1. Lumbar fusion -Bree Collaborative- 1/30/2012 Gary M Franklin, MD, MPH More specific potential actions:  Refer fusion back to WA HTA program for more comprehensive lit review and decision  Support mandatory participation in a comparative effectiveness study of lumbar fusion  Support requiring mandatory hospital participation in Spine Certn/Spine Scope QI effort as a condition of payment  Adopt restrictive BCBSNC policy (could not do this now, in face of WA HTA decision)

2. Fusion Concerns – Concern relates to subset of patients with chronic low back pain (LBP) Spinal fusion covered and not at issue for traumatic injuries, patients with significant instability, congenital defects, neurological issues Fusion surgery outcomes, especially in workers comp. are poor – This patient subset suffers substantial and chronic pain that can be disabling and interferes with life function. There is no gold standard treatment that is curative. Some patients get better with no treatment while others experience temporary or sustained pain reduction or relief from: Medication Physical rehabilitation/care (exercise, rehabilitation, chiropractic, acupuncture) Mental care (education, cognitive behavioral therapy) Surgery followed by rehabilitation – Surgical premise for fusion is that disc degeneration causes pain that can be reduced/eliminated by immobilizing disc(s) – Question whether the surgery is effective (any improvement, incremental improvement, or full resolution) Is effect attributable as much to placebo or the rehabilitative component – Question whether/ when the invasive procedure with attendant significant risk compared with non-surgical alternatives is appropriate Re-operation and surgical complication rates are very high If appropriate, when or who in the LBP group benefit

3. DLI Fusion Guideline -Last updated 2001- Mandatory prior authorization Approval for fusion only if a)measurable instability present and/or b)objective evidence of neurological impairment associated with DDD/bony deformity and/or (since Dec 2009) c) DDD and failed structured, intensive multidisciplinary program (SIMP)

4. Rates of Four Orthopedic Procedures Among Medicare Enrollees, 2002 and 2003 Source: Dartmouth Atlas of Health Care. Standardized Discharge Ratio (Log scale) Source: Dartmouth Atlas Project. Hip Fracture (14.3) Knee Replacement (53.6) Hip Replacement (69.5) Back Surgery (103.8) 0.3 1.0 3.0

5. What is the evidence that fusion improves outcomes? Four randomized controlled clinical trials since 2001(highest level of evidence) Fritzell et al, 2001, Spine 26: 2521-32. Compared to unstructured conservative Rx (PT), fusion paients sign better on pain (but deteriorated after 6 months), function (Oswestry, Million), and RTW; early complications in 17% Kwon et al, 2006, Spine 31: 245-9. Critique of methodology of Fritzell study

6. 3 RCCTs with no evidence of efficacy Brox et al, 2003; Spine 28: 1913-21. Fusion (and PT) vs structured rehab (education, exercize sessions);pain, function (Oswestry) no different at 1 yr; early surgical complictions 18% Fairbank et al, 2005; BMJ 330: 1233-40. Fusion vs intensive cognitive rehab; Oswestry marginally better at 2 years but walking test and SF- 36 no better; 17% with complications or more surgery

7. 3 RCCTs with no evidence of efficacy Brox et al, 2006; Pain 122: 145-155. Fusion vs structured rehab(education, exercize); Oswestry no better at 1 yr

8. WA HTA decisions 2/15/2008-Fusion for DDD covered if structured, intensive, multidisciplinary program (SIMP) not available, or if SIMP fails 8/15/2008-discography for DDD not covered

9. Blue Cross/Blue Shield North Carolina 1/20/11 When lumbar spine fusion surgery is not covered – Meets an included condition (eg, fracture, stenosis with neuro compromise) – Not medically necessary if sole condition is any one or more of the following: Disc herniation Degenerative disc disease Initial diskectomy/laminectomy for neural structure decompression Facet syndrome

10. Compensation status relates to poor outcomes from most procedures Harris I, et al. Association between compensation status and outcome after surgery: A meta-analysis. JAMA 2005; 293: 1644-52. Lumbar fusion: 19 studies; odds ratio of worse outcome for fusion among compensation patients: 4.33 (95% CI: 2.81-6.62)

