Measure Description
Percentage of female patients aged 18 to 70 with stage I (T1c) – III HER2 positive breast cancer for whom appropriate treatment is initiated.
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
All female breast cancer patients aged 18 to 70 with stage I (T1c) – III HER2 positive breast cancer
Definitions:
Use the 2018 ASCO/CAP guideline definitions to determine HER2 status-
HER2 Positive:
- If result is IHC 3+ based on circumferential membrane staining that is complete, intense and in >10% of the invasive tumor cells
- If result is 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 = 6.0 signals/cell
HER2 Equivocal:
- If result is IHC 2+ based on circumferential membrane staining that is incomplete and/or weak/moderate and within > 10% of the invasive tumor cells
- If result is 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
HER2 Negative:
- If result is IHC 1+ based on incomplete membrane staining that is faint/barely perceptible and in > 10% of the invasive tumor cells
- If result is IHC 0 based on no staining observed or membrane staining that is incomplete and is faint/barely perceptible and in ≤ 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
HER2 Indeterminate:
Report HER2 test result as 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 age 18-70 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
At least two patient encounters during performance period (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215
WITHOUT
Telehealth Modifier (including but not limited to): GQ, GT, 95, POS 02
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 EXCLUSION:
Patients with pregnancy during adjuvant treatment course: G2205
Numerator
Patients whose adjuvant treatment course includes both chemotherapy and HER2-targeted therapy
NUMERATOR NOTE: The quality action of this measure is the appropriateness of treatment rather than timeliness of treatment. The timing of administration of HER2-targeted therapies is expected to vary depending on the cytotoxic agents used. The numerator statement is intended to capture an adjuvant treatment course that includes both chemotherapy and HER2-targeted therapy, independent of possible administration sequences. Adjuvant chemotherapy is defined as a chemotherapy regimen initiated within six months of cancer diagnosis. An FDA-approved trastuzumab biosimilar is an appropriate substitute for trastuzumab.
Numerator Options:
Performance Met: Patient received adjuvant treatment course including both chemotherapy and HER2-targeted therapy (G2206)
OR
Denominator Exception: Reason for not administering adjuvant treatment course including both chemotherapy and HER2-targeted therapy (e.g. poor performance status (ECOG 3-4; Karnofsky ≤50), cardiac contraindications, insufficient renal function, insufficient hepatic function, other active or secondary cancer diagnoses, other medical contraindications, patients who died during initial treatment course or transferred during or after initial treatment course) (G2207)
OR
Performance Not Met: Patient did not receive adjuvant treatment course including both chemotherapy and HER2-targeted therapy (G2208)
Rationale
Approximately 15% of patients with breast cancer have tumors that overexpress the human epidermal growth hormone receptor protein (HER2). All of the adjuvant trials of trastuzumab have demonstrated clinically significant improvements in DFS. The benefits of trastuzumab are independent of estrogen receptor (ER)status. The American Society of Clinical Oncology (ASCO) envisions that use of this measure will improve concordance with recommendations for the use of HER2-targeted therapy with chemotherapy for patients with stage I (T1c) – III, HER2 positive breast cancer. We recognize the importance of ensuring that the appropriate patient population receives guideline concordant treatment as studies have shown that the administration of HER2-targeted therapies significantly improves overall survival in patients with high-risk HER2 positive breast cancer (NCCN 2022).
Clinical Recommendation Statements
NCCN Recommendation for Adjuvant HER2-Targeted Therapy
The panel recommends HER2-targeted therapy in patients with HER2-positive tumors. Trastuzumab is a humanized monoclonal antibody with specificity for the extracellular domain of HER2. The panel has designated use of trastuzumab with chemotherapy as a category 1 recommendation in patients with HER2-positive tumors greater than 1 cm (NCCN 2022).
References:
- Gradishar WJ, Moran MS,, Abraham J, et al. NCCN Guidelines Panel. NCCN Clinical Practice Guidelines in Oncology – Breast Cancer. Version 2.2022. December 20, 2021. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
- Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10; 36(20):2105-2122.