Use of Physical Therapy and Subsequent Falls Among Patients With Dizziness in the US.

Importance: Among adults who present for clinical evaluation of dizziness, there is a critical need to identify interventions, such as physical therapy (PT), to mitigate the risk of falls over time. Objective: The primary objective was to examine the association between receipt of PT and falls requiring medical care within 12 months of presentation for dizziness. Secondary objectives included identification of factors associated with falls requiring medical care and factors associated with receipt of PT after presentation for dizziness. Design, Setting, and Participants: This cross-sectional study examined US commercial insurance and Medicare Advantage claims from January 1, 2006, through December 31, 2015. In all, 805 454 patients 18 years or older with a new diagnosis of symptomatic dizziness or vestibular disorders were identified. Data were analyzed from October 1, 2021, to February 1, 2023. Main Outcomes and Measures: Receipt of PT services and the incidence of falls requiring medical care were measured. The association between receipt of PT and falls that occurred 12 months after presentation for dizziness was estimated after accounting for presentation setting (outpatient clinic or emergency department), Charlson Comorbidity Index (CCI; with higher scores indicating greater morbidity), diagnosis code, and sociodemographic characteristics. Results: A total of 805 454 patients presented for dizziness from 2006 through 2015 (median [range] age, 52 [18-87] years; 502 055 females [62%]). Of these patients, 45 771 (6%) received PT within 3 months of presentation for dizziness and 60 060 (7%) experienced a fall resulting in a medical encounter within 12 months after presentation for dizziness. In adjusted models, patients least likely to receive PT were female (adjusted odds ratio [AOR], 0.80; 95% CI, 0.78-0.81), those aged 50 to 59 years (AOR, 0.67 [95% CI, 0.65-0.70] compared with patients aged 18-39 years), and those with more comorbidities (AOR, 0.71 [95% CI, 0.70-0.73] for CCI ≥ 2 vs 0). Receipt of PT services within 3 months of presentation for dizziness was associated with a reduced risk of falls over the subsequent 12 months, with the greatest risk reduction found within 3 months after PT (AOR, 0.14 [95% CI, 0.14-0.15] at 3-12 months vs 0.18 [95% CI, 0.18-0.19] at 6-12 months and 0.23 [95% CI, 0.23-0.24] at 9-12 months). Conclusions and Relevance: Results of this cohort study suggest that receipt of PT after presentation for dizziness was associated with a reduction in fall risk during the subsequent 12 months; thus, timely PT referral for dizziness may be beneficial for these patients. Future research, ideally with a clinical trial design, is needed to explore the independent impact of PT on subsequent falls for adults with dizziness.

Uptake of Biosimilar Among Privately Insured Patients Undergoing Infliximab Treatment.

BACKGROUND: Recent literature has found rapid uptake of short-acting filgrastim biosimilars but slower uptake of other biosimilars, such as infliximab, in both Medicare and privately insured enrollees. OBJECTIVES: To describe patient, provider, and health plan characteristics associated with a switch to biosimilar among existing infliximab patients. RESEARCH DESIGN: We constructed a retrospective panel dataset of patients undergoing active infliximab treatments and the choice of infliximab drug for each infusion. We used mixed logit regression controlling for patient, provider, and health plan characteristics as well as time-fixed effects. SUBJECTS: Medicare Advantage and privately insured enrollees with evidence of active infliximab treatments between 2016 and 2020 (n=357,430). MEASURES: Our primary outcome of interest was to switch from infliximab originator to one of the infliximab biosimilars. Exposure variables of interest variables such as out-of-pocket, site of care, and in-network deductible. RESULTS: Our study found nominally low switching among existing infliximab originator users (3.4%). We found that patients who previously received 1 infliximab originator infusion were 63.7% more likely to switch to biosimilar compared with patients who previously received administration of 20 infliximab originators. We found that biosimilar's placement as health's plan preferred drug was attributed to higher likelihood of biosimilar use (odds ratio: 1.666; P -value=0.001). We did not observe any statistically significant effect among out-of-pocket amount or deductible with respect to switch to infliximab biosimilar. CONCLUSIONS: To encourage uptake and switch to biosimilar, policymakers should consider targeted policies that include leveraging health plan tools such as placement of biosimilar as preferred drug and aim to educate patients on the clinical equivalence between infliximab biosimilar and originator.

Lymphedema self-care: economic cost savings and opportunities to improve adherence.

