# BPH Procedural Treatment: The Case for Value-Based Pay for Performance

Authors: Mark Stovsky; Irina Jaeger
Journal: Advances in Urology
 (2008)

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## Abstract

The concept of “pay for performance” (P4P) applied to the practice of medicine has become a major foundation in current public and private payer reimbursement strategies for both institutional and individual physician providers. “Pay for performance” programs represent a substantial shift from traditional service-based reimbursement to a system of performance-based provider payment using financial incentives to drive improvements in the quality of care. P4P strategies currently embody rudimentarystructure and process (as opposed to outcomes) metrics which set relatively low-performance thresholds. P4P strategies that align reimbursement allocation with “free market” type shifts in cognitive and procedural care using evidence-based data and positive reinforcement are more likely to produce large-scale improvements in quality and cost efficiency with respect to clinical urologic care. This paper reviews current paradigms and, using BPH procedural therapy outcomes, cost, and reimbursement data, makes the case for a fundamental change in perspective to value-based pay for performance as a reimbursement system with the potential to align the interests of patients, physicians, and payers and to improve global clinical outcomes while preserving free choice of clinically efficacious treatments.


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## Body

## 1. Introduction

The
concept of “pay for performance” applied to the practice of medicine
has become a major foundation in current public and private payer reimbursement
strategies for both institutional and individual physician providers. The
number of pay for performance initiatives is growing nationwide [1]. The goal of these programs is ostensibly
to improve quality of care and to reduce healthcare costs by linking clinical
outcomes metrics with reimbursement allocation paradigms. In attempting to achieve
this objective, “pay for performance” programs represent a substantial shift
from traditional service-based reimbursement to a system of performance-based
provider payment using financial incentives to drive improvements in the
quality of care.The
current fee for service system is designed to reimburse healthcare providers
based principally on the volume of services provided, without consideration for
the quality of clinical outcomes. Clearly, though, the face of health care
resource allocation is changing and payers are beginning to scrutinize the costs
and benefits of various treatment options. Further, outcomes research and
performance-based reimbursement initiatives are underway which will change the
basis by which the performance of physicians, ancillary health professionals,
and health care institutions are assessed by payers [2]. Although many questions exist
regarding the introduction of a pay for performance (P4P) system into the field
of urology, this new powerful movement cannot be ignored.Unfortunately,
the majority of currently established quality measures are designed primarily
for primary care physicians and institutional providers such as hospitals.
Initial performance measures that could be applied to urological patients have been
released by CMS as part of its physician voluntary reporting
progress (PVRP) program [3]. Examples
include the use of thromboembolic and antibiotic prophylaxis in surgical
patients [3]. However, these P4P strategies currently embody rudimentary structure and process (as opposed to outcomes)
metrics which set relatively low-performance thresholds [3]. Further, current P4P quality assessment
programs are generally structured using negative reinforcement strategies which
penalize providers with lower reimbursement when performance standards are not
met, but which often keep maximum
attainable reimbursement at predefined par values [4]. Examples include
“straight bonus”, “at-risk financial”, and “tiered copayment” models which may
be either “competitive” (bonus payments distributed to providers based on
performance stratifications) or “noncompetitive” (bonus payments distributed to
all providers who meet a particular performance standard) [4].The net result is that initial
trials at P4P set a “low bar” for quality and cost efficiency and,
therefore, are likely to produce only nominal improvements in clinical outcomes
measures with limited global impact [3].
Moreover, rudimentary P4P metrics are unlikely to differentiate individual
providers in a meaningful way on the basis of clinical outcomes. Conversely, P4P
strategies that align reimbursement allocation with “free market”
type shifts in cognitive and procedural care using evidence-based data and
positive reinforcement are more likely to produce large-scale improvements in
quality and cost efficiency with respect to clinical urologic care.


