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Part XI
Looking Forward
Design ofPayment
andReimbursement Strategies
forFocal Therapy forAcceptance
inValue-Based Care Models
AvinashMaganty, NeilMendhiratta,
AlexanderP.Kenigsberg, DavidJohnson,
CaryN.Robertson, andVishnukamalGolla
40
Introduction
An unsustainable rise in healthcare costs has
spurred the need to shift how we dene value in
our care system and structured reimbursement.
The status quo fee-for-service system incentivizes
the delivery of more, higher-margin services
regardless of outcomes achieved. Alternatively, in
Value-Based Payment (VBP) models, hospitals
and physicians are rewarded for delivering highquality patient outcomes at a reasonable cost [1].
The Affordable Care Act (2010) accelerated
the expansion of VBP models, principally by
founding the Center for Medicare and Medicaid
Innovation (CMMI) to develop and test new
A. Maganty
From the Dow Division of Health Services Research,
Department of Urology, University of Michigan,
Ann Arbor, MI, USA
N. Mendhiratta · A. P. Kenigsberg
Urologic Oncology Branch, National Cancer
Institute, National Institutes of Health,
Bethesda, MD, USA
D. Johnson
Department of Urology, University of North Carolina
School of Medicine, Chapel Hill, NC, USA
C. N. Robertson · V. Golla (*)
Department of Urology, Duke University School of
Medicine, Durham, VA, USA
Department of Surgery, Division of Urology,
Durham, VA, USA
e-mail: Vishnukamal.golla@duke.edu
healthcare payment and delivery models that
improve quality and reduce costs. CMMI is
responsible for implementing accountable care
organizations (ACO), bundled payments, and
several other models for special populations at a
national scale, which have become foundational
VBP programs. In addition to Medicare
Advantage plans, many commercial payers and
employers have increasingly focused on valuebased care to control costs while improving quality and experience for their members and
employees. Providers and healthcare delivery
organizations successfully participating in this
transition to value are gaining strategic, nancial,
and clinical advantages. Similarly, pharmaceutical and medical technology companies are taking
notice of this expanding value-based ecosystem
and are starting to adapt their business models
accordingly.
As a surgical specialty, urology has always
been a leader in adopting new technologies.
Unfortunately, most specialists, including urologists, remain unfamiliar with VBP models with
minimal active participation [2]. Despite the reasons for the slow uptake of VBP models in urology being multifactorial, the emergence of focal
therapy for prostate cancer presents an opportunity for the urology community to examine the
reimbursement challenges in our legacy fee-forservice system and explore the potential for VBP
models to alter the payment landscape for new
technologies.
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
T. J. Polascik et al. (eds.), Imaging and Focal Therapy of Early Prostate Cancer,
https://doi.org/10.1007/978-3-031-66754-1_40
477
478
A. Maganty et al.
In this chapter, we aim to provide urologists
with a clearer understanding of the current state
of VBP models in prostate cancer. We discuss the
current state of reimbursement for focal therapy
and highlight opportunities to improve the adoption of this treatment modality within the context
of VBP.
Value-Based Payments andIts Impact
onProstate Cancer Treatment
The transition to VBP for specialty care remains in
a nascent stage but has started gaining signicant
traction in recent years. This increasing focus on
specialty care has been driven, in part, by the
Centers for Medicare & Medicaid Services (CMS)
mandate to have a majority of Medicare beneciaries in some form of accountable care relationship
with providers by 2030 [3]. In such relationships,
providers take on a degree of responsibility for
both quality and cost of care and agree to tie some
portion of their reimbursement to these metrics.
For accountable care organizations to be successful in these models, specialty providers must have
aligned incentives around both cost and quality
metrics for populations of patients [4].
A concerted effort has been to develop VBPs
that focus on high-cost specialty areas. In specialty care, episode (procedural) or conditionbased bundles are the most common form of
APM. In this arrangement, specialists are
accountable for all costs and quality related to a
single procedure or condition. CMMI has tested
several models that hold hospitals and providers
accountable for medical and surgical episodes of
care initiated either in the inpatient or outpatient
setting, including post-acute care (the Bundled
Payment for Care Improvement (BPCI) and
Bundled Payment for Care Improvement—
Advanced (BPCI-A) Models). For orthopedics, a
Comprehensive Care for Joint Replacement
(CJR) Model holds providers and hospitals
accountable for all care related to a joint replacement surgery. There are condition-based models
for advanced kidney disease and oncology care
that are longitudinal and episodic, respectively
[5, 6]. Episodic VBP models have also emerged
in other specialty areas (i.e., kidney transplant,
bariatric surgery, colonoscopy, etc.) through contracts with commercial health plans and employers. As a result, this type of VBP is most familiar
to surgeons and procedural specialists [2].
