Context.—

Quality measures assess health care processes, outcomes, and patient perceptions associated with high-quality health care, which is commonly defined as care that is effective, safe, efficient, patient centered, equitable, and timely. Such measures are now being used in order to incentivize provision of high-quality health care.

Objective.—

To meet the goals of the Quality Payment Program, quality measures will be developed from clinical practice guidelines and relevant, peer-reviewed research identifying evidence that the measure addresses 3 areas: a high-priority aspect of health care or a specific national health goal or priority; a meaningful focus, such as leading to a desired health outcome; and a gap or variation in care.

Design.—

Within the College of American Pathologists (CAP), the Measures and Performance Assessment Subcommittee is tasked with developing useful performance measures. Participating practitioners can then select measures that are meaningful to their respective patients and practices, and reflect the quality of the services they provide.

Results.—

The CAP developed 23 quality measures for reporting to the Centers for Medicare & Medicaid Services that reflect rigorous clinical evidence and address areas in need of performance improvement.

Conclusions.—

Because the implications of reporting on these pathology-specific metrics are significant, these measures and the process by which they were designed are presented here in peer-reviewed fashion. The measures described in this article (part 1) represent recent efforts by the CAP to develop meaningful measures that reflect rigorous clinical evidence and highlight areas with opportunities for performance improvement.

The Medicare Access and CHIP Reauthorization Act of 2015, which replaced the Sustainable Growth Rate, had broad bipartisan support and established the Quality Payment Program (QPP), which has 2 payment pathways: the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs). The Centers for Medicare & Medicaid Services' (CMS) regulatory policy and implementation of these programs prompted significant advocacy by the College of American Pathologists (CAP) and quality payment measure development efforts on behalf of its membership. A review of the QPP1  previously published by CAP will be updated along with this series of articles. As CMS is implementing MIPS and evolving the program for year 3, it has signaled significant policy shifts in measure development for (and use in) the QPP. CMS continues to indicate that the initial latitude given for measure development has created issues with the number, quality, and redundancy of measures available. CMS is moving away from its approach to measures released previously and is significantly reducing the number of measures in the QPP by actively removing topped-out and extremely topped-out measures, defined as measures with performance benchmarks ≥95% and ≥98%, respectively, increasing the rigor required for submitted measures, including complexity of measures (eg, multistrata and risk-adjusted measures), approving measures with a demonstrated variation in performance (ie, clearly characterizing higher-performing clinicians from lower-performing clinicians), and moving away from claims-based reporting (and claims-based measures).

The CAP Measures and Performance Assessment Subcommittee (hereafter referred to as the “Subcommittee”) of the Economic Affairs Committee is a diverse pathology subspecialty technical expert group with a long track record of successfully creating payment program–related quality measures (ie, Physician Quality Reporting System and MIPS). Most recently, the measures created by this Subcommittee were made publicly available for MIPS reporting in CAP's Pathologists Quality Registry and were deemed suitable for designation as MIPS Clinical Quality Measures (CQM) by CMS.

Regulatory and legislative policy analysis with associated advocacy remain a high priority of CAP to ensure that pathologists have the measures and tools they need to be successful within evolving payment models. Clinical quality measures are proportionally the most important component when determining MIPS-related payment adjustments for pathologists. There are 2 different categories of quality measures to consider: Quality Payment Program (QPP) measures and Qualified Clinical Data Registry (QCDR) measures. Quality Payment Program measures are part of the formal rule-making process of CMS prior to inclusion in the QPP and may also be referred to as MIPS measures. For example, the CAP-stewarded QPP measures are the former Physician Quality Reporting System measures and are available for any eligible clinician to use for MIPS Quality category reporting. The QCDR measures are also approved by the CMS but are created specifically for use in a QCDR to report for MIPS. The QCDR measures can only be reported when a clinician or group reports performance to MIPS through a QCDR that owns or licenses the measure. The Pathologists Quality Registry is a CMS-approved QCDR developed by CAP that pathologists can use to report pathology-specific QCDR and QPP measures. The Measures and Performance Assessment Subcommittee works closely with CAP's Clinical Data Registry Ad Hoc Committee to develop and manage the CAP's measure portfolio. Here, we describe the process of measure development and specifically review a subset of the new QCDR measures relating the pathologist's role in the care of patients with lung cancer, colon cancer, and acute myeloid leukemia (AML) that were approved for use starting in 2019 and continuing into 2020. New measures approved for use in 2020 related to endometrial carcinoma, prostatectomies, and bladder cancer are also discussed.

MEASURE DEVELOPMENT METHODOLOGY

Members of the Subcommittee represent a range of anatomic and clinical pathology subspecialties and practice environments, as well as pathologists with administrative and industry roles. This wide range of expertise is leveraged to identify areas of pathologist practice and involvement that are essential for effective patient care and in which significant and measurable practice variation may exist. Subcommittee members identify measurable practices in these areas and develop measure concepts based on guidelines published by the CAP and other medical specialty societies. Concepts are also identified from peer-reviewed literature as well as the quality improvement activities of various state and nationwide partnerships. The Subcommittee evaluates concepts based on their potential for improvement of clinical processes and patient care; the evidence of a performance gap among pathologists; and the feasibility of collecting the data. Select concepts that achieve Subcommittee consensus are presented to the full CAP Economic Affairs Committee for further consideration and approval.

