Outpatient Prospective Payment System Research Articles

Health Care Resource Utilization (HCRU) and Cost of Management of Cytokine Release Syndrome (CRS) and Neurological Events (NEs) in Patients with R/R CLL/SLL Receiving Lisocabtagene Maraleucel (liso-cel) Treatment in the TRANSCEND CLL 004 Study

Background:Liso-cel is an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells, which is currently being evaluated for treatment of patients with R/R CLL/SLL in the TRANSCEND CLL 004 study (NCT03331198). Initial study results suggested that a single infusion induced CRs or remission in patients with R/R CLL/SLL and had a manageable safety profile, with low to moderate incidence of severe CRS and NEs (Siddiqi T, et al. Lancet 2023). While the clinical consequences of CRS/NEs associated with CAR T cell therapies are well understood, limited data are available on the cost of management of these AEs. This analysis evaluated HCRU and estimated costs of managing CRS/NEs by grade in patients with R/R CLL/SLL who received liso-cel treatment in TRANSCEND CLL 004. Methods: Case report forms were analyzed from the trial database, capturing patient-level HCRU related to the management of CRS/NEs. Only patients that received liso-cel at a dose level of 100 × 10 6 CAR + T cells (dose level 2 [DL2]) and subsequently experienced treatment-emergent CRS and/or NEs were included in this study. Treatment-emergent AEs were defined as those initiated within a 90-day period of liso-cel administration. Costs for management of CRS/NEs were estimated using microcosting methodology. Relevant HCRU observed from the day of AE onset through resolution that was associated with the management of CRS/NEs per protocol management guidelines was identified; unit costs sourced from public databases were applied to each HCRU. Included HCRU categories were: facility (standard inpatient admission, ICU stay), diagnostics (laboratory, imaging), medications (tocilizumab, corticosteroids, vasopressors), and procedures (dialysis, intubation). Cost analyses were conducted from the United States (US) health care system perspective and adjusted to 2023 US dollars. Unit costs were obtained from the US Centers for Medicare & Medicaid Services Hospital Outpatient Prospective Payment System, laboratory and physician fee schedules, IBM ® Micromedex ® RED BOOK ®, and literature. Descriptive statistical analyses stratified by AE severity grade and type of AE experienced were performed. Results: Ninety-four of 108 (87%) patients who received liso-cel at DL2 experienced CRS and/or NEs; 68 (72%) were grade ≤ 2 and 26 (28%) were grade ≥ 3. Overall, 44 (47%) patients had CRS only, 1 (1%) had NEs only, and 49 (52%) experienced both CRS and NEs. The study sample had a mean (standard deviation) age of 64.5 y (7.9) and were predominantly male (69%), White (84%), and non-Hispanic or Latino (90%). HCRU and total length of stay (LOS; the sum of inpatient and ICU stay days) are shown in the Table. All patients had an inpatient stay. ICU admissions only occurred among patients who experienced both CRS and NEs (10/49 [20%]) and were more common among patients with grade ≥ 3 (29%) compared with grade ≤ 2 (12%) AEs. Among patients who had an ICU admission, the median duration of an ICU stay was 5 days. Median total LOS increased with increasing AE severity for patients who had CRS only (grade 1, 5 days; grade 2, 9 days; grade 3, 15 days) and for patients who experienced both CRS and NEs (grade ≤ 2, 12 days; grade ≥ 3, 15 days). Overall, 68% and 62% of patients received tocilizumab and corticosteroids, respectively. Patients with grade ≥ 3 CRS and/or NEs had higher rates of utilization of medications, diagnostics, and procedures than those with grade ≤ 2 (Table). Additionally, patients who experienced both CRS and NEs had higher rates of utilization across all HCRU categories compared with those who experienced CRS or NEs only (Table). Estimated median management costs for CRS or NEs ranged from $14,638 (CRS only grade 1) to $46,802 (experienced both CRS and NEs with CRS or NEs grade ≥ 3) (Figure). Facility-related costs were the largest contributor to median total costs. Conclusions: While most patients treated with liso-cel at DL2 in TRANSCEND CLL 004 experienced CRS and/or NEs, they were primarily of low severity. HCRU and associated costs for management of CRS and/or NEs after liso-cel infusion increased with AE severity.Although everyone in this study required hospitalization, ICU admissions were rare and only observed among patients who experienced both CRS and NEs. Overall, costs of managing CRS and/or NEs were modest.

Estimation of Postinfusion Resource Use and Total Costs of Care for Patients with R/R Follicular Lymphoma (FL) Receiving Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND FL Study

