Lumbar fusion-Bree Collaborative-

1/30/2012Gary 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)

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

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)

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.

HipFracture

(14.3)

KneeReplacement

(53.6)

HipReplacement

(69.5)

BackSurgery(103.8)

0.3

1.0

3.0

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

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

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

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

Blue Cross/Blue Shield North Carolina1/20/11

• 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

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)

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)

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 matterKey-WC fusion outcomes far worse than

previously reported from surgical case series

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

Lumbar Fusion Policy Translation1992: 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

Lumbar Fusion-Effect of Rapid Diffusion of New Technology

Adapted from Franklin et al. Am J Man Care 1998;4:SP178-SP186

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

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

0%

5%

10%

15%

Per

cent

0 100 200 300 400Volume of WC fusion performed by hospital

Source: SID CA & WA, 2008-2009Adjusted for age, sex, comorbidity, and diagnosisHorizontal black line represents overall mean

3 month reoperation rates across hospitalsin California (Black) and Washington (Red)

Martin BI et al, in preparation, 2012

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

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.

Spine SCOAP Development2011 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

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”

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

For electronic copies of this presentation, please e-mail Melinda

Fujiwaravasudha@u.washington.edu

For questions or feedback, please e-mail Gary Franklin

meddir@u.washington.edu

THANK YOU!