5. New SAR Tool 3:45 pm a. Workgroup to review 2017 SAR Questions b. Development of a Dashboard for each NAPBC center

Transcription

1 AGENDA Quality Improvement and Information Technology Committee Friday, June 17, Southeast Conference Room Combined Committee Session: Standards and Accreditation and QI/IT Committees 1:00 pm 1. Expansion of Class of Case Exhibit 1 2. Data Points for Collection Benign Breast Disease group discussion 3. Standard 2.7 Template for collection and submission of discrepant diagnoses data Exhibit 2 4. Clinical Trial Template Exhibit 3 5. Annual Reporting of Quality Measures -Re-implementing Standard Welcome and Call to Order Katharine Yao, MD, FACS, Chair 2:30 pm 2. Approval of Meeting Minutes March 28, 2016 Dr. Yao - Exhibit 4 3. Activities of Data Working Group 2:40 pm a. Manuscript: NAPBC Accreditation Demonstrates Increasing Compliance with Post Mastectomy Radiation Therapy Quality Improvement Measure Exhibit 5 b. Comparison of six NAPBC quality measures (NAPBC vs non-nabpc centers) c. NAPBC database - awaiting date of accreditation and incorporation of SAR data elements 4. Quality Measures 3:15 pm a. Her2neu measure-adopt NQF measure b. CPM as a quality measure c. Should the BCS quality measure be modified? d. NQF Endorsed Measures Exhibit 6 Should NAPBC continue to endorse needle biopsy quality measure 5. New SAR Tool 3:45 pm a. Workgroup to review 2017 SAR Questions b. Development of a Dashboard for each NAPBC center 6. Survey of NAPBC centers (U of Chicago survey lab)` 4:00 pm 7. New Business 4:15 pm 8. Adjourn

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5 6/9/2016 Standard Second Opinion Pathology Consultation Tuesday, June 07, 2016 Powered by 184 Total Responses Date Created: Wednesday, August 06, 2014 Complete Responses: 175 1

6 6/9/2016 Q2: What is your role on the breast care team? Answered: 170 Skipped: 14 Q3: When this standard is implemented do you anticipate your center will be in compliance? Answered: 178 Skipped: 6 2

7 6/9/2016 Q4: If you anticipate being non-compliant, what period of time would it take for you to become compliant? Answered: 119 Skipped: 65 Q5: Please indicate the statement that best describes the current second opinion pathology consultation procedure at your center: Answered: 179 Skipped: 5 3

8 6/9/2016 Q6: Our center reviews select outside pathology slides/reports. The review is based on the following criteria (check all that apply) Answered: 173 Skipped: 11 Q7: Is your center willing to begin to track discrepant diagnoses if given a tool to do so? Answered: 169 Skipped: 15 4

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13 Current fields in SAR: Revised Accrual Table NAPBC Clinical Trials Accrual Type of Trial # Active Trials Location Last complete year # of patients accrued Industry Sponsored Cooperative Group Screening Interventional Behavioral Tissue Collection Only Other Total Annual Analytic Caseload Percent Accrual %

14 NAPBC QI Committee Conference call March 28, 2016 Present: Connolly, Bleicher, Williamson, Whitacre, Rosenberg, Goldstein, Kaufman, Jokich, Kiel, Berger, Miller, O Regan (guest), Kurtzman, Winchester, El-Tamer and Singh (tried to call in but number of participants had exceeded call capacity) Dr. Yao called the meeting to order, welcomed committee members. She reviewed some initiatives of the QI committee: 1. NAPBC database-contains NCDB PUF data with NABPC centers flagged. Still awaiting date of accreditation and SAR data elements to be merged into the database. The SAR data elements will contain much more granular information about the centers, services available at the centers, center characteristics, etc 2. Post mastectomy radiation therapy for four or more positive nodes: Dr. Berger, an ACS clinical scholar, has been working with the NCDB data warehouse file looking at PMRT at NAPBC and non-napbc centers. She is presenting a poster at the ASBS and preparing a manuscript. 3. Catholic Health Initiative: This is a consortium of about 40 CoC centers of which half are NAPBC accredited. They would like to launch a pilot study of NAPBC vs non-napbc centers which would help us develop reports for which centers can compare themselves to other centers. 4. Dr. Yao currently looking for funding for a NAPBC clinical scholar. 5. Dr. Yao working on a survey in collaboration with the UofC survey lab about CPM and management of DCIS Next, she reviewed new quality measures for the committee to consider: 1. HER2neu targeted therapies: This measure would be an accountability measure and everyone on the call agreed with developing this measure. There was discussion about age limits, timing of HER2neu targeted therapies. The final wording of the measure will be: HER2neu targeted therapies are recommended or administered for women with AJCC T1cN0M0, and/or AJCC Stage II, III HER2neu positive invasive breast cancer. Dr. Yao will await final signoff from the committee and then the plan would be to submit this measure to the Quality Integration Committee of the CoC for possible submission eventually to the NQF.