Measure specifications are developed by the Subcommittee in collaboration with the measurement science experts at the Physicians Consortium for Performance Improvement around a denominator and numerator to quantify performance for a measure topic. Identification and definition of clinically relevant denominator exclusions and exceptions further refine the performance calculation. Each measure topic is assigned a National Quality Strategy domain (ie, Person and Caregiver-Centered Experience Outcomes, Patient Safety, Communication and Care Coordination, Community Population and Public Health, Efficiency and Cost Reduction Use of Healthcare Resources, and Effective Clinical Care) and 1 of 19 CMS Meaningful Measures areas. Background evaluation, environmental scan for existing measures, and gap analysis in respective areas are performed by the Subcommittee. Further measure specifications are defined in subcommittee according to existing criteria (Tables 1 through 6).

Table 1

CAP13: Anaplastic Lymphoma Kinase (ALK) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Non–Small Cell Lung Cancer (NSCLC)a

CAP13: Anaplastic Lymphoma Kinase (ALK) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Non–Small Cell Lung Cancer (NSCLC)a
CAP13: Anaplastic Lymphoma Kinase (ALK) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Non–Small Cell Lung Cancer (NSCLC)a

The Subcommittee's structured process for measure development is consensus based. The Subcommittee reviews evidence supporting a measure concept and gauges the importance of the measure, clinical impact, and possible unintended consequences or misinterpretations. After evidence review and impact analysis detect an opportunity for further development of the quality payment measure, a suitable population with defined inclusion and exclusion criteria is characterized and refined by the Subcommittee. If this is successful, draft measures are reviewed by dozens of CAP members, and the Economic Affairs Committee and its other subcommittees during a comment period when pathologists submit comments for consideration by the Subcommittee. Indeed, the responses for the measures addressed in this article help the subcommittee improve the comprehensibility of the measure, increase feasibility of data capture from typical laboratory information systems, understand barriers to achieve the measure, and incorporate additional refinements. Specifications with comments incorporated are then tested for feasibility, reliability, and validity following processes described in the Blueprint for the CMS Measures Management System and consistent with the standards of the National Quality Forum. Testing results reveal deficiencies in the measure specifications or areas of inconsistency. Once testing results have been reviewed, the finalized performance measures are subsequently approved by the Economic Affairs Committee. Importantly, throughout this entire iterative process the chairs of the Subcommittee and Clinical Data Registry Ad Hoc Committee interact with CMS regarding measure concepts in progress and incorporated suggestions or made clarifications to the measures. We believe these interactions lead to superior measures.

GAPS AND OPPORTUNITIES TO IMPROVE PATIENT OUTCOMES

Because many of the guidelines that relate to the use of specific molecular testing of certain neoplasms are comparatively new, one might expect that guideline recommendations have yet to move into routine clinical practice. Presently, many patients do not benefit from having information about key genomic alterations available at the time of medical decision-making. For example, among patients with breast and ovarian cancer, germ line genetic testing has become an integral aspect of their care. However, despite longstanding guidance24  to test high-grade, serous ovarian cancer patients in order to identify BRCA1/2 pathogenic variants, a recent study5  found only a 30% genetic testing rate for patients with ovarian cancer. Among a cohort of women with stages 0 to II breast cancer, approximately 60% (1535 of 2502) reported that no genetic testing was performed or discussed, although guideline6  criteria for patients with breast cancer reinforce the importance of this information to inform breast cancer treatment decisions. The identification of gaps in standards of care enables the Subcommittee to focus its efforts in developing measures for which a perceived improvement in care will be achieved and that will not quickly top out, leading to longevity within MIPS.

The Lung Cancer Mutation Consortium found that overall survival for non–small cell lung carcinoma (NSCLC) patients with an oncogenic driver improved when patients received matched targeted therapy.7  Hence, knowledge of EGFR mutation status is needed for appropriate clinical decision-making in the setting of advanced NSCLC.8,9  Similarly, it has been reported that mismatch repair (MMR) deficiency testing in patients with colorectal cancer remains low, even among patients at high risk, and that for younger-onset colorectal carcinoma (CRC) patients gastroenterologists rely on the pathologist to ascertain the status of MMR and/or microsatellite instability (MSI) when appropriate.10  A recent study11  using the National Cancer Database determined that only 28% of adult CRC patients have MMR testing and only 43% of young-onset CRC patients have testing, confirming a gap reported in an earlier study12  where MSI and/or MMR immunohistochemistry (IHC) testing was documented for only 23% of early-onset CRC patients. Appreciating that appropriate molecular testing to identify relevant mutations in tumors is a rapidly evolving area, several opportunities to measure pathologists' contributions to sharing this information were identified for measure development.

MEASURES

CAP had 21 QCDR measures approved by CMS for use in 2019 and 23 measures approved for use in 2020, including 20 of the original 21 measures.13  Here, we describe the subset of individual QCDR measures relating to the pathologist's role in the care of patients with lung cancer, colon cancer, and AML.

LUNG CANCER MEASURES

CAP13: Anaplastic Lymphoma Kinase (ALK) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Non–Small Cell Lung Cancer (Table 1): Percentage of NSCLC surgical pathology reports that include ALK mutation status.

CAP16: Epidermal Growth Factor Receptor (EGFR) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Non–Small Cell Lung Cancer (Table 2): Percentage of NSCLC surgical pathology reports that include EGFR mutation status.

Table 2

CAP16 Epidermal Growth Factor Receptor (EGFR) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Non–Small Cell Lung Cancer (NSCLC)a

CAP16 Epidermal Growth Factor Receptor (EGFR) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Non–Small Cell Lung Cancer (NSCLC)a
CAP16 Epidermal Growth Factor Receptor (EGFR) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Non–Small Cell Lung Cancer (NSCLC)a

CAP19: ROS1 Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Non–Small Cell Lung Cancer (Table 3): Percentage of NSCLC surgical pathology reports that include ROS1 mutation status.

