Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Biomarkers for Oncology
Policy #:MA06.022f

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

PATHOLOGY PROCEDURES
The following pathology procedures employing testing of biomarkers for oncology are medically necessary, and therefore, covered:

ALK and ROS1 FISH Assays

ALK and ROS1 FISH assays are considered medically necessary and, therefore, covered as predictive biomarkers for Crizotinib therapy.

Cytogenomic Microarray Analysis or A Single Nucleotide Polymorphism (SNP) Array

Cytogenomic microarray analysis, or, alternatively a single nucleotide polymorphism (SNP) array for the same testing is considered medically necessary and, therefore, covered , for the identification of various mutations, which are used in the diagnosis/prognosis of various hematological malignancies.

FISH Tests for Bladder Cancer

FISH tests for bladder cancer are considered medically necessary and, therefore, covered by Local Medicare Carrier based on peer-reviewed literature and approved manufacturer claims.

The OVA1™ Proteomic Assay and the Risk of Ovarian Malignancy Algorithm (ROMA™) Test

OVA1 and ROMA1 proteomic testing as an adjunctive test for the evaluation of ovarian (adnexal) masses is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual is over 18 years of age.
  • Ovarian adnexal mass is present, for which surgery is planned.
  • The individual has not yet been referred to an oncologist.

For OVA1 Test: other clinical and radiological evaluation for ovarian cancer does not indicate malignancy.

UroVysion Bladder Cancer Kit

The use of UroVysion Bladder Cancer Kit is considered medically necessary and, therefore, covered to detect aneuploidy for chromosomes 3,7,17, and loss of the 9p2l locus via fluorescence in situ hybridization (FISH) in urine specimens for the purpose of:
  • Diagnosing bladder cancer in individuals with hematuria; OR
  • Monitoring for tumor recurrence in individuals with previously diagnosed bladder cancer.

VeriStrat® Assay Testing

VeriStrat® assay testing, a mass spectophotometric, serum-based predictive proteomics assay, is considered medically necessary and, therefore, covered for individuals with NSCLC being considered for treatment with EGFR inhibitors (e.g. Erlotinib) where first-line EGFR mutation testing is either wild-type or not able to be tested (e.g., tissue may not be available).


INDIVIDUAL BIOMARKERS
The following biomarkers for oncology within the organ-specific categories are considered medically necessary and, therefore, covered when all of the associated criteria are met, as the noted clinical type(s) of applications including diagnostic (DX), prognostic (PROG) and/or predictive (PRED):

Colorectal Cancer
  • KRAS (12/13)- PRED of resistance to an anti-EGFR agent
  • KRAS codon 61 - PRED of resistance to an anti-EGFR agent
  • KRAS codon 146 - PRED of resistance to an anti-EGFR agent
  • NRAS - PRED of resistance to an anti-EGFR agent
  • BRAF - PRED of resistance to an anti-EGFR agent + DX (sporadic vs. Lynch syndrome)
  • PIK3CA - PRED of resistance to an anti-EGFR agent + PROG for local recurrence
  • MSI by PCR - PRED of 5-FU resistance + DX
  • MLH1 promoter hypermethylation - PRED of 5-FU resistance + DX

Non-Small-Cell Lung Cancer (NSCLC)
  • EGFR- PRED of anti - EGFR response
  • KRAS (12/13) - PRED of anti-EGFR resistance
  • KRAS codon 61 - PRED of anti-EGFR resistance
  • KRAS codon 146 - PRED of anti-EGFR resistance
  • BRAF - PROG + PRED for anti-RAF inhibitor

Melanoma
  • BRAF - PRED of response to Vemurafenib
  • KIT - PRED of response to Imatinib (TKI)
  • NRAS - PROG + PRED for anti-MEK inhibitor

Brain
  • BRAF - PRED
  • EGFR - PRED
  • MGMT - PRED
  • IDH1 - DX + PROG
  • IDH2 - DX + PROG
  • PIK3CA - PRED
  • PTEN - PRED
  • CIMP - PRED

Thyroid
  • BRAF - DX + PRED
  • KRAS - PRED for Selumetinib
  • HRAS - PRED for Selumetinib
  • NRAS - PRED for Selumetinib
  • PIK3CA - PRED
  • RET - DX
  • PAX8/PPARG - DX

Ovary/Fallopian Tube/Peritoneum
  • AKT1 - PRED for PI3K/AKT/mTOR inhibitors
  • BRAF - DX + PROG
  • KRAS - DX + PROG
  • MLH1 promoter hypermethylation - DX
  • MSI by PCR - DX
  • PIK3CA - PRED for PI3K/AKT/mTOR inhibitors
  • PTEN - PRED for PI3K/AKT/mTOR inhibitors
  • TP53 - DX + PROG

Uterus
  • AKT1 - PRED for PI3K/AKT/mTOR inhibitors
  • BRAF - PRED
  • KRAS - PRED
  • MLH1 promoter hypermethylation - DX
  • MSI by PCR - DX
  • PIK3CA - PRED for PI3K/AKT/mTOR inhibitors
  • PTEN - PRED for PI3K/AKT/mTOR inhibitors + DX + PROG
  • TP53 - DX + PROG

Urinary Tract
  • MSI by PCR - DX
  • MLH1 promoter hypermethylation – DX

Prostate
  • PROGENSA® PCA3 Assay to determine the need for repeat prostate biopsies in individuals who have had a previous negative biopsy.

Gastrointestinal Stromal Tumor
  • KIT - PRED for Sumatinib + DX
  • PDGFRA - PRED for Sumatinib + DX

Cancer of Unknown Primary (CUP)

Molecular testing (reported via an NOC code 81479) in the pathologic diagnoses of CUP when a conventional surgical pathology/imaging work-up is unable to identify a primary neoplastic site. Other applications of this technology are non-covered and considered investigational in the use of diagnosis of specific tumor types such as NSCLC and renal cancers.

