LCD ID Number: L36276 Status: A-Approved
LCD Title: Erythropoiesis Stimulating Agents
Geographic Jurisdiction: Florida Other Jurisdictions
Original Determination Effective Date:
Original Determination Ending Date:
Revision Effective Date:
Revision End Date:
CMS National Coverage Policy:
This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Erythropoiesis Stimulating Agents. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Erythropoiesis Stimulating Agents and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.
Internet Only Manual (IOM) Citations:
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
- Chapter 6, Sections 10.2, Other Circumstances in Which Payment Cannot Be Made Under Part A and Section 30 Drugs and Biologicals
- Chapter 11, Section 20.3 Drugs and Biologicals, and 100.6 Applicability of Specific ESRD PPS Policies to AKI Dialysis
- Chapter 15, Section 50.5.2 Erythropoietin (EPO)
- CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
- Chapter 1, Part 2, Section 110.21 Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Condition
- CMS IOM Publication 100-04, Medicare Claims Processing Manual,
- Chapter 6, Section 20.2 Services Excluded from Part A PPS payment
- Chapter 7, Section 100 Epoetin (EPO)
- Chapter 8, Section 30 Publication of the Prospective Payment System (PPS) Base Rate, Section 50 In-Facility Dialysis Bill Processing Procedures, Section 70 Payment for Home Dialysis, Section 80 Home Dialysis Billing to the A/B MAC (A)
- Chapter 17, Section 10 Payment Rules for Drugs and Biologicals, Section 20.5.8 Injections Furnished to ESRD Beneficiaries, Section 80.8 Reporting of Hematocrit and/or Hemoglobin Levels, Section 80.9 Required Modifiers for ESAs Administered to Non-ESRD Patients, Section 80.10 Hospitals Billing for Epoetin Alfa (EPO) and Darbepoetin Alfa (Aranesp) for Non-ESRD Patients, Section 80.11 Requirement for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs), Section 80.12 Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia Therapy.
- CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD
Social Security Act (Title XVIII) Standard References:
- Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
- Title XVIII of the Social Security Act, Section 1842(u) states information related to hemoglobin & hematocrit must be included.
- Title XVIII of the Social Security Act, Section 1881(b)(11)(B) is related to PPS of erythropoietin.
- Title XVIII of the Social Security Act, Section 1881(b)(12)(H) related to no administrative or judicial review.
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