However, despite this focus on specialty care,
urology has largely remained absent from direct
participation in VBP initiatives, even for high
volume, high spend clinical conditions such as
prostate cancer. In 2016, the Large Urology
Group Practice Association (LUGPA) proposed a
condition-based payment model for newly diagnosed localized prostate cancer [7]. For several
reasons, this proposal did not meet criteria for
implementation by CMS. Currently, the only
urology-specic VBP model with a commercial
health plan is a pay-for-performance model that
rewards appropriate utilization of active surveillance and watchful waiting for low-risk prostate
cancer patients [8].
Despite the lack of a prostate cancer-specic
payment model, focal therapy may have an outsized role in the future management landscape of
localized prostate cancer in a value-based ecosystem if longer-term efcacy can be conrmed.
Compared to the current gold standards of surgery and radiation, focal therapy may result in
improved patient-centered functional outcomes
and lower cost. Payers, employers, and ACOs
that are responsible for total cost of care of their
patient populations are focused on identifying
and promoting innovative care models and treatment approaches that provide better clinical outcomes at lower cost, while also improving patient
experience. As focal therapy’s role in prostate
cancer treatment evolves within an expanding
value-focused ecosystem, urologists must gain an
understanding of VBP models to help optimize
the adoption of this treatment modality.
How Regulatory Policies
andInsurance Coverage Impact
Payment Strategy Design
Understanding regulatory policies and how
insurance companies make coverage determinations is critical for designing VBPs for newer
technologies such as focal therapy. In this section, we detail how the FDA currently addressed
40 Design of Payment and Reimbursement Strategies for Focal Therapy for Acceptance in Value-Based…
479
approval for medical devices and provide perspectives on how medical policy for focal therapy was developed.
Food andDrug Administration (FDA)
Authorization ofMedical Devices
The U.S.Food and Drug Administration (FDA)
plays a pivotal role in evaluating and clearance of
new medical devices, ensuring they meet rigorous safety and effectiveness standards before
being marketed and used by healthcare providers.
This includes those used in focal therapy.
The FDA offers different regulatory pathways
for medical device approval based on the device’s
risk and intended use. These pathways include:
• 510(k) clearance: For devices substantially
equivalent to an existing legally marketed
device (i.e., predicate device).
• Premarket approval (PMA): For high-risk
devices requiring comprehensive scientic
evidence, including clinical data, to demon-
strate safety and effectiveness.
• De Novo Classication: For novel devices that
do not have a predicate device, allowing a
risk-based assessment.
Another relevant regulatory pathway is the
FDA’s breakthrough Device Designation, which
is designed to accelerate the development and
review of certain medical devices that offer substantial benets over existing alternatives for
patients. While this designation does not guarantee approval, it streamlines the regulatory process
to support the development of novel devices.
Currently, the FDA statutory standard for medical devices sets a far lower bar than that required
for drug approvals. This is a result of a policy
decision established in 1997. During this time, the
U.S.Congress determined that including randomized controlled trials (RCTs) to generate effective
data for medical devices hindered patient’s access
to novel devices. As a result, Congress prohibited
the FDA from requiring more than “reasonable
assurance” about device safety and efcacy and
RCTs “only where appropriate.” This differs signicantly from a pharmaceutical approval, which
is much more stringent as the FDA favors largescale human clinical trials.
Traditionally, FDA approval requires that
manufacturers conduct preclinical testing to
assess device safety and performance. This can
include laboratory testing, animal studies, and
bench testing. The FDA then reviews these data
to ensure the device’s design, material, and
mechanisms are appropriate for human use.
Specically, the FDA’s approval for focal therapy
was contingent on establishing clinical safety by
showing that the device’s ablative eld did not
extend outside of the targeted volume. Moreover,
they included safety endpoints that looked at but
were not limited to erectile dysfunction, urinary
incontinence, voiding symptoms or dysfunction,
urethral strictures, rectal stulas, and osteomyelitis pubis [9].
