Erythropoiesis Stimulating Agents (ESAs)

Title XVIII of the Social Security Act (SSA)

• Title XVIII of the Social Security Act, Section 1842 (u) Each request for payment, or bill submitted, for a drug furnished to an individual for the treatment of anemia in connection with the treatment of cancer shall include information on the hemoglobin or hematocrit levels for the individual.
• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
• Title XVIII of the Social Security Act, Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
• Title XVIII of the Social Security Act (SSA), Section 1881(b)(1) allows payment for services furnished to individuals who have been determined to have end stage renal disease.
• Title XVIII of the Social Security Act (SSA), Section 1881(11)(B)(i) allows payment for erythropoietin provided by a physician.

IOM Citations:

• CMS Publication 100-02 Medicare Benefit Policy Manual,
  • Chapter 1 – Inpatient Hospital Services Covered Under Part A, Section 30 - Drugs and Biologicals,
  • Chapter 6 – Hospital Services Covered Under Part B, Sections 10.2 – Other Circumstances in Which Payment Cannot be Made Under Part A and 30 - Drugs and Biologicals,
  • Chapter 11 – End Stage Renal Disease (ESRD), Sections 20.3 – Drugs and Biologicals,
  • Chapter 13 – Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Services, Section 120 Services and Supplies Furnished Incident to Physician’s Services, and
  • Chapter 15 – Covered Medical and Other Health Services,
    • Sections 50- Drugs and Biologicals,
    • 50.2 –Determining Self-Administration of Drug or Biological and
    • 50.5.2 – Erythropoietin (EPO).
• CMS Publication 100-03 Medicare National Coverage Determinations (NCD) Manual
  • Chapter 1- Coverage Determinations, Part 2 Section 110.21 - Erythropoiesis Stimulating Agents (ESA’s) in Cancer and Related Neoplastic Conditions.
• CMS Publication 100-04 Medicare Claims Processing Manual,
  • Chapter 4 – Part B Hospital (Including Inpatient Hospital Part B and OPPS),
    • Sections 10 – Hospital Outpatient Prospective Payment System (OPPS),
    • 20 – Reporting Hospital Outpatient Services Using Healthcare Common Procedure Coding System (HCPCS),
    • 50.1 – Outpatient Provider Specific File, and
    • 200.2 – Hospital Dialysis Services for Patients with and without End State Renal Disease (ESRD).
  • Chapter 6 – Inpatient Part A Billing and SNF Consolidated Billing,
    • Sections 10.1 – Consolidate Billing Requirement for SNF,
    • 20 – Services Included in Part A PPS Payment not billable separately by the SNF,
    • 20.2.1 – Dialysis and Dialysis Related Services to a Beneficiary with ESRD, and
    • 20.2.1.1 – ESRD Services.
    • 20.2.1.4 Coding Applicable to EPO Services
  • Chapter 7 - SNF Part B Billing (Including Inpatient Part B and Outpatient Fee Schedule), Section 100 – Epoetin (EPO).
  • Chapter 8 - Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims,
  • Sections 10 – General Description of ESRD Payment and Consolidated Billing Requirements,
    • 10.5 – Hospital Services,
    • 40.85– Pediatric Payment Model for ESRD PPS,
    • 50.1.5 – Lab Services Included in the PPS,
    • 50.2 – Drugs and Biologicals Included in the Composite Rate,
    • 50.2.5 – Drugs and Biologicals Included in the PPS,
    • 50.3 – Required Information for In-Facility Claims Paid Under the Composite Rate and the ESRD PPS,
    • 60.2 – Drugs Furnished in Dialysis Facilities,
    • 60.2.1.1 – Separately Billable ESRD Drugs,
    • 60.2.1.2 – Facilities Billing for ESRD Oral Drugs as Injectable Drug Equivalents,
    • 60.4 - Erythropoietin Stimulating Agents (ESAs),
    • 60.4.1 – ESA Claims Monitoring Policy,
    • 60.4.2 – Facility Billing Requirements for ESAs,
    • 60.4.4 – Payment Amount for Epoetin Alfa (EPO),
    • 60.4.4.1 – Payment for Epoetin Alfa (EPO) in Other Settings,
    • 60.4.4.2 – Epoetin Alfa (EPO) Provided in the Hospital Outpatient Departments,
    • 60.4.5.1 – Self Administered ESA Supply,
    • 60.4.6.3 - Payment for Darbepoetin Alfa (Aranesp),
    • 60.4.6.4 - Payment for Darbepoetin Alfa (Aranesp) in Other Settings,
  • Chapter 17 - Drugs and Biologicals,
    • Sections 10 – Payment Rules for Drugs and Biologicals,
    • 20.5.8 – Injections Furnished to ESRD Beneficiaries,
    • 40.1 – Discarded Erythropoietin Stimulating Agents for Home Dialysis,
    • 80.5 – Self Administered Drugs,
    • 80.8 - Reporting of Hematocrit and/or Hemoglobin Levels,
    • 80.9 – Required Modifiers for ESAs Administered to Non-ESRD patients,
    • 80.10 – Hospitals Billing for Epoetin Alfa (EPO) and Darbepoetin Alfa (Aranesp) for Non-ESRD patients,
    • 80.11 – Requirements for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs),
    • 80.12 – Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia Therapy, and
    • 100 – The Competitive Acquisition Program (CAP) for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis.
• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.
• CMS Publication 100-09, Medicare Contractor Beneficiary and Provider Communication Manual, Chapter 5 - Correct Coding Initiative.
• CMS Coverage & Analysis Group, Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (CAG-00383N), July 30, 2007.