## 2. BPH Evidence-Based Review of Common Procedural Treatment Options

The
management of benign prostatic hyperplasia (BPH) can serve as an excellent
example of how effective P4P paradigms might be structured and implemented in
urologic practice to generate meaningful improvements in clinical outcomes. BPH
is one of the most common medical conditions in the aging male population in
the US
[5]. As pharmacologic and procedural therapies for this disease evolve, myriad
studies evaluating clinical efficacy and cost effectiveness have been
published. This body of research provides a unique lens through which the
problem of implementing P4P principles in urology can be viewed.Transurethral resection of prostate
(TURP) is generally the gold standard treatment for BPH against which the
clinical efficacy of emerging technologies is measured. In 2003, Hoffman et al. published a
systematic review of randomized controlled trials to determine the clinical efficacy
of TURP [6]. The pooled mean percentage
improvement for urinary symptoms ranged from 63% to 77% with standard transurethral
resection, while improvement for peak urinary flow ranged from 96% to 127%. In
a comprehensive review of clinical outcomes and costs for BPH procedural
therapy which included an analysis of the AUA BPH guideline dataset, researchers
reported average TURP improvements from baseline AUA symptom score, maximum
uroflowmetry rate, and quality of life scores of 66%, 117%, and 73%, respectively, 2
years after treatment [7].Complications of TURP are well documented
in the literature. Rassweiler et al. recently updated the rates of
complications for TURP, including information on management and prevention based
on technological evolution [8]. In that
study, technological improvements such as the use of microprocessor-controlled
units, the implementation of video-assisted TURP, and comprehensive training helped to
reduce perioperative complications (recent versus early) including transfusion
rate (0.4% versus 7.1%), TUR syndrome (0.0% versus 1.1%), clot retention (2% versus
5%), and urinary tract infection (1.7% versus 8.2%). However, a comprehensive outcomes review by
Rhee et al. showed that TURP is associated with a substantial risk of
complications including blood transfusion, TUR syndrome, urinary incontinence,
infection, impotence, ejaculatory dysfunction, irritative voiding symptoms, stricture,
hematuria, urinary retention, and the need for retreatment which effects both treatment efficacy
and the cost of care [9].Evidence-based studies that analyze
total cost of care for procedural BPH therapies are also available. One
sophisticated peer reviewed economic analysis estimated the total payer cost
over a 2 year period from the time of treatment, including the cost of initial
treatment, follow-up care, adverse events, and procedural retreatment. According to this study, the 24-month total
procedural cost of TURP was $4927 [7]. With regards to physician reimbursement,
the Medicare 2008 fee schedule figure is approximately $783.11 for the common hospital-based
site of service (Table 1, 2008 Medicare Payment Schedule).Table 1
2008 Medicare
physician payment data for BPH procedural therapies (figures are derived using the CMS
listing for the 2008 fee schedule, the 2008 conversion factor, and the RBRVS
formula).
CPT code/procedureNonfacility Medicare payment schedule 2008Facility Medicare payment schedule 200852601 (TURP complete)N/A$783.1152647 (Indigo laser)$2457.86$606.7752648 (contact laser vaporization of prostate)$2498.50$648.1152649 (laser Enucleation of the Prostate)N/A$951.9955821 (prostatectomy, suprapubic simple)N/A$829.4553850 (microwave thermotherapy)$2901.75$536.3453852 (radiofrequency ablation)$2891.72$582.43Laser vaporization of the prostate (PVP
and HoLAP) has
gained popularity due to the ability of this procedure to ablate large volumes
of prostate tissue with decreased risk of complications. Additional advantages
include reduced need for hospitalization, shorter catheterization times, and
excellent clinical efficacy compared to standard procedural therapies and
emerging minimally invasive treatments. Rajbabu et al. studied the efficiency
of photoselective vaporization of the prostate (PVP) with the potassium titanyl
phosphate (KTP) laser in men with prostates of >100 grams [10]. The mean maximum
urinary flow rate (standard deviation) improved from 8.0 (3.1) to 18.2 (8.1),
