Transcript Title goes here – this sample illustrates a two

Transforming Health Care:
A State Purchaser’s Perspective
Leah Hole-Curry, JD
Washington State Health Care Authority, Health Technology
Assessment
,May 21, 2010
Conflicts and Overview of Agency

CONFLICT DISCLOSURE:
Leah Hole-Curry -WA HCA
– Employed by state government
– No funding or other resources conflict
– no unlabelled/ unapproved use disclosure



Cabinet level agency of approximately 275 employees
Administers 2 health care programs:
– Public Employees Benefit Board (State employees & retirees)
 Self-Insured PPOs (Uniform Medical Plan, Aetna)
 Fully Insured Plans/MCOs (Group Health, Kaiser)
– Basic Health (Income eligible, state-funded program)
Ancillary programs
– Community Health Services (CHS) – Grant Awards
– Prescription Drug Program (PDP)
– Health Technology Assessment (HTA)
– Washington Wellness (state employees & retirees)
The State Budget and Health Care

State budget faces a $2.8 billion shortfall

The state will spend nearly $7 billion to provide medical coverage to millions of
Washington residents in the 2009-11 budget period … about 33% of the budget.
Juvenile/Adult
Corrections (inmate
health care),
$281,686 ,000
Community Clinics,
$25,068 ,000
K-12 Employees,
$1,588,705 ,000
Home Care Worker
Health Benefits,
$101,505 ,000
Medical Assistance
Programs,
$3,582,184 ,000
Child Care Worker
Health Benefits,
$8,700,000
State/Higher
Education
Employees,
$1,040,600,000
Basic Health
$337,757,000
2
Total health benefit cost per employee rises 5.5% in 2009,
the lowest annual increase in a decade.
Workers' earnings
Annual change in total health benefit cost per employee
Overall inflation
20.0%
18.0%
17.1%
16.0%
14.7%
14.0%
12.0%
12.1%
10.0%
8.0%
11.2%
10.1%
8.0%
7.3%
6.0%
6.1%
8.1%
10.1%
7.5%
5.6%*
6.1% 6.1% 6.1% 6.3%
5.5%
4.0%
2.5%
2.0%
2.1%
0.0%
-1.1%
0.2%
-2.0%
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
*Projected
Source: Mercer’s National Survey of Employer-Sponsored Health Plans; Bureau of Labor Statistics, Consumer Price Index,
U.S. City Average of Annual Inflation (April to April) 1990-2009; Bureau of Labor Statistics, Seasonally Adjusted Data from
the Current Employment Statistics Survey (April to April) 1990-2009.
How a Large Purchaser Can Impact the Market

Must change the delivery system to impact cost and quality
– Driving change through purchasing

Must target manageable changes for the long haul (lesson learned from 1993)

Governor targeted key initiatives early and stuck with them
– Emphasis on evidence-based health care
– Promote prevention and healthy lifestyles
– Better manage chronic care
– More transparency in health care system
– Better use of health information technology

Focus has endured despite a bad economy and politics pressure

This focus has helped other employers, health plans and provider groups to think
differently
4
Dartmouth Atlas Identified Issues:
Unwarranted Variation

There are structural problems in the current delivery system
– Underuse of Effective care and Quality Variation
 Align pay incentives; Chronic care management focus; Facilitate Patient
information exchange; Wellness Promotion
– Overuse of Supply Sensitive Care
 Manage Capacity, Reward quality not volume, Promote Conservative Practice
Patterns
– Misuse of Preference Sensitive (Discretionary Treatments)
 Outcomes Research and Shared Decision Making