Leukemias and Lymphomas (A through N)

A.) Acute lymphoid leukemia (ALL)
  • BCR/ABL1 - DX
  • ABL1 (kinase domain) - PROG
  • IGH - DX
  • TCRB - DX
  • TCRG - DX
  • TP53 - PROG
  • MLL/AF4 - DX
  • E2A/PBX1 - DX
  • ETV6/RUNX1 - DX

B.) Acute myeloid leukemia (AML, and including acute promyelocytic leukemia): All PROG, except where noted below
  • PML/RARA - DX
  • RUNX1/RUNX1T1 - DX
  • CBFB/MYH11 - DX
  • FLT3 ITD
  • FLT3 D836
  • NPM1
  • KRAS
  • NRAS
  • KIT
  • CEBPA
  • IDH1
  • IDH2
  • DNMT3A
  • JAK2 (p.V617F)
  • JAK2 (exon 12)
  • MPL
  • DEK/CAN - DX
  • ASXL1
  • EZH2
  • TET2

C.) Hairy cell leukemia
  • IGH somatic hypermutation - PROG
  • IGH – DX

D.) Aplastic anemia
  • TRB - DX
  • TCRG - DX

E.) Burkitt’s lymphoma
  • IGH - DX
  • TP53 - PROG

F.) Myeloproliferative diseases [MPD - essential thrombocytosis (ET), myelofibrosis & polycythemia vera (PV)]
  • BCR/ABL1 - DX
  • JAK2 (p.V617F) - DX
  • JAK2 (exon 12) - DX
  • MPL - DX
  • CALR - DX
  • CSF3R - DX
  • ASXL1 - PROG
  • TET2 - PROG
  • EZH2 - PROG

G.) Chronic myeloid leukemia (CML) and chronic myelomonocytic leukemia (CMML)
  • KRAS - PROG
  • NRAS - PROG
  • BCR/ABL1 - DX
  • ABL1 (kinase domain) - PRED for Imatinib
  • FLT3 ITD - PROG
  • FLT3 D836 - PROG
  • KIT - PROG
  • JAK2 (p.V617F) - PROG
  • JAK2 (exon 12) - PROG

H.) Chronic lymphoid leukemia (CLL)
  • IGH - DX
  • IGH somatic hypermutation - PROG
  • ATM - PROG
  • TP53 - PROG

I.) Follicular lymphoma
  • GH/BCL2- DX

J.) Hypereosinophilia Syndrome (HES)
  • KIT (including p.D816V) - PROG + DX
  • FIP1L1/PDGFRA Fusion - DX

K.) Mantle cell lymphoma
  • CCND1/IGH - DX

L.) Mastocytosis
  • KIT (including p.D816V) - PROG + DX
  • FIP1L1/PDGFRA Fusion - DX
  • TCRG - DX

M.) T-cell prolymphocytic leukemia
  • TCRB - DX
  • TCRG - DX

N.) Myelodysplastic syndrome (MDS): All below biomarkers are PROG.
  • FLT3 ITD
  • FLT3 D836
  • NPM1
  • KRAS
  • NRAS
  • KIT
  • CEBPA
  • IDH1
  • IDH2
  • DNMT3A
  • JAK2 (p.V617F)
  • JAK2 (exon 12)
  • MPL
  • ASXL1
  • EZH2
  • TET2



EXPERIMENTAL/INVESTIGATIONAL
The following services are considered experimental/investigational and, therefore, not covered:
  • Biomarkers from other tumor categories (e.g., breast, pancreas, sarcoma, etc.) and additional emerging biomarkers, within the organ-specific categories detailed in the medically necessary section of this policy.
  • Next-generation sequencing (NGS) methods used for detection and analysis of biomarkers for oncology.

Policy Guidelines

This policy is consistent with Medicare's coverage determination. The Company's reimbursement methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, biomarkers for oncology are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.


Description

The emergence of personalized laboratory medicine has been characterized by a multitude of testing options which can more precisely pinpoint management needs of individual patients. As a result, the growing compendium of products described as biomarkers requires a careful evaluation by both clinicians and laboratorians as to what testing configurations are clinically reasonable and necessary. There are a plethora of burgeoning tools, including both gene-based (genomic) and protein-based (proteomic) assay formats, in tandem with more conventional (longstanding) flow cytometric, cytogenetic, etc. biomarkers. Classified somewhat differently, there are highly diverse approaches ranging from single mutation biomarkers to multiple biomarker platforms, the latter of which often depend upon sophisticated biomathematical interpretative algorithms.

The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention."

Coverage of such biomarkers is predicated upon four fundamental principles:
    1. First, the biomarkers must have proven clinical validity/utility (CVU).

    2. Second, to support the medical necessity of the service, there must be acceptance/uptake of specific testing into patient management. It is essential that providers be familiar enough with all specific biomarkers that they order, such that all test results may become clinically actionable. (Off-label chemotherapeutic agents, corresponding genotypic testing, which is designed to better help guide therapy, may also coverable.)

    3. Third, providers managing oncological conditions must demonstrate that the use of biomarkers will be used to assist in the management/treatment of the beneficiary.

    4. Peer-reviewed full manuscript evidence is required to support combination panels for multiple biomarkers, particularly regarding their alleged composite clinical validity/utility. For example; such potential billing for multiple, diverse biomarkers (e.g., diagnostic/monitoring/prognostic/predictive) can only achieve medical necessity when it is clearly evident how each requested biomarker can be individually contributory.

Finally, it is quite useful to categorize oncology biomarkers into functional clusters that reflect both 1) the predominant intent of testing (with the caveat that individual assays may cross over into more than one category), and 2) the relative evidentiary expectations:
    1. Oncology Biomarkers Used for Diagnosis/Classification/Monitoring/Surveillance: These types of assays are supportable by case-control sensitivity/specificity studies, with appropriate designs in place to minimize the extent of bias and confounding.

    2. Oncology Biomarkers Used for Prognosis/Prediction: Oncology biomarkers used for prognosis/prediction (i.e., a predictive biomarker is associated with response [benefit] or lack of response to a particular therapy, relative to other available therapy, whereas a prognostic biomarker provides information on the likely outcome of the disease in an untreated individual).