15 2. Positive margin rates/re-excision rates: There was extensive discussion about this measure and whether it should be included as a quality measure or not. There were concerns about how to track compliance with this type of measure and whether monitoring re-excision rates or positive margins might lead to more mastectomies. In the end, the committee decided to drop this measure and not pursue it further. 3. Surgical site infections (SSI) after lumpectomy-this is a measure in development at the CDC with the Ambulatory Surgical Center Quality Collaboration. Everyone on the call agreed that this should not be a NAPBC quality measure at this time but committee members were certainly willing to help gather data to help other formulate the measure for other interested parties. 4. Genetics quality measure: Dr. Kaufman brought up a possible quality measure looking at proper use of genetics consultations for newly diagnosed breast cancer patients. Dr. Yao advised him to look further into this measure and how tracking this would result in better outcomes for patients or different outcomes then the current NAPBC genetics standard. The meeting was adjourned at 2 pm and Dr. Yao mentioned that the committee would meet in Chicago at the NAPBC board meeting in June. Two members (Drs Singh and El-Tamer) unfortunately were not able to join in the call because apparently the call had exceeded the maximum number of participants and this will be corrected for the next call. If anyone is interested in getting involved in any of the QI committee initiatives please contact Dr Yao (kyao@northshore.org). Respectfully submitted, Katharine Yao, MD

16 NAPBC Accreditation Demonstrates Improved Compliance with Post Mastectomy Radiation Therapy Quality Measure Elizabeth R. Berger, MD 1,2 ; Edward Wang, PhD 3 ; Cary S. Kaufman, MD 4 ; Ted J. Williamson, MD 5 ; Julio A. Ibarra, MD 6 ; Karen Pollitt, BS 2 ; Richard J. Bleicher, MD 7 ; James L. Connolly, MD 8 ; David P. Winchester, MD 9 ; Katharine A. Yao, MD 3 National Accreditation Program for Breast Centers, American College of Surgeons, Chicago, IL. 1 Loyola University Chicago Stritch School of Medicine, Maywood, IL 2 Division of Research and Optimal Patient Care, American College of Surgeons, Chicago, IL American College of Surgeons, Chicago, IL 3 NorthShore University Health System, Evanston, IL 4 Bellingham Regional Breast Center, Bellingham, WA 5 Willamette Valley Medical Center, McMinnville, OR 6 Memorial Care Health System, Long Beach, CA 7 Fox Chase Cancer Center, Philadelphia, PA 8 Beth Israel Deaconess Medical Center, Boston, MA 9 Cancer Programs, American College of Surgeons, Chicago, IL Corresponding and Reprints Author: Elizabeth Berger, MD Division of Research and Optimal Patient Care American College of Surgeons 633 N. St. Clair Street Chicago, IL Telephone: (312) eberger@facs.org 1

17 44 45 Mini-Abstract 2

18 ABSTRACT: Objective: The Commission on Cancer (CoC) of the American College of Surgeons (ACS) currently accredits more than 1500 general cancer programs. The National Accreditation Program for Breast Centers (NAPBC) was established in 2008 by the ACS as a quality improvement program for patients with breast disease with over 90% of these centers also being CoC-accredited. A quality measure exists within the standards of the NAPBC that every post-mastectomy patient with 4 positive lymph nodes should receive chest wall and regional lymph node radiation therapy. Our objective was to examine how NAPBC accreditation has affected compliance with this quality measure at individual centers, offering a first look at care delivered by NAPBC-accredited centers Methods: Women who underwent mastectomy at either a NAPBC-accredited center or a CoC-only approved hospital were identified ( ) in the NCDB. NAPBC centers that were accredited from were included in the analysis. Patients were nested within centers using a mixed effects model to identify PMRT rates at each center prior to accreditation and after accreditation, adjusting for patient and tumor characteristics Results: Of the 34,752 patients from 477 NAPBC-accredited centers and 958 CoC-only approved hospitals who underwent mastectomy and had 4 positive lymph nodes, 21,638 patients in total received PMRT during the study period (62.3%). The overall trend of PMRT rates for 4 positive nodes at CoC centers increased from 2006 to 2012 ( 4 positive lymph nodes: 51.4% to 62.8%). The baseline radiation rate amongst all NAPBC centers prior to accreditation was 62%. For each year of accreditation ( ), centers had statistically significantly higher rates of radiation in the accreditation year compared to the year prior to accreditation (p < 0.001). The rate of radiation increased post-accreditation in each accreditation year (2009: 62.1% to 71.9%; 2010: 65.5% to 73.2%; 2011: 67.5% to 70.4%). For each year post-accreditation, a center s radiation rate increased by an average of 7%. In an adjusted analysis, independent predictors of receiving radiation in patients with 4 positive nodes were age <50 years old 3

19 (OR %CI: ), lobular carcinoma (OR %CI: ), ER positive (OR= %CI: ) and PR positive tumors (OR %CI: ) and NAPBC accreditation. Patients were significantly less likely to receive radiation if they had Medicare/Medicaid (OR %CI: ; OR % CI: ), lived in the South (OR %CI: ), or had a Charlson/Deyo score 2 (OR %CI: ) Conclusion: NAPBC-accreditation is associated with higher PMRT rates and thus better adherence to the PMRT quality measure. Future studies with more centers and longer follow-up are needed to determine if this trend continues. 81 4

