1. Accountability in Breast and Colorectal Cancer Care Omar M. Rashid MD, JD Complex General Surgical Oncology Fellow

2. Introduction Over the last 15 years there has been a coordinated effort to improve the quality of cancer care in the U.S. & to transition cancer care to “value-based care.”

3. Introduction Provide background on these measures Review salient issues in quality reporting Present the experience at Moffitt Discuss future directions in quality

4. Introduction 1999: “Ensuring Quality Cancer Care” Conclusions: There is a wide quality gap for many Americans in their experience within the cancer care delivery system. There is a need to implement a quality monitoring system utilizing a core set of indicators.

5. Introduction Collaborative effort of multiple national organizations, including ACS, the National Initiative for Cancer Care Quality (NICCQ): Review of the literature 36 quality measures in breast cancer 25 quality measures in colorectal cancer Evaluation of care provided to patients in 5 U.S. cities diagnosed in 1998 with Stage I - III breast cancer and Stage II - III colorectal cancer.

6. Introduction Collaborative effort of multiple national organizations, including ACS, the National Initiative for Cancer Care Quality (NICCQ): Adherence to breast cancer metrics : 13 - 97% individual indicators <85% for 18/36 indicators Adherence to colorectal cancer metrics: 57 - 93% individual indicators <85% for 14/25 indicators

7. Introduction Collaborative effort of multiple national organizations, the Quality Oncology Practice Initiative (QOPI): Focused on individual institutions (address criticisms of focusing on population based data) Provided medical oncology practices tool for self-examination using medical record chart abstraction Evaluated 7 oncology groups in the U.S. in 11 quality indicators at 2 time points, 6 months apart (e.g. patient safety, evidence based and patient-centered care). Findings: significant variation in adherence to 8 of the 11 indicators (73%), supporting NICCQ findings

8. Introduction Collaborative effort of multiple national organizations, including the ACS Commission on Cancer, ASCO, and NCCN, facilitated by the National Quality Forum (NQF): Evaluate quality measures for breast and colorectal cancer to determine which should be implemented as accountability measures Accountability measures are used for public reporting, payment incentive programs, and provider selection by consumers, health plans, or purchasers.

9. Introduction Collaborative effort of multiple national organizations, including the ACS Commission on Cancer, ASCO, and NCCN, facilitated by the National Quality Forum (NQF) formed two panels made up of breast and colorectal experts in surgery, radiotherapy, medical oncology, health care consumers and health services research: Importance: the extent to which a measure reflects variation that has the potential for improvement; Scientific acceptability: that a measure is reliable, valid, precise, and adaptable to patient preference; Usability: information produced as part of the measure could be used to make decisions and/or take actions, and that reported performance levels were statistically, and clinically meaningful; Feasibility: that data can be obtained within the normal flow of clinical care and that implementation of the measure was achievable.

10. Introduction Collaborative effort of multiple national organizations, including the ACS Commission on Cancer (ACoC), ASCO, and NCCN, facilitated by the National Quality Forum (NQF): 4 process-based accountability measures in cancer care: 3 for breast cancer 1 for colorectal cancer 1 outcome-based accountability measure in colorectal cancer 1 surveillance measure in colorectal cancer

11. Breast Cancer Process Measure Tamoxifen or third generation aromatase inhibitor is considered or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0, or Stage II or Stage III hormone receptor positive breast cancer. (HT) Case Eligibility Criteria:  Women only  Adults – patients >=18 at time of diagnosis  First or only cancer diagnosis  Primary tumors of the breast  Epithelial tumors required to be staged according to the AJCC 6 th and 7 th Editions.  Solid tumors only  Invasive tumors only  No reported clinical or pathological evidence of metastatic disease  All or part of first course of treatment was performed at Moffitt Cancer Center

12. Breast Cancer Process Measure Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. (BCS) Case Eligibility Criteria:  Women only  Adults – patients >=18 at time of diagnosis  First or only cancer diagnosis  Primary tumors of the breast  Epithelial tumors required to be staged according to the AJCC 6 th and 7 th Editions.  Solid tumors only  Invasive tumors only  No reported clinical or pathological evidence of metastatic disease  All or part of first course of treatment was performed at Moffitt Cancer Center