Background: Liso-cel, an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells, has previously demonstrated clinically meaningful responses in patients with R/R FL in the global phase 2 TRANSCEND FL study (NCT04245839). Limited evidence is published on estimates of health care resource utilization (HCRU) and cost of postinfusion care among patients with large B-cell lymphoma (LBCL) treated with liso-cel (Palomba ML, et al. Leuk Lymphoma 2021), and no evidence is currently available for patients with R/R FL. This analysis evaluated postinfusion HCRU and estimated cost of care across a 6-month period among patients treated with liso-cel in the TRANSCEND FL study. Methods: In this retrospective analysis, patient-level HCRU data from the TRANSCEND FL study database, including hospitalizations and length of hospital stay (LOS) for the entire hospitalization period postinfusion (standard inpatient [IP] and ICU days), diagnostics (eg, laboratory work and imaging), procedures (eg, dialysis and intubation), and medications (eg, oncology supportive care, prophylactics, and other AE management), were analyzed from the day of liso-cel infusion through 6 months of follow-up. Postinfusion costs (not including the cost of liso-cel) were estimated using a microcosting methodology in which HCRU in the 6-month period was identified and unit costs sourced from public databases or literature (adjusted to 2023 US dollars [USD] using the Consumer Price Index) were applied to each HCRU. Facility costs were sourced from the Healthcare Cost and Utilization Project National Inpatient Sample (2020) databases (Dasta JF, et al. Crit Care Med 2005), and the US Centers for Medicare and Medicaid Services (CMS) Hospital Outpatient Prospective Payment System (OPPS; 2023). Diagnostic and procedure costs were obtained from the CMS OPPS (2023), clinical laboratory fee schedule (2023), physician fee schedule (2023), durable medical fee schedule (2023), and Dasta 2005. Medication cost data were obtained from IBM ® Micromedex ® RED BOOK ® (2023) using wholesale acquisition cost and were uniformly applied across sites of care. Average total cost by month after liso-cel infusion was calculated among patients with ongoing status in that month. Patients censored due to data cutoff were excluded. Results: A total of 130 patients were treated with liso-cel in the TRANSCEND FL study, primarily in the fourth-line setting (45.4%). These patients had a median (range) age of 60 (23‒80) years and were predominantly male (83/130 [63.8%]) and White (69/130 [53.1%]); 45 (34.6%) had unknown race. Among patients who received liso-cel infusions, the estimated mean 6-month postinfusion total cost of care was $89,516 (Figure 1). Most 6-month costs ($77,088 [86.1%]) were incurred in Month 1 after infusion and were primarily driven by facility costs ($66,683 [74.5%]), namely standard IP hospitalization and ICU stays. HCRU and LOS (including standard IP hospitalization and ICU days) are shown in Table 1. Almost all patients were hospitalized in the standard IP setting (128/130 [98.5%]). Few patients were admitted to the ICU (4/130 [3.1%]), and 3/130 (2.3%) had an emergency department visit. Median (range) hospitalization time was 14 (3‒45) days for standard IP and 5 (3‒7) days for ICU stays. Some patients received corticosteroids (30/130 [23.1%]) or tocilizumab (31/130 [23.8%]), and few required intravenous immunoglobulin (11/130 [8.5%]), vasopressors (4/130 [3.1%]), lumbar puncture (2/130 [1.5%]), or mechanical ventilation (1/130 [0.8%]). No patients received dialysis. Conclusions: The majority of costs in the 6-month period after liso-cel infusion among patients with R/R FL in the TRANSCEND FL study were incurred in Month 1 and were facility related (IP and ICU hospitalizations and LOS). These findings, consistent with those previously reported for patients with LBCL treated with liso-cel, support that a single infusion of liso-cel is associated with significantly less HCRU and costs after the initial treatment period in the first month.

Cost Analysis of MR-Guided vs. CT-Guided Radiation Therapy for Locally Advanced Pancreatic Cancer

Stereotactic magnetic resonance guided on-table adaptive radiotherapy (SMART) is an increasingly utilized radiotherapy (RT) treatment for locally advanced pancreatic cancer (LAPC), providing improved local control and overall survival with reduced toxicity. Computed tomography (CT) guided RT options include stereotactic body radiotherapy (SBRT) and hypofractionated RT with volumetric modulated arc therapy (VMAT). Currently there are no financial comparisons for MR vs CT-guided RT for LAPC. We completed a cost analysis comparing the physician and hospital charges associated with RT options for LAPC. To compare RT costs, we identified Current Procedural Terminology (CPT) codes utilized for 5-fraction SMART with adaptation (50 Gy, biological effective dose (BED) 100 Gy), 5-fraction CT-guided SBRT (33 Gy, BED 55 Gy), and 15-fraction CT-guided hypofractionated VMAT (67.5 Gy, BED 98 Gy) in a hospital-based practice setting. Physician and hospital Medicare prices associated with these codes together summarize the overall cost. We determined physician fees using the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule Search to search the Healthcare Common Procedure Coding System (HCPCS) for "professional" costs included within "facility" costs. We determined hospital fees using the Outpatient Prospective Payment System addendum. To standardize costs, we searched for national payment amounts for the 2022 calendar year. Total cost of SMART with adaptation was 136% higher than the cost of CT-SBRT and 149% higher than the cost of hypofractionated RT. Physician fees for SMART were 173% higher and 157% higher than the fees for CT-SBRT and hypofractionated RT, respectively. Hospital fees for SMART were 129% higher and 147% higher than the fees for CT-SBRT and hypofractionated RT, respectively. The total cost of CT-SBRT was only 5% higher than cost of hypofractionated RT. The physician fees for hypofractionated RT were 6% higher than those for CT-SBRT, while the outpatient fees for CT SBRT were 7% higher than those for hypofractionated RT. With recent data demonstrating favorable efficacy and toxicity rates for SMART, practices may increasingly consider investing in this treatment modality. This is the first cost analysis comparing SMART to CT-guided SBRT and hypofractionated RT in LAPC. We demonstrate higher costs of SMART compared to CT-guided RT, attributable primarily to higher number of dosimetry calculations for this modality and for adapted fractions. We also demonstrate comparable costs of lower BED CT-guided SBRT and higher BED hypofractionated RT. Further investigation is needed to assess whether the survival benefit of SMART translates to favorable cost per quality adjusted life year.

Billing & Coding

Billing & Coding

Estimation of Long-Term Post-Infusion Costs of Care for Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Following Administration of Idecabtagene Vicleucel (ide-cel, bb2121) in the KarMMa Clinical Trial