To date, there are three currently FDAapproved focal therapy modalities such as cryotherapy, high-intensity focused ultrasound
(HIFU), and laser ablation. Cryotherapy was
approved with a 510(k) clearance in the early
1990s, and HIFU was de novo approved in
October 2015 with a caveat that it is cleared for
ablation of prostate tissue and not necessarily for
prostate cancer. Most recently, Avenda Health
received 510(k) FDA clearance for its focal laser
ablation system in December 2020 [10].
Understanding the fundamentals of FDA regulatory statutes serves as an essential foundation
for developing reimbursement pathways in focal
therapy, as it has important implications for insurance coverage. However, the FDA approval does
not guarantee that insurance companies will automatically cover reimbursement for the device.
Instead, insurance companies utilize a different
set of criteria when evaluating if a particular
device for focal therapy should be approved.
Insurers often point to the lower FDA regulatory
standards as a reason not to reimburse [11].
Commercial Insurance Standards
forMedical Device Coverage
Insurance coverage for a new device only occurs
when it satises both the clinical conditions set
forth by the FDA and the individual payer’s evidence standards. Payers often set higher standards for the reimbursement approval of new
technologies, such as focal therapy, which may
include additional factors such as the device’s
480
A. Maganty et al.
medical necessity and cost. Payers are primarily
focused on the cost-effectiveness of the new
device relative to other standard-of-care options
and how new devices may impact beneciary
enrollment into their plan. However, commercial
payers do not need to abide by Medicare or FDA
evidence guidelines.
With this in mind, we reviewed the medical
policies for focal therapy for a variety of insurance policies to provide guidance on how insurers are evaluating reimbursement for focal
therapy [12–17]. In general, each of these medical policies provides an extensive review of the
literature with an updated report yearly of the
most current evidence. Decisions to reimburse
are made by evaluating key issues of patient
selection, lesion selection, therapy monitoring,
and modalities used to ablate prostatic lesions
when evaluating for coverage.
These medical policies are similar and cover
data available on ve modalities (Laser ablation,
HIFU, cryoablation, radiofrequency ablation
(RFA), and photodynamic therapy). Importantly,
these coverage policy documents are discussions
that ultimately delineate why many health plans
have taken the position that focal therapy is considered “investigational and not medically necessary” for the treatment of prostate cancer. The
reasons outlined include:
1. Highly heterogenous and inconsistently
reported clinical outcomes.
2. Lack of prospective comparative evidence for
focal therapy vs. current standard of care
treatments (radical prostatectomy, externalbeam radiation, and active surveillance).
3. There is a lack of standardization of methods
to determine the type of lesions and the number of identied lesions that should be treated
to optimize clinical outcomes.
4. Stronger evidence of improvement in better
functional outcomes with focal therapy.
5. Inability to prioritize the effect of the focal
therapy on overall survival due to shorter follow- up periods and small sample sizes.
6. Unclear strength of data on adverse event rate
(which for focal has been shown to be supe-
rior to standard of care) because the evidence
is limited in its quality, reporting, and scope.
7. Lack of clarity from cost-effectiveness data
for focal therapy.
These are all important considerations when
considering perceived gaps in the data and key
points to include when advocating for medical
policy changes and more favorable reimbursement with health plans. It is worth noting that
some insurance plans cover HIFU.Later sections
of this chapter will cover the policy recommendations to help drive effective reimbursement
strategies.
Current State ofReimbursement
forFocal Therapy inProstate Cancer
Prostate cancer focal therapy reimbursement
models can vary by country and healthcare system. In the U.S., Medicare and private insurance
companies typically cover treatments that are
considered medically necessary and have been
proven effective. While published reports on clinical outcomes for patients receiving prostate cancer focal therapy appear promising, it remains a
relatively new strategy with limited long-term
outcome data, which is reected in the coverage
determinations of Medicare and commercial
payers.
Since 1999, Medicare has provided coverage
for cryotherapy for the primary treatment of
localized prostate cancer, primarily based on
clinical reports demonstrating the safety, efcacy,
and medical necessity for whole gland therapy
[18]. Since then, no other ablative therapy was
covered through CMS until salvage whole gland
HIFU was approved in April 2020 [19]. Following
this, a CMS-approved CPT code (55880) allowed
partial Medicare Part B reimbursement of hospital outpatient facility costs associated with HIFU
treatment. Beginning in 2023, the reimbursement
level for hospital facilities performing HIFU procedures was increased to $8557.53 for hospitalbased procedures and $4280.98in the ambulatory
care setting [20]. Despite this, patients seeking
40 Design of Payment and Reimbursement Strategies for Focal Therapy for Acceptance in Value-Based…
481
treatment with HIFU may incur high out-ofpocket costs in the form of copayments, deductibles, and professional fees [21].
