Measure Description
Percentage of 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 breast cancer patients aged 18 to 70 with pathologic stage I (T1c) – III HER2 positive breast cancer diagnosed between July 1st of the previous performance period through June 30th of the current performance period
Denominator Instructions:
For the purposes of this measure, only pathologic staging and HER-2 testing performed between July 1st of the previous performance period through June 30th of the current performance period will be included in the denominator of this measure.
Definitions:
Use the 2018 ASCO/CAP guideline definitions (re-affirmed in 2023) 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 NOTE: This measure includes both female and male breast cancers. While treatment recommendations for males have largely been extrapolated from results of clinical trials focused on breast cancer in females, management of breast cancer in males is similar in overall management to breast cancer in females. Consistent with guidance in NCCN guideline recommendations for adjuvant systemic therapy, chemotherapy with/without HER2-targeted therapy should be recommended for males with breast cancer according to guidelines for females with breast cancer.
The patient must have two encounters during the performance period. This is intended to reflect two separate encounters with the same reporting provider/group during this timeframe. There is no specific timeframe for the requirement for the two encounters that occur during the performance period. For example, two encounters with the same provider/group could occur in the same week. However, two encounters should not be counted if they occur on the same day. For example, the patient has two encounters and one is with a different provider on the same day
Denominator Criteria (Eligible Cases):
Patients age 18-70 years on date of encounter
AND
Diagnosis of breast cancer between July 1st of the previous performance period through June 30th of the current performance period (ICD-10-CM): C50.A0, C50.A1, C50.A2, C50.011, C50.012, C50.019, C50.021, C50.022, C50.029, C50.111, C50.112, C50.119, C50.121, C50.122, C50.129, C50.211, C50.212, C50.219, C50.221, C50.222, C50.229, C50.311, C50.312, C50.319, C50.321, C50.322, C50.329, C50.411, C50.412, C50.419, C50.421, C50.422, C50.429, C50.511, C50.512, C50.519, C50.521, C50.522, C50.529, C50.611, C50.612, C50.619, C50.621, C50.622, C50.629, C50.811, C50.812, C50.819, C50.821, C50.822, C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929
AND
At least two patient encounters during the current performance period (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215
WITHOUT
Encounters conducted via telehealth: M1426
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 = T1c: 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. The timeframe to identify the adjuvant treatment course is within six months of breast cancer pathologic staging. To satisfy the numerator, both chemotherapy and HER2-targeted therapy must occur within six months of pathologic staging. 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 10-20 percent of patients with breast cancer have tumors that overexpress the human epidermal growth factor receptor (HER2) protein (Early Breast Cancer Trialists' Collaborative group (EBCTCG), 2021). High levels of the HER2 protein are linked with a higher likelihood of metastasis, increased risk of disease recurrence, and a decrease in patient survival, but are more likely to respond to targeted therapies (Early Breast Cancer Trialists' Collaborative group (EBCTCG), 2021) & (National Cancer Institute, 2018). Numerous adjuvant trials of trastuzumab have demonstrated clinically significant improvements in disease-free survival, with the HERA, NSABP B31, and NCCTGF N9831 trials also demonstrating significant improvement in overall survival with the use of trastuzumab (Gradishar, Moran, Abraham, & al., 2024). The benefits of trastuzumab are independent of estrogen receptor (ER) status (Gradishar, Moran, Abraham, & al., 2024). 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.
Clinical Recommendation Statements
NCCN Recommendation for Adjuvant HER2-Targeted Therapy
The panel recommends HER2-targeted therapy in patients with HER2-positive tumors. The panel has designated use of trastuzumab with chemotherapy as a category 1 recommendation for all HER2 positive tumors >1cm (Gradishar, Moran, Abraham, & al., 2024).
References:
- Early Breast Cancer Trialists' Collaborative group (EBCTCG). (2021). Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials. The Lancet: Oncology, 22(8), 1139 - 1150. Retrieved from https://doi.org/10.1016/S1470-2045(21)00288-6
- Gradishar, W., Moran, M., Abraham, J., & al., e. (2018, April 11). NCCN Guidelines Panel. NCCN Clinical Practice Guidelines in Oncology – Breast Cancer. Version 6.2024. Retrieved from national Comprehensive Cancer Network: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf National Cancer Institute. (2008, April 11).
- HER2’s Genetic Link to Breast Cancer Spurs Development of New Treatments. Retrieved from National Cancer Institute at the National Institutes of Health: https://www.cancer.gov/research/progress/discovery/her2