Over the past 40 years, healthcare spending in the United States has steadily outpaced
every other sector. In 1980, health care accounted for 9% of the U.S.'s gross domestic
product (GDP). By 2019, that number doubled to 18%.[1] Despite spending the highest per capita, median life expectancy in 2019 in the United
States was only 30th out of 38 Organization for Economic Cooperation and Development
(OECD) countries.[2] To combat growing costs and stagnant outcomes, four laws passed by Congress over
the past 14 years have mandated and facilitated a paradigm change from fee-for-service
to value-based healthcare payment including the American Recovery and Reinvestment
Act (2009), the Affordable Care Act (2010), the Medicare Access and CHIP Reauthorization
act (MACRA, 2015), and the Inflation Reduction Act (2022). Under the new legislation,
clinicians and hospital systems are increasingly reimbursed based on the value, rather
than the amount, of care provided.
While claiming to offer the best value has long been a fundamental advertising technique,
value in healthcare was formally defined in 2010 as quality health outcome per dollar
spent.[3] The American Medical Association subsequently expanded the equation to define value
as the ratio of four variables: outcomes, safety, and service divided by the cost
to the healthcare system ([Fig. 1]).[4]
Fig. 1 The Healthcare Value Equation developed by Porter et al describes the value of care
provided as the ratio of outcomes, safety, and service to the total cost of the care
provided.
Value = Outcomes × Safety × Service/Cost
Based on this equation, valuable treatment options increase quality and quantity of
years lived, have fewer complications, and provide a better patient experience, while
also having lower costs. Most interventional radiologists would likely agree these
are attributes of the care our specialty provides; and the proof, many argue, is in
the spread of interventional radiology (IR) procedures throughout the medical world.
“Bread-and-butter” IR procedures like image-guided percutaneous drainage, needle biopsy,
and central venous access have become mainstays of diagnosis and treatment, replacing
their surgical predecessors.[5] However, current reimbursement trends do not reflect this. Over the past 8 years,
reimbursement for IR procedures has decreased (6.9%) despite an increased demand for
image-guided procedures.[6] The shift to a payment-for-value paradigm now requires that the value of IR care
be made explicit.
The Centers for Medicare and Medicaid Services (CMS) is the largest healthcare payer
in the United States. Tasked by Congress with implementing this value legislation,
CMS has worked closely with epidemiologists, economists, and professional societies
to develop metrics that objectively assess the value of various treatments. Many of
the metrics were designed to broadly incorporate principles from the National Academy
of Medicine's STEEP goals such as safety, efficiency, and equity.[4] Some system-wide metrics familiar to many clinicians include rates of hospital-acquired
infections, postprocedure complications, and acute inpatient readmission rates. Additional
performance metrics have been designed in conjunction with different medical societies
according to their specific management algorithms. CMS and the Society for Interventional
Radiology (SIR) codeveloped metrics for appropriate assessment of retrievable inferior
vena cava filters for removal, clinical outcomes post-endovascular stroke treatment,
door-to-puncture time for endovascular stroke treatment, documentation of angiographic
endpoints and interrogation of ovarian arteries during uterine artery embolization,
and outcomes after varicose vein treatment with saphenous vein ablation.[7] But these measures are the “tip of the iceberg” in assessing the value of IR to
patients across the spectrum of health and disease. Interventional radiologists and
our allies must develop an evidence base that proves quantitatively how IR care is
high-value care. The value equation serves as guidepost for further developing our
value literature. The following brief survey of existing literature aims to highlight
the ways future research can demonstrate the value of IR using transparent, clearly
defined endpoints that are meaningful to patients.
Quality Outcomes
According to the American Medical Association, high-value care reduces mortality and
morbidity. One of the best examples of IR adding quality years of life is the development
of transarterial therapies for hepatocellular carcinoma (HCC) management. Prior to
transarterial chemoembolization (TACE), patients with unresectable HCC, lacking effective
treatment options, were offered only best supportive care. Starting in 1996, Llovet
et al conducted a randomized controlled trial comparing TACE to conservative management.
Prior studies had shown no clinically significant benefit of TACE; however, the authors
believed lack of accounting for performance status (PS) had confounded outcomes in
those studies. Excluding patients with poor PS, their landmark study clearly demonstrated
TACE to confer a significant overall survival benefit compared with conservative management
for patients with multinodular HCC.[8] Recently, Gabr et al reported a multicenter 45-patient series of hepatic explants
after yttrium-90 segmental transarterial radioembolization (TARE) for solitary HCCs
less than 8 cm.[9] Finding complete necrosis in all patients receiving over 400 Gy, the study led to
incorporation of Y90 TARE into the Barcelona Clinic for Liver Cancer's current HCC
treatment guidelines.[10]
Within and beyond the world of oncology, transarterial therapies throughout the body
have been shown to improve outcomes in diverse patient populations. A systematic review
and meta-analysis by Liu et al in 2018 found that uterine artery embolization for
postpartum hemorrhage reduced blood loss and length-of-stay compared to hysterectomy.[11] A randomized, controlled trial published in 2023 demonstrated nearly twice the improvement
in lower urinary tract symptoms (LUTS) after prostate artery embolization (PAE) versus
dual-agent medical therapy for benign prostate hyperplasia.[12]
Safety
Prostate artery embolization also exemplifies of a safe treatment. A systematic review
and meta-analysis by Knight et al compared PAE to transurethral resection of the prostate
(TURP) for the treatment of LUTS secondary to benign prostatic hyperplasia. The meta-analysis
included six studies with 598 patients. The final results showed PAE and TURP led
to equivalent changes in the International Prostate Symptom Score (IPSS), but PAE
had significantly fewer complications.[13]
Postprocedural complications are one of the big targets for the CMS' quality improvement
initiatives. Many interventional radiologic procedures offer equivalent therapeutic
outcomes with less risk compared to surgical counterparts. Another example is percutaneous
thermal ablation for localized renal cell carcinomas. Using population data, Talenfeld
et al in 2018 found similar 5-year cancer-specific survival with percutaneous ablation
versus surgery, one-fifth as many serious adverse events compared to partial or radical
nephrectomy and nearly half the rate of new-onset chronic renal insufficiency versus
radical nephrectomy.[14] In a population study of treatments for early HCC, Charalel et al demonstrated fewer
complications, including fewer ICU days and readmissions, and lower costs with percutaneous
ablation compared to surgery.[15]
Researchers interested in advancing the interventional radiology field must continue
to prove its value with investigations revealing the safety of image-guided endovascular,
endoluminal, and percutaneous procedures in patient-centered, head-to-head comparisons
with surgical and medical therapies.
