

Q5106

40,000 U/mL

SDV

00069-1309

  1. References
  1. Procrit [package insert]. Horsham, PA; Janssen, LP; July 2018. Accessed April 2021. 
  2. Epogen [package insert]. Thousand Oaks, CA; Amgen, Inc; July 2018. Accessed April 2021.
  3. Retacrit [package insert]. Lake Forest, IL; Hospira, Inc; August 2020. Accessed April 2021.
  4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) epoetin alfa. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2021.
  5. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Hematopoietic Growth Factors – Management of Cancer-and Chemotherapy-Induced Anemia Version 2.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2021.
  6. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Myelodysplastic Syndrome Version 3.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2021.
  7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Myeloproliferative Neoplasms Version 1.2020. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2021.
  8. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl. 2012;2(suppl):279-335. https://kdigo.org/guidelines/anemia-in-ckd/. Published August 2012.
  9. Piccoli A, Malagoli A, Komninos G, Pastori G. Subcutaneous epoetin-alpha every one, two, and three weeks in renal anemia. J Nephrol. 2002;15(5):565-574.
  10. Provenzano R, Bhaduri S, Singh AK; PROMPT Study Group. Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study. Clin Nephrol. 2005;64(2):113-123.
  11. Provenzano R, Garcia-Mayol L, Suchinda P,et al; POWER Study Group. Once-weekly epoetin alfa for treating the anemia of chronic kidney disease. Clin Nephrol. 2004;61(6):392-405.
  12. Singh AJ, Szczech L, Tang Kl, et al, “Correction of Anemia With Epoetin Alfa in Chronic Kidney Disease,” N Engl J Med, 2006, 355(20):2085-98.
  13. Fishbane S, Spinowitz BS, Wisemandle WA, et al. Randomized Controlled Trial of Subcutaneous Epoetin Alfa-epbx Versus Epoetin Alfa in End-Stage Kidney Disease. Kidney Int Rep. 2019 May 22;4(9):1235-1247.
  14. Thadhani R, Guilatco R, Hymes J, et al. Switching from Epoetin Alfa (Epogen®) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis. Am J Nephrol. 2018;48(3):214-224.
  15. Fishbane S, Singh B, Kumbhat S, et al. Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease. Clin J Am Soc Nephrol. 2018 Aug 7;13(8):1204-1214.
  16. US Food and Drug Administration. FDA briefing document. Oncologic Drugs Advisory Committee Meeting. BLA 125545: Epoetin Hospira, a proposed biosimilar to Epogen/Procrit (epoetin alfa). Hospira Inc., a Pfizer Company. May 25, 2017.
  17. Fenaux P, Santini V, Spiriti MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658. doi: 10.1038/s41375-018-0118-9.
  18. Park S, Greenberg P, Yucel A, et al. Clinical effectiveness and safety of erythropoietin-stimulating agents for the treatment of low- and intermediate-1-risk myelodysplastic syndrome: a systematic literature review. Br J Haematol. 2019;184(2):134-160. doi: 10.1111/bjh.15707
  19. Greenberg PL, Sun Z, Miller KB, et al. Treatment of myelodysplastic syndrome patients with erythropoietin with or without granulocyte colony-stimulating factor: results of a prospective randomized phase 3 trial by the Eastern Cooperative Oncology Group (E1996). Blood. 2009;114(12):2393-2400.
  20. Peeters, HR, Jongen-Lavrencic, M, Vreugdenhil, G, Swaak, AJ. Effect of recombinant human erythropoietin on anaemia and disease activity in patients with rheumatoid arthritis and anaemia of chronic disease: a randomized placebo controlled double blind 52 weeks clinical trial. Ann Rheum Dis 1996; 55:739.
  21. Pincus T, Olsen NJ, Russell IJ, et al. Multicenter study of recombinant human erythropoietin in correction of anemia in rheumatoid arthritis. Am J Med 1990; 89:161-8.
  22. Saag, MS, Bowers, P, Leitz, GJ, Levine, AM. Once-weekly epoetin alfa improves quality of life and increases hemoglobin in anemic HIV+ patients. AIDS Res Hum Retroviruses 2004; 20:1037.
  23. Grossman, HA, Goon, B, Bowers, P, Leitz, G. Once-weekly epoetin alfa dosing is as effective as three times-weekly dosing in increasing hemoglobin levels and is associated with improved quality of life in anemic HIV-infected patients. J Acquir Immune Defic Syndr 2003; 34:368.
  24. Cervantes F, Alvarez-Laran A, Hernandez-Boluda JC, et al. Erythropoietin treatment of the anaemia of myelofibrosis with myeloid metaplasia: results in 20 patients and review of the literature. British Journal of Haematology, 127: 399–403. doi:10.1111/j.1365-2141.2004.05229.x
  25. Shaffer CL, Ransom JL. Current and theoretical considerations of erythropoietin use in anemia of bronchopulmonary dysplasia. J of Pediatric Pharmacy Practice 1996; 1:23-29.
  26. Reiter PD, Rosenberg AA, Valuck RJ. Factors associated with successful epoetin alfa therapy in premature infants. Ann Pharmacother 2000; 34:433-439.
  27. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) epoetin alfa-epbx. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2021.
  28. Tsiara SN, Chaidos A, Bourantas LK, et al. Recombinant human erythropoietin for the treatment of anaemia in patients with chronic idiopathic myelofibrosis. Acta Haematol. 2007;117(3):156-61. doi: 10.1159/000097463.
  29. Mikhail A, Brown C, Williams JA, et al. Renal association clinical practice guideline on Anaemia of Chronic Kidney Disease. BMC Nephrol. 2017 Nov 30;18(1):345. doi: 10.1186/s12882-017-0688-1.
  30. Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD):  Erythropoiesis Stimulating (ESAs) (L34633). Centers for Medicare & Medicaid Services, Inc. Updated on 12/16/2019 with effective dates 02/09/2020. Accessed April 2021.
  31. CGS Administrators, LLC. Local Coverage Determination (LCD): Erythropoiesis Stimulating Agents (ESA) (L34356). Centers for Medicare & Medicare Services. Updated on 02/24/2021 with effective dates 03/04/2021. Accessed April 2021.
  32. First Coast Service Options, Inc. Local Coverage Determination (LCD): Erythropoiesis Stimulating Agents (L36276). Centers for Medicare & Medicare Services. Updated on 10/25/2019 with effective dates 10/29/2019. Accessed April 2021.
  33. National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions (110.21). Centers for Medicare & Medicare Services, Inc. Updated 01/14/2021 with an effective date 07/30/2007. Accessed April 2021.
  34. Wisconsin Physicians Service Insurance Corporation. Local Coverage Article (LCA): Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) (A56795). Centers for Medicare & Medicaid Services, Inc. Updated on 09/21/2020 with effective dates 10/01/2020. Accessed April 2021.
  35. First Coast Service Options, Inc. Local Coverage Article (LCA): Billing and Coding: Erythropoiesis Stimulating Agents (A57628). Centers for Medicare & Medicaid Services. Updated on 09/25/2020 with effective dates 10/01/2020. Accessed April 2021.
  36. CGS Administrators, LLC. Local Coverage Article (LCA): Billing and Coding: Erythropoiesis Stimulating Agents (ESA) (A56462). Centers for Medicare & Medicaid Services. Updated on 02/24/2021 with effective dates 03/04/2021. Accessed April 2021.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

