Percentage of female patients (aged 18 years and older) with breast cancer who are human epidermal growth factor receptor 2 (HER2)/neu negative who are not administered HER2-targeted therapies
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.
Adult women with breast cancer that are HER2 negative or HER2 undocumented
Use the following definitions to determine HER-2/neu status-
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
• 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
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 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
Transferred to Practice:
Patients who have transferred to the reporting practice after the initiation of HER2 targeted therapy at another practice. This prevents practices from being held accountable for another practices’ prior treatment decisions. The MIPS eligible clinician submitting the measure should have initiated the treatment for the denominator eligible patient.
Denominator Criteria (Eligible Cases):
Female Patients aged ≥ 18 years on date of encounter
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
Patient encounter during performance period (CPT): 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215
Two or more encounters at the reporting site
HER-2/neu Negative or Undocumented/Unknown: G9825
Patient transferred to practice after initiation of chemotherapy: G9826
HER2-targeted therapies not administered during the initial course of treatment
NUMERATOR NOTE: HER-2 targeted therapies are defined as Trastuzumab, Pertuzumab and TDM1.
Performance Met: HER2-targeted therapies not administered during the initial course of treatment (G9827)
Performance Not Met: HER2-targeted therapies administered during the initial course of treatment (G9828)