Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia Therapy (Rev. 3085, Effective: Upon Implementation of ICD-10)

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, nonchemo/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, radioinduced), 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.

Report Medicare Summary Notice message 15.20, “The following policies [NCD 110.21] were used when we made this decision”, and remittance reason code 50, “These are noncovered services because this is not deemed a `medical necessity' by the payer” for denied ESA claims.

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.

• Pub 100-04 Medicare Claims Processing Manual - Chapter 17

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