20 Introduction: The quality of healthcare received by breast cancer patients varies significantly across the United States.[1] The concept of a comprehensive breast center developed in response to this inconsistent, fragmented and inefficient system to evaluate and manage patients with disease of the breast.[2] The first free-standing breast center in the United States was established almost 4 decades by Dr. Silverstein at the University of California, Los Angeles.[3] This was the beginning of a major paradigm shift in the delivery of breast cancer care to address the multidisciplinary needs of breast cancer patients, ideally in a breast center setting. And now despite the abundance of breast centers throughout the United States, there have been few studies to address the quality of care delivered at these centers through evaluation of compliance with standards.[1] The Commission on Cancer (CoC) of the American College of Surgeons (ACS), a multidisciplinary consortium of professional organizations, was established in attempts to improve cancer care through setting standards; through prevention, research, and education and through monitoring of comprehensive cancer care.[4, 5] The CoC accredits hospitals as cancer centers on the basis of 36 standards and requires approved hospitals to report their entire cancer occurrence annually to the National Cancer Data Base (NCDB).[6, 7] There are currently more than 1,500 hospitals accredited by the CoC. The National Accreditation Program for Breast Centers (NAPBC) originated through the cancer programs at the ACS and was established in 2008 with the mission to improve the quality of care and monitoring of outcomes of patients with disease of the breast.[8] Over 90% of the NAPBC centers are also CoC approved hospitals. However, there is a paucity of data demonstrating how NAPBC accreditation enhances breast cancer care at CoC approved hospitals. The United States health care system has undergone a dramatic transformation centered on quality measurement, improvement and documentation of adherence to broadly accepted standards of care. The NAPBC is the one of a very few organizations that has established standards for the evaluation and management of patients with disease of the breast or a survey process to monitor compliance. One of these patient care standards is that every post-mastectomy patient with 4 positive lymph nodes should 5

21 receive chest wall radiotherapy which is consistent with recommendations from the National Comprehensive Cancer Network standard (NCCN) and the American Society of Clinical Oncology (ASCO). We utilized the National Cancer Data Base (NCDB) to (1) evaluate if accreditation by the NAPBC helped increase compliance with the post mastectomy radiation therapy (PMRT) quality standard and to (2) compare compliance rates of PMRT between NAPBC plus CoC-accredited centers versus CoConly approved hospitals

22 Methods: A. Data Source: The National Cancer Data Base (NCDB) is a nationwide, oncology outcomes registry, capturing approximately 70% of newly diagnosed breast malignancies in the United States (U.S.) from more than 1,500 American College of Surgeons Commission on Cancer (CoC)-approved hospitals.[9] Data are abstracted by certified tumor registrars who are audited for accuracy.[10] Data abstraction processes and definitions are similar to other state and national cancer registries, including the National Cancer Institute s (NCI s) Surveillance, Epidemiology and End Results (SEER) database. Within these databases, there is a requirement for routine long-term follow-up and reporting of survival. All data within the NCDB are compliant with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). The study was deemed exempt by the Northwestern University and NorthShore University Health System Institutional Review Board B. Patient Selection: From the NCDB, women older than 18 years of age diagnosed with T1 to T4 non-metastatic primary cancer from January 1, 2006 to December 31, 2013 were identified based upon International Classification of Diseases for Oncology-Third revision and histology codes (See Appendix A). All patients who underwent a mastectomy and had 4 positive lymph nodes were included in the study. Patients with multiple primary cancers, In situ or Stage 4 disease or had neoadjuvant chemotherapy were excluded. There were a total of 34,752 patients who met the inclusion criteria (Figure 1) The NAPBC-accredited centers were identified based upon a unique site identification number within the NCDB. Over 90% of the time, an NAPBC breast center is part of a larger CoC approved hospital. The CoC-only approved hospitals were identified with the CoC random facility identification. There were a total of 477 centers that were accredited by the NAPBC between with a total of 1,435 CoC hospitals (NAPBC-accredited centers and CoC-only) included in the analysis. For clarity, the centers 7

23 accredited by the NAPBC as well as the CoC are designated as NAPBC centers and the hospitals approved only by the CoC are designated as CoC hospitals C. Analytic Variables: Patient-level risk adjustment included patient characteristics: age, race (white, black Hispanic, Asian, other), and insurance (private, Medicare, Medicaid, uninsured, other). Age was studied as a categorical variable. Tumor characteristics were also included in the risk adjustment: histology (invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), mixed IDC/ILC and other), hormone receptor status (ER/PR), Tstage (T1, T2, T3, T4 and unknown) and Grade (grade 1, grade 2, grade 3 and unknown) The hospital characteristics that were included in adjustment were hospital type (National Cancer Institute (NCI) accredited, non-nci academic, and community), population density (metropolitan, urban/rural, and unknown) and accreditation status (NAPBC plus CoC-approved centers vs CoC-only approved hospitals) D. Outcomes & Comparison Groups: The primary outcome of interest was receipt of chest wall radiation after a mastectomy was performed. Comparison to determine the significance of accreditation on compliance with PMRT was performed by 2 approaches. For the first analysis, radiation rates at NAPBC-accredited centers were compared between the year prior to accreditation and the year of accreditation to examine if the change in radiation rate was significantly improved once the center was accredited. The centers were clustered by accreditation year. All patients who underwent radiation in hospitals that were CoC-hospitals were excluded from the first analysis. The second approach assessed the radiation rates of NAPBC-accredited centers versus CoCapproved hospitals, taking into account year of NAPBC accreditation. For CoC-approved hospitals, the year of diagnosis was used to perform the comparison with the NAPBC centers as the date of accreditation for CoC hospitals is unknown within the NCDB

