Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer-Reviewed Literature.

Policy Points The 340B Drug Pricing Program accounts for roughly 1 out of every 100 dollars spent in the $4.3 trillion US health care industry. Decisions affecting the program will have wide-ranging consequences throughout the US safety net. Our scoping review provides a roadmap of the questions being asked about the 340B program and an initial synthesis of the answers. The highest-quality evidence indicates that nonprofit, disproportionate share hospitals may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. CONTEXT: Despite remarkable growth and relevance of the 340B Drug Pricing Program to current health care practice and policy debate, academic literature examining 340B has lagged. The objectives of this scoping review were to summarize i) common research questions published about 340B, ii) what is empirically known about 340B and its implications, and iii) remaining knowledge gaps, all organized in a way that is informative to practitioners, researchers, and decision makers. METHODS: We conducted a scoping review of the peer-reviewed, empirical 340B literature (database inception to March 2023). We categorized studies by suitability of their design for internal validity, type of covered entity studied, and motivation-by-scope category. FINDINGS: The final yield included 44 peer-reviewed, empirical studies published between 2003 and 2023. We identified 15 frequently asked research questions in the literature, across 6 categories of inquiry-motivation (margin or mission) and scope (external, covered entity, and care delivery interface). Literature with greatest internal validity leaned toward evidence of margin-motivated behavior at the external environment and covered entity levels, with inconsistent findings supporting mission-motivated behavior at these levels; this was particularly the case among participating disproportionate share hospitals (DSHs). However, included case studies were unanimous in demonstrating positive effects of the 340B program for carrying out a provider's safety net mission. CONCLUSIONS: In our scoping review of the 340B program, the highest-quality evidence indicates nonprofit, DSHs may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. Future studies should examine heterogeneity by covered entity types (i.e., hospitals vs. public health clinics), characteristics, and time period of 340B enrollment. Our findings provide additional context to current health policy discussion regarding the 340B program.

Health Insurance Coverage and Access to Care by Sexual Orientation During the COVID-19 Pandemic: United States, January 2021-February 2022.

Objectives. To compare health insurance coverage and access to care by sex and sexual minority status during the COVID-19 pandemic and assess whether lack of insurance hindered access to care by sexual minority status. Methods. Using Behavioral Risk Factor Surveillance System data (January 2021-February 2022), we examined differences by sex and sexual orientation among 158 722 adults aged 18 to 64 years living in 34 states. Outcomes were health insurance coverage type and 3 access to care measures. Results. Sexual minority women were significantly more likely to be uninsured than were heterosexual women, and lack of insurance widened the magnitude of disparity by sexual minority status in all measures of access. Compared with heterosexual men with health insurance, sexual minority men with health insurance were significantly more likely to report being unable to afford necessary care. Conclusions. During the pandemic, 1 in 8 sexual minority adults living in 34 study states were uninsured. Among sexual minority women, lack of insurance widened inequities in access to care. There were inequities among sexual minority men with health insurance. Public Health Implications. Sexual minority adults may be disproportionately affected by the unwinding of the COVID-19 public health emergency and may require tailored efforts to mitigate insurance coverage loss. (Am J Public Health. 2024;114(1):118-128. https://doi.org/10.2105/AJPH.2023.307446).

Implementation and sustainability of safe consumption sites: a qualitative systematic review and thematic synthesis.

BACKGROUND: Safe consumption sites (SCSs) serve diverse populations of people who use drugs (PWUD) and public health objectives. SCS implementation began in the 1980s, and today, there are at least 200 known SCSs operating in over twelve countries. While a growing literature supports their effectiveness as a harm reduction strategy, there is limited information on contextual factors that may support or hinder SCS implementation and sustainability. We aimed to fill this gap in knowledge by reviewing existing qualitative studies on SCSs. METHODS: We conducted a systematic review and thematic synthesis of qualitative studies. We identified all peer-reviewed, English-language qualitative studies on SCSs containing original data in PubMed, Web of Science, Google Scholar, and Science Direct as of September 23, 2019. Two authors independently screened, abstracted, and coded content relating to SCS implementation and sustainment aligned with the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation science framework. RESULTS: After removing duplicates, we identified 765 unique records, of which ten qualitative studies met inclusion criteria for our synthesis. Across these ten studies, 236 total interviews were conducted. Overall, studies described how SCSs can (1) keep drug use out of public view while fostering a sense of inclusion for participants, (2) support sustainment by enhancing external communities' acceptability of SCSs, and (3) encourage PWUD utilization. Most studies also described how involving PWUD and peer workers (i.e., those with lived experience) in SCS operation supported implementation and sustainability. DISCUSSION: Our thematic synthesis of qualitative literature identified engagement of PWUD and additional factors that appear to support SCS planning and operations and are critical to implementation success. However, the existing qualitative literature largely lacked perspectives of SCS staff and other community members who might be able to provide additional insight into factors influencing the implementation and sustainability of this promising public health intervention.

