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. 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.
Title XVIII of the Social Security Act, §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, §1881(b)(1) allows payment for services furnished to individuals who have been determined to have end stage renal disease.
CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 1, §30 Drugs and Biologicals
CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 13, §120 Services and Supplies Furnished “Incident to” Physician’s Services
CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals, §50.1 Definition of Drug or Biological, §50.2 Determining Self-Administration of Drug or Biological, §50.3 Incident-to Requirements, §50.4.1 Approved Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.5.2 Erythropoietin (EPO), §50.5.2.1 Requirements for Medicare Coverage for EPO, and §50.5.2.2 Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use
CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, §110.21 Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions
NCD for ESAs for Cancer and Related Neoplastic Conditions - CAG-00383N (cms.gov)
National Coverage Analysis (NCA) for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N) (cms.gov)
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 Pub 100-20 - One-Time Notification (PDF) (cms.gov)
Sorry, you need to login or register to view additional sections of this Medicare policy.