BACKGROUND: Breast cancer-related lymphedema (BCRL) imposes a significant economic burden on patients, providers, and society. There is no curative therapy for BCRL, but management through self-care can reduce symptoms and lower the risk of adverse events. MAIN BODY: The economic burden of BCRL stems from related adverse events, reductions in productivity and employment, and the burden placed on non-medical caregivers. Self-care regimens often include manual lymphatic drainage, compression garments, and meticulous skin care, and may incorporate pneumatic compression devices. These regimens can be effective in managing BCRL, but patients cite inconvenience and interference with daily activities as potential barriers to self-care adherence. As a result, adherence is generally poor and often worsens with time. Because self-care is on-going, poor adherence reduces the effectiveness of regimens and leads to costly treatment of BCRL complications. CONCLUSION: Novel self-care solutions that are more convenient and that interfere less with daily activities could increase self-care adherence and ultimately reduce complication-related costs of BCRL.

Association Between New 340B Program Participation and Commercial Insurance Spending on Outpatient Biologic Oncology Drugs.

Importance: Previous studies have found that hospitals participating in the 340B Drug Pricing Program have higher Medicare Part B spending and expansion into affluent neighborhoods. Less is known about the association of 340B participation with spending by commercial insurance, where reimbursements are higher than Medicare. Objective: To use the Affordable Care Act expansion of eligibility for the 340B Drug Pricing Program to study the association between participation and spending on outpatient-administered oncological drugs for commercially insured patients. Design, Setting, and Participants: This cohort study included a balanced panel hospital cohort containing new and never 340B program participants between 2007 and 2019; more recent data were not included to avoid the effect of disruptions in care due to the COVID-19 pandemic. Descriptive analyses documented spending trends for patients receiving common outpatient-administered biologics used in cancer treatments (bevacizumab, filgrastim, pegfilgrastim, rituximab, and trastuzumab) at 340B (treated) and non-340B (control) hospitals. A difference-in-differences model assessed changes in episode drug spending. Analyses were conducted between December 2021 and June 2022. Exposure: New 340B program participation between 2010 and 2016. Main Outcome and Measures: Total drug episode spending, with control variables including total billed units, drug, calendar-year fixed effects, and hospital fixed effects. Results: Of 95 127 included episodes (56 917 [59.8%] episodes in female patients) across 478 hospitals, patients seen in 340B and non-340B hospitals were similar in sex and drug used, and 340B hospital patients were older than non-340B patients (median [IQR] age for all patients, 61 [51-71] years). New 340B participating hospitals were more likely to be small (<50 beds) and more likely to be in rural settings. In the difference-in-differences analysis, total episode drug spending increased by $4074.69 (95% CI, $1592.84-$6556.70; P = .001) in the year following start of 340B program participation relative to nonparticipants. Heterogeneous group time effects were seen, with earlier participants less likely to have increased episode spending. Conclusions and Relevance: In this cohort study, new 340B participation was associated with statistically significant higher oncological drug episode spending compared with nonparticipants after changes in 340B inclusion rules in 2010. These findings raise questions about unintended consequences of the 340B program on drug spending from the commercially insured population.

Longitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014.

BACKGROUND: The objective of this study was to describe changes in testosterone prescribing following a 2014 US Food and Drug Administration (FDA) safety communication and how changes varied by physician characteristics. METHODS: Data were extracted from a 20% random sample of Medicare fee-for-service administrative claims data from 2011 through 2019. The sample included 1,544,604 unique male beneficiaries who received evaluation and management (E&M) services from 58,819 unique physicians that prescribed testosterone between 2011 and 2013. Patients were categorized based on presence of coronary artery disease (CAD) and non-age-related hypogonadism. Physician characteristics were identified in the OneKey database and included specialty and affiliations with teaching hospitals, for-profit hospitals, hospitals in integrated delivery networks, and hospitals in the top decile of case mix index. Linear segmented models described how testosterone prescriptions changed following a 2014 FDA safety communication and how changes were associated with physician and organizational characteristics. RESULTS: Among 65,089,560 physician-patient-quarter-year observations, mean (standard deviation) age ranged from 72.16 (5.84) years for observations without CAD or non-age-related hypogonadism to 75.73 (6.92) years with CAD and without non-age-related hypogonadism. Following the safety communication, immediate changes in off-label testosterone prescription levels fell by 0.22 percentage points (pp) (95% confidence interval [CI] -0.33 to -0.11) for patients with CAD and by -0.16 pp (95% CI -0.19 to -0.16) for patients without CAD. A similar change was noticed in on-label prescribing levels. Off-label testosterone prescription quarterly trend, however, increased for patients with CAD and without CAD; on-label testosterone prescription trends declined for both groups. Declines in off-label prescribing were larger when treated by primary care physicians vs. non-primary care physicians, and physicians affiliated with teaching compared to nonteaching hospitals. Physician and organizational characteristics were not associated with changes in on-label prescribing. CONCLUSION: On-label and off-label testosterone therapy declined following the FDA safety communication. Certain physician characteristics were associated with changes in off-label, but not on-label, prescribing.