Dispensing of HIV and Hepatitis C Antivirals During COVID-19: An Interrupted Time-Series Analysis of U.S. National Data.

INTRODUCTION: Little is known about the potential changes in the dispensation of life-saving hepatitis C virus (HCV) and HIV antivirals after the initial U.S. outbreak of COVID-19. The objective of this study was to describe the immediate and 1-year impacts of the U.S. outbreak of COVID-19 on monthly dispensing of HIV and HCV antivirals, specifically direct-acting antivirals (DAA) to treat HCV, antiretroviral therapy (ART) to treat HIV, and pre-exposure prophylaxis (PrEP) to prevent HIV. METHODS: Authors used interrupted time-series analysis, examining IQVIA National Prescription Audit (includes 92% of U.S. retail pharmacies and 70% of U.S. mail order and long-term care pharmacies) for changes in monthly dispensed prescriptions, 2 years before and 1 year after the initial U.S. COVID-19 outbreak. Fitted linear segmented regression models were used to assess immediate level and slope changes, excluding data from April 2020 as a washout period. Authors stratified analyses by new/refill, age group, payer type, and delivery channel. RESULTS: After the initial outbreak, DAA prescription dispensing declined by almost one third. The COVID-19 outbreak was associated with an immediate-level decrease in total DAA prescriptions, followed by a slope increase in monthly dispensing. However, by April 2021, monthly DAA dispensing had not recovered to prepandemic levels. In contrast, ART and PrEP dispensing changed little over the same time period. CONCLUSIONS: U.S. dispensing of DAAs to treat HCV fell at the start of the U.S. COVID-19 outbreak and has yet to fully recover to prepandemic levels. Addressing barriers to care is crucial to reaching national HIV and hepatitis C elimination goals.

Supervised Injection Facilities as Harm Reduction: A Systematic Review.

CONTEXT: Supervised injection facilities are harm reduction interventions that allow people who inject drugs to use previously obtained substances under the supervision of health professionals. Although currently considered illegal under U.S. federal law, several U.S. cities are considering implementing supervised injection facilities anyway as a response to the escalating overdose crisis. The objective of this review is to determine the effectiveness of supervised injection facilities, compared with that of control conditions, for harm reduction and community outcomes. EVIDENCE ACQUISITION: Studies were identified from 2 sources: a high-quality, broader review examining supervised injection facility-induced benefits and harms (from database inception to January 2014) and an updated search using the same search strategy (January 2014‒September 2019). Systematic review methods developed by the Guide to Community Preventive Services were used (screening and analysis, September 2019‒December 2020). EVIDENCE SYNTHESIS: A total of 22 studies were included in this review: 16 focused on 1 supervised injection facility in Vancouver, Canada. Quantitative synthesis was not conducted given inconsistent outcome measurement across the studies. Supervised injection facilities in the included studies (n=number of studies per outcome category) were mostly associated with significant reductions in opioid overdose morbidity and mortality (n=5), significant improvements in injection behaviors and harm reduction (n=7), significant improvements in access to addiction treatment programs (n=7), and no increase or reductions in crime and public nuisance (n=7). CONCLUSIONS: For people who inject drugs, supervised injection facilities may reduce the risk of overdose morbidity and mortality and improve access to care while not increasing crime or public nuisance to the surrounding community.

County-level data on U.S. opioid distributions, demographics, healthcare supply, and healthcare access.

The dataset summarized in this article is a combination of several of U.S. federal data resources for the years 2006-2013, containing county-level variables for opioid pill volumes, demographics (e.g. age, race, ethnicity, income), insurance coverage, healthcare demand (e.g. inpatient and outpatient service utilization), healthcare infrastructure (e.g. number of hospital beds or hospices), and the supply of various types of healthcare providers (e.g. medical doctors, specialists, dentists, or nurse practitioners). We also include indicators for states which permitted opioid prescribing by nurse practitioners. This dataset was originally created to assist researchers in identifying which factors predict per capita opioid pill volume (PCPV) in a county, whether early state Medicaid expansions increased PCPV, and PCPV's association with opioid-related mortality. Missing data were imputed using regression analysis and hot deck imputation. Non-imputed values are also reported. Taken together, our data provide a new level of precision that may be leveraged by scholars, policymakers, or data journalists who are interested in studying the opioid epidemic. Researchers may use this dataset to identify patterns in opioid distribution over time and characteristics of counties or states which were disproportionately impacted by the epidemic. These data may also be joined with other sources to facilitate studies on the relationships between opioid pill volume and a wide variety of health, economic, and social outcomes.

Implications of county-level variation in U.S. opioid distribution.

