College of American Pathologists (CAP)/ Physician Consortium for Performance Improvement. Pathology Physician Performance Measurement Set

College of American Pathologists (CAP)/ Physician Consortium for Performance Improvement Pathology Physician Performance Measurement Set Approved by the Consortium June 1, 2007 Pathology Work Group David L. Witte, MD, PhD, FCAP (Co-Chair, pathology) Susan R. Snyder, PhD, MBA (Co-Chair, methodology) Nancy Baxter, MD, PhD (colorectal surgery) Joel V. Brill, MD, AGAF, FACG, CHCQM (gastroenterology) Patrick Fitzgibbons, MD, FCAP (pathology) M. Kay Washington, MD, PhD, FCAP (pathology) Mario Gonzalez, MD, FCAP, FASCP (pathology) Richard M Gore, MD, FACR (diagnostic radiology) Dana Marie Grzybicki, MD, PhD (pathology) Harvey W. Kaufman, MD, FCAP(pathology) Jonathon Myles, MD, FCAP (pathology) Raouf E. Nakhleh, MD, FCAP (pathology) Felicia Nicholson, RN, BSN (health plan representative) Omar Yousef, MD, FCAP (pathology) American Academy Of Orthopaedic Surgeons Robert H Haralson III, MD, MBA (orthopaedic surgery) American Society of Clinical Oncology Kristen McNiff, MPH John Rainey, MD (clinical oncology) American College of Surgeons Courtney H. Maggiulli Guy Orangio, MD, FACS (colorectal surgery) Alison L. Laidley, MD, FACS, FRCS(C) (breast surgery) American Medical Association Karen Kmetik, PhD Beth Tapper, MA Centers for Medicare and Medicaid Services Sylvia Publ, MBA, RHIA College of American Pathologists Lynn Boyd Fay Shamanski, PhD Consortium Consultants Rebecca Kresowik Timothy F. Kresowik, MD 1

Physician Performance Measures (Measures) and related data specifications, developed by the Physician Consortium for Performance Improvement TM (the Consortium), are intended to facilitate quality improvement activities by physicians. These Measures are intended to assist physicians in enhancing quality of care. Measures are designed for use by any physician who manages the care of a patient for a specific condition or for prevention. These performance Measures are not clinical guidelines and do not establish a standard of medical care. The Consortium has not tested its Measures for all potential applications. The Consortium encourages the testing and evaluation of its Measures. Measures are subject to review and may be revised or rescinded at any time by the Consortium. The Measures may not be altered without the prior written approval of the Consortium. Measures developed by the Consortium, while copyrighted, can be reproduced and distributed, without modification, for noncommercial purposes, e.g., use by health care providers in connection with their practices. Commercial use is defined as the sale, license, or distribution of the Measures for commercial gain, or incorporation of the Measures into a product or service that is sold, licensed or distributed for commercial gain. Commercial uses of the Measures require a license agreement between the user and American Medical Association, on behalf of the Consortium. Neither the Consortium nor its members shall be responsible for any use of these Measures. THE MEASURES ARE PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND 2007 American Medical Association. All Rights Reserved Limited proprietary coding is contained in the Measure specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets. The AMA, the Consortium and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT ) or other coding contained in the specifications. THE SPECIFICATIONS ARE PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND. 2

