Insurance Coverage of Prophylactic Mastectomies: A National Review of the United States.

BACKGROUND: Breast cancer is associated with a multitude of risk factors, such as genetic predisposition and mutations, family history, personal medical history, or previous radiotherapy. A prophylactic mastectomy (PM) may be considered a suitable risk-reducing procedure in some cases. However, there are significant discrepancies between national society recommendations and insurance company requirements for PM. MATERIALS AND METHODS: The authors conducted a cross-sectional analysis of insurance policies for a PM. One-hundred companies were selected based on the greatest state enrolment and market share. Their policies were identified through a Web-based search and telephone interviews, and their medical necessity criteria were extracted. RESULTS: Preauthorized coverage of PMs was provided by 39% of insurance policies (n = 39) and 5 indications were identified. There was consensus amongst these policies to cover a PM for BRCA1/2 mutations (n = 39, 100%), but was more variable for other genetic mutations (15%-90%). Coverage of PM for the remaining indications varied among insurers: previous radiotherapy (92%), pathological changes in the breast (3%-92%), personal history of cancer (64%) and family history risk factors (39%-51%). CONCLUSION: There is a marked level of variability in both the indications and medical necessity criteria for PM insurance policies. The decision to undergo a PM must be carefully considered with a patient's care team and should not be affected by insurance coverage status.

In-situ cryo-immune engineering of tumor microenvironment with cold-responsive nanotechnology for cancer immunotherapy.

Cancer immunotherapy that deploys the host's immune system to recognize and attack tumors, is a promising strategy for cancer treatment. However, its efficacy is greatly restricted by the immunosuppressive (i.e., immunologically cold) tumor microenvironment (TME). Here, we report an in-situ cryo-immune engineering (ICIE) strategy for turning the TME from immunologically "cold" into "hot". In particular, after the ICIE treatment, the ratio of the CD8+ cytotoxic T cells to the immunosuppressive regulatory T cells is increased by more than 100 times in not only the primary tumors with cryosurgery but also distant tumors without freezing. This is achieved by combining cryosurgery that causes "frostbite" of tumor with cold-responsive nanoparticles that not only target tumor but also rapidly release both anticancer drug and PD-L1 silencing siRNA specifically into the cytosol upon cryosurgery. This ICIE treatment leads to potent immunogenic cell death, which promotes maturation of dendritic cells and activation of CD8+ cytotoxic T cells as well as memory T cells to kill not only primary but also distant/metastatic breast tumors in female mice (i.e., the abscopal effect). Collectively, ICIE may enable an efficient and durable way to leverage the immune system for combating cancer and its metastasis.

Contralateral prophylactic mastectomy in the setting of breast cancer diagnosis and their insurance coverage in the United States.

BACKGROUND: Contralateral prophylactic mastectomy (CPM) is more common in the United States than the rest of the world. However, the benefit of this procedure is still under question in many breast cancer scenarios. CPM utilization in the United States is in part dependent on a patient's health insurance coverage of breast oncology surgery and any desired reconstruction. However, there are great discrepancies in the coverage provided by insurers. METHODS: The authors conducted a cross-sectional analysis of insurance policies for a CPM in the setting of diagnosed breast cancer. One hundred companies were selected based on their state enrollment and market share. Their policies were identified through a Web-based search and telephone interviews, and their medical necessity criteria were extracted. RESULTS: Of the 100 companies assessed, 36 (36%) had a policy for CPM. Within those, significantly more provided coverage than denied the procedure (72% vs. 25%, p < 0.0001), with the remainder providing case-by-case coverage. Eleven criteria were identified from preauthorized policies, the most common prerequisite was breast cancer diagnosis under 45 years old (n = 9, 35%). Most policies did not differentiate between gender in their policies (n = 25, 69%), but of those that did, 100% (n = 11) provided coverage for men and women, with 82% (n = 9) requiring further criteria from the female patients. CONCLUSION: The coverage of CPM in the United States varies from complete denial to unrestricted approval. This may be due to conflicting reports in the literature as to the utility of the procedure. The decision to undergo this procedure must be taken with thoughtful consideration and the support of a multidisciplinary approach.

Breast Health: Benign Breast Conditions.

Benign breast conditions are heterogenous, with varying clinical presentations. These conditions commonly include nipple discharge, breast pain, palpable masses, common breast lesions, and high-risk breast lesions. Signs and symptoms of these conditions range from pain and abnormal physical examination findings to asymptomatic abnormalities detected on breast imaging. A combination of clinical examination, patient history, and diagnostic studies should be used to make a diagnosis. The primary challenges in addressing new breast symptoms are determination of a clear diagnosis and creation of a management plan, as well as evaluation of future risk of malignancy related to benign diagnoses. Risk assessment can prove difficult in patients of certain racial groups, given the differences in risk attributed to specific benign conditions. This also can prove challenging given the lack of racial diversity in early trials assessing risk in benign breast disease. Many benign breast conditions are diagnosed and managed in the family medicine setting, but some patients may require consultation with a breast subspecialist.