BACKGROUND: Prescription opioids accounted for the majority of opioid-related deaths in the United States prior to 2010, and continue to contribute to opioid misuse and mortality. We used a novel dataset to investigate the distributional patterns of prescription opioids, whether opioid pill volume was associated with opioid-related mortality, and whether early state Medicaid expansions were associated with either pill volume or opioid-related mortality. METHODS: Data on opioid shipments to retail pharmacies for 2006-2013 were obtained from the U.S. Drug Enforcement Administration, and opioid-related deaths (ORDs) were obtained from the Centers for Disease Control and Prevention. We first compared characteristics of counties in the highest and lowest quartiles for per capita pill volume (PCPV). We used adjusted difference-in-differences regression models to identify factors associated with PCPV or ORDs, and whether early state Medicaid expansions were associated with either outcome. All models were estimated as linear regressions with standard errors clustered by county, and weighted by county population. RESULTS: We found large geographic variations in opioid distribution, and this variation appears to be driven by differences in demographics, healthcare access, and healthcare supply. In adjusted models, a one-pill increase in PCPV was associated with a 0.20 increase in ORDs per 100,000 population (95 % CI 0.11-0.30). Early Medicaid expansions were associated with lower PCPV (-2.20, 95 % CI -2.97 to -1.43). CONCLUSIONS: Our findings validate the relationship between PCPV and ORDs, identify important environmental drivers of the opioid epidemic, and suggest early state Medicaid expansions were beneficial in reducing opioid pill volume.

Association of Medicaid Expansion With 5-Year Changes in Hypertension and Diabetes Outcomes at Federally Qualified Health Centers.

Importance: State decisions to expand Medicaid eligibility were particularly consequential for federally qualified health centers (FQHCs), which serve 30 million low-income patients across the US. The longer-term association of Medicaid expansion with health outcomes at FQHCs is unknown. Objective: To assess the 5-year association of Medicaid expansion with uninsurance rates and hypertension and diabetes outcome measures by race and ethnicity in a nationally representative population of FQHCs. Design Setting and Participants: Using a difference-in-differences analysis of a retrospective cohort from the universe of US FQHCs, changes in uninsurance rates and intermediate health outcomes for hypertension and diabetes by race and ethnicity were compared between Medicaid expansion and nonexpansion states before (2012-2013) vs after (2014-2018) expansion. Data were analyzed from September 2020 to March 2021. Exposures: Location in a state that expanded Medicaid eligibility as of 2014. Main Outcomes and Measures: Rates of uninsurance, the proportion of patients with hypertension with a blood pressure less than 140/90 mm Hg, and the proportion of patients with diabetes with glycosylated hemoglobin levels of 9% or less, as stratified by race and ethnicity. Results: Of the patients at 578 expansion-state FQHCs (serving 13.0 million patients per year) and 368 nonexpansion-state FQHCs (serving 6.0 million patients per year) in our study sample, 64.4% were age 18 to 64 years, 57.4% were women, 18.9% were non-Hispanic Black, and 27.3% were Hispanic. Following expansion, FQHCs in Medicaid expansion states experienced a 9.24 percentage point (PP) (95% CI, 7.94-10.54) decline in rates of uninsurance over the pooled 5-year expansion period compared with nonexpansion-state FQHCs. Across this 5-year period, expansion was associated with a 1.61-PP (95% CI, 0.58-2.64) comparative improvement in hypertension control and a 1.84-PP (95% CI, 0.71-2.98) comparative improvement in glucose control. Stratified results suggest that improvements were consistently observed in Black and Hispanic populations. The magnitude of change tended to increase with implementation time. For instance, by year 5, expansion was associated with a 3.38-PP (95% CI, 0.80-5.96) comparative improvement in hypertension control and a 3.88-PP (95% CI, 0.86-6.90) comparative improvement in glucose control among Black populations. Conclusions and Relevance: In this nationally representative cohort study, Medicaid expansion was associated with sustained increases in insurance coverage and improvements in chronic disease outcome measures at FQHCs after 5 years overall and among Black and Hispanic populations. States considering Medicaid expansion may benefit from improved longer-run health measures for underserved patients with chronic conditions.

Team-Based Care to Improve Diabetes Management: A Community Guide Meta-analysis.

CONTEXT: Team-based care has been increasingly used to deliver care for patients with chronic conditions, but its effectiveness for managing diabetes has not been systematically assessed. EVIDENCE ACQUISITION: RCTs were identified from two sources: a high-quality, broader review comparing 11 quality improvement strategies for diabetes management (database inception to July 2010), and an updated search using the same search strategy (July 2010-October 2015). EVIDENCE SYNTHESIS: Thirty-five studies were included in the current review; a majority focused on patients with Type 2 diabetes. Teams included patients, their primary care providers, and one or two additional healthcare professionals (most often nurses or pharmacists). Random effect meta-analysis showed that, compared with controls, team-based care was associated with greater reductions in blood glucose levels (-0.5% in HbA1c, 95% CI= -0.7, -0.3) and greater improvements in blood pressure and lipid levels. Interventions also increased the proportion of patients who reached target blood glucose, blood pressure, and lipid levels, based on American Diabetes Association guidelines available at the time. Data analysis was completed in 2016. CONCLUSIONS: For patients with Type 2 diabetes, team-based care improves blood glucose, blood pressure, and lipid levels.