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Key Concepts in
Interventional Pain Management
Laxmaiah Manchikanti, MD
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Laxmaiah Manchikanti, MD
Chairman of the Board and Chief Executive Officer, ASIPP and SIPMS
Board Certified: ABA, ABA Pain Medicine, ABIPP
Medical Director, PMCP, ASC, PCS
Member: Kentucky CAC; Served on Board of Regents, Murray State
University, KY; KBML; MCAC
Publications: Over 300 publications and 5 books
No outside funding, no grants, no support from industry
Some slides are borrowed from Thomas Hamilton.
Disclaimer
3
The Problem
Expensive critical care
Working harder
Getting paid less
More out-of-pocket expenses
Truth
Sick care
Payors
Government
Bureaucrats
Crisis care
Providers
Physicians
Patients
Three Sides to Health Care Crisis
2
4
The Problem: State of Healthcare Industry
Expensive $2.3 trillion per year 2008 in the U.S. and growing
Pervasive problems with the quality of care that people receive
Large variations and inequities in clinical care
Uncertainty about best practices involving treatments and technologies
Translating scientific advances into actual clinical practice and usable information both for clinicians and patients
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The Problem: The Rising Cost of
Health Care
Facts, Fallacies, and Politics of Comparative Effectiveness
Research: Part I. Basic Considerations
Manchikanti et al. Pain Physician 2010;e23-54
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The Problem: Medicare Expenditure
over 10 Years (1999-2009)
Facts, Fallacies, and Politics of Comparative Effectiveness
Research: Part I. Basic Considerations
Manchikanti et al. Pain Physician 2010;e23-54
3
7AARP Bulletin Dec 2009
8AARP Bulletin Dec 2009
Sources: U.S. Census; “In Search of Health Care Reform,
” Washington Post, June 9, 2009; U.S. Centers for Medicare & Medicaid
Services; Commonwealth Fund; Kaiser Family Foundation.
9 9
The Problem: Regulations
Wasted dollars
$1 trillion
Cost $169 billion without benefit
Total cost $339 billion
Unfunded mandates
Compliance programs: Start-up $60 - > 100,000
Annual $30,000
ICD -10
Single dose vials
Separate waiting room
Insurance interactions total
$ 30 billion annually
$60-88,000 per physician
EMRs - Under funded
Another Y2K
Source: Mello et al, NEJM 2006, 361
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ASCs & IPM
Issues are
insurmountable
11 1111 11
The Problem: Declining ASC Payments
2007-2011 Interim and Final (for top 9 IPM codes)
3% to 18% - 2008
8% to 36% - 2009
11% to 69% 2010
12% to 71% - 2011 and after
TRICARE etc. may pay same or less
Medicare Advantage Plans
10% - 20% less than Medicare
Medicaid
20% or more less than Medicare
Third Party
30% Payers higher than Medicare
40% Payers same as Medicare
30% Payers less than Medicare
…. … and unfunded mandates
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Migration of outpatient IPM
procedures to non-hospital settings
0
500,000
1,000,000
1,500,000
2,000,000
2,500,000
1997 2002 2006
ASC HOPD Office
0%
25%
50%
75%
100%
2002 2006
HOPD Office ASC
Number of Procedures Percentage
5
Explosive Growth
Increasing utilization of interventional techniques excluding continuous epidurals, intraarticular injections,
and trigger point and ligament injections from 1998 to 2008
1,046,630 1,089,797 1,241,479 1,426,369
1,848,3332,203,318
2,848,4043,120,912
3,356,224
3,849,2064,055,231
382,647 357,067400,967
492,632
580,598
622,035
827,655
920,552
1,221,552
731,059
715,286
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Pain Management Professionals Others
Increase from 1998 to 2008 = 234%
Annual Increase = 23.4%
1,642,4461,429,277
1,955,001
2,428,931
2,825,353
3,674,059
1,446,864
4,041,464
4,577,268 4,580,268
4,770,517
78%
76%
75%
75%
76%
73%
77%
77%
73%
75%
74%
Overall Growth Patterns of Interventional Techniques from 1997
to 2006 in Medicare Beneficiaries
Source: Manchikanti et al, Pain Physician 2009; 12:9-34
* Per 100,000 Medicare beneficiaries
Annual
(21.9% Per year)
(15.5% Per year)
Overall Growth Patterns of Facet Joint Interventions from 1997
to 2006 in Medicare Beneficiaries
Source: Manchikanti et al, Pain Physician 2009; 12:9-34
* Per 100,000 Medicare beneficiaries
Annual
6
