The Association Between Metformin Use and New-Onset ICD Coding of Geographic Atrophy.

Purpose: Metformin has been suggested to protect against the development of age-related macular degeneration (AMD) in multiple observational studies. However, the association between metformin and geographic atrophy (GA), a debilitating subtype of AMD, has not been analyzed. Methods: We conducted a case-control study of patients ages 60 years and older with new-onset International Classification of Diseases (ICD) coding of GA in the Merative MarketScan Commercial and Medicare Databases between 2017 and 2021. Cases were matched with propensity scores estimated by age, region, hypertension, and Charlson Comorbidity Index to a control without GA of the same year. Exposure to metformin was assessed for cases and controls in the year prior to their index visit. Conditional multivariable logistic regression, adjusting for AMD risk factors, was used to calculate odd ratios and 95% confidence intervals (CIs). This study design and analysis were repeated in a sample of patients without diabetes. Results: In the full sample, we identified 10,505 cases with GA and 10,502 matched controls without GA. In total, 1149 (10.9%) cases and 1277 (12.2%) controls were exposed to metformin, and in multivariable regression, metformin decreased the odds of new-onset ICD coding of GA by 12% (95% CI, 0.79-0.99). In the sample of patients without diabetes, we identified 7611 cases with GA and 7608 matched controls without GA. Twenty-nine (0.4%) cases and 63 (0.8%) controls were exposed to metformin, and in multivariable regression, metformin decreased the odds of new-onset ICD coding of GA by 47% (95% CI, 0.33-0.83). Conclusions: Metformin may hold promise as a noninvasive, alternative agent to prevent the development of GA. This finding is notable due to shortcomings in recently approved therapeutics for GA and metformin's overall ease of use and few adverse effects. Additional studies are required to explore our findings further and motivate a clinical trial.

Metformin Use and Age-Related Macular Degeneration in Patients Without Diabetes.

Importance: Metformin use may protect against the development of age-related macular degeneration (AMD) based on results from observational studies. However, its potential effectiveness among patients without diabetes remains unclear. Objective: To assess the association between metformin use and the development of AMD in patients without diabetes. Design, Setting, and Participants: This case-control study used data from 2006 to 2017 in the Merative MarketScan Research Database, a nationwide insurance claims database that includes between 27 and 57 million patients in the US with primary or Medicare supplemental health insurance. Cases with AMD and controls without AMD aged 55 years or older were matched 1:1 by year, age, anemia, hypertension, region, and Charlson Comorbidity Index score. Then, cases and matched controls without a diagnosis of diabetes were selected. In subgroup analyses, cases with dry AMD and their matched controls were identified to explore the association between metformin use and AMD staging in patients without diabetes. Data were analyzed between March and September 2023. Exposures: Exposure to metformin in the 2 years prior to the index date (ie, date of AMD diagnosis in cases and date of a randomly selected eye examination for controls) was assessed from the claims database and categorized into quartiles based on cumulative dose (1-270, 271-600, 601-1080, and >1080 g/2 y). Exposure to other antidiabetic medications was also noted. Main Outcomes and Measures: Odds of new-onset AMD development as assessed by multivariable conditional logistic regression after adjusting for known risk factors for AMD, including female sex, hyperlipidemia, smoking, and exposures to other antidiabetic medications. Asymptotic Cochran-Armitage tests for trend were also performed. Results: We identified 231 142 patients with any AMD (mean [SD] age, 75.1 [10.4] years; 140 172 females [60.6%]) and 232 879 matched controls without AMD (mean [SD] age, 74.9 [10.5] years; 133 670 females [57.4%]), none of whom had a diagnosis of diabetes. The sample included 144 147 cases with dry AMD that were matched to 144 530 controls. In all, 2268 (1.0%) cases and 3087 controls (1.3%) were exposed to metformin in the 2 years before their index visit. After data adjustment, exposure to any metformin was associated with reduced odds of any AMD development (adjusted odds ratio [AOR], 0.83; 95% CI, 0.74-0.87), specifically in the dosing quartiles of 1 to 270, 271 to 600, and 601 to 1080 g/2 y. Any metformin use was also associated with a reduced odds of developing dry AMD (AOR, 0.85; 95% CI, 0.79-0.92), specifically in the dosing quartiles of 1 to 270 and 271 to 600 g/2 y. Adjusted odds ratios for any AMD and dry AMD development did not differ across the dosing quartiles. Asymptotic Cochran-Armitage tests for trend revealed 2-sided P = .51 and P = .66 for the any and dry AMD samples, respectively. Conclusions and Relevance: In this case-control study of a population without a diagnosis of diabetes, metformin use was associated with reduced odds of developing AMD. This association does not appear to be dose dependent. These findings provide further impetus to study metformin's usefulness in protecting against AMD in prospective clinical trials.

