Percentage of patients aged 18 years and older with a diagnosis of myelodysplastic syndrome (MDS) or an acute leukemia who had baseline cytogenetic testing performed on bone marrow
This measure is to be submitted a minimum of once per performance period for all myelodysplastic syndrome (MDS) and Acute Leukemia patients seen during the performance period, regardless of when MDS or Acute Leukemia diagnosis was made; the quality action being measured is that baseline cytogenetic testing on bone marrow was performed for each patient with MDS or Acute Leukemia at the time of diagnosis or prior to initiating treatment. It is anticipated that Merit-based Incentive Payment System (MIPS) eligible clinicians who provide services for patients with the diagnosis of myelodysplastic syndromes or an acute leukemia (not in remission) will submit this measure.
Measure Submission Type:
Measure data may be submitted by individual MIPS eligible clinicians, groups, or third party intermediaries. The listed denominator criteria are used to identify the intended patient population. The numerator options included in this specification are used to submit the quality actions as allowed by the measure. The quality-data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third party intermediaries that utilize this modality for submissions; however, these codes may be submitted for those third party intermediaries that utilize Medicare Part B claims data. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.
All patients aged 18 years and older with a diagnosis of myelodysplastic syndrome (MDS) or an acute leukemia
DENOMINATOR NOTE: *Signifies that this CPT Category I code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for MIPS CQMs.
Denominator Criteria (Eligible Cases):
Patients aged ≥ 18 years on date of encounter
Diagnosis for MDS or acute leukemia – not in remission (ICD-10-CM): C91.00, C91.02, C92.00, C92.02, C92.40, C92.42, C92.50, C92.52, C92.60, C92.62, C92.A0, C92.A2, C93.00, C93.02, C94.00, C94.02, C94.20, C94.22, C95.00, C95.02, D46.0, D46.1, D46.20, D46.21, D46.22, D46.4, D46.9, D46.A, D46.B, D46.C, D46.Z
Patient encounter during the performance period (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241*, 99242*, 99243*, 99244*, 99245*
Telehealth Modifier: GQ, GT, 95, POS 02
Patients who had baseline cytogenetic testing performed on bone marrow
NUMERATOR NOTE: Denominator Exception(s) are determined at the time of the diagnosis of MDS or Acute Leukemia or prior to initiating treatment.
Baseline Cytogenetic Testing – Testing that is performed at time of diagnosis or prior to initiating treatment (transfusion, growth factors, or antineoplastic therapy) for that diagnosis
Performance Met: Cytogenetic testing performed on bone marrow at time of diagnosis or prior to initiating treatment (3155F)
Denominator Exception: Documentation of medical reason(s) for not performing baseline cytogenetic testing on bone marrow (e.g., no liquid bone marrow or fibrotic marrow) (3155F with 1P)
Denominator Exception: Documentation of patient reason(s) for not performing baseline cytogenetic testing on bone marrow (e.g., at time of diagnosis receiving palliative care or not receiving treatment as defined above) (3155F with 2P)
Denominator Exception: Documentation of system reason(s) for not performing baseline cytogenetic testing on bone marrow (e.g., patient previously treated by another physician at the time cytogenetic testing performed) (3155F with 3P)
Performance Not Met: Cytogenetic testing not performed on bone marrow at time of diagnosis or prior to initiating treatment, reason not otherwise specified (3155F with 8P)
Cytogenetic testing is an integral component in calculating the International Prognostic Scoring System (IPSS) score. Cytogenetic testing should be performed on the bone marrow of patients with MDS in order to guide treatment options, determine prognosis, and predict the likelihood of disease evolution to leukemia.
For acute leukemias:
In addition to establishing the type of acute leukemia, cytogenetic testing is essential to detect chromosomal abnormalities that have diagnostic, prognostic, and therapeutic significance. Performing cytogenetic analysis on patients with acute myeloid leukemia (AML) identifies a subgroup of patients where further molecular genetics testing is indicated.
Clinical Recommendation Statements
The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines:
Bone marrow aspiration with Prussian blue stain for iron and a biopsy are needed to evaluate the degree and relative proportions of hematopoietic cell maturation abnormalities, percentage of marrow blasts, marrow cellularity, presence or absence of ring sideroblasts (and presence of iron per se), and fibrosis. Cytogenetics for bone marrow samples (by standard karyotyping methods) should be obtained because they are of major prognostic importance. (Category 2A Recommendation) (NCCN MDS, 2020)
Significant independent variables for determining survival and AML evolution outcomes were marrow blast percentage, number of cytopenias, and cytogenetic subgroup (good, intermediate, poor). The percentage of marrow blasts was divisible into four categories: 1) less than 5%, 2) 5% to 10%, 3) 11% to 20%, and 4) 21% to 30%. (Category 2A Recommendation) (NCCN MDS, 2020)
For Acute Leukemias:
In addition to morphologic assessment (blood and BM), the pathologist or treating clinician should obtain sufficient samples and perform conventional cytogenic analysis (i.e., karyotype), appropriate molecular-genetic and/or FISH testing, and FCI. The flow cytometry panel should be sufficient to distinguish between acute myeloid leukemia (including acute promyelotic leukemia), T-ALL (including early T-Cell precursor leukemias), B-cell precursor ALL (B- ALL), and AL of ambiguous lineage for all patients diagnosed with AL. Molecular genetic and/or FISH testing does not, however replace conventional cytogenic analysis. (Strong Recommendation) (CAP/ASH, 2017)
Acute Lymphoblastic Leukemia:
Hematopathology evaluations should include morphologic examination of malignant lymphocytes using Wright- Giemsa-stained slides and hemtoxylin and eosin-stained core biopsy and clot sections; comprehensive immunophenotyping with flow cytometry; and baseline characterization of leukemic clone(s) to facilitate subsequent analysis of minimal residual disease (MRD). Identification of specific recurrent genetic abnormalities is critical for disease evaluation, optimal risk stratification, and treatment planning. (Category 2A Recommendation) (NCCN ALL, 2019)
Acute Myeloid Leukemia:
Although cytogenetic information is often unknown when treatment is initiated in patients with de novo AML, karyotype represents the single most important prognostic factor for predicting remission rates, relapse risks, and [overall survival (OS)] outcomes. (Category 2A Recommendation) (NCCN AML, 2020)
The importance of obtaining adequate samples of marrow or peripheral blood at diagnosis for full karyotyping and FISH cytogenetic analysis for the most common abnormalities cannot be overemphasized. In addition to basic cytogenetic analysis, new molecular markers can help refine prognostics groups, particularly in patients with a normal karyotype. (Category 2A Recommendation) (NCCN AML, 2020)