Provider barriers in uptake of biosimilars: case study on filgrastim.

In this article, we used administrative claims data from the OptumLabs Data Warehouse and American Hospital Association Annual Survey data to examine associations between hospital characteristics and uptake of biosimilar granulocyte colony-stimulating factor treatments. We found that 340B-participating hospitals and non-rural referral center (RRC) hospitals that reported owning rural health clinics were less likely to administer the lower-cost biosimilars, whereas the opposite was true for hospitals that are RRCs. To our knowledge, our study offers a first look at an underappreciated source of disparities in access to lower-cost medications such as biosimilars. Results from our study reveal opportunities for targeted policies to encourage adoption of lower-cost treatments, particularly among hospitals that serve rural communities where patients often have fewer choices in care site.

Proposing An Innovative Bond To Increase Investments In Social Drivers Of Health Interventions In Medicaid Managed Care.

Interventions to address social drivers of health (SDH), such as food insecurity, transportation, and housing, can reduce future health care costs but require up-front investment. Although Medicaid managed care organizations have incentives to reduce costs, volatile enrollment patterns and coverage changes may prevent them from realizing the full benefits of their SDH investments. This phenomenon results in the "wrong-pocket problem," in which managed care organizations underinvest in SDH interventions because they cannot capture the full benefit. We propose a financial innovation, an SDH bond, to increase investments in SDH interventions. Issued by multiple managed care organizations in a Medicaid coverage region, the bond would raise immediate funds for SDH interventions that are coordinated across the organizations and delivered to all enrollees of the region. As the benefits of SDH interventions accrue and cost savings are realized, the amount managed care organizations must pay back to bond holders adjusts according to enrollment, addressing the wrong-pocket problem.

Effect of Integrating Access to a Prescription Drug Monitoring Program Within the Electronic Health Record on the Frequency of Queries by Primary Care Clinicians: A Cluster Randomized Clinical Trial.

Importance: Tools that are directly integrated with the electronic health record (EHR) workflow can reduce the hassle cost of certain guideline-concordant practices, such as querying a prescription drug monitoring program (PDMP) before prescribing opioids. Objective: To investigate the effect of integrating access to a PDMP within the EHR on the frequency of program queries by primary care clinicians. Design Settings and Participants: The PRINCE (Prescribing Interventions for Chronic Pain Using the Electronic Health Record) randomized trial used a factorial cluster design at the clinic level in 43 primary care clinics in Minnesota. In all, 309 clinicians participated; 161 clinicians were given EHR-integrated access to PDMP at the intervention clinics, and 148 clinicians had the usual access at the control clinics. The intervention went live on August 27, 2020, and data were collected through March 3, 2021. Intervention: Single sign-on access to the Minnesota PDMP was integrated into the EHR, allowing clinicians to query a patient's controlled substance prescription and dispensing history as recorded in the Minnesota PDMP directly from the patient's EHR record without logging into a separate web portal. Additionally, the integration tool alerted clinicians and reminded them to review the PDMP if a patient had 3 or more opioid prescriptions in the past year and 1 or more in the past 6 months. Clinics in the control group did not receive access to the EHR-integrated PDMP tool; instead, these participants logged into the PDMP web portal separately. Main Outcomes and Measures: Monthly PDMP query counts for primary care clinicians, overall and by modality (EHR-based, web-based, via a clinical delegate), adjusted for clinician characteristics, including type (physician, nurse practitioner, physician assistant), sex, and years in practice. Data were analyzed from August 2021 to May 2022. Results: Of the 43 participating clinics with 309 clinicians, 21 clinics with 161 clinicians (102 [63.4%] women; 114 [70.8%] physicians; tenure, 10.6 [4.4] years) received the PDMP integration intervention. Baseline unadjusted monthly PDMP query rates for the average clinician were 6.6 (95% CI, 4.4-9.9) vs 8.8 (95% CI, 6.0-13.1) queries in the control vs the PDMP integration group, respectively. During the intervention, PDMP query rates for the average clinician were 6.9 (95% CI, 4.7-10.3) vs 14.8 (95% CI, 10.0-22.0) queries among the control vs the PDMP integration group, respectively. Compared with the control group, the EHR-integrated PDMP tool produced a 60% greater increase in the relative change in monthly PDMP queries (95% CI, 51%-70%). An increase in PDMP queries via the EHR-integrated PDMP tool drove this increase, while web-based and delegate queries declined by 39% more among the intervention compared with the control group (95% CI, 34%-43%). Conclusions and Relevance: This cluster randomized clinical trial found that integrating access to the PDMP in the EHR increased PDMP-querying rates, suggesting that direct access reduced hassle costs and can dramatically improve adherence to guideline-concordant care practices among primary care clinicians. Trial Registration: ClinicalTrials.gov Identifier: NCT04601506.

