BREAST MEASURE SPECIFICATIONS. Cancer Programs Practice Profile Reports (CP 3 R) Rapid Quality Reporting System (RQRS)

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1 BREAST MEASURE SPECIFICATIONS Cancer Programs Practice Profile Reports (CP 3 R) Rapid Quality Reporting System (RQRS) Introduction The Commission on Cancer s (CoC) National Cancer Data Base (NCDB) staff has undertaken an effort to improve the transparency with which the measures in the CP 3 R and RQRS reporting systems are calculated. To this end, for each measure, supporting information, three tables and a flow-diagram are provided: The measure type, clinical rationale and references are provided. The Measure Item List table provides each cancer registy data item used in the assessment of the indicated measure. This includes the FDS data item name, the North American Association of Central Cancer Registry (NAACCR) item number and a brief description of each item. The Case Eligibility Criteria table itemizes the steps taken to determine whether cases belong in the measure denominator for cases diagnosed 2010 and later. Each condition is described and is accompanied by the data item and code values used in the assesment. The Numerator Criteria table illustrates how cases are assessed to determine whether they qualify for the numerator of the measure, in other words are concordant for the standard of care. A flow-diagram is provided to illustrate the steps through which cases pass as they are evaluted for the indicated measure. The number appearing in each flow-diagram element corresponds to the assessment criteria appearing in the Case Eligibility Criteria and Numerator Criteria tables. Measure Descriptions This document provides specifications for the following measures: Measure (NQF #219) Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. (NQF #0559) Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer. (NQF #0220) Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB - III hormone receptor positive breast cancer. Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes. (NQF #0221) Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer. Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer. Note: Newly adopted measures will be integrated into CP 3 R prior to their release in RQRS. Measure Abbreviation BCSRT MAC HT MASTRT nbx BCS Measure Type Accountability Accountability Accountability Accountability Quality Improvement Surveillance Released March

2 Measure Type There are several types of measures approved by the CoC. Evidence-based measures or accountability measures promote improvements in care delivery and are the highest standard for measurement. These measures demonstrate provider accountability, influence payment for services and promote transparency. The quality improvement measure function is to monitor the need for quality improvement or remediation. Generally, these measures are for individual program use. Surveillance measures are used to identify the status quo, generate information for decision making, and/or to monitor patterns and trends of care. The following Table summarizes the purposes and use of these measures: Measure Type Accountability Quality Improvement Surveillance Measure definition and use High level of evidence supports the measure, including multiple randomized control trials. These measures can be used for such purposes as public reporting, payment incentive programs, and the selection of providers by consumers, health plans, or purchasers. Evidence from experimental studies, not randomized control trials supports the measure. These are intended for internal monitoring of performance within an organization. Limited evidence exist that supports the measure or the measure is used for informative purposes to accredited programs. These measures can be used for to identify the status quo as well as monitor patterns and trends of care in order to guide decision-making and resource allocation. Released March

3 BCSRT Breast measure: Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. Measure Type: Accountability NQF # 0219 Clinical Rationale: There is extensive evidence from randomized clinical trials demonstrating the impact of radiation with breast conservation surgery. It reduces the risk of local recurrence in the breast and may have a small impact on survival. The limitation for the purpose of a measure for provider accountability to women under the age of 70 is because of high-level evidence that women with small, estrogen receptor positive cancer (the majority of women over age 70 with breast cancer) gain only a very small reduction in local recurrence and no difference in lifetime mastectomy rate and no difference in survival. The impact as measured by performance gap, improvement in outcome, and numbers of cases affected has been specifically examined by Hasset et al. References: Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: Meta-analysis of individual patient data for 10,801 women in 17 randomized trials. Lancet. 2011;378 (9804): Hassett MJ, Hughes ME, Niland JC, et al. Selecting high priority quality measures for breast cancer quality improvement. Med Care. 2008;46: Hughes KS, Schnaper LA, Berry D, et al. Lumpectomy plus Tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. New Engl J Med. 2004;351: BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

4 Measure Item List FDS Data Item NAACCR # Description Primary Site 400 Anatomic site of origin of the cancer Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Pathologic Stage Group 910 AJCC Pathologic Stage Group Surgical Procedure of the Primary Site 1290 Surgical procedure performed on the primary site of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by a physician Date of Last Contact or Death 1750 Date of last contact with the patient, or date of patient death Vital Status 1760 Vital status of the patient, as of the date of last contact or death Radiation Treatment Modality 1570 Dominant modality of radiation therapy administered as first course treatment for the cancer, at the reporting facility and all other facilities Date Radiation Started 1210 Date of initiation of radiation Exclusion (This is a user field in CP 3 R, it is not a FDS item) N/A Field used to manually exclude cases 4 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

