Measure Description
Percentage of female patients (aged 18 years and older) with AJCC stage I (T1c) – III, human epidermal growth factor receptor 2 (HER2) positive breast cancer receiving adjuvant chemotherapy who are also receiving Trastuzumab
Instructions
This measure is to be submitted a minimum of once per performance period for patients with breast cancer seen during the performance period. This measure may be submitted by Merit-based Incentive Payment System (MIPS) eligible clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding.
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
Adult women with AJCC stage I (T1c) – III, HER2 positive breast cancer who receive adjuvant chemotherapy
Definitions:
Use the following definitions to determine HER2 status-
Positive:
IHC 3+ based on circumferential membrane staining that is complete, intense
• ISH positive based on:
• Single-probe average HER2 copy number = 6. 0 signals/cell
• Dual-probe HER2/CEP17 ratio = 2. 0 with an average HER2 copy number = 4. 0 signals/cell
• Dual-probe HER2/CEP17 ratio = 2. 0 with an average HER2 copy number < 4. 0 signals/cell
• Dual-probe HER2/CEP17 ratio < 2. 0 with an average HER2 copy number = 6. 0 signals/cell
Equivocal:
• IHC 2+ based on circumferential membrane staining that is incomplete and/or weak/moderate and within > 10% of the invasive tumor cells or complete and circumferential membrane staining that is intense and within = 10% of the invasive tumor cells
ISH equivocal based on:
• Single-probe ISH average HER2 copy number = 4. 0 and < 6. 0 signals/cell
• Dual-probe HER2/CEP17 ratio < 2. 0 with an average HER2 copy number = 4. 0 and < 6. 0 signals/cell
Negative:
IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within > 10% of the invasive tumor cells or IHC 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within = 10% of the invasive tumor cells
ISH negative based on:
• Single-probe average HER2 copy number < 4. 0 signals/cell
• Dual-probe HER2/CEP17 ratio < 2. 0 with an average HER2 copy number < 4. 0 signals/cell
Indeterminate:
Indeterminate if technical issues prevent one or both tests (IHC and ISH) from being reported as positive, negative, or equivocal.
Conditions may include:
• Inadequate specimen handling
• Artifacts (crush or edge artifacts) that make interpretation difficult
• Analytic testing failure.
Denominator Criteria (Eligible Cases):
Female Patients aged ≥ 18 years on date of encounter
AND
Diagnosis of breast cancer (ICD-10-CM): C50. 011, C50. 012, C50. 019, C50. 111, C50. 112, C50. 119, C50. 211, C50. 212, C50. 219, C50. 311, C50. 312, C50. 319, C50. 411, C50. 412, C50. 419, C50. 511, C50. 512, C50. 519, C50. 611, C50. 612, C50. 619, C50. 811, C50. 812, C50. 819, C50. 911, C50. 912, C50. 919
AND
Patient encounter during performance period (CPT): 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215
AND
Two or more encounters at the reporting site
AND
Breast Adjuvant Chemotherapy administered: G9829
AND
HER-2/neu positive: G9830
AND
AJCC stage at breast cancer diagnosis = II or III: G9831
OR
AJCC stage at breast cancer diagnosis = I (IA or IB) and T-Stage at breast cancer diagnosis does NOT equal = T1, T1a, T1b: G9832
AND NOT
DENOMINATOR EXCLUSIONS:
Patient transfer to practice after initiation of chemotherapy: G9833
OR
Patient has metastatic disease at diagnosis: G9834
Numerator
Trastuzumab administered within 12 months of diagnosis
NUMERATOR NOTE: If Trastuzumab was not administered within 12 months of diagnosis, the presence of the denominator exception should be examined during that same time period.
Numerator Options:
Performance Met: Trastuzumab administered within 12 months of diagnosis (G9835)
OR
Denominator Exception: Reason for not administering Trastuzumab documented (e. g. patient declined, patient died, patient transferred, contraindication or other clinical exclusion, neoadjuvant chemotherapy or radiation NOT complete) (G9836)
OR
Performance Not Met: Trastuzumab not administered within 12 months of diagnosis (G9837)