The Atlas points to three strategies
– Improving the scientific basis of care delivery
– Promoting the growth of organized, accountable care
– Shared savings programs- to reduce overuse and improve coordination
Wennberg, et al. http://www.dartmouthatlas.org/atlases/Unwarranted_Variations.pdf
6
Variability:
Back Surgery per 1,000 Medicare Enrollees (2002-03)
10.0
9.0
8.0
7.0
6.0
5.0
4.0
3.0
Spokane
Tacoma
Olympia
Yakima
Seattle
Everett
Port Angeles
2.0
1.0
7
6.2
5.7
5.3
4.5
4.2
4.1
2.8
Health Care Quality Defects Occur at Alarming Rates
Sources: modified from C. Buck, GE; Dr. Sam Nussbaum, WellPoint; Premera 2004 Quality Score Card; March of Dimes
IRS Phone-in Tax Advice
Recommended
well-child visits (WA)
Treatment of
Bronchitis (WA)
Breast cancer
Screening (WA)
Adverse drug
events
Defects per million
1,000,000
100,000
10,000
1,000
100
Hospital acquired infections
U.S. birth defects
Detection &
treatment of
depression
Hospitalized patients
injured through negligence
Overall Health Care
Quality in U.S.
Airline baggage handling
(Rand Study 2003)
U.S Airline
flight fatalities/
U.S. Industry
Best of Class
NBA
Free-throws
10
1
1
2
3
4
5
6
(69%)
(31%)
(7%)
(.6%)
(.002%)
(.00003%)
∑ level (% Defects)
Evidence Based Health Care

Cutting edge programs that have become part of our offerings:
– Prescription Drug Program

Preferred drug list used by PEBB, Medicaid, and workers compensation programs
– Drug Purchasing Consortium

Pooling of state and private purchasing power, used by PEBB & workers compensation
– Health Technology Assessment

State pays for procedures and medicine that show evidence of efficacy, cost-effectiveness,
and safety

Estimated savings of $27 million since 2007
– Patient decision aid pilot

Focus on high-variation, preference-sensitive areas that involve multiple options and
tradeoffs, e.g. cardiac disease; breast & prostate cancer
– Advanced imaging management

Using evidence based guidelines, identify highest cost/utilization advanced diagnostic
imaging services for state programs
9
Why Health Technology?

Part of an overall strategy

Medical technology is a primary driver of cost
– The development and diffusion of medical technology are primary
factors in explaining the persistent difference between health spending
and overall economic growth.
– Some health experts arguing that new medical technology may
account for about one-half or more of real long-term spending growth.
Kaiser Family Foundation, March 2007: How Changes in Medical Technology Affect Health Care Costs

Medical Technology has quality gaps
– Medical technology diffusing without evidence of improving quality Highly
correlated with misues, overutilization, underutilization.
Cathy Schoen, Karen Davis, Sabrina K.H. How, and Stephen C. Schoenbaum, “U.S. Health System
Performance: A National Scorecard,” Health Affairs, Web Exclusive (September 20, 2006): w459
10
HTA Program Elements
1. HCA Administrator Selects Technology
Nominate, Review, Public Input, Prioritize
Semi-annual
2. Vendor Produce Technology Assessment Report
Key Questions and Work Plan, Draft, Comments, Finalize
2-8 Months
3. Clinical Committee makes Coverage Determination
Review report, Public hearing
Meet Quarterly
4. Agencies Implement Decision
Implements within current process unless statutory conflict
11
2. Evidence Report
Key Questions and Work Plan, Draft, Comments, Finalize
Fifteen reports to date
• Comprehensive, unbiased, peer-reviewed technology assessment
reports that summarize and rate the available clinical literature.
• Highlight that many technologies have widespread use and a lot of
evidence, but the data is unreliable, low quality, or absent on health
benefit and value.
• Out of the hundreds of thousands or articles, more than 6,000
potentially relevant articles were identified, and 1073 were reviewed,
and 383 articles were critically appraised:
Av Days Av Month
Public Comment
83
2.8
Report
155
5.2
Overall
435
14.5
KEY HTA Products
Pay for What Works: Better Information is Better health

Transparency: Publish topics, criteria, reports, open
meeting

Technology Assessment Report: Formal, systematic
process to review appropriate healthcare technologies.

