Analysis of Devices Authorized by the FDA for Clinical Decision Support in Critical Care.

This case series study examines the clinical evidence cited for US Food and Drug Administration­approved clinical decision support devices for use in the critical care setting.

The Revolving Door In Health Care Regulation.

Of people appointed to the Department of Health and Human Services between 2004 and 2020, 15 percent had been employed in private industry immediately before their appointment. At the end of their tenure, 32 percent exited to industry. The greatest net exits to industry were from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.

Health Care Privacy Risks of AI Chatbots.

This Viewpoint notes that as clinicians incorporate new AI tools (such as chatbots) into their practice, they must also remain vigilant of the risks these tools pose to other aspects of patient care such as privacy.

Using remotely monitored patient activity patterns after hospital discharge to predict 30 day hospital readmission: a randomized trial.

Hospital readmission prediction models often perform poorly, but most only use information collected until the time of hospital discharge. In this clinical trial, we randomly assigned 500 patients discharged from hospital to home to use either a smartphone or wearable device to collect and transmit remote patient monitoring (RPM) data on activity patterns after hospital discharge. Analyses were conducted at the patient-day level using discrete-time survival analysis. Each arm was split into training and testing folds. The training set used fivefold cross-validation and then final model results are from predictions on the test set. A standard model comprised data collected up to the time of discharge including demographics, comorbidities, hospital length of stay, and vitals prior to discharge. An enhanced model consisted of the standard model plus RPM data. Traditional parametric regression models (logit and lasso) were compared to nonparametric machine learning approaches (random forest, gradient boosting, and ensemble). The main outcome was hospital readmission or death within 30 days of discharge. Prediction of 30-day hospital readmission significantly improved when including remotely-monitored patient data on activity patterns after hospital discharge and using nonparametric machine learning approaches. Wearables slightly outperformed smartphones but both had good prediction of 30-day hospital-readmission.

Insurance and racial disparities in prior authorization in gynecologic oncology.

While prior authorization aims to reduce unnecessary care, it may limit or delay medically necessary care. Delays in cancer care can impact survival and are more common in historically-marginalized populations. Our objective was to examine to what extent disparities occurred in prior authorizations for gynecologic oncology. Using electronic medical records, we performed a retrospective review of prior authorization occurrence during gynecologic oncology care and analyzed the association with patient race and insurance in a multivariate regression model. In this cohort of 1,406 patients treated at an academic gynecologic oncology practice, patients with Medicare Advantage and patients of Asian descent were more likely to experience prior authorization. Addressing insurance-mediate disparities, such as in the occurrence of prior authorization, may help reduce disparities in gynecologic cancer care.

Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing: A Cluster Randomized Clinical Trial.

Importance: Statins reduce the risk of major adverse cardiovascular events, but less than one-half of individuals in America who meet guideline criteria for a statin are actively prescribed this medication. Objective: To evaluate whether nudges to clinicians, patients, or both increase initiation of statin prescribing during primary care visits. Design, Setting, and Participants: This cluster randomized clinical trial evaluated statin prescribing of 158 clinicians from 28 primary care practices including 4131 patients. The design included a 12-month preintervention period and a 6-month intervention period between October 19, 2019, and April 18, 2021. Interventions: The usual care group received no interventions. The clinician nudge combined an active choice prompt in the electronic health record during the patient visit and monthly feedback on prescribing patterns compared with peers. The patient nudge was an interactive text message delivered 4 days before the visit. The combined nudge included the clinician and patient nudges. Main Outcomes and Measures: The primary outcome was initiation of a statin prescription during the visit. Results: The sample comprised 4131 patients with a mean (SD) age of 65.5 (10.5) years; 2120 (51.3%) were male; 1210 (29.3%) were Black, 106 (2.6%) were Hispanic, 2732 (66.1%) were White, and 83 (2.0%) were of other race or ethnicity, and 933 (22.6%) had atherosclerotic cardiovascular disease. In unadjusted analyses during the preintervention period, statins were prescribed to 5.6% of patients (105 of 1876) in the usual care group, 4.8% (97 of 2022) in the patient nudge group, 6.0% (104 of 1723) in the clinician nudge group, and 4.7% (82 of 1752) in the combined group. During the intervention, statins were prescribed to 7.3% of patients (75 of 1032) in the usual care group, 8.5% (100 of 1181) in the patient nudge group, 13.0% (128 of 981) in the clinician nudge arm, and 15.5% (145 of 937) in the combined group. In the main adjusted analyses relative to usual care, the clinician nudge significantly increased statin prescribing alone (5.5 percentage points; 95% CI, 3.4 to 7.8 percentage points; P = .01) and when combined with the patient nudge (7.2 percentage points; 95% CI, 5.1 to 9.1 percentage points; P = .001). The patient nudge alone did not change statin prescribing relative to usual care (0.9 percentage points; 95% CI, -0.8 to 2.5 percentage points; P = .32). Conclusions and Relevance: Nudges to clinicians with and without a patient nudge significantly increased initiation of a statin prescription during primary care visits. The patient nudge alone was not effective. Trial Registration: ClinicalTrials.gov Identifier: NCT04307472.