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ASC Game Changer
May 14, 2009
New Conditions of Coverage (CfC)
Effective May 18, 2009
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ASC Focus
Rapid Growth
5,175 Ambulatory Surgical Centers (ASCs)
currently participate in Medicare
> 2,600 Accredited by AAAHC
> 4,500 Total Accredited
61% increase from CY 2000 – CY 2009
May 14, 2009
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Changes in ASC Oversight
New Conditions:
Quality Assessment/Performance Improvement
Patients’ Rights
Infection Control
Patient Admission, Assessment & Discharge
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Changes in ASC Oversight
Revised Conditions:
Governing Body (Contract Services,
Hospitalization & Disaster Preparedness
Plan)
Surgical Services (Anesthetic Risk &
Evaluation)
Laboratory & Radiologic Services
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Changes in ASC Oversight
More surveys
Volunteers sought for FY 2009
30% of non-deemed ASCs to be surveyed in FY 2010
Also increasing FY 2010 ASC validation surveys
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ARRA Initiative
$50 M to States for HAI control
Great timing:
CMS pilot shows ASC infection control
problems
GAO endorses CMS pilot approach
CMS requested $10 M to enhance ASC
oversight
8
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ARRA Initiative
FY 09 $ available to volunteers
FY 10 new survey process mandatory
ARRA $ may be requested for added costs
Application details distributed to SAs
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Infection Control
§416.51: The ASC must maintain an
infection control program that seeks to
minimize infections and communicable
diseases.
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Core Infection Control
Components
Hand hygiene
Injection practices
Instrument reprocessing High-level disinfection
Sterilization
Environmental cleaning
Point of care devices (e.g., glucometers)
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Unsafe Injection Practices
Outbreaks
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Injection Safety
Needles are used for only one patient
Syringes are used for only one patient
Medication vials are always entered with:
New needle
New syringe
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Single-dose and Multi-dose
Medications
Single-dose medications One patient
One procedure
Multi-dose medications Ideally dedicated to one patient
If used for more than one patient, must follow strict parameters
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Handling of Single-dose Medications
and Supplies
Used for a single patient only! Single-dose medication vials
Manufacturer-prefilled syringes
Bags of IV solution
Medication administration tubing and connectors
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Key Concepts for Successful IPM
Indentify
and
Manage
Develop
Organization
Understand
History
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Key Concepts for Successful IPM
Indentify
and
Manage
Develop
Organization
Understand
History
11
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Added: 422 Procedures
Deleted: 203 Procedures
60% of interventional procedures to be deleted
Remaining 40% faced cuts
Proposed Rule, June 1998
ASC Issues: Looking Back
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ASC Issues
2000: Nine replacement codes added to ASC-covered list
Aug. 2000: HOPD PPS implemented
IPP APCs inconsistent with the mandate that groups include services
that are alike both clinically and in resource utilization
Hospitals refusing to schedule OR time for IPP
Feb. 2001:
ASIPP testifies before APC Panel, presents new APC groupings of
IPP
Nov. 2001: HOPD IPP APCs regrouped
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181165
181173
273
804
250
301
615
288
352
633
322 331
622
358 358
600
391 391
748
449 449
923
474 474
949
485 485
893
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Increasing HOPD Payment Rates
(62310, 62311) (64470*, 64475*) (62264, 64622)
ASC Issues: HOPD Payments
Nov. 2001: ASIPP proposes new classification
APC 0207 APC 0207 APC 0203
For 2010: 64470=64490 and 64475=64495
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ASC Issues: Medicare Modernization Act