Use of Neuroimaging for Patients With Dizziness Who Present to Outpatient Clinics vs Emergency Departments in the US.

Importance: Overuse of costly neuroimaging technology is associated with low-value care for the prevalent symptom of dizziness. Although quality improvement initiatives have focused on the overuse of computed tomography (CT) scans in emergency departments (EDs), most patients with dizziness present to outpatient clinics. To inform practice and policy, a comprehensive understanding of the uses and costs of neuroimaging across settings and episodes of care is needed. Objective: To characterize neuroimaging use, timing, and spending as well as factors associated with imaging acquisition within 6 months of presentation for dizziness in outpatient vs ED settings. Design, Setting, and Participants: This cross-sectional study of commercial and Medicare Advantage claims for 805 454 adults (≥18 years of age) with new diagnoses of dizziness was conducted from January 1, 2006, through December 31, 2015. Data were analyzed from October 1, 2020, to September 30, 2021. Main Outcomes and Measures: Use of neuroimaging (CT scan, magnetic resonance imaging [MRI], angiography, and ultrasonography) and total spending on neuroimaging were measured. Kaplan-Meier analysis was performed. The associations of neuroimaging with setting, sociodemographic characteristics, and clinicians were estimated with multivariable analyses. Results: A total of 805 454 individuals with dizziness (502 055 women [62%]; median age, 52 years [range, 18-87 years]) were included in this study; 156 969 (20%) underwent neuroimaging within 6 months of presentation (65 738 of 185 338 [36%] presented to EDs and 91 231 of 620 116 [15%] presented to outpatient clinics). The median time to neuroimaging was 0 days (95% CI, 0-2 days) after ED presentation and 10 days (95% CI, 9-10 days) after outpatient presentation. Neuroimaging was independently associated with advanced age, comorbidity, race and ethnicity, ED presentation, and outpatient clinician specialty. Across sites, a head CT scan was the most used test on presentation date (92% of tests [46 852 of 51 022]). Within 6 months of presentation, a head CT scan was the most used test (47% of all tests [177 949 of 376 149]), followed by brain MRI (25% [93 130 of 376 149]), cerebrovascular ultrasonography (15% [56 175 of 376 149]), and magnetic resonance angiography (9% [34 026 of 376 149]). Of $88 646 047.03 in total neuroimaging spending, MRI accounted for 70% ($61 730 251.95), CT scans for 19% ($16 910 506.24), and ultrasonography for 11% ($10 005 288.84). Per-test median spending ranged from $68.97 (CT scan of the head) to $319.63 (MRI of the brain) among commercially insured individuals and $43.21 (CT scan of the head) to $362.02 (MRI of the orbit, face, and neck) among Medicare Advantage beneficiaries. Conclusions and Relevance: The findings of this cross-sectional study suggest that use of neuroimaging for dizziness is prevalent across settings. Interventions to optimize the use of neuroimaging must occur early in the patient care journey to discourage guideline-discordant use of CT scans, advocate for judicious MRI use (particularly in ambulatory settings), and account for the effects of price transparency.

Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration.

