Assessment of conflicts of interest in literature on monoclonal antibodies for chronic rhinosinusitis with nasal polyposis using the Open Payments Database.

BACKGROUND: Accurate conflict of interest (COI) information is essential for promoting transparency and trust in research. We aim to assess COI disclosure patterns in monoclonal antibodies (MABs) research for chronic rhinosinusitis with nasal polyposis (CRSwNP) using the Open Payments Database (OPD). METHODS: Studies on FDA-approved MABs for CRSwNP (dupilumab, omalizumab, mepolizumab) published between 2019 and 2021 with at least one US author were identified through PubMed. Industry-reported payments from the manufacturers (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline) between 2018 and 2021 in OPD's General Payments category were collected. Authors were cross-checked against OPD metadata using a previously published ChatGPT-based algorithm. Additionally, this novel algorithm analyzed COI statements for relevant author‒company specific disclosures, identifying disclosed and undisclosed payments made 3‒15 months prior to publication. RESULTS: A total of 214 unique authors from 76 studies were included. Of 30 articles that received at least one relevant payment, 21 (70%) were found to have an undisclosed COI, with a mean total undisclosed payment of $4890 and a median of $10,331. Fifty-six authors had relevant OPD payments and 40 (71.4%) authors did not declare a potential COI. Interestingly, 158 authors had no relevant payments and 62 (39.2%) declared a potential COI. Author order was not significantly associated with potential under- or over-disclosure. CONCLUSION: This study characterizes COI disclosure patterns in rhinosinusitis-relevant MABs research using a novel automated approach. Given the discrepancy between disclosures and industry-reported payments, our findings suggest a need for improved disclosure education and practices.

Characterizing the Rise in Dupilumab Prescriptions and Costs: A Medicare Part D Study.

Dupilumab indications have expanded since 2017 Food and Drug Administration (FDA) approval, though evolving prescribing patterns remains to be explored. Annual 2017 to 2021 Medicare Part D claims data was queried. The number of prescribers rose from 142 in 2017 to 6244 in 2021 (r = 0.971; P = .006). Accordingly, the number of Medicare claims and costs both rose, from 2444 to 157,401 (r = 0.986; P = .002) and from $7.59 million to $540.5 million (r = 0.982; P = .003), respectively. While dermatologists made up the bulk of providers in 2017 (78.9%), they only made up 38.1% of providers in 2021. Otolaryngologists were the least represented specialty. In 2021, most providers (98.0%) had only 10 or fewer Medicare patients for whom they prescribed dupilumab. Dupilumab is becoming an increasingly prevalent treatment modality for a variety of indications in the Medicare population. This comes with an incredibly large financial burden on patients and Medicare. The profile of prescribers has changed, mirroring the FDA-approved indications.

Medicare volume and reimbursement trends in lingual and hyoid procedures for obstructive sleep apnea.

OBJECTIVES: This study aims to analyze utilization and reimbursement trends in lingual and hyoid surgery for obstructive sleep apnea (OSA). METHODS: Annual retrospective data on lingual and hyoid OSA surgeries was obtained from the 2000-2021 Medicare Part B National Summary Datafiles. Current Procedural Terminology (CPT) codes utilized included 21,685 (hyoid myotomy and suspension [HMS]), 41,512 (tongue base suspension [TBS]), 41,530 (radiofrequency ablation of the tongue [RFT]) and 42,870 (lingual tonsillectomy [LT]). RESULTS: The number of lingual and hyoid OSA surgeries rose 2777 % from 121 in 2000 to 3481 in 2015, before falling 82.9 % to 594 in 2021. Accordingly, Medicare payments rose 17,899 % from an inflation-adjusted $46,958 in 2000 to $8.45 million in 2015, before falling drastically to $341,011 in 2021. As the number of HMSs (2000: 91; 2015: 84; 2021: 165), TBS (2009: 48; 2015: 31; 2021: 16), and LTs (2000: 121; 2015: 261; 2021: 234) only experienced modest changes in utilization, this change was largely driven by RFT (2009: 340; 2015: 3105; 2021: 179). Average Medicare payments for RFT rose from $1110 in 2009 to $2994 in 2015, before falling drastically to $737 in 2021. CONCLUSION: Lingual and hyoid surgery for OSA has overall fallen in utilization among the Medicare population from 2000 to 2021. However, there was a brief spike in usage, peaking in 2015, driven by the adoption (and then quick dismissal) of RFT. The rise and fall in RFT use coincide with the rise and fall in reimbursement.