Signed into Law, December 2003 Payment rates to be frozen at 2003 rates
New ASC payment methodology to be implemented between
January 2006 and January 2008
GAO should recommend whether to use the outpatient PPS
procedure groups and relative weights as the basis for the ASC
payment system
GAO report released in 2006
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ASC Issues: Lobbying
GAO study • 84% HOPD expense
Lobbying by ASC organizations• FASA and AAASC
• Weaker sections not represented (Example:
IPM)
Legislation• None successful
ASC Issues: Impact by Specialty
7.0%
-5.0%
20.0%21.0%
0.0%
23.0%
18.0%
0.0%
10.0%
23.0%
-1.0%
Derm GI GS OB.. Opth Ortho Oto Pain Pulm Uro Vas
28.0%
-19.0%
79.0%85.0%
3.0%
92.0%
72.0%
-15.0%
5.0%
40.0%
89.0%
Derm GI GS OB.. Opth Ortho Oto Pain Pulm Uro Vas
2008 Rates
2008 Fully Implemented Rates
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Key Concepts for Successful IPM
Indentify
and
Manage
Develop
Organization
Understand
History
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Organization: Why Bother?
Determines Productivity
Reduces Frustration
Reduces Rework
Optimizes Perception of Service
Excellence in the minds of your customers
Optimizes performance
Income
Satisfaction for all
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Organization: Hewlett-Packard’s
Statement of Principles
We should strive to meet certain fundamental requirements:
FIRST, the most capable people available should be selected for each assignment within the organization.
SECOND, enthusiasm should exist at all levels.
THIRD, even though an organization is made up of people fully meeting the first two requirements, all levels should work in unison toward common objectives.
Goals are:
1. Profit 5. Our people
2. Customers 6. Management
3. Fields of interest 7. Citizenship
4. Growth
Paul D. Sweeney and Dean B. McFarlin
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How Do You Organize?
Organization is a vehicle for a successful
enterprise which requires:
Leadership
Motivation
Decision making and delegation
Time management
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How Do You Organize?
Organization is a vehicle for a successful
enterprise which requires:
Leadership
Motivation
Decision making and delegation
Time management
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How Do You Organize: Leadership
Ability to influence a group toward the
achievement of goals
Requires a leader and follower(s)
Different from management??
Leadership = doing the right things
Management = doing things right
Successful vs. effective managers
15
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Leadership Styles
Directing
The leader provides specific instructions and closely supervises task accomplishment
Coaching
The leader continues to direct and closely supervise task accomplishment, but also explains decisions, solicits suggestions, and supports progress
Supporting
The leader facilitates and supports subordinates’ efforts toward task accomplishment and shares responsibility for decision-making with them
Delegating
The leader turns over responsibility for decision making and problem solving to subordinates
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Organization: Fatal Flaws of
Leaders Who Derail
Insensitive to others
Aloof and arrogant
Betrayal of trust
Overly ambitious
Over-managing
Unable to think strategically
Unable to adapt to situations
Overly dependent on an advocate or mentor
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How Do You Organize?
Organization is a vehicle for a successful
enterprise which requires:
Leadership
Motivation
Decision making and delegation
Time management
16
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Education alone is not enough.
• Many “educated” individuals achieve very little on or off
the job.
• They know what to do, and they know how to do it.
The problem is they’re not motivated enough to do much
about it.
Motivation is not enough.
• If you motivate an idiot, all you have is a motivated idiot.
In today’s competitive world, the really successful person is
not only educated, but also motivated.
Organization: Solutions
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How Do You Organize?