Service
The last variable in the numerator of the healthcare value equation is service. The
Agency for Healthcare Research and Quality (AHRQ) administers the Consumer Assessment
of Healthcare Providers and Systems (CAHPS) survey of patient experiences.[16] Questions can include ratings on facility cleanliness, physician communication,
and details on privacy. In this case, more favorable patient experiences correspond
to higher value of care provided. Medicare uses these surveys in conjunction with
clinical and administrative data to penalize low-performing and reward high-performing
healthcare providers, such as via the value-based purchasing (pay for performance)
initiatives. The CAHPS program distinguishes experience from satisfaction, experience
being based on factors more likely to influence health outcomes, like patients' clear
understanding of their plan of care, and the ease and completeness of care coordination.
Interventional radiologists directly interact with their patients; therefore, multiple
opportunities exist to prove value through patient experience. On an individual level,
IRs can improve patient experience by reducing wait times, openly communicating with
patients, and empowering patients to make decisions about their care with shared decision-making
techniques.[17] On a larger scale, IR can leverage its inherently interdisciplinary position in
health systems to improve patient experience by facilitating care coordination and
playing a more proactive role in care transitions.
Cost
Cost is the only variable in the denominator of the healthcare value equation. In
the context of the value equation, expensive treatments decrease the value of care,
whereas inexpensive treatments result in more valuable care. Often using time-dependent
activity-based costing (TDABC), detailed costs can be described from the hospital
perspective, as done by LaRoy et al, who compared institutional data from patients
receiving medicine infusion ports in IR suites versus operating rooms.[18] These authors found similar rates of complications between the two groups, but costs
from placements in IR suites were nearly half of those from insertions in operating
rooms.
Often less detailed, but much more readily generalizable costs can be described from
the societal payer perspective, with Medicare, Medicaid, or private insurance claims
data often providing the most straightforward means of economic analysis and largest
sample sizes. Trivedi et al used the Medicare limited data set to compare 5-year societal
costs for dialysis access maintenance in Medicare beneficiaries, finding similar rates
of dialysis shunt patency, with a cost from maintenance by interventional radiologists
of less than half compared to access maintenance by surgeons, $71,000 versus $179,000.[19]
Cost-effectiveness and cost-utility studies can sometimes yield information specific
to a variety of particular clinical scenarios. Though often methodologically complex,
for example, employing Markov and Monte Carlo probabilistic decision tree modeling,
these studies can produce outcomes in terms of directly applicable to health policy,
such as quality-adjusted life-years and incremental cost-effectiveness ratios. Pron
et al, performing a systematic review of cost-effectiveness studies of vertebral augmentation
for osteoporotic fractures, found vertebroplasty and kyphoplasty to be cost-effective
in multiple settings, being associated with earlier health gains and shorter hospital
stays.[20]
Demonstrating Quality Care Requires Quality Research
A specialty centered in disruptive technology, the field of IR has a track record
of developing novel microinvasive techniques leveraging the latest advances in materials
science and image guidance. These first-in-human studies are, by necessity, usually
case series. Such early transitional, bench-to-bedside exploratory studies are essential
in breaking new ground but are rarely sufficient to change practice guidelines, referral
patterns, and payment policies. As reimbursement for health services becomes increasingly
value-based, more and more robust health services research is required to prove in
the most concrete and relevant terms possible: the quality, safety, service, and cost
benefits of IR care. While many of the most impactful IR studies have been randomized
controlled trials and systematic reviews ([Fig. 2]), well-designed pragmatic trials and population health studies can provide complementary
real-world data, often with greater generalizability. Where large real-world data
specific to IR care do not yet exist, those data must be gathered by the Society of
Interventional Radiology's VIRTEX registry.[21] Those interested in proving IR's worth must partner within and across professional
societies, such as with the SIR and Neiman Health Policy Research Institute,[22] collaborating whenever possible with health economists and health policy experts.
Studies must be quantitative, disease-specific, and comparative, and they must focus
on concrete, transparent, patient-centered endpoints. IR professional societies, like
SIR and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE),
should double and redouble their support of investigators seeking foundation and federal
funding for pivotal IR studies. And IR researchers should seek to incorporate as many
of the variables of the value equation into their investigations as possible, illustrating
in the clearest terms that IR care is valuable to patients, healthcare systems, and
society as a whole.
Fig. 2 Hierarchy of scientific evidence. (Adapted from Evidence-Based Practice: Levels of
Evidence. Evidence Based Pyramid, John Moritz Library, Nebraska Methodist College.)