Independent Coverage decision: Committee of practicing
clinicians make decisions that are scientifically based,
transparent, and consistent across state health care
purchasing agencies.
Key focus questions:
• Is it safe?
• Is it effective?
• Does it provide value (improve health
outcomes)?
13
HTA Outcomes

Technologies selected
– 17 technologies selected since 2007
 3 first year; 5 second year; 8 third year

Analysis completed
– Over 6,000 articles/trials reviewed
– 15 comprehensive technology assessment reports

Coverage Decisions
– 9 public meetings and 13 decisions, where reliable evidence:
 7 show benefit and support coverage for certain situations
 5 do not yet show benefit and are not covered
 1 shown unsafe or ineffective
– Estimated $27 million cost avoided
– Projected Utilization impact: 3 increased; 3 same; 7 decrease
14
Health Technology Assessment Program Outcome
Topic
Health Technology Assessment Program
Evidence
CostDate
Safe
Effective
Effective
Decision
Health
Benefit Coverage
Utilization
Impact
(annual figure)
Upright MRI
May-07
Equal
Insufficient
Less
N/A
No
$2,990,000
Ped Bariatric Surgery <18
Aug-07
Insufficient
More
Insufficient
No
$0
Ped Bariatric Surgery 18-21
Aug-07
Less
More
Insufficient
Yes
Lumbar Fusion
Nov-07
Less
Equal/More
Less
Yes
No
Yes/
Conditions
Yes/
Conditions
$5,240,639
$589,485
Discography
Feb-08
Insufficient
Insufficient
Insufficient
No
No
$324,000
Virtual Colonoscopy (CTC)
Feb-08
Equal
Equal/More
Less
No
No
$11,100,000
Insufficient
Equal
No
No
$691,326
Equal
Less
No
No
$400,000
Intrathecal Pump for chronic noncancer
Feb-08 pain
Insufficient
Arthroscopic Knee Surgery
Aug-08
Less
Artificial Disc Replacement
Nov-08
Equal
Computed Tomographic
Angiography (cardiac)
Nov-08
Equal
Equal
Equal/More
Yes
Cardiac Stents
May-09
Equal
Equal/More
Less
Yes
Equal/More Insufficient
Yes
Yes/
Conditions
Yes/
Conditions
Yes/
Conditions
0*
$5,063,928
$966,760
$27,366,138
*Insufficient current data to calculate conservative estimate.
ConsumerReports.org
10 overused tests and treatments
November 2007
1 BACK SURGERY. … surgery, which can cost $20,000 plus physician's fees …..
2 HEARTBURN SURGERY. operation, costs $14,600 or more
3 PROSTATE TREATMENTS. . over treated with surgery that costs $17,000, or by
radiation therapy for $20,700
4 IMPLANTED DEFIBRILLATORS. … cost some $90,000 over a lifetime.
5 CORONARY STENTS. Billions are spent each year….
6 CESAREAN SECTIONS. ..cost almost $7,000, about 55 percent more than natural
delivery...
7 WHOLE-BODY SCREENS. CT scans, which can cost $1,000 … no proven benefits
for healthy people. A few CT scans a year can increase your lifetime risk of cancer.
8 HIGH-TECH ANGIOGRAPHY. Using a CT …costs an average of $450...standard
angiography is sometimes still needed.
9 HIGH-TECH MAMMOGRAPHY. Using software to flag suspicious breast X-rays
would add $550 million a year to national costs if used for all mammograms. But a 2007
study found that this technique failed to improve the cancer-detection rate significantly,
yet resulted in more needless biopsies.
10 VIRTUAL COLONOSCOPY. …Though less costly than a standard colonoscopy, the
virtual test isn't cost-effective because any suspicious finding requires retesting with the
real thing.
Copyright © http://www.consumerreports.org/cro/health-fitness/index.htm 2000-2006 Consumers Union of U.S., Inc.
16
New Health Purchasing Focus:
Hierarchy of Evidence
Best:
Meta-analysis of large randomized head-to-head trials.
Large, well-designed head-to head randomized controlled
clinical trials (RCT):
Long-term studies, real clinical endpoints
Well accepted intermediates
Poorly accepted intermediates
Smaller RCTs, or separate, placebo-controlled trials
Well-designed observational studies, e.g., cohort studies,
case-control studies
Safety data without efficacy studies
Case series, anecdotes
Least:
Expert opinion, non-evidence-based expert panel reports, and
other documents with no direct clinical evidence
17
Evidence in Health Care Decision Making

Level 3: “What would I recommend to the state or
nation?”
– Must be based on rigorous assessment of the scientific
evidence.
– Affects hundreds of thousands, even millions of people.