18.5 (9.2), 17.9 (7.8), and 19.3 (9.8) mL/s at 3, 6, 12, and 24 months,
respectively. The IPSS and quality of life (QoL) scores showed similar
improvements. There were no major complications, and no patient developed
transurethral resection syndrome or required a blood transfusion [10]. Tan et al. have also published on the clinical efficacy of
this technique [11].Other researchers have performed formal
meta-analysis of KTP laser vaporization demonstrating improvements in symptom
score, maximal flow rate, and QoL scores of 76%, 221%, and 83% at 24 months,
respectively [7]. Further, when compared to ILC, TUNA, TUMT, and TURP, laser
vaporization displayed very low adverse event rates including the risks of incontinence,
UTI, impotence, ejaculatory dysfunction, irritative voiding, bladder neck
stenosis/stricture, urinary retention, hematuria, and reoperation [7].These investigators estimated the
24-month total procedural cost, including expenditures for initial treatment,
follow-up care, adverse events, and procedural retreatment to be $3589 [7]. The
2008 Medicare fee schedule reimbursement for laser vaporization differs
significantly based on the on the site of service with approximate physician
fee schedule reimbursement of $648.11 and $2498.50 for procedures performed in
the hospital and office settings, respectively (Table 1, 2008 Medicare payment schedule).Interstitial laser coagulation (ILC)
of the prostate can be performed in the hospital inpatient, hospital outpatient,
ambulatory surgery center, or office settings under local, regional, or general
anesthesia. In 1998, Williams reported the
introduction of a volume-based treatment formula with 12-month follow-up [12]. In this study, treatment outcomes were
evaluated at 3-, 6-, and 12-month intervals using the American Urological
Association (AUA/IPSS) BPH symptom score, maximal urinary flow,
prostate size, and postvoid residual urine volume. The AUA symptom score
decreased from 23.2 (range 17–28) prior to
treatment to 9.4 (range 4–14) at 3 months,
6.6 (range 5–12) at 6 months,
and 7.2 (range 4–11) at 12 months.
The maximal flow rate improved from 8.4 (range 5–10) milliliters
per second before treatment to 14.1 (range 10–20) mL/s at 3
months, 14.8 (range 10–18) mL/s at 6
months, and 16.8 (range 12–25) mL/s at 12
months after treatment. In addition, Williams reported no significant
postprocedure complications [12]. Other investigators, in a more recent comprehensive
review and meta-analysis of ILC published studies, demonstrated average
improvements from baseline of 62%, 89%, and 55% for AUA symptom score, maximum
uroflowmetry rate, and the quality of life score, respectively, at 24 months
posttreatment [7]. Unfortunately, ILC has demonstrated a relatively high risk
of reoperation with one study reporting 16% of men requiring TURP within 2
years of initial treatment of 16% [13].In comparison, another peer-reviewed
report using formal meta-analysis techniques demonstrated relatively high
adverse event rates and a weighted average probability of retreatment of 10%
along with a 24-month total procedural cost (including cost of initial
treatment, follow-up care, adverse events, and procedural retreatment) of $4754
[7]. As with laser vaporization, the 2008 Medicare physician reimbursement
depends on the site of service in which the procedure is performed. In that regard, the approximate physician
reimbursement for ILC is $606.77, and $2457.86 for the hospital and office
settings, respectively (Table 1, 2008 Medicare payment schedule).Transurethral Radiofrequency needle
ablation (TUNA) of prostate is generally performed in the
outpatient setting under local or regional anesthesia. Bouza et al. performed a
systematic review and meta-analysis of TUNA in symptomatic BPH [14]. Although
evidence was limited by methodological issues, the analysis indicated that while
TUNA significantly improved BPH parameters with respect to baseline, these
improvements did not match those achieved with TURP. In addition, the clinical efficacy
declined in the long term with a retreatment rate significantly higher than that of TURP [14].In a review and meta-analysis of
minimally invasive BPH procedural therapies, TUNA demonstrated improvements
from baseline AUA symptom score, maximum uroflowmetry rate, and quality of life
scores of 52%, 35%,
and 68%, respectively, at 6 months after treatment [7]. These rates declined at
24 months follow up to 44% improvement in symptom score and 28% improvement in