Medicaid Acceptance Varies by Physician Seniority and Specialty in California.

Given varied insurance acceptances and differing pay between insurances, our objective was to examine the number of California physicians enrolled in Medicare and Medicaid (Medi-Cal), stratified by specialty and graduation year. Medi-Cal and Medicare providers were extracted from publicly available databases (Centers for Medicare & Medicaid Services and California Health and Human Services) and were subsequently merged into one dataset using National Provider Identifier. From there, we stratified physicians by specialty and graduation year. We found that emergency medicine, radiology, pathology, anesthesiology, general surgery, and internal medicine had the highest percent of Medi-Cal-accepting physicians, whereas dermatology, psychiatry, physical medicine & rehabilitation, and plastic & reconstructive surgery physicians had the lowest. There also appears to be an inverse relationship between acceptance of Medi-Cal and earlier year of graduation (P < 0.05). This study demonstrated striking variability in Medi-Cal acceptance based upon physician years in practice and specialty. Older, experienced physicians, as well as physicians of certain specialties, are less likely to accept Medi-Cal.

Restarting Antithrombotic Therapies After Endoscopic Sinus Surgery: A Systematic Review.

OBJECTIVES: Antithrombotic therapies, comprised of both anticoagulant and antiplatelet agents, are routinely paused prior to endoscopic sinus surgery (ESS) to reduce the risk of perioperative hemorrhage. At present, no clear guidelines exist to guide otolaryngologists on when to resume these agents after ESS. Our goal was to systematically review the existing literature related to this topic. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we systematically queried the PubMed, Embase, Ovid, Web of Science, Cochrane, and CINAHL databases to identify publications reporting on antithrombotic and antiplatelet therapy in the context of ESS. The primary outcomes we sought were recommendations on the timing of antithrombotic therapy resumption after ESS. RESULTS: Of the 104 unique articles identified, all were screened for relevance by 2 independent reviewers based on title and abstract, 20 underwent full-text review, and 6 met inclusion criteria for analysis. Of these, 3 were literature reviews, 2 were case-control studies, and 1 was a cohort study. All publications discussed when to pause antithrombotic therapy prior to surgery while only 3 articles discussed resumption of these agents. Recommendations were mixed. CONCLUSION: A paucity of literature exists on the resumption of antithrombotic therapies after ESS. As a major determining factor in patient morbidity, guideline-based resumption of these therapies is needed.

Taste dysfunction after endoscopic endonasal resection of olfactory groove meningioma: Case series and review of the literature.

PURPOSE: The incidence of ageusia and dysgeusia after endoscopic endonasal (EEA) resection of olfactory groove meningioma (OGM) is not well established despite recognized impairment in olfactory function. METHODS: We retrospectively administered a validated taste and smell survey to patients undergoing EEA for resection of OGM at two institutions. Demographics and clinical characteristics were collected and survey responses were analyzed. RESULTS: Twelve patients completed the survey. The median time from surgery was 24 months. The average total complaint score was 5.5 out of 16 [0-13]. All patients reported a change in sense of smell while only 42 % reported a change in sense of taste. Taste changes did not consistently associate with laterality or size of the neoplasm. Significant heterogeneity existed when rating severity of symptoms. CONCLUSIONS: To our knowledge this is the first case series examining taste changes after EEA resection of OGM. Despite universal olfactory dysfunction, only a minority of patients reported a change in their sense of taste. Our findings may improve patient counseling and expectations after surgery.

ChatGPT for Automated Cross-Checking of Authors' Conflicts of Interest Against Industry Payments.