B20

Human immunodeficiency virus [HIV] disease

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

D46.9

Myelodysplastic syndrome, unspecified

D46.A

Refractory cytopenia with multilineage dysplasia

D46.B

Refractory cytopenia with multilineage dysplasia and ring sideroblasts

D46.C

Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

D46.Z

Other myelodysplastic syndromes

D47.1

Malignant neoplasm of peripheral nerves of upper limb, including shoulder

D47.4

Malignant neoplasm of peripheral nerves of abdomen

D61.1

Drug-induced aplastic anemia

D63.0

Anemia in neoplastic disease

D63.1

Anemia in chronic kidney disease

D63.8

Anemia in other chronic diseases classified elsewhere

D64.81

Anemia due to antineoplastic chemotherapy

D64.9

Anemia unspecified

D75.81

Secondary polycythemia

I12.9

Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease

I13.0

Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease

I13.10

Hypertensive heart and chronic kidney disease without heart failure, with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease

N18.30

Chronic kidney disease, stage 3 (moderate), unspecified

N18.31

Chronic kidney disease, stage 3a

N18.32

Chronic kidney disease, stage 3b

N18.4

Chronic kidney disease, stage 4 (severe)

N18.9

Chronic kidney disease, unspecified

Z41.8

Encounter for other procedures for purposes other than remedying health state

Z51.11

Encounter for antineoplastic chemotherapy

Z51.89

Encounter for other specified aftercare

Dual coding requirements:

  • Preoperative use: must bill D63.8 or D64.9 AND Z41.8
  • Anemia due to zidovudine in HIV patients: must bill D61.1 AND B20
  • Anemia due to CKD (not on dialysis): must bill D63.1 AND N18.31, N18.32, or N18.4

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): ALL

NCD/LCD Document (s): NCD110.21

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=110.21&bc=gAAAAAAAAAAAAA%3d%3d&

Jurisdiction(s): 5, 8

NCD/LCD Document (s): L34633

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L34633&bc=gAAAAAAAAAAAAA==

Jurisdiction(s): 15

NCD/LCD Document (s): L34356

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L34356&bc=gAAAAAAAAAAAAA==

Jurisdiction(s): N

NCD/LCD Document (s): L36276

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L36276&bc=gAAAAAAAAAAAAA==

 

Jurisdiction(s): 5, 8

NCD/LCD Document (s): A56795

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56795&bc=gAAAAAAAAAAA

Jurisdiction(s):  N

NCD/LCD Document (s): A57628

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A57628&bc=gAAAAAAAAAAA

Jurisdiction(s):  15

NCD/LCD Document (s): A56462

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56462&bc=gAAAAAAAAAAA

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

Epoetin alfa (Epogen®; Procrit®; Retacrit™)

Non-Dialysis Prior Auth Criteria
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White MRx.PNG