Perspectives on Medical Treatment and Disability Guidelines: How Do They Improve Functional Outcomes?

1. Perspectives on Medical Treatment and Disability Guidelines: How Do They Improve Functional Outcomes? David C. Deitz, MD, PhD National Medical Director, Commercial Market Claims Liberty Mutual Group LWCC October 14, 2011

2. Themes for this talk • General review of guidelines and workers compensation • Do guidelines work? • Guidelines in the context of good medicine • Questions

3. A few key premises • Guidelines are not going to disappear • They are going to continue to be involved in healthcare payment decisions for the foreseeable future • They are widespread and fairly well understood by both medical professionals and the public

4. WC Medical Care • Medical costs now comprise 59% of WC losses (NCCI, 2010). • WC medical inflation is higher than the CPI and the group health inflation rate • Remains heavily driven by musculoskeletal care • Costs continue to increase despite 10 year trend towards decreasing fatalities and decreasing severity of workplace injury (BLS data) • Disability durations have not improved • WC has become very different from group health

5. Potential Uses of Guidelines • Precertification (traditional UM) • Concurrent review • Retrospective Review • Physician profiling (network management) • Quality assessment/improvement

6. Types of Guidelines • Appropriateness of care – typically, applied to procedure or service-based care such as PT • Setting of care – Inpt, Outpt, Office, etc • Duration of care – Inpt LOS, Disability • Misc – Assistant surgeon, rehab, etc.

7. Guidelines – Why? • Meet statutory requirements to precertify certain categories of treatment, e.g., surgery • Intervene in ongoing care which is excessive or inappropriate • Make payment decisions for care that has already occurred • Evaluate duration of disability • Make judgments concerning quality

8. What are Evidence-Based Practice Guidelines? • Two components • Systematic reviews • Evidence search • Study analysis, grading, synopsis • Summaries • Use of systematic reviews to formulate usable recommendations for patient care • Includes formulation of strategies and tactics to ensure consistent use of proven medical practices

9. Refresher: Evidence Based Medicine “…the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. …means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” Sackett D.L et al. BMJ ’96 312:71-80

10. EBM - Why Is This Part of It? • Goal is, when possible, to use EBM as the foundation for clinical practice guidelines (CPGs) • All CPGs are NOT evidence-based • Can be data driven or consensus based • Sometimes the quality of the evidence is not adequate • When this is the case, the default position is to use the best available evidence • All guidelines in use rely on expert consensus in these situations

11. Treatment Guidelines Used in Worker’s Compensation • American College of Occupational and Environmental Medicine (ACOEM) • Work Loss Data Institute ODG Treatment • Colorado DWC Medical Treatment Guidelines • State-developed or modified from one or more of the above • Nothing (32 states)

12. Disability Guidelines • Medical Disability Advisor (Presley-Reed) • Official Disability Guidelines (WorkLoss Data Institute) These provide guidance on expected duration of impairment and RTW following common injuries, but are not treatment guidelines

13. Guidelines – Discussion Issues • Why do we need guidelines? • Why can’t we just do this with networks? • Shouldn’t we use guidelines developed by the specialty involved with the care? • If guidelines disagree, how can any of them be valid?

14. Why do payers need guidelines? • No uniformity in medical practice - many interventions proposed w/o evidence, but at increasing expense to system. • Employers are held accountable for payment, but w/o guidelines there is no provider accountability other than professional ethics. • Predictability in payment simplifies system for all stakeholders – in our current healthcare model, bill adjudication is critical. (there are other models) • Give me a viable alternative

15. Why can’t we just do this with networks? • Faulty assumption – that poor quality or inefficient care is always isolated to a few providers (“bad apples”1) – although this may be useful in some situations, like narcotics • Insufficient data to profile specialty care effectively • Small demonstrations show effectiveness (Louisiana!2) but scalability has yet to be proven 1-NEJM 1989; 320: 53-56. 2-JOEM 2006; 48(9):873-882

16. Shouldn’t we use specialty guidelines? • Not necessarily • While stakeholder buy-in is valuable, no data indicate that specialty guidelines developed in absence of data are any more effective in promoting better care that other guidelines • Redefinition of evidence is often tailored to needs of the specialty

17. When guidelines disagree.... • Guidelines rarely disagree when evidence is available. • Points of divergence are always emphasized by guideline opponents (the glass is never 9/10 full) • Back care guidelines developed in Europe, Australia, NZ and the US are in substantial agreement • ACOEM, ODG and Colorado are all in substantial agreement in treatment of most common workplace injuries, including uncomplicated low back pain