Contemporary management of the axilla in breast cancer.

The care of patients with breast cancer in the modern era involves a multimodal approach to treating locoregional and distant disease. Recent studies have demonstrated that the extent of surgical intervention in both the breast and axilla can be minimized through a personalized approach based on breast cancer stage, subtype, and planned adjuvant therapies. The older approach focused on complete removal of the axillary contents for appropriate staging and to determine the need for adjuvant systemic therapy and radiation. This approach has been replaced by sentinel lymph node biopsy, which allows for axillary staging with the removal of only the nodes most likely to contain metastatic disease. Sentinel lymph node biopsy obviates the need for complete axillary lymph node dissection in patients with node-negative disease. Clinical trials have also shown that axillary dissection can be avoided in those patients with low axillary disease burden in the sentinel nodes who are undergoing breast-conserving therapy. Radiation can also be used as an alternative to axillary dissection in patients with positive sentinel nodes, without increasing the risk for regional recurrence. Further studies are needed in patients undergoing mastectomy to determine the optimal strategy for axillary management in the setting of limited disease in the sentinel nodes. The use of neoadjuvant chemotherapy allows the ability to evaluate an individual tumor's response to therapy, thereby increasing the possibility of breast-conserving surgery and reduction in the extent of axillary surgery. This review will explore the evolution of management of the axilla in patients with clinically node-negative and node-positive disease, and will provide insights into future directions in breast cancer care.

Patient experience with breast reconstruction process following bilateral mastectomy in BRCA mutation carriers.

BACKGROUND: Many patients with BRCA mutations consider bilateral mastectomy for risk reduction (RRM) or when diagnosed with cancer (TM). Limited data exist to help inform patients about the reconstruction (recon) process. We sought to identify factors associated with unforeseen procedures following RRM or TM in BRCA positive patients. METHODS: We retrospectively evaluated records from 178 BRCA positive patients who had RRM or TM with recon from 1997 to 2013 in a single healthcare system. Univariate and multivariate logistic regression was used to assess factors associated with unexpected procedures. RESULTS: One hundred four patients had RRM, and 78 had TM. Median time to completion was 9.0 months (95% CI 7.2-10.8). Overall, 57.3% of patients had an unexpected procedure and 21.9% had a complication requiring surgery. Unexpected revisions were associated with increasing age and radiation (in TM). CONCLUSIONS: BRCA positive patients may have multiple revision surgeries. The likelihood of unexpected procedures increases with age. Future studies are needed to inform patients about the recon process.

Relationship Between Operating Room Teamwork, Contextual Factors, and Safety Checklist Performance.

BACKGROUND: Studies show that using surgical safety checklists (SSCs) reduces complications. Many believe SSCs accomplish this by enhancing teamwork, but evidence is limited. Our study sought to relate teamwork to checklist performance, understand how they relate, and determine conditions that affect this relationship. STUDY DESIGN: Using 2 validated tools for observing and coaching operating room teams, we evaluated the association between checklist performance with surgeon buy-in and 4 domains of surgical teamwork: clinical leadership, communication, coordination, and respect. Hospital staff in 10 South Carolina hospitals observed 207 procedures between April 2011 and January 2013. We calculated levels of checklist performance, buy-in, and measures of teamwork, and evaluated their relationship, controlling for patient and case characteristics. RESULTS: Few teams completed most or all SSC items. Teams more often completed items considered procedural "checks" than conversation "prompts." Surgeon buy-in, clinical leadership, communication, a summary measure of teamwork overall, and observers' teamwork ratings positively related to overall checklist completion (multivariable model estimates from 0.04, p < 0.05 for communication to 0.17, p < 0.01 for surgeon buy-in). All measures of teamwork and surgeon buy-in related positively to completing more conversation prompts; none related significantly to procedural checks (estimates from 0.10, p < 0.01 for communication to 0.27, p < 0.001 for surgeon buy-in). Patient age was significantly associated with completing the checklist and prompts (p < 0.05); only case duration was positively associated with performing more checks (p < 0.10). CONCLUSIONS: Surgeon buy-in and surgical teamwork characterized by shared clinical leadership, open communication, active coordination, and mutual respect were critical in prompting case-related conversations, but not in completing procedural checks. Findings highlight the importance of surgeon engagement and high-quality, consistent teamwork for promoting checklist use and ensuring a safe surgical environment.

Surgeons' Perspectives on Avoiding Nonbeneficial Treatments in Seriously Ill Older Patients with Surgical Emergencies: A Qualitative Study.

