Reprocessing capabilities of newly approved devices for use in surgery.

INTRODUCTION: Single-use medical devices used in surgery can create environmental waste and increased costs. Reprocessed medical devices may reduce cost and environmental impact. This study investigated the reprocessing capabilities of newly FDA-approved devices in surgery. METHODS: Devices were identified using the publicly-available FDA Releasable 510(k) Database from 2018 to 2023 using the instrument product codes for laparoscope, general, and plastic surgery (GCJ); and electrosurgical (GEI) devices. GCJ and GEI devices were categorized based on usage, and the number of devices (total, single, and reprocessed) were extracted. Costs were obtained from public websites. RESULTS: There were 658,510(k) applications for surgical devices, representing 3.8 % (658/16723) of total applications. Reprocessing capabilities existed for 29 % of GCJ devices and 14 % of GEI devices. Among GCJ devices, 5 (56 %) laparoscopy and 16 (38 %) camera devices had reprocessing capabilities. For GEI devices, 7 (50 %) laparoscopic and 5 (50 %) cable devices had reprocessing capabilities. Only one (6 %) tissue ablation device had reprocessing capabilities. The average cost of GCJ and GEI single-use devices ($11314; $8554, respectively) was less than reprocessed counterparts ($17206; $16134, respectively). CONCLUSION: Reprocessing capabilities for newly approved surgical devices are variable and overall limited. To enhance adoption of reprocessing in surgical practice, future efforts will likely be needed to expand the reprocessing potential of new surgical devices.

Geographic Disparities and Payment Variation for Immediate Lymphatic Reconstruction in Massachusetts.

BACKGROUND: Little is known about practice patterns and payments for immediate lymphatic reconstruction (ILR). This study aims to evaluate trends in ILR delivery and billing practices. METHODS: We queried the Massachusetts All-Payer Claims Database between 2016 and 2020 for patients who underwent lumpectomy or mastectomy with axillary lymph node dissection for oncologic indications. We further identified patients who underwent lymphovenous bypass on the same date as tumor resection. We used ZIP code data to analyze the geographic distribution of ILR procedures and calculated physician payments for these procedures, adjusting for inflation. We used multivariable logistic regression to identify variables, which predicted receipt of ILR. RESULTS: In total, 2862 patients underwent axillary lymph node dissection over the study period. Of these, 53 patients underwent ILR. Patients who underwent ILR were younger (55.1 vs 59.3 years, P = 0.023). There were no significant differences in obesity, diabetes, or smoking history between the two groups. A greater percentage of patients who underwent ILR had radiation (83% vs 67%, P = 0.027). In multivariable regression, patients residing in a county neighboring Boston had 3.32-fold higher odds of undergoing ILR (95% confidence interval: 1.76-6.25; P < 0.001), while obesity, radiation therapy, and taxane-based chemotherapy were not significant predictors. Payments for ILR varied widely. CONCLUSIONS: In Massachusetts, patients were more likely to undergo ILR if they resided near Boston. Thus, many patients with the highest known risk for breast cancer-related lymphedema may face barriers accessing ILR. Greater awareness about referring high-risk patients to plastic surgeons is needed.

Local practice variations and payer differences underlie state-wide disparities in oncoplastic breast surgery.

BACKGROUND: Little is known about disparities in oncoplastic breast surgery delivery. METHODS: The Massachusetts All-Payer Claims Database was queried for patients who received lumpectomy for a diagnosis of breast cancer. Oncoplastic surgery was defined as adjacent tissue transfer, complex trunk repair, reduction mammoplasty, mastopexy, flap-based reconstruction, prosthesis insertion, or unspecified breast reconstruction after lumpectomy. RESULTS: We identified 18 748 patients who underwent lumpectomy between 2016 and 2020. Among those, 3140 patients underwent immediate oncoplastic surgery and 436 patients underwent delayed oncoplastic surgery. Eighty-one percent of patients who underwent oncoplastic surgery did so in the same county as they underwent a lumpectomy. However, the relative frequency of oncoplastic surgery varied significantly among counties. In multivariable regression, public insurance status (odds ratio: 0.87, 95% confidence interval: 0.80-0.95, p = 0.002) was associated with lower odds of undergoing oncoplastic surgery, even after adjusting for macromastia, other comorbidities, and county of lumpectomy. Average payments for lumpectomy with oncoplastic surgery were more than twice as high from private insurers ($840 vs. $1942, p < 0.001). CONCLUSION: Disparities in the receipt of oncoplastic surgery were related to differences in local practice patterns and the type of insurance patients held. Expanding services across counties and considering billing reform may help reduce these disparities.

