Developing a Value Framework: Utilizing Administrative Data to Assess an Enhanced Care Initiative.

BACKGROUND: There remains no tool to quantify the total value of comparative processes in health care. Hospital administrative data sets are emerging as valuable sources to evaluate performance. Thus, we use a framework to simultaneously assess multiple domains of value associated with an enhanced recovery initiative using national administrative data. MATERIALS AND METHODS: Risk-stratified clinical pathways for patients undergoing pancreatic surgery were implemented in 2016 at our institution. We used a national administrative database to characterize changes in value associated with this initiative. Value metrics assessed included in-hospital mortality, complication rates, length of stay (LOS), 30-day readmission rates, and institutional costs. We compared our performance with other hospitals both before and after implementation of the pathways. Metrics were graphed on radar charts to assess overall value. RESULTS: 22,660 cases were assessed. Comparing 75 cases at our institution and 5520 cases at all other hospitals before pathway implementation, mean in-hospital LOS was 9.6 versus 10.8 d, in-hospital mortality was 0.0% versus 1.9%, mean costs were $23,585 versus $21,387, 30-day readmission rates were 1.3% versus 7.4%, and complication rates were 8.0% versus 11.2%, respectively. Comparing 334 cases at our institution and 16,731 cases at all other hospitals after pathway implementation, mean in-hospital LOS was 7.7 versus 10.3 d, in-hospital mortality was 0.3% versus 1.6%, mean costs were $19,428 versus $22,032, 30-day readmission rates were 6.6% versus 7.5%, and complication rates were 6.3% versus 10.3%, respectively. Notably, LOS and institutional costs were reduced at our institution after implementation of the enhanced clinical care pathways. Our costs were higher than comparators before implementation, but lower than comparators after implementation. CONCLUSIONS: Herein, we used an analytic framework and used national administrative data to assess the value of an enhanced care initiative as benchmarked with data from other hospitals. We thus illustrate how to identify and measure opportunities for targeted improvements in health care delivery. We also recognize the limitations of the use of administrative data in a comprehensive assessment of value in health care.

Cost-effectiveness analysis of endocrine therapy alone versus partial-breast irradiation alone versus combined treatment for low-risk hormone-positive early-stage breast cancer in women aged 70 years or older.

PURPOSE: We performed a cost-effectiveness analysis of three strategies for the adjuvant treatment of early breast cancer in women age 70 years or older: an aromatase inhibitor (AI-alone) for 5 years, a 5-fraction course of accelerated partial-breast irradiation using intensity-modulated radiation therapy (APBI-alone), or their combination. METHODS: We constructed a patient-level Markov microsimulation from the societal perspective. Effectiveness data (local recurrence, distant metastases, survival), and toxicity data were obtained from randomized trials when possible. Costs of side effects were included. Costs were adjusted to 2019 US dollars and extracted from Medicare reimbursement data. Quality-adjusted life-years (QALY) were calculated using utilities extracted from the literature. RESULTS: The strategy of AI-alone ($12,637) was cheaper than both APBI-alone ($13,799) and combination therapy ($18,012) in the base case. All approaches resulted in similar QALY outcomes (AI-alone 7.775; APBI-alone 7.768; combination 7.807). In the base case, AI-alone was the cost-effective strategy and dominated APBI-alone, while combined therapy was not cost-effective when compared to AI-alone ($171,451/QALY) or APBI-alone ($107,932/QALY). In probabilistic sensitivity analyses, AI-alone was cost-effective at $100,000/QALY in 50% of trials, APBI-alone in 28% and the combination in 22%. Scenario analysis demonstrated that APBI-alone was more effective than AI-alone when AI compliance was lower than 26% at 5 years. CONCLUSIONS: Based on a Markov microsimulation analysis, both AI-alone and APBI-alone are appropriate options for patients 70 years or older with early breast cancer with small cost differences noted. A prospective trial comparing the approaches is warranted.

Survival outcomes for patients with stage IVB vulvar cancer with grossly positive pelvic lymph nodes: time to reconsider the FIGO staging system?