Association Between Nephrologist Ownership of Dialysis Facilities and Clinical Outcomes.

Importance: Ownership of US dialysis facilities presents a financial conflict of interest for nephrologists, who may change their clinical practice to improve facility profitability. Objective: To investigate the association between nephrologist ownership of freestanding dialysis facilities and clinical outcomes. Design, Setting, and Participants: This cross-sectional study was conducted using US Renal Data System data linked to a data set of freestanding nonpediatric dialysis facility owners. Participants were a sample of all adults with fee-for-service Medicare receiving dialysis for end-stage kidney disease from January 2017 to November 2017 at included facilities. Data were analyzed from April 2020 through August 2022. Exposures: Outcomes associated with nephrologist ownership were assessed using a difference-in-differences analysis comparing the difference in outcomes between patients treated by nephrologist owners and patients treated by nonowners within facilities owned by nephrologists after accounting for differences in patient outcomes between nephrologist owners and nonowners in other facilities. Main Outcomes and Measures: Outcomes plausibly associated with nephrologist ownership were evaluated: (1) treatment volumes (missed treatments and transplant waitlist status); (2) erythropoietin-stimulating agent (ESA) use and related outcomes (anemia, defined as hemoglobin level <10 g/dL, and blood transfusions), (3) quality metrics (mortality, hospitalizations, 30-day readmissions, hemodialysis adequacy, arteriovenous fistula use, and hemodialysis catheter use for ≥3 months), and (4) home dialysis use. Results: A cohort of 251 651 patients (median [IQR] age, 66 [46-85] years; 112 054 [44.5%] women; 9765 Asian [3.9%], 86 837 Black [34.5%], and 148 617 White [59.1%]; 38 938 Hispanic [15.5%]) receiving dialysis for end-stage kidney disease were included. Patient treatment by nephrologist owners at their owned facilities was associated with a 2.4 percentage point (95% CI, 1.1-3.8 percentage points) higher probability of home dialysis, a 2.2 percentage point (95% CI, 3.6-0.7 percentage points) lower probability of receiving an ESA, and no significant difference in anemia or blood transfusions. Patient treatment by nephrologist owners at their owned facilities was not associated with differences in missed treatments, transplant waitlisting, mortality, hospitalizations, 30-day readmissions, hemodialysis adequacy, or fistula or long-term dialysis catheter use. Conclusions and Relevance: This cross-sectional cohort study found that nephrologist ownership was associated with increased home dialysis use, decreased ESA use, and no change in anemia or blood transfusions.

Prior authorization in gynecologic oncology: An analysis of clinical impact.

BACKGROUND: Prior authorization was designed to minimize unnecessary care and reduce spending but has been associated with delays in necessary care. Our objective was to estimate the occurrence of prior authorization, and impact on cancer care, in gynecologic oncology. METHODS: We performed a retrospective cross-sectional study of patients seen in University of Pennsylvania gynecologic oncology practices (January-March 2021). Using electronic medical records, we measured the incidence of prior authorization during the 3-month period and prior experience of prior authorization for cancer care overall and by type of order (chemotherapy, imaging, surgery, prescription drugs). We assessed the impact of prior authorization occurrence on clinical outcomes (time to service, changes in care). RESULTS: Of the 2112 clinic visits of 1406 unique patients, 5% experienced prior authorization during the 3-month study period. An additional 20% faced prior authorization requests earlier in cancer care. Of the 83 prior authorization requests, imaging accounted for the majority (54%) followed by supportive medications (29%) and chemotherapy (17%). After appeal, 79% of cases were approved. For patients whose prior authorizations were approved, there was a mean of 16 days from order placement to care delivery (95% CI 11-20, range 0-98 days). Of the 17 denials, 3 (18%) led to a substantial change in care (i.e., not receiving planned treatment). CONCLUSION: 25% of gynecologic oncology patients experienced prior authorization during their cancer care. While 80% of claims were ultimately approved, patients experienced over a 2-week delay in care when prior authorization occurred. Reform is needed to reduce the burden of prior authorization in oncology.