24 E. Statistical Analysis: Differences in categorical variables were examined using the Pearson s Chi square test. Independent sample t tests were used for normally distributed continuous variables and Mann-Whitney tests were used for skewed continuous variables. An aggregate rate of radiation for each year was calculated for NAPBC-accredited centers in 2009, 2010 and A risk-adjusted, mixed effects model was developed to compare the pre-accreditation radiation rate to the post-accreditation rates of centers by accreditation year with patients being nested within centers. Hierarchical modeling was also used to compare NAPBCaccredited versus CoC- approved hospitals The level of statistical significance was set at All p values reported were based on two-sided tests. Statistical analyses were performed with SAS version 9.4 (SAS, Cary, NC)

25 Results: 34,752 patients from 477 NAPBC-accredited centers and 958 CoC- approved hospitals were included in the analysis. Table 1 demonstrates the results of preoperative and perioperative outcome variables for patients with 4 positive lymph nodes and underwent mastectomy at NAPBC-accredited centers versus CoC-approved hospitals. Most of the difference in patient characteristics between those who were treated at NAPBC-accredited centers and those treated at CoC-approved hospitals were statistically significant however were not clinically meaningful. The NAPBC centers treated 55.6% of patients with private insurance versus 50.1% of patients at CoC hospitals. There was also significant regional variation with 5.8% of patients from NAPBC-accredited centers being treated in New England compared to only 2.5% of patients at CoC hospitals. As expected, there were a significantly higher proportion of patients treated at Academic centers (28.1%) in the NAPBC group compared to the CoC group (16.4%). The tumor histology, hormonal status and grade were all similar across the two cohorts of patients. Of the 34,752 patients, 15,675 patients were treated at NAPBC-accredited centers and 19,077 were treated at CoC hospitals. 21,638 patients in total received PMRT during the study period (62.3%). Of the 15,675 patients treated at NAPBC-accredited centers, 10,348 received radiation (66.0%) and 11, 290 patients at CoC-hospitals received radiation (59.2%). In 2006, the centers that became NAPBCaccredited demonstrated significantly higher compliance with the PMRT quality measure compared to CoC-hospitals. In each year after 2006, the radiation rate for NAPBC centers was higher than the radiation rate for CoC hospitals. However, the change in radiation rate between pre-accreditation and year of accreditation in the NAPBC centers was significantly different than the overall increase of radiation rate from in CoC hospitals Comparison of pre-accreditation versus year of accreditation in NAPBC centers The NAPBC centers were grouped into cohorts by year of accreditation. There were 102 centers accredited in 2009 that treated 3,656 patients, 115 centers accredited in 2010 that treated 3,584 patients 10

26 and 107 centers accredited in 2011 that treated 3,247 patients. The radiation rate in 2009 NAPBC centers had the most significant increase from pre-accreditation to year of accreditation with an absolute increase of 9.8% (Figure 1). The radiation rate continued to increase in 2009 centers post-accreditation. The 2010 NAPBC centers also had a significant increase in radiation rates between pre-accreditation year and accreditation year (65.5% to 73.2%). The 2010 centers had a slight decline in rate in 2011 but increased to 74.5% in The overall increase in the 2011 NAPBC centers was the least significant, however remained significantly different. All centers in all years had significant increases of radiation rates from 2006 to Comparison of NAPBC centers versus CoC Centers The NAPBC centers were compared to the CoC hospitals. The CoC hospitals had an increasing trend of radiation rate from (51.4% in 2006; 63.7% in 2011) with a slight decrease in 2012 (62.8%). In 2009, the NAPBC centers had a statistically significantly higher rate of radiation (71.9%) then the CoC hospitals (56.3%). This was true for 2010 NAPBC centers and 2011 NAPBC centers when compared to CoC hospitals. Centers accredited in 2010 had a radiation rate of 73.2% in 2010, which was significantly higher than the CoC hospitals in 2010 with a radiation rate of 60.2%. The 2011 NAPBC centers PMRT rate was 70.4% in 2011 which was significantly higher than the CoC hospitals radiation rate in 2011 (63.7%) In hierarchical modeling, it was demonstrated that in each accreditation year, the patients at NAPBC centers had a significantly higher association with PMRT compared to the CoC hospitals (2009: OR % CI ; 2010: OR % CI ; 2011: OR % CI ) (Table 3). Other patient factors associated with PMRT were younger age, Asian race, ILC or mixed IDC/ILC, and ER or PR positive tumors. If patients were older, had a lower income, had Medicare/Medicaid or were uninsured, or had higher Charlson scores than they were significantly less likely to get PMRT. Compared to patients in the New England region, patients in the Middle Atlantic, Mountain, Pacific, and 11

