Transcript Perspectives on Our Future in Pathology

Perspectives on
Our Future in
Pathology
Gene N. Herbek, MD, FCAP
Secretary-Treasurer, College of
American Pathologists
Wisconsin Society of Pathologists
Annual Meeting
November 1, 2008
Copyright © 2008 College of American Pathologists (CAP). All
rights reserved. Participants are permitted to duplicate the
materials for educational use only within their own institution.
These materials may not be used for commercial purposes or
altered in any way.
Disclosures
The following speaker has no
relevant financial relationships with
commercial interests:
Gene N. Herbek, MD, FCAP
Objectives
• Discuss market forces and technology
advancements that are accelerating
changes in the delivery of health care
• Explore the implications for pathology
practice
• Identify what pathologists can do to stay
relevant in the dynamic health care
environment
Our landscape is
changing
Technology is an accelerator…
Automation and
robotics
Bioinformatics
Biomarkers
Molecular Targeting
Nanotechnology
Personalized
Medicine
…transforming the delivery of
patient care
Proactive
Health
Management
Chaotic
Flux
Medicine
Reactiv
e Care
Time
Clinical transformation
is occurring
Even the autopsy is changing!
• CT used to enhance autopsy
• Pathologist and radiologist
collaborate
• May create renewed interest
– Uniform, comprehensive documentation
– Increased understandability
– Non-infectious procedure; no
interference
– More efficient, targeted minimallyinvasive autopsy
– Less intrusive for families with religious
concerns
…but technology is
not the only driver
An aging population changes
the nature our practice
Source: U.S. Census Bureau
The nature of disease is changing
Atherosclerosis
% of Total Deaths in the US
Alzheimer’s disease
Septicemia
Renal disease
Chronic liver disease and cirrhosis
Diabetes mellitus
Pneumonia and influenza
Chronic lung disease
Cerebrovascular diseases
Cancer
Heart disease
0
5
10
15
20
25
1979
Source: National Vital Statistics Reports, Vol 47, No 9, Nov 10, 1998; Vol 56, No 10, Apr 24, 2008
30
1996
35
2005
40
45
50
Government regulations are
inhibiting progress
• Applying arcane standards to new
technologies
• Requiring more paperwork not less
• Continuous battles over
government agency oversight
responsibilities (CMS, FDA, and
CDC)
• Inconsistent application of
requirements; different standards
of practice
• New roles for pathologists and
others not recognized
US health care spending is
outpacing GDP growth
Recent developments in
the world economy will
only worsen the pressure
on health care spending
Information overload is crippling
quality care
…and most of the rest of
the developed world is
experiencing a shortage of
pathologists
Newfoundland–May 2008
India–Nov 2007
Australia–Jul 2008
China–Mar 2007
It’s knocking!!!
There has never been
a greater need for
pathology expertise
and resources
Pathologists have a bright future in
the house of medicine
•
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Researcher/Innovator
Test Provider
Interpreter
Clinical Data Integrator
Clinical Consultant
Lab Director
Business Developer
Practice Leader
…but gaps exist that are slowing
progress
• Focus on generating results
• Lack of integration of AP and
CP knowledge & management
• Lack of ‘pathologist integrator’ to
balance sub-specialization trend
• Pathologist stereotype: poor
communicator, risk adverse,
• Insufficient preparedness of new
methodical, process-oriented
pathologists entering practice
and data driven
• Production of fragmented,
• Lack of clinical experience
disassociated data
The specialty lines defined by
our diagnostic tools are fading
• Distinctions within pathology are already
rapidly diminishing
• Traditional lines within and between
specialties will continue to gray
• All specialties will look for new
modalities to improve and refine their
diagnoses
Pathologists need a
bias for action and…
…a new mindset
• No barrier between AP or CP • Collaboration with others
• Providing more than just the
• Assuming a central role in the
diagnosis
treatment team
• Dissatisfaction with being just • Clinical involvement; greater
the ‘doctor’s doctor’
patient interaction
• Continuous passion for
learning
• New technology & technology
integration
• New practice techniques
• New management & soft skills
Risk taking and a
willingness to fill the void
and own the space
It has taken us 500 years to get to
this point!!
Mid-1700s: Cuff-style
microscope; 1st to
provide ease of use
and accurate focusing
mechanisms
1595: 1st
Compound
Microscope
1680s: English
Tripod
Microscope
1899: Ernst Leitz
Compound Binocular
Microscope
1998: State of the art contains
accessories for DIC, fluorescence,
polarized light, phase contrast,
and photomicrography
It is no longer
about the tools
we use
The unfortunate perception
Pathologists and
pathology laboratories
are only interested in
performing tests
We must focus on
expanding our value
Quality care requires quality
testing
Right patient…
Right test…accurate results…
Right report…right treatment…
Right clinician partner
This “next revolution in
medicine” will fall on the
shoulders of physicians who
provide primary care. The
demands on family physicians
will be significant as they gear
up to provide information on
genetic testing to their
patients, help interpret test
results for them and consider
prescribing new genetic
therapies that become
available.