Table 3

CAP19: ROS1 Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Non–Small Cell Lung Cancer (NSCLC)a

CAP19: ROS1 Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Non–Small Cell Lung Cancer (NSCLC)a
CAP19: ROS1 Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Non–Small Cell Lung Cancer (NSCLC)a

Background

Lung cancer is a malignancy with high prevalence and represents a leading cause of cancer-related mortality in the United States, with NSCLC accounting for 84% of all lung cancers.14,15  Various gene alterations are demonstrated oncogenic drivers for NSCLC, including mutations of EGFR, ALK, and ROS1. The Lung Cancer Mutation Consortium has found that two-thirds of NSCLC patients have an oncogenic driver mutation and that overall survival improves if patients receive matched targeted therapy.7 

Information about certain driver mutations in a lung carcinoma is commonly needed at some point during a patient's treatment to inform decisions about management of the patient's disease. Pathologists are uniquely well positioned at the time of signing out a surgical pathology report to provide this important information. Capturing such detail is helpful for pathologists and physicians who subsequently refer to the pathologist's report but who may not otherwise be aware of highly relevant information regarding key genomic alterations. When this pertinent information is not captured in patient's report, the risk of unnecessary repeat testing is increased, as is the risk of possible delays in treatment while redundant testing is pursued. Recently updated molecular testing guidelines for lung cancer patients revealed opportunities for the development of measures of pathologists' contribution to patient care that are meaningful to both patients and clinicians. Based on these guidelines, CAP developed measures to monitor the success of pathologists in effectively communicating key information about NSCLC for the purpose of care coordination and efficient use of resources. ALK, EGFR, and ROS1 are 3 genes with established evidence to support the appropriateness of testing lung carcinomas to detect mutations that guide patient management.

Related Guidance

ALK

Knowledge of ALK rearrangement is necessary for appropriate clinical decision-making in advanced NSCLC. Approximately 5% of lung adenocarcinomas have ALK protein overexpression associated with a chromosomal rearrangement involving the ALK gene. Patients with such tumors respond to therapy with ALK tyrosine kinase inhibitors, such as crizotinib.16  In addition to identifying tumors that are likely to respond to targeted therapies, ALK rearrangement often predicts an inferior response to immunotherapies. Given the potential treatment implications, testing for the presence of an ALK gene rearrangement is recommended before or during first-line therapy.17,18  CAP13 (Table 1) details how these guideline recommendations19  were transformed into a measure for pathologists, taking into account various practice settings and access to testing.

EGFR

Approximately 20% of lung adenocarcinomas contain an EGFR activating mutation that predicts response to therapy with EGFR tyrosine kinase inhibitors such as erlotinib.17,2024  Alternative treatments are considered when a characteristic EGFR mutation is discovered before or during first-line chemotherapy. In addition to identifying tumors that are likely to respond to targeted therapies, EGFR mutation status often predicts inferior response to immunotherapies.18  A significant number of patients with early-stage disease will progress to advanced disease, at which point EGFR mutation status can inform appropriate management of patients at the time of recurrence or progression. For these reasons, EGFR has long been recognized in clinical practice guidance19  as a critical gene to assess, and CAP16 (Table 2) illustrates how a measure was created from these guideline recommendations.

ROS1

ROS1 rearrangement occurs in 1% to 2% of NSCLCs and predicts response to crizotinib and ceritinib therapy, which are first-line treatments. Response rates, including complete responses, approach 70%.17,25,26  Knowledge of ROS1 rearrangement is thus crucial for appropriate clinical decision-making in advanced NSCLC. Alternative treatments are considered when ROS1 rearrangement is discovered before or during first-line chemotherapy. As with ALK and EGFR, because guideline statements unequivocally support the important role of ROS1 testing to inform the care of lung cancer patients, CAP19 (Table 3) demonstrates how these recommendations were used to create a meaningful metric.

Summary

In this age of precision medicine and increasing availability of targeted therapies for appropriately characterized lung carcinomas, pathologists play a key role in understanding and interpreting the testing that is crucial for development of a successful patient management plan and/or necessary to avoid harm or undue delay in appropriate patient care. The 3 aforementioned measures specifically address molecular testing that is well established as appropriate for understanding a patient's lung cancer. Whether the pathologist is performing and reporting the appropriate test result or communicating with their clinical colleagues when certain testing would be appropriate, the pathologist demonstrates how his or her knowledge and action impact “Communication and Care Coordination,” one of the National Quality Strategy domains. This action by the pathologist can also serve to promote informed utilization of potentially expensive tests, so as to avoid inappropriate repeat testing.

COLON CANCER MEASURES

CAP15: BRAF Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Metastatic Colorectal Adenocarcinoma (Table 4): Percentage of metastatic colorectal adenocarcinoma surgical pathology reports that address biomarker evaluation for BRAF mutation.

Table 4

CAP15: BRAF Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Metastatic Colorectal Adenocarcinomaa

CAP15: BRAF Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Metastatic Colorectal Adenocarcinomaa
CAP15: BRAF Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Metastatic Colorectal Adenocarcinomaa

CAP18: Mismatch Repair (MMR) or Microsatellite Instability (MSI) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients with Primary or Metastatic Colorectal Carcinoma (Table 5): Percentage of all primary or metastatic colorectal carcinoma surgical pathology reports that address the status of biomarker evaluation for MMR by IHC or MSI by DNA-based testing status, or both.