Change Request References:

• CR 10318 ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs), January 18, 2018. NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer)
• CR 10818, Quarterly Update to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Effective July 1, 2018
• CR 10781, July 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS), Effective July 1, 2018
• CR 10624 Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes, Effective July 1, 2018
• CR 10859 Transmittal 2200 Issued 11/02/2018: Tenth Revisions (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2019
• CR 11005 Transmittal 2202 Issued 11/9/2018 International Classification of Diseases, 10th Revision, (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2017
• CR 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019
• CR 11244 Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS) Effective 01/01/2020
• CR 12027 Transmittal 10566 Issued 01/14/2021 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)-effective April 1, 2021

Naturally occurring human erythropoietin (EPO) is a glycoprotein produced mainly in the kidneys. It stimulates the division and differentiation of committed erythroid progenitors in bone marrow. A number of chronic conditions, especially chronic renal failure, result in decreased production of or relative resistance to erythropoietin, often causing anemia. Supplementation by synthetic drugs with structures identical or similar to naturally occurring erythropoietin has been proven safe and effective in correcting anemia in certain groups of patients. Normal plasma erythropoietin levels may vary from 0.01 to 0.03 U/ml (10-30 mU/mL). These levels may increase 100 to 1000 - fold during hypoxia or anemia, and one may see levels from 1,000 to 30,000 mU/mL. Certain conditions blunt this normal physiological response to anemia and so erythropoietin levels do not rise. This causes or aggravates anemia. Anemia of chronic renal failure, as well as certain other anemias, despite adequate erythropoietin levels, may respond to supplemental erythropoietin administration.

Erythropoietin stimulating agents (ESAs) are a covered benefit to treat patients who have one of the FDA approved conditions, and have either symptomatic anemia or are transfusion dependent:

Group A: End Stage Renal Disease (ESRD) ON Dialysis
Group B: Chronic Kidney Disease (CKD) NOT on Dialysis
Group C: Indications other than Renal Disease

Group A: End Stage Renal Disease (ESRD) ON dialysis
The likelihood of anemia associated with erythropoietin deficiency increases as renal failure progresses, because the diseased kidneys are unable to produce sufficient quantities of erythropoietin. The anemia of Chronic Renal Failure (CRF) should not be confused with the anemia of chronic disease. In the latter, inflammatory cytokines suppress the endogenous production of erythropoietin and erythropoiesis directly. Measurable levels of circulating cytokines may be found in stable dialysis patients, but, in the absence of inflammation, do not adversely affect the action of ESAs. In patients with impaired renal function and a normochromic, normocytic anemia, it is rare for the serum erythropoietin level to be elevated. Therefore, measurement of erythropoietin levels in such patients is not likely to guide clinical decision making or ESA therapy. Anemia can develop relatively early in the course of CRF and has been associated with a serum creatinine as low as 2.0 mg/dL.

1. The hemoglobin level prior to initiation of ESA treatment is less than 10 g/dL (or the hematocrit is less than 30%).
2. Diagnosis of end stage renal disease

Group B: Chronic Kidney Disease NOT on dialysis

1. The hemoglobin level prior to initiation of ESA treatment is less than 10 g/dL (or the hematocrit is less than 30%).
2. Serum creatinine equal to or greater than 3, creatinine clearance less than 60 ml/min, or glomerular filtration rate (GFR) less than 60 mL/min/1.73 m2.