Importance: In 2013 and 2016, the US Food and Drug Administration (FDA) issued warnings and recommended limited use of fluoroquinolones for patients with certain acute conditions. It is not clear how prescribers have responded to these warnings. Objective: To analyze changes in prescribing of fluoroquinolones after the 2013 and 2016 FDA warnings and to examine the physician characteristics associated with these changes. Design, Setting, and Participants: This cross-sectional study used Medicare administrative claims data on Medicare fee-for-service beneficiaries and OneKey data on physicians and their organizations from January 1, 2011, to December 31, 2017. The sample was restricted to outpatient visits for sinusitis, bronchitis, and uncomplicated urinary tract infections. An interrupted time series approach was used to analyze the changes in the prescription rate after each FDA warning. Data analysis was performed between January 1, 2011, and December 31, 2017. Interventions: Two FDA black box warnings released in August 2013 and July 2016. Main Outcomes and Measures: The main outcome was an indicator for fluoroquinolone prescriptions in 3 periods: before the 2013 warning (baseline period), after the 2013 warning but before the 2016 warning (postwarning period 1), and after the 2016 warning (postwarning period 2). Results: The sample comprised 1 238 397 unique patients with a total of 2 720 071 outpatient acute care visits. Of this sample, 848 360 were women (68.5%), and the mean (SD) age was 69.7 (12.6) years. The immediate prescribing levels of fluoroquinolones in postwarning period 1 increased by 3.42 percentage points (95% CI, 3.23-3.62; P < .001) and declined by -0.77 percentage points (95% CI, -1.00 to -0.54; P < .001) in postwarning period 2. The prescribing trend increased by 0.08 percentage points per month (95% CI, 0.08-0.10; P < .001) in postwarning period 1 and 0.06 percentage points per month (95% CI, 0.04-0.08; P < .001) in postwarning period 2. In postwarning period 1, the prescribing levels for physicians who were affiliated with hospitals with a top 10th percentile case mix index vs those without such affiliation decreased by -1.13 percentage points (95% CI, -1.92 to -0.34; P = .005), whereas the levels for primary care physicians declined by -1.34 percentage points (95% CI, -1.78 to -0.88; P < .001) compared with non-primary care physicians in postwarning period 2. Physicians at teaching hospitals were the only ones who showed a decline in prescribing trend in postwarning period 1. Conclusions and Relevance: This cross-sectional study found an overall decline in prescribing of fluoroquinolones after the release of FDA warnings. Understanding the association of physician and organizational characteristics with fluoroquinolone prescribing behavior may ultimately help to identify mechanisms to improve de-adoption.

Association of 3 CDC opioid prescription guidelines for chronic pain and 2 payer pharmacy coverage changes on opioid initiation practices.

BACKGROUND: Due to the US opioid epidemic, in March of 2016, the Centers for Disease Control and Prevention (CDC) published new guidelines for primary care providers on opioid prescribing for chronic pain. Payer coverage changes were also implemented to help modify opioid prescribing behavior. Whether these initiatives were associated with changes in opioid initiation patterns is unknown. OBJECTIVE: To assess the association between 3 of the 2016 CDC guidelines and 2 subsequent payer pharmacy coverage changes with changes in opioid initiation behavior across different provider specialties. METHODS: We conducted a real-world evidence study using claims data from OptumLabs Data Warehouse between January of 2014 and December of 2018. Subjects were continuously enrolled opioid naive patients, aged at least 18 years, who had at least 1 chronic pain diagnosis within 2 weeks before their first (first-time) opioid prescription. The study used multiple treatment period segmented regression analysis to evaluate the association, across different provider specialties, between the CDC guideline release and the payer pharmacy coverage changes with immediate change in level and overall change in the rate of first-time extended-release opioid prescriptions, firsttime opioid prescriptions at doses of at least 50 MME (morphine milligram equivalent) per day, and first-time opioid prescriptions with overlapping benzodiazepine prescription. RESULTS: The CDC guidelines were not associated with any change in the rate of first-time prescriptions of extended-release opioids. However, a January 2017 payer pharmacy coverage change was associated with a reduction over time in first-time extended-release opioid prescription rates by 22.15 in every 100,000 prescriptions (CI = -40.04 to -2.92, P = 0.013). The CDC guidelines were associated with an immediate decline in level of first-time opioid prescription at doses of at least 50 MME per day by 74.00 in every 10,000 prescriptions (CI = -124.86 to -23.13, P = 0.004) and an increased rate of decline over time by 13.64 in every 10,000 prescriptions (CI = -17.07 to -10.21, P < 0.001). These associations varied across provider types and specialties. The March 2018, payer coverage change was associated with an immediate reduction in level of first-time opioid prescriptions at doses of at least 50 MME per day across all specialties and an increased reduction over time among surgeons. The CDC guidelines were associated, respectively, with a reduction in the rate of overlapping first-time opioid prescriptions with benzodiazepines among family medicine, internal medicine, surgeons, emergency medicine providers, and providers with unknown specialty by 6.11, 5.10, 2.89, 11.43, and 9.11 in every 10,000 prescriptions monthly (CI = -9.48 to -2.73, -9.86 to -0.35, -5.40 to -0.38, -17.26 to -5.61 and -11.96 to -6.25, respectively, P < 0.001, P = 0.035, P = 0.024, P < 0.001 and P < 0.001). CONCLUSIONS: Some specialist providers also adopted the CDC guidelines, and the response to the guidelines differed across various provider specialties. Some CDC guidelines were associated with a reduction in high-risk first-time opioid prescriptions. Payer pharmacy coverage changes reinforced the guidelines both in situations where the CDC guidelines did and did not show any association. DISCLOSURE: This research was funded by Agency for Healthcare Research and Quality (R01 HS025164; PI: Karaca-Mandic). Karaca-Mandic reports grants from the American Cancer Society and Sempre Health, along with fees from Tactile Medical and Precision Health Economics, unrelated to this study. The other authors have nothing to disclose.