Level 2: “What would I recommend to my patient/client?”
– Influenced by prior experience, but the scientific evidence may
play a greater role.
– Affects possibly hundreds of people.
Level 1: “Would you have this done for yourself or for
someone else in your immediate family?”
– Influenced by one’s personal experience with the disease and
capacity to deal with risk.
– Affects few people.
Used with Permission from Dr. Mark Helfand, OHSU
18
Evidence for use in Policy
Decisions
Different Data Sources

Efficacy
– How technology functions in “best environments”



Randomized trials-distinguish technology from other variables
Meta-analysis
Effectiveness
– How technology functions in “real world”



Population level analyses
Large, multicenter, rigorous observational cohorts (consecutive pts/objective observers)
Safety
– Variant of effectiveness



Population level analyses
Case reports/series, FDA reports
Cost
– Direct and modeled analysis


Administrative/billing data (charge vs cost)
Context
– Mix of historic trend, utilization data, beneficiary status, expert opinion
19
3. HTCC Decision Basis

Clinical Committee Decision must give greatest weight to most
valid and reliable evidence
– Objective Factors for evidence consideration

Nature and Source of evidence

Empirical characteristics of the studies or trials upon which evidence is based

Consistency of outcomes with comparable studies
– Additional evaluation factors

Recency (date of information)

Relevance (applicability of the information to the key questions presented or participating agency programs and clients)

Bias (presence of conflict of interest or political considerations)
WAC 182-55-030: Committee coverage determination process
20
3. Health Technology
Clinical Committee
Chair:
Brian R. Budenholzer, MD, FAAFP
Vice-Chair:
C. Craig Blackmore, MD, MPH
Members
– Megan Morris, CPO, LPO
– Lydia Bartholomew, MD, MHA, CPE, FAAFP
– Louise Kaplan, RN, MN, PhD, ARNP
– Michael Myint, MD, MS
– Carson E. Odegard, DC, MPH
– Richard C. Phillips, MD, MS, MPH
– Michelle Simon, PhD, ND
– Michael Souter, MB, Ch-B, DA, FRCA
– Chris Standeart, MD,
21
What’s the Real Problem?
•We want to pay for Highly Effective Benefits!
• We have to be careful not to pay for Ineffective and Unsafe Benefits!
• We need a process for Everything in between!
Grades the evidence
A
B
C
D
Confidence
High
?
Limited
Low
Benefit
Large
Moderate
Unknown/Inferior
Topic Background:
Disease/Diagnosis

Coronary heart disease (CHD) is an important public
health concern, very prevalent where patients range
from no symptoms to chest pain (angina), to heart
attack- myocardial infarction (MI), or death.
Prediction of risk and symptoms is difficult.

Treatment includes:

– Manage and reduce risk
– Medication therapy
– Surgical treatment by mechanically opening the artery


Use of PCI has steadily risen over past decade while
bypass remains relatively unchanged and PCI accounts
for over 60% of surgical treatment.
Unanswered questions remain about best use of each
option, when, and for what patients
23
Topic Background:
Selected Topic




Cardiac stents are small tubes placed in an artery to
keep it open. Stents are either not coated (bare metal
stents) or coated with a drug (drug eluting stents)
Stent advantages include physically opening the artery
and being less invasive than bypass surgery
Stent disadvantages include targeted solution to
widespread disease, unclear protocols, clotting and reoperation
Important, unanswered questions remain about whether
and when stent placement is appropriate versus other
medical management or surgery.
– What patient, disease level, and timing are best for this invasive
procedure
24
Agency Prioritization

Safety concern: High
– Primary safety concerns: long term risks, procedure risks, frequency,
FDA panel findings on thrombosis for DES off label.