Introduction: RRMM is associated with poor prognosis and decreased overall survival. Chimeric antigen receptor (CAR) T cell therapies have emerged as a potential single-infusion treatment option for these patients. Ide-cel (bb2121), a B-cell maturation antigen (BCMA)-directed CAR T cell therapy for treatment of RRMM, has demonstrated frequent, deep, and durable responses in heavily pretreated patients in the KarMMa clinical trial (Munshi NC, et al. N Engl J Med 2021;384:705-716). However, evidence on long-term healthcare resource utilization (HCRU) and associated costs of care following ide-cel administration is very limited; this abstract provides a long-term update to a previous 12-month (mo) cost-of-care analysis (Hari P, et al. Value Health 2021;24[Suppl 1]:S29-S30). The objective of this study was to estimate the 2-year (y) post-infusion cost of care for patients with RRMM who received ide-cel in the KarMMa trial. Methods: This retrospective study used the KarMMa clinical trial database to analyze the HCRU and cost associated with ide-cel. We identified resource use and employed a micro-costing methodology to estimate post-infusion costs. Beginning on the index date (day of ide-cel infusion) up to a 2-y follow-up period, we analyzed the following HCRU categories: facility (standard inpatient [IP] and intensive care unit [ICU]), diagnostic (eg, lab work and imaging), medication (eg, supportive care, prophylactic treatment, and adverse event management), and procedure (eg, dialysis and intubation); and length of stay (LOS) (number of standard IP days and ICU days). Given that some patients in the trial were administered ide-cel outside the United States (US), any HCRU inconsistent with US clinical practice were adapted to reflect the US perspective. Next, we applied unit costs to each HCRU in the time period. Unit costs were from the US health system (provider) perspective and adjusted to 2022 USD. Cost per standard IP day ($2944) was estimated from 2018 Healthcare Cost and Utilization Project databases and cost per ICU day ($8426) sourced from Dasta JF, et al. Crit Care Med 2005;33:1266-1271. Medication cost data were obtained from REDBOOKTM using wholesale acquisition cost and were uniformly applied across sites of care. Diagnostic, transfusion, and procedure costs were taken from the Centers for Medicare & Medicaid Services lab fee schedule, physician fee schedule, or outpatient prospective payment system. Unit costs were estimated by applying a payment-to-cost ratio to any Medicare reimbursement rates. Costs were then adjusted to reflect cost to the site of care where the HCRU occurred. Costs were aggregated by HCRU category (facility, medication, procedure, and diagnostic) and partitioned by mo following ide-cel administration. An average total cost by post ide-cel infusion mo was calculated among patients with ongoing status in that mo. Patients censored because of data cut off were excluded. Results: A total of 128 patients were treated with ide-cel in the KarMMa trial. Patients had a mean (standard deviation [SD]) age of 59.8 (9.3) y, and were predominantly male (59.4%), White (80.5%), and non-Hispanic (80.5%). HCRU and LOS, including standard IP and ICU days, are shown in Table 1. Mean (SD) LOS throughout the follow-up period was 22.3 (13.3) days for standard IP and 1.6 (4.8) days for ICU. Total LOS ranged from 14 to 114 days with a median of 19.5 days and a mean (SD) of 23.9 (14.4) days (protocol required IP stay ≥ 14 days post infusion). HCRU, especially in y 2 and for medications, may have been related to management of toxicity or progressive disease. All patients were hospitalized (per trial protocol); 20.3% had an ICU stay. Most patients received antibiotics (96.1%) and tocilizumab + corticosteroids (54.7%), some received corticosteroids only (45.3%), and few had vasopressor use (14.8%). A minority of patients required dialysis (0.8%) or intubation (3.9%). The estimated mean 2-y post-infusion cost of care was $123,157. Most of the 2 y costs post-infusion were incurred in y 1 (85.7%) with 54% in mo 1 and were driven primarily by facility costs, namely standard IP and ICU stays (Figure 1). Conclusions: This study is the first to estimate long-term (national average-based) cost of care following CAR T cell therapy for patients with RRMM. Findings suggest that a single infusion of ide-cel is associated with substantially reduced HCRU and long-term costs following the initial treatment period. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Medical center reimbursement for vascular procedures has increased over time while professional reimbursement has declined

ObjectiveThe United States healthcare system uses different methods for assigning medical center reimbursement (MCR) and professional reimbursement (PR) for clinical services. We hypothesized that PR has not increased proportionately to MCR for the same vascular services. MethodsMCR and PR were compared for commonly performed inpatient and outpatient vascular procedures between 2012 and 2021. MCR was calculated using the Medicare inpatient prospective payment system and outpatient prospective payment system. MCR is based on the Centers for Medicare and Medicaid Services definition and criteria for comorbidities and the occurrence of complications; thus, changes in MCR were reported as a range based on the degree of comorbidities and complications using the Diagnosis Related Group. PR was calculated using the Medicare physician fee schedule, which assigns a numerical work relative value unit to each surgical service, with final compensation determined by an annually adjusted conversion factor to yield a final dollar amount. The expected reimbursement based on the observed inflation during the study period using the consumer price index was calculated and compared to the actual reimbursement. ResultsFrom 2012 to 2021, MCR for inpatient procedures increased 20% to 26% for carotid endarterectomy, 24% to 27% for femoral endarterectomy, 24% to 27% for femoropopliteal bypass with vein, 14% to 19% for thoracic endovascular aortic repair, and 15% for aortobifemoral bypass. During the same period, PR increased 3.3% for carotid endarterectomy but decreased for femoral endarterectomy (−5.0%), femoropopliteal bypass (−4.6%), thoracic endovascular aortic repair (−4.2%), and aortobifemoral bypass (−5.0%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 10% to 17% reduction but MCR outpaced inflation by 3.7% to 10%. For outpatient procedures, MCR increased 117% for tibial angioplasty, 24% for superficial femoral artery (SFA) stenting, 62% for tunneled dialysis catheter (TDC) insertion, and 24% for iliac stenting but decreased 0.43% for arteriovenous fistula (AVF) creation and 7.6% for radiofrequency ablation (RFA). PR increased 0.91% for SFA stenting but decreased for tibial angioplasty (−17%), AVF creation (−6.4%), TDC insertion (−7.1%), iliac stenting (−3.8%), and RFA (−22%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 13% to 32% reduction. In contrast, MCR outpaced inflation 7.5% to 88% for tibial angioplasty, SFA stenting, TDC insertion, and iliac stenting but experienced a reduction for AVF (−13%) and RFA (−19%). ConclusionsMCR for commonly performed vascular procedures has increased and outpaced inflation. In contrast, PR for these same services has decreased across all procedure types. This decrease in PR was exacerbated when adjusted for inflation. This inequity in the reimbursement methods between MCR and PR poses a threat to the viability of the physician workforce. Either changes to the reimbursement methods or a reallocation of reimbursement to physicians are imperative to sustain physician practices.

Trends in Medicare Physician and Facility Fee Reimbursement in Orthopaedic Foot and Ankle

