The Cost of Hysterectomy: The Affordable Care Act and Why PAGS Conference

The Cost of Hysterectomy:
The Affordable Care Act and Why
MIS is More Relevant Than Ever
PAGS Conference
Dec 13, 2013
Amanda Nickles Fader, MD
Associate Professor and Director,
The Kelly Gynecologic Oncology Service
Johns Hopkins Hospital
Disclosures
• Ethicon Endosurgery consultant
Research Interests
• Minimally invasive surgical innovations
• Health care reform and impact on
delivery of gynecologic and oncology
care
MIS Surgeons Celebrity
Endorsements/Commandments
“Laparotomy is a sin!” “Robotic surgery makes
me feel young again!”
-Ted Lee, MD;
MIS fellowship director,
Magee-Womens Hospital
-Tommaso Falcone, MD
Chairman, CCF
Let’s Talk Money
• Discussion on costs of anything is not sexy
• But it’s practical and very relevant to our
survival as surgical speciality
• In an evolving health care landscape with
increasing scrutiny on medical practices, are
your surgical preferences supported by the
literature in terms of outcomes/costs/patient
satisfaction?
At a cross roads…
The Best of Times and the
Worst of Times…
• Era of surgical
innovation
• Rapidly rising health
care costs
• Gadgets and
technology options in
the operating room
abound!
• Evolving performance
metrics
• More surgical choices
for patients
• Reimbursement models
changing
Objectives
• Discuss how the Affordable Care Act will
impact our approach to gynecologic surgery
• Define patient satisfaction, quality, cost and
value with respect to hysterectomy surgery
• Review current U.S. hysterectomy trends
• Review the cost-effectiveness of various
hysterectomy types and less invasive options
Patient Protectection and
Affordable Care Act 2013
• The most significant regulatory overhaul of the U.S.
healthcare system since the passage of Medicare and
Medicaid in 1965
• Goals: increasing quality/affordability of health insurance,
lowering the uninsured rate, and reducing healthcare costs
• Delivery Reforms
– Accountable care organizations – global capitated payment to
care organization with primary care, specialty care and hospital
care.
– Meant to reward for quality (overall outcomes AND patient
satisfaction)
ACA Continued
• Payment Reforms
– Episode based payments for hospital based
surgery and other episodes of care
– Value-based purchasing - payment dependent
upon metric performance
– Pay for performance – payment incentives for
specific metric performance
ACA and the Current U.S. Health
Care Economy
• In a health care economy with limited
resources, providers and consumers of
health care services need to be
accountable for the end result and the
cost of care
• Measurement of benefits and costs is
challenging
What Does this Mean for the
Gynecology Surgeon?
Downsides
– Reduced payments for
hospital-acquired
infections and other
complications
Upsides
– Payment incentives for
increased outcome quality
– Payment incentives for high
patient satisfaction scores
– Move towards single
payment for management – Standardization of health
of disease
care delivery may improve
overall outcomes
– Lower volume surgeons
may be at risk
– High volume surgeons
likely to benefit
Balancing Quality and Cost
with Hysterectomy
• Huge requirement for savings in the health system +
• Limited budget available for health care +
• Increased demand to be clinically excellent have led to
the need to evaluate cost and effectiveness of
treatments
• Introduction of new technology for hysterectomy as
well as the push for shorter hospital stays
– New data are needed to estimate the most cost-effective method
of hysterectomy
Defining the Terms
•
•
•
•
Quality
Patient Satisfaction
Cost
Value
Patient Satisfaction =
Quality?
Quality
• An emerging health care policy issue
• Classic clinical measures of quality are clinical
outcome and avoidance of complications
•
Institute of Medicine: “The degree to which health
services for individuals and populations increase
the likelihood of desired health outcomes and are
consistent with current professional knowledge”
• Centers for Medicare & Medicaid Services (CMS),
hospitals, and insurance providers striving to better
define and measure quality of health care (QoHC)
What are typical quality
measures for hysterectomy?