Table 5

CAP18: Mismatch Repair (MMR) or Microsatellite Instability (MSI) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Primary or Metastatic Colorectal Carcinomaa

CAP18: Mismatch Repair (MMR) or Microsatellite Instability (MSI) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Primary or Metastatic Colorectal Carcinomaa
CAP18: Mismatch Repair (MMR) or Microsatellite Instability (MSI) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Primary or Metastatic Colorectal Carcinomaa

Background

Colorectal cancer has the fourth highest incidence and is the second most common cause of cancer death in the United States.15  The overall incidence is higher in men, and it increases with age. The cornerstone of therapy is surgery followed by chemotherapy for high-stage disease and/or neoadjuvant radiotherapy for rectal cancer. The importance of understanding the molecular pathogenesis of colorectal carcinoma and its impact on prognosis and therapy response has become increasingly apparent during the past 2 decades.27 

Related Guidance

In May 2017, the American Society of Clinical Oncology (ASCO), the American Society for Clinical Pathology (ASCP), the Association for Molecular Pathology (AMP), and CAP collaborated to develop an evidence-based clinical practice guideline on molecular biomarker testing for patients with early and advanced colorectal cancer. This guideline describes standard molecular biomarker testing to inform targeted therapy decisions and advance personalized care for these patients.28  The current evidence-based recommendations for the molecular testing of CRC tissues were developed so that new advances in the molecular testing for clinical management of CRC can be integrated. In caring for patients with colorectal carcinoma, BRAF mutation and MMR/MSI status have been recommended as 2 biomarkers that should be assessed to guide treatment.

BRAF

BRAF activating mutations occur in about 8% of advanced disease patients with CRC and in approximately 14% of patients with localized stage II and stage III CRC. As such, BRAF-mutated tumors constitute a substantial subset of patients with CRC.28  More importantly, information regarding BRAF mutation can play an important role during a patient's treatment.29  BRAF V600 mutation is useful for prognostic stratification, and its presence makes response to panitumumab or cetuximab highly unlikely unless given with a BRAF inhibitor. Pathologists are well positioned when signing out the surgical pathology report to assess the necessity and disclose the status of BRAF evaluation for that sample. The aforementioned guidelines from ASCO, ASCP, AMP, and CAP, and the National Comprehensive Cancer Network (NCCN) Colon guideline highlight the importance of this biomarker.28,30,31  Thus, CAP15 (Table 4) shows how to measure pathologists' contribution to the successful implementation of these guidelines and education of their clinical colleagues to guide patient care.

MMR/MSI Detection

Detection of defective MMR in colorectal carcinomas is important for detection of Lynch syndrome (hereditary nonpolyposis colorectal cancer syndrome),32,33  which accounts for approximately 2% to 4% of all colorectal carcinomas and has important clinical implications for management of the affected patient and family members.34,35  In the Molecular Biomarkers for the Evaluation of Colorectal Cancer guideline from ASCO, ASCP, AMP, and CAP, investigation of MMR status is recommended for all patients with colorectal cancer in order to identify those patients at high risk for Lynch syndrome, for prognostic stratification and possible clinical management decisions,34  consistent with recommendations from the NCCN.31  In addition to effects on prognosis and implication for response to systemic therapy, knowledge of MMR/MSI status can be valuable when considering the extent of colonic resection.

Two initial tests can be performed on colorectal specimens to identify individuals who might have Lynch syndrome: 1) IHC for MMR protein expression, which is typically diminished in the context of MMR gene mutation(s); or 2) analysis for MSI, which results from the MMR protein deficiency. The NCCN guidelines indicate that IHC and MSI on newly diagnosed colorectal and endometrial cancers to determine Lynch syndrome irrespective of family history are cost effective and have been supported for colorectal cancer and endorsed by the Evaluation of Genomic Applications in Practice and Prevention working group at the Centers for Disease Control and Prevention, the US Multi-Society Task Force on Colorectal Cancer, and the American Gastroenterological Association.36  Because clinical practice guidelines have consistently supported the importance of MMR/MSI evaluation of colorectal carcinomas to guide disease management, CAP18 (Table 5), was designed to measure pathologists' contribution to this activity.

Summary

Similar to the 3 prior lung cancer measures, pathologists can play a key role in highlighting what testing is indispensable for developing an optimal treatment plan and avoiding delays in appropriate patient care for individuals suffering from colorectal cancer. The 2 measures described above address molecular testing at various points during a patient's treatment that is recommended by multispecialty stakeholders for colorectal adenocarcinoma.

As with the lung cancer measures, these measures serve to demonstrate how pathologists can either effectively communicate appropriate test results or communicate guideline recommendations to their clinical colleagues. These quality measures are reflective of the National Quality Strategy “Communication and Care Coordination” domain.

AML MEASURE

CAP17: FMS-like Tyrosine 3–Internal Tandem Duplication (FLT3-ITD) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Acute Myeloid Leukemia (Table 6): Percentage of AML pathology reports that include FLT3-ITD status.

Table 6

CAP17: FMS-like Tyrosine 3–Internal Tandem Duplication (FLT3-ITD) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Acute Myeloid Leukemia (AML)a

CAP17: FMS-like Tyrosine 3–Internal Tandem Duplication (FLT3-ITD) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Acute Myeloid Leukemia (AML)a
CAP17: FMS-like Tyrosine 3–Internal Tandem Duplication (FLT3-ITD) Biomarker Testing to Inform Clinical Management and Treatment Decisions in Patients With Acute Myeloid Leukemia (AML)a

Background

Acute myeloid leukemia is a heterogeneous hematologic malignancy that accounts for approximately 20 000 new cases and more than 10 000 deaths annually in the United States.14  It is the most common adult form of acute leukemia. A number of gene mutations that affect both AML prognosis and guide therapeutic decision-making have been identified.37,38  In 2017, a joint effort of the American Society of Hematology and CAP produced a guideline publication39  that addressed the essential elements needed during the initial workup of acute leukemia. One of the key recommendations focused on FLT3-ITD testing, which can inform the clinician and patient of important prognostic information and can guide patient management. Pathologists are uniquely well positioned at the time of signing out the pathology report to detail the disposition of FLT3-ITD testing for that specimen.