INTERACTIONS OF METFORMIN AND OTHER MEDICATIONS IN REDUCING THE ODDS OF AGE-RELATED MACULAR DEGENERATION IN A COHORT OF PATIENTS WITH DIABETES.

PURPOSE: A previous study from our group demonstrated protective effects of the use of metformin in the odds of developing age-related macular degeneration (AMD). This is a subgroup analysis in a cohort of patients with diabetes to assess the interaction of metformin and other medications in protecting diabetic patients against developing AMD. METHODS: This is a case-control analysis using data from the Merative MarketScan Commercial and Medicare databases. Patients were 55 years and older with newly diagnosed AMD and matched to controls. We performed multivariable conditional logistic regressions, which adjusted for known risk factors of AMD and tested multiple interaction effects between metformin and 1) insulin, 2) sulfonylureas, 3) glitazones, 4) meglitinides, and 5) statins. RESULTS: The authors identified 81,262 diabetic cases and 79,497 diabetic controls. Metformin, insulin, and sulfonylureas demonstrated independent protective effects against AMD development. Sulfonylureas in combination with metformin demonstrated further decreased odds of AMD development compared with metformin alone. The other medication group (exenatide, sitagliptin, and pramlintide) slightly increased the odds of developing AMD when taken alone, but the combination with metformin alleviated this effect. CONCLUSION: The authors believe that their results bring them one step closer to finding an optimal effective hypoglycemic regimen that also protects against AMD development in diabetic patients.

Industry Payments for Vibegron and Prescribing Patterns Among Urologic Clinicians.

This cross-sectional study compares the prescribing practices among urologists and advanced practice clinicians who received vs did not receive payment from drug manufacturers.

Associations Between Autoimmune Disease and the Development of Age-Related Macular Degeneration.

Purpose: The pathogenesis of age-related macular degeneration (AMD) likely implicates the dysregulation of immune response pathways. Several studies demonstrate that the pathogenic elements of AMD resemble those of autoimmune diseases, yet the association between AMD development and most autoimmune diseases remain unexplored. Methods: We conducted a case-control analysis of patients ages 55 and older with new-onset International Classification of Diseases (ICD) coding of dry, wet, or unspecified AMD between 2005 and 2019 in the Merative MarketScan Commercial and Medicare Databases. The diagnosis of an autoimmune disease was defined by an outpatient or inpatient claim with a relevant ICD code in the 12 months before the index visit. Conditional multivariable logistic regression, adjusted for AMD risk factors, was used to calculate odd ratios and 95% confidence intervals. Results: We identified 415,027 cases with new-onset ICD coding for AMD matched with propensity scores to 414,853 controls. In total, 16.1% of cases and 15.9% of controls were diagnosed with any autoimmune disease. The diagnosis of any autoimmune disease did not affect the odds of new-onset ICD coding for AMD in multivariable regression (OR = 1.01; 95% CI, 0.999-1.02). Discoid lupus erythematosus (OR = 1.29; 95% CI, 1.12-1.48), systemic lupus erythematosus (SLE) (OR = 1.21; 95% CI, 1.15-1.27), giant cell arteritis (OR = 1.19; 95% CI, 1.09-1.30), Sjogren's syndrome (OR = 1.17; 95% CI, 1.09-1.26), and Crohn's disease (OR = 1.13; 95% CI, 1.06-1.22) increased the odds of a new-onset ICD coding for AMD. Conclusions: Most autoimmune diseases do not affect the odds of developing AMD but several common autoimmune disorders such as SLE and Crohn's disease were associated with modestly increased odds of AMD. Further studies are needed to validate and investigate the underlying mechanisms of these associations.

Industry Payments to Urologists and Urologic Advanced Practice Providers in 2021.