27 231 South regions were all significantly less likely to undergo PMRT. 12

28 Discussion: To achieve locoregional control and reduce locoregional recurrence, the role of PMRT has been established by several randomized control trials (RCT) that found that PMRT afforded patients an absolute survival benefit of about 10% at 10 years.[11-15] Thus, PMRT has been the standard of care in the United States for breast cancer patients with 4 positive lymph nodes and/or T3-T4 tumors for the past 15 years.[16-18] Our study demonstrates significantly improved compliance with PMRT nationwide following implementation of a national accreditation program. This finding was demonstrated both between pre-accreditation versus post-accreditation within the NAPBC centers and between NAPBCaccredited versus CoC-approved hospitals. Risk adjusted analyses showed that NAPBC accreditation resulted in a significantly higher rate of compliance. The study also demonstrated that centers who achieved NAPBC-accreditation continued to have increasing compliance with the PMRT quality measure after accreditation. The NAPBC accreditation process positively affects compliance with the PMRT quality standards leading to more patients with four or more tumor positive nodes undergoing PMRT. The demonstrated improvements in compliance rates are most likely because of implementation of a more formalized accreditation program mandating reporting and accountability. This has been demonstrated in the bariatric surgery literature with the adoption of bariatric centers of excellence (COE) improving mortality and complication rates.[19] In various studies, outcomes reporting appear to be the most significant factor and have been largely recognized as the reason accreditation programs are associated with lower morbidity and mortality. [20] State-wide Collaboratives have also demonstrated the power of externally audited, prospectively collected clinical data for outcomes assessment and analysis to improve costs and quality of care.[21, 22] Such Collaboratives are extremely resource intensive and are possible only with significant financial support. In light of this, a unified national accreditation program, such as the NAPBC, is an important initiative in addition to the already well established verification program of the Commission on Cancer.[4, 23] The NAPBC program enhances the CoC-accreditation and further insures high compliance with breast cancer quality measures. A survey study published by Knutson et al that assessed views and perceptions about the importance and impact of accreditation 13

29 demonstrated that over 90% of respondents stated that accreditation either by the CoC of NAPBC improved patient care and outcomes.[23] Comparing pre and post-accreditation longitudinal data within hospitals provide a strong argument for national accreditation policy because comparing accredited to never accredited hospitals could suffer from selection bias. The argument could be made that hospitals that successfully undergo accreditation were better or more proactive hospitals vested in breast cancer care thus introducing bias in the hospital analysis.[19] Demonstrating that NAPBC centers radiation rates improved postaccreditation negates this argument and supports the claim that NAPBC accreditation improves compliance with quality measures. Patients at NAPBC centers were also independently correlated with increased likelihood of receiving PMRT when adjusting for multiple patient, tumor and facility factors. This is the first study to assess whether a correlation between NAPBC accreditation and compliance with breast disease quality measures. Literature from Rauscher et al. demonstrated that mammography facilities who were accredited by the CoC and the National Consortium of Breast Centers (NCBC) had higher compliance with benchmarks in mammography quality measures compared to those accredited by the CoC only.[24] There is a paucity of surgical literature in evaluating effectiveness of accreditation in longer-term outcomes. And although our findings demonstrate that the CoC-only centers have effectively increased the percentage of patients receiving radiation therapy each year, the NAPBCaccredited facilities are setting a higher benchmark with regards to compliance. These findings suggest that additional NAPBC accreditation offers benefits beyond what the CoC-accreditation offers including a centralized database with an interactive program to assess quality measures and provide real-time feedback for physicians managing patients.[2] The commitment of the NAPBC to adherence to longer term quality measures stems from an institutional commitment to breast disease care with meticulous data collection and follow-up. The Affordable Care Act (ACA) has introduced three separate new programs that link Medicare payment to hospital performance in the areas of quality, efficiency, outcomes and patient experience. Medicare has begun to implement the ACA-mandated pay-for-performance programs and the quality 14

30 measures used to assess these programs are process, outcome, patient experience and structure measures.[25] As quality of care in the United States becomes increasingly linked to payment, accreditation programs will have even broader reaching impact if shown to improve the delivery of care to patients. Accredited organizations demonstrate their commitment to quality patient care to patients, providers, payers and policymakers.[23] Studies have shown that both government and private payers have a strong interest in the rapid maturation of the technology platforms and standards, as well as the organizational frameworks that have a better chance of placing information and decision support for cancer care in order to help with reimbursements.[26] It has also been demonstrated that accredited cancer centers (CoC) generally perform better for processes of care, patient-reported experiences and costs but paradoxically worse on outcomes measures.[27] The strengths of this study include the sample size, dataset used and years of analysis. The NCDB is an ideal database to capture over 70% of all cancer cases in the United States annually. It also allowed for designation of NAPBC centers versus non-napbc centers while being able to identify characteristics of patients and the hospitals using the NCDB variables. In addition, the study time of is an appropriate timeframe to evaluate the PMRT measure as this is based on the current NCCN guidelines. There are certain limitations that should be considered in this study. First, the NCDB is an administrative dataset with possible coding errors as well as the inability to access more clinical rich data. More specifically, coding errors related to receipt of radiation may cause lower than or higher than anticipated rates of radiation at the individual centers. Second, NAPBC-accredited hospitals have a roster of physician providers. Thus, data submitted to the NCDB from hospitals with NAPBC accreditation may include data from physicians who do not participate in the NAPBC breast center at that site. This is a small number of physicians and thus is unlikely to change the overall results. Third, there is the inability to compare year of CoC accreditation to year of NAPBC-accreditation as the dataset does not provide year of CoC-accreditation. Last, although it is possible to identify trends of radiation rates within 15

