Association Between a Bundled Payment Program for Lower Extremity Joint Replacement and Patient Outcomes Among Medicare Advantage Beneficiaries.

Importance: Much of the evidence for bundled payments has been drawn from models in the traditional Medicare program. Although private insurers are increasingly offering bundled payment programs, it is not known whether they are associated with changes in episode spending and quality. Objective: To evaluate whether a voluntary bundled payment program offered by a national Medicare Advantage insurer was associated with changes in episode spending or quality of care for beneficiaries receiving lower extremity joint replacement (LEJR) surgery. Design, Setting, and Participants: Cross-sectional study of 23 034 LEJR surgical episodes that emulated a stepped-wedge design by using the time-varying, geographically staggered rollout of the bundled payment program from January 1, 2012, to September 30, 2019. Episode-level multivariable regression models were estimated within practice to compare changes before and after program participation, using episodes at physician practices that had not yet begun participating in the program during a given time period (but would go on to do so) as the control. Data analyses were performed from July 1, 2021, to June 30, 2022. Exposures: Physician practice participation in the bundled payment program. Main Outcomes and Measures: The primary outcome was episode spending (plan and beneficiary). Secondary outcomes included postacute care use (skilled nursing facility and home health care), surgical setting (inpatient vs outpatient), and quality (90-day complications [including deep vein thrombosis, wound infection, fracture, or dislocation] and readmissions). Results: The final analytic sample included 23 034 LEJR episodes (6355 bundled episodes and 16 679 control episodes) from 109 physician practices participating in the program. Of the beneficiaries, 7730 were male and 15 304 were female, 3057 were Black, 19 351 were White, 447 were of other race or ethnicity (assessed according to the Centers for Medicare & Medicaid Services beneficiary race and ethnicity code, which reflects data reported to the Social Security Administration), and 179 were of unknown race and ethnicity. The mean (SD) age was 70.9 (7.2) years. Participation in the bundled payment program was associated with a 2.7% (95% CI, 1.3%-4.1%) decrease in spending per episode (mean episodic spending, $21 964 [95% CI, $21 636-$22 296] vs $22 562 [95% CI, $22 346-$22 779]), as well as reductions in skilled nursing facility use after discharge (21.3% for bundled episodes vs 25.0% for control episodes; odds ratio [OR], 0.81 [95% CI, 0.67-0.98]) and increased use of the outpatient surgical setting (14.1% for bundled episodes vs 8.4% for control episodes; OR, 1.79 [95% CI, 1.53-2.09]). The program was not associated with changes in quality outcomes, including 90-day complications (8.8% for bundled episodes vs 8.6% for control episodes; OR, 1.02 [95% CI, 0.86-1.20]) and readmissions (4.3% for bundled episodes vs 4.6% for control episodes; OR, 0.92 [95% CI, 0.75-1.13]). Conclusions and Relevance: In this study of an LEJR bundled payment program offered by a national Medicare Advantage insurer, findings suggest that physician practice participation in the program was associated with a decrease in episode spending without changes in quality. Bundled payments offered by private insurers, including Medicare Advantage plans, are an alternate payment option to fee for service that may reduce spending for LEJR episodes while maintaining quality of care.

Early vs late filling of new heart failure prescription and its association with avoidable hospital admissions.

BACKGROUND: Individuals with heart failure (HF) are at increased risk for hospitalization and readmission after discharge. The impact of timing to new prescription filling on avoidable HF hospitalization is understudied in HF management. The Agency of Healthcare Research and Quality identifies HF-related inpatient admissions as potentially avoidable if they could be managed successfully in outpatient settings. OBJECTIVE: To compare avoidable HF hospitalization rate and all-cause and HF-related costs in patients who were early fillers (≤30 days) vs late fillers (>30 days) of newly prescribed HF medications following an HF-related inpatient stay or emergency department visit. METHODS: This retrospective cohort study used the Humana Research Database to identify patients with at least 1 claim for a new HF medication from January 1, 2018, to June 30, 2019. Eligible patients were enrolled in a Medicare Advantage Prescription Drug plan for at least 12 months pre-index and 6-months post-index (ie, first new HF prescription). Individuals who were early (n = 794) vs late fillers (n = 397) were propensity-score matched in a 2:1 ratio to balance baseline characteristics. A logistic regression model was fitted to compare avoidable HF hospitalization in those who were late fillers vs early fillers. Mean cost differences were compared using paired t-test. Outcomes were measured 6-months post-index. RESULTS: Late fillers had greater odds of experiencing an avoidable HF hospitalization compared with early fillers (odds ratio = 1.65; P = 0.001). Late filling was associated with a 49.5% increase in average all-cause medical costs (P < 0.0001), a 13.6% decrease in average all-cause pharmacy costs (P = 0.0929), and a 39.4% increase in average all-cause total costs (P < 0.0001). HF-related costs showed similar trends. CONCLUSION: Compared with patients who filled their prescription within 30 days of discharge following an HF admission, those who delayed the filling of a new HF prescription experienced increased likelihood of an avoidable readmission, and late filling was associated with increased 6-month total and medical costs. DISCLOSURES: Humana Healthcare Research, Inc., funded the research and article development. No external funds were used in the creation of this work. All authors are/were employees of Humana Inc. and/or Humana Healthcare Research, Inc., at the time of the work.

