It’s Not Just Opioids€™s Not Just Opioids: Problematic Interventional Pain Treatments Graves...

© Paradigm Outcomes, Proprietary

It’s Not Just Opioids: Problematic Interventional Pain Treatments

Graves Owen, MD Medical Director, Texas Pain Rehabilitation Institute

Steve Moskowitz, MD Senior Medical Director, Paradigm

Part I: Procedures

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First, a Few Housekeeping Points

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1-877-668-4490, code 667 344 676 ##


Our conversation centers on three primary goals.

Today’s Webinar Objectives

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Understand why many interventional pain procedures are overused

Determine who is a legitimate candidate (and who is not)

Define a meaningful response


Pharmacy (Non

Opioid) 15%

Pharmacy (Opioid)

13%

Surgery/ Facility/

Physician 33%

DME and Home Health

22%

Other Medical

17%

Typical Complex Pain Case Spend

The Costs Add Up, and Are Not Simply Pharmacy

While costs may be moderate in a given year, they represent significant expense over time. Changing this trajectory requires intervening beyond just pharmacy.

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Source: Paradigm Analytics. Based on 10,000 open lost time claims, of which 600 met complexity criteria.


Procedures including:

– Epidural Steroid Injection (ESI)

– Facets

– Radiofrequency Ablation

– Spinal Cord Stimulators

Non-Opioid Painkillers

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Today’s webinar focuses on interventional procedures.

Common Interventional Pain Procedures

Today’s Webinar Part 2: Fall 2014

Find replays of our 2013 webinar series on pain at http://www.paradigmcorp.com/resources/webinars

http://www.paradigmcorp.com/resources/webinars


Physician Factors1

■ Belief in a “trial”

■ Reliance on clinical experience

■ Over-reliance on a surrogate outcome

■ Patients’ expectations (real or assumed)

■ Adherence to pathophysiological model

■ Desire to “do something”

Business Factors2

■ More patients, more treatments

■ No strong proof this has helped

■ Pharmaceutical and medical products industry influence on pain practice

■ Competition

■ Advertising/unrealistic expectations

■ Insurance incentives

1. Why do doctors use treatments that do not work? BMJ (Clinical research ed.) 2004 Vol: 328(7438):474-475 2. The Impact of the “Business” of Pain Medicine on Patient Care; Taylor, Pain Medicine 2011; 12: 763–772

Why Are Interventional Procedures Overused?

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Our Presenters

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• Head of Medicine at the Texas Pain Rehabilitation Institute

• President of the Texas Pain Society • Peer reviewer on pain medicine for the

American Academy of Pain Medicine

• Senior medical director for Paradigm’s pain program

• Physiatrist with 30 year experience treating pain and complex neurological

• 26 years experience in managed care and program development

Dr. Steven Moskowitz Dr. Graves Owen


Graves Owen, MD

An In-Depth Look at the Devices


■ Official Disability Guides (ODG)

– Radiculopathy (10% of cases)

– Diagnosis of radiculopathy defined by AMA guides 5th edition

• Should have concordant motor and/or sensory deficits

– Negative SLR test rules out radiculopathy

■ ASIPP Guides

– Radiculitis or radiculopathy (ODG does not recognize diagnosis of radiculitis)

■ NASS Guides (EMG/NCV not recommended)

■ No evidence that TF ESI provide significantly better outcomes

Patients without a validated diagnosis should not have the procedure.

Epidural Steroid Injection (ESI) Indications

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■ Unresponsive to conservative care (exercise, NSAID)

■ No series of 3 ESI

■ No more than one level (Interlaminar)

■ No more than two levels (transforaminal)

■ Do not combine ESI with other blocks such as facets or TPI

■ Do not perform Cervical and Lumbar ESI on the same day

■ Repeat ESI if 50-70% pain reduction for at least 6 weeks (limit to 4 ESI per year) if there is significant functional improvement or medication reduction

Reserve for validated radiculopathy only.