31 NAPBC centers and CoC-approved hospitals, there are limited outcome variables within the NCDB which makes drawing conclusions about actual improvement in patient care more difficult Conclusion: The multidisciplinary treatment of women with breast cancer is complex and continues to evolve. This study demonstrates that the NAPBC program significantly improves compliance with PMRT which translates into better survival rates for breast cancer patients. Given these findings, national accreditation is beneficial and patients should consider this when being treated for breast disease. It is imperative that stakeholders of cancer care, including patients, are engaged with cancer quality measure development and implementation. Future studies reflecting other quality indicators for breast cancer care are needed to confirm that accreditation has significant effects on overall breast center quality and compliance. 16

32 References: 1. Moran, M.S., et al., Quality measures, standards, and accreditation for breast centers in the United States. Int J Radiat Oncol Biol Phys, (1): p Winchester, D.P., The National Accreditation Program for Breast Centers: quality improvement through standard setting. Surg Oncol Clin N Am, (3): p , x. 3. Silverstein, M.J., The Van Nuys Breast Center: the first free-standing multidisciplinary breast center. Surg Oncol Clin N Am, (2): p Bilimoria, K.Y., et al., Comparison of commission on cancer-approved and -nonapproved hospitals in the United States: implications for studies that use the National Cancer Data Base. J Clin Oncol, (25): p Commission on Cancer. [cited 2016 May 11th]; Available from: 6. Bilimoria, K.Y., et al., The National Cancer Data Base: a powerful initiative to improve cancer care in the United States. Ann Surg Oncol, (3): p Commision on Cancer: Cancer Program Accredtiation: Categories of Approval. [cited 2016 May 11th]; Available from: 8. National Accreditation Program for Breast Centers. [cited 2016 May 11th]; Available from: 9. National Cancer Data Base Frequently Asked Questions. [cited 2016 March 15th]; Available from: How are Cancer Programs Accredited? [cited 2016 March 15th]; Available from: Overgaard, M., 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, (14): p Smith, B.D., G.L. Smith, and B.G. Haffty, Postmastectomy radiation and mortality in women with T1-2 node-positive breast cancer. J Clin Oncol, (7): p Ragaz, J., et al., Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med, (14): p Cuzick, J., et al., Cause-specific mortality in long-term survivors of breast cancer who participated in trials of radiotherapy. J Clin Oncol, (3): p Overgaard, 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, (9165): p Taylor, M.E., et al., ACR appropriateness criteria on postmastectomy radiotherapy expert panel on radiation oncology-breast. Int J Radiat Oncol Biol Phys, (4): p Recht, A., et al., Postmastectomy radiotherapy: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol, (5): p Harris, J.R., et al., Consensus Statement on postmastectomy radiation therapy. Int J Radiat Oncol Biol Phys, (5): p Telem, D.A., et al., The effect of national hospital accreditation in bariatric surgery on perioperative outcomes and long-term mortality. Surg Obes Relat Dis, (4): p Elixhauser, A., et al., Comorbidity measures for use with administrative data. Med Care, (1): p Kwon, S., et al., The impact of accreditation on safety and cost of bariatric surgery. Surg Obes Relat Dis, (5): p Nguyen, N.T., et al., Outcomes of bariatric surgery performed at accredited vs nonaccredited centers. J Am Coll Surg, (4): p

33 Knutson, A.C., et al., The role of the American College of Surgeons' cancer program accreditation in influencing oncologic outcomes. J Surg Oncol, (5): p Rauscher, G.H., et al., Beyond the mammography quality standards act: measuring the quality of breast cancer screening programs. AJR Am J Roentgenol, (1): p Ryan, A.M., J. Blustein, and L.P. Casalino, Medicare's flagship test of pay-for-performance did not spur more rapid quality improvement among low-performing hospitals. Health Aff (Millwood), (4): p National Research Council. Delivering high-quality cancer care: Charting a new course for a system in crisis. The National Academies Press 27. Merkow, R.P., et al., Relationship between cancer center accreditation and performance on publicly reported quality measures. Ann Surg, (6): p

34 Commission on Cancer Quality Care Measures Measure specifications and updates for harmonization with American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN) and National Accreditation Programs for Breast Centers (NAPBC) prior to submission to the NQF for measure maintenance. Contents Colon Measures... 2 NQF 0225 At least 12 regional lymph nodes are removed and pathologically examined for resected colon cancer NQF 0223: Adjuvant chemotherapy is considered or administered within 4 months (120 days) of surgery to patients under the age of 80 with AJCC III (lymph node positive) colon cancer... 3 Breast Measures... 4 NQF 0219: Breast Conservation Surgery Followed by RT... 4 NQF 0559: Chemotherapy for HR Breast Cancer... 5 NQF 0220 Hormone Therapy for HR+ Breast Cancer : Needle biopsy to establish diagnosis of cancer precedes surgical excision/resection