Category:Ankle; Ankle Arthritis; Arthroscopy; Bunion; Diabetes; Hindfoot; Lesser Toes; Midfoot/Forefoot; Sports; TraumaIntroduction/Purpose:The purpose of the study was to examine the trends in physician and facility reimbursement for the orthopaedic foot and ankle subspecialty utilizing the 23 most common foot and ankle surgeries based on national payment amounts.Methods:The Current Procedural Terminology (CPT) codes and corresponding Medicare Severity - Diagnosis Related Group (MS-DRG) codes for the 23 most common orthopaedic foot and ankle surgeries were identified. With the CPT codes, physician reimbursement was obtained through querying the Medicare Physician Fee Schedule (MPFS) for the work, malpractice, and practice expense relative value units (RVU) and then multiplying the total RVUs by the yearly conversion factor. CPT codes were also utilized to gather hospital outpatient reimbursement data from the Hospital Outpatient Prospective Payment System (OPPS) database. Hospital inpatient reimbursement rates were obtained from the Hospital Inpatient Prospective Payment System (IPPS) database utilizing the MS-DRG codes. All amounts were then adjusted for inflation using the Consumer Price Index (CPI).Results:From 2008 to 2021, physician reimbursement for the 23 most common orthopaedic foot and ankle surgeries decreased by 20%, with a mean Compound Annual Growth Rate (CAGR) of -1.7%. Hospital inpatient reimbursement increased by 34.7% with a mean CAGR of 2.3%; while outpatient hospital reimbursement increased by 97.2% with a mean CAGR of 5.1%.Conclusion:Over the past 13 years, physician reimbursement for common orthopaedic foot and ankle surgeries has declined while hospital reimbursement has increased. The larger increase in outpatient reimbursement compared to inpatient reimbursement highlights how CMS aims to transition surgeries from the inpatient setting to the more efficient and less expensive outpatient setting. This downward pressure on physician reimbursement while incentivizing outpatient services could have many unintended consequences on the landscape of foot and ankle practice in the US.

Stereotactic Body Radiotherapy and Yttrium-90 in the Treatment of Hepatocellular Carcinoma: A Comparison of Outcomes and Costs

<h3>Purpose/Objective(s)</h3> Stereotactic Body Radiotherapy (SBRT) and Yttrium-90 (Y90) are two modalities utilized for non-operative treatment of hepatocellular carcinoma (HCC). Although there is increasing use of these two modalities, data comparing outcomes and cost are limited. Gaining an understanding of treatment outcomes and costs of SBRT and Y90 would help guide decisions made by multidisciplinary tumor boards. We hypothesize that use of SBRT and Y90 will result in similar oncologic outcomes and costs. <h3>Materials/Methods</h3> Patients treated for HCC with SBRT or Y90 Segmentectomy between January 2018 and January 2020 at one institution were retrospectively reviewed. Demographic, treatment, and outcome data were collected. Demographic and treatment specifics were compared between treatment modalities utilizing Chi square tests. Oncologic outcomes were compared utilizing Kaplan Meier analysis. A subset of SBRT and Y90 patients were randomly selected for cost analysis. Common Procedural Terminology and Healthcare Common Procedure Coding System codes were gathered for the patients' treatments using the institution's Clinical Research Database then entered in Medicare's Physician Fee Schedule and Outpatient Prospective Payment System to determine and compare total cost. <h3>Results</h3> Eighty-seven patients were analyzed, 24 treated with SBRT and 63 treated with Y90. Median follow-up was 315 days. There were no differences in age, race, sex, and number of co-morbidities between the treatment cohorts. Patients treated with SBRT were more likely to have received prior liver directed therapy than those treated with Y90 (66.7% SBRT vs 12.7% Y90, <i>P</i> = 0.000011), to have larger tumors (4.52cm vs 2.96cm, <i>P</i> = 0.000879), and have a greater AJCC staging (<i>P</i> = 0.011606). The treatment related toxicity for the entire cohort was 51.7%, with no difference in toxicity between the treatment groups (50.0% for SBRT vs 52.4% for Y90, <i>P</i> = 0.986424). The one-year local control rate was 87%, with no difference between the treatment groups (87% vs 89%, <i>P</i> = 0.76). In both treatment groups, death was more attributable to other causes (62.5% SBRT vs. 53.8% Y90) than disease progression (37.5% SBRT vs. 38.5% Y90). Average total cost of SBRT was $12,885. Physician professional charges were $1,383 and facility charges were $11,502. Average total cost of Y90 was $19,393. Physician professional charges were $2,178, including charges for both Interventional Radiology and Nuclear Medicine, and facility charges were $17,215. <h3>Conclusion</h3> Both SBRT and Y90 appear to be effective treatments in the management of HCC with high rates of local control. Treatment with SBRT, on average, was at a lower cost than Y90. More research is needed to further evaluate the clinical and cost effectiveness in treating non-operable HCC with SBRT and Y90.

Despite Equivalent Medicare Reimbursement, Facility Costs for Outpatient Total Knee Arthroplasty Are Higher Than Unicompartmental Knee Arthroplasty

BackgroundWith the recent removal of total knee arthroplasty (TKA) from the Centers for Medicare and Medicaid Services (CMS) Inpatient Only list, facility reimbursement for outpatient TKA now falls under the Outpatient Prospective Payment System at the same rate as unicompartmental knee arthroplasty (UKA). The purpose of this study was to compare true facility costs of patients undergoing outpatient TKA with those undergoing UKA. MethodsWe reviewed a consecutive series of 2310 outpatient TKA and 231 UKA patients from 2018 to 2019. Outpatient status was defined as a hospital stay of less than 2 midnights. Facility costs were calculated using a time-driven, activity-based costing algorithm. Implants, supplies, medications, and personnel costs were compared between outpatient TKA and UKA patients. A multivariate analysis was performed to control for confounding medical and demographic variables. ResultsWhen compared with patients undergoing UKA, outpatient TKA patients had higher implant costs ($3403 vs $3081; P < .001) and overall hospital costs ($6350 vs $5594; P < .001). Outpatient TKA patients had a greater length of stay (1.2 vs 0.5 days; P < .001) and greater postoperative personnel costs ($783 vs $166; P < .001) than UKA patients. When controlling for comorbidities, outpatient TKA was associated with a $803 (P < .001) increase in overall facility costs compared with UKA. ConclusionDespite equivalent reimbursement from CMS as UKA, outpatient TKA has increased facility costs to the hospital. Although implant costs can vary greatly by institution, CMS should consider appropriately reimbursing outpatient TKA for the additional personnel costs when compared with UKA.

