CMS Pub. 100-04, ch. 17, § 80.12

Patients for Anti-Anemia Therapy

(Rev. 3721, Issued: 02-24-17, Effective: 05-25-17, Implementation: 05-25-17)

The national coverage determination (NCD) titled, “The Use of ESAs in Cancer and

Other Neoplastic Conditions” lists coverage criteria for the use of ESAs in patients who

have cancer and experience anemia as a result of chemotherapy or as a result of the

cancer itself. The full NCD can be viewed in Publication 100-03 of the NCD Manual,

section 110.21.

Effective for claims with dates of service on and after January 1, 2008, non-ESRD ESA

services for HCPCS J0881 or J0885 billed with modifier EC (ESA, anemia, non-chemo/radio) shall be denied when any one of the following diagnosis codes is present on

the claim:

ICD-9-CM Applicable

• any anemia in cancer or cancer treatment patients due to folate deficiency (281.2),

• B-12 deficiency (281.1, 281.3),

• iron deficiency (280.0-280.9),

• hemolysis (282.0, 282.2, 282.9, 283.0, 283.2, 283.9-283.10, 283.19), or

• bleeding (280.0, 285.1),

• anemia associated with the treatment of acute and chronic myelogenous

leukemias (CML, AML) (205.00-205.21, 205.80-205.91); or

• erythroid cancers (207.00-207.81).

ICD-10-CM Applicable

• any anemia in cancer or cancer treatment patients due to folate deficiency -

(D52.0, D52.1, D52.8, or D52.9),

• B-12 deficiency - (D51.1, D51.2, D51.3, D51.8, D51.9, or D53.1),

• iron deficiency - (D50.0, D50.1, D50.8, and D50.9),

• hemolysis - (D55.0, D55.1, D58.0, D58.9, D59.0, D59.1, D59.2, D59 4, D59.5,

D59.6, D59.8, or D59.9),

• bleeding - (D50.0, D62),

• anemia associated with the treatment of acute and chronic myelogenous

leukemias (CML, AML) - (C92.00, C92.01, C92.02, C92.10, C92.11, C92.12,

C92.20, C92.21, C92.40, C92.41, C92.42, C92.50, C92.51, C92.52, C92.60,

C92.61, C92.62, C92.90, C92.91, C92.A0, C92.A1, C92.A2, C92Z0, C92Z1, or

C92Z2), or

• erythroid cancers - (C94.00, C94.01, C94.02, C94.20, C94.21, C94.22, C94.30,

C94.31, C94.80, C94.81, D45).

Effective for claims with dates of service on and after January 1, 2008, contractors shall

deny non-ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EC (ESA,

anemia, non-chemo/radio) for:

• any anemia in cancer or cancer treatment patients due to bone marrow fibrosis,

• anemia of cancer not related to cancer treatment,

• prophylactic use to prevent chemotherapy-induced anemia,

• prophylactic use to reduce tumor hypoxia,

• patients with erythropoietin-type resistance due to neutralizing antibodies; and

• anemia due to cancer treatment if patients have uncontrolled hypertension.

Effective for claims with dates of service on and after January 1, 2008, non-ESRD ESA

services for HCPCS J0881 or J0885 billed with modifier EB (ESA, anemia, radio-induced), shall be denied.

Effective for claims with dates of service on and after January 1, 2008, contractors shall

deny non-ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EA (ESA,

anemia, chemo-induced) for anemia secondary to myelosuppressive anticancer

chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia

when a hemoglobin 10.0g/dL or greater or hematocrit 30.0% or greater is reported.

NOTE: ESA treatment duration for each course of chemotherapy includes the 8 weeks

following the final dose of myelosuppressive chemotherapy in a chemotherapy regime.

Effective for claims with dates of service on and after January 1, 2008, Medicare

contractors shall have discretion to establish local coverage policies for those indications

not included in NCD 110.21.

Denials of claims for ESAs are based on reasonable and necessary determinations

established by NCD 110.21. A provider may have the beneficiary sign an Advanced

Beneficiary Notice, making the beneficiary liable for services not deemed reasonable and

necessary and thus not covered by Medicare.

The contractor shall use the following remittance advice messages and associated codes

when rejecting/denying claims under this policy. This CARC/RARC combination is

compliant with CAQH CORE Business Scenario Three.

Group Code: PR or CO

CARC: 50

RARC: N/A

MSN: 15.20

Medicare contractors have the discretion to conduct medical review of claims and reverse

the automated adjudication if the medical review results in a determination of clinical

necessity.