OBJECTIVE: To evaluate treatment outcomes for patients with vulvar cancer with grossly positive pelvic lymph nodes (PLNs). METHODS: From a database of 516 patients with vulvar cancer, we identified patients with grossly positive PLNs without distant metastasis at initial diagnosis. We identified 20 patients with grossly positive PLNs; inclusion criteria included PLN 1.5cm or larger in short axis dimension on CT/MRI (n=11), FDG-avid PLN on PET/CT (n=3), or biopsy-proven PLN disease (n=6). Ten patients were treated with chemoradiation therapy (CRT), 4 with RT alone, and 6 with various combinations of surgery, RT or CRT. Median follow-up time for patients who had not died of cancer was 47months (range, 4-228months). RESULTS: Mean primary vulvar tumor size was 6.4cm; 12 patients presented with 2009 AJCC T2 and 8 with T3 disease. All patients had grossly positive inguinal nodes, and the mean inguinal nodal diameter was 2.8cm. The 5-year overall survival and disease specific survival rates were 43% and 48%, respectively. Eleven patients had recurrences, some at multiple sites. There were 9 recurrences in the vulva, but no isolated nodal recurrences. Four patients developed distant metastasis within 6months of starting radiation therapy. CONCLUSIONS: Aggressive locoregional treatment can lead to favorable outcomes for many patients with grossly involved PLNs that is comparable to that of grossly involved inguinal nodes only. We recommend modification of the FIGO stage IVB classification to more accurately reflect the relatively favorable prognosis of patients with PLN involvement.

Role of simulation-based training and assessment to improve brachytherapy competency among radiation oncology residents.

Simulation is a technique used in healthcare to replicate clinical scenarios and improve patient safety, efficacy, and efficiency. Simulation-based medical education facilitates training and assessment in healthcare without increasing risk to patients, supported by ample evidence from surgical/procedural specialties. Simulation in radiation oncology has been leveraged to an extent, with successful examples of both screen-based and hands-on simulators that have improved confidence and performance in trainees. In the current era, evidence substantiates a significant deficit in brachytherapy procedure education, with radiation oncology residents reporting low confidence in this procedural skill, largely attributable to insufficient caseloads at some centers. Simulation-based medical education can facilitate structured training and competency-based assessment in brachytherapy skills. This review discusses existing advances and future directions in brachytherapy simulation, using examples from simulation in surgical specialties.

A Medicare Claims Analysis of Racial and Ethnic Disparities in the Access to Radiation Therapy Services.

PURPOSE: Reduced access and utilization of radiation therapy (RT) is a well-documented healthcare disparity observed among racial and ethnic minority groups in the USA and a contributor to the inferior health outcomes observed among Black, Hispanic, and Native American patient groups. What is less understood are the points during the process of care following RT consultation at which patients either fail to complete their prescribed treatment or encounter delays. Identification of those points where significant differences exist among different patient groups may help identify opportunities to close gaps in the access of clinically indicated RT. METHODS AND MATERIALS: This analysis examines 261,559 RT episodes abstracted from Medicare claims and beneficiary data between 2016 and 2018 to determine rates of treatment initiation following planning and timeliness of treatment completion for different racial groups. RESULTS: Failure to initiate treatment was observed to be 29.3% relatively greater for Black, Hispanic, and Native American patients than for White and Asian patients. Among episodes for which treatment was initiated, Black and Hispanic patients were observed to require a significantly greater number of calendar days (when adjusted for fraction number) for completion than for White, Asian, and Native American patients. CONCLUSIONS: There appears to be a patient cohort for which RT disparities may be more marginal in their effects-allowing for access to consultation and treatment prescription but not for treatment initiation or timely completion of treatment-and may therefore permit effective solutions to help address current differences in cancer outcomes.

Radiation Therapy Expenditures Through the First 8 Performance Periods of the Oncology Care Model at a Statewide Multispecialty Health System.