There are a complex and diverse set of study methods that can drive the robust formulation of evidence for such esoteric testing, which are well-summarized by Deverka et al. at the Center for Medical Technology Policy, but there are currently NO standardized thresholds and/or benchmarks for evaluating the CVU/medical necessity of emerging biomarkers. However, the following sources (although not exhaustive and complete) may help support CVU when requesting a reconsideration for coverage of biomarkers that are not included in this LCD:
    1. FDA labeling documentation.

    2. National Comprehensive Cancer Network (NCCN) Biomarkers Compendium recommendations, particularly where Category 1 evidence is noted.

    3. Findings from well-established, independent technology assessments (e.g., Evaluation of Genomic Applications in Practice and Prevention (EGAPP), Agency for Healthcare Research and Quality (AHRQ), Blue Cross and Blue Shield Association Technology Evaluation Center (BCBSA TEC) and the Cochrane Collaboration).

    4. Other independent, objective evaluations and/or systematic literature reviews, which can substantively contribute to the evidence base, including, but not restricted to, emerging National Institutes of Health (National Cancer Institute) guidelines for the accrual of genomics/proteomics clinical validity/utility evidence. This category may also include a mobilized systematic literature review venue, within the Local Medicare Carrier's jurisdiction, which can provide a rigorous, objective evaluation of emerging biomarker evidence. Although there is not a prescriptive format for such systematic reviews, there must be at least documentation (submitted to Local Medicare Carrier) regarding inclusion of the following three elements:
    • Some type of recurring/periodic Committee structure, which is comprised of at least qualified biomathematicians/methodologists, molecular pathology laboratory specialists and relevant clinicians (e.g., oncologists).
    • There is no preference between such a Committee being based at a single site, or even rotating among several sites, as long as there is active sharing of the critical evaluations in a manner that enables sufficiently broad input into this process, and a feasibly wide acceptance of this process by representative molecular pathology stakeholders.
    • There is a procedural transparency of the biomarker evaluations via minutes (or a summary of minutes) available to Local Medicare Carrier.

    Please note that this policy addresses molecular biomarker testing, but does involve some other types of related biomarker testing, such as proteomics.

References

Novitas Solutions Inc.LCD L34796 Biomarkers for Oncology. Available at:
http://www.novitas-solutions.com/LCDSearchResults/faces/spaces/search/page/lcd.jspx?Jurisdiction=JL&medicareType=Part+B&_afrWindowMode=0&lcdID=L34796&_afrLoop=988485804075000&State=Pennsylvania&_adf.ctrl-state=obup573fk_13. Accessed August 4, 2014.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT ALK AND ROS1 FISH ASSAYS:

88120 88121

THE FOLLOWING CODE IS USED TO REPRESENT CYTOGENOMIC MICROARRAY
ANALYSIS, OR, A SINGLE NUCLEOTIDE POLYMORPHISM (SNP) ARRAY:

81406

THE FOLLOWING CODES ARE USED TO REPRESENT FISH TESTS FOR BLADDER CANCER:

88120 88121

THE FOLLOWING CODES ARE USED TO REPRESENT THE OVA1™ PROTEOMIC ASSAY AND THE RISK OF OVARIAN MALIGNANCY ALGORITHM (ROMA™) TESTS

84999 81500 81503

THE FOLLOWING CODES ARE USED TO REPORT UROVYSION™ BLADDER CANCER KIT:

88120 88121

THE FOLLOWING CODES ARE USED TO REPRESENT VERISTRAT® ASSAY TESTING:

84999

INDIVIDUAL BIOMARKERS

THE FOLLOWING CODES ARE USED TO REPRESENT BIOMARKERS FOR COLORECTAL CANCER:

KRAS (12/13)

81275

KRAS codon 61

81403

KRAS codon 146

81479

NRAS

81404

BRAF

81210

PIK3CA

81479

MSI by PCR

81301

MLH1 promoter hypermethylation

81292, 81293, 81294


THE FOLLOWING CODES ARE USED TO REPRESENT BIOMARKERS FOR NON-SMALL CELL LUNG CANCER (NSCLC):

EGFR- PRED of anti - EGFR response

81235

KRAS (12/13) - PRED of anti-EGFR resistance

81275

KRAS codon 61 - PRED of anti-EGFR resistance

81403

KRAS codon 146 - PRED of anti-EGFR resistance

81479

BRAF - PROG + PRED for anti-RAF inhibitor

81210

THE FOLLOWING CODES ARE USED TO REPRESENT BIOMARKERS FOR MELANOMA:
BRAF - PRED of response to Vemurafenib

81210

KIT - PRED of response to Imatinib (TKI)

81404

NRAS - PROG + PRED for anti-MEK inhibitor

81404

THE FOLLOWING CODES ARE USED AS BIOMARKERS FOR MALIGNANCIES OF THE BRAIN:

BRAF - PRED

81210

EGFR - PRED

81235

MGMT - PRED

81287

IDH1 - DX + PROG

81403

IDH2 - DX + PROG

81403

PIK3CA - PRED

81479

PTEN - PRED

81321, 81322, 81323, 81479

CIMP - PRED

81479

THE FOLLOWING CODES ARE USED FOR BIOMARKERS FOR MALIGNANCIES OF THE THYROID

0018U

BRAF - DX + PRED

81210

KRAS - PRED for Selumetinib

81275, 81403, 81479

HRAS - PRED for Selumetinib

81403

NRAS - PRED for Selumetinib

81404

PIK3CA - PRED

81479

RET - DX

81404

PAX8/PPARG - DX

81401

THE FOLLOWING CODES ARE USED FOR BIOMARKERS FOR MALIGNANCIES OF THE OVARY/FALLOPIAN TUBE/PERITONEUM:

