Percentage of adult patients (aged 18 or over) with metastatic colorectal cancer and RAS (KRAS or NRAS) gene mutation spared treatment with anti-EGFR monoclonal antibodies
This measure is to be submitted once per performance period for patients with colorectal 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 patients with metastatic colorectal cancer who have a RAS (KRAS or NRAS) gene mutation
RAS mutation testing – RAS testing for this measure refers to assays that detect mutations in codons 12 and 13 of exon 2, codons 59 and 61 or exon 3 and codons 117 and 146 in exon 4 in KRAS or NRAS. Do not include results from mutations at other codons or assays for other alterations (e.g., BRAF, PI3K, PTEN genes). The College of American Pathologists (CAP) Perspectives on Emerging Technology (POET) Report on RAS mutation testing provides additional guidance on testing.
If multiple RAS mutation tests have been performed, refer to the most recent test results.
Denominator Criteria (Eligible Cases):
Patients aged ≥ 18 years on date of encounter
Diagnosis of colon or rectal cancer (ICD-10 CM): C18.0, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9, C19, C20
Patient encounter during the performance period: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215
Two or more encounters at the reporting site
Patient has metastatic disease at diagnosis: G9842
RAS (KRAS or NRAS) gene mutation: G9843
Anti-EGFR monoclonal antibody therapy not received
Anti-EGFR monoclonal antibody – cetuximab or panitumumab.
Performance Met: Patient did not receive anti-EGFR monoclonal antibody therapy (G9844)
Performance Not Met: Patient received anti-EGFR monoclonal antibody therapy (G9845)
The American Society of Clinical Oncology (ASCO) envisions that use of this measure will improve concordance with recommendations for RAS testing for patients with metastatic colorectal cancer. We recognize the importance of ensuring that the appropriate patient population receives guideline concordant treatment as studies demonstrate that the administration of EGFR-targeted therapies, specifically cetuximab or panitumumab, offer no clinical benefit to patients diagnosed with RAS-mutated tumors. Clinical trial data strongly suggest that patients with KRAS or NRAS mutations are better served with other targeted therapies, especially considering the harms and costs of anti-EGFR treatment. Therefore, the measure focus is on halting use of anti-EGFR MoAb therapies in patients who will not derive any benefit.
Clinical Recommendation Statements
ASCO published a Guideline in 2017 as an update to the 2015 Provisional Clinical Opinion. This measure has been modified according to the Guideline and Provisional Clinical Opinion to address expanded RAS gene mutation testing in metastatic colorectal carcinoma by extending to additional KRAS mutations and expanding to include NRAS mutations.
This measure is based on an ASCO Guideline:
“Colorectal carcinoma patients being considered for anti-EGFR therapy must receive RAS mutational testing. Mutational analysis should include KRAS and NRAS codons 12, 13 of exon 2; 59, 61 of exon 3; and 117 and 146 of exon 4 (“expanded” or “extended” RAS)”
Sepulveda AR, Hamilton SR, Allegra CJ, et al: Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology. Journal of Clinical Oncology 35:1453-1486, 2017
This measure is also based on an ASCO Provisional Clinical Opinion:
“RAS mutational testing of colorectal carcinoma tissue should be performed in a Clinical Laboratory Improvement Amendments–certified laboratory for all patients who are being considered for anti-EGFR MoAb therapy. Mutational analysis should include KRAS and NRAS codons 12 and 13 of exon 2; 59 and 61 of exon 3; and 117 and 146 of exon 4.
The weight of current evidence indicates that anti-EGFR MoAb therapy (currently cetuximab and panitumumab) should only be considered for treatment of patients with mCRC who are identified as having tumors with no mutations detected after such extended RAS mutation analysis.”
Allegra CJ, Rumble RB, Hamilton SR, Mangu PB, Roach N, Hantel A, et al. Extended RAS gene mutation testing in metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015. J Clin Oncol 2015;34:179– 85.