• Surgical site infection
• 30-day perioperative complications
• Readmissions
• Survival
• Guideline-adherent care
Quality Measures
• These metrics do not:
1). Adequately reflect the overall patient’s health
care experience or
2). The impact of the intervention (ie hysterectomy
on health-related quality of life, including the
disease-specific outcome (ie successful relief of
pain, bleeding or treatment of cancer)
IOM Recommendations
• Dramatically improved information
technology infrastructure
• Patient safety initiatives
• Reform medical education: developed the
concept of “the core competencies”
An Early View on the Merits of
MIS and Patient Satisfaction
• “The cleaner and gentler the act of
operation, the less pain the patient suffers,
the smoother and quicker the
convalescence, the more exquisite her
healed wound, the happier her memory of
the whole incident.”
-Lord Moynihan, MD; 1917
Famed Bristish Surgeon
President, Royal College of Surgeons
Patient Satisfaction
• Patient satisfaction a key determinant of QoHC and
component of pay-for-performance metrics
• CMS Hospital Inpatient Value-Based Purchasing
(HIVBP) program, Medicare reimbursements linked to
patient satisfaction and surveys completed by
patients
• 2013: CMS will make value-based incentive payments
to acute care hospitals based, on results of patient
satisfaction surveys completed
• Critical that gynecologic surgeons better understand
this vital and complex issue
Patient Satisfaction Continued
• Multifaceted and a challenging outcome to define
• Patient expectations of care, attitudes and
psychosocial factors contribute to satisfaction
– Pain, depression
• Surgeons focused on surgical technique and
objective outcomes as measures of “patient
satisfaction”
• Patients place great value on the surgeon-patient
interaction
Why Does This Matter?
• CMS uses Hospital Consumer
Assessment of Healthcare
Providers and Systems
(HCAHPS) survey to assess
patient satisfaction in
Medicare patients after an
inpatient hospitalization
• First national, standardized,
and publicly reported survey
of patients’ perspectives of
hospital care
How Do We Define Cost in
Surgery ?
• Measuring cost of care is complex
• Encompasses direct costs of treatment
• May include indirect societal costs
• What about costs to the surgeon?
What Impacts
Costs/Reimbursement?
• Complexity of the
procedure
• Surgeon skill set and
learning curve
• Length of procedure and
patient comorbidities
• Utilization of PAs, cosurgeons versus
residents/fellows as
assistants
• Turn over times and OR
efficiency
• Payor mix
• Choice of tools/equipment • Insurance carriers and
negotation of
rates negotiated
reimbursement rates
Direct vs. Indirect Costs
Direct Costs of Care
• Hysterectomy type
• Cost of instrumentation
/technology
• Anesthesia time
• Pathology consult
• OR time/staffing
• Surgeon or consultant
fees
• Length of Stay
• Intraop complications or
unexpected consults
Indirect/Downstream Costs
• Time away from work or
family role
• Loss of productivity
• Cost of caretakers
• Impairment of QoL
• Long-term effects of
treatment/complications
• Cost to the surgeon
(fatigue, back/neck
injury)
What is Value?
• Value proposition in health care
• An analysis of the benefits of care
relative to the direct cost and risk of
providing the care
What is Value?
• Excellent
outcomes
• Low morbidity
rates
= HIGH VALUE!
• Happy Patients
• Care at low cost
Value of a Surgical
Procedure
• Many ways to measure value of a procedure
• Current process measures such as blood loss,
time of operation, rate of PE/DVT, visceral injury
and SSI, readmission to hospital and “take back
surgery”
• Some are collecting disease-specific and generic
health outcome measures from which utility
scores can be calculated
Value Depends on
Perspective: Patient
• Easy access, rapid communication, a
clean and efficient office, short wait
times, pleasant staff
• Sometime process is even more
important than quality outcome
because difficult for patient to evaluate
differences in outcomes
• Cost often not an important factor in
the eyes of the patient unless a direct
out-of-pocket payment
Value Depends on
Perspective: Hospitals
• Hospitals and facilities providing care may
measure outcome and costs by factors that
affect their short-term, single admission
interaction, including:
– LOS
– Health care services utilization
– Complications
• Most studies on hysterectomy costs only
examine inpatient or short-term outcomes
Value Depends on
Perspective: Payor
• Want to increase enrollment which means
customers must be happy with both the
process and outcome, cost is most critical
• May focus on a timeframe that is longer that
a single admission, and may include:
– Readmission within 90 days, or cost of outpatient
care.