Organization is a vehicle for a successful
enterprise which requires:
Leadership
Motivation
Decision making and delegation
Time management
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Organization: The Decision-Making
Process
“Making Decisions, 9th ed.” Samuel C. Certo
17
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Organization: The Decision-
Making Process
“Making Decisions, 9th ed.” Samuel C. Certo
“Making Decisions, 9th ed.” Samuel C. Certo
50
How Do You Organize?
Organization is a vehicle for a successful
enterprise which requires:
Leadership
Motivation
Decision making and delegation
Time management
51
Organization: Mastering Your Time
Remember that Murphy’s Laws apply to everything you do: Everything takes longer than you expect.
Everything costs more than you originally plan.
Whatever can go wrong, will go wrong.
Of all the things that can go wrong, the worst possible thing will go wrong at the worse possible time and cost far more than you ever expected.
“Murphy was an optimist.”
18
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Key Concepts for Successful IPM
Indentify
and
Manage
Develop
Organization
Understand
History
53
Top 10 Considerations
1. Facility
2. Personnel
3. Scheduling
4. Evaluation & Management Services
5. Procedures
6. Documentation
7. Billing and Coding
8. Public Relations
9. Outcomes
10. Publications and Politics
54
Feasible
Functional
Practical
Location – Location - Location
Identify and Manage: Facility
19
55
Under staffed
Low expenditures
Poor service
Patient dissatisfaction
More work by physician
Less comfort
Inefficient
Reduced productivity
Same or lower net profit/income
Identify and Manage: Personnel
“People are the most important commodity”
Well staffed
High expenditures
Good service
Patient satisfaction
Less work by physician
Comfort
Efficiency
Productivity
Higher net profit/income
56
Identify and Manage: Personnel
Dimensions of Organizational Commitment Affective (“I want to be here”)
Continuance (“I have to be here”)
Normative (“I should be here”)
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Identify and Manage: Personnel
About half (55 percent) of today’s employees have no
enthusiasm for their work.
These people are “not engaged.”
They don’t have much loyalty to their organization or much
desire to improve their job.
One in five (19 percent) were so negative about their jobs
that they actually poison the workplace.
When these employees call in sick, organizations are more
productive and efficient.
20
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Identify and Manage: Personnel
If companies could get 3.7% more work out of
each employee, the equivalent of 18 more
minutes of work each 8 hour shift, the gross
domestic product in the United States would
swell by $355 billion, twice the GDP of Greece.
Average wasted time
1.7 hours/day
59
Pre-evaluation
Appointment – information
Questionnaires
Record collection
Evaluation Day
Check-in
Nurse – interview
Physician evaluation
Discharge
Identify and Manage: Initial Evaluation
60
Identify and Manage: Follow-Up Services
Check-in
MD – visit
Check-out
21
Scheduling – Single Physician
Time 15 Evaluations
7:30 am New Pt. Evaluation
7:30 am New Pt. Evaluation
8:00 am New Pt. Evaluation
8:30 am New Pt. Evaluation
9:00 am New Pt. Evaluation
9:00 am New Pt. Evaluation
9:30 am New Pt. Evaluation
9:30 am New Pt. Evaluation
10:30 am New Pt. Evaluation
10:30 am New Pt. Evaluation
1:00 pm New Pt. Evaluation
1:30 pm New Pt. Evaluation
2:00 pm New Pt. Evaluation
2:30 pm New Pt. Evaluation
2:30 pm New Pt. Evaluation
Time 30 Follow ups
7:15 am x 3 Follow up
7:30 am x 3 Follow up
8:30 am x 2 Follow up
9:00 am x 2 Follow up
10:00 am x 3 Follow up
11:00 am x 2 Follow up
12:30 pm x 3 Follow up
1:00 pm x 3 Follow up
2:00 pm x 3 Follow up
2:30 pm x 2 Follow up
3:00 pm x 2 Follow up
3:30 pm x 2 Follow up
62
Identify and Manage: Procedural
Scheduling
Time
7:30 am Treatment
7:30 am Treatment
7:30 am Treatment
7:30 am Treatment
8:00 am Treatment
8:00 am Treatment
8:15 am Treatment
8:15 am Treatment
8:30 am Treatment
8:30 am Treatment
8:45 am Treatment
63
Medical Necessity is based on patient need – Not provider need
or ability to provide certain services
It is much more important to document what you have done than
how much you know about a procedure or technique
It is essential to establish Medical Necessity for each encounter.