This local policy defines the potential eligibility for coverage of ESAs in the treatment of anemia in patients with chronic renal failure/insufficiency. For this purpose, WPS adopts the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) recommendation, derived largely from the NHANES III analysis. Patients with glomerular filtration rate (GFR) Grade III or higher, a GFR less than 60 ml/min/1.73m 2, should be evaluated for anemia and treated with an erythropoietic agent if appropriate and in accordance with the NKF Guidelines for Anemia of Chronic Kidney Disease.

Group C: Indications other than Renal Disease

1. Anemia associated with cancer and related Neoplastic conditions.
   This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to CMS Pub 100-03 Medicare National Coverage Determination (NCD) Manual, Chapter 1 – Coverage Determinations, Part 2 Section 110.21 – Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions.
   • The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is less than 10 g/dL (or the hematocrit is less than 30%).
     
     
2. Anemia related to therapy with Zidovudine (AZT) and/or other Nucleoside Reverse Transcriptase Inhibitors (NRTI) therapy for acquired immunodeficiency syndrome (AIDS) or AIDS-related complex (ARC) must meet the coverage requirements in CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services, Section - 50.5.2. – Erythropoietin (EPO) (Rev. 1, 10-01-03).
   • The hemoglobin level prior to initiation of ESA treatment is less than 10 g/dL (or the hematocrit is less than 30%).
     
     
3. Anemia associated with chemotherapeutic medications when medically necessary for a non-cancer diagnosis or following stem cell transplantation and associated immunosuppression.
   • The hemoglobin level prior to initiation of ESA treatment is less than 10 g/dL (or the hematocrit is less than 30%).
     
     
4. Myelodysplastic Syndrome (MDS)
   Anemia is observed in 90 percent of individuals with MDS. Those MDS patients with an endogenous erythropoietin level of less than 500 mU/mL are more likely to respond to ESA therapy.
   • ESA therapy is indicated for patients who meet the following:
     1. Have a confirmed diagnosis of MDS with a bone marrow biopsy,
     2. the anemia is symptomatic,
     3. there is reasonable expectancy of longer survival,
     4. therapy will end or reduce the need for transfusions,
     5. Anemia with Hgb is less than or equal to 10g/dL or HCT is less than or equal to 30%, one week before the initial injection.
     6. pretreatment erythropoietin levels of 500 or less
   • If after two months of treatment, there is no significant increase in Hgb/HCT and/or a significant decrease in transfusion requirements, erythropoietin analogs therapy should be stopped.
     
     
5. Anemia of Chronic disease (Anemia of inflammatory disease)
   In anemia of chronic disease, inflammatory cytokines suppress the endogenous production of erythropoietin and erythropoiesis directly. This anemia usually results from a combination of slightly shortened red blood cell survival, the sequestration of iron in the reticuloendothelial systems, and erythropoietin levels that are less than expected for the degree of anemia. The diagnosis is usually exclusionary, meaning other causes of the anemia have been ruled out.
   
   Anemia of cancer is not considered a chronic disease for this purpose and should not be billed as such. Medicare will cover the use of epoetin alfa or darbepoetin alfa for the refractory anemia of chronic disease for patients with Rheumatoid Arthritis, Systemic Lupus Erythematosis, Chronic Hepatitis C, Crohn's Disease and Ulcerative Colitis when one of the conditions listed below in A is met along with both B and C criteria:
   1. At least one of the conditions below:
      • low or normal serum iron
      • low or normal iron binding capacity
      • normal or elevated serum ferritin
      • adequate iron stores in bone marrow
   2. The pretreatment HCT level is 30 percent or less and/or if the patient has been transfusion dependent.
   3. The pretreatment erythropoietin level is 100 mU/mL or less.
      
      
6. Prophylactic pre-operative use for reduction of allogenic blood transfusions prior to elective hip and knee replacement surgery. (CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services, Section - 50.5.2.2 - Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use (Rev. 1, 10-01-03).).
   
   Epoetin alfa or Darbepoetin alfa are covered for use in specific patients prior to surgery to reduce risk of transfusion:
   • who are undergoing hip or knee surgery;
   • have an anemia with a hemoglobin between 10 and 13 gm/dL. (this indication requires a lead time of at least 3 weeks prior to surgery);
   • are not candidates for autologous blood transfusion;
   • are expected to lose more than 2 units of blood; and
   • have had a work-up so that their anemia appears to be that of chronic disease.
     
     
   A weekly dosage regimen for 3 weeks prior to surgery (e.g., days 21, -14, -7) and on the day of surgery will be covered. The components listed above must be documented in the medical record. Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving ESAs who were not receiving prophylactic anticoagulation.
   