Purpose of Measures: These clinical performance measures, developed by the College of American Pathologists and the Physician Consortium for Performance Improvement (Consortium), are designed for individual quality improvement. Unless otherwise indicated, the measures are also appropriate for accountability if appropriate methodological, statistical, and implementation rules are achieved. Measure #1: Breast Cancer Resection Pathology Reporting- pt category and pn category with histologic grade Measure #2: Colorectal Cancer Resection Pathology Reporting- pt category and pn category with histologic grade Intended Users and Patient Population: These measures are designed for use by physicians and for calculating reporting or performance measurement at the individual physician-level. When existing hospital-level or plan-level measures are available for the same measurement topics, the Consortium attempts to harmonize the measures to the extent feasible. Measure #1 is designed for any pathologist who examines breast tissue specimens following resection in a laboratory or institution Measures #2 is designed for any pathologist who examines colorectal tissue specimens following resection in a laboratory or institution Measure Specifications The Consortium seeks to specify measures for implementation using multiple data sources, including paper medical record, administrative (claims) data, and particular emphasis on Electronic Health Record Systems (EHRS). Draft specifications to report on these measures for Anesthesiology using administrative (claims) data are included in this document. We have identified codes for these measures, including ICD-9 and CPT (Evaluation & Management Codes, Category I and where Category II codes would apply). Specifications for additional data sources, including EHRS, will be fully developed at a later date. Measure Exclusions: For process measures, the Consortium provides three categories of reasons for which a patient may be excluded from the denominator of an individual measure: Medical reasons Includes: - not indicated (absence of organ/limb, already received/performed, other) - contraindicated (patient allergic history, potential adverse drug interaction, other) - other medical reason(s) Patient reasons Includes: - patient declined - economic, social, or religious reasons - other patient reason(s) System reasons Includes: - resources to perform the services not available - insurance coverage/payor-related limitations - other reasons attributable to health care delivery system These measure exclusion categories are not available uniformly across all measures; for each measure, there must be a clear rationale to permit an exclusion for a medical, patient, or system reason. The exclusion of a patient may be reported by appending the appropriate modifier to the CPT Category II code designated for the measure: Medical reasons: modifier 1P Patient reasons: modifier 2P System reasons: modifier 3P 3

Although this methodology does not require the external reporting of more detailed exclusion data, the Consortium recommends that physicians document the specific reasons for exclusion in patients medical records for purposes of optimal patient management and audit-readiness. The Consortium also advocates the systematic review and analysis of each physician s exclusions data to identify practice patterns and opportunities for quality improvement. For example, it is possible for implementers to calculate the percentage of patients that physicians have identified as meeting the criteria for exclusion. Please refer to documentation for each individual measure for information on the acceptable exclusion categories and the codes and modifiers to be used for reporting. Measures #1-2 in the Pathology measurement set are process measures. For outcome measures, the Consortium specifically identifies all acceptable reasons for which a patient may be excluded from the denominator. Each specified reason is reportable with a CPT Category II code designated for that purpose. There are no outcome measures in the Pathology measurement set. The Consortium continues to evaluate and likely will evolve its methodology for handling exclusions as it gains experience in the use of the measures. The Consortium welcomes comments on its exclusions methodology. Data Capture and Measure Calculation The Consortium intends for physicians to collect data on each patient eligible for a measure. Feedback on measures should be available to physicians by patient to facilitate patient management and in aggregate to identify opportunities for improvement across a physician's patient population. Measure calculations will differ depending on whether a rate is being calculated for performance or reporting purposes. The method of calculation for performance follows these steps: first, identify the patients(reports) who meet the eligibility criteria for the denominator (PD); second, identify which of those patients(reports) meet the numerator criteria (A); and third, for those patients(reports) who do not meet the numerator criteria, determine whether an appropriate exclusion applies and subtract those patients(reports) from the denominator (C). (see examples below) The methodology also enables implementers to calculate the rates of patient exclusions and to further analyze both low and high rates, as appropriate (see examples below). The method of calculation for reporting differs. One program which currently focuses on reporting rates is the Centers for Medicare and Medicaid Services (CMS) Physician Quality Reporting Initiative (PQRI). Currently, under that program design, the components that make up the numerator include all patients(reports) from the eligible population for which the physician has reported, including: the number of patients(reports) who meet the numerator criteria (A), the number of patients(reports) for whom valid exclusions apply (C) and also the number of patients(reports) who do not meet the numerator criteria (D). These components, where applicable, are summed together to make up the inclusive reporting numerator. The calculation for reporting will be the reporting numerator divided by the reporting denominator. (see examples below). Examples of calculations for reporting and performance are provided for each measure. Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Numerator (A) Includes: Number of patients(reports) meeting numerator criteria Performance Denominator (PD) Includes: Number of patients(reports) meeting criteria for denominator inclusion Denominator Exclusions (C) Include: Number of patients(reports) with valid medical, patient or system exclusions (where applicable; will differ by measure) 4

