+
Guidelines And
The New Reality:
Moving From
American
“Exceptionalism”
To A Broader Role
In Health Reform
By Susan Dentzer
Editor-in-Chief, Health Affairs
Presentation to the “Evidence-Based
Guidelines Affecting Policy, Practice and
Stakeholders” Conference
New York Academy of Medicine
December 11, 2012
+ This presentation at a glance

A quiz

Issues in guidelines and health reform

Guidelines and US health care “exceptionalism”

Guidelines in the context of the Triple Aim – the core
of health reform

Making best use of guidelines: examples and
implications

Some conclusions
+ Who Said the Following?

“Step outside the guidelines of the official umpires and
make your own rules and your own reality.”
Was it…
Dr. Jackson Avery, medical resident, played by Jesse Williams on TV
show Grey’s Anatomy. Is hardworking, driven, observant and eager, and
can be overly competitive and confident.
Or was it..
Dr. Leonard Gillespie (Raymond Massey), left, senior physician to intern
Dr. James Kildare (Richard Chamberlain) on 1960s TV Show Dr. Kildare
Or was it …
Dr. Gregory House (actor Hugh Lawrie), the know-it-all, egomaniacal
diagnostic specialist on Fox television show House
Or was it …
William Stewart Halsted, the brilliant cancer surgeon at Johns Hopkins
who invented the radical mastectomy and had an almost lifelong addition to
cocaine and later, to morphine
Or was it …
…who, against the advice of doctors, reportedly spent nine months on
“alternative therapies,” including a special diet, before finally undergoing
surgery for neuroendocrine tumors of the pancreas
+
American Guideline “Exceptionalism”

Wanting to be able to go outside the guidelines is as
American as apple pie

Despite proliferation of guidelines, wanting not to practice
“cookbook medicine” is a powerful force in American
medicine to this day

American patients often think of themselves as “unique”
and falling outside the norms of whatever guidelines exist

These forces pose a challenge in the context of health
reform initiatives that are heavily dependent on guidelines
The Triple Aim

Better health

Better health care

Lower cost

Core principle now at heart
of major U.S. payment and
delivery system reform
efforts
+
Donald Berwick, MD
Former Administrator
Centers for Medicare
and Medicaid Services
+ Essential role of guidelines

Guidelines deemed critical to quality improvement and
narrowing unnecessary variation in health care

Guidelines form basis of performance metrics that are at
heart of new payment systems

Guidelines underpin shared decision making and other
efforts to create a more patient-centered health care
system
+ The Role of Guidelines in US Health Care

Clearly essential to achieve Triple Aim

For every physician who recognizes this, there is at least
one or more who are deeply suspicious

The public is equally skeptical
+
The Pareto Principle

Also known as the 80–20
rule, the law of the vital few,
and the principle of factor
sparsity

Formulated by Italian
economist Vilfredo Pareto

States that, for many events,
roughly 80% of the effects
come from 20% of the causes

Very few Americans seem to
want to believe that they are
part of the more readily
explainable 80 percent!
+ Our ambivalence
+ Americans’ Distrust of Rigid Guidelines –
Especially About Health

E.g., reaction to U.S.
Preventive Services Task
Force guidelines on
mammography before age
50 or PSA’s

“Death Panels” – polls
show roughly 1/3 of
Medicare beneficiaries
believe these are in the
Affordable Care Act
+ Ample Reasons for Suspicion

Conflict of interest in
development of guidelines;
funding from industry

Fear that guidelines are for the
“average” patient, or “one size
fits all,” and not for me or for
my patient

See, for example, Alan S.
Gerber et al, “A National
Survey Reveals Public
Skepticism About Research-
 Overall [respondents] were more
Based Treatment Guidelines,”
likely to rate the arguments against
Health Affairs, October 2010,
treatment guidelines far more favorably
pp. 1882-1884
than expected.
+ “A National Survey Reveals Public
Skepticism About Research-Based
Treatment Guidelines”
Internet-based survey of 1,026
U.S. respondents conducted
in 2009
by Alan S. Gerber et al
Health Affairs, October 2010
Americans’ Responses To Arguments For And Against Treatment Guidelines, 2009.
Gerber A S et al. Health Aff 2010;29:1882-1884
©2010 by Project HOPE - The People-to-People Health Foundation, Inc.
+ Even Don Berwick Has Qualms
 “Leaving choice ultimately up to the patient and family means
that evidence-based medicine may sometimes take a back seat.
 “Should patient ‘wants’ override professional judgment about whether
an MRI is needed?” My answer is, basically, ‘Yes.’