Efficacy concern: High
– Primary concerns: efficacy of stenting to prevent death or major cardiac
event and high stent diffusion with low or mixed evidence on
appropriateness
– Concerns about high use variation especially 70% non-FDA approved
uses in generally sicker or more complicated patients; drug eluting stent
use; use instead of optimized medical therapy in lower risk patients and
instead of CABG in high risk patients;

Cost Concern: Medium
– Cost concerns reflect mainly concern about over or mis-utilization, and
wide cost differences between treatment choices.
25
WA Cardiac Stent Procedure Utilization:
2004-2007
Clinical Outcomes Assessment Program (COAP)*
Year
2004
15,158
2005
15,330
2006
15,686
2007
14,164
10,022
5,136
10,146
5,184
10,265
5,421
9,135
5,029
34%
34%
35%
36%
PCI Procedures with Stents
13,348
14,104
14,542
13,032
% stented PCIs
Count of All Stents
Count of Bare Metal Stents
Count of Drug-Eluting Stents
% Bare Metal Stents
88%
18,860
3,224
15,636
17%
92%
19,931
1,408
18,523
7%
93%
21,048
2,122
18,926
10%
92%
19,688
5,214
14,474
26%
Total PCI Procedures**
No Prior PCI
Repeat Procedures
% Repeat Procedures
* A program of the Foundation for Healthcare Quality in WA state
** Inpatient and outpatient procedures
26
WA Public Purchasing
Cardiac Stent Procedure Utilization: 2004-2007
2004
Total Costs*
2005
2006
2007
$14,263,103
$15,505,519
$17,218,988
$16,544,589
988
1010
1040
954
Bare Metal***
175
80
117
283
Drug-Eluting***
781
919
904
650
Total Procedures**
* Inpatient, outpatient, Medicaid and Uniform Medical Plan as primary and secondary payors
** Procedure codes 36.06, 36.07, 92980, 92981, G0290 and G0291 performed as primary or secondary procedure
*** Excludes patients who received both types in same procedure
Average Per Procedure Costs
Inpatient
Bare Metal
Drug-Eluting
BMS/ DES Difference
$22,360
$26,497
$4,137
$13,038
$17,345
$4,307
Outpatient
Bare Metal
Drug-Eluting
27
Key Questions

Key Questions: Stent Focus
– Originally Off Label usage
– Change Direction to create overview of stent use to set context and
take advantage of initial research,
– Focus review on well defined and studied sub-topic: Bare metal stents
versus drug eluting stents
– Removes some controversy of stent question of overall when or whether to
cover, focuses on which type
– Remains significant issue due to high utilization of drug eluting stents (local and
agency data about 80%)
– Recent FDA focus on safety concerns of DES
– Agency’s cost of over $3,000 additional for DES

Future Topic
– Broader questions remain on when and in whom stents are most
appropriate. May be informed by subsequent topics, reviews, or
potential collaborative and other agency efforts.
28
Evidence Report: Primary data sources
•
HTAs or similar reports
2
(Hill, ECRI) did own meta-analysis of RCTs
 1 (KCE) used results from previous meta-analyses
 1 (Ontario) did meta-analysis on registry studies
 4 (Hill, KCE, Ontario, FinOHTA) did full economic analyses
•
Meta-analyses published after HTAs
1
meta-analysis in general populations included 38 RCTs, N =
18,023 (Stettler 2007 Lancet 370(9591): 937-48)
1
meta-analysis with outcomes for diabetic patients separated
and length of anti-platelet therapy evaluated from 35 RCTs, N
= 14,799 (Stettler 2008 BMJ 337: a1331)
HTA Report interpretation: What we know
Effectiveness


There is no statistically significant difference between DES and BMS with
regard to death, cardiac death or myocardial infarction up to 4 years.
DES are consistently associated with lower rates of TLR
Safety



While no statistically significant differences in stent thrombosis or late stent
thrombosis were seen, analyses may be underpowered; no comparative studies
for bleeding
Among diabetic patients, < 6 months of dual anti-platelet therapy was
associated with a 2-fold increase in death and cardiac death with DES but there
was no difference in MI regardless of therapy duration
Nonrandomized studies show mixed results for death and MI
Cost:
Most extensive CEAs concluded DES were not cost-effective in general
populations; ICERs driven by DES cost, #,TLR
Guidelines:
 Professional guidelines do not address use of DES vs. BMS