Costs of Postinfusion Monitoring By Site of Care for Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Who Received Third-Line or Later Treatment with Lisocabtagene Maraleucel (liso-cel) in the Transcend NHL 001 and Outreach Trials

Background: Chimeric antigen receptor (CAR) T cell therapy is generally limited to inpatient settings; yet, exploration of outpatient infusion and monitoring is ongoing. Information on health care resource utilization (HCRU) and costs associated with CAR T cell therapy administration is limited and may differ by postinfusion monitoring site. Liso-cel is an investigational, CD19-directed, defined composition, 4-1BB CAR T cell product administered at equal target doses of CD8+ and CD4+ CAR+ T cells. An interim analysis from the OUTREACH study (NCT03744676) observed lower HCRU with outpatient vs inpatient administration (Bachier et al. J Clin Oncol 2020;38:8037). The patient journey after CAR T cell therapy administration may differ for patients with outpatient vs inpatient monitoring and may result in varying costs of care. This study estimated the cost of postinfusion monitoring by site of care for patients with R/R LBCL who received third-line or later treatment with liso-cel in the TRANSCEND NHL 001 (TRANSCEND; NCT02631044) and OUTREACH clinical trials. Methods: This retrospective study analyzed HCRU reported in clinical trial databases from TRANSCEND and OUTREACH. A 2-step microcosting method was used to identify key HCRU and to estimate postinfusion costs: (1) HCRU was analyzed from the index date (day of liso-cel infusion) through the 6-month follow-up; and (2) costs were applied to each HCRU. HCRU included standard inpatient and intensive care unit (ICU) length of stay (LOS), diagnostics (laboratory work and imaging), procedures (dialysis and intubation), and medications (supportive care, prophylactic treatment, and adverse event management). Unit costs were obtained from the health care system (provider) perspective and adjusted to 2020 US dollars. Cost per standard inpatient day ($2,542) was estimated from Healthcare Cost and Utilization Project databases, and cost per ICU day ($7,556) was sourced from Dasta et al (Crit Care Med. 2005;33:1266-77). All medication costs were obtained from REDBOOK (IBM Micromedex) using wholesale acquisition costs. Diagnostic and procedure costs were obtained from the Centers for Medicare &amp; Medicaid Services laboratory fee schedule, physician fee schedule, or outpatient prospective payment system. A payment-to-cost ratio was applied to Medicare payment rates to estimate unit costs. Costs were adjusted to reflect the site of care where the HCRU occurred. A cost ratio was applied to adjust costs from the physician's office/community oncology clinic to the hospital outpatient department (Winfield, Muhlestein, Leavitt Partners; 2017) and from outpatient to inpatient (Meisenberg et al. Bone Marrow Transplant. 1998;21:927-32). Costs were aggregated by HCRU category, specifically medications, diagnostics, procedures, and facility costs. An average total cost by post-liso-cel infusion month was calculated for patients with ongoing status in that month (patients censored due to data cutoff were not included). Analyses were stratified by site of postinfusion monitoring (inpatients vs outpatients). Results: A total of 303 patients with R/R LBCL across the 2 trials received liso-cel and postinfusion monitoring (inpatients, n = 256; outpatients, n = 47). HCRU and LOS, including standard inpatient and ICU days, are shown in the Table. Inpatients had higher rates of inpatient stays (&amp;lt;100% vs 62%) and tocilizumab use (for CRS and/or NE; 20% vs 9%) than outpatients, respectively. Rates of ICU admission, corticosteroid use, vasopressor use, dialysis, and intubation were similar between groups. Median and average LOS in standard inpatient and ICU settings were higher among inpatients. Median (range) total LOS for inpatients and outpatients was 15 (0-88) and 4 (0-77) days, respectively. The estimated mean postinfusion cost of care was $89,535 for inpatients and $36,702 for outpatients. Over 6 months, most costs were incurred in the first month after infusion ($50,369 [56%] for inpatients and $19,837 [54%] for outpatients). Costs were largely driven by facility costs, namely standard inpatient and ICU stays (Figure). Conclusions: Lower overall HCRU was observed with outpatient liso-cel postinfusion monitoring, primarily due to hospitalizations, which resulted in a mean 6-month cost savings of $52,833 (59%) compared with inpatient monitoring. These results are based on national average costs and may not be generalizable to specific institutions. Disclosures Palomba: Regeneron: Research Funding; Juno Therapeutics, a Bristol-Meyers Squibb Company: Honoraria, Research Funding; Genentech: Research Funding; Merck: Honoraria; Novartis: Honoraria; Celgene: Honoraria; Pharmacyclics: Honoraria. Jun:Bristol-Myers Squibb Company: Current Employment, Current equity holder in publicly-traded company. Garcia:Bristol-Myers Squibb Company: Current equity holder in publicly-traded company; Juno Therapeutics, a Bristol-Myers Squibb Company: Current Employment. Lymp:Bristol-Myers Squibb Company: Current equity holder in publicly-traded company; Juno Therapeutics, a Bristol-Myers Squibb Company: Current Employment. McGarvey:Pfizer, Inc.: Ended employment in the past 24 months; BluePath Solutions: Current Employment. Gitlin:BMS: Research Funding. Pelletier:BMS: Current Employment, Current equity holder in publicly-traded company. Nguyen:BluePath Solutions: Current Employment.

Conversion to Biosimilar Pegfilgrastim-Jmdb from Pegfilgrastim with on-Body Injector Device in Diffuse Large B-Cell Lymphoma: Simulation Modeling of Cost-Savings and Budget-Neutral Expanded Access to Prophylaxis and Anti-Neoplastic Therapy Considering Device Failure Rate