Physician Network Connections Associated With Faster De-Adoption of Dronedarone for Permanent Atrial Fibrillation.

BACKGROUND: Physicians' professional networks are an important source of new medical information and have been shown to influence the adoption of new treatments, but it is unknown how physician networks impact the de-adoption of harmful practices. METHODS: We analyzed changes in physicians' use of dronedarone after the PALLAS trial (Palbociclib Collaborative Adjuvant Study; November 2011) showed that dronedarone increased the risk of death from cardiovascular events among patients with permanent atrial fibrillation. Deidentified administrative claims from the OptumLabs Data Warehouse were combined with physicians' demographic information from the Doximity database and publicly available data on physicians' patient-sharing relationships compiled by the Centers for Medicare and Medicaid Services. We used a linear probability model with an interrupted linear time trend specification to model the impact of the PALLAS trial on physicians' dronedarone usage between 2009 and 2014. RESULTS: Before the PALLAS trial, the use of dronedarone was increasing by 0.22 percentage points per quarter (95% CI, 0.19-0.25) in our Medicare Advantage sample (N=343 429 patient-quarter observations) and 0.63 percentage points per quarter (95% CI, 0.52-0.75) in our commercially insured sample (N=44 402 patient-quarter observations). After the PALLAS trial and subsequent United States Food and Drug Administration black box warning, physicians in the Medicare Advantage sample with an above-median number of network connections to other physicians decreased their quarterly usage of dronedarone by 0.12 percentage points more per quarter (95% CI, -0.20 to -0.04; P=0.031) than physicians with equal to or below the median number of network connections. Similar patterns existed in the commercially insured sample (P=0.0318). CONCLUSIONS: After controlling for a wide range of patient, physician, and geographic characteristics, physicians with a greater number of network connections were faster de-adopters of dronedarone for patients with permanent atrial fibrillation after the PALLAS trial and subsequent United States Food and Drug Administration black box warning detailed the harmfulness of dronedarone for these patients. Policies for improving physicians' responsiveness to new medical information should consider utilizing the influence of these important professional network relationships.

Site of care potentially limits cost savings from biosimilars.

OBJECTIVES: The first FDA-approved biosimilar was launched in 2015: filgrastim-sndz (Zarxio), a biosimilar for the reference drug filgrastim (Neupogen). Filgrastim is a granulocyte colony-stimulating factor used to prevent and treat neutropenia. In this study, we examined the association between site of care and drug cost across reference filgrastim, tbo-filgrastim (Granix; a version of filgrastim approved as a biosimilar in Europe and as a new drug in the United States), and biosimilar filgrastim administrations among the commercially insured. STUDY DESIGN: Retrospective study using administrative claims data. METHODS: We used OptumLabs Data Warehouse to identify the site of care of each short-acting filgrastim administration among commercial enrollees between January 1, 2014, and December 31, 2019. RESULTS: For each filgrastim product, model-adjusted median drug costs were higher in the outpatient hospital setting than for the same drug administered in the office setting. Comparing drug costs within the same setting, in the office setting, costs of biosimilar and tbo-filgrastim were $103.61 and $94.07 lower than reference filgrastim, respectively (P < .001 for each comparison). In the outpatient hospital setting, adjusted median costs for tbo-filgrastim were lower than those for reference filgrastim (-$132.90; P < .001), but adjusted median costs of the biosimilar were slightly higher ($20.50; P = .025). CONCLUSIONS: Although previous work has found lower costs for biosimilar filgrastim compared with reference filgrastim, here we found that site of care can change this calculus, reducing savings. After adjusting for patient characteristics and geography, we found that drug cost savings for biosimilar filgrastim were limited to the office setting, with no savings in the outpatient hospital setting.