Trends in Medically Integrated Dispensing Among Oncology Practices.

PURPOSE: The integration of pharmacies with oncology practices-known as medically integrated dispensing or in-office dispensing-could improve care coordination but may incentivize overprescribing or inappropriate prescribing. Because little is known about this emerging phenomenon, we analyzed historical trends in medically integrated dispensing. METHODS: Annual IQVIA data on oncologists were linked to 2010-2019 National Council for Prescription Drug Programs pharmacy data; data on commercially insured patients diagnosed with any of six common cancer types; and summary data on providers' Medicare billing. We calculated the national prevalence of medically integrated dispensing among community and hospital-based oncologists. We also analyzed the characteristics of the oncologists and patients affected by this care model. RESULTS: Between 2010 and 2019, the percentage of oncologists in practices with medically integrated dispensing increased from 12.8% to 32.1%. The share of community oncologists in dispensing practices increased from 7.6% to 28.3%, whereas the share of hospital-based oncologists in dispensing practices increased from 18.3% to 33.4%. Rates of medically integrated dispensing varied considerably across states. Oncologists who dispensed had higher patient volumes (P < .001) and a smaller share of Medicare beneficiaries (P < .001) than physicians who did not dispense. Patients treated by dispensing oncologists had higher risk and comorbidity scores (P < .001) and lived in areas with a higher % Black population (P < .001) than patients treated by nondispensing oncologists. CONCLUSION: Medically integrated dispensing has increased significantly among oncology practices over the past 10 years. The reach, clinical impact, and economic implications of medically integrated dispensing should be evaluated on an ongoing basis.

Intensity of end-of-life care for gynecologic cancer patients by primary oncologist specialty.

OBJECTIVE: The association of primary oncologist specialty, medical oncology versus gynecologic oncology, on intensity of care at the end of life in elderly patients with gynecologic cancer is unclear. METHODS: This retrospective cohort study used Surveillance, Epidemiology and End Results-Medicare (SEER-M) data. Subjects were fee-for-service Medicare enrollees aged 65 years and older who died of a gynecologic cancer between January 2006 and December 2015. The primary outcome was a composite score for high-intensity care received in the last month of life. Secondary outcomes included invasive procedures and Medicare spending in the last month of life. Simple and multivariable linear and logistic regression analyses evaluated differences in outcomes by primary oncologist specialty. Linear regressions were repeated after creating a more similar control group through nearest-neighbor propensity score matching. RESULTS: Of 12 189 patients, 7705 (63%) had a medical primary oncologist in the last year of life. In adjusted analyses, patients with a gynecologic versus medical primary oncologist received lower rates of high-intensity end-of-life care (53.9% vs 56.6%; p=0.018). Results were similar for the propensity score-matched cohorts. However, having a gynecologic versus medical primary oncologist was associated with higher rates of invasive procedures in the last month of life (43% vs 41%; p=0.014) and higher Medicare spending ($83 859 vs $74 849; p=0.004). CONCLUSIONS: Both specialties engage in overall high levels of intense end-of-life care, with differences by specialty in aspects of aggressive care and spending at the end of life. Physician-level training could be a target for educational or quality improvement initiatives to improve end-of-life cancer care delivery.

Association of gynecologic oncology versus medical oncology specialty with survival, utilization, and spending for treatment of gynecologic cancers.