13. Breast Cancer Process Measure Combination chemotherapy is considered or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1cN0M0, or Stage II or III hormone receptor negative breast cancer. (MAC) Case Eligibility Criteria:  Women only  Adults – patients >=18 at time of diagnosis  First or only cancer diagnosis  Primary tumors of the breast  Epithelial tumors required to be staged according to the AJCC 6 th and 7 th Editions.  Solid tumors only  Invasive tumors only  No reported clinical or pathological evidence of metastatic disease  All or part of first course of treatment was performed at Moffitt Cancer Center

14. Colorectal Cancer Process Measure Adjuvant chemotherapy is considered or administered within 4 months (120 days) of diagnosis for patients under the age of 80 with AJCC Stage III (lymph node positive) colon cancer. (ACT) Case Eligibility Criteria:  Adults – patients >=18 at time of diagnosis  First or only cancer diagnosis  Primary tumors of the colon and rectum  Epithelial tumors required to be staged according to the AJCC 6 th and 7 th Editions.  Solid tumors only  Invasive tumors only  No reported clinical or pathological evidence of metastatic disease  All or part of first course of treatment was performed at Moffitt Cancer Center

15. Colorectal Cancer Outcome Measure At least 12 regional lymph nodes are removed and pathologically examined for resected colon cancer. (12RLN) Case Eligibility Criteria:  Adults – patients >=18 at time of diagnosis  First or only cancer diagnosis  Primary tumors of the colon and rectum  Epithelial tumors required to be staged according to the AJCC 6 th and 7 th Editions.  Solid tumors only  Invasive tumors only  No reported clinical or pathological evidence of metastatic disease  All or part of first course of treatment was performed at Moffitt Cancer Center

16. Colorectal Cancer Surveillance Measure Radiation therapy is considered or administered within 6 months (180 days) of diagnosis for patients under the age of 80 with clinical or pathologic AJCC T4N0M0 or Stage III receiving surgical resection for rectal cancer. Although this measure was not endorsed by the NQF, it is supported by the ACoC, the National Comprehensive Cancer Network (NCCN), and the American Society of Clinical Oncology (ASCO).

17. Cancer Program Practice Profile Reports (CP 3 R) The Web-based Cancer Program Practice Profile Reports (CP 3 R) offer local providers comparative information to assess adherence to and consideration of standard of care therapies for major cancers. This reporting tool provides a platform from which to promote continuous practice improvement to improve quality of patient care at the local level and also permits hospitals to compare their care for these patients relative to that of other providers. The aim is to empower clinicians, administrators, and other staff to work cooperatively and collaboratively to identify problems in practice and delivery and to implement best practices that will diminish disparities in care across CoC-accredited cancer programs.

18. The Commission on Cancer has developed a mechanism, the Rapid Quality Reporting System (RQRS), that enables accredited cancer programs to report data on patients concurrently, provide hospitals notification of treatment expectations, and show a hospital its year-to-date concordance rate relative to the state, other similar hospitals, and hospitals at the national level. RQRS Eligibility 1) Cancer program is currently CoC accredited. 2) All CoC programs wishing to participate in RQRS must have a Hospital registrar, Cancer Program Administrator, Cancer Liaison Physician and Cancer committee chair with CoC Datalinks access and up-to-date unique contact (e- mail) information. Where the CLP and the CCC are the same individual, this requirement is waived.

19. Absolute adherence to the quality measures is collected and reported without explanation for reasons for non-adherence. The threshold requirement of 90% or greater is set as the standard for quality care.

20. Quality in Cancer Care How does this approach compare to other efforts to improve the quality of cancer care? How well do these metrics actually measure quality? Will improving compliance actually improve quality?

21. Cancer Center Accreditation Centralized Gastric Cancer Treatment Treatment Guidelines Uniform Surgical Approach Process Measures for Gastric Cancer Public Reporting of Institutional Survival Outcomes Public Health Early Detection Screening Efforts U.S. XX Europe X Japan XXXXXX Korea XXX China XXX Table 2. Summary of systems-based measures to improve gastric cancer care and outcomes, as instituted by country. *Rashid OM, Prabhakaran S, Song K, Wong J. Gastric Cancer: Risk Factors, Treatment, and Clinical Outcomes. “Geographical Differences in Risk Factors, Systems, and Outcomes in Gastric Cancer.” (In Press)

22. Quality in Cancer Care A retrospective review was performed of all eligible cases of breast and colon cancer reported to the American College of Surgeons (ACS) at a single institution from 2008 – 2012. Coding for compliance was performed using the ACS Commission on Cancer standards for accountability measures for breast and colon cancer. Timing-based quality indicators for stage I-III breast cancer include radiation therapy administered within 1 year (BXT), hormonal therapy within 1 year (BHT), and adjuvant chemotherapy within 120 days of diagnosis (BAT); for stage III colon cancer, the measure is adjuvant chemotherapy within 120 days of diagnosis (CCT).