5 Case Eligibility Criteria Diagram Reference Assessment FDS Item FDS Codes 1 Diagnosis of breast cancer Primary Site C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C Exclude manually censored cases Exclude: Exclusion (This is a user field in CP Patient enrolled in a clinical trial R, it is not a that directly impacts delivery of the FDS item) standard of care 3 Female patients only Sex 2 4 Adult patient under the age of 70 at diagnosis Age at Diagnosis First or only diagnosis of malignant neoplasm Sequence Number 00 or 01 6 Epithelial tumors which can be staged, according to the AJCC 7 th Ed. (Excluding rare tumors: Mixed tumor, malignant, NOS Histology , Mullerian mixed tumor 8980 Carcinosarcoma Carcinosarcoma, embryonal) 7 Invasive tumors Behavior Code 3 8 Pathologic evidence of in situ or Pathologic Stage Group 0, 4 metastatic disease (exclude) Pathologic M (c1,p1) 9 If Pathologic Stage Group is Clinical evidence of in situ or metastatic Clinical Stage Group unknown, Clinical Stage Group 0, 4 disease (exclude) Clinical M (c1,p1) 10 All or part of the first course of treatment was performed at the reporting facility Class of Case Receipt of Breast Conserving Surgery Surgical Procedure of the Primary Site Patient reported living within the Date of Initial Diagnosis # Elapsed days between Dx and Last Contact > 365 treatment timeframe period of 365 days Date of Last Contact or Death from date of diagnosis Vital Status Vital Status=1 5 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

6 Diagram Reference Numerator Criteria Assessment FDS Item FDS Codes Radiation Treatment Modality 13 Radiation Therapy Administered within 365 days following Diagnosis Date of Initial Diagnosis 20-32, 40-43, 50-55, 60-62, 98 AND # Elapsed days between Dx and Rx 365 Date Radiation Therapy Started Notes: 1) No changes have been made to the measure specifications for the BCSRT measure with March 2015 release of CP 3 R. 2) Updates in the August 2015 CP3R release: Exclude rare tumors: Mixed tumor, malignant, NOS Mullerian mixed tumor Carcinosarcoma Carcinosarcoma, embryonal) 3) Updates in the November 2015 CP3R release: a. Allow for manual exclusion with censor 80. 4) Updates in August 2016: a. NAACCRv16 add c or p prefix to TNM. 6 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

7 7 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

8 MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer Measure Type: Accountability NQF # 0559 Clinical Rationale: There is extensive documentation of the benefit of multi-agent chemotherapy in women with hormone receptor negative breast cancer. Chemotherapy reduces the risk of distant disease recurrence and death by about one-third. The restriction to women under age 70 is because this measure is for the purpose of provider accountability. There are limited data in women over age 70 to guide recommendations, and a higher fraction of these women have reasons to omit chemotherapy, including co-morbidity. References: 1. Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Comparisons between different polychemotherapy regimens for early breast cancer: Meta-analysis of long- term outcome among 100,000 women in 123 randomized trials. Lancet. 2012;379(9814): Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Adjuvant chemotherapy in estrogen-receptor-poor breast cancer: Patient level meta-analysis of randomized trials. Lancet. 2008;371(9606): Early Breast Cancer Trialists Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomized trials. Lancet. 2005;365(9472): Haslett MJ, Hughes ME, Inland JC, et al. Selecting high priority quality measures for breast cancer quality improvement. Med Care. 2008;46: MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