AKT1 - PRED for PI3K/AKT/mTOR inhibitors

81479

BRAF - DX + PROG

81210

KRAS - DX + PROG

81275, 81403, 81479

MLH1 promoter hypermethylation - DX

81292, 81293, 81294

MSI by PCR - DX

81301

PIK3CA - PRED for PI3K/AKT/mTOR inhibitors

81479

PTEN - PRED for PI3K/AKT/mTOR inhibitors

81321, 81322, 81323, 81479

TP53 - DX + PROG

81405

THE FOLLOWING CODES ARE USED FOR BIOMARKERS FOR MALIGNANCIES OF THE UTERUS:

AKT1 - PRED for PI3K/AKT/mTOR inhibitors

81479

BRAF - PRED

81210

KRAS - PRED

81275, 81403, 81479

MLH1 promoter hypermethylation - DX

81292, 81293, 81294

MSI by PCR - DX

81301

PIK3CA - PRED for PI3K/AKT/mTOR inhibitors

81479

PTEN - PRED for PI3K/AKT/mTOR inhibitors + DX + PROG

81321, 81322, 81323, 81479

TP53 - DX + PROG

81405

THE FOLLOWING CODES ARE USED FOR BIOMARKERS FOR MALIGNANCIES OF THE URINARY TRACT:

MSI by PCR - DX

81301

MLH1 promoter hypermethylation – DX

81292, 81293, 81294

THE FOLLOWING CODES ARE USED FOR BIOMARKERS FOR MALIGNANCIES OF THE PROSTATE:

PROGENSA® PCA3

81479

THE FOLLOWING CODES ARE USED FOR BIOMARKERS FOR MALIGNANCIES OF THE GASTROINTESTINAL STROMAL TUMOR:

KIT - PRED for Sumatinib + DX

81404

PDGFRA - PRED for Sumatinib + DX

81404

THE FOLLOWING CODES ARE USED FOR BIOMARKERS OF CANCER OF UNKNOWN PRIMARY (CUP):

81479

"Molecular testing (reported via an NOC code 81479) in the pathologic diagnoses of CUP when a conventional surgical pathology/imaging work-up is unable to identify a primary neoplastic site. Other applications of this technology are non-covered and considered investigational in the use of diagnosis of specific tumor types such as NSCLC and renal cancers."


THE FOLLOWING CODES ARE USED FOR BIOMARKERS FOR LEUKEMIAS AND LYMPHOMAS:

ACUTE LYMPHOID LEUKEMIA (ALL)

BCR/ABL1 - DX

81206, 81207, 81208

ABL1 (kinase domain) - PROG

81403

IGH - DX

81261

TCRB - DX

81340

TCRG - DX

81342

TP53 - PROG

81405

MLL/AF4 - DX

81479

E2A/PBX1 - DX

81401

ETV6/RUNX1 - DX

81401

ACUTE MYELOID LEUKEMIA (AML, AND INCLUDING ACUTE PROMYELOCYTIC LEUKEMIA): ALL PROG, EXCEPT WHERE NOTED BELOW

PML/RARA - DX

81315

RUNX1/RUNX1T1 - DX

81401

CBFB/MYH11 - DX

81401

FLT3 ITD

81245

FLT3 D836

81479

NPM1

81310

KRAS

81275, 81403, 81479

NRAS

81404

KIT

81402

CEBPA

81403

IDH1

81403

IDH2

81403

DNMT3A

81403

JAK2 (p.V617F)

81270

JAK2 (exon 12)

81403

MPL

81402

DEK/CAN - DX

81479

ASXL1

81479

EZH2

81479

TET2

81479


HAIRY CELL LEUKEMIA

IGH somatic hypermutation - PROG

81263

IGH – DX

81261


APLASTIC ANEMIA

TRB - DX

81340

TCRG - DX

81342


BURKITT'S LYMPHOMA

IGH - DX

81261

TP53 - PROG

81405

MYELOPROLIFERATIVE DISEASES (MPD - ESSENTIAL THROMBOCYTOSIS (ET), MYELOFIBROSIS & POLYCYTHEMIA VERA (PV))

BCR/ABL1 - DX

81206, 81207, 81208

JAK2 (p.V617F) - DX

81270

JAK2 (exon 12) - DX

81403

MPL - DX

81402

CALR - DX

81479

CSF3R - DX

81479

ASXL1 - PROG

81479

TET2 - PROG

81479

EZH2 - PROG

81479


CHRONIC MYELOID LEUKEMIA (CML) AND CHRONIC MEYLOMONOCYTIC LEUKEMIA (CMML)

KRAS - PROG

81275, 81403

NRAS - PROG

81404

BCR/ABL1 - DX

81206, 81207, 81208

ABL1 (kinase domain) - PRED for Imatinib

81403

FLT3 ITD - PROG

81245

FLT3 D836 - PROG

81479

KIT - PROG

81402

JAK2 (p.V617F) - PROG

81270

JAK2 (exon 12) - PROG

81403

CHRONIC LYMPHOID LEUKEMIA (CLL)

IGH - DX

81261

IGH somatic hypermutation - PROG

81263

ATM - PROG

81479

TP53 - PROG

81405

FOLLICULAR LYMPHOMA

IGH/BCL2

81479


HYPEREOSINOPHILIA SYNDROME (HES)

KIT (including p.D816V) - PROG + DX

81402

FIP1L1/PDGFRA Fusion - DX

81401

MANTLE CELL LYMPHOMA

CCND1/IGH - DX

81401

MASTOCYTOSIS

KIT (including p.D816V) - PROG + DX

81402

FIP1L1/PDGFRA Fusion - DX

81401

TCRG - DX

81342

T-CELL PROLYMPHOCYTIC LEUKEMIA

TCRB - DX

81340

TCRG - DX

81342

MYELODYSPLASTIC SYNDROME (MDS): ALL BELOW BIOMARKERS ARE PROG.