~Francis Collins, MD, PhD
Yeah, right.
We are clinicians with a direct
impact on patient care
Pathology
In this new era of personalized
medicine, pathologists have a direct
impact on patient care…
Do Not Treat
K-ras Testing
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Treat with Erbitux
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Langreth, R. (2008), ‘Imclone’s Gene Test Battle’, Forbes.com, 16May
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Treat with Erbitux
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Treatment
Success
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Journey to a place where no man
has gone before
Centralized Diagnostic
Intelligence
The accumulation, management and use
of patient information, clinical
observations, diagnostic test results and
reference material to make diagnostic
decisions, prognostic judgments and
therapeutic recommendations
The challenge starts with
the raw material…
…but doesn’t stop
there
You are responsible for a cycle of
activities which begin before and
conclude after the actual testing
• Consultation between the primary care clinician
and pathologist
• Accurate identification of the patient and referring
doctor
• Correct collection and storage of the specimen
• Timely and accurate delivery and readability of the
result
• And, more consultation between the pathologist
and the referring clinician
We must interact with patients
and other clinicians
• Broaden our sphere of influence
• Expand beyond the tissue on the slide—all
diagnostic tools are available to you
• Market our services for consults
• Expand value by influencing prognosis
and treatment
…be a part of the treatment team
…and we can never forget
What we do is dead
serious and when it’s
not done right has real
patient consequences
Canada's pathology problem
May 16, 2008
October 5, 2005
Officials in St. John’s disclose they are
sending breast cancer tests to Toronto
because of lab errors. But the full scope
of the problem wasn’t revealed until May,
2007, when documents filed as part of a
class-action lawsuit showed more than
300 women were giving incorrect results.
An inquiry into the problems began in
March.
2005
2008
May 18, 2007
President and CEO of Eastern Health
authority, George Tilley, offers an apology
for not publicly disclosing all information
regarding faulty breast cancer tests, which
occurred between 1997 and 2005.
2005
2008
February 11, 2008
Officials in Miramichi, New Brunswick
launch an investigation into the work of
pathologist Rajgopal Menon after an audit
of 227 breast and prostate cancer biopsies
found 18% of the cases had incomplete
results and 3% were misdiagnosed. An
inquiry in the programs began this May.
2005
2008
April 30, 2008
Grey Bruce Health Services, which serves
the Owen Sound, Ontario area, announces
an investigation into work done by
pathologist Barry Sawka after a review
found a 6% error rate and missed cancer
diagnoses.
2005
2008
“[We're] coming to grips with the
fact this isn't a dream. It's more
like a nightmare and it looks like
it's going to get worse. Suddenly
it clicked. This is likely going to
get a lot worse before it gets
better.”
Andrew Padmos
CEO, Royal College of Physicians
and Surgeons of Canada
March 2008
“It’s time to try and fix the problem”
Jagdish Butany, MD
President, Canadian Association of Pathologists
Potential solutions the Canadian medical associations
have identified
– Creation of large laboratories where all medical tests in a region
would be analyzed by specialists rather than general
pathologists
– Mandatory requirement for a 2nd pathologist to sign off on tests
showing malignancies
– Creation of standardized terminology, interpretation measures
and handling procedures to ensure all lab staff across country
use the same thresholds to make a diagnosis
– Requirements for all foreign pathologists to receive the same
accreditation in Canada
March 16, 2008
Could this happen in the US?
“…if the College does not move quickly
to address these issues, [we] will bring
in legislation forcing it to make
changes.”
Mike Murphy
New Brunswick Health Minister
February 2008
Breast Cancer Test Errors Cause
January 4, 2008, 8:09 am
Faulty Treatment
Posted by Jacob Goldstein
It is not opposition
but indifference
that separates men.
~Mary Parker Follett
Let’s not find
ourselves in the
same situation
Historically, CAP’s
‘improvement’ focus has
been on the laboratory
It is time we focus on
what we do everyday
The HER2/neu story: best practice
guidelines are needed
• Level of HER2 testing was
providing an inconsistent
level of care for patients
– Only ~1/4 performed technical
validation before offering
HER2 testing
– Only ~1/3 participated in PT
• About half of labs that used FDA-approved
IHC kits vary from the FDA-approved method
• Patient Impact: inappropriate treatment
The Center is a strategic
driver in the transformation
of pathology
It provides a forum and the
organizational focus
necessary to formalize
and accelerate CAP’s
development of standards
and best practices…
…with concentration in
areas directly involved in
the practice of pathology,
pathologists and their
role in laboratory
medicine
The CAP Center will…
• Conduct research necessary to support
development of best practices and standards
• In the absence of evidence-based standards,
will facilitate coordination of consensus activities
• Support standards development and research in
other areas on behalf of other entities
• Provide output that can be used by CAP and
other organizations; provide input to the Institute
We can’t do it alone
Requires strategic relationships
with stakeholders that share
common goals or offer unique
expertise and perspectives
– Industry—diagnostics, pharma, etc.