18. The real problems • Over-emphasis on the lack of evidence issue • Dissemination of evidence/best practices • Provider passive-aggressiveness regarding guidelines (sometimes not so passive), which leads to.... • Poor compliance with best practices, which leads to... • Deficient quality of care

19. The lack of evidence “problem” • A perpetual straw man. There will never be enough. • It gets better and better each year • The dissemination and compliance problems are much bigger • Lack of evidence is a poor rationale for including WC patients in unproven or experimental treatments – and there is evidence for that. WC patients have consistently worse outcomes than group health patients across a spectrum of procedures (Harris I et. al. 2005; JAMA 293: 1644-52)

20. The dissemination problem • Long cycle between evidence for a best practice and actual adoption of that practice in provider community • Examples abound in spine care: • Lack of activity prescription for acute low back pain. Rest, including bed rest, has been shown to be detrimental, but still prescribed • Narcotic use for acute LBP See Crossing the Quality Chasm, IOM 2001

21. The Compliance Problem • Providers don’t like guidelines • Providers don’t follow guidelines • “Physicians viewed guidelines as providing helpful information, but constraining their practice and not helpful in making decisions for individual patients.” * • Providers consistently overestimate their compliance with best practices • But.... *Tierney WM, et al, J Gen Intern Med 2003; 18:967–976

22. Guidelines Can Improve Outcomes • Adherence to CHF best practices led to lower admission rates for CHF1 • Better guideline compliance associated with lower mortality for community-acquired pneumonia2 • Meta-analysis: activity prescription for chronic low back pain led to better outcomes3 • And... 1 – Komajda et al. Eur Heart J 2005; 26: 1653-59 2 – Menendez et al Amer J Resp Crit Care Med 2005;172:757-762 3 – Liddle et al Pain 2004; 107: 176-190

23. So, Do Guidelines Work?

24. State Experiences with WC Medical Treatment Guidelines

25. Colorado • Colorado guidelines have reduced losses and cut premiums for employers • Viewed favorably by most physicians, which has fostered adoption by other states • Dispute resolution is efficient and timely • Quality has not been formally studied

26. California • 2004 reforms included implementation of ACOEM guidelines. Substantial lowering in treatment costs seen for next 2 years • Modifications to guidelines have weakened effectiveness. • CWCI analysis of impacts concluded no adverse effects to injured workers w/ significant cost saving.

27. Texas • Data from WCRI indicate reductions in physical medicine with implementation of ODG guidelines • No clear evidence on outcomes

28. Other states • New York – effectiveness unclear. Implementation slowed by adjudication process • Washington – monopolistic state fund, guidelines very effective w/in that context • Massachusetts – not evidence-based guidelines, minimal impact

29. What happens when best practices are not followed? • Many poor outcomes in WC are associated with care that is not recommended by any guideline • A few examples……

30. Narcotics Prescribing: Proven Detrimental Effects on WC Claims

31. Opioids and Workers Compensation Outcomes “Those who received more than 450 mg MEA were, on average, disabled 69 days longer than those who received no early opioids…” (Webster et al, Spine 2007) “For the small group of workers with compensable back injuries who receive opioids longer-term (111/1843, 6%), opioid doses increase substantially and only a minority shows clinically important improvement in pain and function. The amount of prescribed opioid received early after injury strongly predicts long-term use.”(Franklin et al, Clin J Pain 2009) “Average claim costs of workers receiving seven or more opioid prescriptions were three times more expensive than those of workers who receive zero or one opioid prescription, and these workers were 2.7 times more likely to be off work and had 4.7 times as many days off work.” (Swedlow et al CWCI Special Report 2008) 31

32. Guidelines Are Not the Answer Helpful? Important? Yes, but there needs to be more

33. The Key Questions • Are medical outcomes for injured workers as good as they could be? • How can we improve medical care, treatment outcomes and disability in WC?

34. Overall US health status • We’re reasonably healthy from a world perspective • Along with W Europe, we have an epidemic of disability • Costs are high for what we get, and rising • We don’t get great value for our investment

35. 35 Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2008 Dimensions of a High Performance Health System: the US Scorecard !!!

