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LCD ID Number: L34633 Status: A-Approved
LCD Title: Erythropoiesis Stimulating Agents (ESAs)
Geographic Jurisdiction: Michigan Other Jurisdictions
Original Determination Effective Date:
10/01/2015
Original Determination Ending Date:
Revision Effective Date:
06/01/2023
Revision End Date:
CMS National Coverage Policy:
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
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