Related Guidance

FLT3-ITD mutation is a common molecular alteration detected in approximately 20% to 30% of AML patients,40,41  and it is prognostic of reduced relapse-free and overall survival.37,42,43  Additionally, according to the NCCN guidelines, the patient management pathway may vary based on other parameters, such as an otherwise normal karyotype. Given the potential variability in treatment approach,44  it is valuable for pathologists to include information about FLT3-ITD in their reports to enable optimal management.45  Earlier identification of FLT3 mutations better characterizes patients who may be suitable for targeted treatment46  that can help patients achieve longer and more durable remissions. If the status is not documented, redundant testing may be performed, unnecessarily increasing costs and delaying treatment decisions. The recent guideline publication strongly recommends that for pediatric and adult patients with suspected or confirmed AML of any type, the pathologist or treating clinician should ensure that testing for FLT3-ITD is obtained.39,47  With this in mind CAP17 (Table 6) was developed to measure success in reporting FLT3-ITD status.

Summary

As with the other molecular markers described in the present study, information specifically addressing FLT3-ITD status is anticipated to be only sporadically present in pathology reports because of the relatively recent guideline publication. This measure is aimed to demonstrate the importance of pathologists effectively communicating appropriate test results and communicating guideline recommendations to their clinical colleagues. This quality measure is reflective of the National Quality Strategy “Communication and Care Coordination” domain.

GYNECOLOGIC AND GENITOURINARY CANCER MEASURES

CAP31: Endometrial Carcinoma Testing for MMR, MSI or both (Table 7): percentage of surgical pathology reports with a pathologic diagnosis or endometrial carcinoma that include a statement on MSI and/or MMR IHC.

Table 7

CAP31: Endometrial Carcinoma Testing for Mismanagement Repair (MMR), Microsatellite Instability (MSI), or Botha

CAP31: Endometrial Carcinoma Testing for Mismanagement Repair (MMR), Microsatellite Instability (MSI), or Botha
CAP31: Endometrial Carcinoma Testing for Mismanagement Repair (MMR), Microsatellite Instability (MSI), or Botha

CAP30: Urinary Bladder Biopsy Diagnostic Requirements for Appropriate Patient Management (Table 8): percentage of urinary bladder carcinoma pathology reports that include the procedure, histologic tumor grade, histologic type, muscularis propria presence, lymphovascular invasion presence, and tumor extension, and meet the maximum 2–business day turnaround time requirement.

Table 8

CAP30: Urinary Bladder Biopsy Diagnostic Requirements for Appropriate Patient Managementa

CAP30: Urinary Bladder Biopsy Diagnostic Requirements for Appropriate Patient Managementa
CAP30: Urinary Bladder Biopsy Diagnostic Requirements for Appropriate Patient Managementa

CAP32: Prostate Cancer Gleason Pattern, Score and Grade Group (Table 9): percentage of all radical prostatectomy surgical pathology reports for prostate cancer patients that include Gleason pattern used in determining the Gleason score, total Gleason score, and grade group classification.

Table 9

CAP32: Prostate Cancer Gleason Pattern, Score, and Grade Group Classificationa

CAP32: Prostate Cancer Gleason Pattern, Score, and Grade Group Classificationa
CAP32: Prostate Cancer Gleason Pattern, Score, and Grade Group Classificationa

Background

Uterine carcinoma is the most common malignancy of the female genital tract. Similar to what is described above for colorectal carcinoma, the detection of hereditary cancer syndromes such as Lynch syndrome has significant clinical implications for both the affected patient and his or her family members. Recent guideline recommendations indicate that all patients with endometrial carcinoma should be tested for evidence of defective MMR.48,49 

Reporting requirements for both urinary and prostate cancers were recently updated.5054  For example, updated cancer staging systems and prostate grade groups should be included in pathology reports when appropriate. Complete, accurate, and timely pathology reports are essential to enabling appropriate clinical decisions to be made and to avoid delays in treatment.

Related Guidance

Endometrial MMR/MSI

Lynch syndrome is due to defective DNA MMR and accounts for approximately 5% of endometrial carcinomas. Universal screening for Lynch syndrome has become the standard of care for patients with colorectal or endometrial carcinoma. As with colorectal carcinoma, screening can be achieved through MSI testing and/or IHC. Positive screening results indicate that further workup is needed to diagnose Lynch syndrome. Prior to NCCN guideline release for uterine neoplasms, the incorporation of prognostic biomarkers in patient management decisions of patients with endometrial cancer were not well defined. However, as therapeutic options become refined and patient management decisions impacted by those results, it has become increasingly important for these biomarkers to be readily available.48,49  Patients with Lynch syndrome have a higher lifetime risk of malignancies, including endometrial, colorectal, ovarian, and brain. However, prior to these guidelines, practice patterns led to only 18% of women receiving a genetic referral.55,56  CAP31 (Table 7) was designed to measure pathologists' contribution to providing critical results needed for patient management decisions.