FLT3 ITD

81245

FLT3 D836

81479

NPM1

81310

KRAS

81275, 81403, 81479

NRAS

81404

KIT

81402

CEBPA

81403

IDH1

81403

IDH2

81403

DNMT3A

81403

JAK2 (p.V617F)

81270

JAK2 (exon 12)

81403

MPL

81402

ASXL1

81479

EZH2

81479

TET2

81479

EXPERIMENTAL/INVESTIGATIONAL
  • Biomarkers from other tumor categories (e.g., breast, pancreas, sarcoma, etc.) and additional emerging biomarkers, within the organ-specific categories detailed in the medically necessary section of this policy.
  • Next generation sequencing (NGS) methods used for detection and analysis of biomarkers for oncology

MISCELLANEOUS

81170, 81218, 81219, 81272, 81273, 81276, 81311, 81314, 81538


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT COLORECTAL CANCER ALSO INCLUDING THE SMALL BOWEL
C17.0 Malignant neoplasm of duodenum
C17.1 Malignant neoplasm of jejunum
C17.2 Malignant neoplasm of ileum
C17.3 Meckel's diverticulum, malignant
C17.8 Malignant neoplasm of overlapping sites of small intestine
C17.9 Malignant neoplasm of small intestine, unspecified
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT NON-SMALL CELL LUNG CARCINOMA
C33 Malignant neoplasm of trachea
C34.00 Malignant neoplasm of unspecified main bronchus
C34.01 Malignant neoplasm of right main bronchus
C34.02 Malignant neoplasm of left main bronchus
C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
C34.2 Malignant neoplasm of middle lobe, bronchus or lung
C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or lung
C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung
C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung
C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung
C34.91 Malignant neoplasm of unspecified part of right bronchus or lung
C34.92 Malignant neoplasm of unspecified part of left bronchus or lung
C38.4 Malignant neoplasm of pleura
C45.0 Mesothelioma of pleura

THE FOLLOWING CODES ARE USED TO REPRESENT MELANOMA
C43.0 Malignant melanoma of lip
C43.10 Malignant melanoma of unspecified eyelid, including canthus
C43.111 Malignant melanoma of right upper eyelid, including canthus
C43.112 Malignant melanoma of right lower eyelid, including canthus
C43.121 Malignant melanoma of left upper eyelid, including canthus
C43.122 Malignant melanoma of left lower eyelid, including canthus
C43.20 Malignant melanoma of unspecified ear and external auricular canal
C43.21 Malignant melanoma of right ear and external auricular canal
C43.22 Malignant melanoma of left ear and external auricular canal
C43.30 Malignant melanoma of unspecified part of face
C43.31 Malignant melanoma of nose
C43.39 Malignant melanoma of other parts of face
C43.4 Malignant melanoma of scalp and neck
C43.51 Malignant melanoma of anal skin
C43.52 Malignant melanoma of skin of breast
C43.59 Malignant melanoma of other part of trunk
C43.60 Malignant melanoma of unspecified upper limb, including shoulder
C43.61 Malignant melanoma of right upper limb, including shoulder
C43.62 Malignant melanoma of left upper limb, including shoulder
C43.70 Malignant melanoma of unspecified lower limb, including hip
C43.71 Malignant melanoma of right lower limb, including hip
C43.72 Malignant melanoma of left lower limb, including hip
C43.8 Malignant melanoma of overlapping sites of skin
C43.9 Malignant melanoma of skin, unspecified
D03.0 Melanoma in situ of lip
D03.10 Melanoma in situ of unspecified eyelid, including canthus
D03.111 Melanoma in situ of right upper eyelid, including canthus
D03.112 Melanoma in situ of right lower eyelid, including canthus
D03.121 Melanoma in situ of left upper eyelid, including canthus
D03.122 Melanoma in situ of left lower eyelid, including canthus
D03.20 Melanoma in situ of unspecified ear and external auricular canal
D03.21 Melanoma in situ of right ear and external auricular canal
D03.22 Melanoma in situ of left ear and external auricular canal
D03.30 Melanoma in situ of unspecified part of face
D03.39 Melanoma in situ of other parts of face
D03.4 Melanoma in situ of scalp and neck
D03.51 Melanoma in situ of anal skin
D03.52 Melanoma in situ of breast (skin) (soft tissue)
D03.59 Melanoma in situ of other part of trunk
D03.60 Melanoma in situ of unspecified upper limb, including shoulder
D03.61 Melanoma in situ of right upper limb, including shoulder
D03.62 Melanoma in situ of left upper limb, including shoulder
D03.70 Melanoma in situ of unspecified lower limb, including hip
D03.71 Melanoma in situ of right lower limb, including hip
D03.72 Melanoma in situ of left lower limb, including hip
D03.8 Melanoma in situ of other sites
D03.9 Melanoma in situ, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT BRAIN NEOPLASM
C71.0 Malignant neoplasm of cerebrum, except lobes and ventricles
C71.1 Malignant neoplasm of frontal lobe
C71.2 Malignant neoplasm of temporal lobe
C71.3 Malignant neoplasm of parietal lobe
C71.4 Malignant neoplasm of occipital lobe
C71.5 Malignant neoplasm of cerebral ventricle
C71.6 Malignant neoplasm of cerebellum
C71.7 Malignant neoplasm of brain stem
C71.8 Malignant neoplasm of overlapping sites of brain
C71.9 Malignant neoplasm of brain, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT THYROID MOLECULAR BIOMARKERS
C73 Malignant neoplasm of thyroid gland
D34 Benign neoplasm of thyroid gland
D44.0 Neoplasm of uncertain behavior of thyroid gland
E04.1 Nontoxic single thyroid nodule
E04.2 Nontoxic multinodular goiter