35 Colon Measures NQF 0225 At least 12 regional lymph nodes are removed and pathologically examined for resected colon cancer. Measure Current Specifications General description Percentage of patients >18yrs of age, who have primary colon tumors (epithelial malignancies only), experiencing their first diagnosis, at AJCC stage I, II or III who have at least 12 regional lymph nodes removed and pathologically examined for resected colon cancer. Numerator 12 or more regional lymph nodes are pathologically examined Numerator details Regional Lymph Nodes Examined [NAACCR Item#830] = Denominator Include, if all of the following characteristics are identified: Age >=18 at time of diagnosis Primary tumors of the colon Epithelial malignancy only AJCC Stage I, II, or III Surgical resection performed at the reporting facility Denominator exclusions Exclude, if any of the following characteristics are identified: Age <18; non epithelial and non invasive tumors; metastatic disease (AJCC Stage IV); not treated surgically at the reporting facility; perforation of the primary site; acute obstruction Changes since last endorsement Since the last endorsement, this measure has been updated to include any tumor diagnosis, no longer limited to first or only malignant primaries. Due to advances in medical oncology, drug development, surgical techniques and radiotherapeutic techniques, more patients are living longer and being cured of their cancer only to develop a subsequent malignancy. For this reason when patients are being operated on for curative intent, we are holding these patients to the standard of care of a threshold minimum lymph node removal established in the Commission on Cancer Quality Measures. We also now allow for exclusion of cases based on perforation to the primary site and acute obstructions because acute perforation or obstruction of colon cancer is a surgical emergency. The primary surgical objective is to deal with these life threatening conditions expeditiously without regard to a meticulous lymphadenectomy. Furthermore, the diagnosis may not be known at the time of the emergent surgery. The preoperative diagnosis may be diverticulitis or other benign conditions. 2

36 NQF 0223: Adjuvant chemotherapy is considered or administered within 4 months (120 days) of surgery to patients under the age of 80 with AJCC III (lymph node positive) colon cancer Measure General description Numerator Numerator details Denominator Denominator exclusions Changes since last endorsement Current Specifications Percentage of patients under the age of 80 with AJCC III (lymph node positive) colon cancer for whom adjuvant chemotherapy is recommended and not received or administered within 4 months (120 days) of diagnosis. Chemotherapy is administered within 4 months (120 days) of diagnosis or it is recommended and not received Chemotherapy [NAACCR Item#1390]=82 87 OR; Chemotherapy [NAACCR Item#1390]=3, and Date Chemotherapy Started (NAACCR Item#1220] <=120 days following Date of Diagnosis [NAACCR Item# 340] Include, if all of the following characteristics are identified: Age at time of diagnosis Known or assumed to be first or only cancer diagnosis Primary tumors of the colon Epithelial malignancy only At least one pathologically examined regional lymph node positive for cancer (AJCC Stage III) All or part of 1st course of treatment performed at the reporting facility Known to be alive within 4 months (120 days) of diagnosis Exclude, if any of the following characteristics are identified: Age <18 and >=80; not a first or only cancer diagnosis; non epithelial and non invasive tumors; no regional lymph nodes pathologically examined; metastatic disease (AJCC Stage IV); not treated surgically; died within 4 months (120 days) of diagnosis; Patient participating in clinical trial which directly impacts receipt of standard of care. Minor changes have been made to this measure. Cases are now excluded from the measure if participation in a clinical trial directly impacts the receipt of the standard of care and compliance with this measure. The title has been modified to state treatment is recommended rather than considered to be more consistent with the definitions in the registry codes used in assessing measure compliance. 3

37 Breast Measures NQF 0219: Breast Conservation Surgery Followed by RT Measure Specifications General description Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. Percentage of female patients, age 18 69, who have their first diagnosis of breast cancer (epithelial malignancy), at AJCC stage I, II, or III, receiving breast conserving surgery who receive radiation therapy within 1 year (365 days) of diagnosis. Numerator Regional Treatment Modality [NAACCR Item#1570]=20 98, and Date Radiation Started [NAACCR Item#1210] <= 365 days following the Date of Diagnosis [NAACCR Item#340] Denominator Sex [NAACCR Item#220]=2; Age at Diagnosis [NAACCR Item#230] < 70; AND Surgical Procedure of the Primary Site [NAACCR Item#1290] = Denominator exclusions Men; Age <18 and >=70; not a first or only cancer diagnosis; non epithelial, rare tumors (8940 Mixed tumor, malignant, NOS, 8950 Mullerian mixed tumor, 8980 Carcinosarcoma, 8981 Carcinosarcoma, embryonal), malignant phyllodes tumors and non invasive tumors; metastatic disease (AJCC Stage IV); not treated surgically; died within 1 year (365 days) of diagnosis, Patient enrolled in a clinical trial that directly impacts delivery of the standard of care. Brief description of changes Since the last endorsement maintenance minor changes to this measure have been instituted. since last endorsement. The word considered has been replaced in the numerator statement with recommended to be more consistent with the registry codes used in assessing measure compliance. Rare histologies which are not supported by clinical evidence were removed from inclusion: 8200 adenoid cystic carcinoma, 8940 Mixed tumor, malignant, NOS 8950 Mullerian mixed tumor 8980 Carcinosarcoma 8981 Carcinosarcoma, embryonal 9020 phyllodes tumor An exclusion for patients in which participation in a clinical trial directly impacts the delivery of the standard of care has been added. 4