OBJECTIVE: To compare industry payments from drug and medical device companies to urologists and urologic advanced practice providers (APPs) in 2021. METHODS: We used the 2020 Medicare Data on Provider Practice and Specialty file to identify single-specialty urology practices, defined as those where the majority of physicians were urologists. We then used the Open Payments Program Year 2021 data to summarize the value and number of industry payments to urologists and APPs, including nurse practitioners and physician assistants, in these practices. We calculated the total value and number of payments and median total value and number of payments per provider for urologists and urologic APPs. RESULTS: We identified 4418 urologists and 1099 APPs working in single-specialty urology practices in 2021 (Table 1). Of these, 3646 (87%) urologists received at least one industry payment, totaling $14,755,003 from 116,039 payments, and 954 urologic APPs (87%) received at least one industry payment, including 463 nurse practitioners (85%), totaling $401,283 from 13,035 payments, and 491 physician assistants (89%), totaling $543,429 from 14,626 payments. We observed significantly greater median total value and number of payments per provider for urologists ($620 and 24 payments) compared to urologic APPs ($473 and 21 payments; P < .001 and P = .017, respectively). CONCLUSION: A similar percentage of urologists and urologic APPs received industry payments in 2021. While urologists received a higher total number and total value of payments in 2021, urologic APPs were a common target of industry marketing payments.

Trends in the Vasectomy Rate Among Privately Insured Men Aged 18-64 in the United States Between 2014 and 2021.

OBJECTIVE: To update trends in the vasectomy rate among privately insured men aged 18-64 in the United States (U.S.) between 2014 and 2021. MATERIALS AND METHODS: We used commercial health insurance claims data between 2014 and 2021 to calculate the annual vasectomy rate in men aged 18-64 in the U.S. We performed these calculations nationally and by age group, marital status, maternal age of a wife, number of children, U.S. Census Bureau region, geography, geographical region, and state. We calculated the absolute and relative changes in these rates from 2014 to 2021 to study how much and how quickly they changed. RESULTS: The vasectomy rate among privately insured men aged 18-64 in the U.S. increased by 0.11%-a 26% change-from 2014 (0.427%) to 2021 (0.537%). The absolute changes were greatest in men with 3 or more children (0.489%), with 2 children (0.295%), with a wife not of advanced maternal age (0.276%), and aged 35-44 (0.243%). The relative changes were greatest in men with no children (61%), with a wife of advanced maternal age (40.8%), who were single (40.6%), and aged 18-24 (36.7%). In every region except the Northeast, the absolute and relative changes were greater in rural geographies compared to urban geographies. CONCLUSIONS: The vasectomy rate among privately insured men aged 18-64 in the U.S. increased between 2014 and 2021. Further investigation is needed to ensure demand for vasectomies may continue to be met.

Increasing Role of the Advanced Practice Provider in Men's Health Clinics: An Analysis of Medicare and Commercial Claims in the United States.

INTRODUCTION: As urological care delivery in the U.S. continues to evolve to meet patient needs, we aim to clarify the role of advanced practice providers for publicly and privately insured patients in the treatment of male urological conditions commonly encountered in men's health clinics. METHODS: Medicare and commercial insurance claims from the Physician/Supplier Procedure Summary and Merative MarketScan Commercial Database were queried for procedures submitted by advanced practice providers between 2010 and 2021. Common urological conditions were identified using Current Procedural Terminology codes and grouped into 4 categories: testicular hypofunction, erectile dysfunction and Peyronie's disease, benign prostatic hyperplasia, and scrotal pain. The proportion of procedures submitted by advanced practice providers was calculated for each year and category. RESULTS: From 2010 to 2021, the proportion of advanced practice provider-submitted service counts for each condition within the MarketScan group increased up to 5-fold, with benign prostatic hyperplasia representing the greatest growth. The proportion of advanced practice provider-submitted service counts within the Medicare group increased up to 8-fold, with erectile dysfunction/Peyronie's disease representing the greatest fold change. The proportion of claims submitted by advanced practice providers treating all 4 conditions was higher in 2021 than 2010 in both publicly and privately insured groups. CONCLUSIONS: The role of advanced practice providers in men's urological health is increasing for both privately and publicly insured patient populations. Advanced practice providers play a critical role in urological care and can help to improve access to men's health.

Epidemiology of pediatric cartilage restoration procedures in the United States: insurance and geography play a role.