Bladder Cancer Reporting

Early in 2019, the CAP protocol for reporting bladder tumor specimens was updated.57  Although not considered a requirement for accreditation purposes, several key elements are considered standard of care and are essential for patient management. However, despite published guidelines indicating the necessity of complete reporting on urinary bladder carcinoma, recent studies still indicate gaps in the pathology report, with more than 20% of reviewed reports lacking histology, grade, microscopic extent, or presence versus absence of muscularis propria.5860  In an attempt to improve this low rate of report completeness while maintaining turnaround standards, measure CAP30 (Table 8) was created.

Prostate Cancer Reporting

Clinically, the 9 Gleason scores (2–10) are lumped into different groups based on prognosis and management decisions. Based on this experience and research, a grade group schema based on 5 prognostic categories was recommended for use during the 2014 International Society of Urological Pathology consensus conference.53,54  However, because of reported interobserver variability, it is still recommended that in addition to the Gleason grade group, a full score and Gleason pattern be recorded for every patient.60,61  CAP32 (Table 9) was created to promote consistency in reporting of prostate cancer and provide further education on the importance of grade group in clinical decision-making.

Summary

As with the other molecular biomarkers described in the present study, reporting of MMR/MSI test results in endometrial carcinoma pathology reports is anticipated to be inconsistent. This measure, CAP31, aims to demonstrate the importance of a pathologist effectively performing and/or communicating appropriate test results based on guideline recommendations to his or her clinical colleagues. Similarly, the presence of complete bladder and prostate cancer pathology reports is essential for appropriate clinical decision-making. CAP30 and CAP32 aim to further promote effective communication and transfer of complete health information between the pathologist and managing clinical team. These quality measures are reflective of the National Quality Strategy “Communication and Care Coordination” domain.

CONCLUSIONS

Physicians are challenged to test for the right genes in the right patients in order to obtain relevant information that guides treatment decisions in a timely fashion. These referring physicians depend on pathologists' diagnostic impressions and available supplemental test information in order to present the best patient management options. When patients' pathology reports include the relevant gene mutation status, adherence to evidence-based guidelines and elimination of unnecessary duplicative testing are possible. Consistent with the National Quality Strategy domain of Communication and Care Coordination, these measures help pathologists monitor their success in effectively communicating important information for the purpose of care coordination and efficient use of resources.