uroflowmetry rates. However, the improvement of quality of life score appeared
to be maintained at 61% [7]. This report also demonstrated the probabilities of
adverse events for the procedure to be significant, including a 31% rate of
dysuria/irritative voiding symptoms, 20% risk of urinary retention, and 17% chance
of urinary tract infection. The weighted average reoperation rate reported in
this study was 23%, the highest of all treatment modalities reviewed [7].The 24-month total procedural cost including
expenditures for initial treatment, follow-up care, adverse events, and
procedural retreatment has been estimated at $6179 [7]. An analysis of 2008
Medicare physician reimbursement for TUNA shows approximate values of $582.43 and
2891.72 for the facility and nonfacility settings, respectively. In practice,
however, the procedure is generally performed in the office site of service by
most physicians (Table 1, 2008 Medicare payment schedule).Transurethral microwave therapy (TUMT)
of the prostate also affords the advantage of being performed in the office
setting using minor sedation and local anesthesia. In evaluating clinical
measures of efficacy, Hoffman et al. performed a review of randomized
controlled trials to evaluate urinary symptom improvement, urinary function,
prostate volume, mortality, morbidity, and retreatment rates [15]. In that evaluation, the pooled mean urinary
symptom scores decreased by 65%, while the pooled mean peak urinary flow rates increased
by 70%. Compared to TURP, TUMT was associated with decreased risk of retrograde
ejaculation, the formation of clinically significant strictures and hematuria, the
need for blood transfusions, and the development of transurethral resection
syndrome. However, the analysis showed an increased risk for posttreatment
dysuria and urinary retention as well as the need for retreatment related to
deterioration in BPH symptoms [15].An analysis of reported outcomes
data from the comprehensive AUA BPH guidelines demonstrated 39%–46% symptom score improvement at 24 months [7].
Maximal uroflowmetry rate and quality of life score improvements ranged from
28%–45% and 24%–52% at 24 months,
respectively [7]. The weighted average probability
of an adverse event varied based on the equipment used, with a 74% rate of
dysuria/irritative voiding for the Prostatron Version 2.5 versus 28% when using
the Prostatron Version 2.0. The rates of reoperation again varied depending on
the system used, ranging from 10% to 16% [7]. Other commonly reported adverse
events included incontinence (range 2–6%), UTI (9%),
impotence (range 1–3%), stricture
(range 1–3%), and
retention (range 6–23%) [7].In that study, the expected cost
per patient at 24 months, including expenditures for initial treatment,
follow-up care, adverse events, and procedural retreatment was $5461 when using
Prostatron 2.0, $5488 with Prostatron 2.5 and $5699 with the Targis system [7].A review of 2008 Medicare fee
schedule physician reimbursement for TUMT indicates an approximate value of $2901.75
in the office site of service and $536.34 for a hospital-based procedure (Table1, 2008 Medicare payment schedule). However, virtually, all TUMT procedures are
currently performed in the office outpatient setting.Laser enucleation of the prostate (HoLEP) is generally
performed in the hospital outpatient or inpatient setting and provides a
relatively minimally invasive means of removing a broad range of obstructing
prostate adenomas. Studies of clinical efficacy have documented profound
improvements in outcomes metrics including symptom score, quality of life score,
and uroflowmetry rates that compare favorably to the gold standard TURP procedure
[16, 17]. In addition, HoLEP tends to
produce relatively low-adverse event rates including objective assessments for
the risks of transfusion, impotence, irritative voiding, retention,
incontinence, stricture, and UTI compared to other BPH ablation procedures [16–19]. However, HoLEP carries a relatively high risk of bladder mucosal
injury and a steep learning curve to achieve technical competence relative to other
transurethral therapies. While meta-analytic cost data comparing HoLEP to other
procedural BPH therapies is not generally available, the approximate 2008
Medicare fee schedule physician reimbursement for this procedure is $951.99
utilizing a hospital site of service (Table 1, 2008 Medicare payment schedule).