“On the whole, I prefer that we take the risk of overuse along with
the burden of giving real meaning to the phrase ‘a fully informed patient.’

There should be a “mature dialogue, in which an informed professional
engages in a full conversation about why he or she—the professional—
disagrees with a patient’s choice.
 If, over time, a pattern emerges of scientifically unwise or unsubstantiated
choices…then we should seek to improve our messages, instructions,
educational processes, and dialogue to understand and seek to remedy
the mismatch.”
Source: Donald M. Berwick, “Confessions of An Extremist,” Health Affairs, Month TK, 2009.
+ Guidelines: National Qualms, Or NICE
versus AHRQ

National Institute For Health
And Clinical Excellence in
England

Has published hundreds of
guidelines – “guidances” -to date

On NICE’s web site: “Our
evidence-based
guidance…help[s] resolve
uncertainty about which
medicines, treatments,
procedures and devices
represent the best quality
care and which offer the best
value for money for the
NHS.”

Agency for Healthcare
Research ad Quality

Prohibited from creating own
guidelines after the ‘90s
upheaval

Runs National Guidelines
Clearinghouse
Andrew Dillon of NICE; Carolyn Clancy of AHRQ
+ Variation Across Markets in Episode Costs
and Care Quality for Cardiac
Catheterization (Diagnostic)
100%
98%
96%
Market Quality Score
94%
92%
90%
More than 3-fold
variation in price;
nearly 20 percentage
point difference in quality
88%
86%
84%
82%
80%
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
Median Episode Costs in Market
Note: Data includes only physicians designated as providing higher-quality care.
$16,000
+ Variability, even among “the best”

“A Collaborative

“High Value Healthcare Collaborative”, including Cleveland Clinic,
DHMC, Denver Health, Intermountain, Mayo (more since added)

Pooled data to examine differences in primary total knee
replacements (total US costs 2008 = $9 billion)

Found substantial variations in such metrics as hospital lengths-ofstay; found longer operating times associated with higher .
complication rates

Used findings to alter care, including more coordinated management
for complex patients

Cost data forthcoming

Source: Ivan M. Tomek et al, Health Affairs, June 2012 vol. 31 no. 6 1329 ff
Of Leading Health Systems Finds Wide Variations In
Total Knee Replacement Delivery And Takes Steps To Improve Value”
+ Comparison among institutions
Metric
A
B
C
D
E
Total
Mean
LOS
3.6
4.2
3.9
3.3
3.2
3.2
Median
LOS
3
4
3
3
3
3
By
MD # of
procedures
(annual)
0-99
3.6
3.8
4.4
3.5
3.3
3.5
200+
--
--
3.4
3.0
2.8
2.9
Surgery
on Mon.
3.6
4.2
3.7
3.2
2.9
3.1
On
Fri.
3.6
--
4.3
3.4
3.0
3.3
31.2%
difference,
low
to
high
16%
difference
+ “Shared Decision Making:”
Patients and Physicians

Largest observational study done to date on shared decision making
for patients contemplating joint replacement surgery for hips and
knee osteoarthritis

Group Health, system serving more than 600,000 patients in
Washington State and Northern Idaho

Intervention: use of decision aids prepared by Informed Medical
Decisions Foundation and an affiliated company, Health Dialog

Introduction of decision aids in use across Group Health system
resulted in short-term reductions in surgeries: 26 percent fewer hip
replacements, 38 percent fewer knee replacements, and lower costs
in range of 12 percent to 2 percent

Findings support concept that patient decision aids for some
conditions highly sensitive to patients’ and physicians’ preferences
for care reduce the rates of elective surgery and lower costs.