• So…if cost is higher there has to be benefit
Hysterectomy Trends
• The most common gynecologic surgical
procedure performed in the United States
• One of the most common performed
worldwide
• Accounts for over $5 billion health care
dollars
Percentage of U.S.
Women Undergoing
Hysterectomy
20%
Age
40
33%
65
43%
85
U.S. Hysterectomy Rates
by Year
Wright JD, Obstet Gynecol, Aug 2013
Most Hysterectomies
Benign
• 9/10 hysterectomies are performed for
noncancerous conditions
• Usually not life threatening GYN problem, but
may have a negative impact on quality of life
• New, improved alternatives are increasingly
employed and are responsible for the fall in
the rate of hysterectomies performed in the
last decade
Benign Hysterectomy
Trends
80%
60%
40%
20%
10%
Hysterectomies for
Malignancy
• Life threatening
• 70% for
endometrial cancer
• 20% ovarian
cancer
• 10% ovarian
cancer
• Always medically
indicated to
perform surgery
Oncology Hysterectomy
Trends
100%
80%
60%
40%
20%
When Is It Reasonable to
Consider Hysterectomy?
• When less invasive interventions are:
– Unsuccessful
– Not tolerated
– Unacceptable to the patient or felt by
physician to be inappropriate for the
treatment of the clinical condition
– A gynecologic malignancy is diagnosed
Evaluating the necessity
of hysterectomy
• 497 women who had benign hyst between 1993-1995
in So. California
• Appropriateness assessed using two sets of criteria
– RAND/UCLA appropriateness method
– ACOG criteria sets for hysterectomies
• Most common indications were fibroids (60%), pelvic
relaxation (11%), pain (9%), and bleeding (8%)
• 70% of the hysterectomies did not meet
appropriateness criteria recommended by the expert
panel and 76% by ACOG criteria hysterectomy
Hysterectomy Route…Now
What?
• The route chosen depends upon:
– The woman's clinical circumstances
– The surgeon's technical expertise and
training background
– The surgeon's personal preference
– Availability of surgical tools/technology
AAGL Position Statement
“It is the position of the AAGL that
most hysterectomies for benign
disease should be performed either
vaginally or laparoscopically and that
continued efforts should be taken
to facilitate these approaches.”
“ Surgeons without the requisite
training and skills required for the safe
performance of VH or LH should enlist
the aid of colleagues who do or should
refer patients requiring hysterectomy
to such individuals for their surgical
care.”
SLS Society Position
Statements
• “Given advantages that VH and LH offer to women,
their families, their employers, and the health care
system in general, it seems desirable to optimize
their application in women requiring hysterectomy
because of benign uterine conditions”
• “Abdominal hysterectomy should be reserved for the
minority of women for whom a laparoscopic, robotic
or vaginal approach is not appropriate”
The Laparotomy Problem
• Professional organizations and research
institutes have issued guidelines in
support of minimally invasive procedures
– Vaginal and laparoscopic hysterectomy in
particular, when choosing the method of
hysterectomy
• Despite these recommendations and
evidence of superior health and economic
outcomes, most hysterectomies continue
to be performed via laparotomy
Why?
• Women's health organizations recommend
avoiding laparotomy, and advise abdominal
hysterectomy (AH) only when the vaginal or
laparoscopic route is not possible or ruled out
• We must ask ourselves why practice tends to go
against this consensus
• Why are so many hysterectomies still performed
by laparotomy when the majority of choles and
appendectomies are performed via MIS?