## 3. Structuring Pay for Performance in Urology: The BPH Example

Armed with a thorough understanding
of clinical outcomes, cost, and reimbursement data for commonly performed BPH
procedural options, it is now possible to examine opportunities for developing
P4P programs in urology using this disease entity as an example. To be sure, few would dispute the conceptual value
of transforming the current system of medical service reimbursement with a more
rationale, evidence-based approach. The challenge in proposing a P4P scheme for
BPH procedural therapy is to understand the method by which physician
reimbursement for professional services is calculated and the role of this
system in influencing clinical outcomes. Then, a proposal can be developed
which outlines potential ways that physician payment allocation might be restructured
to drive aggregate physician decision making toward the selection of procedural
services that result in improved outcomes while also preserving free choice from
a market basket of therapeutic alternatives with heterogeneous clinical and
economic performance characteristics.The first step in proposing an
effective pay for performance initiative for BPH procedural therapy is to
internalize the complexity of the calculation used to formulate Medicare
reimbursement for specific treatment options.
At its core, the resource-based relative value scale system for
physician payments (RBRVS) was developed from the principle that the “relative
value” of physician services is comprised of 3 essential components: (1) the
physician work expended
performing a medical service, (2) the practice expense attributable to
providing that service, and (3) the component of malpractice expense that can
be allocated to the distinct procedural or cognitive care [20]. Total Medicare
health care expenditures are limited based on the sustainable growth rate (SGR)
method which is, in turn, linked to changes in the gross domestic product (GDP)
[20]. Critical flaws of the current system of determining physician payments
for medical services include problems with the calculation of actual work input
values for specific services, the inconsistent allocation of practice expenses
for hospital, ambulatory surgery center and office-based care, and the coupling
of health expenditures with GDP which may not reflect inflationary pressures
specific to the practice of medicine. However, most important to the discussion
of P4P implementation in urology is the total absence of clinical and economic
outcomes measures or performance standards in the RBRVS calculation.A review of the previous analysis
of outcomes, cost, and physician payment data for BPH procedural treatment in
the context of the RBRVS methodology provides an unambiguous view of the way
that reimbursement strategies can affect clinical outcomes. From this review, two major points are evident. First, physician reimbursement for BPH
procedural therapy demonstrates marked variation based primarily on differences
in key inputs to the RBRVS calculation which are impacted by the technologies
employed and the site of service utilized in performing these procedures. Second, even allowing for adjustments based
on procedural overhead cost, there is clear misalignment between evidence-based
clinical outcomes measures and current Medicare fee schedule physician
reimbursement for commonly performed BPH procedures.This misalignment creates an environment
in which choices between objective outcomes measures and physician
reimbursement are in competition during the process of BPH procedural treatment
selection. In this way, the current reimbursement paradigm for BPH procedural
therapy actually works to select for less optimal clinical outcomes as
physicians are forced into an awkward position, where rational decisions cannot
be made on the basis of clinical outcomes and reimbursement at the same time. To
be sure, other factors should also play a substantial role in determining the
appropriate BPH procedural treatment for a given patient. Proper treatment
selection should reflect sound joint decision making and consumer-centered care
that reflects both the physician’s use of evidence-based information and the
incorporation of patient specific factors including the relative importance of
adverse event rates, comorbidities, location of service, objective clinical
improvement, and cost. However, by placing
reimbursement and outcomes in direct opposition, the current volume-based
methodology for allocating physician reimbursement for BPH therapies creates a
sizeable barrier to the development of a workable pay for performance program.Addressing the challenge of
proposing a viable P4P paradigm for BPH procedural treatment or any other
medical service requires several important steps. First, policymakers must fix the RBRVS/SGR
methodology to resolve recurring problems with the econometric formula
including, but not limited to, inaccuracies in the estimation of the practice
expense component for procedural reimbursement and the flawed link between
physician payment calculations and variation in the GDP [20].Second, the RBRVS formula should be modified to
embody clinical outcomes performance metrics using, for example, additional factors
that reflect the relative difference between individual procedures and services
based on measurable evidence based data. Finally, key reimbursement decision
makers should change the frame of reference from a punitive system of
individual physician performance assessment to a “supply side” approach which
utilizes a realignment of physician payments with outcomes to influence aggregate physician-patient joint decision
