Paying for Quality: Oncology Standards and Measures

2. Paying for Quality: Oncology Standards and Measures

3. Disclosure Information M. Weston Chapman, MBA Employment or Leadership Position: Creative Healthcare Kelley D. Simpson Employment or Leadership Position: Oncology Solutions, LLC, Senior Partner Consultant or Advisory Role: Oncology Solutions, LLC Stock Ownership: Oncology Solutions, LLC Please note, all disclosures are reported as submitted to the Cancer Center Business Summit and are available at cancerbusinesssummit.com.

4. Wes Chapman Practical Considerationsand Examples

5. Medical MetricsAHRQ Donabedian Framework • Structural Metrics • The capabilities of delivery organizations, their professionals and staff, and the policy environment in which health care is delivered. • Process Metrics • Assess the activities carried out by health care professionals to deliver services, often guided by evidence-based clinical guidelines. The evidence supporting guidelines varies in strength. • Outcome Metrics • Measuring health outcomes is central to assessing the quality of care, and notoriously difficult. Many "outcome measures" actually use processes of care or use of services as "proxies" for patient's health states.

6. A Parallel Universe: Oncology Professional Certifications http://www.mwestonchapman.com/a-critical-quality-consideration-which-oncology-clinical-certifications-matter/

7. Why This Matters: Today Metrics = • Translating the Triple Aim into Real World Metrics Measured in Structure,Process,Outcomes or Certifications Measured In Dollars Health Outcomes VALUE = TOTAL Actual Cost

8. Process for Metric Development – The Anna Karenina Principle – A Filter Technique • The Anna Karenina principle describes an endeavor in which a deficiency in any one of a number of factors dooms it to failure – set a filter to test your metrics, and knock out the ones that don’t make it. • Why is the metric required? E.g. regulatory, CMA, ACO, research etc. • Is it Structural (easy), Process (moderate), or Outcome (hard) • Can I use one that I’m already collecting (electronic defined field best)? • Am I collecting it consistently and reliably? • How does it fit my Balanced Scorecard or KPIs? • Is it benchmarked; to improvement or maintenance? • Is it raw data or composite (raw is best – allows control charts)? • Will it actually help me to do a better job? • Can I get it on a timely basis – am I willing to use it for a long time? • Do I know the cost of gathering & use – and is the metric worth it?

9. Three Real World Examples • Alignment Structure:Co-Management Agreement (CMA) • Bundled Payment Evaluation (part of a CMA) • Oncology ACO/Capitation

10. Co-Management Agreement (CMA) • Alignment Structure: CMA • Major Physician Group affiliated with Cancer Center • The Questions: • Are these things working?Are they getting harder over time?Are they designed to increase VALUE? • The Criteria: • Donabedian/AHRQ Model: Structural, Process, Outcome plus Work Listing & Revenue Enhancements • Purpose Metrics: Improvement Metrics vs. Maintenance • Impact Metrics: Patient Care, Difficulty (subjective scale 1-5) • Balanced Scorecard: Patient Care & Satisfaction, Internal Process, Learning & Growth, Financial • Overlap Metrics: Maintained and Measured for other purposes (e.g. QOPI)

11. Co-Management AgreementA Major Structural Rework Metrics move to Donabedian Model Major Shift to Improvement Metrics

12. Co-Management AgreementA Major Structural Rework Metrics more difficult to achieve, but much more impact on patient care Metrics much more efficient Major Improvement in Balanced Scorecard(Allows for double counting) Outcome: A much better CMA, but data gathering still late (typically end of evaluation period), painful and expensive

13. Bundled Payment • Alignment Structure: Payment in Bundles with Multiple Payers • Major Physician Group affiliated with Medical Center • The Question: • Are these things working? • Are they getting better over time? • Are they designed to increase VALUE? • The Criteria: • Correct and Timely Attribution by Diagnosis & Payer – 90+% • Correct & Timely Determination of Compliance – 80+%

14. Bundled PaymentA Real “Hair on Fire” Situation • Impossible to Verify/Validate Attribution • And, Impossible to Verify/Validate Compliance • No Audit Trail Created • Real Money on the Line • Multiple Payers • OUTCOME: • Nothing to be done. • No systems (manual or electronic). • Validation of Attribution and Compliance a prerequisite – is this situation unique?