Unlike Medicare, private insurance coverage
for focal therapy is variable, with coverage criteria encompassing factors such as treatment setting (primary versus salvage), ablation energies,
and other individual circumstances. Many managed care plans –HMOs and PPOs– require prior
authorization before treatment with focal therapy.
Indeed, specic payers (i.e., regional divisions of
Blue Cross & Blue Shield) require prior authorization for prostate ablation using HIFU and do
not offer reimbursement for any other type of
prostate focal therapy modality regardless of
clinical circumstances, citing heterogeneous and
incomplete reported clinical outcomes to justify
such treatments. In such cases, patients interested
in focal therapy may opt to pay out-of-pocket.
Self-pay models can also vary in cost to the
patient, with some centers charging patients only
for the treatment. In contrast, others charge
patients for all care episodes, including pretreatment workup and posttreatment follow-up, with
costs ranging up to and above $25,000 per treatment [22].
While current reimbursement strategies make
it feasible for patients to receive focal therapy in
select circumstances, challenges include inconsistent insurance reimbursement criteria and
incomplete coverage. From a healthcare cost perspective, the potential escalation of lifetime costs
if patients receive more than one focal therapy
treatment is a concern. Indeed, while retreatment
rates up to 20% may be considered clinically
acceptable by society guidelines, multiple retreatments may quickly lead to signicantly increased
expenditures for potentially modest improvements in clinical quality of life outcomes [23].
Another avenue for patients to obtain focal
therapy without incurring costs is through enrollment in clinical trials. Currently, over 95 focal
therapy trials are registered and actively recruiting on ClinicalTrials.gov, with an additional 20
registered trials due to open recruitment in the
future [24]. Enrollment in a clinical trial offers
several advantages, including nancial support
for treatment and, often, treatment-related
expenses (study-related procedures, travel, lodging, lost income, etc.) and access to novel therapeutic modalities.
The reimbursement landscape for medical
treatments can change with the evolution of best
practices and standards of care. It is essential to
verify coverage and reimbursement details with a
patient’s specic insurance company when considering therapy options, especially for relatively
novel treatments such as prostate cancer focal
therapy. As the advantages and long-term efcacy of focal therapy techniques are further
dened in clinical trials, insurance coverage for
this treatment modality is sure to change in relation to clinical trial results.
Designing Value-Based
Reimbursement Strategies forFocal
Therapy
The overall goal of any value-based payment
model is to incentivize quality and care efciency. Unsurprisingly, this laudable goal is challenging to achieve, as models must align the
often-conicting interests of multiple stakeholders, including those of patients, physicians, and
payers. While clearly challenging to design and
implement, successful payment models may be
developed by employing a framework provided
by the Center for Healthcare Quality and Payment
Reform. In this section, we leverage this framework to outline the key components to consider
for a value-based reimbursement strategy for
focal therapy. Specically, successful payment
models must allow for sufcient exibility in
how services are reimbursed, provide accountability for spending, and ensure appropriate
quality.
Payment forServices
Payment models must clearly dene the set of
services being reimbursed and under what circumstances those services are reimbursable.
482
A. Maganty et al.
Ideally, models should provide physicians with
sufcient exibility to deliver high-quality, costeffective care yet tailored to individual patient’s
needs. Increased exibility is derived from the set
of services covered under a single payment (i.e.,
the larger the number of services, the greater the
provider has the exibility to provide care without generating incremental costs to the payer). In
general, there are several common payment
methods for services that could be applicable to
focal therapy: pay-for-performance, episodebased bundled payments, and capitation models.
Performance-based payments link some portion of reimbursement with quality of care and
outcomes. This often involves either providing a
bonus payment (and sometimes penalties) or
adjustments in the payment rate based on prior
performance on quality metrics. Applying such a
model to focal therapy would require dening
quality measures relevant to focal therapy in the
context of more extensive existing pay-forperformance programs, such as the Merit-based
Incentive Payment System (MIPS) initiated by
CMS in 2017. However, currently, few measures
in the program are relevant for urologic conditions, and none are relevant for focal therapy
[26]. Furthermore, pay-for- performance models
typically do nothing to ensure appropriate treatment and, in fact, can incentivize increasing volume and “cherry- picking” of healthier patients.