THE FOLLOWING CODES ARE USED TO REPRESENT NEOPLASM OF THE UTERUS/OVARY/FALLOPIAN TUBE
C45.1 Mesothelioma of peritoneum
C48.1 Malignant neoplasm of specified parts of peritoneum
C48.2 Malignant neoplasm of peritoneum, unspecified
C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C54.0 Malignant neoplasm of isthmus uteri
C54.1 Malignant neoplasm of endometrium
C54.2 Malignant neoplasm of myometrium
C54.3 Malignant neoplasm of fundus uteri
C54.8 Malignant neoplasm of overlapping sites of corpus uteri
C54.9 Malignant neoplasm of corpus uteri, unspecified
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.9 Malignant neoplasm of unspecified ovary
C57.00 Malignant neoplasm of unspecified fallopian tube
C57.01 Malignant neoplasm of right fallopian tube
C57.02 Malignant neoplasm of left fallopian tube
C57.10 Malignant neoplasm of unspecified broad ligament
C57.11 Malignant neoplasm of right broad ligament
C57.12 Malignant neoplasm of left broad ligament
C57.20 Malignant neoplasm of unspecified round ligament
C57.21 Malignant neoplasm of right round ligament
C57.22 Malignant neoplasm of left round ligament
C57.3 Malignant neoplasm of parametrium
C57.4 Malignant neoplasm of uterine adnexa, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT URINARY TRACT NEOPLASM
C65.1 Malignant neoplasm of right renal pelvis
C65.2 Malignant neoplasm of left renal pelvis
C65.9 Malignant neoplasm of unspecified renal pelvis
C66.1 Malignant neoplasm of right ureter
C66.2 Malignant neoplasm of left ureter
C66.9 Malignant neoplasm of unspecified ureter
C68.0 Malignant neoplasm of urethra
C68.1 Malignant neoplasm of paraurethral glands
C68.8 Malignant neoplasm of overlapping sites of urinary organs
C68.9 Malignant neoplasm of urinary organ, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT PROSTATE MOLECULAR BIOMARKERS
C61 Malignant neoplasm of prostate
N40.0 Benign prostatic hyperplasia without lower urinary tract symptoms
N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms
N40.2 Nodular prostate without lower urinary tract symptoms
N40.3 Nodular prostate with lower urinary tract symptoms
N42.83 Cyst of prostate

THE FOLLOWING CODES ARE USED TO REPRESENT GASTROINTESTINAL STROMAL TUMOR
D48.1 Neoplasm of uncertain behavior of connective and other soft tissue
D48.2 Neoplasm of uncertain behavior of peripheral nerves and autonomic nervous system

THE FOLLOWING CODES ARE USED TO REPRESENT ACUTE LYMPHOID LEUKEMIA (ALL)
C91.00 Acute lymphoblastic leukemia not having achieved remission
C91.01 Acute lymphoblastic leukemia, in remission
C92.02 Acute myeloblastic leukemia, in relapse

THE FOLLOWING CODES ARE USED TO REPRESENT ACUTE MYELOID LEUKEMIA (AML, AND INCLUDING ACUTE PROMYELOCYTIC LEUKEMIA)
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.01 Acute myeloblastic leukemia, in remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.41 Acute promyelocytic leukemia, in remission
C92.42 Acute promyelocytic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.51 Acute myelomonocytic leukemia, in remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.61 Acute myeloid leukemia with 11q23-abnormality in remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse

THE FOLLOWING CODES ARE USED TO REPRESENT HAIRY CELL LEUKEMIA
C91.40 Hairy cell leukemia not having achieved remission
C91.41 Hairy cell leukemia, in remission
C91.42 Hairy cell leukemia, in relapse

THE FOLLOWING CODES ARE USED TO REPRESENT APLASTIC ANEMIA
D60.0 Chronic acquired pure red cell aplasia
D60.1 Transient acquired pure red cell aplasia
D60.8 Other acquired pure red cell aplasias
D60.9 Acquired pure red cell aplasia, unspecified
D61.01 Constitutional (pure) red blood cell aplasia
D61.09 Other constitutional aplastic anemia
D61.1 Drug-induced aplastic anemia
D61.2 Aplastic anemia due to other external agents
D61.3 Idiopathic aplastic anemia
D61.89 Other specified aplastic anemias and other bone marrow failure syndromes
D61.9 Aplastic anemia, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT BURKITTS LYMPHOMA
C83.70 Burkitt lymphoma, unspecified site
C83.71 Burkitt lymphoma, lymph nodes of head, face, and neck
C83.72 Burkitt lymphoma, intrathoracic lymph nodes
C83.73 Burkitt lymphoma, intra-abdominal lymph nodes
C83.74 Burkitt lymphoma, lymph nodes of axilla and upper limb
C83.75 Burkitt lymphoma, lymph nodes of inguinal region and lower limb
C83.76 Burkitt lymphoma, intrapelvic lymph nodes
C83.77 Burkitt lymphoma, spleen
C83.78 Burkitt lymphoma, lymph nodes of multiple sites
C83.79 Burkitt lymphoma, extranodal and solid organ sites

THE FOLLOWING CODES ARE USED TO REPRESENT MYELOPROLIFERATIVE DISEASES (MPD - ESSENTIAL THROMBOCYTOSIS [ET], MYELOFIBROSIS & POLYCYTHEMIA VERA [PV]) MOLECULAR BIOMARKERS
D45 Polycythemia vera
D47.1 Chronic myeloproliferative disease
D47.3 Essential (hemorrhagic) thrombocythemia
D75.81 Myelofibrosis

THE FOLLOWING CODES ARE USED TO REPRESENT CHRONIC MYELOID LEUKEMIA (CML) AND CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)
C92.10 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
C92.11 Chronic myeloid leukemia, BCR/ABL-positive, in remission
C92.12 Chronic myeloid leukemia, BCR/ABL-positive, in relapse

THE FOLLOWING CODES ARE USED TO REPRESENT CHRONIC LYMPHOID LEUKEMIA (CLL)
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse

THE FOLLOWING CODES ARE USED TO REPRESENT FOLLICULAR LYMPHOMA
C82.00 Follicular lymphoma grade I, unspecified site
C82.01 Follicular lymphoma grade I, lymph nodes of head, face, and neck
C82.02 Follicular lymphoma grade I, intrathoracic lymph nodes
C82.03 Follicular lymphoma grade I, intra-abdominal lymph nodes
C82.04 Follicular lymphoma grade I, lymph nodes of axilla and upper limb
C82.05 Follicular lymphoma grade I, lymph nodes of inguinal region and lower limb
C82.06 Follicular lymphoma grade I, intrapelvic lymph nodes
C82.07 Follicular lymphoma grade I, spleen
C82.08 Follicular lymphoma grade I, lymph nodes of multiple sites
C82.09 Follicular lymphoma grade I, extranodal and solid organ sites
C82.10 Follicular lymphoma grade II, unspecified site
C82.11 Follicular lymphoma grade II, lymph nodes of head, face, and neck
C82.12 Follicular lymphoma grade II, intrathoracic lymph nodes
C82.13 Follicular lymphoma grade II, intra-abdominal lymph nodes
C82.14 Follicular lymphoma grade II, lymph nodes of axilla and upper limb
C82.15 Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb
C82.16 Follicular lymphoma grade II, intrapelvic lymph nodes
C82.17 Follicular lymphoma grade II, spleen
C82.18 Follicular lymphoma grade II, lymph nodes of multiple sites
C82.19 Follicular lymphoma grade II, extranodal and solid organ sites
C82.20 Follicular lymphoma grade III, unspecified, unspecified site
C82.21 Follicular lymphoma grade III, unspecified, lymph nodes of head, face, and neck
C82.22 Follicular lymphoma grade III, unspecified, intrathoracic lymph nodes
C82.23 Follicular lymphoma grade III, unspecified, intra-abdominal lymph nodes
C82.24 Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb
C82.25 Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb
C82.26 Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes
C82.27 Follicular lymphoma grade III, unspecified, spleen
C82.28 Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites
C82.29 Follicular lymphoma grade III, unspecified, extranodal and solid organ sites
C82.30 Follicular lymphoma grade IIIa, unspecified site
C82.31 Follicular lymphoma grade IIIa, lymph nodes of head, face, and neck
C82.32 Follicular lymphoma grade IIIa, intrathoracic lymph nodes
C82.33 Follicular lymphoma grade IIIa, intra-abdominal lymph nodes
C82.34 Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb
C82.35 Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb
C82.36 Follicular lymphoma grade IIIa, intrapelvic lymph nodes
C82.37 Follicular lymphoma grade IIIa, spleen
C82.38 Follicular lymphoma grade IIIa, lymph nodes of multiple sites
C82.39 Follicular lymphoma grade IIIa, extranodal and solid organ sites
C82.40 Follicular lymphoma grade IIIb, unspecified site
C82.41 Follicular lymphoma grade IIIb, lymph nodes of head, face, and neck
C82.42 Follicular lymphoma grade IIIb, intrathoracic lymph nodes
C82.43 Follicular lymphoma grade IIIb, intra-abdominal lymph nodes
C82.44 Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb
C82.45 Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb
C82.46 Follicular lymphoma grade IIIb, intrapelvic lymph nodes
C82.47 Follicular lymphoma grade IIIb, spleen
C82.48 Follicular lymphoma grade IIIb, lymph nodes of multiple sites
C82.49 Follicular lymphoma grade IIIb, extranodal and solid organ sites
C82.60 Cutaneous follicle center lymphoma, unspecified site
C82.61 Cutaneous follicle center lymphoma, lymph nodes of head, face, and neck
C82.62 Cutaneous follicle center lymphoma, intrathoracic lymph nodes
C82.63 Cutaneous follicle center lymphoma, intra-abdominal lymph nodes
C82.64 Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb
C82.65 Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb
C82.66 Cutaneous follicle center lymphoma, intrapelvic lymph nodes
C82.67 Cutaneous follicle center lymphoma, spleen
C82.68 Cutaneous follicle center lymphoma, lymph nodes of multiple sites
C82.69 Cutaneous follicle center lymphoma, extranodal and solid organ sites
C82.80 Other types of follicular lymphoma, unspecified site
C82.81 Other types of follicular lymphoma, lymph nodes of head, face, and neck
C82.82 Other types of follicular lymphoma, intrathoracic lymph nodes
C82.83 Other types of follicular lymphoma, intra-abdominal lymph nodes
C82.84 Other types of follicular lymphoma, lymph nodes of axilla and upper limb
C82.85 Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb
C82.86 Other types of follicular lymphoma, intrapelvic lymph nodes
C82.87 Other types of follicular lymphoma, spleen
C82.88 Other types of follicular lymphoma, lymph nodes of multiple sites
C82.89 Other types of follicular lymphoma, extranodal and solid organ sites
C82.90 Follicular lymphoma, unspecified, unspecified site
C82.91 Follicular lymphoma, unspecified, lymph nodes of head, face, and neck
C82.92 Follicular lymphoma, unspecified, intrathoracic lymph nodes
C82.93 Follicular lymphoma, unspecified, intra-abdominal lymph nodes
C82.94 Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb
C82.95 Follicular lymphoma, unspecified, lymph nodes of inguinal region and lower limb
C82.96 Follicular lymphoma, unspecified, intrapelvic lymph nodes
C82.97 Follicular lymphoma, unspecified, spleen
C82.98 Follicular lymphoma, unspecified, lymph nodes of multiple sites
C82.99 Follicular lymphoma, unspecified, extranodal and solid organ sites

THE FOLLOWING CODE IS USED TO REPRESENT HYPEREOSINOPHILIA SYNDROME (HES)
D72.1 Eosinophilia

THE FOLLOWING CODES ARE USED TO REPRESENT MANTLE CELL LYMPHOM:
C83.10 Mantle cell lymphoma, unspecified site
C83.11 Mantle cell lymphoma, lymph nodes of head, face, and neck
C83.12 Mantle cell lymphoma, intrathoracic lymph nodes
C83.13 Mantle cell lymphoma, intra-abdominal lymph nodes
C83.14 Mantle cell lymphoma, lymph nodes of axilla and upper limb
C83.15 Mantle cell lymphoma, lymph nodes of inguinal region and lower limb
C83.16 Mantle cell lymphoma, intrapelvic lymph nodes
C83.17 Mantle cell lymphoma, spleen
C83.18 Mantle cell lymphoma, lymph nodes of multiple sites
C83.19 Mantle cell lymphoma, extranodal and solid organ sites

