Oncology / Hematology - JE Part B
Oncology and Hematology
On this page, view the below information.
Medical Oncology is the treatment of cancers using chemotherapy and other therapies such as biological, hormonal and immunotherapy. Oncology has three major areas: medical, surgical and radiation.
Hematology is the science and study of blood; especially problems with red and white blood cells, platelets, blood vessels, bone marrow, spleen, blood-forming organs and blood diseases (e.g., leukemia, lymphoma, sickle-cell anemia and hemophilia). One of the most common tests is a complete blood count or CBC to detect infections, immune system disorders, blood cancers, clotting problems, etc.
To immediately access the Oncology-Hematology related-topic information, click on these below:
- Erythropoietin Stimulating Agents (ESA) Treatments
- Billing and Coding
- Hematocrit or Hemoglobin Readings
- Related Articles
Medicare covers cancer medications and Part B drugs which are often intravenous (IV) infusion chemotherapy drugs or anti-nausea medicines. Erythropoietin Stimulating Agents (ESAs) stimulate a patient's bone marrow to form new red blood cells. They are used to treat anemia by elevating or maintaining the red blood cell level (as demonstrated by the hematocrit and/or hemoglobin levels); therefore, decreasing anemia and the need for blood transfusions. Two ESA drugs are Epoetin Alfa (treatment of anemia in cancer patients on chemotherapy) and Darbepoetin alfa (treatment of anemia in patient with non-myeloid malignancies, where anemia is due to the effect of administered chemotherapy).
ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia is only reasonable and necessary under the following specified conditions:
- Hemoglobin level immediately prior to initiation or maintenance of ESA is < 10 g/dL (or hematocrit < 30%)
- Starting ESA dose is recommended FDA label; no more than 150 U/kg/three times weekly for epoetin and 2.25 mcg/kg/1 time weekly for darbepoetin alpha. Equivalent doses may be provided over other approved time periods.
- Maintenance of ESA therapy = starting dose; if hemoglobin level remains below 10g/dL (or hematocrit is < 30%) four weeks after initiation of therapy and the rise in hemoglobin is > 1g/dL (hematocrit > 3%)
- For patients whose hemoglobin rises < 1g/dl (hematocrit rise < 3%), compared to pretreatment baseline over four weeks of treatment and whose hemoglobin level remains < 10g/dL after the four weeks of treatment (or hematocrit < 30%), recommended FDA label starting dose may be increased once by 25%. Continued use of the drug is not reasonable and necessary if hemoglobin rises < 1g/dl (hematocrit rise < 3%), compared to pretreatment baseline by eight weeks of treatment
- Continued administration of the drug is not reasonable and necessary if rapid rise in hemoglobin > 1g/dl (hematocrit > 3%) over two weeks of treatment; unless hemoglobin remains below or subsequently falls to < 10g/dL (or the hematocrit is < 30%)
- Continuation and reinstitution of ESA therapy must include dose reduction of 25% from previously administered dose
- ESA treatment duration for each course of chemotherapy includes the eight weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen
ESA treatment is not reasonable and necessary for beneficiaries with certain clinical conditions, either because of a harmful effect of the ESA on their underlying disease or because the underlying disease increases their risk of adverse effects related to using ESA.
- For End Stage Renal Disease (ESRD) services, see Noridian's ESRD page under Browse by Specialty
- For Drugs, see Noridian's Drugs, Biologicals and Injections under Browse by Topic
- For Radiation Oncology, see Noridian's Radiation Oncology page under Browse by Specialty
Billing and Coding
For the treatment of cancer; drugs, not self-administered, include ESA administration HCPCS codes:
- J0881 (Darbepoetin Alfa; Aranesp, 1 mcg; non-ESRD use)
- J0885 (Epoetin Alfa; Epogen, Procrit, 1000 units; non-ESRD use)
All non-ESRD claims billing J0881 and J0885 must be reported with one of the following modifiers:
- EA (ESA, anemia, chemo-induced)
- Denies diagnosis(es) for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia when hemoglobin >10.0g/dL > or hematocrit >30.0%
- EB (ESA, anemia, radio-induced)
- Denies any claims billed with appended modifier EB
- EC (ESA, anemia, non-chemo/radio)
- Denies diagnosis(es) for anemia in cancer or cancer treatment patients due to folate deficiency or bone marrow fibrosis, B-12 or iron deficiency, Hemolysis, bleeding, anemia associated with treatment of acute and chronic myelogenous leukemias (CML, AML), erythroid cancers, prophylactic use to prevent chemotherapy induced anemia, reduce tumor hypoxia, Erythropoietin-type resistance due to neutralizing antibodies or uncontrolled hypertension
CPT 96372 (therapeutic, prophylactic or diagnostic injection; specify substance or drug; subcutaneous or intramuscular) covers the administration with above J codes.
To report test results, follow instructions below with the multiple endocrine adenomatosis (MEA) segment:
- Electronic Billing: For electronic claims (ASC X12 837 professional claim format), report hemoglobin or hematocrit readings in Loop 2400 MEA segment. Leading zeros must be suppressed for electronic billing, unless necessary to satisfy a minimum length requirement. The length of a numeric type data element does not include the optional sign.