BACKGROUND: We examined the association of gynecologic oncology (GYO) versus medical oncology (MEDONC) based care with survival, health care utilization and spending outcomes in women undergoing chemotherapy for advanced gynecologic cancers. METHODS: Women with newly diagnosed stage III-IV uterine, ovarian, and cervical cancers from 2000 to 2015 were identified in SEER-Medicare. We assessed the association of provider specialty with overall survival, emergency department utilization, admissions, and spending. Outcomes were assessed using unadjusted and Inverse Treatment Probability Weighted propensity-score applied, multi-variable cox modeling, Poisson regression, and generalized models of log-transformed data. RESULTS: We identified 7930 gynecologic cancer patients (4360 ovarian, 2934 uterine, 643 cervix). 37% were treated by GYO and 63% by MEDONC. For ovarian patients, GYO care was associated with improved OS (median OS 3.3 v. 2.9 years; HR 0.85, 95%CI 0.80, 0.91, p < .0001) and similar mean spending per month ($4015 v. $4316, mean ratio 0.97 (95% CI 0.93, 1.02), p = .19), compared to MEDONC in adjusted analyses. For uterine patients, GYO care was associated with similar OS, but decreased spending ($3573 v. $4081, mean ratio 0.87 (95% CI.81, 0.93), p < .0001), and decreased ED utilization (RR 0.76, 95% CI 0.69, 0.85, p < .0001). For cervical patients, GYO care was associated with similar OS, and similar spending. Admissions were more likely in ovarian (RR 1.23, 95%CI 1.11, 1.37, p = .0001) and cervical patients (RR 1.26, 95% CI 1.05, 1.51, p = .015) treated by GYO, in adjusted analyses. CONCLUSIONS: GYO based care was associated with improved OS and equal spending for patients with advanced stage ovarian cancer. Uterine and cervix patients had similar OS, and less or equal spending respectively, when treated by GYO compared to MEDONC.

Interventional cardiologists' attitudes towards pharmacogenetic testing and impact on antiplatelet prescribing decisions.

Aim: To determine if interventional cardiologists' knowledge and attitudes toward pharmacogenetic (PGx) testing influenced their antiplatelet prescribing decisions in response to CYP2C19 results. Materials & methods: Surveys were administered prior to participating in a randomized trial of CYP2C19 testing. Associations between baseline knowledge/attitudes and agreement with the genotype-guided antiplatelet recommendations were determined using multivariable logistic regression. Results: 50% believed that PGx testing would be valuable to predict medication toxicity or efficacy. 64% felt well informed about PGx testing and its therapeutic application. However, PGx experience, knowledge, nor attitudes were significantly associated with agreement to genotype-guided antiplatelet recommendations. Conclusion: Cardiologists' knowledge and attitudes were not associated with CYP2C19-guided antiplatelet prescribing, but larger studies should be done to confirm this finding.

Lay abstract Our study aimed to determine if interventional cardiologists' knowledge and attitudes toward pharmacogenetic (PGx) testing influenced their medication prescribing decisions in response to variations in patients' genes. Surveys were given to the cardiologist prior to their participation in a PGx study. Associations between initial knowledge/attitudes and agreement with the PGx-guided medication recommendations were determined. 50% believed that PGx testing would be valuable to predict medication toxicity or efficacy. A total of 64% felt well informed about PGx testing and its therapeutic application. However, PGx experience, knowledge, or attitudes did not align with antiplatelet prescribing decisions. Cardiologists' knowledge and attitudes were not associated with PGx-guided medication prescribing, but larger studies should be done to confirm this finding.

Access to pharmacies and pharmacy services in New York City, Los Angeles, Chicago, and Houston, 2015-2020.

BACKGROUND: Despite the importance of pharmacies in ensuring medications and health care needs are met, there is limited up-to-date information regarding access to pharmacies or their services in the United States. OBJECTIVES: To evaluate trends and disparities in access to pharmacies in 4 largest cities in the United States, New York City, Los Angeles, Houston, and Chicago, by neighborhood racial and ethnic composition from 2015 to 2020. METHODS: Data from the National Council for Prescription Drug Programs (2015-2020) and the American Community Survey (2015-2019) were used. We examined neighborhoods (i.e., census tracts) and evaluated disparities in "pharmacy deserts" (low-income neighborhoods (1) whose average distance to the nearest pharmacy was at least 1 mile or (2) whose average distance to the nearest pharmacy was at least 0.5 mile and at least 100 households had no vehicle access). We also evaluated the differences in pharmacy closures and the availability of pharmacy services. RESULTS: From 2015 to 2020, the percent of neighborhoods with pharmacy deserts declined in New York City (from 1.6% to 0.9% of neighborhoods, P < 0.01), remained stable in Los Angeles (13.7% to 13.4%, P = 0.58) and Houston (27.0% to 28.5%, P = 0.18), and increased in Chicago (15.0% to 19.9%, P < 0.01). Pharmacy deserts were persistently more common in Black and Latino neighborhoods in all 4 cities. As of 2020, pharmacies in Black and Latino neighborhoods were also more likely to close and less likely to offer immunization, 24-hour, and drive-through services than pharmacies in other neighborhoods. CONCLUSION: To reduce disparities in access to medications and health care services, including those in response to the coronavirus disease 2019 pandemic (e.g., testing and vaccinations), policies that improve pharmacy access and expand the provision of pharmacy services in minority neighborhoods are critical.