OBJECTIVE: The Centers for Medicare & Medicaid Services "OpenPayments" database tracks industry payments to US physicians to improve research conflicts of interest (COIs) transparency, but manual cross-checking of articles' authors against this database is labor-intensive. This study aims to assess the potential of large language models (LLMs) like ChatGPT to automate COI data analysis in medical publications. STUDY DESIGN: An observational study analyzing the accuracy of ChatGPT in automating the cross-checking of COI disclosures in medical research articles against the OpenPayments database. SETTING: Publications regarding Food and Drug Administration-approved biologics for chronic rhinosinusitis with nasal polyposis: omalizumab, mepolizumab, and dupilumab. METHODS: First, ChatGPT evaluated author affiliations from PubMed to identify those based in the United States. Second, for author names matching 1 or multiple payment recipients in OpenPayments, ChatGPT undertook a comparative analysis between author affiliation and OpenPayments recipient metadata. Third, ChatGPT scrutinized full article COI statements, producing an intricate matrix of disclosures for each author against each relevant company (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline). A random subset of responses was manually checked for accuracy. RESULTS: In total, 78 relevant articles and 294 unique US authors were included, leading to 980 LLM queries. Manual verification showed accuracies of 100% (200/200; 95% confidence interval [CI]: 98.1%-100%) for country analysis, 97.4% (113/116; 95% CI: 92.7%-99.1%) for matching author affiliations with OpenPayments metadata, and 99.2% (1091/1100; 95% CI: 98.5%-99.6%) for COI statement data extraction. CONCLUSION: LLMs have robust potential to automate author-company-specific COI cross-checking against the OpenPayments database. Our findings pave the way for streamlined, efficient, and accurate COI assessment that could be widely employed across medical research.

Incidence and Reimbursement Trends for Facial Fracture Repair in the Elderly: A Medicare Analysis.

OBJECTIVES: The aim was to describe incidence and reimbursement trends of surgical repair of facial fractures among the Medicare population. METHODS: The annual procedure data from the Centers for Medicare and Medicaid Service National Part B Data File from 2000 to 2019 were queried. RESULTS: The total number of surgically corrected facial fractures increased from 10,148 in 2000 to 19,631 in 2019 in a linear pattern (r = 0.924). Specifically, nasal bone/septum fracture repairs increased the most by 200.6% (n = 4682 to n = 14,075), whereas operations for TMJ dislocations, malar/zygoma fractures, and alveolar ridge/mandibular fractures decreased by 27.9%, 12.3%, and 3.2%, respectively, between 2000 and 2019. Correspondingly, the total Medicare reimbursement rose from $2,574,317 in 2000 to $4,129,448 in 2019 (r = 0.895). However, the mean reimbursement for all procedures decreased from $376.63 to $210.35 (44.1% fall) over the same time after adjusting for inflation, with this trend holding for individual fracture types as well. CONCLUSIONS: Given the population's increasing age, there has been a significant increase in the number of surgical repairs of facial fractures in Medicare patients between 2000 and 2019. However, this is largely driven by an increase in nasal bone/septum closed reductions, with stagnant and, in some cases, declining incidence among other fracture repairs. The reason is unclear and may be related to an increase in nonoperative management or poor outcomes. Nevertheless, like other subfields within otolaryngology and medicine at large, payments have lagged far behind, which may play some role. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:659-665, 2024.

A Medicare Physician Fee Schedule Analysis of Reimbursement Trends in Laryngology from 2000 to 2021.