References

References
1
Cardona
DM
,
Black-Schaffer
S
,
Shamanski
F
,
Myles
JL
.
Medicare's new quality payment program has started–are you ready?
Arch Pathol Lab Med
.
2017
;
141
(
6
):
741
745
.
2
National Comprehensive Cancer Network
.
Genetic/familial high-risk assessment: breast and ovarian: guidelines version 2.2019-July 30, 2018
.
https://www.nccn.org/. Accessed May 31
,
2019
.
3
American College of Obstetricians and Gynecologists
;
ACOG Committee on Practice Bulletins–Gynecology
;
ACOG Committee on Genetics
;
Society of Gynecologic Oncologists
.
ACOG Practice Bulletin No. 103: hereditary breast and ovarian cancer syndrome
.
Obstet Gynecol
.
2009
;
113
(
4
):
957
966
.
4
Committee on Practice Bulletins–Gynecology, Committee on Genetics, Society of Gynecologic Oncology
.
Practice Bulletin No. 182: hereditary breast and ovarian cancer syndrome
.
Obstet Gynecol
.
2017
;
130
(
3
):
e110
e126
.
5
Kurian
AW
,
Li
Y
,
Hamilton
AS
, et al.
Gaps in incorporating germline genetic testing into treatment decision-making for early-stage breast cancer
.
J Clin Oncol
.
2017
;
35
(
20
):
2232
2239
.
6
Daly
MB
,
Pilarski
R
,
Axilbund
JE
, et al.
Genetic/familial high-risk assessment: breast and ovarian, version 2.2015
.
J Natl Compr Canc Netw
.
2016
;
14
(
2
):
153
162
.
7
Kris
MG
,
Johnson
BE
,
Berry
LD
, et al.
Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs
.
JAMA
.
2014
;
311
(
19
):
1998
2006
.
8
Cheema
PK
,
Raphael
S
,
El-Maraghi
R
, et al.
Rate of EGFR mutation testing for patients with nonsquamous non-small-cell lung cancer with implementation of reflex testing by pathologists
.
Curr Oncol
.
2017
;
24
(
1
):
16
22
.
9
Lee
DH
,
Tsao
MS
,
Kambartel
KO
, et al.
Molecular testing and treatment patterns for patients with advanced non-small cell lung cancer: PIvOTAL observational study
.
PLoS One
.
2018
;
13
(
8
):
e0202865
.
10
Noll
A
,
J Parekh
P
,
Zhou
M
, et al.
Barriers to Lynch syndrome testing and preoperative result availability in early-onset colorectal cancer: a National Physician Survey study
.
Clin Transl Gastroenterol
.
2018
;
9
(
9
):
e185
.
11
Shaikh
T
,
Handorf
EA
,
Meyer
JE
,
Hall
MJ
,
Esnaola
NF
.
Mismatch repair deficiency testing in patients with colorectal cancer and nonadherence to testing guidelines in young adults
.
JAMA Oncol
.
2018
;
4
(
2
):
e173580
.
12
Karlitz
JJ
,
Hsieh
MC
,
Liu
Y
, et al.
Population-based Lynch syndrome screening by microsatellite instability in patients ≤50: prevalence, testing determinants, and result availability prior to colon surgery
.
Am J Gastroenterol
.
2015
;
110
(
7
):
948
955
.
13
2020 Pathology quality measures
.
College of American Pathologists Web site
.
December
31,
2019
.
14
Siegel
RL
,
Miller
KD
,
Jemal
A.
Cancer statistics, 2018
.
CA Cancer J Clin
.
2018
;
68
(
1
):
7
30
.
15
Surveillance research program
.
National Cancer Institute Web site
.
May
31,
2019
.
16
Shaw
AT
,
Kim
DW
,
Nakagawa
K
, et al.
Crizotinib versus chemotherapy in advanced ALK-positive lung cancer
.
N Engl J Med
.
2013
;
368
(
25
):
2385
2394
.
17
Lindeman
NI
,
Cagle
PT
,
Aisner
DL
, et al.
Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology
.
Arch Pathol Lab Med
.
2018
;
142
(
3
):
321
346
.
18
National Comprehensive Cancer Network
.
Non-small cell lung cancer: guidelines version 5.2019. June 7, 2019
.
https://www.nccn.org/. Accessed June 11
,
2019
.
19
Lindeman
NI
,
Cagle
PT
,
Beasley
MB
, et al.
Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology
.
Arch Pathol Lab Med
.
2013
;
137
(
6
):
828
860
.
20
Maemondo
M
,
Inoue
A
,
Kobayashi
K
, et al.
Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR
.
N Engl J Med
.
2010
;
362
(
25
):
2380
2388
.
21
Mitsudomi
T
,
Morita
S
,
Yatabe
Y
, et al.
Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial
.
Lancet Oncol
.
2010
;
11
(
2
):
121
128
.
22
Mok
TS
,
Wu
YL
,
Thongprasert
S
, et al.
Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
.
N Engl J Med
.
2009
;
361
(
10
):
947
957
.
23
Pao
W
,
Miller
V
,
Zakowski
M
, et al.
EGF receptor gene mutations are common in lung cancers from “never smokers” and are associated with sensitivity of tumors to gefitinib and erlotinib
.
Proc Natl Acad Sci U S A
.
2004
;
101
(
36
):
13306
13311
.
24
Rosell
R
,
Carcereny
E
,
Gervais
R
, et al.
Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial
.
Lancet Oncol
.
2012
;
13
(
3
):
239
246
.
25
Takeuchi
K
,
Soda
M
,
Togashi
Y
, et al.
RET, ROS1 and ALK fusions in lung cancer
.
Nat Med
.
2012
;
18
(
3
):
378
381
.
26
Bergethon
K
,
Shaw
AT
,
Ou
SH
, et al.
ROS1 rearrangements define a unique molecular class of lung cancers
.
J Clin Oncol
.
2012
;
30
(
8
):
863
870
.
27
Brenner
H
,
Kloor
M
,
Pox
CP
.
Colorectal cancer
.
Lancet
.
201426
;
383
(
9927
):
1490
1502
.
28
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 American Society of Clinical Oncology
.
Arch Pathol Lab Med
.
2017
;
141
(
5
):
625
657
.
29
Meyers
M
,
Wagner
MW
,
Hwang
HS
,
Kinsella
TJ
,
Boothman
DA
.
Role of the hMLH1 DNA mismatch repair protein in fluoropyrimidine-mediated cell death and cell cycle responses
.
Cancer Res
.
2001
;
61
(
13
):
5193
5201
.
30
Benson
AB
,
Venook
AP
,
Al-Hawary
MM
, et al.
NCCN guidelines insights: colon cancer, version 2.2018
.
J Natl Compr Canc Netw
.
2018
;
16
(
4
):
359
369
.
31
National Comprehensive Cancer Network
.
Colon cancer: guidelines version 2.2019. May 15, 2019
.
https://www.nccn.org/. Accessed June 11
,
2019
.
32
Barrow
E
,
Hill
J
,
Evans
DG
.
Cancer risk in lynch syndrome
.
Fam Cancer
.
2013
;
12
(
2
):
229
240
.
33
Vasen
HF
,
Blanco
I
,
Aktan-Collan
K
, et al.
Revised guidelines for the clinical management of Lynch syndrome (HNPCC): recommendations by a group of European experts
.
Gut
.
2013
;
62
(
6
):
812
823
.
34
Rubenstein