Introduction: Approvals of biosimilar pegfilgrastim products in recent years have reduced the costs of single-dose prophylaxis of chemotherapy-induced (febrile) neutropenia (CIN/FN). While reference pegfilgrastim with on-body injector (PEG-OBI) offers convenience to patients over use of next day pre-filled syringe (PFS), PEG-OBI has a reported failure rate of 1.7-6.9% that predisposes patients to increased risk of CIN/FN episodes. Incremental FN-related hospitalizations (FN-HOSP) associated with PEG-OBI failure contribute to the cost differential between PEG-OBI and assured prophylaxis with biosimilar PEG-PFS. Cost savings generated from conversion to biosimilar PEG-jmdb create opportunities for providing expanded access on a budget-neutral basis to additional CIN/FN prophylaxis or anti-neoplastic treatment. Hence, in a panel of 15,000 patients with diffuse large B-cell lymphoma (DLBCL), we aimed to: 1) quantify the cost-savings from assured prophylaxis with biosimilar PEG-jmdb over PEG-OBI accounting for device failures, 2) simulate the additional CIN/FN prophylaxis that could be achieved from the cost-savings, and 3) model the expanded access to anti-neoplastic treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) that could be provided on a budget-neutral basis through reallocation of cost-savings. Methods: Simulation analysis in a panel of 15,000 DLBCL patients at risk for CIN/FN from the US payer perspective utilized. Costs of medication were based on Q1 2020 average selling price (ASP) for PEG-OBI, PEG-jmdb, and R-CHOP drugs derived from CMS Q3 2020 reimbursement limits; cost of PEG-OBI and PEG-jmdb administration per CMS Outpatient Prospective Payment System; between one and six cycles of prophylaxis; conversion rates from PEG-OBI to biosimilar PEG-jmdb ranging from 10% to 100%; and PEG-OBI failure rates of 1% to 7%. Differential base rate of FN-HOSP in NHL (rate of FN-HOSP without colony-stimulating factor [CSF] minus rate with CSF) was 10.03% over a 6-cycle regimen with 56% occurring in cycle 1 (Chrischilles et al., Cancer Control 2002; 13.25% with CSF, 23.28% without). FN-HOSP costs in 2012 of $25,676 per episode for NHL patients (Tai, J Oncol Pract 2017) were adjusted per the Consumer Price Index for Medical Care to $31,914 for 2020. Results: Conversion from PEG-OBI to biosimilar PEG-jmdb in a panel of 15,000 DLBCL patients generated savings ranging from $379,230 (for one cycle of prophylaxis at 10% conversion) to $22,753,800 (6 cycles at 100%) considering the cost of medication plus administration. These cost-savings could provide access to between 110 (1 cycle at 10% conversion) and 6,623 (6 cycles at 100%) additional cycles of PEG-jmdb on a budget-neutral basis, or between 58 and 3,452 cycles of R-CHOP, respectively. Taking incremental FN-HOSP costs due to PEG-OBI failure into consideration, cost-savings in cycle one from conversion to PEG-jmdb, ranged from $406,118 (at 10% conversion and PEG-OBI failure of 1%) to $5,674,454 (at 100% conversion and 7% PEG-OBI failure). These savings translated into expanded access to between 118 additional cycles of PEG-jmdb or 62 cycles of R-CHOP (at 10% conversion and 1% PEG-OBI failure) and 1,652 cycles of PEG-jmdb or 861 cycles of R-CHOP (at 100% conversion and 7% PEG-OBI failure). Over a 6-cycle regimen, savings increase to $2,323,394 (at 10% conversion and 1% PEG-OBI failure) to $26,114,789 (at 100% conversion and 7% PEG-OBI failure). These additional savings increased expanded access to PEG-jmdb to between 676 additional cycles of PEG-jmdb or 353 cycles of R-CHOP (at 10% conversion and 1% PEG-OBI failure) and 7,601 cycles of PEG-jmdb or 3,962 cycles of R-CHOP (at 100% conversion and 7% PEG-OBI failure). Conclusions: CIN/FN prophylaxis with biosimilar PEG-jmdb generates substantial cost savings compared to PEG-OBI when considering drug and administration costs. Savings further increase when the costs of FN-HOSP related to PEG-OBI failure are taken into account. Reallocation of savings realized through conversion to biosimilar pegfilgrastim-jmdb provide expanded access to additional CIN/FN prophylaxis and anti-neoplastic treatment on a budget-neutral basis while reducing risk and associated hospitalization costs associated with inadequate prophylaxis due to device failure. Disclosures McBride: Coherus BioSciences: Consultancy, Speakers Bureau; Merck: Speakers Bureau; Pfizer: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Bristol-Myers Squibb: Consultancy. MacDonald:Sandoz: Consultancy; Coherus BioSciences: Research Funding; Mylan: Consultancy; Novartis: Consultancy; Janssen: Consultancy; Rockwell Medical: Consultancy; Terumo: Consultancy; Celgene: Consultancy; MorphoSys: Consultancy. Abraham:Sandoz: Consultancy; Mylan: Consultancy; Janssen: Consultancy; Rockwell Medical: Consultancy; Terumo: Consultancy; Celgene: Consultancy; Coherus BioSciences: Research Funding, Speakers Bureau; MorphoSys: Consultancy.

Accountability Of Resources And Cost For Different Modalities

To evaluate feasibility in terms of cost for special treatment procedures across different modalities. An analysis of the cost of alternative state of the art treatment modalities was done to evaluate the necessity of more treatment options, compared to the financial gain provided by each. We used the 2019 Hospital Outpatient Prospective Payment System (HOPPS) to determine reimbursement for each treatment and assumptions on the time of physicist involvement, treatment planning, treatment time, time of radiation oncologist involvement (e.g. for gammaknife where the radiation oncologist stay during treatment), number of fractions per patient, average salaries and initial cost of modality and continuing cost of service contracts. We assumed one source exchange for gammaknife to extend its useful live. We did not include any existing overhead that will be the same between these modalities, rather just the cost of what is needed additionally for some modalities. We determined the maximum number of fractions that can be treated annually for each modality and the expected lifetime of each modality. We then calculated the number of patients needed annually to cover cost. For stereotactic radiosurgery modalities, i.e. CyberKnife, Linac-based, Linac/MRI, and gammaknife, the annual breakeven points were 25, 34, 41, and 74 patients respectively. For HDR the breakeven was 31 patients each year and 10 for a hyperthermia unit. For protons the number is higher with 152 patients. For each modality there is a limit on the number of patients that can be treated annually, depending on treatment time and common fractionations used for each modality. This favored Linac-based SRS and SBRT where the annual capacity was 1020 patients, because it was assumed that they are dedicated to stereotactic treatments, i.e. few fractions per patient and fastest treatment time. The annual capacity of patients treated with protons were 254, because of the assumption of 25 fractions per patient on average. For Gammaknife, CyberKnife, Linac/MRI, hyperthermia, and HDR the limits were 524, 331, 337, 104, and 433 respectively, because of long treatment times and/or planning times. Although hyperthermia needed the lowest number of patients to breakeven, its gain and limit on patient’s treated annually were the lowest because of a large need of physics and therapy time and relatively high service contracts. For large centers where there might be a larger number of patients that might benefit from a given modality, the cost can be reduced as staff gain more expertise to do these cases faster. Accountability for resources must be balanced by the number of patients that might benefit from it. Having more options of different modalities for state-of-the-art patient care might increase the potential number of patients and a center’s research potential, but it will also decrease the gain of each modality because of staff’s time, expertise, and service cost.

Impact of reduced elective ophthalmic surgical volume on U.S. hospitals during the early coronavirus disease 2019 pandemic.