11. Recent DLI case Initial injury 7/5/99- L3, L4, L5 laminectomy/foraminotomy; RTW as trucker; Cat 3 PPD Injury 1/7/01 – 9/25/01- L5-S1 anterior lumbar interbody fusion with BAK cages – 11/2/01-fusion revision requested – 8/13/03- laminectomy redo L4,5,S1; L5-S1 instrumented fusion based on ? Pseudoarthrosis – CAT 4 PPD (fusions + S1 radiculopathy) – 12/16/03-RTW trucking  Injury 6/28/08  6/24/09- Removal L5-S1 hardware; exploration, decompression L4-S1  10/12/11-L4,L5 laminectomy, Pedicle screw, transforaminal interbody fusion L4-5; intertransverse fusion L4-5 (Paid by another party since denied by Dept)

12. Washington State WC Outcomes Franklin et al, 1994; Spine 20: 1897-903 N= 388 from 1986-87 68% TTD at 2 years; 23% more surgery by 2 yrs Instrumentation doubled risk of reoperation Surgical experience didn’t matter Key-WC fusion outcomes far worse than previously reported from surgical case series

13. 1992-DLI Lumbar fusion guideline No prior surgery -measurable instability on flexion/extension xrays -Spondylolisthesis with measurable instability OR neurologic signs/symptoms -only single level fusion

14. Lumbar Fusion Policy Translation 1992: tightened lumbar fusion guideline to include measurable instability; exclude pure “discogenic” back pain; exclude cases of acute disc herniation Adapted from Elam et al. Medical Care 1997;35:417-424

15. Lumbar Fusion-Effect of Rapid Diffusion of New Technology Adapted from Franklin et al. Am J Man Care 1998;4:SP178-SP186

16. Washington State WC Outcomes Juratli et al, 2006; Spine 31:2715–23. 1950 fusion subjects from 1994-2000 85% received cages and/or instrumentation 64% disabled at 2 yrs; 22% reoperated by 2 yrs + 12% other complications Cage/instrumentation use increased complications without improving disability or reoperation rate

17. Juratli et al, Mortality (WC)after Lumbar Fusion Surgery, Spine 2009; 34: 740-47 N=2378 fusions between 1994-2001 Death records-103 deceased by 1994 90 day perioperative mortality 0.29%-assoc with repeat fusion Age and gender adjusted all cause mortality 3.1 deaths/1000 worker yrs Opioid-related deaths 21% of deaths and 31.4% of potential life lost Risk > with instrumentation/cages and DDD

18. Martin BI et al, in preparation, 2012

19. Most recent DLI paid fusion #’s  2000-406  2001-418  2002-447  2003-418  2004-412  2005-366  2006-381  2007-341  2008-345  2009-412  2010-410  2011-369 (incomplete) WA HTA decision implemented 12/2009

20. Why Spine SCOAP? Martin BI, Mirza SK, Flum DR, Wickizer TM, Heagerty PJ, Lenkoski AF, Deyo RA. Repeat surgery after lumbar decompression for herniated disc: the quality implications of hospital and surgeon variation. Spine J. 2011 Dec 20.

21. Spine SCOAP Development 2011 Milestones Pilot mode July 1, 2011 5-10% sample from 9 hospitals 1000 cases for 2011 2012 Plan 3000 cases, 80% fusion/20% all other case types LSDF funding and Industry gifts to FHCQ 18 hospitals (80% of eligible spine procedures) Unique Features Patient-reported outcomes at baseline through 4 years (funded) Focus on fusions Hosts a multi-stakeholder spine forum-advisory board

22. How Spine SCOAP and CER Decrease Variation QI activity shines light on variability in indications and outcomes across centers/surgeons – Quarter by quarter improvements starting in 6 months – Works through “outlier” effect CER study shows definitively what works and what doesn’t Both help inform HTA decisions and payment policy Bree collaborative could help by making QI or CER activity a “community standard”

23. What direction shall we go?  Refer fusion back to WA HTA program for more comprehensive lit review and decision  Support mandatory participation in a comparative effectiveness study of lumbar fusion  Support requiring mandatory hospital participation in Spine Certn/Spine Scope QI effort as a condition of payment  Adopt restrictive BCBSNC policy (could not do this now, in face of WA HTA decision) Highest priority Second priority Your input

24. For electronic copies of this presentation, please e-mail Melinda Fujiwara vasudha@u.washington.edu For questions or feedback, please e-mail Gary Franklin meddir@u.washington.edu THANK YOU!