JH
,
Enns
R
,
Heidelbaugh
J
,
Barkun
A
;
Clinical Guidelines Committee. American Gastroenterological Association Institute guideline on the diagnosis and management of Lynch syndrome
.
Gastroenterology
.
2015
;
149
(
3
):
777
782
.
35
Schmeler
KM
,
Lynch
HT
,
Chen
LM
, et al.
Prophylactic surgery to reduce the risk of gynecologic cancers in the Lynch syndrome
.
N Engl J Med
.
2006
;
354
(
3
):
261
269
.
36
National Comprehensive Cancer Network
.
Genetic/familial high-risk assessment: colorectal: guidelines version 1.2018. July 12, 2018
.
https://www.nccn.org/. Accessed May 31
,
2019
.
37
Kottaridis
PD
,
Gale
RE
,
Frew
ME
, et al.
The presence of a FLT3 internal tandem duplication in patients with acute myeloid leukemia (AML) adds important prognostic information to cytogenetic risk group and response to the first cycle of chemotherapy: analysis of 854 patients from the United Kingdom Medical Research Council AML 10 and 12 trials
.
Blood
.
2001
;
98
(
6
):
1752
1759
.
38
National Comprehensive Cancer Network
.
Acute myeloid leukemia: guidelines version 3.2019. May 7, 2019
.
https://www.nccn.org/. Accessed May 31
,
2019
.
39
Arber
DA
,
Borowitz
MJ
,
Cessna
M
, et al.
Initial diagnostic workup of acute leukemia: guideline from the College of American Pathologists and the American Society of Hematology
.
Arch Pathol Lab Med
.
2017
;
141
(
10
):
1342
1393
.
40
Gilliland
DG
,
Griffin
JD
.
The roles of FLT3 in hematopoiesis and leukemia
.
Blood
.
2002
;
100
(
5
):
1532
1542
.
41
Estey
E
,
Döhner
H.
Acute myeloid leukaemia
.
Lancet
.
2006
;
368
(
9550
):
1894
1907
.
42
Port
M
,
Böttcher
M
,
Thol
F
, et al.
Prognostic significance of FLT3 internal tandem duplication, nucleophosmin 1, and CEBPA gene mutations for acute myeloid leukemia patients with normal karyotype and younger than 60 years: a systematic review and meta-analysis
.
Ann Hematol
.
2014
;
93
(
8
):
1279
1286
.
43
Schlenk
RF
,
Döhner
K
,
Krauter
J
, et al.
Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia
.
N Engl J Med
.
2008
;
358
(
18
):
1909
1918
.
44
Daver
N
,
Schlenk
RF
,
Russell
NH
,
Levis
MJ
.
Targeting FLT3 mutations in AML: review of current knowledge and evidence
.
Leukemia
.
2019
;
33
(
2
):
299
312
.
45
Patnaik
MM
.
The importance of FLT3 mutational analysis in acute myeloid leukemia
.
Leuk Lymphoma
.
2018
;
59
(
10
):
2273
2286
.
46
Stone
RM
,
Mandrekar
SJ
,
Sanford
BL
, et al.
Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation
.
N Engl J Med
.
2017
;
377
(
5
):
454
464
.
47
de Haas
V
,
Ismaila
N
,
Advani
A
, et al.
Initial diagnostic work-up of acute leukemia: ASCO clinical practice guideline endorsement of the College of American Pathologists and American Society of Hematology guideline
.
J Clin Oncol
.
2019
;
37
(
3
):
239
253
.
48
McConechy
MK
,
Talhouk
A
,
Li-Chang
HH
, et al.
Detection of DNA mismatch repair (MMR) deficiencies by immunohistochemistry can effectively diagnose the microsatellite instability (MSI) phenotype in endometrial carcinomas
.
Gynecol Oncol
.
2015
;
137
(
2
):
306
310
.
49
National Comprehensive Cancer Network
.
Uterine neoplasms: guidelines version 1.2018
. ,
2019
.
50
Magers
MJ
,
Lopez-Beltran
A
,
Montironi
R
,
Williamson
SR
,
Kaimakliotis
HZ
,
Cheng
L.
Staging of bladder cancer
.
Histopathology
.
2019
;
74
(
1
):
112
134
.
51
Amin
MB
,
Edge
SB
,
Greene
FL
,
et al, eds. AJCC Cancer Staging Manual. 8th ed
.
New York, NY
:
Springer;
2017
.
52
Humphrey
P
,
Amin
MB
,
Berney
D
, et al.
Acinar adenocarcinoma
.
In
:
Moch
H
,
Humphrey
PA
,
Ulbright
T
,
Reuter
VE
,
eds
.
Pathology and Genetics: Tumors of the Urinary System and Male Genital Organs. 4th ed
.
Zurich, Switzerland
:
WHO Press;
2015
:
3
28
.
53
Epstein
JI
,
Zelefsky
MJ
,
Sjoberg
DD
, et al.
A contemporary prostate cancer grading system: a validated alternative to the Gleason score
.
Eur Urol
.
2016
;
69
(
3
):
428
435
.
54
Epstein
JI
,
Egevad
L
,
Amin
MB
,
Delahunt
B
,
Srigley
JR
,
Humphrey
PA
;
Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: definition of grading patterns and proposal for a new grading system
.
Am J Surg Pathol
.
2016
;
40
(
2
):
244
252
.
55
Pokharel
HP
,
Hacker
NF
,
Andrews
L.
Changing patterns of referrals and outcomes of genetic participation in gynaecological-oncology multidisciplinary care
.
Aust N Z J Obstet Gynaecol
.
2016
;
56
(
6
):
633
638
.
56
Lu
KH
,
Ring
KL
.
One size may not fit all: the debate of universal tumor testing for Lynch syndrome
.
Gynecol Oncol
.
2015
;
137
(
1
):
2
3
.
57
Protocol for the examination of biopsy and transurethral resection of bladder tumor (TURBT) specimens from patients with carcinoma of the urinary bladder
.
College of American Pathologists Web site
.
December
31,
2019
.
58
Hansel
DE
,
Miller
JS
,
Cookson
MS
,
Chang
SS
.
Challenges in the pathology of non-muscle-invasive bladder cancer: a dialogue between the urologic surgeon and the pathologist
.
Urology
.
2013
;
81
(
6
):
1123
1130
.
59
Schroeck
FR
,
Pattison
EA
,
Denhalter
DW
, et al.
Early stage bladder cancer: do pathology reports tell us what we need to know?
Urology
.
2016
;
98
:
58
63
.
60
Epstein
JI
,
Amin
MB
,
Reuter
VR
,
Mostofi
FK
.
The World Health Organization/International Society of Urological Pathology Consensus classification of urothelial (transitional cell) neoplasms of the urinary bladder: Bladder Consensus Conference Committee
.
Am J Surg Pathol
.
1998
;
22
(
12
):
1435
1448
.
61
Gansler
T
,
Fedewa
SA
,
Lin
CC
,
Amin
MB
,
Jemal
A
,
Ward
EM
.
Trends in diagnosis of Gleason score 2 through 4 prostate cancer in the National Cancer Database, 1990–2013
.
Arch Pathol Lab Med
.
2017
;
141
(
12
):
1686
1696
.

Author notes

The authors have no relevant financial interest in the products or companies described in this article.