15. Accountable Care Organization • Alignment Structure: Private Label ACO • Multiple sites intra-state: Classic ACO design; Quality Hurdles and Shared Savings Format • The Questions: • Can private label ACOs work in Oncology? • What criteria are used to pick the participants? • What metrics measure quality, what metrics measure operations? • Are they designed to increase VALUE? • The Criteria: • Donabedian/AHRQ Model: Structural, Process, Outcome plus Work Listing • Purpose Metrics: Improvement Metrics vs. Maintenance • Balanced Scorecard: Patient Care & Satisfaction, Internal Process, Learning & Growth, Financial • Overlap Metrics: Maintained and Measured for other purposes (e.g. QOPI)

16. Accountable Care Organization • Key Considerationsfor Selection: • Oncology Professional Certifications (see slide 4) • Most Expensive • Willingness to Innovate (no risk taking) • Original only contained 7 data points – Insufficient to Operate Efficiently • Retrospective data analysis and savings determination

17. Accountable Care OrganizationA Major Metric Rework Proposed Metrics more difficult to achieve, but much more impact on patient care Sufficient Metrics to evaluate key processes Major Improvement in Balanced Scorecard improves operations Outcome:A much better ACO, but data gathering still late, painful and expensive

18. Accountable Care OrganizationA Major Metric Rework Proposed

19. Real World Considerations • Electronic data is widely available …but very difficult to source efficiently • Big data has great promise but severe limitations • Existing personnel overloaded • Normal chart review won’t work • Should we be considering Business ProcessOutsourcing (BPO)?

20. Kelley D. Simpson Real-Time Examples

21. A Range of MetricsBeing Utilized at Varying Levels • Generally, metrics are developed in a few categories • Typically, 3 to 5 indicators are measured in each category • Clinical quality care indicators • Program development indicators • Patient satisfaction indicators • Clinical research • Community outreach • Marketing • Most metrics are process improvement in nature • Metrics are normally reviewed annually and adjusted and/or new metrics are defined for the next year Hospital and physicians do not clearly define the end goal and timing for each metric Immature data capture and ongoing management processes; Cumbersome, often staff intensive and varied system integration No metric ranking methodology exists Expectations of the parties are not fully understood COMMONPITFALLS

22. Sample Metrics: CLINICAL QUALITY #1

23. Sample Metrics: CLINICAL QUALITY #2a

24. Sample Metrics: CLINICAL QUALITY #2a

25. Sample Metrics:PROGRAM DEVELOPMENT & PATIENT SATISFACTION Program Development Patient Satisfaction

26. SAMPLE Measurement Ranking Method • Each category ranked to ensure factors directly controlled by the Physicians receive the most weight. Likewise, the factors that may be impacted by other individuals and circumstances would be weighted less. • Physician must satisfy a minimum percentage of the quality indicators. • Clinical Quality Care Indicators are ranked at 40% • Program Development is ranked at 30% • Satisfaction Measures are ranked at 30% • Physicians must satisfy a minimum of 50% percent of the quality indicators to qualify for any work related RVU payments associated with the quality measures. • Hospital responsible for bonus payments on a group basis; Physicians then have the opportunity to allocate the payments based on an individual performance basis. • Graduated scale delineates the percentage of quality measures that need to be met in order to achieve desired bonus payments. Please note that if less than 50% of the quality measures are met, Physicians will not receive a bonus payment for the period.

27. SAMPLE Measures, Ranking and Payment Methodology

28. SAMPLE Measures, Ranking and Payment Methodology (cont’d)

29. Clinical and Quality Program Development

30. Kathy Lokay President and CEO D3 Oncology Solutions

31. Disclosure • Employment: D3 Oncology Solutions whose products include the Via Pathways

32. VALUE • Outcomes divided by Cost • Value increases: • If outcomes increase and cost stays the same • If costs decrease but outcomes stay the same • Supercharged: If costs decrease and outcomes increase!

33. OUTCOMES • What “outcomes” are important in oncology? • Survival? PFS, DFS, RR, etc.? • Quality of Life • Free of symptoms • Free of distress • Fewer hospitalizations/ED visits • Adherence to evidence based medicine?

34. COSTS • What are “costs” in oncology? • Cost to payer? • Cost to employer? • Cost to patient? • Copays, coinsurance • Tiered for site of service or category of service • Cost to practice? • Internal costs? Staffing, drugs, equipment • Margins? • Cost to society? • Missed work

35. VALUE • Value is a complex set of inputs that vary by the affected stakeholder • If everyone agreed on VALUE, it would be easier to make decisions on where to spend our dollars in oncology!

36. UK’s NICE System* • Public body of the Department of Health that advises the NIH on coverage policies • Invert the VALUE equation to Cost / Outcome • Outcome is Quality Adjusted Life Year (QALY)* • Decisions on the “value” of a drug are made in terms of whether it has a Cost / QALY of less than £30,000 compared to the best existing therapy* • This is allowed to increase for end of life cancer drugs* • Lenalidomide was first to be approved at £43,800* *http://en.wikipedia.org/wiki/National_Institute_for_Health_and_Care_Excellence

37. Example: • Existing Drug A • $2,000 per month for 4 months • 48 months of OS benefit • New Drug B • $10,000 per month for 4 months • 52 months of OS benefit • Incremental VALUE: • $8,000 per month for 4 months or $32,000 per year • 4 months of OS • Cost per QALY of $96,000 or £59,000 • Wouldn’t be approved in the UK unless Pharma dropped the price to $5,900/month • Today, it would get approved and paid at $8,000/mo in the US!