Each service has to stand on its own.
-CMS
Identify and Manage: Document
Medical Necessity
22
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Service must be:
Safe and effective
Not experimental or investigational
Appropriate as to the duration and frequency considered
appropriate for the service, and in terms of whether it is:
• Furnished in accordance with accepted standards of medical
practice for the diagnosis or treatment of the patient’s
condition or to improve the patient’s function
• Furnished in a setting appropriate to the patient’s medical
needs and condition
• Ordered and/or furnished by qualified personnel
• One that meets, but does not exceed, the patient’s medical need
Medical Necessity: Reasonable
and Necessary
65
1 History and physical examination
2. Informed consent
3. Description of intravenous access, sedation, and physiologic monitoring (if utilized)
4. Appropriate patient positioning and sterile preparation
Procedural Documentation
Key Components:
5. Anatomic needle placement Local Anesthetic / Steroids / Other Solutions
Fluoroscopy
Contrast
Pain Provocation
6. OR Staff
7. Description of complications (if any) and if none stated as such
8. Listing of post injection instructions to patient, including symptom monitoring as
appropriate
9. Patient status at discharge
10. Post follow-up
66
Modifiers
Add-on codes
Bilateral codes
Unlisted procedures
Correct coding polices
• Column 1 (Comprehensive)
• Column 2 (Component)
• Mutually exclusive
Identify and Manage: Saga of
Coding
23
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Coding is complex
Requires skill and effort
But, it is not rocket science
Physician must be involved in coding
Coding is not black and white
May be several ways to code procedures
Physicians are the only individuals who know what
was done
An informed MD coder is always better than a
non-MD coder
Identify and Manage: Coding
68
ATC Annual Conference, Chris Durbin
68
Why Public Relations?
Engaging in PR = Win/Win situation
Good for the profession
Good for your professional association
Good for your business
More and satisfied patients
Profitable
Family referrals are the best
Pass “yo mama test”
69
Why Outcomes?
To make marketing decisions
To provide accountability
To improve the knowledge base of medicine
Outcomes are where the Treasures can be found.
Robert L. Kane, Understanding Health Care, Outcomes Research. 1997
“Physicians control 70% of health care cost
expenditures”
24
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Why Publish?
Desire to share your exciting research
findings with others in hope of fame and
fortune
Remember: if it hasn’t been published it
hasn’t been done
Don Bowen, Bedford Institute of Oceanography, Dartmouth, Nova Scotia
71
Why Politics?