OBJECTIVE: The purpose of this study is to characterize Medicare reimbursement trends for laryngology procedures over the last two decades. METHODS: This analysis used CMS' Physician Fee Schedule (PFS) Look-Up Tool to determine the reimbursement rate of 48 common laryngology procedures, which were divided into four groups based on their practice setting and clinical use: office-based, airway, voice disorders, and dysphagia. The PFS reports the physician service reimbursement for "facilities" and global reimbursement for "non-facilities". The annual reimbursement rate for each procedure was averaged across all localities and adjusted for inflation. The compound annual growth rate (CAGR) of each procedure's reimbursement was determined, and a weighted average of the CAGR for each group of procedures was calculated using each procedure's 2020 Medicare Part B utilization. RESULTS: Reimbursement for laryngology procedure (CPT) codes has declined over the last two decades. In facilities, the weighted average CAGR for office-based procedures was -2.0%, for airway procedures was -2.2%, for voice disorders procedures was -1.4%, and for dysphagia procedures was -1.7%. In non-facilities, the weighted average CAGR for office-based procedures was -0.9%. The procedures in the other procedure groups did not have a corresponding non-facility reimbursement rate. CONCLUSION: Like other otolaryngology subspecialties, inflation-adjusted reimbursements for common laryngology procedures have decreased substantially over the past two decades. Because of the large number of physician participants and patient enrollees in the Medicare programs, increased awareness and further research into the implications of these trends on patient care is necessary to ensure quality in the delivery of laryngology care. LEVEL OF EVIDENCE: NA Laryngoscope, 134:247-256, 2024.

Treatment, Management, and Otolaryngology Consultation for Epistaxis in the Emergency Room: An Institutional Experience.

BACKGROUND: Epistaxis is a common reason for emergency department (ED) visits, accounting for approximately 1 of every 200 ED visits in the United States annually and up to one-third of all otolaryngology (ENT)-related ED encounters. OBJECTIVES: To detail reasons for ENT consultation for epistaxis in the ED, understand how consultation impacts patient care, assess follow-up patterns after emergency care, and study patient care after transfer or referral into the ED. METHODS: Retrospective chart review of 592 adult patients with epistaxis managed in a tertiary care ED setting between 2017 and 2018. Patients with known follow-up, ENT consult in the ED, or admission were included, while patients with trauma, recent head and neck surgery, or abnormal anatomy were excluded. RESULTS: The most common reasons for ENT consultation for epistaxis were for advanced management, referral to the ED from an outside facility or provider, and recent head and neck surgery. In total, 48.2% of patients treated for epistaxis in the ED received an ENT consultation. ENT consultation was associated with a higher likelihood of receiving absorbable or nonabsorbable packing (92.4% vs 36.1%). In total, 40.4% of patients referred into the ED from an outside facility or provider had no change in their management after receiving an ENT consult. Patients referred to the ED and White patients were significantly more likely to receive an ENT consult. Secondary analyses revealed that more White patients had an established outpatient ENT provider than patients of other races. On multivariate analysis, patients who received an ENT consult spent 75.2 min longer in the ED. CONCLUSION: The high percentage of patients referred or transferred to the ED for epistaxis management with no change in interventions after ENT consultation indicates a continued need to develop more precise clinical care pathways. Additionally, there may be gaps between White and non-White patients in access to ENT care.

Portable MRI to assess optic chiasm decompression after endoscopic endonasal resection of sellar and suprasellar lesions.

OBJECTIVE: Low-field portable MRI (pMRI) is a recent technological advancement with potential for broad applications. Compared with conventional MRI, pMRI is less resource-intensive with regard to operational costs and scan time. The application of pMRI in neurosurgical oncology has not been previously described. The goal of this study was to demonstrate the efficacy of pMRI in assessing optic nerve decompression after endoscopic endonasal surgery for sellar and suprasellar pathologies. METHODS: Patients who underwent endoscopic endonasal surgery for sellar and suprasellar lesions at a single institution and for whom pMRI and routine MRI were performed postoperatively were retrospectively reviewed to compare the two imaging systems. To assess the relative resolution of pMRI compared with MRI, the distance from the optic chiasm to the top of the third ventricle was measured, and the measurements were compared between paired equivalent slices on T2-weighted coronal images. The inter- and intrarater correlations were analyzed. RESULTS: Twelve patients were included in this study (10 with pituitary adenomas and 2 with craniopharyngiomas) with varying degrees of optic chiasm compression on preoperative imaging. Measurements were averaged across raters before calculating agreement between pMRI and MRI, which demonstrated significant interrater reliability (intraclass correlation coefficient [ICC] = 0.78, p < 0.01). Agreement between raters within the pMRI measurements was also significantly reliable (ICC = 0.93, p < 0.01). Finally, a linear mixed-effects model was specified to demonstrate that MRI measurement could be predicted using the pMRI measurement with the patient and rater set as random effects (pMRI ß coefficient = 0.80, p < 0.01). CONCLUSIONS: The results of this study suggest that resolution of pMRI is comparable to that of conventional MRI in assessing the optic chiasm position in relation to the third ventricle. Portable MRI sufficiently demonstrates decompression of the optic chiasm after endoscopic endonasal surgery. It can be an alternative strategy in cases in which cost, scan-time considerations, or lack of intraoperative MRI availability may preclude the ability to assess adequate optic nerve decompression after endoscopic endonasal surgery for sellar and suprasellar lesions.