9 Measure Item List FDS Data Item NAACCR # Description Primary Site 400 Anatomic site of origin of the cancer Sex 220 Gender Age at Diagnosis 230 Age of Patient at the time of diagnosis Sequence Number 560 Sequence of malignant or nonmalignant neoplasm over the lifetime Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Pathologic Stage Group 910 AJCC Pathologic Stage Group Surgical Procedure of the Primary Site 1290 Surgical procedure performed on the primary site of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by physician Date of Last Contact or Death 1750 Date of last contact with the patient or date of death Vital Status 1760 Vital Status as of the date of last contact CS Tumor Size (AJCC7) 2800 Largest dimension of the primary tumor, in millimeters Tumor Size Summary (AJCC8) 756 Most accurate measurement of solid primary tumor (AJCC8) Pathologic N 890 AJCC Pathologic N CS Site Specific Factor Estrogen Receptor Assay CS Site Specific Factor Progesterone Receptor Assay Chemotherapy 1390 Chemotherapy at any facility Date Chemotherapy Started 1220 Date of initiation of chemotherapy CS Site Specific Factor HER2 Result Immunotherapy 1410 Type of immunotherapy administered at any facility Date Immunotherapy Started 1240 The date of the initiation of immunotherapy Exclusion (This is a user field in CP 3 R, it is not a FDS item) N/A Field used to manually exclude cases 9 MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

10 Case Eligibility Criteria Diagram Reference Assessment FDS Item FDS Codes 1 Diagnosis of breast cancer Primary Site C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C Exclude manually censored cases Exclude: Exclusion (This is a user field in CP Patient enrolled in a clinical trial R, it is not that directly impacts delivery of the a FDS item) standard of care 3 Female patients only Sex 2 4 Adult patient under the age of 70 at diagnosis Age at Diagnosis First or only diagnosis of malignant or non-malignant neoplasm Sequence Number 00 or 01 6 Epithelial tumors which can be staged, according to the AJCC 7 th Ed. (Excluding adenoid cystic carcinoma, and excluding rare tumors: Histology , , Mixed tumor, malignant, NOS Mullerian mixed tumor 8980 Carcinosarcoma Carcinosarcoma, embryonal) 7 Invasive tumors Behavior Code 3 8 Exclude Pathologic evidence of in situ or Pathologic Stage Group 0, 4 metastatic disease Pathologic M (c1,p1) If Pathologic Stage Group is unknown, If Pathologic Stage Group is Clinical Stage Group exclude clinical evidence of in situ or unknown, Clinical Stage Group 0, 4 9 metastatic disease Clinical M (c1,p1) 10 All or part of the first course of treatment was performed at the reporting facility Class of Case MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

11 11 Surgically treated Patient reported living within the treatment timeframe period of 120 days from date of diagnosis AJCC T1cN0M0 tumor AJCC Stage IB - III tumor 14 Hormone Receptor Negative Surgical Procedure of the Primary Site Date of Initial Diagnosis Date of Last Contact or Death Vital Status Pathologic N CS Tumor Size (AJCC7 for Dx Year<2016) Tumor Size Summary (AJCC8 for Dx Year >=2016) CS Site Specific Factor 1 (Estrogen Receptor) CS Site Specific Factor 2 (Progesterone Receptor) # Elapsed days between Dx and Last Contact > 120 Vital Status=1 Pathologic N = (c0,p0,pi-,p0i-,pi+,p0i+,pm-,p0m-,pm+,p0m+) and [CS Tumor Size = ( , ) or Tumor Size Summary = ( )] Pathologic N = (p1,p1m,p1mi,p1a,p1b,p1c,p2,p2a,p2b,p3,p3a,p3b,p3c) (note: AJCC6 pathologic N values are used for cases diagnosed before 2010) Estrogen Receptor = 020 and Progesterone Receptor = 020, 030 Estrogen Receptor = 030 and Progesterone Receptor = MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

12 Numerator Criteria Diagram Reference Assessment FDS Item FDS Codes 15 Combination Chemotherapy administered within 120 following diagnosis Chemotherapy Recommended, but not administered Starting in 2013, for HER2 positive cases, Chemotherapy and Immunotherapy both administered within 120 days following diagnosis, or single agent chemo within 120 days of diagnosis and BRM recommended Chemotherapy Date Chemotherapy Started Date of Initial Diagnosis CS Site Specific Factor 15 (HER2) Immunotherapy Date Immunotherapy Started Chemotherapy = 03 and #Elapsed Days between Dx and Rx 120 Chemotherapy = 82, 85, 86, 87 If DX Year > 2012 and HER2(ssf15) = 010, (Chemotherapy = 02 and Immunotherapy = 01 and #Elapsed Days between Dx and Rx 120 or Chemotherapy = 02 and #Elapsed Days between Dx and Rx 120 and Immunotherapy = 82, 85, 86, 87) 12 MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

