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-
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 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)
Rationale
Approximately 15% of patients with breast cancer have tumors that overexpress the human epidermal growth hormone receptor protein (HER2). The American Society of Clinical Oncology (ASCO) envisions that use of this measure will improve concordance with recommendations for Trastuzumab administration for patients with AJCC stage I(T1c) – III, HER2/neu 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 Trastuzumab significantly improves overall survival in patients with high-risk HER2 positive breast cancer.
Clinical Recommendation Statements
Cancer Care Ontario guideline on optimal systemic therapy for early breast cancer in women.
Trastuzumab plus chemotherapy is recommended for all patients with her2-positive, node-positive breast cancer and for patients with her2-positive, node-negative breast cancer greater than 1 cm in size. Key Evidence and Qualifying Statements: Phase iii clinical studies have demonstrated improved DFS and OS with the addition of trastuzumab to chemotherapy (compared with chemotherapy alone) in her2-positive early breast cancer.
References:
1. Eisen, A., K. G, Fletcher, et. al, “Optimal Systemic Therapy for Early Breast Cancer in Women: A Clinical Practice Guideline.” Curr Onc 22. 0 (2014): Available at: Optimal Systemic Therapy for Early Breast Cancer in Women: A Clinical Practice Guideline
2. 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.