Focal therapy is amenable to an episode-based
payment model, that provides a single payment
to cover all treatment-related services, from diagnosis to posttreatment care. For example, this
may include evaluation and management ofce
visits, diagnostic testing (i.e., multiparametric
MRI, targeted prostate biopsies, and genomic
testing), the therapy itself (i.e., cryoablation,
high-intensity focused ultrasound, etc.), follow up (repeat PSA testing, repeat MRI, and repeat
biopsies), and retreatment. This payment model
incentivizes providers to achieve optimal clinical
outcomes from a focal therapy treatment with the
most efcient use of resources. Challenges of
episode-based bundled payments include dening the set of services to cover in the bundled
payment, determining the appropriate price of the
payment given the variability in patient acuity,
and dening episode timing (episode trigger,
duration, and termination). Additionally,
procedure- specic, clinically relevant quality
measures are essential to ensure that providers do
not skimp on necessary care to lower costs. Like
pay-for-performance, bundled payments may
also incentivize volume, particularly among
patients who are expected to have better
outcomes.
Condition-based bundled payment models
provide a set payment per patient for care of a
given condition, typically over an extended
period of time. In this instance, payment would
be provided for all prostate cancer-related services rather than for a specic treatment. Instead
of reimbursing providers for each individual services related to their prostate cancer, this type of
model incentivizes providers to provide the most
efcient treatment that best aligns with patients’
preferences and disease biology. These models
most effectively align incentives around valuebased outcomes but are very challenging to
administer and are the most severe departure
from the status quo payment model. Conditionbased bundled payments have all of the same
challenges as episode-based bundled payments
but are magnied given the greater degree of
clinical variability, a broader set of included services, greater opportunity for “leakage” of services outside of the control of the primary
provider, and a longer time frame.
Controlling Spending andUtilization
Inherent in value-based payment model design is
a mechanism to incentivize judicious spending.
Such incentives can vary depending on the mechanism of reimbursement for services within a
given model. For example, bundled payment
models dene costs for episodes of care based on
benchmarks determined from either prior performance, national trends, or peer performance.
Providers are incentivized to reduce spending
because they either obtain a portion of the savings or are liable to repay spending that exceeds
the benchmark. Similarly, capitated payment
models provide a lump sum payment per patient,
40 Design of Payment and Reimbursement Strategies for Focal Therapy for Acceptance in Value-Based…
483
and providers are then responsible for spending
judiciously. Spending in pay-for-performance
models, on the other hand, is just one component
of how providers are assessed. The extent to
which they may constrain utilization is contingent upon how much weight is placed on the
spending component and how clinically valid the
quality measures are.
Evaluating costs, particularly for specialized
care such as focal therapy for prostate cancer, can
pose several challenges. First, costs must be
appropriately allocated to a provider’s scope of
care. Prostate cancer is often managed like a
chronic condition, and therefore, men can have
signicant interaction with the health system
over their lifetime. Some of this care may be
related to prostate cancer and some may not.
Furthermore, it will be important to dene the
time horizon over which providers are held
accountable for cost as those undergoing focal
therapy are closely followed and may require
retreatment, either with additional focal therapy
or other strategies (i.e., radiation or surgery).
Ensuring Appropriate Quality
Quality assessment is essential for a value-based
program design. The institute of medicine denes
six quality domains for healthcare services such
as safety, efcacy, patient-centeredness, timeliness, efciency, and equity [27]. Dening quality
measures is not trivial and requires a careful balance between accurate quality assessment and
measurement burden. Measures must have a
strong evidence base to provide validity.
Measures should span multiple quality domains
to ensure a balanced assessment of care. The set
of measures need not be comprehensive, but
rather, a parsimonious set that would be most
impactful for patients undergoing focal therapy
should be prioritized. Importantly, measures
must be assessed without excess burden to
providers.
