Description
Erythropoiesis stimulating agents (ESAs) stimulate the bone marrow to make more red blood cells and are United States Food and Drug Administration (FDA) approved for use in reducing the need for blood transfusion in patients with specific clinical indications. Medical records will be reviewed to determine if the use of ESA in cancer and related neoplastic conditions meets Medicare coverage criteria.
Affected Code(s)
J0881, J0885, and Q5106 that were billed with modifiers EA and EB
Applicable Policy References
1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary Payer
2. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e)- Payment of Benefits
3. 42 CFR §405.929- Post-Payment Review
4. 42 CFR §405.930- Failure to Respond to Additional Documentation Request
5. 42 CFR §405.980- Reopening of Initial Determinations, Redeterminations, Reconsiderations, Decisions, and Reviews, (b)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Initiated by a Contractor; and (c)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Requested by a Party
6. 42 CFR §405.986- Good Cause for Reopening
7. National Coverage Determinations (NCD) Manual, Chapter 1- Coverage Determinations, Part 2, §110.21 Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions
8. Medicare Benefit Policy Manual, Chapter 15- Covered Medical and Other Health Services, §50 Drugs and Biologicals
9. Medicare Claims Processing Manual, Chapter 17- Drugs and Biologicals, §10- Payment Rules for Drugs and Biologicals, §40- Discarded Drugs and Biologicals; §70- Claims Processing Requirements- General; §80.9- Required Modifiers for ESAs Administered to Non-ESRD Patients; and §80.12- Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia Therapy
10. Medicare Program Integrity Manual, Chapter 3- Verifying Potential Errors and Taking Corrective Actions, §§3.1- 3.6.6
11. CGS Administrators, LLC, LCD L34356- Erythropoiesis Stimulating Agents (ESA); Effective 10/01/2015; Revised 3/02/2023
12. First Coast LCD L36276- Erythropoiesis Stimulating Agents; Effective 10/01/2015; Retired 2/9/2023
13. Palmetto GBA LCD L39237- Erythropoiesis Stimulating Agents; Effective 7/24/2022; Revised 01/18/24
14. WPS LCD L34633- Erythropoiesis Stimulating Agents (ESAs); Effective 10/01/2015; Revised 6/01/2023
15. CGS Administrators, LLC, LCA A56462- Billing and Coding: Erythropoiesis Stimulating Agents (ESA), Effective 10/03/2019; Revised 11/16/23
16. First Coast LCA A57628- Billing and Coding: Erythropoiesis Stimulating Agents; Effective 10/03/2018; Retired 2/9/2023
17. Palmetto LCA A58982- Billing and Coding: Erythropoiesis Stimulating Agents; Effective 7/24/2022; Revised 01/18/24
18. WPS LCA A56795- Billing and Coding: Erythropoiesis Stimulating Agents (ESAs); Effective 08/01/2019; Revised 6/01/2023
19. AMA CPT Codebook
20. HCPCS Level II Codebook
21. AHA ICD-10-CM Diagnosis Codebook