23. Breast Cancer Process Measure 312 BAT 272 Adherent40 Non-adherent 5 Lost 35 Delayed Treatment 14.8 Days DXAT 10.6 Days13.5 Days27 Days 83.7 Days DXAT 16.2 Days49.1 Days98.3 Days 1st Visit SurgeryMed Onc 1st Visit SurgeryMed Onc

24. BAT A* N=312 BAT NA* N=40 p value Diagnosis to Adjuvant Therapy65.1 ± 27.8 147.4 ± 41.3 3.7x10 -16 Diagnosis to 1 st visit14.8 ± 19.0 83.7 ± 42.1 1x10 -8 1 st visit to Surgery10.6 ± 6.3 16.2 ± 4.8 0.1 Surgery to Med/Rad Onc13.5 ± 7.3 49.1 ± 13.8 2x10 -19 Med/Rad Onc to Adjuvant Therapy27.0 ± 14.5 98.3 ± 27.5 2x10 -19

25. BAT Number of cases312 (%) Non-adherent40 (12.8) REASON FOR NON-ADHERENCEN=40 -Lost to follow up5 (12.5) -Patient refusal0 (0) -Treatment delay35 (87.5) REASON FOR DELAYN=35 --Patient choice11 (31.4) --Outside delay19 (54.3) --Diagnosis by suspicion4 (11.4) --Insurance delay1 (2.9) --Other procedure0 (0) --2 nd malignancy0 (0) --Complications0 (0)

26. Colorectal Cancer Process Measure 122 CCT 106 Adherent16 Non-adherent 2 Lost 14 Delayed Treatment 6.7 Days DX CT 10 Days36.6 Days17.9 Days 38.2 Days DX CT Surgery 35.7 Days63.2 Days24.7 Days 1st Visit Med Onc Surgery 1st Visit Med Onc

27. CCT A N=106 CCT NA N=16 p value Dx to Adjuvant Therapy 68.7±24.5159.5±512x10 -6 Dx to 1 st visit 6.7±12.238.2±30.80.005 1 st visit to Surgery 10.0±14.535.7±22.70.004 Surgery to Med Onc 36.6±11.463.2±42.70.04 Med Onc to Adjuvant Therapy 17.9±18.924.7±19.80.26

28. CCT Number of cases122 (%) Non-adherent16 (13.1) REASON FOR NON-ADHERENCEN=16 -Lost to follow up2 (12.5) -Patient refusal0 (0) -Treatment delay14 (87.5) REASON FOR DELAYN=14 --Patient choice6 (42.9) --Outside delay4 (28.6) --Diagnosis by suspicion2 (14.3) --Insurance delay1 (7.1) --Other procedure0 (0) --2 nd malignancy0 (0) --Complications1 (7.1)

29. Breast Cancer Process Measure 28.4 Days XT Surgery 12 Days37.6 Days75.3 Days 48.7 Days DXXT 15 Days142.2 Days284.4 Days 897 BXT 842 Adherent55 Non-adherent 14 Lost11 Refused 30 Delayed Treatment DX 1st Visit Rad Onc 1st Visit SurgeryRad Onc

30. BXT A* N=842 BXT NA* N=55 p value Diagnosis to Adjuvant Therapy112.9 ± 74.5 426.6 ± 166.6 2x10 -5 Diagnosis to 1 st visit28.4 ± 36.2 48.7 ± 64.7 0.03 1 st visit to Surgery12.0 ± 5.6 15.0 ± 6.1 2x10 -4 Surgery to Med/Rad Onc37.6 ± 24.8 142.2 ± 55.5 2x10 -5 Med/Rad Onc to Adjuvant Therapy75.3 ± 49.6 284.37 ± 111.1 2x10 -5

31. BXT Number of cases897 (%) Non-adherent55 (6.1) REASON FOR NON-ADHERENCEN=55 -Lost to follow up14 (25.5) -Patient refusal11 (20) -Treatment delay30 (54.5) REASON FOR DELAYN=30 --Patient choice4 (13.3) --Outside delay22 (73.3) --Diagnosis by suspicion2 (6.7) --Insurance delay1 (1.8) --Other procedure0 (0) --2 nd malignancy0 (0) --Complications1 (1.8)