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One evaluation day per physician
8-11 new patients per physician
15-20 follow-ups per physician
300-450 new patients per year
750-1,000 established patient visits per year
Two procedure days per physician
20-30 procedures per day
40-60 procedures per week
200-300 procedures per month
2,400-3,600 procedures per year
Separate Evaluation
& Procedure Days
Reevaluation
Impression
Management plan
Medical and
rehabilitation therapies
Diagnostic interventions Therapeutic interventional
management
Persistent pain
New pain
Worsening pain
Adequate pain relief and
improvement in functional status
Repeat comprehensive evaluationContinue Therapeutic Management
EVALUATION AND MANAGEMENT
History
Pain history
Medical history
Psychosocial history
Assessment
Physical
Functional
Psychosocial
Diagnostic testing
Manchikanti et al, Pain Physician 2009
An Algorithmic Approach to Diagnosis of Chronic Low Back Pain Without Disc Herniation
Chronic Low Back Pain
Based on clinical evaluation
Positive Negative
Facet Joint Blocks
Positive Negative
Provocative Discography
Positive Negative
Sacroiliac Joint Injections
Positive Negative
Epidural Injections
Stop process
Positive Negative
Epidural Injections
Positive Negative
Facet Joint Blocks
Positive Negative
Provocative Discography
Positive Negative
Sacroiliac Joint Injections
Stop process
Positive Negative
Sacroiliac Joint Injections
Positive Negative
Facet Joint Blocks
Positive Negative
Provocative Discography
Positive Negative
Epidural Injections
Stop process
Manchikanti et al, Pain Physician 2009
26
Chronic low back pain
Somatic pain Radicular pain
i. Facet joint pain
Medial branch blocks or
Radiofrequency thermoneurolysis
*Intraarticular injections
ii. SI joint pain
*SI joint interventions
iii. Discogenic pain
• Intradiscal therapy
• Caudal or Interlaminar epidurals
• ? Adhesiolysis
i. No Surgery / post-surgery / spinal stenosis
Step 1: Caudal / Interlaminar
or
Transforaminal epidural
Step 2: Percutaneous Adhesiolysis
ii. No surgery
Step 3: Percutaneous disc decompression
iii. Post-surgery
Step 4: Spinal cord Stimulation or
Implantable/Infusion system
Manchikanti et al , Pain Physician 2009* Not based on evidence
An Algorithmic Approach:
Low Back Pain Therapeutic Interventional Techniques
An Algorithmic Approach: Neck Pain Without Disc Herniation
Chronic Neck Pain
Based on Clinical Evaluation
Positive Negative
Epidural Injections#
Positive Negative
Facet Joint Blocks
Stop process
* Not based on evidence synthesis
# Transforaminal epidural injections have been associated with reports of risk Manchikanti et al, Pain Physician 2009
Positive Negative
Facet Joint Blocks
Positive Negative
Epidural Injections#
Positive Negative
Provocation Discography*
Stop process
OR
Stop process
OR
Chronic neck pain
Somatic pain Radicular pain
I. Facet joint pain
Medial branch blocks or
radiofrequency thermoneurolysis
II. Discogenic pain
Interlaminar epidural injections#
or
Surgical referral
or
Stop intervention
I. No surgery/post-surgery/spinal stenosis
Step 1: cervical interlaminar epidural
injections
II. No previous surgery
Step 2: Surgical disc decompression
III. Post surgery
Step 3: *Spinal cord stimulation
Step 4: Intrathecal infusion system
An Algorithmic Approach:
Neck Pain - Therapeutic Interventional Techniques
Manchikanti et al, Pain Physician 2009
* Not based on evidence
27
Chronic Thoracic Pain
Based on Clinical Evaluation
Positive Negative
Epidural Injections#
Positive Negative
Facet Joint Blocks
Stop process
* - not based on evidence
# Transforaminal epidural injections have been associated with reports of riskManchikanti et al, Pain Physician 2009
Positive Negative
Facet Joint Blocks
Positive Negative
Epidural Injections#
Positive Negative
Provocation Discography*
Stop process
OR
Stop process
OR
An Algorithmic Approach:
Thoracic pain without disc herniation or radiculitis
An Algorithmic Approach:
Thoracic Pain - Therapeutic Interventional Techniques
Manchikanti et al , Pain Physician 2009
Chronic thoracic pain
Somatic pain Radicular pain
I. Facet joint pain
Medial branch blocks or
radiofrequency thermoneurolysis
II. Discogenic pain
Interlaminar epidural injections
or
Stop intervention
I. No surgery/post-surgery/spinal stenosis
Step 1: Interlaminar epidural injections
II. No previous surgery
Step 2: Surgical disc decompression
III. Post surgery
Step 3: *Spinal cord stimulation
Step 4: *Intrathecal infusion system
* Not based on evidence
81
Laxmaiah Manchikanti, MD
Phone: (270) 554-8373 ext. 101
Phone (ASIPP): (270) 554-9412
E-mail: [email protected]