Historical trends in health care-related financial holdings among members of Congress.

BACKGROUND: Revelations that some members of Congress, including members of key health care committees, hold substantial personal investments in the health care industry have raised concerns about lawmakers' financial conflicts of interest (COI) and their potential impact on health care legislation and oversight. AIMS: 1) To assess historical trends in both the number of legislators holding health care-related assets and the value and composition of those assets. 2) To compare the financial holdings of members of health care-focused committees and subcommittees to those of other members of the House and Senate. METHODS: We analyzed 11 years of personal financial disclosures by all members of the House and Senate. For each year, we calculated the percentage of members holding a health care-related asset (overall, by party, and by committee); the total value of all assets and health care-related assets held; the mean and median values of assets held per member; and the share of asset values attributable to 9 health asset categories. FINDINGS: During the study period, over a third of all members of Congress held health care-related assets. These assets were often substantial, with a median total value per member of over $43,000. Members of health care-focused committees and subcommittees in the House and Senate did not hold health care-related assets at a higher rate than other members of their respective chambers. CONCLUSIONS: These findings suggest that lawmakers' health care-related COI warrant the same level of attention that has been paid to the COI of other actors in the health care system.

An increase in multi-site practices: The shifting paradigm for gynecologic cancer care delivery.

OBJECTIVE: To assess whether the number of practice sites per gynecologic oncologist (GO) and geographic access to GOs has changed over time. METHODS: This is a retrospective repeated cross-sectional study using the 2015-2019 Physician Compare National File. All GOs in the 50 United States and Washington, DC, who had completed at least one year of practice were included in the study. All practice sites with complete addresses were included. Linear regression analyses estimated trends in GOs' number of practice sites and geographic dispersion of practice sites. Secondary analyses assessed temporal trends in the number of geographic areas served by at least one GO. RESULTS: Although there was no significant change in the number of GOs from 2015 to 2019 (n = 1328), there was a significant increase in the number of practice sites (881 to 1416, p = 0.03), zip codes (642 to 984, p = 0.03), HSAs (404 to 536, p = 0.04), and HRRs (218 to 230, p = 0.03) containing a GO practice. The mean number of practice sites (1.64 versus 2.13, p < 0.001) and dispersion of practice sites (0.03 versus 0.43 miles, p = 0.049) per GO increased significantly. CONCLUSIONS: Between 2015 and 2019, an increasing number of GOs have multi-site practices, and more geographic regions contain a GO practice. Improvements in geographic access to GOs may represent improved access to care for many women in the US, but its effect on patients, physicians, and geographic disparities is unknown.

The Effects of Market Competition on Cardiologists' Adoption of Transcatheter Aortic Valve Replacement.