The American Urologic Association (AUA)
has not yet dened quality measures for focal
therapy. While the AUA has endorsed several
measures suitable for public reporting for pros-
tate cancer care, almost all these measures focus
on processes (e.g., avoiding the use of bone scans
for patients with low-risk disease) rather than
outcomes. Although data for focal therapy will
require continued maturation to dene clinically
valid quality standards, it is conceivable that
measures may span the continuum of focal therapy care. For example, quality pretreatment
assessment may be determined based on using
validated questionnaires to assess functional status, measures of shared decision-making, and
clinical appropriateness. Diagnosis may require
the use of certain imaging modalities and specic
biopsy techniques (targeted vs. saturation vs. systematic biopsy alone) to most appropriately
select candidates for focal therapy. Unlike other
therapeutic options such as prostatectomy or
radiation, appropriate posttreatment follow-up
for focal therapy requires periodic biopsies.
Dening successful treatment remains challenging and may require assessing both functional
and oncologic outcomes, including treatment
failure and/or retreatment rates. Consensus denitions of treatment failure, including pathologic
outcomes and location of failure (in-eld failure
or out-of-eld), must be dened. Similarly,
benchmark retreatment rates must be established
for different patient populations. We will discuss
potential measures of quality and the current
state of evidence supporting them in the next
section.
Dening Quality Measures forFocal
Therapy
Current evidence for focal therapy demonstrates
signicant heterogeneity regarding oncologic
outcomes. The reasons for this are likely multifactorial. There are potential drivers of quality
along the care continuum, including diagnosis
and risk stratication, patient selection, treatment, and follow-up. Reimbursement strategies
could be targeted toward each of these episodes
of care to drive high-quality treatment.
Accurate initial diagnosis and risk stratication depends on high-quality multiparametric
MRI. There is a high level of variability in the
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A. Maganty et al.
quality of MRI scans obtained, which is further
compounded traditionally by interobserver variability in reads of MRIs. The PI-RADS version 2
system for evaluating prostate cancer lesions has
improved issues of interobserver variability [25].
Tools to evaluate and equalize the quality of multiparametric MRI quality have been slower to
gain adoption. A promising solution for ensuring
adequate quality of MRIs in the clinically localized prostate cancer space is the PI-QUAL system [28]. This 5-point Likert scale evaluates the
suitability of MRI images for diagnostic evaluation, with a 3 indicating sufcient quality and≥4
indicating good or optimal quality. Given the
importance of MRI guidance for focal therapy
administration, MRI suitability is a vital quality
indicator for a focal therapy program, and documentation of this quality could be incorporated as
a criterion for reimbursement.
Biopsy strategy and technique also play roles
in adequately risk-stratifying patients. Multiple
studies have demonstrated that MRI-targeted
biopsy increases the detection of clinically signicant prostate cancer [29, 30]. Furthermore,
data show that rates of upgrading to Grade Group
≥3 at radical prostatectomy are lowest when a
combined systematic plus targeted biopsy
approach are adopted, rather than either approach
alone(16.8% systematic, 8.7% targeted, 3.5%
combined) [31]. Given the investigational nature
of focal therapy and great interest in long-term
outcomes, it is important for both patient safety
and evaluation of therapeutic quality that patients
are most accurately stratied, and thus either a
combined systematic plus targeted approach or a
saturation biopsy +/− targeted approach are preferred. While combined techniques take additional time and thus may have some cost, it is
reasonable to hypothesize that more accurate risk
stratication may ultimately yield cost savings in
terms of avoidance of salvage treatments.
MRI-directed biopsies can be performed using
a variety of techniques, including fusion biopsy
with software guidance, MRI in-bore, or cognitive targeting. There is conicting evidence on
which is the optimal technique for identifying
clinically signicant prostate cancer, both onco-
logic and from a cost perspective [32]. There is
some evidence that cognitive fusion may be less
preferred overall, particularly for smaller lesions
[33, 34]. Given the ability to track biopsy needle
cores at the time of focal ablation, however, there
is a proposed quality benet to the use of a fusion
biopsy or in-bore technique to ensure visually
that the ablation zone covers the sampled area.
This hypothesis, however, will require further
validation. The type of biopsy technique
employed may be a reasonable target for qualitybased reimbursement as the literature evolves to
answer these questions.
Patient selection criteria represent another
important quality metric that merits evaluation.
There is signicant heterogeneity in what is considered an appropriate focal therapy candidate.
