Comparative Effectiveness and the United States Healthcare System: Success, Failure and Politics

Transcription

1 Comparative Effectiveness and the United States Healthcare System: Success, Failure and Politics Michael C. Stoner, MD Division of Vascular Surgery

2 What is CER? CER is the conduct of systematic research comparing different strategies Wide array of methodologies Decisions and global outcomes Quality and efficiency gaps CER stakeholders Patients, providers, payors and decisionmakers

3 CER Framework Provide real-world patient centric outcomes Actual practice diverges from classic RCTs, but not exclusive of RCTs CER methodology can fill in holes between RCTs Cost-efficacy Objective basis for healthcare reform issues Identify waste and regionalization

4 Knowledge gap

5 Heterogeneous care Local-regional centers of excellence Access to vascular surgeons Supply-sensitive care Some preference-sensitive care Care variation leads to: Inefficiency Waste Inferior outcomes

6 CMS Trust Fund

7 Vascular Surgery $151b spent on non-cardiac vascular diagnoses Direct and indirect costs Rapid expansion of expensive devices Certainly you don t want to wait for the data Vascular surgeons uniquely positioned to offer all possible treatments

8 CER and Vascular Diseases Healthcare reform Cost containment Patient optimization Case selection Improved clinical outcomes Lower resource utilization $1.2b spent on AAA

9 RCT RCTs cleanest data, high internal validity Needs external validity Classic pharma RCT: agent v. placebo Efficacy, not comparative effectiveness Frustration on scalability of RCT results to real-world Limited follow-up time

10 RCTs and External Validity HTN population in primary care practice Chronic health conditions would exclude 50% from RCTs Benoxaprophen NSAID trial Eli Lilly FDA approval based on large age-range population Severe side effects in elderly patients Pulled from market Fortin M. Ann Fam Med 2006

11 Observational trials Selection and practice bias can led to internal validity issues Single or small number of institutions may not scale to real-world practice Failures observational trials tested by RCT: Anti-arrhythmic drugs for SCD High-dose CTx/ BMT for breast CA

12 CER Success in Vascular Surgery Established role for carotid revascularization NASCET / ACAS trials High internal and external validity Sub-group analyses Mode of revascularization CREST trial Largely complementary treatment strategies Define optimal treatment, complications

13 Data Void in Vascular Surgery Explosion of new catheter-based devices Industry-sponsored trials Lesion-based endpoints May not scale to re-world practice Often with historical controls Restricted study populations i.e. LACI trial and ESRD

14 Laser in the real-world Laser atherctomy Updated technology with big promises LACI trial: 92% success 1.0 All Primary revascularization % Time (months) Stoner MC. J Vasc Surg 2007

15 Critical Limb Ischemia Complex disease process Heterogeneous patient population ESRD v. DM treat the same? Anatomic distribution of disease Role of non-vascular adjuncts At-risk population Ideal disease state for CER-based research

16 CLI revascularization model Critical Limb Ischemia Bypass Endovascular Healing Amputation

17 The re-intervention issue Misalignment between provider (fee-forservice) and cost-efficacy Pay for frequency of care, not effective care Outpatient atherectomy charges Patient-centric CER can help define optimal cost-efficacy pathways Need to track outcomes patients care about Amputation, number of office visits, independence

18 Amortized cost model Cost(t) = cost per day of patency Summation of all costs t = time in days Failed patency (t = pa) Cost/day of patency static

19 Cost of patency ($/patient-day) Cost model $12,366 ± 496 $7,540 ± Time (days) $335 ± 150 $226 ± 85 Open Endovascular

20 IOM CE Priorities

21 Cost-efficacy review Partnership with Mayo Clinic Review of cost-efficacy literature Claudication Exercise, endovascular, bypass CLI Endovascular and bypass 1, studies

22 Recovery Act 2009: $1.1b for CER

23 Response to AHRQ Multi-center claudication grant: COMPARE-IC Re-world observational component Medical optimization Supervised exercise Endovascular Surgical bypass Concurrent longitudinal Medicare study Endorsed by SVS, SVM, PAD coalition