making.The potential benefits to
structuring an effective pay for performance paradigm for BPH procedural
therapy are enumerable. Effective treatment selection can have an enormous
impact on downstream outcomes indicators including the degree of clinical
improvement and the risk of adverse events which, in turn, largely determine
the real cost of care [7]. Further, pay
for performance methodologies that use physician reimbursement as an incentive
to value-based (as opposed to volume-based)
decision making are more likely to result in sustainable quality improvement [20]. Properly structured P4P programs can then
form the foundation upon which effective reimbursement strategy is built.Conversely, punitive P4P programs
that use rudimentarystructure and process metrics are unlikely to produce
lasting quality or cost improvements as these methodologies do little to
promote competition based on the overall value of medical services provided [20].
Moreover, these crude measures create performance standard thresholds that are
relatively easy to achieve and that promote the tendency to shape clinical
decision making simply to satisfy a particular quality metric [3]. The net
result of P4P programs based on individual physician performance assessment is
a tendency toward interval scale rankings that are unable to accurately
differentiate providers based on quality of care and which do not address the
misalignment of reimbursement and clinical outcomes present in the current
payment paradigm for BPH procedures.Hypothetically, physician
reimbursement for BPH procedures can be structured in at least 3 basic ways. At
one extreme, physician payments can be allocated without incorporating clinical
outcomes measures in the calculation. This case example results in the current
system, where the choice from among competing alternatives is based on a number
of interrelated factors. In this scenario, while procedures with superior
efficacy will sometimes be chosen, clinical outcomes in the aggregate will
never be optimized as competing incentives allow less efficacious treatments to
be selected disproportionately. At the other extreme, physician payments can be
allocated equally among the various treatment alternatives. This case would
result in an environment, where there is no direct economic incentive to choose
any one BPH treatment. In this scenario, treatment decision making may result
in the selection of procedures with healthier outcomes characteristics but the
lack of economic incentives would continue to result in a subset of providers
utilizing less efficacious alternatives for other reasons including differences
in the learning curve to master particular techniques and the capacity of some
technologies to be more amenable to volume-based practice.In the end,value-based P4P is
the only practicable way to appropriately structure BPH procedural treatment
selection to improve clinical outcomes by aligning the interests of physicians,
patients, and payers with rational reimbursement policy. In this case,
physician payments would be weighted and allocated based on a validated
analysis of evidence-based outcomes data. BPH procedures that exhibit better
outcomes performance characteristics would be allocated greater physician
reimbursement and competition between reimbursement and outcomes would be curbed.
Moreover, value-based P4P that
utilizes clinical outcomes as the core performance measure, as opposed to
punitive structure and process metrics, would move away from individual
physician performance assessment with its inherent limitations to a system that
maintains free choice from among the available treatment alternatives while at
the same time providing market-based positive reinforcement to globally influence
aggregate physician decision making toward procedures with superior
outcomes characteristics (in much the same way, for instance, as the federal
reserve shapes financial decisions through manipulations of key interest rates
and the money supply). In this way, the frame of reference and focus appropriately
shifts from the
individual provider to the therapies provided and allows physicians and patients to make rational,
evidence-based treatment decisions.Certainly, the rate limiting step
in the development ofvalue-based P4P for BPH procedural treatment or any other medical condition is the availability
of clinically meaningful outcomes criteria which can be populated with uniform
evidence-based data [3]. However,
previous research has indeed shown that high quality meta-analysis of AUA guideline
and other peer-reviewed data can be performed and meshed with Medicare cost
figures to compare BPH procedures in an unbiased fashion [7]. Further, value-based
P4P can integrate more sophisticated metrics including “total cost of care” which by incorporating factors such as the
costs of initial therapy, follow-up care, management of adverse events, and
retreatment can act as a valuable measure of clinical efficacy [7].In conclusion, doctors and other providers should be rightly
cautious about current P4P initiatives that use rudimentary metrics and
punitive reimbursement policy and which fail to differentiate participants or improve
aggregate clinical outcomes. However,
urologists, patients, and payers should embrace the concept ofvalue-based
pay for performance as a reimbursement system with the potential to
align the interests of these distinct constituencies and to improve global
clinical outcomes while preserving free choice of clinically efficacious
treatments.



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