13 Notes: 1) Beginning with the March 2015 release of CP3R, ER/ PR negative HER2 positive cases diagnosed in 2013 and later will be considered compliant with the measure if single agent chemotherapy is administered and immunotherapy is recommended or administered within 120 days of diagnosis. 2) September 2015 CP3R release updates: Excluding adenoid cystic carcinoma, Exclude rare tumors: Mixed tumor, malignant, NOS Mullerian mixed tumor Carcinosarcoma Carcinosarcoma, embryonal) 3) November 2015 CP3R release updates: a. Allow for manual exclusion with censor 80. 4) August 2016 Updates: a. NAACCRv16 add c or p prefix to TNM. b. Added AJCC8 Tumor Size Summary for Dx Year>=2016 c. Other Documentation clarifications, no change to rule. 13 MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

14 14 MAC Breast measure: Combination chemotherapy is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

15 HT Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer Measure Type: Accountability NQF # 0220 Clinical Rationale: There is extensive evidence that hormone (endocrine) therapy with hormone receptor positive breast cancer reduces the risk of local recurrence, contralateral breast cancer, distant recurrence, and death. Measure specifies use of Tamoxifen or third-generation aromatase inhibitor rather than specifying Tamoxifen for premenopausal and aromatase inhibitor for postmenopausal because of (a) difficulty in clearly identifying from records or administrative data the menopause status, and (b) variation in appropriate use of Tamoxifen in postmenopausal women and some reasonable use of aromatase inhibitor in premenopausal women with the use of ovarian suppression. References: 1. Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: Patient-level meta-analysis of randomized trials. Lancet. 2011;378(9793): Cuzick J, Sestak I, Baum M, et al. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trail. Lancet Oncol. 2010;11: Burstein JH, Prestrud AA, Seidenfeld J, et al. American Society of Clinical Oncology clinical practice guidelines: Update on adjuvant endocrine therapy for women with hormone receptor positive breast cancer. J Clin Oncol. 2010;28: HT Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

16 Measure Item List FDS Data Item NAACCR # Description Primary Site 400 Organ of origin of the cancer Sex 220 Sex of patient Age at diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Pathologic Stage Group 910 AJCC Pathologic Stage Group Surgical Procedure of the Primary Site 1290 Surgical procedure performed on the primary site of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by a physician Date of Last Contact or Death 1750 Date of last contact with the patient, or date of patient death Vital Status 1760 Vital status of the patient, as of the date of last contact or death CS Tumor Size (AJCC7) 2800 Largest dimension of the primary tumor, in millimeters Tumor Size Summary (AJCC8) 756 Most accurate measurement of solid primary tumor (AJCC8) Pathologic N 890 AJCC Pathologic N CS Site Specific Factor Estrogen Receptor Assay CS Site Specific Factor Progesterone Receptor Assay Hormone Therapy 1400 Type of hormone therapy administered as first course treatment for the cancer, at the reporting facility and all other facilities Date Hormone Therapy Started 1230 Date of initiation of hormone therapy Exclusion (This is a user field in CP 3 R, it is not a FDS item) N/A Field used to manually exclude cases 16 HT Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

17 Case Eligibility Criteria Diagram Reference Assessment FDS Item FDS Codes 1 Diagnosis of breast cancer Primary Site C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C Exclude manually censored cases Exclude: Exclusion (This is a user field in CP Patient enrolled in a clinical trial R, it is not that directly impacts delivery of the a FDS item) standard of care 3 Female patients only Sex 2 4 Adult patient at diagnosis Age at Diagnosis First or only diagnosis of malignant or non-malignant neoplasm Sequence Number 00 or 01 6 Epithelial tumors which can be staged, according to the AJCC 7 th Ed. (Excluding rare tumors: Mixed tumor, malignant, NOS Histology , Mullerian mixed tumor 8980 Carcinosarcoma Carcinosarcoma, embryonal) 7 Invasive tumors Behavior Code 3 Exclude pathologic evidence of in situ or Pathologic Stage Group 0, 4 8 metastatic disease Pathologic M (c1,p1) If Pathologic Stage Group is unknown, If Pathologic Stage Group is Clinical Stage Group exclude clinical evidence of in situ or unknown, Clinical Stage Group 0, 4 9 metastatic disease Clinical M (c1,p1) 10 All or part of the first course of treatment was performed at the reporting facility Class of Case Surgically treated Surgical Procedure of the Primary Site Patient reported living within the treatment timeframe period of 365 days from date of diagnosis Date of Initial Diagnosis Date of Last Contact or Death Vital Status # Elapsed days between Dx and Last Contact >365 Vital Status=1 17 HT Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