The clinical impact of MRI on surgical planning for patients with in-breast tumor recurrence.

OBJECTIVE: The objective of this study was to evaluate the clinical utility of breast MRI for patients with known in-breast tumor recurrence (IBTR). The aim was to determine if the addition of breast MRI altered surgical approach or multidisciplinary management. Previous studies have focused on using breast MRI for surgical planning for index breast cancers (BC) or detecting IBTR. However, the clinical impact of obtaining MRI in the setting of known IBTR has not been evaluated. METHODS: A single-institution retrospective chart review was performed to compare surgical approach and multidisciplinary management for patients diagnosed with isolated IBTR who did and did not undergo breast MRI following IBTR diagnosis. RESULTS: IBTR was identified in 69 patients, 46% of whom underwent MRI. There was no difference in the operative approach (p = 0.14) for IBTR patients who did and did not undergo breast MRI Additionally, there was no difference in multidisciplinary care, treatment order, metastatic disease identification, or mortality between cohorts. A relatively small subgroup of patients (n = 3) required change in surgical plan based on MRI results. Patients proceeding with surgery first who also underwent breast MRI experienced a significantly longer time to surgical intervention (p = 0.03). CONCLUSION: Breast MRI following IBTR diagnosis infrequently impacted clinical management, including surgical approach and multidisciplinary care. MRI for local disease assessment at the time of IBTR should be used selectively based on clinical concern.

Is bioimpedance spectroscopy a useful tool for objectively assessing lymphovenous bypass surgical outcomes in breast cancer-related lymphedema?

PURPOSE: We sought to determine if bioimpedance spectroscopy (BIS) measurements can accurately assess changes in breast cancer-related lymphedema (BCRL) in patients undergoing lymphovenous bypass (LVB). METHODS: Patients undergoing LVB for BCRL refractory to conservative treatment from 1/2015 to 12/2018 were identified from an IRB-approved prospectively maintained database at a single institution. All breast cancer patients were assessed with baseline BIS measurements prior to any oncologic surgery and serial BIS during follow-up office visits including before and after LVB. Clinicopathologic information, LVB operative details, and pre- and post-LVB operative BIS measurements were collected. Analysis focused on clinically significant BIS change, defined as two standard deviations (SD), and comparing LVB anastomosis to BIS changes. RESULTS: During the study timeframe, nine patients underwent LVB for treatment of BCRL. The majority (78%) received radiation, taxane chemotherapy, and underwent axillary dissection. An average of 5.6 LVB anastomoses were performed per patient. The average change in BIS following LVB was a 3SD reduction, indicating a clinically significant change. This improvement was stable over time, with persistent 2SD reduction at 22 months postoperatively. The number of LVB anastomoses performed did not significantly correlate with the degree of BIS change. CONCLUSIONS: This is the first study to utilize BIS measurements to assess response to LVB surgical intervention for BCRL. BIS measurements demonstrated clinically significant improvement after LVB, providing objective evidence in support of this surgical treatment for BCRL. BIS changes should be reported as key objective data in future studies assessing BCRL interventions, including response to LVB.

Decellularized cartilage may be a chondroinductive material for osteochondral tissue engineering.

Extracellular matrix (ECM)-based materials are attractive for regenerative medicine in their ability to potentially aid in stem cell recruitment, infiltration, and differentiation without added biological factors. In musculoskeletal tissue engineering, demineralized bone matrix is widely used, but recently cartilage matrix has been attracting attention as a potentially chondroinductive material. The aim of this study was thus to establish a chemical decellularization method for use with articular cartilage to quantify removal of cells and analyze the cartilage biochemical content at various stages during the decellularization process, which included a physically devitalization step. To study the cellular response to the cartilage matrix, rat bone marrow-derived mesenchymal stem cells (rBMSCs) were cultured in cell pellets containing cells only (control), chondrogenic differentiation medium (TGF-ß), chemically decellularized cartilage particles (DCC), or physically devitalized cartilage particles (DVC). The chemical decellularization process removed the vast majority of DNA and about half of the glycosaminoglycans (GAG) within the matrix, but had no significant effect on the amount of hydroxyproline. Most notably, the DCC group significantly outperformed TGF-ß in chondroinduction of rBMSCs, with collagen II gene expression an order of magnitude or more higher. While DVC did not exhibit a chondrogenic response to the extent that DCC did, DVC had a greater down regulation of collagen I, collagen X and Runx2. A new protocol has been introduced for cartilage devitalization and decellularization in the current study, with evidence of chondroinductivity. Such bioactivity along with providing the 'raw material' building blocks of regenerating cartilage may suggest a promising role for DCC in biomaterials that rely on recruiting endogenous cell recruitment and differentiation for cartilage regeneration.