3D printing for virtual surgical planning of nasoseptal flap skull-base reconstruction: A proof-of-concept study.

KEY POINTS: 3D printing for virtual surgical planning of nasoseptal flap skull base reconstruction is a viable approach. Results indicate improved mucosal preservation but further research is needed to define impact on quality of life.

Image guided dilation of sinus ostium in revision sinus surgery.

PURPOSE: Assess if a rigid, image-guided balloon could be used effectively and safely in revision sinus surgery. MATERIALS AND METHODS: A prospective, non-randomized, single-arm, multicenter study to assess the safety and device performance of the NuVent™ EM Balloon Sinus Dilation System. Adults with CRS in need of revision sinus surgery were enrolled for balloon sinus dilation of a frontal, sphenoid, or maxillary sinus. The primary device performance endpoint was the ability of the device to (1) navigate to; and (2) dilate tissue in subjects with scarred, granulated, or previously surgically-altered tissue (revision). Safety outcomes included the assessment of any operative adverse events (AEs) directly attributable to the device or for which direct cause could not be determined. A follow-up endoscopy was conducted at 14 days post-treatment for assessment of any AEs. Performance outcomes included the surgeon's ability to reach the target sinus (es) and dilate the ostia. Endoscopic photos were captured for each treated sinus pre- and post-dilation. RESULTS: At 6 US clinical sites, 51 subjects were enrolled; 1 subject withdrew before treatment due to a cardiac complication from anesthesia. 121 sinuses were treated in 50 subjects. The device performed as expected in 100 % of the 121 treated sinuses, with investigators able to navigate to the treatment area and dilate the sinus ostium without difficulty. Ten AEs were seen in 9 subjects, with 0 related to the device. CONCLUSION: The targeted frontal, maxillary or sphenoid sinus ostium were safely dilated in every revision subject treated, with no AEs directly attributed to the device.

Trends in clinical trials for olfactory dysfunction in the COVID-19 era.

KEY POINTS: Nearly half of all olfactory dysfunction (OD) clinical trials since 2010 are COVID-19-related. COVID-19-related OD trials are published significantly faster than COVID-19-unrelated trials. High-quality clinical trials and publications are crucial to discovering effective treatments.

Subdural empyema secondary to pansinusitis after coronavirus disease 2019 infection in an immunocompetent patient: illustrative case.

BACKGROUND: Superimposed intracranial infection is an uncommon but clinically significant complication in patients with active coronavirus disease 2019 (COVID-19), particularly in those with predisposing immunocompromising conditions. OBSERVATIONS: The authors describe a case of subdural empyema, secondary to extension from pansinusitis, in a 20-year-old otherwise healthy immunocompetent male who was recently diagnosed with COVID-19. Despite his critical condition at time of presentation, he made a full clinical recovery with aggressive multidisciplinary surgical management between neurosurgery and otolaryngology, despite negative cultures to guide directed antimicrobial therapy. Ultimately, use of molecular-based polymerase chain reaction testing diagnosed Aspergillus fumigatus as the offending pathogen after the patient had already recovered and was discharged from the hospital. LESSONS: This case demonstrates the potential for significant superimposed intracranial infection even in young, healthy individuals, infected by COVID-19 and suggests an aggressive surgical approach to achieve source control, particularly in the absence of positive cultures to guide antimicrobial therapies, may lead to rapid clinical improvement.

Medicare Utilization and Reimbursement Variation Between Rural and Urban Otolaryngologists.