Difficult Issue
• If not trained in residency/fellowship,
difficult (and costly) to adopt new
practices
• No incentivization for referral to the
more experienced MIS surgeon
Abdominal Hysterectomy
• AH is not currently contraindicated
• Sufficient surgical resources that demonstrate
superiority for it to be relegated to the end of the
list of options
• Scientific evidence favors VH and laparoscopic
hysterectomy (LH)
– Lower complication rates, produce less postoperative
pain and shorter hospital stays, improved QoL, and
allow a more rapid return to normal activity
Vaginal Hysterectomy and
Costs Savings
• Society of Pelvic Reconstructive Surgeons
estimate a potential saving of US
$1,184,000 for every 1000 hysterectomies
performed via the vaginal route
• Reduction in complications of 20%
• Subsequential indirect economical
benefits (e.g., hospital stay and early work
incorporation)..
Vaginal Hysterectomy
• Offers great access to the uterus
• Fulfills criteria MIS (natural orifice)
• The vagina is the most cost-effective “trocar portsite” permitting uterine manipulation, pelvic
dissection and easy removal of the specimen
• Multiple previous C-sections, abdominopelvic
surgeries or with precancerous/cancerous
pathology
EVALuate Trial
• Two parallel randomized trials
– One comparing LH with AH
– The other comparing LH with VH
• 1346 women had surgery, 950 followed up at one
year
• Higher complication rate and longer OR time in
LH arm vs. AH, but better QoL at 6 weeks, faster
recovery and shorter hospital stays in LH arm
• No differences in VH study, longer OR times in LH
arm
Garry R, Brit Med J, 2004
Cost Effectiveness of LH vs
AH vs. VH
•LH more costly than AH
hysterectomy, though additional
costs are lower in comparison with
AH than with VH
•The LH has a small beneficial
effect in terms of quality adjusted
life years (QALYs)
•LH not cost effective relative to
VH
•May be cost effectiveness
compared with AH, especially if
disposables used
Schulfer et al, Brit Med J, 2004
Evaluate Trial: An
Unrealistic trial population?
• Majority of hysterectomies 12 week size or less
• Mean BMI: 26
• Mean number of Ceserean sections: 0
• Mean uterine size: 6 weeks
• No information on how many more AH or VH
versus LH surgeries surgeons had performed
Cost of Vaginal, Abdominal,
Robotic and Laparoscopic
• In 2009, 688 patients underwent a benign
hysterectomy
• 185 (26.9%) hysterectomies were abdominal, 135
(19.6%) vaginal, 352 (51.5%) laparoscopic, and 14
(2.0%) robotic.
•
The rate of intraoperative complication was 1.7% for
abdominal, 0.8% for vaginal, 0.3% for laparoscopic,
and 0 for robotic.
Wright, Einnarson, JSLS 2013
Cost Study
• Mean total patient costs were $43,622 for
abdominal, $31,934 for vaginal, $38,312 for
laparoscopic, and $49,526 for robotic
hysterectomies.
• Costs were significantly influenced by
method of hysterectomy, operative time,
and length of stay
Laparoscopic Hyst Costs
• Disposable vs.
• FRED or anti-FOG = $40
undisposable trocars
– 3-4 disposable trocars • Carter-Thomason
= $100-160
Device = $150
• Uterine manipulator--$88100
• Skin glue = $30
• Multifunctional
instrument (Ligasure,
Harmonic) = $350-500
• Sutures = $15
• Morcellator = $150-300
x1-3
• Endostich device = $150
Grand total = >$1200
Laparoscopic Hyst: Cost
Saving Measures
• Consider non-disposable
trocars
• Consider bipolar, PK and
monopolar energy
• Can shave $500-600
off costs
• Alternatively, some
technology may help
• EEA sizer or sponge stick
decrease OR costs
by decreasing OR
time
• Morcellate manually
• Suture with needle drivers
Robotic Hysterectomy: Costs
Compared to Open
Historic
Cohort
N=160
da Vinci Cohort
N=180
p-value
$6,623
$2,658
<.001
237
2,977
<.001
Without amortization
10,368
7,644
<.001
With amortization
10,368
8,370
.002
Hospital
accommodations
OR Costs
Overall Costs*
Data from: Lau S, Outcomes and Cost Comparisons After Introducing a Robotics Program for
Endometrial Cancer Surgery. Obstetrics & Gynecology. 2012 April; vol 119(4):717-724.