   
7. Prophylactic pre-operative use for reduction of allogenic blood transfusions prior to elective noncardiac or nonvascular surgery.
   Epoetin alfa-epbx (biosimilar) is covered for use in specific patients who are at high risk for perioperative blood loss prior to surgery to reduce risk of transfusion:
   • who are undergoing elective, noncardiac or nonvascular surgery;
   • have an anemia with a hemoglobin > 10 to < 13 gm/dL;
   • are not candidates for autologous blood transfusion.
     
     
   The recommended Epoetin alfa-epbx (biosimilar) regimens are:
   • 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before
     surgery, on the day of surgery, and for 4 days after surgery.
   • 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery.
     
     
   The components listed above must be documented in the medical record.
   Deep venous thrombosis prophylaxis is recommended during Epoetin alfa-epbx (biosimilar) therapy.
   
   
8. Myelofibrosis
   Primary myelofibrosis (PMF) is a myeloproliferative neoplasm (MPN) associated with bone marrow fibrosis, cytopenias, constitutional symptoms, hepatosplenomegaly, and/or extramedullary hematopoiesis.
   
   Anemia is considered a negative prognostic risk factor for survival in patients with PMF. Symptomatic anemia is observed in more than 50% of the patients at the time of diagnosis. It is essential to rule out and treat the most commons cause of anemia before considering other treatment options.
   Leukoreduced RBC transfusion support is recommended for symptomatic anemia, EPO-stimulating agents (ESAs), danazol and immunomodulatory agents (lenalidomide, thalidomide, and pomalidomide) have also been evaluated for the management of PMF-associated anemia.
   The use of recombinant human EPO or darbepoetin alfa has resulted in anemia responses (transfusion independence with normal hemoglobin levels, sustained increase in hemoglobin level s[>2g/dl] within 12 weeks, or >50% reduction in transfusion requirements within 12 weeks) in 45% to 60% of patients. Lowered serum EPO levels (<125mU/ml), smaller spleen size, and low RBC transfusion requirements have been associated with favorable responses.
   
   Primary myelofibrosis is overlapping with Myelodysplastic Syndrome (MDS) on the spectrum, and like MDS, diagnosed by bone marrow pathology.

Goals of ESA Therapy

The goals of ESA Therapy are based on the medication used and the condition being treated as well as individual response to the medication. Doses must be titrated according to the patient’s response. ESA therapy need not be stopped completely simply due to the achievement of the target Hgb and/or Hct. However, judicious, appropriately timed dose adjustments are expected to prevent inappropriate increases in Hgb and Hct levels. Continued use and determination of dosage level must be medically reasonable and necessary.

Review of Management of Primary Myelofibrosis (PMF)in UpToDate authored by Ayalew Tefferi, MD suggests that anemia in PMF is a significant source of impaired quality of life, and may cause fatigue, weakness, exercise intolerance, angina, dizziness, cognitive impairment, or an altered sense of well-being. Patients should be evaluated for bleeding, hemolysis, and nutritional deficiencies, and other remediable causes. Most reported responses to erythropoietin stimulating agents (ESA) in patients with PMG were noted in those patients not requiring transfusion support and/or those with inappropriately low serum erythropoietin levels.
NCCN Version 2.2019 Myeloproliferative Neoplasms suggest using ESA in the management of myelofibrosis associated anemia after ruling out coexisting causes and treating those coexisting causes in anemic patients with serum erythropoietin levels under 500mU/ml.

Quality-Moderate
Strength-Moderate
Weight-Weak

Documentation Requirements
Adequate documentation is essential for high-quality patient care and to demonstrate the reasonableness and medical necessity of the medication administrated. Documentation must support the criteria for coverage as described in the Coverage Indications, Limitations, and/or Medical Necessity section of this LCD. This information along with the documentation requirements listed below must be in the patient’s medical record and available to Medicare upon request. Diagnosis codes must be submitted with each claim, along with lab results to support the diagnosis and required parameters listed in the LCD.

When ESAs are used for the treatment of Myelodysplastic Syndrome (MDS), the following information must be included in the patient's record:

1. an Erythropoietin level (less than or equal to 500 IU/L) is required,
2. report of bone marrow biopsy supporting diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia as listed above,
3. the start date at the beginning of the trial period,
4. if treatment is responsive or non-responsive at the end of the trial. A trial need not take the entire 12 weeks, if it is determined earlier that the patient is not responding this must be documented in the patient's record,
5. pretreatment Hgb or HCT level obtained within one week of the initial injection,
6. laboratory results pertinent to treatment such as serum ferritin, serum transferrin, Hgb or HCT with date obtained, and
7. a narrative evaluation regarding response to the therapy.

When ESAs are given for ESRD/CKD the following information must be in the patient’s record:

NOTE: Creatinine and weight identified below are required on EPO claims as applicable.