PURPOSE: Our purpose was to use real world data to assess trends in radiation therapy (RT) treatment fractionation and cost under the Oncology Care Model (OCM) through the first 8 performance periods (PPs). METHODS: We identified 17,157 episodes of care from 9898 patients treated at a statewide multispecialty health system through the first 8 6-month PPs (PP1-8: July 1, 2016, to June 30, 2020) of the OCM. Spending was stratified by 10 expenditure domains (eg, Part B/D drugs, radiation oncology [RO], etc), and 21 disease sites were extracted from claims data, from which an analysis of RO expenditures was performed on 2219 episodes from 2033 patients treated with RT. Expenses are expressed in per-beneficiary, per-episode terms. RESULTS: RO expenditures comprised 3% ($14.7M) of total spending over the 8 periods. By primary cancer, the largest RO expenses were for breast ($2.9M; 20%), prostate ($2.9M; 19%), and lung cancer ($2.8M; 13%). For RO, total per-episode average spending remained roughly constant between PP1 ($6314) and PP8 ($6664; Ptrend > .05) and decreased ($6314-$6215) when indexed to the Consumer Price Index for July 2016. Average number of RT fractions per episode decreased from 19.2 in PP1 to 18.6 in PP8; this decrease was most notably seen for breast (-2.1), lung (-2.8), and female genitourinary (-3.5) cancers. Intensity-modulated RT (IMRT) charges accounted for $7.6M (51%) of RT spending and increased 5% from PP1 to 8, whereas conventional external beam RT made up $3.0M (21%) and decreased 8%. Expenses for image guidance ($2.5M; 17%; +2% from PP1-8) and stereotactic RT ($1.3M; 9%; +1%) increased. CONCLUSIONS: In inflation-adjusted terms, total RO expenditures have declined despite greater use of IMRT, stereotactic RT, and image guidance. Conversely, oncology costs have risen because of drug spending. Successful payment models must prioritize high-cost spending areas-including novel drug therapies-while accounting for high-value care and patient outcomes.

Cost-Effectiveness Analysis of Ultra-Hypofractionated Whole Breast Radiation Therapy Alone Versus Hormone Therapy Alone or Combined Treatment for Low-Risk ER-Positive Early Stage Breast Cancer in Women Aged 65 Years and Older.

PURPOSE: The optimal management of early-stage, low-risk, hormone-positive breast cancer in older women remains controversial. Recent trials have shown that 5-fraction ultrahypofractionated whole-breast irradiation (U-WBI) has similar outcomes to longer courses, reducing the cost and inconvenience of treatment. We performed a cost-utility analysis to compare U-WBI to hormone therapy alone or their combination. METHODS AND MATERIALS: We simulated 3 different treatment approaches for women age 65 years or older with pT1-2N0 ER-positive invasive ductal carcinoma treated with lumpectomy with negative margins using a Markov microsimulation model. The strategies were U-WBI performed with a 3-dimensional conformal technique over 5 fractions without a boost ("radiation therapy [RT] alone"), adjuvant hormone therapy (anastrozole for 5 years) without RT ("aromatase-inhibitor [AI] alone"), or the combination of the 2. The combination strategy was calibrated to match trial results, and the relative effectiveness of the RT alone and AI alone strategies were inferred from previous randomized trials. The primary endpoint was the cost-effectiveness of the 3 strategies over a lifetime horizon as measured by the incremental cost-effectiveness ratio (ICER), with a value of $100,000/quality-adjusted life-year deemed "cost-effective." RESULTS: The model results compared with the prespecified target outcomes. On average, RT alone was the least expensive strategy ($14,775), with AI alone slightly more ($14,998), and combination therapy the costliest ($19,802). RT alone dominated AI alone (the incremental cost-effectiveness ratio [ICER] -$5089). Combination therapy, compared with RT alone, was slightly more expensive than our definition of cost-effective (ICER $113,468) but was cost-effective compared with AI alone (ICER $54,451). Probabilistic sensitivity analysis demonstrated RT alone to be cost-effective in 50% of trials, with combination therapy in 36% and AI alone in 14%. CONCLUSIONS: U-WBI alone appears the more cost-effective de-escalation strategy for these low-risk patients, compared with AI alone. Combining U-WBI and AI appears more costly but may be preferred by some patients.