– Advocacy groups
– Government agencies
– Other associations
– CAP Members
…with an intense focus on
improving patient care
Why would CAP pursue this
initiative?
• Heightened focus on
improving what we do as
pathologists everyday
• Recognition as the primary
source for pathology best
practices and standards
• Strengthened advocacy efforts
• Improve the specialty without added government
regulation or legislation
• Influence improvements in patient care
CAP’s Transformational
response is multi-faceted
• Best Practices/Standards
• Education
• Better integration with
the House of Medicine
especially in the era of
Personalized Medicine
• Emerging technology
investigation
• Strengthened advocacy
• Laboratory improvement
program expansion
• Accreditation redesign
• Membership growth and
segmented services
…and more
Federal Advocacy
• Physician Payment Issues
– 2008-09 Medicare Physician Fee Schedule
– POD Labs and Other CJVs
– Pay for Performance
– Medically Unlikely Edits (MUEs)
– TC Grandfather
• Gynecologic Cytology Proficiency Testing
State Advocacy Issues
Direct Billing for Anatomic Scope of Practice
Pathology Services
– Working with state
– 14 states – Direct Billing
– 6 states – Anti-mark up
– 14 states – Disclosure
pathology and medical
societies
– Opposed to allied health
professionals seeking to
order, perform and
evaluate clinical
laboratory tests
Securing Our Place in
the Future requires more
than advocacy and best
practices
Change is inevitable…
…Growth is optional
How can CAP help?
• Education to introduce new concepts, improve and
standardize practice, and develop new skills
• Programs that provide ways for pathologists to
demonstrate their competency and proficiency
• Forums to encourage adoption of emerging
technologies that improve the effectiveness of disease
diagnosis, prognosis, and patient treatment plans
• Tools that can be used to learn new concepts, improve
practice techniques, demonstrate quality, etc.
The CAP Institute is not just about
producing “smarter” pathologists
The CAP Institute will
help you be a better
physician
The Institute will enable pathologists
to function as physicians
• Teach pathologists about and how to use new and existing
technologies
• Help pathologists transform their practice
• Teach pathologists how to take on new roles
• Recognize individual pathologists for their
proficiency/competence in specific narrow and broad domains
• Provide pathologists with a method to gage their progress in
learning new skills
• Identify emerging technologies and trends and develop
programs that target the innovators and early adopters in the
specialty
• Utilize new and innovative delivery mechanisms
The Institute will
facilitate transformation
of pathologists from the
stereotypical ‘cave
dwellers’ to leading
players on the patient
care treatment team
The Institute will strengthen and
expand our current programs…
• Annual Meeting
• Futurescape
• Pathology Practice
Management (PPM)
• Virtual Management
College (VMC)
• Education Courses
…and offer new learning
experiences
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Cross Specialty Forums
Practical Assessments
Mentoring Programs
Practice-specific Custom
Programs
• Certificate Programs
• CAP Self Assessment Modules
• PRODs/Chairs Training
Programs
…with the tools necessary to put
your learning to work
• Just In Time Practice Support / Tool kits
– Practice management tools (e.g., coding services,
sample contracts, RCE calculator)
– Special Interest Groups (SIGs)
– Customized internet alerts on key topic areas
– Podcasts
– RSS Information Push for the latest ‘buzz’
– Wiki-type tools for technology vendor comparisons
• Best Practices/Technology Database
The Institute will also support MOC
• ~1200 pathologists
• 95 CME courses
• 348 abstracts
• Launched transformation
campaign
• Record Resident attendance
• Energized HOD
One size
doesn’t fit all
Why the CAP Certificate Program?
• To help pathologists signal to others that they
possess special expertise
• Members want to be recognized for skills they
have developed in areas not certified by the
ABP (e.g., GI or breast pathology)
• Pathology departments lack a method to
identify qualified prospects
• In some regions of the country self-declared
specialists compete for business with general
pathologists
The College is stepping up.
Will you?
What are the program
requirements?
• Be certified by ABP in AP or CP
• Demonstrate a minimum amount of practice
experience in an area of pathology
• Have completed a minimum amount of
acceptable CME in that area during the
previous 3 years
• Pass an examination that measures practical
knowledge related to patient diagnosis and
management
• Successfully complete one or more practical
assessments that measure particular practice
skills
We are listening
• How can we design and
deliver programs that
better meet your future
transformation needs?
• On what areas should
CAP focus in order to
bring you the greatest
value?
Change is the law of life. And those
who look only to the past or present
are certain to miss the future.
~ John F. Kennedy
When it comes to the future,
there are three kinds of people:
those who let it happen, those
who make it happen, and those
who wonder what happened.
~ John M. Richardson, Jr.