Adoption of MIS: Evidence from
Brigham and Women’s Hospital
Total Mean
Cost
2006
2009
% Difference
P
Composite
Cost
11,812 ±8,510
12,296 ±6,606
4.1
0.142
Abdominal
Hysterectomy
13,347 ±9,855
12,678 ±7,471
-5.0
<0.147
Laparoscopic
Hysterectomy
9,288 ±4,050
12,329 ±6,317
32.7
<0.001
Vaginal
Hysterectomy
7,693 ±2,378
11,820 ±6,000
53.7
<0.001
Robotic
Hysterectomy
16,004 ±2,397
11,004 ±4,208
-31.2
<0.001
High volume surgery matters!!
Surgeons appear to be more efficient and costs go down w/
increasing cases and further along learning curve
GM Jonsdottir et al. Increasing minimally invasive hysterectomy: effect on cost and complications
Obstet Gynecol. 2011 May;117(5):1142-9
Robotic Conventional vs. Single
Site Costs
Instrument
dV Single-Site
Cost Estimate
dV Multi-Port Cost
Estimate
Monopolar Hook/
Scissors
$140
$320
Bipolar Maryland
or PK® Dissecting
Forceps
$270
$270
Needle Driver
$130
$220
Single-Site Port
$150
---
Seals & MCS Tip
Cover
$72
$70
Trocars
(reusable) $0
$50
Drapes
$200
$200
Total
$962
$1,130
Johns Hopkins
Reimbursement Model
Vaginal
LSC
Total
52
81
174
169
Mean
LOS
1.2
1.4
1.3
3.5
0.01
$5900
$7600
$8700
$20,020
0.01
Total
Costs
$13,050
$14,700
$15,081
$33,800
0.01
Net
Margin
$5613
$4990
$5591
$6,091
0.05
OR Costs
Robotic
ABD
P value
65%
MIS
Simple hysterectomies (uteri <14 weeks, <2-3 pelvic surgeries,
Benign disease = VH or LH
Difficult or malignant/radical hysterectomies (cervix CA,
Stage IV endometriosis = robotic or AH
Robotic Hidden Costs
• Most robotic studies do not incorporate
the expensive capitol and maintenance
costs of the robot:
• $2.5 million cost (does not include
Firefly, Single Site etc)
• $110,000/yearly maintenance and
instrument costs
Succesful Robotic
Programs
• Very high volume
• 3-5 cases/robot day
• Difficult cases mix
• Oncology, endo, myomectomy,
prostatectomy, cardiac surgery
Critical Appraisal of the
Hysterectomy CostEffectiveness Literature
• No consistent methodology for
measuring costs
• Most studies did not look at
downstream costs (readmissions,
longterm patient outcomes, cost of
complications)
Assessing Trends in Hyst
Training
Preparedness of
Hyst Training
Residency
Program
Director
Trainee
Vaginal
38.1%
27.8%
Laparoscopic
28.6%
22.2%
0%
2.8%
76.2%
58.3%
Robotic
Abdominal
Burkett et al, Female Pelvic Med Reconstr Surg, 2011 Sep
Resident Education
• What direction must we take in the future?
• Must improve the training of resident doctors in
vaginal and laparoscopic surgery.
• Vaginal anatomy often taught inadequately
• The ability to perform some of the technical
aspects of VH, such as opening the anterior and
posterior peritoneum should be as routine as
opening abdomen layers for a gynecologial
surgeon
And What About The
Surgeon?