BACKGROUND: For decades, the prevailing assumption regarding the diffusion of high-cost medical technologies has been that competitive markets favor more aggressive adoption of new treatments by health care providers (ie, the "Medical Arms Race"). However, novel regulations governing the adoption of transcatheter aortic valve replacement (TAVR) may have disrupted this paradigm when TAVR was introduced. OBJECTIVE: The objective of this study was to assess the relationship between the market concentration of physician group practices and the adoption of TAVR in its first years of use. RESEARCH DESIGN: This was a retrospective cohort study. SUBJECTS: Physician group practices (n=5116) providing interventional cardiology services in the United States from May 1, 2012, to December 31, 2014. MEASURES: The first use of TAVR as indicated by a fee-for-service Medicare claim. Covariates including characteristics of the physician groups (ie, case volume, hospital affiliation, mean patient risk) as well as county-level and market-level characteristics. RESULTS: By the close of 2014, 9.3% of practices had adopted TAVR. Cox proportional hazards models revealed a hazard ratio of 1.26 (95% confidence interval: 1.16-1.37, P<0.001) per 1000 point increase in the physician group practice Herfindahl-Hirschman Index, indicating each 1000 point increase in group practice Herfindahl-Hirschman Index was associated with a 26% relative increase in the rate of TAVR adoption. CONCLUSIONS: Adoption of TAVR by physician groups in concentrated markets was potentially a consequence of the unique regulations governing TAVR reimbursement, which favored the adoption of TAVR by physician groups with greater market power. These findings have important implications for how future regulations may shape patterns of technology adoption.

Income Disparities In Access To Critical Care Services.

The coronavirus disease 2019 (COVID-19) pandemic has highlighted the importance of intensive care unit (ICU) beds in preventing death from the severe respiratory illness associated with COVID-19. However, the availability of ICU beds is highly variable across the US, and health care resources are generally more plentiful in wealthier communities. We examined disparities in community ICU beds by US communities' median household income. We found a large gap in access by income: 49 percent of the lowest-income communities had no ICU beds in their communities, whereas only 3 percent of the highest-income communities had no ICU beds. Income disparities in the availability of community ICU beds were more acute in rural areas than in urban areas. Policies that facilitate hospital coordination are urgently needed to address shortages in ICU hospital bed supply to mitigate the effects of the COVID-19 pandemic on mortality rates in low-income communities.

Association of State Medicaid Expansion With Hospital Community Benefit Spending.

Importance: Medicaid expansion was widely expected to alleviate the financial stresses faced by hospitals by providing additional revenue in the form of Medicaid reimbursements from patients previously receiving uncompensated care. Among nonprofit hospitals, which receive tax-exempt status in part because of their provision of uncompensated care, Medicaid expansion could have released hospital funds toward other community benefit activities. Objective: To examine changes in nonprofit hospital spending on community benefit activities after Medicaid expansion. Design, Setting, and Participants: This cohort study used difference-in-differences analysis of 1666 US nonprofit hospitals that filed Internal Revenue Service Form 990 Schedule H detailing their community benefit expenditures between 2011 and 2017. The analysis was conducted from February to September 2019. Exposures: State Medicaid expansion between 2011 and 2017. Main Outcomes and Measures: Percentage of hospital operating expenditures attributable to charity care and subsidized care, bad debt (ie, unreimbursed spending for care of patients who did not apply for charity care), unreimbursed Medicaid spending, noncare direct community spending, and total community benefit spending. Results: Of 1478 hospitals in the sample in 2011, nearly half (653 [44.2%]) were small hospitals with fewer than 100 beds, and nearly 70% of hospitals (1023 [69.2%]) were in urban areas. Among the 1666 nonprofit hospitals, Medicaid expansion was associated with a decrease in spending on charity care and subsidized care (-0.68 [95% CI, -0.99 to -0.37] percentage points from a baseline mean [SD] of 3.6% [4.0%] of total hospital expenditures; P < .001) and in bad debt (-0.17 [95% CI, -0.32 to -0.01] percentage points). There was an increase in unreimbursed spending attributable to caring for Medicaid patients (0.85 [95% CI, 0.60 to 1.10] percentage points; P = .04), which canceled out uncompensated care savings from the expansion. Noncare direct community expenditures decreased overall (-0.24 [95% CI, -0.48 to 0.00] percentage points; P = .049). Direct community expenditures remained more stable in small hospitals (-0.07 [95% CI, -0.20 to 0.05] percentage points; P =.26) compared with large hospitals (-0.37 [95% CI, -0.86 to 0.12] percentage points; P = .14) and in nonurban hospitals (0.02 [95% CI, -0.09 to 0.14] percentage points; P = .70) compared with urban hospitals (-0.36 [95% CI, -0.73 to 0.01] percentage points; P = .06). Conclusions and Relevance: In this study, Medicaid expansion was associated with a decrease in nonprofit hospitals' burden of providing uncompensated care, but this financial relief was not redirected toward spending on other community benefits.