24 Key Points: Observational Cohort Observational, non-randomized Real-world outcomes Regionalization Ethnic and socioeconomic profile Will fund supervised exercise Patient-centric measures and outcomes Traditional surgical metrics are secondary

25 Study Sites 13 study sites, aggregate 4,590 IC patients / yr Regional, ethnic and socioeconomic diversity

26 COMPARE-IC Hypothesis Many patients fail to experience meaningful benefit from invasive treatments for IC Baseline variables (age, comorbidities, functional status, anatomy) can discriminate these patients More selective therapy will yield better results and more effective healthcare delivery

27 Patient-centric IC Model #1

28 Patient-centric IC Model #2

29 Observational Cohort Eligible pt. seen in clinic Screening Visit - Consent Pre-Treatment Baseline Visit Refusals/Exclusions (complete screening form) Medical Therapy Medical Therapy & Standardized Exercise Medical Therapy & Endovascular Treatment Medical Therapy & Surgical Treatment Exercise Initiation Visit Revascularization Visit Revascularization Visit Standardized Exercise x 6 Mo. No Study Termination F/U Visits (every 6 Mo. up to 24 Mo.) New Treatment Assignment before 24 Mo. of F/U Were there 2 revascularizations or 3 separate treatment assignments since enrollment? Yes

30 Outcome Model

31 Healthcare Finances PROFIT MARGIN CONTRIBUTION MARGIN Indirect Cost Direct Cost Reimbursement

32 Value Construct

33 Example Patient A Patient B Length of Stay (d) 1 5 Complication freedom (d) 30 4 Modified CCI 4 5 Total Charges ($K) Contribution Margin ($K) Hospital Value ($/d) -2.7K 1K Patient Value (d/$10k)

34 30000 Value Relationship: Open Current Reimbursement Hospital Value ($/day) K Base Patient Value (day/$)

35 30000 Value Relationship: Open Current Reimbursement Hospital Value ($/day) K Base Patient Value (day/$)

36 CER Politics Affordable Care Act signed into law March 2010 Debate over the role of CER Government rationing?

37 2007 Legislative Debate Democratic legislature Renewed interest in healthcare reform Initial debate over makeup of CER institure Funding Impact on Medicare coverage Parent agency or non-government alignment

38 S 3408 Introduced concept of publicprivate entity Health Care Comparative Effectiveness Research Institute Part of CHIP reauthorization bill, ultimately dropped Influenced presidential debate and eventual healthcare act Max Baucus Kent Conrad

39 2008 CER Looks Bipartisan one of the keys to eliminating waste and missed opportunities an independent institute to guide reviews and research on comparative effectiveness We must make public more information on treatment options and doctors records, and require transparency regarding medical outcomes, quality of care, costs and prices.

40 Post-election Congress Republicans distanced themselves from CER Raised concerns of healthcare rationing Death Panel Comparison to UK NICE system S 1679 Edward Kennedy s AHRQ-based CE institute Multiple Republican amendments made through HELP committee

41 2009 PCORI and Mammograms Senate Finance Committee introduces Patient- Centered Outcomes Research Institute Republicans introduced funding restrictions and limits to Institute (coverage, costefficacy) US Preventative Services Task Force no mammograms for low risk < 50 yro Public outcry over rationing

42 2010 and Scott Brown Scott Brown (R-Massachusetts) takes Kennedy s seat Effectively kills H.R. government-housed CE institute PCORI makes its way into healthcare act Secondary role for AHRQ and NIH heads Prohibited from $/QUALY studies Emphasis on training and award money

43 PCORI and CER Today $1.1b for CER funding through AHRQ PCORI private, non-profit 503c1 corporation Diverse board of governors Establish priorities with emphasis on healthcare delivery, disparities and chronic disease Diverse stakeholders input and utilize the data Strong bias for patient-centric process

44 CER versus Personalized Medicine Promise of biomedical research Genomic-level patient-centric care Represents the rationing debate CER and average response Worry that individual patients will wash out Appropriate heterogeneous observational studies and RCTs make these complementary

45 Further Reading Academic Medicine June 2011 Health Affairs October 2010 CBO Report December 2007 SVS CER Statement JVS 2009

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