Remaining Questions
EFFECTIVENESS
 Are statistically significant findings also clinically significant? Are the risk
differences of public health importance?
 How should the relative importance of the various outcomes be weighed, over
the short-term and over the long-term?
 What are the specific indications for DES vs. BMS in general and special
populations? What are the indications for TLR?
SAFETY
 Is TLR/TVR correlated with decreased rates of death, cardiac death and MI
over the long term? Why or why not?
 How might newer DES designs or drugs compare with BMS for various
outcomes in the short term and long term?
 What is the long term safety of prolonged anti-platelet use?
COST
 Will methodologically rigorous US-based CEAs draw different conclusions from
HTA CEAs as ICERs are driven by DES cost, number of stents and TLR?
 How does comparison of DES vs. BMS fit within the bigger context of
comparative effectiveness with medical therapy, CABG and other treatments?
Cardiac Stents (HTCC Decision)

Effective? Majority voted that the comprehensive evidence
reviewed shows DES and BMS effective
The committee identified four key health outcomes that impacted effectiveness;
with three have high quality evidence available.
– Freedom from Cardiac Mortality: the committee concluded that data from
multiple RCTs demonstrated that there is no overall or cardiac related benefit
with DES compared to BMS.
– Freedom from Myocardial Infarction (MI): the committee concluded that the
data from multiple RCTs demonstrated that there is no benefit from DES
compared to BMS in reducing rates of MI.
– Freedom or reduction of revascularization (TVR): the committee concluded that
data from multiple RCTs demonstrates a benefit of an 11% reduction in the rate
of revascularization with use of DES compared to BMS.
– Quality of Life: the committee believes that quality of life is an important health
outcome to demonstrate overall effect of treatment, but concluded that there
was not reliable data to conclude whether DES provided a benefit over BMS.
The committee discussed the previous revascularization reduction as a
component of quality of life
32
Cardiac Stents (Decision)

Safety?
Majority voted that the comprehensive evidence
reviewed shows DES and BMS are equally safe
– Morbidity related to Stent Thrombosis: The committee agreed with the evidence report
conclusions that these are rare events, where even the larger RCT’s and observational
data may not be powered to detect. However, the best available meta analysis of RCT
data shows difference relied heavily on the most recent meta-analysis with four year
follow up: 1.4% SES; 1.7%PES and 1.2%BMS.
– Bleeding: the committee concluded that bleeding is a very serious complication. Due to
dual anti-platelet therapy proscribed with DES, this complication could be higher in DES;
but not enough information and registry data, though lower quality, showed equivalence
with 3.4% BMS vs 3.6% DES rate.
– Stent Fracture: The committee agreed that this issue was not applicable since evidence
was not obtainable on this outcome and no other reason to believe rates between the two
stent types would be different.

Value?
The committee agreed that overall, DES is not cost-effective, especially
considering the state’s $3,600 differential, where lower price premiums produced staggering
cost per QALYs.

For certain subpopulations of high risk patients, some HTAs reported, and five committee
members agreed that DES is cost-effective.
33
WA HTA Cardiac Stent Coverage Decision

Based on the deliberations of key health outcomes, the committee decided
– that the current evidence on Cardiac Stents demonstrates that there is sufficient
evidence of a health benefit to cover the use of cardiac stents, but limit the use of
Drug eluting stents to certain circumstances.
– The committee found that drug eluting stents were proven to be equivalent to bare
metal stents in safety and efficacy overall. The committee found that drug eluting
stents were proven to be more effective in one area: reducing revascularization, and
were proven to cost more

Bare Metal Stents are covered without conditions.

Drug eluting stents are conditionally covered for:
– Stent diameter of 3 mm or less;
– Length of stent(s) of longer than 15 mm placed within a single vessel;
– Patients with diabetes mellitus;
– Stents placed to treat in stent restenosis; or
– Treatment of left main coronary disease
34
Change is a Journey
•
•
Lessons learned
•
Be Transparent
•
Engage the provider community
•
Find Common Values
•
Make Consistent Coverage Decisions
•
Make Bias Free zones
Challenges
•
Resource intensive
•
Collaborations involve time and tradeoffs
•
Cultural change - new decision model (not persuasion, expert or political clout)
•
Often identifies information gaps
35