ESI Indications

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■ Fair evidence for short term benefits (less than 3 months) for diagnosis of radiculopathy

– Implications: not a good treatment for long standing radiculopathies

■ Poor to no evidence for conditions other than a radiculopathy (low back pain, FBSS, stenosis)

■ Poor outcome for “chronic” radiculopathy

■ One study found worst outcomes for spinal stenosis

– ODG and APS Guides 2009

ESI Evidence

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■ Infections (1-2%), severe infections (1 in 1,000), spinal infections (1 in 10,000)

■ Bleeding (Epidural hematoma 1 in 4,000)

■ Respiratory arrest (over sedation, local, IT opioids, pneumothorax)

■ Dural puncture headache

■ Urinary retention (opioids, local)

■ Neurologic injury (direct trauma to cord/nerve, vertebral artery injection, occlusion, embolism, or hematoma causing paralysis)

■ Exposure to corticosteroids

This is not without risk.

ESI Complications

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■ Official Disability Guides (ODG) for diagnosis:

– Tenderness to palpation in the paravertebral areas (over the facet region)

– A normal sensory examination

– Absence of radicular findings, although pain may radiate below the knee

– Normal straight leg raising exam.

– Pain on spinal extension has been suggested a indicator of facet symptoms.

■ There is no correlation between facet hypertrophy on diagnostic imaging and success of facet injections

The degree to which facets contribute to lower back pain is controversial.

Facet Signs and Symptoms

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– No evidence of:

• Radiculopathy

• Spinal Stenosis

• Previous Fusion

– No more than 2 joints injected at one time

– Not recommended for thoracic spine

– Considered successful if produces 70% relief initially and at least 50% relief for 6 weeks or more

– Should be combined with additional evidenced based treatments such as exercise

– No strong evidence for or against intraarticular facet injections

■ ASIPP does not recommend interartcicular facets

Indications for injections.

Intraarticular Facet and Medial Branch Block Injections

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– Only recommended as a diagnostic tool

– No difference in outcome when steroid or other agents are added to local

■ Successful diagnosis if 80% pain relief for duration of local anesthetic; ASIPP agrees

– Caution required if block helps for more than 12-24 hours

■ Psychosocial comorbidities are associated with decreased success from the block

■ ASIPP Guides

– As above plus:

• pain more than 3 months

• average pain of at least 6/10

• failed conservative care such as PT

Indications for medial branch blocks.

Medial Branch Blocks

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■ Uses radiofrequency energy to burn/destroy the MBB nerve.

■ Requires accurate diagnosis from the MBB block. 80% or more relief for the duration of the local anesthetic. This amount of relief should be associated with significant functional improvement and decreased medication usage.

■ Maximum of two times per year (ASIPP Guides).

■ Should result in functional improvement and medication reduction.

■ Evidence is limited:

– Cervical, 4 studies with total N=148

– Lumbar, 3 studies with total N=229

Professed to provide longer lasting relief of facet-mediated pain.

Radiofrequency (RF) Ablation of Medial Branch Nerves

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Dropped Head Syndrome


■ SCS is a device that uses electrical stimulation as a way to attenuate pain signals to the brain. The device is placed in the epidural space between the brain and the damaged nerve that is the “pain generator.”

■ Peripheral Nerve Stimulation (PNS) uses the same technology but places the stimulator lead adjacent to a peripheral nerve. While the evidence is weak for this technique, it has promise for these rare conditions.

■ Peripheral Field Stimulation places the stimulator lead subcutaneous. However, this technique has been widely overused. There is no evidence to support this technique.

■ New high frequency stimulation is being tested in the US. Promises greater success rates.

Spinal Cord Stimulation

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■ ODG:

■ Failed Back Surgery Syndrome:

– Symptoms must be primary in the extremities

– Limited responses to conservative care

– Psychological clearance and realistic expectations

– No evidence of SUD

– No contraindications for trial (infection/anticoagulation)

– Trial considered successful if 50% decrease pain, medication reduction or increased function

■ CRPS:

– Similar indications and trial requirements as FBSS

Heavily marketed and overused.