THE FOLLOWING CODE IS USED TO REPRESENT MASTOCYTOSIS
C96.20 Malignant mast cell neoplasm, unspecified
C96.21 Aggressive systemic mastocytosis
C96.22 Mast cell sarcoma
C96.29 Other malignant mast cell neoplasm

THE FOLLOWING CODES ARE USED TO REPRESENT T-CELL PROLYMPHOCYTIC LEUKEMIA
C95.90 Leukemia, unspecified not having achieved remission
C95.91 Leukemia, unspecified, in remission
C95.92 Leukemia, unspecified, in relapse

THE FOLLOWING CODES ARE USED TO REPRESENT MYELODYSPLASTIC SYNDROME (MDS)
D46.0 Refractory anemia without ring sideroblasts, so stated
D46.1 Refractory anemia with ring sideroblasts
D46.20 Refractory anemia with excess of blasts, unspecified
D46.21 Refractory anemia with excess of blasts 1
D46.22 Refractory anemia with excess of blasts 2
D46.4 Refractory anemia, unspecified
D46.9 Myelodysplastic syndrome, unspecified
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
D46.Z Other myelodysplastic syndromes

MEDICARE IS ESTABLISHING THE FOLLOWING LIMITED COVERAGE FOR CYTOGENOMIC MICROARRAY ANALYSIS (81406), OR ALTERNATIVELY A SINGLE NUCLEOTIDE POLYMORPHISM (SNP) ARRAY FOR THE SAME TESTING, WHOSE RESULTANT MUTATION IDENTIFICATIONS ARE USED IN THE DIAGNOSIS/PROGNOSIS OF VARIOUS HEMATOLOGICAL MALIGNANCIES
C90.00 Multiple myeloma not having achieved remission
C90.01 Multiple myeloma in remission
C90.02 Multiple myeloma in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.40 Acute promyelocytic leukemia, not having achieved remission
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.01 Acute monoblastic/monocytic leukemia, in remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C93.10 Chronic myelomonocytic leukemia not having achieved remission
C94.00 Acute erythroid leukemia, not having achieved remission
D46.0 Refractory anemia without ring sideroblasts, so stated
D46.1 Refractory anemia with ring sideroblasts
D46.20 Refractory anemia with excess of blasts, unspecified
D46.21 Refractory anemia with excess of blasts 1
D46.22 Refractory anemia with excess of blasts 2
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
D46.4 Refractory anemia, unspecified
D46.Z Other myelodysplastic syndromes
D46.9 Myelodysplastic syndrome, unspecified
D47.01 Cutaneous mastocytosis
D47.02 Systemic mastocytosis
D47.09 Other mast cell neoplasms of uncertain behavior
D47.2 Monoclonal gammopathy
D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
D89.0 Polyclonal hypergammaglobulinemia
D89.2 Hypergammaglobulinemia, unspecified

MEDICARE IS ESTABLISHING THE FOLLOWING LIMITED COVERAGE FOR MYELOMA GENE EXPRESSION PROFILE (MYPRS) (81479)
C90.00 Multiple myeloma not having achieved remission
C90.02 Multiple myeloma in relapse

Note: C90.00 should be reported after initial diagnosis has been made and C90.02 should be reported if there has been a relapse with a change in treatment planned.



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A


Misc Code

N/A:

N/A


Coding and Billing Requirements


Cross References

Related Documents




Policy History

Revisions for MA06.022f
01/01/2020This version of the policy will become effective on 01/01/2020 due to coding updates.

Narratives for the following codes are being revised in this policy:

81404, 81406

Revisions for MA06.022e
12/04/2019This policy has been reissued in accordance with the Company's annual review process.
01/01/2019Effective 01/01/2019, narrative of the following procedure code has been revised due to coding updates:

81287

Revisions for MA06.022d
11/21/2018This policy has been reissued in accordance with the Company's annual review process.
10/01/2018
    This policy was identified for the ICD-10 code update, effective 10/01/2018.

    The following ICD-10 codes have been deleted from this policy: C43.11, C43.12, D03.11, D03.12

    The following ICD-10 codes have been added to this policy: C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122

Revisions for MA06.022c
11/22/2017This policy has been reissued in accordance with the Company's annual review process.
10/01/2017This policy has been identified for the ICD-10 & CPT code updates, effective 10/01/2017.


    The following ICD-10 code has been deleted from this policy:

    C96.2

    The following ICD-10 codes have been added to this policy:

    C96.20
    C96.21
    C96.22
    C96.29
    D47.01
    D47.02
    D47.09


    The following CPT code has been added to this policy as an experimental/investigational service:

    0018U

Revisions for MA06.022b
12/09/2016This policy has been reissued in accordance with the Company’s annual review process
10/01/2016This version of the policy will become effective 10/01/2016.
This policy has been identified for the ICD-10 CM code update, effective 10/01/2016.

The following ICD-10 CM code narratives have been revised in this policy:
    N40.0
    FROM: Enlarged prostate without lower urinary tract symptoms
    TO: Benign prostatic hyperplasia without lower urinary tract symptoms
    N40.1
    FROM: Enlarged prostate with lower urinary tract symptoms
    TO: Benign prostatic hyperplasia with lower urinary tract symptoms

Revisions for MA06.022a
01/01/2016This policy has been identified for the CPT code update, effective 01/01/2016.

The following CPT codes have been added to this policy:
    81170, 81218, 81219, 81272, 81273, 81276, 81311, 81314, 81538

The narratives for the following CPT codes have been revised in this policy:
    81210, 81275, 81401, 81402, 81403, 81404, 81405, 81406

Revisions for MA06.022
10/01/2015The policy has been reviewed to include ICD-10 codes.

Revisions for MA06.022:
01/01/2015This is a new policy.
This policy has been identified for the CPT code update, effective 01/01/2015:

The following narrative change (as indicated in bold) was made to CPT code 81245:

FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis;
internal tandem duplication (ITD) variants (ie, exons 14, 15)






Version Effective Date: 01/01/2020
Version Issued Date: 01/03/2020
Version Reissued Date: N/A