36. What does all this add up to? • The most expensive healthcare system in the world • Mediocre quality for the expense • Lots of access problems • An epidemic of disability • A drag on economic productivity

37. Quality of Care for WC • There is minimal industry or regulatory focus on this issue • Duration of care for WC injuries may extend for years, or life. • Many studies show treatment outcomes are worse in WC patients c/w group health • Few state systems collecting medical/disability outcomes data, fewer have analyzed in detail • Outcomes following administrative/judicial proceedings not tracked at all • Most studies of QOC have indicated that better care is cost-beneficial or at worst, cost neutral

38. Value Equation Quality Cost Value =

39. Value Equation in Healthcare Quality (Health Outcomes) Cost Value =

40. So, where do guidelines fit in? • Provide a best-practice standard • Allow opportunities for practice improvement • Allow benchmarking for system performance • There’s no improvement without a goal

41. LM experience – Low Back Injuries • Largest lost time category • Majority involve <7 days disability, but • Small proportion (<5%) accounts for >30% of costs • Significant # of treatments and practices with no evidentiary support • Passive treatment modalities for > 2 weeks • 20% MRI's requested w/in 4 weeks of injury (major trauma excluded • >15,000 requests for mechanical traction

42. There are unique challenges to improving outcomes in WC • Multiple clinical standards across states • War on evidence • Healthcare information systems worse than group health • Conflicts of interest

43. The Healthcare Industry • 17% of GNP – and a big employer • Increasing entanglement of physicians and hospitals with medical-industrial complex • Very limited oversight • Financial rewards very large

44. J Am Acad Orthop Surg 2009;17:102-111 Dr. ______ serves as a board member, owner, officer, or committee member for the American Spinal Injury Association, North American Spine Society, AO North America, Computational Biodynamics, Progressive Spinal Technology, and Applied Spinal Technology; is a member of a speakers bureau or has made paid presentations on behalf of Stryker, Medtronic Sofamor Danek, and DePuy; is a paid consultant for Biomet, DePuy, Medtronic Sofamor Danek, Orthofix, Stryker, Thieme, and Vertilink; has received research or institutional support from AO North America, DePuy, Medtronic Sofamor Danek, and Stryker; has received royalties from Aesculap/B. Braun, Biomet, DePuy, Globus Medical, Lippincott, Medtronic Sofamor Danek, Stryker, Thieme, and K2 Spine; has stock or stock options in Globus Medical, Disc Motion Technology, Zygoloc, Vertebron, Progressive Spinal Technologies, Computational Biodynamics, Stout Medical, Paradigm Spine, K-2 Medical, Replication Medica, Spinology, Osteotech, Applied Spinal Technology, Spine Medica, Orthovita, Vertilink, Small Bone Technologies, NeuCore, Crosscurrent, Syndicom, In Vivo, Flagship Surgical, and Pearl Driver; and has or has not received financial or material support from the medical or orthopaedic publications Spine and Journal of Neurosurgery Spine.

45. ISSUE: MARCH 2009  |  VOLUME: 35:3 Routine Audit Uncovered Reuben FraudMissing IRB Info Led To Discovery of Fabricated DataAdam Marcus • Prominent pain researcher at Univ Massachusetts/Baystate Med Ctr • 21 studies to be retracted • Most involved analgesics and their use in common procedures, including shoulder and spine surgery • Some studies were used to lobby FDA regarding potential agency actions http://www.anesthesiologynews.com/index.asp?section_id=3&show=dept&ses=ogst&issue_id=494&article_id=12641

46. But there’s oversight, right?

47. THE FOOD AND DRUG ADMINISTRATION’S OVERSIGHT OF CLINICAL INVESTIGATORS’ FINANCIAL INFORMATION January 2009 • FINDINGS • One percent of clinical investigators disclosed a financial interest. • FDA cannot determine whether sponsors have submitted financial information for all clinical investigators. • Forty-two percent of FDA-approved marketing applications were missing financial information. • FDA did not document a review of any financial information for 31 percent of marketing applications. • Neither FDA nor sponsors took action for 20 percent of marketing applications with disclosed financial interests. OEI-05-07-00730; http://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf

48. Researchers Go Unchecked, Report Says By GARDINER HARRIS PUBLISHED: JANUARY 19, 2008 WASHINGTON — The National Institutes of Health do almost nothing to monitor the financial conflicts of university professors to whom it provides grants, a government report found, and the huge federal research agency does not want to start now. ….. “For us to try to manage directly the conflict-of-interest of an N.I.H. investigator would be not only inappropriate but pretty much impossible,” said Dr. Norka Ruiz Bravo, the institutes’ deputy director for extramural research. (emphasis added)

49. Conflict of Interest “Every dollar of waste, fraud, and abuse is a dollar of income to someone in the system.” - Victor Fuchs, Stanford Univ. JAMA. 2009;301(9):963-964

50. Ask the Critics • Are they trying to improve care? Is there evidence for better outcomes for patients using (or not using) clinical practices they suggest? • What kinds of conflicts of interest exist?