How do insurance firms respond to financial risk sharing regulations? Evidence from the Affordable Care Act.

Many insurance markets have reinstated premium stabilization programs to ensure financial protection from market volatility. In this paper, we focus on one such regulation-risk corridors (RCs)-in the context of the Health Insurance Marketplaces established under the Affordable Care Act. We develop a model to show how the program provided incentives for some insurers to lower their premiums. The RCs program was defunded unexpectedly for coverage year 2016, before its legislated end in 2016. Consistent with the model, we find that making a RCs claim before the program ended is associated with higher premium growth after the program's demise. The model and empirical evidence are consistent with the view that the end of the RCs program contributed to premium growth in the Marketplaces.

The association of vertically integrated care with health care use and outcomes.

OBJECTIVE: To determine whether vertically integrated hospital and skilled nursing facility (SNF) care is associated with more efficient use of postdischarge care and better outcomes. DATA SOURCES: Medicare provider, beneficiary, and claims data from 2012 to 2014. STUDY DESIGN: We compared facility characteristics, quality of care, and health care use for hospital-based SNFs and "virtually integrated" SNFs (defined as freestanding SNFs with close referral relationships with a single hospital) relative to nonintegrated freestanding SNFs. Among patients admitted to integrated SNFs, we estimated differences in health care use and outcomes for patients originating from the parent hospital (ie, receiving vertically integrated care) versus other hospitals using linear regressions that included SNF fixed effects. We estimated bounds for our main estimates that incorporated potential omitted variables bias. DATA EXTRACTION METHODS: We identified hospital-based SNFs based on provider data. We defined virtually integrated SNFs based on patient flows between hospitals and SNFs. We identified SNF episodes, preceding hospital stays, patient characteristics, health care use, and patient outcomes using Medicare data. PRINCIPAL FINDINGS: Consistent with prior research, integrated SNFs performed better on quality measures and health care use relative to nonintegrated SNFs (eg, hospital-based SNFs had 11-day shorter stays compared with nonintegrated SNFs adjusting for patient characteristics, P < .001). Stroke patients admitted to hospital-based SNFs from the parent hospital had shorter preceding hospital stays (adjusted difference: -1.2 days, P = .001) and shorter initial SNF stays (adjusted difference: -2.7 days, P = .049); estimates were attenuated but still robust accounting for potential omitted variables bias. For stroke patients, associations between vertically integrated care and other outcomes were either statistically insignificant or not robust to accounting for potential omitted variables bias. CONCLUSIONS: Vertically integrated hospital and SNF care was associated with shorter hospital and SNF stays. However, there were few beneficial associations with other outcomes, suggesting limited coordination benefits from vertical integration.

Translational Effect of Provider-Focused, Multi-State, Multi-Clinic Asthma Care Quality Improvement Program on Patient-Level Health Care Costs.

INTRODUCTION/OBJECTIVES: Enhancing Care for Patients with Asthma (ECPA), a year-long provider-focused, multi-state, multi-clinic quality improvement program, decreased avoidable utilizations among patients with asthma, but its effects on health care expenditures were not determined. This study examined the translational and sustainable effects of improved care through ECPA on individual-level total health care costs due to asthma. METHODS: We conducted a retrospective pretest-posttest quasi-experimental study in which attributed 1683 patients in a 12-month pre-ECPA implementation period served as their own control. We constructed the total annual asthma-related health care costs per patient occurred during pre-ECPA implementation, ECPA implementation, and post-ECPA completion. We used 3-level generalized linear mixed models (GLMMs) to estimate the ECPA effect on the annual health care costs and account for correlation between the repeated outcome measures for each patient and nested clinic. All costs were adjusted for inflation to 2014 U.S. dollars, the last year of program observation. RESULTS: Total asthma-related health care costs among the 1683 included patients decreased from an average of $7033 to $3237 per person-year (pre-ECPA implementation vs implementation). Using the cost data from the 12-month pre-ECPA implementation period as a reference, GLMMs found that the ECPA implementation was associated with a reduction in total annual asthma-related health care costs by 56.4% (95% CI -60.7%, -51.8%). During the 12-months after ECPA completion period, health care costs were also found to be significantly lower, experiencing a 57.3% reduction. CONCLUSIONS: The economic benefits of ECPA provide a justification to adopt this quality improvement initiative to more primary care clinics at a national level.