32. Breast Cancer Process Measure 35.5 Days 1,349 Adherent84 Non-adherent 35 Lost 49 Delayed Treatment 1,433 BHT DXHT 12.8 Days50.4 Days100.8 Days 76.8 Days DXHT 15 Days142.0 Days283.9 Days 1st Visit SurgeryMed Onc 1st Visit SurgeryMed Onc

33. BHT A* N=1349 BHT NA* N=84 p value Diagnosis to Adjuvant Therapy198.3 ± 82.6 425.9 ± 99.1 4x10 -20 Diagnosis to 1 st visit35.5 ± 42.9 76.75 ± 81.3 9x10 -5 1 st visit to Surgery12.8 ± 5.3 15.0 ± 5.0 6x10 -5 Surgery to Med/Rad Onc50.4 ± 28.5 142.0 ± 33.0 8x10 -23 Med/Rad Onc to Adjuvant Therapy100.8 ± 56.9 283.9 ± 66.0 8x10 -23

34. BHT Number of cases1,433 (%) Non-adherent84 (5.9) REASON FOR NON-ADHERENCEN=84 -Lost to follow up35 (41.7) -Patient refusal0 (0) -Treatment delay49 (58.3) REASON FOR DELAYN=49 --Patient choice21 (42.9) --Outside delay12 (24.5) --Diagnosis by suspicion5 (10.2) --Insurance delay2 (4.1) --Other procedure1 (2) --2 nd malignancy1 (2) --Complications6 (12.2)

35. Quality in Cancer Care Our center averaged an annual compliance with the adjuvant therapy measures of approximately 90%. Larger scale studies are indicated to determine whether: refinements in coding guidelines that account for patient preferences clear diagnosis dates cross-facility care could better reflect quality of care, and also promote improved patient- centered multidisciplinary management.

36. Quality in Cancer Care

38. September, 2013: “Delivering high-quality cancer care: charting a new course for a system in crisis” Annual cost of cancer care from 2004 to 2010 increased from $72 billion to $125 billion. Recommendations: more patient centered care better coordination among disciplines mandatory national publicly reported cancer care quality program develop “meaningful quality measure for cancer care with a focus on outcome measures”

39. 1.Hewitt M, Simone JV: Ensuring quality cancer care. Washington, D.C, Institute of Medicine and National Research Council, 1999 2.Schneider EC, Epstein AM, Malin JL, et al: Developing a system to assess the quality of cancer care: ASCO's National Initiative on Cancer Care Quality. Journal of Clinical Oncology 15:2985-2991, 2004 3.Malin JL, Schneider EC, Epstein AM, et al: Results of the National Initiative for Cancer Care Quality: how can we improve the quality of cancer care in the United States? Clinical Oncology 24:626-634, 2006 4.Neuss MN, Desch CE, McNiff KK, et al: A process for measuring the quality of cancer care: the Quality Oncology Practice Initiative. Journal of Clinical Oncology 23:6233-6239, 2005. 5.Desch CE et al. American Society of Clinical Oncology/National Comprehensive Cancer Network Quality Measures. JCO, vol 26, num 21, 2008. 6. American Society of Clinical Oncology/National Comprehensive Cancer Network Quality Measures. JCO, vol 26, num 21, 2008). 7. Stewart, Andrew K., et al. "The Rapid Quality Reporting System: A new quality of care tool for CoC-accredited cancer programs." J Registry Manag 38.1 (2011): 61-63. 8. Levit, Laura, et al. "Delivering high-quality cancer care: charting a new course for a system in crisis." Institute of Medicine. Washington, DC: Institute of Medicine (2013). 9. Mariotto, A. B., K. R. Yabroff, Y. Shao, E. J. Feuer, and M. L. Brown. 2011. Projections of the cost of cancer care in the United States: 2010- 2020. Journal of the National Cancer Institute 103(2):117-128. 10.Rashid OM, Prabhakaran S, Song K, Wong J. Gastric Cancer: Risk Factors, Treatment, and Clinical Outcomes. “Geographical Differences in Risk Factors, Systems, and Outcomes in Gastric Cancer.” (In Press) References

40. Acknowledgments David Shibata, MD, FACS Chief of Colorectal Oncology Christine Laronga, MD, FACS Chair of FL ACS CoC Tom W. Ross, MS, RPh Director of quality and safety Karen A. Coyne RN, CTR, MSc Director cancer registry Angela Reagan, Coordinator, Research Program Vernon K. Sondak, MD, FACS Program Director

41. QUESTIONS ???????