A primer on time-driven activity-based costing in brachytherapy.

Emphasis on value-based healthcare has led to increasing use of time-driven activity-based costing (TDABC) across medical departments. When applied to brachytherapy, TDABC provides insight into differences in costs across various modes of therapy, the nuances that drive cost including institutional factors and involved personnel, and discrepancies in reimbursement which influence clinical practice. This is especially important with the new alternative payment model (APM) in radiation oncology which offers fixed reimbursement per 90-day episode of care. The TDABC model can thus be utilized to improve efficiency, optimize the role of ancillary staff in treatment planning and care delivery, and implement shorter fraction schedules when clinically appropriate to promote value-based care. Ultimately, application of this methodology could potentiate changes to practice and incentives to improve patient care. In this review, we discuss the utility and limitations of TDABC in the context of existing studies in brachytherapy which have utilized this methodology.

Geographic access to brachytherapy services in the United States.

PURPOSE: Disparities in geographic access to medical care exist in nearly all fields of medicine including radiation oncology. We aim to update knowledge of the geographic distribution of radiation oncologists in the United States. METHODS AND MATERIALS: We used the Physician and Other Supplier Public Use File (PUF) from the Centers for Medicare & Medicaid Services (CMS) as well as the International Atomic Energy Agency (IAEA) Directory of Radiotherapy Centers (DIRAC) database to identify practices that either coded for or are marked as having access to brachytherapy services. Geographic analysis was performed on several levels including United States (US) Census region, Dartmouth Atlas Healthcare Referral Region, and the county level. RESULTS: We identified 327 providers that billed for a brachytherapy code during the calendar year 2018 and 564 facilities providing brachytherapy. Within the 306 HRRs in the US, 149 have access to brachytherapy. This represents 247.5 million people based on 2018 estimates of population from the US Census Bureau. This implies that 76.7% of people within the US live in an HRR with access to brachytherapy, and, conversely, that 75.3 million people (23.3%) do not. Numerically, counties in metropolitan areas were more likely to have access to brachytherapy than those outside of a metropolitan area. CONCLUSIONS: Geographic disparities exist in access to brachytherapy; metropolitan counties are more likely to have access than non-metropolitan counties. We support continued development of databases of brachytherapy providers and programs that may support travel and lodging costs to minimize these disparities.

An Overview of the Radiation Oncology Alternative Payment Model and Impact on Practices Serving Vulnerable Populations.

Radiation oncology reimbursement methodology has been largely unchanged over the past 30 years, and new approaches are of great interest to practicing radiation oncologists and other health care stakeholders. Traditional radiation oncology reimbursement is based on a series of individual codes for evaluation and management (professional) and technical services, yielding a complex reimbursement system. In an attempt to move toward a simpler, episodic payment model, bundling all of the codes into a single payment, an alternative payment model for radiation oncology was developed. The radiation oncology alternative payment model is a revolutionary change in how radiation oncologic services will be reimbursed and has potential to affect all aspects of radiation oncologic care. Here, the authors review the origin of the currently proposed radiation oncology model and discuss potential implications of this model on the provision of care, especially as it relates to rural practices and other underserved and vulnerable patient populations.

Impact of the Radiation Oncology Alternative Payment Model on Brachytherapy Reimbursement.