18 AJCC T1cN0M0 tumor 13 AJCC Stage IB - III tumor 14 Hormone Receptor Positive Pathologic N CS Tumor Size (AJCC7 for Dx Year<2016) Tumor Size Summary (AJCC8 for Dx Year >=2016) Pathologic N= (c0, p0,pi-,p0i-,pi+,p0i+,pm-,p0m-,pm+,p0m+) and [CS Tumor Size = ( , ) or Tumor Size Summary = ( )] Pathologic N= (p1,p1m,p1mi,p1a,p1b,p1c,p2,p2a,p2b,p3,p3a,p3b,p3c) (note: AJCC6 pathologic N values are used for cases diagnosed before 2010) CS Site Specific Factor 1 (Estrogen Receptor) Estrogen Receptor = 10, 30 CS Site Specific Factor 2 (Progesterone Receptor) Progesterone Receptor = 10, HT Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

19 Diagram Reference Numerator Criteria Assessment FDS Item FDS Codes Hormone Therapy 15 Hormone Therapy Administered within 365 days following Diagnosis Hormone Therapy Recommended, but not Administered Date of Initial Diagnosis Hormone Therapy = 01 and # Elapsed days between Dx and Rx 365 Hormone Therapy = 82, 85, 86, 87 Date Hormone Therapy Started Notes: 1) August 2015 CP3R release updates:: Exclude rare tumors: Mixed tumor, malignant, NOS Mullerian mixed tumor Carcinosarcoma Carcinosarcoma, embryonal 2) November 2015 CP3R release updates: a. Allow for manual exclusion with censor 80. 3) August 2016 release updates: a. NAACCRv16 add c or p prefix to TNM. b. Added AJCC8 Tumor Size Summary for Dx Year>=2016 c. Other Documentation clarifications, no change to rule. 19 HT Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

20 20 HT Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

21 MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes. Measure Type: Accountability Clinical Rationale: There is consensus that post-mastectomy radiation should be recommended for women with breast cancer and with >=4 positive regional lymph nodes (1). Numerous studies have shown a significant reduction in locoregional recurrence rates, disease-free survival rates, and even overall survival with this adjuvant therapy (2-8). As a result of this proven benefit, guidelines from both the American Society of Clinical Oncology (ASCO) (9) and the National Comprehensive Cancer Network (NCCN) (10) include this recommendation, which was also adopted by the Quality Integration Committee of the Commission on Cancer in May of References: 1. Gnant M, Harbeck N, Thomssen C. St. Gallen 2011: Summary of the consensus discussion. Breast Care. 2011;6: Ragaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, et al. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997;337: Overgaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, et al. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial. Lancet. 1999;353: Overgaard M, Hansen PS, Overgaard J, Rose C, Andersson M, Bach F, et al. Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial. N Engl J Med. 1997;337: Gebski V, Lagleva M, Keech A, Simes J, Langlands AO. Survival effects of post-mastectomy adjuvant radiation therapy using biologically equivalent doses: a clinical perspective. J Natl Cancer Inst. 2006;98: Van de Steene J, Vinh-Hung V, Cutuli B, Storme G. Adjuvant radiotherapy for breast cancer: effects of longer follow-up. Radiother Oncol. 2004;72: MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes.

22 7. Ragaz J, Olivotto IA, Spinelli JJ, Phillips N, Jackson SM, Wilson KS, et al. Locoregional radiation therapy in patients with high-risk breast cancer receiving adjuvant chemotherapy: 20-year results of the British Columbia randomized trial. J Natl Cancer Inst. 2005;97: Whelan TJ, Julian J, Wright J, Jadad AR, Levine ML. Does locoregional radiation therapy improve survival in breast cancer? A metaanalysis. J Clin Oncol. 2000;18: Recht A, Edge SB, Solin LJ, Robinson DS, Estabrook A, Fine RE, et al. Postmastectomy radiotherapy: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2001;19: MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes.