Performance Calculation NOTE: For purposes of the Pathology measurement set, please substitute reports for patients in all measure calculation tables. A (# of patients meeting numerator criteria) PD (# patients in denominator) C (# patients with valid denominator exclusions) It is also possible to calculate the percentage of patients (reports) excluded overall, or excluded by medical, patient, or system reason where applicable: Overall Exclusion Calculation C (# of patients with any valid exclusion) PD (# patients in denominator) OR Exclusion Calculation by Type C1 (# patients with medical reason) PD (# patients in denominator) C2 (# patients with patient reason) PD (# patients in denominator) C3 (# patients with system reason) PD (# patients in denominator) Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following components, where applicable. (There may be instances where there are no patients to include in A, C, D, or E). A. Number of patients(reports) meeting additional denominator criteria (for measures where true denominator cannot be determined through ICD-9 and CPT Category I coding alone) AND numerator criteria C. Number of patients(reports) with valid medical, patient or system exclusions (where applicable; will differ by measure) D. Number of patients(reports) not meeting numerator criteria and without a valid exclusion E. All other patients(reports) not meeting additional denominator criteria (for measures where true denominator cannot be determined through ICD-9 and CPT Category I coding alone) Reporting Denominator (RD) Includes: RD. Denominator criteria (identifiable through ICD-9 and CPT Category I coding) Reporting Calculation NOTE: For purposes of the Pathology measurement set, please substitute reports for patients in all measure calculation tables. A(# patients meeting numerator criteria) + C(# of patients with valid exclusions) + D(# of patients NOT meeting numerator criteria) + E(# of patients not meeting additional denominator criteria) RD (# patients in denominator) 5

Pathology Measure #1: Breast Cancer Resection Pathology Reporting pt category (primary tumor) and pn category (regional lymph nodes) with histologic grade This measure may be used as an Accountability measure Clinical Performance Measure Numerator: Reports that include the pt category, the pn category and the histologic grade Denominator: All breast cancer resection pathology reports (excluding biopsies) Denominator Exclusions: Documentation of medical reason(s) for not including the pt category, the pn category or the histologic grade (eg; re-excision without residual tumor; non-carcinomas) Measure: Percentage of breast cancer resection pathology reports that include the pt category (primary tumor), the pn category (regional lymph nodes) and the histologic grade The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: Patient management and treatment guidelines promote an organized approach to providing quality care. The (American College of Surgeons Commission on Cancer) CoC requires that 90% of pathology reports that include a cancer diagnosis contain the scientifically validated data elements outlined in the surgical case summary checklist of the College of American Pathologists (CAP) publication Reporting on Cancer Specimens 1. All invasive breast carcinomas, with the exception of medullary carcinoma should be graded. The grading system used must be specified in the report; the Nottingham combined histologic grade (Elston-Ellis modification of Scarff-Bloom-Richardson grading system) is recommended. Within each stage grouping there is a relation between histologic grade and outcome 2 TNM staging information is included in factors proven to be of prognostic import and useful in clinical patient management. 3 Rationale for the measure: Therapeutic decisions for breast cancer management are stage driven and cannot be made without a complete set of pathology descriptors. Incomplete cancer resection pathology reports may result in misclassification of patients, rework and delays, and suboptimal management. The College of American Pathologists (CAP) has produced evidence-based checklists of essential pathologic parameters that are recommended to be included in cancer resection pathology reports. These checklists have been endorsed as a voluntary standard by National Quality Forum (NQF) and are considered the reporting standard by the Commission on Cancer (CoC) of the American College of Surgeons (ACS). The CAP recently conducted a structured audit of breast cancer pathology report adequacy at 86 institutions. Overall, 35% of eligible reports were missing at least one of the ten CAP-recommended breast cancer elements. Cancer Care Ontario (CCO) conducted a similar study in 2005 and found that 25% of breast cancer pathology reports did not include all of the information required by the CAP standards. While the exact percentage of breast cancer resection pathology reports that are missing the pt category, the pn category and the histologic grade is unknown, these are essential elements in breast cancer treatment decisions and should be included in every pathology report when possible. Data capture and calculations: 6

Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator, Denominator, and Denominator Exclusions. Numerator (A) Includes: Reports that include the pt category, the pn category and the histologic grade Denominator (PD) Includes: Breast cancer resection pathology reports (excluding biopsies) Denominator Exclusions (C) Include: Documentation of medical reason(s) for not including the pt category, the pn category or the histologic grade Performance Calculation A (# of reports meeting numerator criteria) PD (# of reports in denominator) C (# of reports with valid denominator exclusions) Components for this measure are defined as: A # of reports that include the pt category, the pn category and the histologic grade PD # of breast cancer resection pathology reports (excluding biopsies) C # of reports with valid medical reason(s) for not including the pt category, the pn category or the histologic grade Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Reports that include the pt category, the pn category and the histologic grade C. Reports that do not include the pt category, the pn category and the histologic grade, but for which there is a valid documented medical reason for not doing so D. Reports that do not include the pt category, the pn category and the histologic grade, and there is a no documented medical reason for not doing so Reporting Denominator (RD) Includes: Breast cancer resection pathology reports (excluding biopsies) Reporting Calculation A(# of reports meeting numerator criteria + C(# of reports with valid exclusions) + D(# of reports NOT meeting numerator criteria) RD (# of reports in denominator) Components for this measure are defined as: A # of reports that include the pt category, the pn category and the histologic grade C # of reports with valid medical reason(s) for not including the pt category, the pn category or the histologic grade D # of reports that do not include the pt category, the pn category and the histologic grade, and there is a no documented medical reason for not doing so RD # of breast cancer resection pathology reports (excluding biopsies) 7

Measure Specifications Measure #1: Breast Cancer Resection Pathology Reporting- pt category and pn category with histologic grade Measure specifications will be provided for multiple data sources. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. Note: Patients with multiple pathology reports related to the same breast tumor will be counted only once. Pathology reports for the same breast neoplasm addressed in previous pathology reports up to six months following the index resection pathology report will not be included in assessing this clinical performance measure. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population): All breast cancer resection pathology reports (excluding biopsies) ICD-9 diagnosis codes: 174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9, 175.0, 175.9 AND CPT service codes: 88307, 88309 Denominator Exclusion: Documentation of medical reason(s) for not including the pt category, the pn category or the histologic grade (eg; re-excision without residual tumor; non-carcinomas) Append modifier to CPT Category II code: 3260F-1P Numerator: Reports that include the pt category, the pn category and the histologic grade Report the CPT Category II code designated for this numerator: 3260F pt (primary tumor), pn (regional lymph node), and histologic grade documented in pathology report B. Electronic Health Record System (in development) C. Paper Medical Record (in development) 8

Pathology Measure #2: Colorectal Cancer Resection Pathology Reporting pt category (primary tumor) and pn category (regional lymph nodes) with histologic grade This measure may be used as an Accountability measure Clinical Performance Measure Numerator: Reports that include the pt category, the pn category and the histologic grade Denominator: All colon and rectum cancer resection pathology reports Denominator Exclusions: Documentation of medical reason(s) for not including the pt category, the pn category or the histologic grade (eg; non-carcinomas; anal canal) Measure: Percentage of colon and rectum cancer resection pathology reports that include the pt category (primary tumor), the pn category (regional lymph nodes) and the histologic grade The following clinical recommendation statements are quoted verbatim from the referenced clinical guidelines and represent the evidence base for the measure: Patient management and treatment guidelines promote an organized approach to providing quality care. The (American College of Surgeons Committee on Cancer) CoC requires that 90% of pathology reports that include a cancer diagnosis contain the scientifically validated data elements outlined in the surgical case summary checklist of the College of American Pathologists (CAP) publication Reporting on Cancer Specimens. 1 Surgical resection is the primary therapy for most colorectal carcinomas, and the most important prognostic indicators are related to the pathologic findings in the resection specimen. The anatomic extent of disease is by far the most important prognostic factor in colorectal cancer. Pathologic staging depends on pathologic documentation of the anatomic extent of disease, whether or not the primary tumor has been completely removed. If a biopsied tumor is not resected for any reason (eg, when technically unfeasible) and if the highest T and N categories or the M1 category of the tumor can be confirmed microscopically, the criteria for pathologic classification and staging have been satisfied without total removal of the primary cancer. 4 Rationale for the measure: Therapeutic decisions for colorectal cancer management are stage driven and cannot be made without a complete set of pathology descriptors. Incomplete cancer resection pathology reports may result in misclassification of patients, rework and delays, and suboptimal management. The College of American Pathologists (CAP) has produced evidence-based checklists of essential pathologic parameters that are recommended to be included in cancer resection pathology reports. These checklists have been endorsed as a voluntary standard by National Quality Forum (NQF) and are considered the reporting standard by the Commission on Cancer (CoC) of the American College of Surgeons (ACS). The CAP recently conducted a structured audit of colorectal cancer pathology report adequacy at 86 institutions. Overall, 34% of eligible reports were missing at least one of the ten CAP-recommended colorectal cancer elements. Cancer Care Ontario (CCO) conducted a similar study in 2005 and found that 31% of colorectal cancer pathology reports did not include all of the information required by the CAP standards. While the exact percentage of colorectal cancer resection pathology reports that are missing the pt category, the pn category and the histologic grade is unknown, these are essential elements in colorectal cancer treatment decisions and should be included in every pathology report when possible. Data capture and calculations: Calculation for Performance For performance purposes, this measure is calculated by creating a fraction with the following components: Numerator and 9

