Measure Description
Percentage of patients aged 18 years and older, seen within a 12-month reporting period, with a diagnosis of chronic lymphocytic leukemia (CLL) made at any time during or prior to the reporting period who had baseline flow cytometry studies performed and documented in the chart
Instructions
This measure is to be submitted a minimum of once per performance period for all chronic lymphocytic leukemia (CLL) patients seen during the performance period, regardless of when the diagnosis of CLL is made; the quality action being measured is that the baseline flow cytometry study occurred for each patient with CLL 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 chronic lymphocytic 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.
Denominator
All patients aged 18 years and older, seen within a 12-month reporting period, with a diagnosis of chronic lymphocytic leukemia (CLL) made at any time during or prior to the performance period
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
AND
Diagnosis for CLL – not in remission (ICD-10-CM): C91.10, C91.12
AND
Patient encounter during the performance period (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241*, 99242*, 99243*, 99244*, 99245*
WITHOUT
Telehealth Modifier: GQ, GT, 95, POS 02
Numerator
Patients who had baseline flow cytometry studies performed and documented in the chart
Definition:
Baseline Flow Cytometry Studies – Refer to testing that is performed at time of diagnosis or prior to initiating treatment for that diagnosis. Treatment may include anti-neoplastic therapy.
NUMERATOR NOTE: Denominator Exception(s) are determined at the time of the diagnosis of CLL or prior to initiating treatment.
Numerator Options:
Performance Met: Baseline flow cytometry studies performed at time of diagnosis or prior to initiating treatment (3170F)
OR
Denominator Exception: Documentation of medical reason(s) for not performing baseline flow cytometry studies (3170F with 1P)
OR
Denominator Exception: Documentation of patient reason(s) for not performing baseline flow cytometry studies (e.g., receiving palliative care or not receiving treatment as defined above) (3170F with 2P)
OR
Denominator Exception: Documentation of system reason(s) for not performing baseline flow cytometry studies (e.g., patient previously treated by another physician at the time baseline flow cytometry studies were performed) (3170F with 3P)
OR
Performance Not Met: Baseline flow cytometry studies not performed at time of diagnosis or prior to initiating treatment, reason not otherwise specified (3170F with 8P)
Rationale
Due to the distinct pattern of protein antigens expressed in CLL, flow cytometry should be performed in order to confirm the diagnosis, correctly characterize the pathological cells, and determine prognosis. In some instances, flow cytometry may also offer additional therapeutically relevant information. (DiGiuseppe JA, Borowitz MJ. Clinical utility of flow cytometry studies in the chronic lymphoid leukemias. Semin Oncol. 1998:25(1):6-10.)
Clinical Recommendation Statements
The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines:
The diagnosis of CLL requires the presence of at least 5 x 109/L monoclonal B-lymphocytes in the peripheral blood and the clonality of B-cells should be confirmed by flow cytometry. (Category 2A Recommendation) (NCCN, 2020)
Flow cytometry of peripheral blood is adequate for the diagnosis of CLL, and bone marrow biopsy is generally not required. (Category 2A Recommendation) (NCCN, 2020)