2024 MIPS Measure #491: Mismatch Repair (MMR) or Microsatellite Instability (MSI) Biomarker Testing Status in Colorectal Carcinoma, Endometrial, Gastroesophageal, or Small Bowel Carcinoma

Quality ID 491
NQF 3661
High Priority Measure Yes
Specifications Registry
Measure Type Process
Specialty Pathology

Measure Description

Percentage of surgical pathology reports for primary colorectal, endometrial, gastroesophageal or small bowel carcinoma, biopsy or resection, that contain impression or conclusion of or recommendation for testing of mismatch repair (MMR) by immunohistochemistry (biomarkers MLH1, MSH2, MSH6, and PMS2), or microsatellite instability (MSI) by DNA-based testing status, or both.

 

Instructions

This measure is to be submitted each time a primary colorectal, endometrial, gastroesophageal or small bowel carcinoma, biopsy or resection surgical pathology examination is performed 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 surgical pathology reports for primary colorectal, endometrial, gastroesophageal or small bowel carcinoma, biopsy or resection

Denominator Criteria (Eligible Cases):

Patients regardless of age

AND

Diagnosis of primary colorectal, endometrial, gastroesophageal or small bowel carcinoma, biopsy or resection (ICD-10-CM): C15.3, C15.4, C15.5, C15.8, C15.9, C16.0, C16.1, C16.2, C16.3, C16.4, C16.5, C16.6, C16.8, C16.9, C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, C18.0, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9, C19, C20, C26.0, C54.1, C54.3, C54.8, C54.9, C55

AND

Patient procedure during the performance period (CPT): 88305, 88307, 88309

WITHOUT

Telehealth Modifier (including but not limited to): GQ, GT, 95, POS 02, POS 10

AND NOT

DENOMINATOR EXCLUSION:

Patients with an existing diagnosis of Lynch Syndrome (ICD-10-CM): Z15.04, Z15.09, Z80.0

OR

Patients with an existing diagnosis of squamous cell carcinoma of the esophagus: M1192

OR

Hospice services provided to patient any time during the measurement period: M1191

 

Numerator

Surgical pathology reports that contain impression or conclusion of or recommendation for testing of MMR by immunohistochemistry, MSI by DNA-based testing status, or both

Numerator Options:

Performance Met: Surgical pathology reports that contain impression or conclusion of or recommendation for testing of MMR by immunohistochemistry, MSI by DNA-based testing status, or both (M1193)

OR

Denominator Exception: Documentation of medical reason(s) surgical pathology reports did not contain impression or conclusion of or recommendation for testing of MMR by immunohistochemistry, MSI by DNA-based testing status, or both tests were not included (e.g., patient will not be treated with checkpoint inhibitor therapy, no residual carcinoma is present in the sample [tissue exhausted or status post neoadjuvant treatment], insufficient tumor for testing) (M1194)

OR

Performance Not Met: Surgical pathology reports that do not contain impression or conclusion of or recommendation for testing of MMR by immunohistochemistry, MSI by DNA-based testing status, or both, reason not given (M1195)

 

Rational

Detection of defective mismatch repair in colorectal carcinomas is important for detection of Lynch syndrome (hereditary nonpolyposis colorectal cancer syndrome [HNPCC]), which accounts for approximately 2 percent to 4 percent of all colorectal carcinomas and has clinical implications for treatment of the affected patient and family members (Sepulveda et al, 2017; Rubenstein et al, 2015). National Comprehensive Cancer Network (NCCN) recommends that all patients with a personal history of colon or rectal cancer should have MMR or MSI testing (NCCN, 2022). In the 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 American Society of Clinical Oncology it is recommended that mismatch repair status testing in patients with colorectal cancers is necessary for the identification of patients at high risk for Lynch syndrome and/or prognostic stratification (Sepulveda et al, 2017).

One of two different initial tests can be performed on colorectal specimens to identify individuals who might have Lynch Syndrome: 1) immunohistochemistry (IHC) for MMR protein expression, which is often diminished because of mutation; or 2) analysis for microsatellite instability (MSI), which results from MMR deficiency. NCCN guidelines state IHC and MSI on newly diagnosed colorectal and endometrial cancers regardless of family history to determine Lynch Syndrome, is cost effective and has been confirmed for colorectal cancer and endorsed by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group at the CDC, the US Multi-Society Task Force on Colorectal Cancer, and the American Gastroenterological Association (NCCN, 2022; NCCN, 2019).

References

Sepulveda AR, 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 American Society of Clinical Oncology. Arch Pathol Lab Med. 2017 May;141(5):625-657.

Rubenstein, JH et al Diagnosis and management of Lynch syndrome. Gastroenterology. 2015 Sept: 149 (3):777-782. (Update to guideline in progress)

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 2.2022. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Uterine Neoplasms. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf

 

Clinical Recommendation Statements

This measure is based on recommendations in an upcoming guideline regarding use of MMR/MSI testing in patients being considered for checkpoint inhibitor therapy (June 2021; see MMR/MSI Guideline for more information). Although recommendations have existed for screening colorectal cancer (see Biomarkers in CRC for more information) and endometrial cancer (see NCCN Guidelines for more information), universal testing remains elusive. Data collected for these two cancer types in the Pathologists Quality Registry shows significant gap (performance rates of 71.05 percent with a standard deviation of 22.37 points and 76.63 percent with a standard deviation of 15.08 points respectively from 2020). Furthermore, only 42 percent of US-based practices gastroenterologists recommend universal MMR/MSI testing for colorectal cancer patients (Jain et al., 2019), and 50 percent of clinicians for endometrial cancer patients (Pan et al., 2018). Due to the recent nature of the recommendation for testing of gastric and small bowel cancer patients, rates of testing are difficult to ascertain, but a 2017 study showed that MMR/MSI testing was performed in only 51 percent of cases (Mathiak et al., 2017). A 2018 survey of clinicians found that 0 percent of respondents recommend universal testing of small bowel cancer cases (Pan et al., 2018).

Testing for MMR/MSI will benefit patients and the health care system by making care more targeted. A better understanding of the genetic makeup of an individual’s cancer allows oncologists to design a personalized care plan, meaning patients get the right care faster. This will improve patients’ health faster and save the health care system wasted costs.

References

Jain A, Shafer L, Rothenmund H, Kim CA, Samadder J, Gupta S, Singh H. Suboptimal Adherence in Clinical Practice to Guidelines Recommendation to Screen for Lynch Syndrome. Dig Dis Sci. 2019 Dec;64(12):3489-3501. doi: 10.1007/s10620-019-05692-6.

Pan, J. Y., Haile, R. W., Templeton, A., Macrae, F., Qin, F., Sundaram, V., & Ladabaum, U. (2018). Worldwide Practice Patterns in Lynch Syndrome Diagnosis and Management, Based on Data From the International Mismatch Repair Consortium. Clin Gastroenterol Hepatol, 16(12), 1901-1910 e1911. doi:10.1016/j.cgh.2018.04.025

Mathiak M, Warneke VS, Behrens H-M, Haag J, Boger C, Kruger S and Rocken C (2017) Clinicopathologic Characteristics of Microsatellite Instable Gastric Carcinomas Revisited: Urgent Need for Standardization. Appl Immunohistochem Mol Morphol; 25(1):12-24.

Register with MDinteractive