The Impact of Breast Implant Cohesivity on Rippling and Revision Procedures in 2-Stage Prepectoral Breast Reconstruction.

Background: Rippling remains one of the most common complications following prepectoral implant-based reconstruction (IBR). Objectives: The purpose of this study was to assess how implant cohesivity, a measure of elasticity and form stability, affects the incidence of rippling in prepectoral IBR. Methods: We performed a retrospective cohort study of 2-stage prepectoral IBR performed between January 2020 and June 2022 at the Brigham and Women's Hospital and Dana-Farber Cancer Institute, comparing outcomes in patients who received Allergan Natrelle least cohesive, moderately cohesive, and most cohesive silicone gel implants. Outcomes of interest were rippling and reoperation for fat grafting. Results: A total of 129 patients were identified, of whom 52 had the least cohesive implants, 24 had the moderately cohesive implants, and 53 patients had the most cohesive implants. The mean follow-up time was 463 (±220) days. A decreased incidence of rippling was seen with moderately cohesive (odds ratio [OR] 0.30, P < .05) and most cohesive (OR 0.39, P < .05) implants. Third stage reoperation for fat grafting was less frequent in patients with the most cohesive implant (OR 0.07, P < .05). In subgroup analyses, the patients with the most cohesive implant, who did not receive fat grafting at the time of initial implant placement, did not require reoperation for fat grafting (0%). Conclusions: The use of highly cohesive implants in prepectoral IBR is associated with decreased rippling and fewer reoperations for fat grafting.

The Use of Unlisted Billing Codes for Microsurgical Breast Reconstruction and Implications for Code Consolidation.

BACKGROUND: Private insurers have considered consolidating the billing codes presently available for microvascular breast reconstruction. There is a need to understand how these different codes are currently distributed and used to help inform how coding consolidation may impact patients and providers. METHODS: Using the Massachusetts All-Payer Claims Database between 2016 and 2020, patients who underwent microsurgical breast reconstruction following mastectomy for cancer-related indications were identified. Multivariable logistic regression was used to test whether an S2068 claim was associated with insurance type and median household income by patient ZIP code. The ratio of S2068 to CPT19364 claims for privately insured patients was calculated for providers practicing in each county. Total payments for professional fees were compared between billing codes. RESULTS: There were 272 claims for S2068 and 209 claims for CPT19364. An S2068 claim was associated with age < 45 years (OR: 1.89, 95% CI: 1.11-3.20, p = 0.019), more affluent ZIP codes (OR: 1.11, 95% CI: 1.03-1.19, p = 0.004), and private insurance (OR: 16.13, 95% CI: 7.81-33.33, p < 0.001). Median total payments from private insurers were 101% higher for S2068 than for CPT19364. In all but two counties (Worcester and Hampshire), the S-code was used more frequently than CPT19364 for their privately insured patients. CONCLUSION: Coding practices for microsurgical breast reconstruction lacked uniformity in Massachusetts, and payments differed greatly between S2068 and CPT19364. Patients from more affluent towns were more likely to have S-code claims. Coding consolidation could impact access, as the majority of providers in Massachusetts might need to adapt their practices if the S-code were discontinued.

Use of patient-reported outcome measures after breast reconstruction in low- and middle-income countries: a scoping review.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly administered in high-income countries to monitor health-related quality of life of breast cancer patients undergoing breast reconstruction. Although low- and middle-income countries (LMICs) face a disproportionate burden of breast cancer, little is known about the use of PROMs in LMICs. This scoping review aims to examine the use of PROMs after post-mastectomy breast reconstruction among patients with breast cancer in LMICs. METHODS: MEDLINE, Embase, Web of Science, CINAHL, and PsycINFO were searched in August 2022 for English-language studies using PROMs after breast reconstruction among patients with breast cancer in LMICs. Study screening and data extraction were completed. Data were analyzed descriptively. RESULTS: The search produced 1024 unique studies, 33 of which met inclusion criteria. Most were observational (48.5%) or retrospective (33.3%) studies. Studies were conducted in only 10 LMICs, with 60.5% in China and Brazil and none in low-income countries. Most were conducted in urban settings (84.8%) and outpatient clinics (57.6%), with 63.6% incorporating breast-specific PROMs and 33.3% including breast reconstruction-specific PROMs. Less than half (45.5%) used PROMs explicitly validated for their populations of interest. Only 21.2% reported PROM response rates, ranging from 43.1 to 96.9%. Barriers and facilitators of PROM use were infrequently noted. CONCLUSIONS: Despite the importance of PROM collection and use in providing patient-centered care, it continues to be limited in middle-income countries and is not evident in low-income countries after breast reconstruction. Further research is necessary to determine effective methods to address the challenges of PROM use in LMICs.