Denominator. Numerator (A) Includes: Reports that include the pt category, the pn category and the histologic grade Denominator (PD) Includes: Colon and rectum cancer resection pathology reports (excluding biopsies) Denominator Exclusions (C) Include: Documentation of medical reason(s) for not including the pt category, the pn category or the histologic grade Components for this measure are defined as: A PD C Performance Calculation A (# of reports meeting numerator criteria) PD (# of reports in denominator) C(# of reports with valid medical exclusion # of reports that include the pt category, the pn category and the histologic grade # of colon and rectum cancer resection pathology reports (excluding biopsies) # of reports with valid medical reason(s) for not including the pt category, the pn category or the histologic grade Calculation for Reporting For reporting purposes, this measure is calculated by creating a fraction with the following components: Reporting Numerator and Reporting Denominator Reporting Numerator includes each of the following instances: A. Reports that include the pt category, the pn category and the histologic grade C. Reports that do not include the pt category, the pn category and the histologic grade, but for which there is a valid documented medical reason for not doing so D. Reports that do not include the pt category, the pn category and the histologic grade, and there is a no documented medical reason for not doing so Reporting Denominator (RD) Includes: Colon and rectum cancer resection pathology reports (excluding biopsies) Reporting Calculation A(# of reports meeting numerator criteria) + C(# of reports with valid exclusions) + D(# of reports NOT meeting numerator criteria) RD (# of patients in denominator) Components for this measure are defined as: A C # of reports that include the pt category, the pn category and the histologic grade # of reports that do not include the pt category, the pn category and the histologic grade, but for which there is a valid documented medical reason for not doing so D RD # of reports that do not include the pt category, the pn category and the histologic grade, and there is a no documented medical reason for not doing so # of colon and rectum cancer resection pathology reports (excluding biopsies) 10

Measure Specifications Measure #2: Colorectal Cancer Resection Pathology Reporting- pt category and pn category with histologic grade Measure specifications will be provided for multiple data sources. A. Administrative claims data Administrative claims data collection requires users to identify the eligible population (denominator) and numerator using codes recorded on claims or billing forms (electronic or paper). Users report a rate based on all patients in a given practice for whom data are available and who meet the eligible population/denominator criteria. (Note: The specifications listed below are those needed for performance calculation.) Denominator (Eligible Population): All colon and rectum cancer resection pathology reports (excluding biopsies) ICD-9 diagnosis codes: 153.0, 153.1, 153.2, 153.3, 153.4, 153.5, 153.6, 153.7, 153.8, 153.9, 154.0, 154.1, 154.8 AND CPT service code: 88309 Denominator Exclusion: Documentation of medical reason(s) for not including the pt category, the pn category or the histologic grade (eg; non-carcinomas; anal canal) Append modifier to CPT Category II code: 3260F-1P Numerator: Reports that include the pt category, the pn category and the histologic grade Report the CPT Category II code designated for this numerator: 3260F: pt (primary tumor), pn (regional lymph node), and histologic grade documented in pathology report B. Electronic Health Record System (in development) C. Paper Medical Record (in development) 11

References 1 American College of Surgeons Commission on Cancer. Cancer Program Standards 2004 Revised Edition. Available at: http://www.facs.org/cancer/coc/cocprogramstandards.pdf. Accessed August 29, 3006 2 Breast, Protocol applies to all invasive carcinomas of the breast. College of American Pathologists. Revised January 2005. Available at: http://www.cap.org/apps/docs/cancer_protocols/2005/breast05_pw.pdf. Accessed August 29, 2006. 3 Fitzgibbons PL, Page DL, Weaver D, et al. Prognostic factors in breast cancer. College of American Pathologists consensus statement 1999. Arch Pathol Lab Med. 2000:124:966-978. 4 Colon and Rectum, Protocol applies to all invasive carcinomas of the colon and rectum. College of American Pathologists. Revised January 2005. Available at: http://www.cap.org/apps/docs/cancer_protocols/2005/colonrectum05_pw.pdf. Accessed August 29, 2006. 12