38. Are we headed to the NICE model? • Probably not at a government level • Very difficult societal decisions would have to be made • Value of a year of life of a US citizen • Will we still be forced to address value in some other way? • Absolutely: our cost problem isn’t going away. • Rationing will occur in other forms • Benefit design on coinsurance • Network tiering • Increasing prior auth’s • Risk or Gain Share Contracting • ACCOUNTABLE CARE ORGANIZATIONS

39. Why do we need to measure quality/outcomes in oncology? • To make sure that patients are getting the best care for them • Maximize survival • Minimize side effects • Minimize distress • To help patients avoid care they don’t need (ineffective technologies, hospitalizations, etc.) • Ensure that care is not withheld or “skimped” when new incentives are in place (gain share, case rates, capitation)

40. Where are today’s oncology quality measures getting it right? • We are definitely off to a good start… • Most national measures are appropriately focused on: • Staging within 30 days of first office visit • Pain and other symptom management • End of life metrics (treatment intent, hospice use, chemo in last 14 days, etc.) • Post surgical adjuvant chemo (although never specified) • Appropriate use of WELL ESTABLISHED therapies and biomarkers (tamoxifen for ER/PR +, traztuzamabfor Her2+, Anti-EGFR MoAb therapy for KRAS wild type)

41. Where do today’s oncology quality measures fall short? • Don’t measure the outcome patients really care about • Will I live longer than if I were treated by someone else? • THIS IS THE HARDEST ONE OF ALL – we may never get to this one! • Don’t measure hospitalization and ED visit rates • Often, THESE DATA MUST COME FROM YOUR PAYERS, not from patient charts • Don’t measure adherence to many aspects of evidence based care, especially for newer drugs and diagnostics • WE CAN SOLVE FOR THIS ONE! GUIDELINES AND PATHWAYS!

42. Pace of change in oncology is very high • 12 new drugs or expanded indications of existing drugs approved year to date in 2013* • None of these are reflected in any national quality measures • 13 new drugs and 10 expanded indications of existing drugs approved in 2012* • None of these are reflected in any national quality measures *http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm279174.htm

43. National Quality Measures are and will always be missing: • Key evidence based medicine standards in less common diseases • Newly published data

44. Guidelines vs. Pathways • “Guidelines”: • Range of acceptable evidence based approaches to care • Typically updated at least annually • “Pathways”: • Prioritization of a small number of evidence based options that have the highest VALUE that can be standardized and applied to most patients (80%?) • Typically updated quarterly Guidelines Pathways

45. Pathways: Just Drugs?

46. How is VALUE prioritized in a Pathways program? • Today: • Not as a ratio between cost and outcome • We’re not ready for the NICE model in the US… • Instead: • First based on OUTCOME only: • If A > B for efficacy • If A = B for efficacy, then toxicity • Cost is only incorporated if A=B for efficacy and toxicity • Future: • Asking Disease Committees to provide secondary options for patients who are unable to afford the primary pathway option • Recommendation would be another regimen with slightly less efficacy but with a much lower cost

47. How do pathways increase VALUE? • Increases the numerator (Outcomes) • Highest efficacy • Lowest Toxicities • Fewer ED visits and hospitalizations • Decreases the denominator (Cost) • When regimens are comparable for efficacy and toxicity • Fewer hospitalizations (due to lower toxicity regimens or less futile care) • Avoids giving high cost treatments where benefit is unproven • Strives to ensure: • Patients always get the best evidence based care • Care is standardized 80% of the time • Fewer dosing/mixing errors • Better teaching and anticipation of toxicities • Ability to measure outcomes

48. Pathways vs. National Quality Measures • Not either/or • They are complementary / additive • Quality measures allow for broad based comparison to other cancer centers for: • Critical process measures • Adherence to well established care guidelines • Clinical pathways measure adherence to • Evidence based medicine that is: • Standardized to those with the highest value • Up to date based on new science • Narrowed to promote use of the highest value options in 80% of patients

49. Pathways AND National Quality Measures • Single set across the practice for ALL payers, ALL patients • Need standardization for: • Ethical reasons • Logistical / workflow reasons • Cost reasons • Different measures for each payer? • Different pathways rules and portals for each payer? • Practice Differentiation with Referring Physicians • Taking RISK or GAIN SHARING

50. Our Appeal to Payers… • Allow practices to improve the care of your members through lean methods of standardization of quality and EBM • Don’t ask practices to track a unique set of quality measures just for your members • Allow them to utilize the national measures they collect for all their patients • For practices who adopt a credible set of clinical pathways and can demonstrate high adherence, remove prior authorization process requirements (or collaborate to automate PA’s) and incent savings • Reasonable to still expect: • Secure transmissions of Treatment Plan and key clinical information • Transparency into their pathways process and content • Monthly reporting of key pathways metrics • Not reasonable to expect them to adopt different pathways for your members… • Save both sides money and hassle!