23 Measure Item List FDS Data Item NAACCR # Description Primary Site 400 Organ of origin of the cancer Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime of the patient Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Pathologic Stage Group 910 AJCC Pathologic Stage Group Surgical Procedure of the Primary Site 1290 Surgical procedure performed on the primary site of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by a physician Date of Last Contact or Death 1750 Date of last contact with the patient, or date of patient death Vital Status 1760 Vital status of the patient, as of the date of last contact or death Regional Lymph Nodes Examined 830 The total number of regional lymph nodes that were removed and examined by the pathologist Regional Lymph Nodes Positive 820 The exact number of regional lymph nodes that were examined by the pathologist and found to contain metastases Regional Treatment Modality 1570 Dominant modality of radiation therapy administered as first course treatment for the cancer, at the reporting facility and all other facilities Reason for No Radiation 1430 The reason that no regional radiation therapy was administered to the patient Date Radiation Started 1210 Date of initiation of radiation Exclusion (This is a user field in CP 3 R, it is not a FDS item) N/A Field used to manually exclude cases 23 MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes.

24 Case Eligibility Criteria Diagram Reference Assessment FDS Item FDS Codes 1 Diagnosis of breast cancer Primary Site C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C Exclude manually censored cases Exclude: Exclusion (This is a user field in CP Patient enrolled in a clinical trial that R, it is not directly impacts delivery of the standard a FDS item) of care 3 Female patients only Sex 2 4 Adult patient at diagnosis Age at Diagnosis > First or only diagnosis of malignant or non-malignant neoplasm Sequence Number 00 or 01 6 Tumors which can be staged, according to the AJCC 7 th Ed. (Excluding rare tumors: Mixed tumor, malignant, NOS Histology , Mullerian mixed tumor 8980 Carcinosarcoma Carcinosarcoma, embryonal) 7 Invasive tumors Behavior Code 3 Pathologic evidence of metastatic disease Pathologic Stage Group 4 (exclude) Pathologic M (c1,p1) (If Pathologic Stage Group 8 Clinical evidence of metastatic disease Clinical Stage Group is unknown) 4 (exclude) Clinical M (c1,p1) 9 All or part of the first course of treatment was performed at the reporting facility Class of Case Surgically Treated Mastectomy Cases Surgical Procedure of the Primary Site MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes.

25 11 Patient reported living within the treatment timeframe period of 365 days from date of diagnosis Date of Initial Diagnosis Date of Last Contact or Death Vital Status # Elapsed days between Dx and Last Contact > 365 Vital Status=1 12 The number of regional lymph nodes that were examined by the pathologist and found to contain metastases is 4 or more Regional Lymph Nodes Examined Regional Lymph Nodes Positive #Regional Lymph Nodes Positive > 4 AND #Regional Lymph Nodes Examined > #Regional Lymph Nodes Positive 25 MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes.

26 Diagram Reference Numerator Criteria Assessment FDS Item FDS Codes 13 Radiation Therapy Recommended or Administered within 365 days following Diagnosis Radiation Treatment Modality Reason for No Radiation Date of Initial Diagnosis Date Radiation Therapy Started Radiation Treatment Modality = 20-32, 40-43, 50-55, 60-62, 98 and #Elapsed days between Dx and Rx 365 Radiation Treatment Modality=00 and Reason for No Radiation=2-7 Notes: 1) No changes have been made to the measure specifications for the MASTRT measure with March 2015 release of CP 3 R. 2) Updates in the August 2015 CP3R release: Exclude rare tumors: Mixed tumor, malignant, NOS Mullerian mixed tumor Carcinosarcoma Carcinosarcoma, embryonal) 3) Updates in the November 2015 CP3R release: a. Allow for manual exclusion with censor 80. 4) Updates in August 2016: a. NAACCRv16, add c or p prefix to TNM. 26 MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes.

27 27 MASTRT Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with 4 positive regional lymph nodes.

28 nbx Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer Measure Type: Quality Improvement NQF # 0221 Clinical Rationale: Percutaneous needle biopsy (PNB) for breast tissue diagnosis has emerged as a quality metric for breast disease management. In 2003, the National Comprehensive Cancer Network identified needle biopsy as preferred over surgical excision for breast diagnosis (Bevers et al.). In 2005, a multidisciplinary international consensus conference concluded that PNB is the optimal initial tissue-acquisition method and the procedure of choice for image-detected breast abnormalities. (Silverstein, p588) More recently, the National Accreditation Program for Breast Centers established palpation-guided or image-guided needle biopsy as the initial diagnostic approach rather than open biopsy as one of 19 clinical management standards by which breast centers are measured. Thus, PNB represents an important transition in breast cancer management of specific interest to surgeons. (Quoted from Calhoun and Anderson; p. 2191). References: 1. Bevers TB, Anderson BO, Bonaccio E, et al: NCCN clinical practice guidelines in oncology: Breast cancer screening and diagnosis. J Natl Compr Canc Netw 7: , Calhoun, K.E. and Anderson, B.O. Needle Biopsy for Breast Cancer Diagnosis: A Quality Metric for Breast Surgical Practice. JCO, 32 (21), pp Eberth JM, Xu Y, Smith GL, et al: Surgeon influence on use of needle biopsy in patients with breast cancer: A national Medicare study. J Clin Oncol 32: , Moran MS, Kaufman C, Burgin C, et al: What currently defines a breast center? Initial data from the national accreditation program for breast centers. J Oncol Pract 9:e62-e70, Silverstein MJ, Lagios MD, Recht A, et al: Image-detected breast cancer: State of the art diagnosis and treatment. J Am Coll Surg 201: , nbx Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