To estimate the financial impact of coronavirus disease 2019 (COVID-19)-related shutdowns on ophthalmic surgery performed at hospital outpatient departments (HOPDs) in the United States. Nationally representative sample of U.S. hospital payment and cost data. Retrospective review and economic impact analysis. The Nationwide Ambulatory Surgery Sample (NASS) was used to identify ophthalmic surgical procedures and associated charges, which were performed at HOPDs. The highest volume elective ophthalmic procedures were identified. The total hospital cost and payment amount was calculated for each procedure using the Hospital Outpatient Prospective Payment System (OPPS) maintained by the Centers for Medicare & Medicaid Services. Net facility income (estimated payments less OPPS rates) was determined for each elective surgical procedure category and stratified by hospital teaching status. In 2017, elective cataract, strabismus, and keratoplasty surgeries were performed 1 230 992 times at HOPDs. The total cost of these elective surgeries was 2350 million U.S. dollars (USD), with a total hospital payment of 3624 to 3786 million USD. This led to an estimated net income of 1278 to 1440 million USD overall to U.S. hospitals in the NASS dataset from elective ophthalmic surgery (approximately 107 to 120 million USD per month), with a larger proportion performed in teaching hospitals. The cessation of elective ophthalmic surgeries at HOPDs during COVID-19 resulted in a significant loss of income for hospitals in the United States and teaching experiences for trainees at academic medical centers.

Amount of CMS Reduction in Facility Reimbursement Following Removal of Total Hip Arthroplasty From the Inpatient-Only List Far Exceeds Reduction in Actual Care Cost

BackgroundStarting in 2020, Centers for Medicare and Medicaid Services (CMS) removed total hip arthroplasty (THA) from the inpatient-only list, resulting in an average of $1637 per case reduction in facility reimbursement. The purpose of this study is to determine whether the reduction in reimbursement is justified by comparing the difference in true facility costs between inpatient and outpatient THA. MethodsWe identified a consecutive series of 5271 primary THA procedures from 2015 to 2019. Itemized procedural costs were calculated using a time-driven activity-based costing algorithm. Outpatient procedures were defined as those with less than a 24-hour length of stay. We compared patient demographics, comorbidities, and itemized costs between inpatient and outpatient procedures. A multivariate analysis was performed to determine the independent effect of outpatient status on true facility costs. ResultsThere were 783 (14.9%) outpatient THA procedures. The outpatient THA procedures incurred lower mean personnel ($1428 vs $2226, P < .001), supply ($4713 vs $4739, P < .001), and overall facility costs ($6141 vs $6595, P < .001) when compared with the same THA procedures done inpatient. When controlling for confounding variables, outpatient status was associated with a reduction in total facility costs of $825 (95% confidence interval, $734-$916, P < .001). ConclusionThe reduction in CMS reimbursement far exceeds the $825 per-patient cost savings that can be achieved by a facility by performing THA as an outpatient. CMS should reconsider the Outpatient Prospective Payment System classification of THA to better incentivize surgeons to perform THA as a lower-cost outpatient procedure when safe and appropriate.

Is the New Outpatient Prospective Payment System Classification for Outpatient Total Knee Arthroplasty Appropriate?

BackgroundIn 2018, the Centers for Medicare and Medicaid Services removed total knee arthroplasty (TKA) from the inpatient-only list, resulting in payment through the Outpatient Prospective Payment System with an average $3157 reduction. The purpose of this study is to determine if the reimbursement is justified by comparing the difference in facility costs between inpatient and outpatient TKAs. MethodsWe identified 4496 consecutive primary TKA procedures performed at 2 hospitals from 2015 to 2019. Itemized facility costs were calculated using a time-driven activity-based costing algorithm. Outpatient procedures were defined as those with a length of stay of less than 2 midnights (3851, 86%). Patient demographics, comorbidities, and itemized costs were compared between groups. A multivariate regression analysis was performed to determine the independent effect of outpatient status on true facility costs. ResultsOutpatient TKA patients had lower mean postoperative personnel costs ($1809 vs $947, P < .001), supply costs ($4347 vs $4229, P < .001), and overall total facility costs ($7371 vs $6937, P < .001) than inpatient TKA patients. Controlling for a younger patient cohort with fewer medical comorbidities, outpatient status was associated with a reduction in total facility costs of $972 (95% confidence interval $883-$1060, P < .001) compared to inpatient TKA. ConclusionOutpatient TKA costs hospitals nearly $1000 per patient less than inpatient TKA, yet the average difference in Medicare reimbursement for an outpatient procedure is $3157 less per patient. Centers for Medicare and Medicaid Services should reconsider the Outpatient Prospective Payment System classification of TKA to better incentivize surgeons to perform TKA as a lower cost outpatient procedure when safe and appropriate.

Estimating the Financial Impact of Site-Neutral Payments for Outpatient Consultations in Oral and Maxillofacial Surgery

Estimating the Financial Impact of Site-Neutral Payments for Outpatient Consultations in Oral and Maxillofacial Surgery

Supervision Requirements in the 2020 Hospital Outpatient Prospective Payment System

Supervision Requirements in the 2020 Hospital Outpatient Prospective Payment System

Economic Evaluation of Chimeric Antigen Receptor T-Cell Therapy by Site of Care Among Patients With Relapsed or Refractory Large B-Cell Lymphoma

Chimeric antigen receptor (CAR) T-cell therapies are currently administered at a limited number of cancer centers and are primarily delivered in an inpatient setting. However, variations in total costs associated with these therapies remain unknown. To estimate the economic differences in the administration of CAR T-cell therapy by the site of care and the incidence of key adverse events. A decision-tree model was designed to capture clinical outcomes and associated costs during a predefined period (from lymphodepletion to 30 days after the receipt of CAR T-cell infusion) to account for the potential incidence of acute adverse events and to evaluate variations in total costs for the administration of CAR T-cell therapy by site of care. Cost estimates were from the health care practitioner perspective and were based on data obtained from the literature and publicly available databases, including the Healthcare Cost and Utilization Project National Inpatient Sample, the Medicare Hospital Outpatient Prospective Payment System, the Medicare physician fee schedule, the Centers for Medicare and Medicaid Services Healthcare Common Procedure Coding System, and the IBM Micromedex RED BOOK. The model evaluated an average adult patient with relapsed or refractory large B-cell lymphoma who received CAR T-cell therapy in an academic inpatient hospital or nonacademic specialty oncology network. The administration of CAR T-cell therapy. Total cost of the administration of CAR T-cell therapy by site of care. The costs associated with lymphodepletion, acquisition and infusion of CAR T cells, and management of acute adverse events were also examined. The estimated total cost of care associated with the administration of CAR T-cell therapy was $454 611 (95% CI, $452 466-$458 267) in the academic hospital inpatient setting compared with $421 624 (95% CI, $417 204-$422 325) in the nonacademic specialty oncology network setting, for a difference of $32 987. After excluding the CAR T-cell acquisition cost, hospitalization and office visit costs were $53 360 (65.3% of the total cost) in academic inpatient hospitals and $23 526 (48.4% of the total cost) in nonacademic specialty oncology networks. The administration of CAR T-cell therapy in nonacademic specialty oncology networks was associated with a $29 834 (55.9%) decrease in hospitalization and office visit costs and a $3154 (20.1%) decrease in procedure costs. The potential availability of CAR T-cell therapies that are associated with a lower incidence of adverse events and are suitable for outpatient administration may reduce the total costs of care by enabling the use of these therapies in nonacademic specialty oncology networks.