- Test Results: MEA01=TR
- Hemoglobin: MEA02=R1
- Hematocrit: MEA02=R2
- Test results: MEA03 (3-digit plus decimal point numeric test result)
- Paper Billing: For CMS-1500 paper claims, leading zeros are entered, if the test result is less than three numbers (match format example; 04.5). Zeros are entered so the decimal is in the correct position. Hemoglobin and Hematocrit test results are reflected by a four (4)-byte value with three numbers and format "nn.n" with decimal point between second and third number. Report the test results in Item 19 (narrative/comment field).
- Three-digit number reported (such as 31.2) = 31.2
- Two-digit number reported (such as 4.5) = 04.5
- Two-digit whole number reported (such as 28) = 28.0
- Single decimal position reported (such as .9) = 00.9
- One-digit whole number reported (such as 7) = 07.0
- Test result reported as 2-digits and 2 decimal places (such as 26.25) = 26.2
Chimeric Antigen Receptor (CAR) T-Cell Therapy - Part B Billing
National Coverage Determination (NCD) 110.24 provides coverage requirements for CAR T-cell therapy. Effective January 1, 2022, with implementation date January 3, 2023. CMS will allow CAR T-cell therapy to be billed by Part B providers limited to places of service 11 for office or 49 for independent clinic. Therapy is not allowed in an Ambulatory Surgical Center (ASC). Billing by Part A providers and facilities remains unchanged.
Special instructions apply for the CAR T-cell products due to the dollar amount necessary to submit these charges. The current claims processing system limits the dollar amount field to seven digits and the dollar amount for this therapy is eight digits. The HCPCS code description states a single unit of one therapeutic dose.
Number of service = 1
HCPCS codes covered:
- Q2041 - Yescrta
- Q2042 - Kymriah
- Q2053 - Tecartus
- Q2054 - Breyanzi
- Q2055 - Abecma
- Q2056 - Carvykti (effective 10/1/2022)
- J3490, J3590, J9999 - used when
- Dose of CAR T-cell therapy exceeds code descriptor
- When other CAR T-cell therapy obtains FDA approval but has not received a HCPCS code
Must utilize modifiers:
- LU - fractionated payment CAR T-cell therapy
- 76 - repeat procedure or service by same provider
- KX - medical policy requirements have been met
The total payment for the CAR T-cell HCPCS are divided by 10 and the claim line items billed in 0.1-unit fractions. The claim will have a total of 10 fractional units to reach the total Medicare allowed payment amount. Depending on the Medicare allowed payment for the CAR T-cell HCPCS, some providers will be able to submit 5 separate claims for 0.2 units on each claim.
CAR T-cell product allowed payment = $445,000. Five claim lines would be needed with the following modifiers on each line:
Q2041 LU-KX 0.2 units = $89,000.06
Q2041 LU-KX-76 0.2 units = $89,000.00
Q2041 LU-KX-76 0.2 units = $88,999.99
Q2041 LU-KX-76 0.2 units = $88,999.98
Q2041 LU-KX-76 0.2 units = $88,999.97
- For clinical trials under NCD policy 310.1
- Code 0540T on claim line
- Append modifier Q1
- Include diagnosis Z00.6
- Do not use KX modifier or diagnoses from NCD 110.24
Additional information is included in Change Request (CR) 12928
Medical records from physician or nonphysician practitioner, must be made available upon request and includes patient counseling with:
- Diagnosis and prognosis
- Treatment options/plan
- Patient's weight in kilograms
- Erythropoietin analog units administered per kilogram of body weight
- If usual doses exceeding, medical justification of erythropoietin analogs administration
- ICD-10 diagnosis alone does not ensure coverage
- Side effects and recovery
When documenting lab tests, include the treating physician's oncology flow sheet and note verbiage "CBC" or "WBC":
- CPT 85025 or the complete blood count (CBC) with automated hemoglobin (Hgb), hematocrit (Hct), red blood cell count (RBC), white blood count (WBC) and platelet count and automated differential WBC count
- CPT 85027 without automated differential WBC count
- Without valid order, medical necessity not supported
Top errors seen when documentation requested:
- E/M - missing supportive documentation (i.e., daily and progress notes, evaluation, clinical documentation, etc.)
- E/M - documentation supports CPT/HCPCS down coding
- Injection/Infusion - documentation does not support medical necessity, missing physician order/intent
- Imaging or Lab test - documentation supports CPT/HCPCS code change
- Bundled service billed for separate payment
- National Coverage Determination (NCD) Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions (110.21)
- NCD - Chimeric Antigen Receptor (CAR) T-cell Therapy (110.24)
- CMS Internet Only Manual (IOM) Publication 100-02, Medicare Benefit Policy, Chapter 15, Sections 50-50.6 and 60; Incident To, Covered Medical Services, Off-label Drugs
- CMS IOM Publication 100-04, Medicare Claims Processing, Chapter 12, Section 30.5; Chemotherapy Administration
- CMS IOM Publication 100-04, Medicare Claims Processing, Chapter 17, Sections 40 and 100.2.9; Drugs and Biologicals
- American Society of Clinical Oncology (ASCO)
- CMS Oncology Care Model (OCM) 2016-2021
Last Updated Fri, 24 Feb 2023 18:57:28 +0000
The below are topic specific articles which have been published to "Latest Updates" and sent out in Noridian emails within the past two years. Exclusions to this include time sensitive related announcements such as: Noridian and CMS educational events, Ask-the-Contractor Teleconferences and claims processing downtime.