Source: D Arterburn et al, “TK,” Health Affairs, September 2012
Institute of
Medicine
Study Released
September 2012
Targets of
Opportunity
For Savings
+ Payment Innovation:
Improving Value And Affordability
Old Model
New Model
Reward unit cost
Reward health
outcomes and
population health
Inadequate focus on
care efficiency and
patient centeredness
Lower cost while
improving patient
experience
Payment for unproven
services; limited
alignment with quality
Improve quality, safety
and evidence
+ Intermountain Healthcare:
Eliminating Elective Pre-Term
Induction of Labor

Intermountain has applied evidence-based protocols and
process improvement methodology to more than 60
clinical processes that constitute roughly 80 percent of
care

Example: pre-term elective induction of labor

Elective delivery before 39 weeks’ gestation is associated
with significant neonatal morbidity; initial inductions
frequently lead to cesarean delivery

Source: Clark SL et al, “Neonatal and maternal outcomes associated with elective term delivery,”
Obstetrics, August 29, 2008.
+ Intermountain Healthcare:
Eliminating Elective Pre-Term
Induction of Labor

Intermountain system now requires that providers
demonstrate through electronic health record that all
criteria for elective deliveries are met, including length of
gestation

Results: Inappropriate elective induction rate fell 28
percent to less than 2 percent; women spend 750 fewer
hours in delivery per year

C-section rate at Intermountain is 40 percent lower than
national average, producing overall cost savings of $50
million

$10 million reduction in maternal and newborn variable
costs annually
+ IOM Consensus Study’s Conclusions, 2011

Guidelines International Network database
currently contains more than 3,700 clinical
practice guidelines from 39 countries

Nearly 2,700 guidelines in the National
Guidelines Clearinghouse, part of AHRQ

Most guidelines suffer from shortcomings in
development, including

Failure to represent a variety of disciplines
in guideline development groups

Lack of transparency in how
recommendations are derived and rated

No thorough external review process
+ IOM Study’s Conclusions

Eight standards proposed for developing
trustworthy guidelines; AHRQ should pilot test

Recommendation that all guidelines comply

Department of Health and Human Services
should create a mechanism to identify
trustworthy guidelines

Multi-faceted strategies should be carried out to
promote adherence to trustworthy guidelines

Increased adoption of EHRs and computer-aided
clinical decision support should advance
guideline promulgation but guideline developers
need to be attentive to format
+ Role of Patient-Centered Outcomes
Research Institute
“The organization was supposed to
advance the nation’s agenda on
comparative effectiveness research, but
that terminology—with its dry, clinical
connotations—had been stripped from the
name [PCORI]…
“In other words, no faceless, numbercrunching bunch of bureaucrats calculating
quality-adjusted life-years was this.
Rather, the institute would focus on
identifying the best treatments for unique
patients, and especially those most fearful
that their needs would be slighted:
minorities, the disabled, and the seriously
or terminally ill.”
Source: Dentzer interview of Joe V. Selby published
In December 2011 issue of Health Affairs
+ Difficulty of Squaring Clinical Guidelines
With Performance Incentives

“Evidence-based guidelines
are not an ideal platform for
performance incentives.”

Conceptual basis for assigning
responsibility is unclear when
a patient is treated by multiple
physicians

Performance measures based
on the most rigorous and
direct evidence often apply to
“a small, narrowly defined
patient population.”

There are considerable deficits
in state-of-the-art guidelines

Guidelines need to be tied to
strong incentives; if so they
are, they will be much more
likely to be used.”

Source: Alan M. Garber, “Evidence-Based
Guidelines As A Foundation For
Performance Incentives,” Health Affairs,
Jan.-Feb. 2005, pp. 174-179.
Accountable Care Organizations
+ ACO’s and Performance Metrics

In Medicare Shared Savings Program, ACOs required to
report on quality measures for each of three performance
years

ACOs must report and achieve performance improvement
on 33 quality distinct quality measures in four different
domains: Patient/Caregiver Experience; Care Coordination
and Patient Safety; Preventative Health; and At Risk
Populations.

Measures are based on existing guidelines in these areas
+ Growing Sophistication of Use of
Guidelines in Assessing Performance

“The Global Outcomes Score’: A Quality Measure, Based
on Health Outcomes, That Compares Current Care To A
Target Level Of Care”

David M. Eddy et al, Health Affairs, November 2012

New method for measuring quality of care, e.g., for
members of ACOs

GO Score = proportion of adverse outcomes expected to
be prevented in a population under current levels of care
compared to a target level of care, such as 100 percent
performance on certain clinical guidelines
+ Need to Build Trust
+
Some
Conclusions
“I don’t believe there’s any problem in
this country, no matter how tough it is,
that Americans, when they roll up their
sleeves, can’t completely ignore.”
The Late Comedian
George Carlin
“The Americans always do the right thing…after
they’ve exhausted all the other alternatives.”
Sir Winston Churchill
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The End
The End