PURPOSE: The Radiation Oncology Alternative Payment Model (RO Model) will test prospective radiotherapy episode-based payments for 16 common disease sites. We created an automated analytics platform to calculate the impact of the RO Model vs historical fee-for-service episode reimbursements for brachytherapy treatments within five community oncology practices for prostate, uterine, and cervical cancer. METHODS AND MATERIALS: Claims data between January 1, 2017 and October 2, 2019 for prostate, uterine, and cervical cancer were analyzed as per the RO Model Final Rule methodology. Expected professional and technical component (PC and TC) reimbursements were compared for episodes that utilized brachytherapy alone vs combination modality (external beam and brachytherapy) in the RO Model vs historical reimbursements. RESULTS: 6,022 RO Model-defined episodes (60% prostate, 28% uterine, 13% cervical) were generated. Brachytherapy monotherapy episodes (14%) would have an average positive reimbursement in the RO Model (+$2,163 for prostate, +$711 for uterine, +$533 for cervical for the PC; +$12,168 for prostate, +$8,181 for uterine, +$11,322 for cervical for the TC), while combination modality episodes (15%) would have an average negative reimbursement in the RO Model (-$183 for prostate, -$1,701 for uterine, -$2,195 for cervical for the PC; -$374 for prostate, -$5,026 for uterine, -$2,801 for cervical for the TC). CONCLUSIONS: Brachytherapy monotherapy episodes for prostate, uterine, and cervical cancer will benefit from an increase in payment, whereas combination modality episodes will receive lower reimbursement. Large shifts in episodic payment may be related to practice-wide adjustments and pricing based on partial episodes of care that may ultimately limit access to care for vulnerable patient populations with cancer.

Improving efficiency and reducing costs of MRI-Guided prostate brachytherapy using Time-Driven Activity-Based costing.

INTRODUCTION: Integrated quality improvement (QI) and cost reduction strategies can help increase value in cancer care. Time-driven activity-based costing (TDABC) is a bottom-up costing tool that measures resource use over the full care cycle. We applied standard QI and TDABC methods to improve workflow efficiency and reduce costs for MRI-guided prostate brachytherapy. METHODS AND MATERIALS: We constructed process maps of the baseline prostate brachytherapy workflow from initial consultation through one year after treatment. Process maps reflected resources and time required at each step. TDABC costs were calculated by multiplying each process time by the cost per min of the resource(s) used at that step. We then used plan-do-study-act methodology to identify workflow inefficiencies and implement solutions to reduce resource consumption. RESULTS: The highest cost components at baseline were the operating room (OR) (40%), imaging (8.7%), and consultation (7.6%). Higher-than-expected costs (3%) were incurred during surgery scheduling. After targeted QI initiatives, OR time was reduced from 90 to 70 min, which reduced overall cost by 5%. Personnel task downshifting reduced costs by 10% at consultation and 77% at surgery scheduling. Re-engineering of follow-up protocols reduced costs by 8.4%. Costs under the new workflow decreased by 18.2%. CONCLUSIONS: TDABC complements traditional QI initiatives by quantifying the highest cost steps and focusing QI initiatives to reduce costs and improve efficiency. As payment reform evolves toward bundled payments, TDABC and QI initiatives will help providers understand, communicate, and improve the value of cancer care.

American Brachytherapy Society radiation oncology alternative payment model task force: Quality measures and metrics for brachytherapy.

PURPOSE: Brachytherapy is an essential technique to deliver radiation therapy and is involved in the treatment of multiple disease sites as monotherapy or as an adjunct to external beam radiation therapy. With a growing focus on the cost and value of cancer treatments as well as new payment models, it is essential that standardized quality measures and metrics exist to allow for straightforward assessment of brachytherapy quality and for the development of clinically significant and relevant clinical data elements. We present the American Brachytherapy Society consensus statement on quality measures and metrics for brachytherapy as well as suggested clinical data elements. METHODS AND MATERIALS: Members of the American Brachytherapy Society with expertise in disease site specific brachytherapy created a consensus statement based on a literature review and clinical experience. RESULTS: Key quality measures (ex. workup, clinical indications), dosimetric metrics, and clinical data elements for brachytherapy were evaluated for each modality including breast cancer, cervical cancer, endometrial cancer, prostate cancer, keratinocyte carcinoma, soft tissue sarcoma, and uveal melanoma. CONCLUSIONS: This consensus statement provides standardized quality measures and dosimetric quality metrics as well as clinical data elements for each disease site to allow for standardized assessments of brachytherapy quality. Moving forward, a similar paradigm can be considered for external beam radiation therapy as well, providing comprehensive radiation therapy quality measures, metrics, and clinical data elements that can be incorporated into new payment models.

Radiation Oncology Alternative Payment Model (APM): An Introduction and Primer for the Proposed Rule for Practices and Providers.