OBJECTIVES: The purpose of this study is to analyze the epidemiology of children and adolescents undergoing osteochondral autograft transplantation (OAT), osteochondral allograft transplantation (OCA), and autologous chondrocyte implantation (ACI) in the United States. METHODS: The Pediatric Health Information System, a national database consisting of 49 children's hospitals, was queried for all patients undergoing OAT, OCA, and ACI between 2012 and 2018. Demographic information was collected for each subject. United States Census guidelines were used to categorize hospitals geographically. Univariate analysis was followed by purposeful entry multivariate regression to adjust for confounding factors. RESULTS: A total of 809 subjects with a mean age of 15.4 ± 2.4 years were included in the analysis. Of these, 48.6% underwent OCA, 41.9% underwent OAT, and 9.5% underwent ACI. After adjusting for confounders in a multivariate model, ACI was 3.6 times more likely to be performed in patients with private insurance than those that were publicly insured (95% CI 1.6-8.0, p = 0.002). Furthermore, a patient in the Northeast was 33.1 times more likely to undergo ACI than in the West (95% CI 4.5-246.1, p = 0.001). OAT was performed most frequently in the West and Midwest (52.4% and 51.8% of the time, respectively; p < 0.001). CONCLUSION: In the United States, there is substantial variation in the procedures performed for cartilage restoration in children and adolescents. Though ACI is the least commonly selected operation overall, it is significantly more likely to be performed on patients with private insurance and those in the Northeast.

Evaluation of Industry Payments to US Advanced Practice Clinicians in 2021.

Importance: Advanced practice clinicians (APCs) are a growing part of the US health care system, and their financial relationships with pharmaceutical and medical device companies have not been well studied. Objectives: To examine the value, frequency, and types of payments made to APCs and the association of state scope-of-practice laws with these payments. Design, Setting, and Participants: This cross-sectional study used 2021 Open Payments Program data to analyze payments from pharmaceutical or medical device companies to physicians or APCs between January 1 and December 31, 2021. Doctors of medicine and osteopathy were categorized as physicians, and nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, certified nurse midwives, and anesthesiologist assistants as APCs. Main Outcomes and Measures: The total value and total number of payments were calculated in aggregate and per clinician for each type of APC, all APCs, and physicians. These calculations were repeated by submitting manufacturer, form of payment, nature of payment, and state scope-of-practice law for nurse practitioners, physician assistants, and physicians. Results: A total of 412 000 physicians and 232 000 APCs collectively received $1.99 billion in payments from industry in 2021, of which APCs received $121 million (6.1%). The median total value of payments per clinician for physicians was $167 (IQR, $45-$712) and for APCs was $117 (IQR, $33-$357). The median total number of payments per clinician was equal for physicians and APCs (n = 4). The most common payments to APCs included food and beverage ($69 million [57.6%]), compensation for services other than consulting ($32 million [26.4%]), and consulting fees ($8 million [6.6%]). Advanced practice clinicians in states with the most restrictive scope-of-practice laws received 15.9% lower total value of payments than those in the least restrictive states (P = .002). Physician assistants received 7.6% (P = .005) higher value and 18.1% (P < .001) greater number of payments than nurse practitioners. Conclusions and Relevance: In this cross-sectional study, 232 000 APCs collectively received $121 million in industry payments in 2021. The frequency of industry interactions with APCs was similar to that for physicians, but the average value was lower. The greater value of payments to APCs who practice in states with the least restrictive scope-of-practice laws suggests that industry payments may be related to clinician autonomy.

The Growth of Advanced Practice Providers in Urology Procedural Care: Evidence from Public and Private Health Insurers.

OBJECTIVE: To understand the growing role of advanced practice providers (APPs) in urologic care, we investigated urology procedural claims submitted to public and private health insurers. METHODS: We used Medicare summary and commercial health insurance claims from 2010 to 2020 to calculate the number and proportion of common urologic procedures performed by APPs. To characterize broader trends across urology, we categorized the urologic procedures into five groups: cancer procedures, cystoscopy procedures, imaging procedures, urgent procedures, and voiding dysfunction. RESULTS: APPs submitted an increasing proportion of Medicare and commercial urology procedural claims between 2010 and 2020 (2% and 1% more claims, respectively), including several procedure groups: voiding dysfunction (12% and 4%), urgent procedures (8% and 5%), cancer procedures (3% and 2%), and cystoscopy procedures (1% and 1%). APPs consistently submitted a larger proportion of claims to Medicare than private insurers and, as of 2019, voiding dysfunction and cancer procedures were the most common urologic procedures performed by APPs in the Medicare data (82,749 and 73,837 procedures, respectively). In 2020, procedures with the greatest proportion of Medicare and commercial claims submitted by APPs included percutaneous tibial nerve stimulation (24% and 10% of claims, respectively), bladder installations (16% and 8%), neurostimulator programming (14% and 7%), and complicated Foley catheter placement (12% and 7%). CONCLUSION: APPs account for a growing proportion of urology procedural claims submitted to public and private health insurers. Stakeholders need to be aware of these changes in the urologic workforce to maintain the standard of care across urology.