OBJECTIVE: To compare billing practices, reimbursement rates, and patient populations of otolaryngology (ORL) physicians practicing in rural and urban settings. STUDY DESIGN: Retrospective cross-sectional study. SETTING: Medicare Provider Utilization and Payment Data: Physician and Other Supplier Data. METHODS: Medicare-allowed payments, number of services, and number of patients were gathered along with patient population comorbidity statistics, including average hierarchical condition category risk scores. RESULTS: In 2019, 92% of the overall total 8959 ORL physicians practiced in an urban setting. These 8243 urban ORL physicians, on average, billed for 51 (interquartile range [IQR], 31-67) unique Healthcare Common Procedure Coding System (HCPCS) codes, cared for 393 (IQR, 172-535) Medicare patients, performed 1761 (IQR, 502-2070) services, and collected $139,957 (IQR, $55,527-$178,479) per provider. In contrast, the 704 rural ORL physicians, on average, billed for a greater number of unique HCPCS codes (59; IQR, 37-77; P < .001), treated more Medicare patients (445; IQR, 242-614; P < .001), and performed more services (2330; IQR, 694-2748; P < .001) but collected about the same per provider ($141,035; IQR, $56,555-$172,864; P = .426). Older age was associated with rural practice (P = .027). Among both urban and rural ORL physicians, the variety and complexity of procedures and patient comorbidity profiles were comparable. CONCLUSION: Most ORL physicians practice in large urban settings, a finding potentially related to financial sustainability and career opportunity. With an already small workforce, the aging rural ORL physician population is an identifiable weak point in the otolaryngology specialty that must be addressed with geo-specific recruitment campaigns, rural work incentivization, and the development of career advancement opportunities in rural areas.

Dacryocystitis in a patient with Samter's triad.

Samter's triad, also known as aspirin-exacerbated respiratory disease, is characterized by nasal polyposis, bronchial asthma, and aspirin intolerance. Here, we present a case of a 36-year-old woman with a history of Samter's triad and recurrent dacryocystitis. After combined dacryocystorhinostomy and endoscopic sinus surgery, pathological specimens of the lacrimal sac showed respiratory fibrosis with chronic inflammation and eosinophilic infiltration. Our case demonstrates that Samter's triad is a potential etiology for inflammatory nasolacrimal duct obstruction.

A Unique Subset: Idiopathic Intracranial Hypertension Presenting as Spontaneous CSF Leak of the Anterior Skull Base.

Introduction Spontaneous cerebrospinal fluid (CSF) leaks represent a unique clinical presentation of idiopathic intracranial hypertension (IIH), lacking classical features of IIH, including severe headaches, papilledema, and markedly elevated opening pressures. Methods Following a single-institution retrospective review of patients undergoing spontaneous CSF leak repair, we performed a literature review of spontaneous CSF leak in patients previously undiagnosed with IIH, querying PubMed. Results Our literature review yielded 26 studies, comprising 716 patients. Average age was 51 years with 80.8% female predominance, and average body mass index was 35.5. Presenting symptoms included headaches (32.5%), visual disturbances (4.2%), and a history of meningitis (15.3%). Papilledema occurred in 14.1%. An empty sella was present in 77.7%. Slit ventricles and venous sinus stenosis comprised 7.7 and 31.8%, respectively. CSF leak most commonly originated from the sphenoid sinus (41.1%), cribriform plate (25.4%), and ethmoid skull base (20.4%). Preoperative opening pressures were normal at 22.4 cm H 2 O and elevated postoperatively to 30.8 cm H 2 O. 19.1% of patients underwent shunt placement. CSF leak recurred after repair in 10.5% of patients, 78.6% involving the initial site. A total of 85.7% of these patients were managed with repeat surgical intervention, and 23.2% underwent a shunting procedure. Conclusion Spontaneous CSF leaks represent a distinct variant of IIH, distinguished by decreased prevalence of headaches, lack of visual deficits, and normal opening pressures. Delayed measurement of opening pressure after leak repair may be helpful to diagnose IIH. Permanent CSF diversion may be indicated in patients exhibiting significantly elevated opening pressures postoperatively, refractory symptoms of IIH, or recurrent CSF leak.