29 Measure Item List FDS Data Item NAACCR # Description Primary Site 400 Organ of origin of the cancer Sex 220 Sex of patient Age at diagnosis 230 Age of patient at diagnosis Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Pathologic Stage Group 910 AJCC Pathologic Stage Group Surgical Diagnostic and Staging procedure Exclusion (This is a user field in CP 3 R, it is not a FDS item) 1350 Identifies the procedure(s) performed in an effort to diagnose and/or stage disease N/A Field used to manually exclude cases 29 nbx Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

30 Case Eligibility Criteria Diagram Reference Assessment FDS Item FDS Codes 1 Primary Site - Breast Primary Site C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C50.9 Exclude: 90 - Patient refusal 12 - Patient medically unable to hold position for image guided biopsy 13 - Patient requires sub areolar excision for nipple discharge 14 - Lesion too superficial Breast too small Exclude censored cases Exclusion (This is a user field in CP Lesion inaccessible by needle biopsy R, it 17 - Cancer found in prophylactic mastectomy or through an is not a FDS item) elective procedure 18 - Benign high risk lesions diagnosed by needle biopsy, requiring excisional biopsy 19 - Discordant biopsy results compared to suspicious imaging 20 - Patient presents with co-morbid conditions that directly impacts delivery of the standard of care 21 - Diagnosed via cytology FNA only 3 Female Sex 2 4 Adult patient at diagnosis Age at Diagnosis 018 non-phyllodes Tumors (Also excluded are rare tumors: Mixed tumor, malignant, NOS Mullerian mixed tumor 8980 Carcinosarcoma Carcinosarcoma, embryonal) Histology 9020, and 8940, 8950, 8980, In Situ and Invasive tumors Behavior Code 2, 3 7 Cases Diagnosed at Staff Physician office or at the Reporting Facility and treated or decision not to treat at the Reporting Facility Class of Case 10, 11, 12, 13,14 8 Exclude metastatic disease Clinical M Pathologic M Clinical Stage Group Pathologic Stage Group Clinical M and Pathologic M (c1,p1) AND Pathologic Stage Group 4; If Pathologic Stage Group is missing, Clinical Stage Group 4 30 nbx Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

31 Diagram Reference Numerator Criteria Assessment FDS Item FDS Codes 9 Biopsy (incisional, needle, aspiration) to the primary site Surgical Diagnostic and Staging Procedure 02 (codes 07 and 09 excluded from the denominator as not eligible) Notes: 1) Starting with the March 2015 release of CP3R, cases will be ineligible for the breast nbx measure if they are metastatic or males. An additional manual exclusion category (19) has also been added. 2) Updates for the breast nbx measure in the September 2015 CP3R release: Exclude rare tumors: Mixed tumor, malignant, NOS Mullerian mixed tumor Carcinosarcoma Carcinosarcoma, embryonal) 3) Updates in the November 2015 CP3R release: a. Allow for manual exclusion with censor 20, replace censor 11 with 90. 4) Updates in the December 2015 CP3R release: a. Modified measure title b. Modified description for censor 20 c. Added new censor 21. 5) Updates in August 2016: a. NAACCRv16, add c or p prefix to TNM. 31 nbx Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

