Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A59939 (Billing and Coding: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A59939: Billing and Coding: MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms (Billing and Coding, effective 2025-11-20)
- Covered ICD-10-CM codes
- 15
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 11
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C94.40 | — |
| C94.41 | — |
| C94.42 | — |
| C94.6 | — |
| D45 | Polycythemia vera |
| D46.9 | — |
| D46.Z | — |
| D47.1 | — |
| D47.3 | — |
| D47.4 | — |
| D75.1 | — |
| D75.81 | — |
| D75.838 | — |
| D75.839 | — |
| D75.89 | — |
Procedure codes: 0027U, 0040U, 81206, 81207, 81208, 81219, 81270, 81279, 81338, 81339, 81479.
Coverage indications, limitations and medical necessity
This policy provides limited coverage for multi-gene non-next generation sequencing (NGS) panel testing and limited coverage for single-gene testing for the diagnostic workup of patients with suspected BCR-ABL negative myeloproliferative neoplasms (MPNs). Classical BCR-ABL negative MPNs include Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF), and non-classical BCR-ABL negative MPNs include Chronic Neutrophilic Leukemia (CNL) and Chronic Eosinophilic Leukemia, Not Otherwise Specified (CEL, NOS), among other rare entities. Myelodysplastic/Myeloproliferative neoplasms are considered a separate class outside the scope of this LCD.
Testing myeloid and suspected neoplasms by NGS is covered by a separate LCD, MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies (L38176) .
ALL of the following criteria must be met:
• The patient is being evaluated for a BCR-ABL -negative MPN according to national or international consensus diagnostic criteria (i.e., World Health Organization (WHO); International Consensus Classification (ICC)).
• Testing follows the assessment of BCR-ABL (this is required unless the patient is only suspected of having PV).
• The test is comprised of 1 or more highly sensitive single- or multi- gene assays (i.e., quantitative polymerase chain reaction [PCR], digital droplet PCR [ddPCR]) that can accurately detect a minimum variant allele frequency (VAF) of ≤1% for JAK2 (and 1-3% for CALR and MPL when they are included in the testing).
• If testing is performed using single gene tests, a sequential and reflexive approach is expected. Once a positive result is obtained and the appropriate diagnosis is established, further testing should stop unless required for subsequent management of the patient or as further described below.
• When testing for the classical BCR-ABL -negative MPNs (PV, ET, or PMF) using single gene tests, reflex testing to the next gene will be considered reasonable and necessary according to the following sequence of tests for known driver mutations:
• BCR-ABL negative test results, progress to ii.
• Note: For the rare patient with high clinical suspicion of PV despite a positive BCR-ABL result, testing for a mutation in JAK2 mutation may still be performed.
• JAK2 V617F negative test results (this includes JAK2 V617F positive at JAK2 , exon 12 (required when PV is suspected)
• Calreticulin ( CALR ) and Thrombopoietin Receptor ( MPL ) driver mutations (required when ET or PMF is suspected)
• Note: testing for CALR/MPL does NOT require a negative JAK2 exon 12, just a negative JAK2 V617F result.
• If testing is performed using a panel (i.e., multiplex PCR) the panel must include at least the minimum necessary genes and gene alterations that would be reasonably expected by the test to achieve a diagnosis according to national or international consensus guidelines, given the specific MPN subtype suspected. For example:
• Molecular testing for mutations in JAK 2 (including V617F and exon 12), CALR and MPL genes is considered medically necessary for the identification of the classical MPNs.
• However, if the accelerated/blast phase of PMF is suspected at diagnosis, molecular testing should also include acute myeloid leukemia (AML)- associated mutations and would likely require the performance of a NGS panel; in this case, a panel that does not include the AML-associated mutations does not meet the minimum necessary gene requirements.
• Additional MPN-associated genes must also be included as appropriate for the identification of other non-classical BCR-ABL -negative MPNs. For example, when CNL is suspected, testing for the colony stimulating factor 3 receptor ( CSF3R ) is required. Note also that testing for CNL requires the exclusion of the classical BCR-ABL -negative MPNs.
• Patients with high suspicion of a BCR-ABL negative MPN who test negative by a non-NGS test for mutations in JAK2 (including the detection of JAK2 V617F at a VAF CALR , MPL and/or CSF3R may have a subsequent NGS panel performed for additional relevant mutations, as outlined in national or international consensus guidelines. The additional testing by NGS must comprise non-duplicative genetic alterations.
• Clinical validity (CV) of analytes measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population.
• The test is being used (a) in a patient who is part of the population in which the test was analytically validated and (b) according to the intended use of the test.
• The test satisfactorily completes a technical assessment (TA) that will evaluate and confirm that analytical validity (AV), clinical validity (CV), and clinical utility (CU) have been demonstrated.
• Tests utilizing a similar methodology or evaluating a similar molecular analyte to a test for which there is a generally accepted testing standard or for which existing coverage exists must demonstrate equivalent or superior test performance (i.e., sensitivity and/or specificity) when used for the same indication in the intended-use population.
• Testing is performed for diagnosis and not as a test of cure or for monitoring minimal residual disease (MRD).
NOTE: Testing by NGS falls outside of the scope of this LCD but must fulfill the criteria outlined in LCD L38176, MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies .
Summary of evidence (opening)
THE MOLECULAR DIAGNOSIS OF MYELOPROLIFERATIVE NEOPLASMS
Myeloproliferative neoplasms (MPNs) are a group of conditions that cause abnormal growth of blood cells in the bone marrow. They include polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF), and other entities such as chronic myeloid leukemia (CML), chronic neutrophilic leukemia (CNL), chronic eosinophilic leukemia not otherwise specified (CEL-NOS) and MPN, unclassifiable (MPN-U). PV, ET, and PMF are further classified as Philadelphia chromosome- or BCR-ABL -negative MPNs. 1
The diagnosis of a MPN is suspected based upon clinical, laboratory, and pathological findings (i.e., bone marrow morphology). MPNs are related, but distinct from, myelodysplastic syndromes (MDS). In general, MDS are characterized by morphologic dysplasia and ineffective or dysfunctional blood cells, while MPNs are typically characterized by an increase in the number of blood cells (erythrocytosis, thrombocytosis, and/or leukocytosis).
Classification systems for MPNs include those established by the World Health Organization (WHO) and the International Consensus Classification (ICC). 2,3 The ICC was established with input from prior WHO editors and senior advisors, leaders from the Society for Hematopathology (SH) and the European Association for Haematopathology (EAHP). 4 Though there is significant overlap between the 2 classification systems, there are some differences between them. For example, the WHO 5 th edition no longer incorporates increased red cell mass as a diagnostic criterion for the diagnosis of PV. 2
The contractor cites 19 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2025-08-17
- Current revision effective
- 2025-08-17
- Last reviewed by the contractor
- 2025-06-26
- MCD version
- 3
Other related documents: A60251 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Wisconsin Physicians Service Insurance Corporation hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L40022 cover?
Testing myeloid and suspected neoplasms by NGS is covered by a separate LCD, MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies (L38176) . The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L40022 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L40022?
The companion billing and coding article A59939 lists 15 ICD-10-CM codes in 1 group that support medical necessity; the first 15 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L40022?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.