• Date of the Patient’s most recent HCT or Hgb.
• Most recent HCT or Hgb level - (prior to initiation of EPO therapy).
• Date of most recent HCT or Hgb level - (prior to initiation of EPO therapy).
• Patient’s most recent serum creatinine - (within the last month, prior to initiation of EPO therapy).
• Date of most recent serum creatinine - (prior to initiation of EPO therapy).
• Patient’s weight in kilogram.
• Patient’s starting dose per kilogram - (The usual starting dose is 50-100 units per kilogram.)

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 8 – Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.4 - Payment Amount for Epoetin Alfa. (EPO) (Rev. 10640, Issued:08-06-21, Effective:09-07-21, Implementation:09-07-21).

Payment for ESRD-related EPO is included in the ESRD Prospective Payment System and is not separately payable on Part B claims with dates of service on or after January 1, 2011.

Utilization Guidelines
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 -Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1 – ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Epogen® is reduced to 400,000 units from 500,000. Maximum Allowable Administrations The maximum number of administrations of EPO for a billing cycle is 13 times in 30 days and 14 times in 31 days.

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 - Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1- ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Aranesp® is reduced to 1200 mcg from 1500 mcg. Darbepoetin alfa is given not more than once per week according to its Food and Drug Administration approved labeling. Maximum Allowable Administrations The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30 / 31 days.

Effective January 1, 2020 the MUEs for ESAs exceeding the threshold limits above are discontinued under the ESRD PPS.

Effective January 1, 2012, ESRD facilities are required to report hematocrit or hemoglobin levels on all ESRD claims. Reporting the value 99.99 is not permitted when billing for an ESA.

Cotter, D., Thamer, M., Narasimhan, K., Zhang, Y., & Bullock, K. Translating Epoetin research into practice: the role of government and the use of scientific evidence. Health Affairs. 2006, 25(5):1249-1259.

Drueke, T.B., Locatelli, F., Clyne, N., & et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. The New England Journal of Medicine. 2006, 355(20):2071-2084.

Giannouli, S., Voulgarelis, M., Ziakas, P.D., & Tziousfas, A.G.. Anaemia is systemic lupus erythematosus: from pathophysiology to clinical assessment. Annals of the Rheumatic Diseases. 2006, 65(2):144-148.

Grossi, A., & Liumbruno, G.M. New drugs in the treatment of myelodysplastic syndromes: Are they changing the role of transfusion support? Blood Transfusion. 2008, 6(4):191-198.

Kliger AS, Foley RN, Goldfarb DS, et al. Kdoqi US commentary on the 2012 KDIGO clinical practice ... - ajkd.org. https://www.ajkd.org/article/S0272-6386(13)00978-5/full. Accessed April 19, 2023.

Mannone, L., Gardin, C., Quarre, M.C., & et. al. High-dose Darbepoetin alpha in the treatment of anaemia of lower risk myelodysplastic syndrome results of a phase II study. British Journal of Haematology. 2006, 133(5):513-519.

National Comprehensive Cancer Network. NCCN Guidelines Version 2.2015 Cancer – and Chemotherapy-Induced Anemia. NCCN Clinical Practice Guidelines in Oncology 2014.

Park, S., Grabar, S., Kelaidi, C., & et al. Predictive factors of response and survival in myelodysplastic syndrome treated with erythropoietin and G-CSF: the GFM experience. Blood. 2008, 111(2):574-782.

Singh, A.K., Szczech, L., Tang, K.L., & et al. Correction of anemia with Epoetin alfa in chronic kidney disease. The New England Journal of Medicine. 2006, 355(20):2085-2098.

Tortorice, K., Yee, H., Bini, E., & et. al. Recombinant Erythropoietin Criteria for Use for Hepatitis C Treatment-Related Anemia. VA Government 2007.

Van Wyck, D.B., Eckardt, K.W., Adamson, J.W., 7 et al. KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. American Journal of Kidney Diseases. 2007, 50(3):471-530.

FDA labels

Tefferi, A. Management of Primary Myelofibrosis. UpToDate website. https://www.uptodate.com/
Updated Jul 30, 2019. Accessed Aug. 07, 2019.

National Comprehensive Cancer Network (NCCN). https://www.nccn.org/
Guidelines for Treatment of Cancer by Site: Myeloproliferative Neoplasms, Version 1.2021 April 13, 2021. Accessed May 24, 2021.

The World Health Organization (WHO) https://www.who.int/. Classification of myeloid neoplasm and acute leukemia, International Classification of Diseases. ICD-10 online version. Accessed Aug. 08, 2019.