38 NQF 0559: Chemotherapy for HR Breast Cancer Measure General description Numerator Denominator Statement Denominator exclusions Brief description of changes since last endorsement. Current Specifications 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. Combination chemotherapy is administered within 4 months (120 days) of the date of diagnosis or it is recommended and not received or Single agent chemotherapy and BRM is administered within 4 months (120 days) of the date of diagnosis or it is recommended and not received for HER2 positive patients diagnosed in 2013 and after Women under the age of 70 with AJCC T1cN0M0, or Stage IB III hormone receptor negative breast cancer Men; Age <18 and >=70; not a first or only cancer diagnosis; non epithelial and non invasive tumors; rare tumors (8940 Mixed tumor, malignant, NOS, 8950 Mullerian mixed tumor, 8980 Carcinosarcoma, 8981 Carcinosarcoma, embryonal), malignant phyllodes tumors, tumor size <=1cm and AJCC pn=0; ERA unknown or positive; PRA unknown or positive; metastatic disease (AJCC Stage IV); not treated surgically; died within 4 months (120 days) of diagnosis. Patient enrolled in a clinical trial which directly impacts delivery of the standard of care Since the last endorsement maintenance minor changes to this measure have been instituted. The word considered has been replaced in the numerator statement with recommended to be more consistent with the registry codes used in assessing measure compliance. Rare histologies which are not supported by clinical evidence were removed from inclusion: 8200 adenoid cystic carcinoma, 8940 Mixed tumor, malignant, NOS 8950 Mullerian mixed tumor 8980 Carcinosarcoma 8981 Carcinosarcoma, embryonal 9020 phyllodes tumor Based on changes in SEER coding of chemotherapy and immunotherapy Her2 positive patients diagnosed after 2013 are compliant with the standard if they receive multi agent chemotherapy or single agent chemotherapy plus immunotherapy, or if these treatments are recommended and not received. Exclusion of patients in which participation in a clinical trial directly impacts the delivery of the standard of care has been added. 5

39 NQF 0220 Hormone Therapy for HR+ Breast Cancer Measure General description Numerator Numerator details Denominator Statement Denominator exclusions Changes since last endorsement Current Specifications Percentage of female patients, age >18 at diagnosis, who have their first diagnosis of breast cancer (epithelial malignancy), at AJCC stage T1cN0M0,IB to III, who's primary tumor is progesterone or estrogen receptor positive with tamoxifen or third generation aromatase inhibitor (recommended or administered) within 1 year (365 days) of diagnosis Hormone therapy is administered within 1 year (365 days) of the date of diagnosis or it is recommended and not received Hormone Therapy [NAACCR Item#1400]=82 87 OR; Hormone Therapy [NAACCR Item#1400]=1, AND Date Hormone Therapy Started (NAACCR Item#710] <=365 days following Date of Diagnosis [NAACCR Item# 340] Include if all of the following characteristics are identified: Women, Age >=18 at time of diagnosis, Known or assumed to be first or only cancer diagnosis, Epithelial malignancy only, Primary tumors of the breast, AJCC T1cN0M0 or Stage IB III, Primary tumor is estrogen receptor positive or progesterone receptor positive, All or part of 1st course of treatment performed at the reporting facility, Known to be alive within 1 year (365 days) of date of diagnosis Exclude, if any of the following characteristics are identified: Men, Under age 18 at time of diagnosis, Second or subsequent cancer diagnosis, Tumor not originating in the breast, Non epithelial malignancies, exclude malignant phyllodes tumors, exclude : 8940 Mixed tumor, malignant, NOS, 8950 Mullerian mixed tumor, 8980 Carcinosarcoma,8981 Carcinosarcoma, embryonal; Stage 0, in situ tumor, AJCC T1mic, or T1a tumor, Stage IV, metastatic tumor, Primary tumor is estrogen receptor negative and progesterone receptor negative, None of 1st course therapy performed at reporting facility, Died within 1 year (365 days) of diagnosis, Patient enrolled in a clinical trial that directly impacts delivery of the standard of care Since the last endorsement maintenance minor changes to this measure have been instituted. The word considered has been replaced in the numerator statement with recommended to be more consistent with the registry codes used in assessing measure compliance. Rare histologies which are not supported by clinical evidence were removed from inclusion: 8200 adenoid cystic carcinoma, 8940 Mixed tumor, malignant, NOS 8950 Mullerian mixed tumor 8980 Carcinosarcoma 8981 Carcinosarcoma, embryonal 9020 phyllodes tumor Exclusion of patients in which participation in a clinical trial directly impacts the delivery of the standard of care has been added.. 6

40 0221: Needle biopsy to establish diagnosis of cancer precedes surgical excision/resection This measure is not being submitted for NQF endorsement maintenance. Needle biopsy to establish the diagnosis of breast cancer is an important quality measure which the CoC reports to our constituents and assesses with the CoC Standards. However, we have decided not to perform additional testing required to maintain NQF endorsement based on staffing and other priorities. The CoC has updated the measure specifications to the point that this measure requires additional reliability and validity testing to maintain NQF endorsement. To adequately measure needle biopsy utilizing NAACCR cancer registry items, the NCDB/CoC has developed 11 manual exclusions to the measure. These include: Patient refusal Patient medically unable to hold position for image guided biopsy Patient requires sub areolar excision for nipple discharge Lesion too superficial Breast too small Lesion inaccessible by needle biopsy Cancer found in prophylactic mastectomy or through an elective procedure Benign high risk lesions diagnosed by needle biopsy, requiring excisional biopsy Discordant biopsy results compared to suspicious imaging Patient presents with co morbid conditions. Based on these changes the CoC has decided to withdraw this measure from NQF endorsement 7