Bioactive Microsphere-Based Scaffolds Containing Decellularized Cartilage.

The aim of this study was to fabricate mechanically functional microsphere-based scaffolds containing decellularized cartilage (DCC), with the hypothesis that this approach would induce chondrogenesis of rat bone marrow-derived mesenchymal stem cells (rBMSCs) in vitro. The DCC was derived from porcine articular cartilage and decellularized using a combination of physical and chemical methods. Four types of scaffolds were fabricated: poly(d,l-lactic-co-glycolic acid) (PLGA) only (negative control), TGF-ß-encapsulated (positive control), PLGA surface coated with DCC, and DCC-encapsulated. These scaffolds were seeded with rBMSCs and cultured up to 6 weeks. The compressive modulus of the DCC-coated scaffolds prior to cell seeding was significantly lower than all other scaffold types. Gene expression was comparable between DCC-encapsulated and TGF-ß-encapsulated groups. Notably, DCC-encapsulated scaffolds contained 70% higher glycosaminoglyan (GAG) content and 85% more hydroxyproline compared to the TGF-ß group at week 3 (with baseline levels subtracted out from acellular DCC scaffolds). Certainly, bioactivity was demonstrated in eliciting a biosynthetic response from the cells with DCC, although true demonstration of chondrogenesis remained elusive under the prescribed conditions. Encapsulation of DCC appeared to lead to improved cell performance relative to coating with DCC, although this finding may be a dose-dependent observation. Overall, DCC introduced via microsphere-based scaffolds appears to be promising as a bioactive approach to cartilage regeneration, although additional studies will be required to conclusively demonstrate chondroinductivity.

The bioactivity of cartilage extracellular matrix in articular cartilage regeneration.

Cartilage matrix is a promising material for cartilage regeneration given the evidence supporting its chondroinductive character. The "raw materials" of cartilage matrix can serve as building blocks and signals for tissue regeneration. These matrices can be created by chemical or physical processing: physical methods disrupt cellular membranes and nuclei but may not fully remove all cell components and DNA, whereas chemical methods combined with physical methods are effective in fully decellularizing such materials. It is important to delineate between the sources of the cartilage matrix, that is, derived from matrix in vitro or from native tissue, and then to further characterize the cartilage matrix based on the processing method, decellularization or devitalization. With these distinctions, four types of cartilage matrices exist: decellularized native cartilage (DCC), devitalized native cartilage (DVC), decellularized cell-derived matrix (DCCM), and devitalized cell-derived matrix (DVCM). One currently marketed cartilage matrix device is decellularized, although trends in patents suggest additional decellularized products may be available in the future. To identify the most relevant source and processing for cartilage matrix, testing needs to include targeting the desired application, optimizing delivery of the material, identify relevant FDA regulations, assess availability of materials, and immunogenic properties of the product.

The potential of encapsulating "raw materials" in 3D osteochondral gradient scaffolds.

Scaffolds with continuous gradients in material composition and bioactive signals enable a smooth transition of properties at the interface. Components like chondroitin sulfate (CS) and bioactive glass (BG) in 3D scaffolds may serve as "raw materials" for synthesis of new extracellular matrix (ECM), and may have the potential to completely or partially replace expensive growth factors. We hypothesized that scaffolds with gradients of ECM components would enable superior performance of engineered constructs. Raw material encapsulation altered the appearance, structure, porosity, and degradation of the scaffolds. They allowed the scaffolds to better retain their 3D structure during culture and provided a buffering effect to the cells in culture. Following seeding of rat mesenchymal stem cells, there were several instances where glycosaminoglycan (GAG), collagen, or calcium contents were higher with the scaffolds containing raw materials (CS or BG) than with those containing transforming growth factor (TGF)-ß3 or bone morphogenetic protein (BMP)-2. It was also noteworthy that a combination of both CS and TGF-ß3 increased the secretion of collagen type II. Moreover, cells seeded in scaffolds containing opposing gradients of CS/TGF-ß3 and BG/BMP-2 produced clear regional variations in the secretion of tissue-specific ECM. The study demonstrated raw materials have the potential to create a favorable microenvironment for cells; they can significantly enhance the synthesis of certain extracellular matrix (ECM) components when compared to expensive growth factors; either alone or in combination with growth factors they can enhance the secretion of tissue specific matrix proteins. Raw materials are promising candidates that can be used to either replace or be used in combination with growth factors. Success with raw materials in lieu of growth factors could have profound implications in terms of lower cost and faster regulatory approval for more rapid translation of regenerative medicine products to the clinic.