Estimated Costs Associated With Radiation Therapy for Positive Surgical Margins During Radical Prostatectomy

Prostate cancer is the most common malignant neoplasm among men and is the one with the highest positive surgical margin (PSM) rate. This high rate is due to the difficulty in balancing the risk of extraprostatic disease and excising periprostatic structures, which ultimately affects patients' quality of life. In the case of a PSM, the appropriateness of adjuvant radiation therapy (aRT) should be discussed. The financial burden of PSMs on health systems has not been investigated. To estimate the financial costs associated with a PSM during radical prostatectomy on the basis of the odds of undergoing aRT. This cohort study used data on men with prostate cancer from the US National Cancer Database (January 1, 2010, through December 31, 2015). Data were requested in March 2019, accessed in April 2019, and analyzed in August 2019. Treatment with radical prostatectomy followed by aRT, if indicated. The attributable risk fraction of PSMs on undergoing aRT was estimated from a logistic regression with aRT administration as the outcome. The analysis was adjusted for patients' socioeconomic and demographic characteristics and tumor characteristics. The aRT cost for the year 2019 was calculated using the Medicare Physician Fee Schedule and the Hospital Outpatient Prospective Payment System. The fraction of this cost attributable to a PSM was estimated according to its attributable risk fraction. In total, 230 175 men were identified (median [interquartile range] age at diagnosis, 62.0 [56.0-67.0] years). Overall, 22.8% of the patients had a PSM. Patients with PSMs were more likely than those without PSMs to be older (median [interquartile range] age, 62.0 [56.0-66.0] years vs 62.0 [57.0-67.0] years) and nonwhite (9320 patients [17.8%] vs 29 872 patients [16.8%]), to have higher comorbidity scores (1604 patients [3.1%] vs 4884 patients [2.7%] with a Charlson-Deyo Comorbidity Index score ≥2) and worse tumor characteristics (category T3 and T4 disease, 26 394 patients [50.3%] vs 36 040 patients [20.3%]), and to have lower socioeconomic indicators (median annual income <$30 000, 5708 patients [10.9%] vs 17 874 patients [10.1%]; proportion of individuals without a high school degree in the area ≥29%, 6925 patients [13.2%] vs 22 648 patients [12.7%]). In addition, PSMs were documented more frequently at nonacademic institutions than academic ones (31 702 patients [60.5%] vs 20 714 patients [39.5%]). A total of 11 585 patients (5.0%) underwent aRT, and 7698 of them (3.3%) had a PSM at the final pathology examination. When controlling for patients' socioeconomic and demographic characteristics and tumor characteristics, men with PSMs were more likely than those with negative margins to undergo aRT, with an odds ratio of 3.79 (95% CI, 3.63-3.96; P < .001). The attributable risk fraction of the presence of a PSM on aRT was 44% (95% CI, 42%-45%). The attributable cost of a PSM was calculated as $17 356 (95% CI, $16 567-$17 751). Assuming 60 000 prostatectomies in 2019 and similar trends of PSM and aRT, the overall health burden attributable to PSMs was calculated to be $52 068 000 (95% CI, $49 701 000-$53 253 000). The estimated aRT cost attributable to the presence of a PSM was $17 356, resulting in $52 068 000 in spending on aRT in 2019. Strategies to reduce PSMs could be associated with a reduction in the overall health costs of surgically treated PCa.

Total Knee Replacement: The Inpatient-Only List and the Two Midnight Rule, Patient Impact, Length of Stay, Compliance Solutions, Audits, and Economic Consequences

BackgroundIn November 2017, CMS finalized the 2018 Medicare Outpatient Prospective Payment System rule that removed TKA from the Medicare inpatient-only (IPO) list. This action had significant and unexpected consequences. MethodsWe looked at 3 levels of the IPO rule impact on TKA for Medicare beneficiaries: a national comparison of FFS inpatient and outpatient classification for 2017 vs 2018; a survey of AAHKS surgeons completed in April 2019; and an in-depth analysis of a large academic medical center experience. An analysis of change in admission classification of patients with TKA over time, number of QIO audits, compliance solutions for the new rule, and cost implications of those compliance solutions were evaluated. ResultsHospital reimbursement averages $10,122 in an outpatient facility but does not include the physician payment. Average hospital reimbursement in the inpatient setting is $11,760. The difference in hospital reimbursement varies widely (90th percentile decrease, $6725 vs 10th percentile $2048). Physician payments are the same in both settings (avg $1403). Patients with TKA not designated for inpatient admissions are not eligible for bundle payment programs. Patients designated as outpatients are subjected to higher out-of-pocket expenses. Patients may have an annual Medicare Part B Deductible ($185) and a 20% copay as well as prescription and durable medical equipment costs. An AAHKS survey demonstrated that 45.08% were with inpatient designation only, 17.62% were with outpatient designation only, 25.39% were designated as necessary, and 10.1% were designated by the hospital. This survey showed that 66 of 374 (17.65%) patients had undergone a QIO audit as a result of issues with the IPO rule. An evaluation of an AMC demonstrated that since January 1, 2018, 470 of 690 (68.1%) of CMS patients with TKA left in less than 2 midnights. The institution was subjected to 2 QIO audits. ConclusionsThere are many unintended consequences to the IPO rule application to TKA.