• Frasniak et al, Am J Obstet Gynecol
2012
– 88% of gyn surgeons report back or neck
pain with vaginal or laparoscopic surgery
– Needs assessment or “Save the Surgeon”
Program desperately needed
Controversy with Surgical
Trials
• Very little information on skill set and experience
of the surgeon participants in the trials
• Where are they at in their learning curve?
• Must be equally skilled in both modalities studied
• (ie VH vs. AH or LH vs. RA-LH etc)
• Argue that only high volume, experienced
surgeons should be allowed to enroll patients
The Impact on Surgical
Innovation
• How do we innovate in an era of high health
care costs and reform?
• Innovation allows for clinical progress but
expensive
• Surgeon learning curves with new technology
• More support from industry and simulation
Health Care Policy Changes
• Hysterectomy policy requires a change
• How much money could be saved if standard
guidelines were followed?
• Essential to explore all the medical tools available to
treat uterine disease in order to offer our patients
more conservative treatments or MIS options
Hysterectomy CostEffectiveness Summary
• There is no clear cut answer for every
type of patient re: the perfect choice in
hysterectomy
– Related to patient, surgeon, hospital and
disease-related factors
• For MOST (likely ≥80%), open
abdominal disease is NOT the right
answer
Hysterectomy CostEffectiveness Summary
• Vaginal hysterectomy the safest route and
has the best cost–effectiveness ratio,
making it the first-choice option in clinical
practice
– 14 week size or less
– Benign disease
– No history of advanced endometriosis/frozen
pelvis
– No adnexal masses
– **Refer to high volume vaginal surgeon if you
are not comfortable
Hysterectomy CostEffectiveness Summary
• LH cost effective in the following indications compared
with AH:
–
–
–
–
Risk-reducing hysterectomy +/- BSO
Adnexal masses
Endometriosis
Very large uteri
• RA-LH potentially cost effective in high volume centers
when used for the following indications compared w/ AH
or LH
– Cancer staging
– Radical hysterectomy (cervix, uterine or stage IV endometriosis
– Myomectomy
Another Look at the ACA…
• Quality
• Patient
Satisfaction
• Costs
• Value
• How do we pull this all
together and consider:
– Patient value
perceptions/goals
– Hospital financial goals
– Third-party payor goals
– Surgeon preferences
and goals
GYN Program Goals
• 75% or higher MIS hysterectomy rate
• Develop departmental policies regarding
appropriateness for VH, LH, RA-LH and AH
– Similar to
• Monitor patient satisfaction scores and measure
short and longterm objective measures (surgical
outcomes, complication rates)
• Develop skill in at least one MIS option, but
versatility within a practice or individual surgeon
key
How do we solve the
problem of volume?
• Not enough hysterectomies for all GYNs to be
high volume surgeons (defined as n=~25/year)
• Designate 1-2 individuals in a practice to perform
all hysterectomies
– Incentive referral to high volume surgeons
• “Teach the teachers” program at Hopkins—low
volume surgeons have opportunity to learn from
and operate with a high volume surgeon
• Separate the O from the G in residency training
An Argument for Surgical
Versatility
•
Use of technology in medicine has historically outpaced the
availability of data to support rapid adoption
– Market forces may influence consumers, physicians and
health care organizations
•
Are controlled data available to justify widespread adoption
of a technology?
•
Are claims of clinical superiority sound?
•
Is health care resource utilization being optimized?
Conclusions
• In 1996 Stovall and Summitt concluded: “well
designed clinical trials examining short term
outcomes, economics, and quality of life were
required to determine the role of laparoscopic
hysterectomy”
• Still need more than ever
• Need gynecology surgeons as stakeholders at
the table to help define quality indicators for
straightforward vs. medically/surgically complex
patients
The Bottom Line
• Must merge good old fashioned customer
service with surgical innovation and new
thinking
• High volume surgeons have better
outcomes..but are they more likely to
provide quality outcomes at lower costs?
Acknowledgments