Spinal Cord Stimulation Indications

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■ AAPM Practice Guides 2007

■ Unresolved psychiatric comorbidities (depression, anxiety)

■ Unresolved secondary gain

■ Active/untreated SUD

■ Non-organic signs/inconsistent history and PE

■ Presence of major comorbid chronic pain syndrome

■ Alternative treatments with similar or better risk/benefit profile remain untried

■ Cardioverter defibrillator

These contraindications should eliminate many candidates.

SCS Relative Contraindications

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■ Cord injury

■ Dural puncture

■ Infection

■ Epidural hematoma

■ Electrode (lead) migration

■ Implant generator failure

■ Mechanical failure of lead or extension cable

An SCS is a significant, long-term commitment.

SCS Complications

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■ APS

■ Evidence: fair

– Limited by number, quality, and size of studies

■ Net benefit: moderate

– 10-20 improvement on ODI

– 10-20 improvement on VAS

– Chou Spine 2009

SCS Evidence

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Great Treatment, Good Technique, Poor Candidate

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Steve Moskowitz, MD

Case Management Considerations


■ Lack of effectiveness/not getting better

– No functional gain

– No decrease in toxic medication

– Increasing treatments rather than decreasing

■ Side effects

– Needing additional treatment

– Effects that limit function further

■ Complications

– Exposure to unwarranted risks

– Exacerbates illness behavioR/ disappointment

■ High cost

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If you have a case with this treatment response, the claim needs special handling.

Poor Patient Selection Causes Poor Clinical Outcome


Clinical correlation suggested.

Clinically Meaningful Outcomes

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Restoration of function

Decreased need for medical care and

interventions

Game-changing decrease in pain

complaint


■ Work functions and/or activities of daily living, self report of disability

■ Physical impairments

■ Approach to self-care and education

■ Return to normal quality of life

■ Behavioral

From ODG: WorkSafe Official Disability Guidelines

With restoration of function as a goal in mind, here’s how to measure effectiveness.

Measuring Effectiveness in an Individual

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■ Medication use

– Decrease in opioid dose or frequency

– Decrease in muscle relaxants

– Decrease in medication refill frequency

■ Passive PT

■ Other procedures

■ Physician visit frequency

Look for decreased need for medical care and other (more harmful) interventions.

Other Effectiveness Measures

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■ Return to work motivation

■ Return to vocational activities

Decrease Increase


Look for measurable, game-changing improvement.

Significant Improvement

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For a better clinical response, approach this systematically.

Claim Step Strategy

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Step 1

Validate that IW has a diagnosis

appropriate to the treatment request.

Documentation should be clear.

Step 2

Validate that IW meets inclusion criteria for good

outcome, absent risk factors for poor

outcome.

Step 3

Ensure there is a specific treatment outcome measure planned. Plan for

improved function, decreased need for meds, and better

comfort.

Step 4

Route to UR, CM, or other if steps 1-3

were not met. Route to systematic

management if this is a recurring theme.


■ Get an objective confirmation of the diagnosis

■ Know that a specific diagnosis is the gateway to appropriate treatment

■ Understand the conflict of interest of an MD referring IW to himself/herself

■ Develop a strategy to help an IW who is not a legitimate candidate for a procedure

■ Map out clear goals to gauge outcome following a procedure; communicate goals to the IW

Claim Management Strategy Tips

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Objective Durable Meaningful

To Create a Game-Changing Treatment Plan, Goals Must Be:


Submit your questions in the Q&A panel on the right of your screen.

Question and Answer Session

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Mary Baranowski

• Follow Paradigm on Twitter: www.twitter.com/ParadigmSays

• Find informative videos on our YouTube channel: www.youtube.com/paradigmoutcomes

• Read Outlook on Outcomes, Paradigm’s blog: www.paradigmcorp.com/blog

Experiencing computer audio broadcast problems? Please use the toll-free dial-in number: 1-877-668-4490, access code 667 344 676 # #

Dr. Graves Owen Dr. Steven Moskowitz

http://www.twitter.com/ParadigmSays

http://www.youtube.com/paradigmoutcomes

http://www.paradigmcorp.com/blog

It’s Not Just Opioids€™s Not Just Opioids: Problematic Interventional Pain Treatments Graves...

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