Physician variation in the de-adoption of ineffective statin and fibrate therapy.

OBJECTIVE: To describe physicians' variation in de-adopting concurrent statin and fibrate therapy for type 2 diabetic patients following a reversal in clinical evidence. DATA SOURCES: We analyzed 2007-2015 claims data from OptumLabs® Data Warehouse, a longitudinal, real-world data asset with de-identified administrative claims and electronic health record data. STUDY DESIGN: We modeled fibrate use among Medicare Advantage and commercially insured type 2 diabetic statin users before and after the publication of the ACCORD lipid trial, which found statins and fibrates were no more effective than statins alone in reducing cardiovascular events among type 2 diabetic patients. We modeled fibrate use trends with physician random effects and physician characteristics such as age and specialty. DATA EXTRACTION: We identified patient-year-quarters with one year of continuous insurance enrollment, type 2 diabetes diagnoses, and fibrate use. We designated the physician most responsible for patients' diabetes care based on evaluation and management visits and prescriptions of glucose-lowering drugs. PRINCIPAL FINDINGS: Fibrate use increased by 0.12 percentage points per quarter among commercial patients (95% CI, 0.10 to 0.14) and 0.17 percentage points per quarter among Medicare Advantage patients (95% CI, 0.13 to 0.20) before the trial and then decreased by 0.16 percentage points per quarter among commercial patients (95% CI, -0.18 to -0.15) and 0.05 percentage points per quarter among Medicare Advantage patients (95% CI, -0.06 to -0.03) after the trial. However, 45% of physicians treating commercial patients and 48% of physicians treating Medicare Advantage patients had positive trends in prescribing following the trial. Physicians' characteristics did not explain their variation (pseudo R2  = 0.000). CONCLUSION: On average, physicians decreased fibrate prescribing following the ACCORD lipid trial. However, many physicians increased prescribing following the trial. Observable physician characteristics did not explain variations in prescribing. Future research should examine whether physicians vary similarly in other de-adoption settings.

US Trends in COVID-19-Associated Hospitalization and Mortality Rates Before and After Reopening Economies.

Importance: After abrupt closures of businesses and public gatherings in the US in late spring 2020 due to the COVID-19 pandemic, by mid-May 2020, most states reopened their economies. Owing in part to a lack of earlier data, there was little evidence on whether state reopening policies influenced important pandemic outcomes-COVID-19-related hospitalizations and mortality-to guide future decision-making in the remainder of this and future pandemics. Objective: To investigate changes in COVID-19-related hospitalizations and mortality trends after reopening of US state economies. Design Setting and Participants: Using an interrupted time series approach, this cross-sectional study examined trends in per-capita COVID-19-related hospitalizations and deaths before and after state reopenings between April 16 and July 31, 2020. Daily state-level data from the University of Minnesota COVID-19 Hospitalization Tracking Project on COVID-19-related hospitalizations and deaths across 47 states were used in the analysis. Exposures: Dates that states reopened their economies. Main Outcomes and Measures: State-day observations of COVID-19-related hospitalizations and COVID-19-related new deaths per 100 000 people. Results: The study included 3686 state-day observations of hospitalizations and 3945 state-day observations of deaths. On the day of reopening, the mean number of hospitalizations per 100 000 people was 17.69 (95% CI, 12.54-22.84) and the mean number of daily new deaths per 100 000 people was 0.395 (95% CI, 0.255-0.536). Both outcomes displayed flat trends before reopening, but they started trending upward thereafter. Relative to the hospitalizations trend in the period before state reopenings, the postperiod trend was higher by 1.607 per 100 000 people (95% CI, 0.203-3.011; P = .03). This estimate implied that nationwide reopenings were associated with 5319 additional people hospitalized for COVID-19 each day. The trend in new deaths after reopening was also positive (0.0376 per 100 000 people; 95% CI, 0.0038-0.0715; P = .03), but the change in mortality trend was not significant (0.0443; 95% CI, -0.0048 to 0.0933; P = .08). Conclusions and Relevance: In this cross-sectional study conducted over a 3.5-month period across 47 US states, data on the association of hospitalizations and mortality with state reopening policies may provide input to state projections of the pandemic as policy makers continue to balance public health protections with sustaining economic activity.