Several consensus panels have been assembled to
address this question. While many open questions
remain, these panels coalesce around the notion
that low and intermediate-risk patients with an
MRI-visible and biopsy-concordant index lesion
are the ideal candidates [35]. Indeed, there are
questions about whether low-risk patients should
be treated, as they can be safely monitored on
active surveillance, and nearly 80% retain focal
therapy eligibility over time [36]. Given a potentially limited benet relative to active surveillance,
there may be a role for varying reimbursement
based on appropriate utilization (e.g., % of treated
focal therapy patients with intermediate-risk disease) and potentially incentivizing against overutilization in those who are least likely to benet
from focal ablation. There may also be a role for a
reimbursement schema based on the appropriate
application of focal therapy to a patient cohort
(e.g., not treating high- risk patients or those with
MRI-invisible disease outside of research protocol). Prostate cancer treatment involves a quintessential preference- sensitive decision, where there
are multiple options with variable expected outcomes. Ensuring that treatment appropriately
aligns with patient preferences through preference
elicitation and documentation of shared decisionmaking is critical yet very challenging to implement into clinical practice.
40 Design of Payment and Reimbursement Strategies for Focal Therapy for Acceptance in Value-Based…
485
With regard to treatment modality, there is
limited head-to-head evidence comparing the
oncologic efcacy of modalities. Various best
practices should be adopted in treatment planning and execution, some of which are modality
agnostic and some modality specic. There is
signicant evidence that prostate cancer extends
beyond the MRI visible lesion, up to 1cm [37,
38]. While it is not clear exactly what an optimal
margin might be, and there are unique predictive
tools being developed to determine this [39], it is
reasonable to consider the documentation of
treatment margin an important quality metric.
Time will tell if ultimately, a 5mm–10mm documented margin (as it is not always possible to
have such margins given anatomic limitations) or
an Articial Intelligence-based margin prediction
will be best. However, it bears consideration that
the quality of focal therapy delivery can be based
on an evidence-based margin assessment.
Some modalities have been demonstrated to
be more effective with multiple administrations
of ablation. The use of two freeze-thaw cycles
has been demonstrated in prostate cryotherapy to
correlate with more complete cancer destruction
[40]. Similarly, recent evidence indicates that two
ablative cycles using high-intensity focused
ultrasound can reduce levels of in-eld recurrence [43]. Payments based on adherence to documented modality-specic best practice
approaches could incentivize the delivery of efcacious rather than expeditious care.
The optimal follow-up regimen for focal therapy patients is an area of active investigation.
Consensus statements agree that PSA should be
followed every 3months following ablation for
the rst year, an MRI obtained at 6 and 18months,
and a biopsy obtained at 6–12months [44]. These
intervals are evolving and likely to change.
However, they represent a tangible metric as a
surrogate for a high-quality focal therapy program. It should be considered best practice to
adhere to these consensus guidelines of focal
therapy developed by thought leaders and potentially have reimbursement tied to the percentage
of patients adhering to the proposed schedule.
Future decision tools, such as the PI-FAB score,
which assigns a score of 1–3 (based on MRI
imaging and PSA kinetics (1- do not biopsy, 2biopsy if PSA rising, 3- biopsy), could also be a
promising quality metric for focal programs once
validated fully.
Ultimately, the difculty in tying focal therapy payment to quality metrics is the rapidly
evolving nature of the literature on focal therapy
and heterogeneity in focal therapy outcomes
across programs. Furthermore, high-quality cost
analyses in this space are often lacking. The use
of tangible quality metrics, such as the use of
PI-QUAL ≥4 MRIs, the use of combined biopsy
techniques, the percentage of patients treated
who meet consensus eligibility criteria, appropriate treatment margin documentation, and the use
of consensus follow-up schema, can incentivize
delivery of improved care. At the same time, scientic nuances continue to be resolved.
Policy Considerations
andRecommendations
As a newer technology, focal therapy epitomizes
the challenges faced by emerging medical interventions seeking adoption within the U.S. healthcare system. The median time for novel therapies
to secure Medicare coverage is 5.7 years [41].
Consequently, patients may be left with restricted
access to potentially transformative treatments.
For focal therapy, which is still accruing mature
clinical data, this prolonged timeline can mean
that when reimbursement policies are in place,
the technology may have further evolved, or
newer data may be available, rendering the reimbursement criteria obsolete or not entirely
pertinent.
The variability in coverage milestones further
complicates the picture for focal therapy. For
example, if the introduction and widespread
adoption of focal therapy is spearheaded by
smaller manufacturers or institutions, they might
encounter disproportionate challenges in navigating the complex reimbursement landscape. This
could unintentionally limit the accessibility and
affordability of such innovative treatments to