BACKGROUND: Clinical decisions for seriously ill older patients with surgical emergencies are highly complex. Measuring the benefits of burdensome treatments in this context is fraught with uncertainty. Little is known about how surgeons formulate treatment decisions to avoid nonbeneficial surgery, or engage in preoperative conversations about end-of-life (EOL) care. OBJECTIVE: We sought to describe how surgeons approach such discussions, and to identify modifiable factors to reduce nonbeneficial surgery near the EOL. DESIGN: Purposive and snowball sampling were used to recruit a national sample of emergency general surgeons. Semistructured interviews were conducted between February and May 2014. MEASUREMENTS: Three independent coders performed qualitative coding using NVivo software (NVivo version 10.0, QSR International). Content analysis was used to identify factors important to surgical decision making and EOL communication. RESULTS: Twenty-four surgeons were interviewed. Participants felt responsible for conducting EOL conversations with seriously ill older patients and their families before surgery to prevent nonbeneficial treatments. However, wide differences in prognostic estimates among surgeons, inadequate data about postoperative quality of life (QOL), patients and surrogates who were unprepared for EOL conversations, variation in perceptions about the role of palliative care, and time constraints are contributors to surgeons providing nonbeneficial operations. Surgeons reported performing operations they knew would not benefit the patient to give the family time to come to terms with the patient's demise. CONCLUSIONS: Emergency general surgeons feel responsible for having preoperative discussions about EOL care with seriously ill older patients to avoid nonbenefical surgery. However, surgeons identified multiple factors that undermine adequate communication and lead to nonbeneficial surgery.

Can 360-Degree Reviews Help Surgeons? Evaluation of Multisource Feedback for Surgeons in a Multi-Institutional Quality Improvement Project.

BACKGROUND: Medical organizations have increased interest in identifying and improving behaviors that threaten team performance and patient safety. Three hundred and sixty degree evaluations of surgeons were performed at 8 academically affiliated hospitals with a common Code of Excellence. We evaluate participant perceptions and make recommendations for future use. STUDY DESIGN: Three hundred and eighty-five surgeons in a variety of specialties underwent 360-degree evaluations, with a median of 29 reviewers each (interquartile range 23 to 36). Beginning 6 months after evaluation, surgeons, department heads, and reviewers completed follow-up surveys evaluating accuracy of feedback, willingness to participate in repeat evaluations, and behavior change. RESULTS: Survey response rate was 31% for surgeons (118 of 385), 59% for department heads (10 of 17), and 36% for reviewers (1,042 of 2,928). Eighty-seven percent of surgeons (95% CI, 75%-94%) agreed that reviewers provided accurate feedback. Similarly, 80% of department heads believed the feedback accurately reflected performance of surgeons within their department. Sixty percent of surgeon respondents (95% CI, 49%-75%) reported making changes to their practice based on feedback received. Seventy percent of reviewers (95% CI, 69%-74%) believed the evaluation process was valuable, with 82% (95% CI, 79%-84%) willing to participate in future 360-degree reviews. Thirty-two percent of reviewers (95% CI, 29%-35%) reported perceiving behavior change in surgeons. CONCLUSIONS: Three hundred and sixty degree evaluations can provide a practical, systematic, and subjectively accurate assessment of surgeon performance without undue reviewer burden. The process was found to result in beneficial behavior change, according to surgeons and their coworkers.

Cyclosporine A--protection against microvascular hyperpermeability is calcineurin independent.

BACKGROUND: Mitochondria-mediated apoptotic signaling contributes to microvascular hyperpermeability. We hypothesized that cyclosporine A (CsA), which protects mitochondrial transition pores, would attenuate hyperpermeability independent of its calcineurin inhibitory property. METHODS: Hyperpermeability was induced in microvascular endothelial cell monolayers using proapoptotic BAK or active caspase-3 after CsA or a specific calcineurin inhibitor, calcineurin autoinhibitory peptide (CIP), treatment. Permeability was measured based on fluorescein isothiocyanate-albumin flux across the monolayers. Mitochondrial transmembrane potential (MTP) was determined using 5,5',6,6'-tetrachoro-1,1',3,3'-tetraethylbenzimidazolyl carbocyanine iodide. Mitochondrial release of cytochrome c was measured using an enzyme-linked immunosorbent assay and caspase-3 activity fluorometrically. RESULTS: CsA-attenuated (10 nmol/L) but not CIP-attenuated (100 mumol/L) BAK induced hyperpermeability (P < .05), CsA- but not CIP-attenuated BAK induced a decrease in MTP and an increase in cytochrome c levels and caspase-3 activity (P < .05). CsA and CIP were ineffective against caspase-3-induced hyperpermeability. CONCLUSIONS: CsA attenuated hyperpermeability by protecting MTP, thus preventing mitochondria-mediated apoptotic signaling. The protective effect of CsA is independent of calcineurin inhibition.