PURPOSE: The Radiation Oncology Alternative Payment Model (RO-APM) is an alternative payment model under which Medicare patients would be reimbursed using an episode-based payment schema rather than the current fee-for-service schema. The Center for Medicare and Medicaid Services Innovation Center has published a proposed rule for the RO-APM. However, there is no accessible resource that summarizes information about the proposed rule in an easily understandable form. METHODS AND MATERIALS: Information regarding the RO-APM was accessed through the Center for Medicare and Medicaid Services Innovation Center website and listening sessions and review of the proposed rule. We summarize the most important information regarding the background, mechanics, and timeline of the proposed rule to facilitate wider understanding in the radiation oncology community and answer commonly held questions. RESULTS: The proposed rule for the RO-APM would cover 40% and have widespread effect on the future of radiation oncology. We provide a primer that summarizes important information regarding the rule for practices and providers. CONCLUSION: The proposed RO-APM will change the landscape of radiation oncology reimbursement. Understanding the implications of the model will be key to maintining a successful practice.

Disproportionate Negative Impact of the Radiation Oncology Alternative Payment Model on Rural Providers: A Cost Identification Analysis of Medicare Claims.

PURPOSE: The Radiation Oncology Alternative Payment Model (APM) is a Medicare demonstration project that will test whether prospective bundled payments to a randomly selected group of physician practices, hospital outpatient departments, and freestanding radiation therapy centers reduce overall expenditures while preserving or enhancing the quality of care for beneficiaries. The Model follows a complicated pricing methodology that blends historical reimbursements for a defined set of services made to professional and technical providers to create a weighted payment average for each of 16 cancer types. These averages are then adjusted by various factors to determine APM payments specific to each participating provider. METHODS: This impact study segregates APM participants into rural and urban groups and analyzes the effect of the Radiation Oncology Alternative Payment Model on their fee-for-service reimbursements. RESULTS: The main findings of this study are (1) the greater net-negative revenue impact on rural facilities versus urban facilities that would have participated in the Model this year and (2) the relative lack of high-value treatment services (ie, stereotactic radiotherapy and brachytherapy) delivered by rural facilities that exacerbates their negative impact. CONCLUSION: As such, rural providers participating in the Model in its current form may face greater risk to their economic viability and greater difficulty in funding technology improvements necessary for the achievement of high-quality care compared with their urban counterparts.

Radiation Oncology's Place in Payment Reform: ASTRO Advocates for a Place at the Table.

In its current form, the Radiation Oncology Model (RO Model) prioritizes payment cuts over true value-based payment transformation. With significant modifications to the payment methodology, the reporting requirements, and recognition of the unique challenges faced by disadvantaged populations, the RO Model can protect patient access to care, preserve the physician-patient decision-making process, and ensure the delivery of high-quality, efficient radiation therapy treatment. The American Society for Radiation Oncology has spent several years advocating for a meaningful alternative payment model for radiation oncology and continues to push The Center for Medicare and Medicaid Innovation for changes to the RO Model that will recognize these key outcomes.

The Case for Brachytherapy: Why It Deserves a Renaissance.

The recent global events related to the coronavirus disease of 2019 pandemic have significantly changed the medical landscape and led to a shift in oncologic treatment perspectives. There is a renewed focus on preserving treatment outcomes while maintaining medical accessibility and decreasing medical resource utilization. Brachytherapy, which is a vital part of the treatment course of many cancers (particularly prostate and gynecologic cancers), has the ability to deliver hypofractionated radiation and thus shorten treatment time. Studies in the early 2000s demonstrated a decline in brachytherapy usage despite data showing equivalent or even superior treatment outcomes for brachytherapy in disease sites, such as the prostate and cervix. However, newer data suggest that this trend may be reversing. The renewed call for shorter radiation courses based on data showing equivalent outcomes will likely establish hypofractionated radiation as the standard of care across multiple disease sites. With shifting reimbursement, brachytherapy represents the pinnacle in hypofractionated, conformal radiation therapy, and with extensive long-term data in support of the treatment modality brachytherapy is primed for a renaissance.