32 32 nbx Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

33 BCS Breast measure: Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer. Measure Type: Surveillance Clinical Rationale: Based on multiple prospective randomized trials (1,2) from both the United States and Europe which have demonstrated equivalent results as measured by overall patient survival, consensus exists that breast conservation treatment is an appropriate method of primary therapy for the majority of women with Stage I and II breast cancer and is preferable because it provides survival rates equivalent to those of total mastectomy and axillary dissection while preserving the breast (3). Additional trials have also determined that breast conservation treatment is a reasonable approach and is generally applicable for most women with Stage 0 breast cancer (ductal carcinoma in situ or DCIS) (4,5). However, not all patients are appropriate candidates for, or select, breast conservation treatment. The rate of breast conservation surgery will vary significantly based on patient age, stage of disease, as well as other factors, and therefore will also vary between institutions based on case mix. No ideal or expected rate of breast conservation treatment has been established, or is implied. This measure is being reported to institutions so they are aware of their individual patterns of treatment (surveillance measure) and can compare their rates of breast conservation surgery with other institutions, regionally and nationally. References: 1. Fisher B, Anderson S, Bryant J, et al: Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med 347: , Veronesi U, Cascinelli N, Mariani L, et al: Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med 347: , NIH Consensus Conference: Treatment of Early-Stage Breast Cancer. JAMA 1991;265(3): Fisher B, Dignam J, Wolmark N, et al.: Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol 16 (2): , BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

34 5. Bijker N, Meijnen P, Peterse JL, et al.: Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial a study by the ETC Breast Cancer Cooperative Group and ETC Radiotherapy Group. J Clin Oncol 24 (21): , Measure Item List FDS Data Item NAACCR # Description Primary Site 400 Organ of origin of the cancer Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime of the patient Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Clinical T 940 AJCC Clinical T Clinical N 950 AJCC Clinical N Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Surgical Procedure of the Primary Site at this facility 670 Surgical procedure performed to the primary site at this facility Exclusion (This is a user field in CP 3 R, it is not a FDS item) N/A Field used to manually exclude cases 34 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

35 Case Eligibility Criteria Diagram Reference Assessment FDS Item FDS Codes 1 Diagnosis of breast cancer Primary Site C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C Exclude manually censored cases Exclude: Exclusion 80 - Patient enrolled in a clinical trial that directly impacts (This is a user field in CP 3 R, it is not a FDS item) delivery of the standard of care 90 Patient refusal 3 Female patients only Sex 2 4 Adult patient at diagnosis Age at Diagnosis First or only diagnosis of malignant or non-malignant neoplasm Sequence Number 00 or 01 6 Tumors which can be staged, according to the AJCC 7 th Ed. (Excluding rare tumors: Mixed tumor, malignant, NOS Histology , Mullerian mixed tumor 8980 Carcinosarcoma Carcinosarcoma, embryonal) 7 In Situ and Invasive tumors Behavior Code 2, 3 Clinical T Pathologic T Clinical T = Blank, Pathologic T = pis, Clinical N = (c0,c0i-,c0i+,c0m-,c0m+), and Clinical Stage Group = 0 Clinical T = (pis,c1mi,c1,c1a,c1b,c1c), Clinical N = (c0,c0i-,c0i+,c0m-,c0m+) Clinical T = (c0,c1mi,c1,c1a,c1b,c1c), Clinical N =c1mi AJCC clinical stage 0, I, or II breast 8 cancer Clinical T = (c2,c3), Clinical N = (c0,c0i-,c0i+,c0m-,c0m+) Clinical N Clinical T = (c0, c1mi, c1, c1a, c1b, c1c, c2), Clinical N = (c1,c1a,c1b,c1c) Clinical M (c1,p1) Pathologic M (c1,p1) Clinical Stage Group 3, 3A, 3B, 3C, 4 35 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

36 9 All or part of the first course of treatment was performed at the reporting facility Class of Case Surgically Treated Mastectomy and BCS Cases Surgical Procedure of the Primary Site at this facility BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

37 Numerator Criteria Diagram Reference Assessment FDS Item FDS Codes 11 Administration of Breast conservation surgery Surgical Procedure of the Primary Site at this facility Notes: 1) Updates for the BCS measure in the September 2015 CP3R release: Exclude rare tumors: Mixed tumor, malignant, NOS Mullerian mixed tumor Carcinosarcoma Carcinosarcoma, embryonal 2) Updates in the November 2015 CP3R release: a. Allow for manual exclusion with censor 80 and 90. b. Allow blank ct, ptis, cn0, cm0 with cstage Group 0 as Clinical Stage 0. 3) Updates in the August 2016 CP3R release: a. Add c and p TNM prefixes for NAACCRv BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

38 38 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.