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Understanding and Mitigating Health Inequities Eliminating racial health inequities requires a movement away from disparities as the focus of research and toward a research agenda centered on achie...

As cultural and linguistic diversity increases in the U.S., as it has for the past century, so does recognition by the health and social service fields of the urgency to respond appropriately to th...

The US Department of Health and Human Services (HHS) has developed and is implementing an agency-wide Digital Communications Strategy. A robust strategy to coordinate digital communications is vital at times of crisis, such as the COVID-19 pandemic - and will be needed as part of an effective HHS campaign to motivate individuals who are hesitant to accept coronavirus vaccines. Using science-based principles of systems change, a four-phase approach was developed in alignment with the 21st Century Integrated Digital Experience Act (IDEA). Phase I involved announcing a plan for creating and implementing the HHS Digital Communications Strategy, including support for it from the HHS Secretary. Phase II involved gathering information and stakeholder support, with an interview research study as the central component for providing input and encouraging stakeholder engagement. Phase III focused on building the Strategy through an iterative process. Phase IV, which is ongoing, concentrates on implementing the Strategy, measuring the impact of digital communications and supporting the budget required to modernize Federal digital communications approaches to meet the American public's needs. Learnings from the work so far are consistent with those from prior HHS systems change efforts in communications - and are helping to improve the Strategy in real time.

Background The US faces remarkable food and nutrition challenges. A new federal effort to strengthen and coordinate nutrition research could rapidly generate the evidence base needed to address these multiple national challenges. However, the relevant characteristics of such an effort have been uncertain. Objectives Our aim was to provide an objective, informative summary of 1) the mounting diet-related health burdens facing our nation and corresponding economic, health equity, national security, and sustainability implications; 2) the current federal nutrition research landscape and existing mechanisms for its coordination; 3) the opportunities for and potential impact of new fundamental, clinical, public health, food and agricultural, and translational scientific discoveries; and 4) the various options for further strengthening and coordinating federal nutrition research, including corresponding advantages, disadvantages, and potential executive and legislative considerations. Methods We reviewed government and other published documents on federal nutrition research; held various discussions with expert groups, advocacy organizations, and scientific societies; and held in-person or phone meetings with >50 federal staff in executive and legislative roles, as well as with a variety of other stakeholders in academic, industry, and nongovernment organizations. Results Stark national nutrition challenges were identified. More Americans are sick than are healthy, largely from rising diet-related illnesses. These conditions create tremendous strains on productivity, health care costs, health disparities, government budgets, US economic competitiveness, and military readiness. The coronavirus disease 2019 (COVID-19) outbreak has further laid bare these strains, including food insecurity, major diet-related comorbidities for poor outcomes from COVID-19 such as diabetes, hypertension, and obesity, and insufficient surveillance on and coordination of our food system. More than 10 federal departments and agencies currently invest in critical nutrition research, yet with relatively flat investments over several decades. Coordination also remains suboptimal, documented by multiple governmental reports over 50 years. Greater harmonization and expansion of federal investment in nutrition science, not a silo-ing or rearrangement of existing investments, has tremendous potential to generate new discoveries to improve and sustain the health of all Americans. Two identified key strategies to achieve this were as follows: 1) a new authority for robust cross-governmental coordination of nutrition research and other nutrition-related policy and 2) strengthened authority, investment, and coordination for nutrition research within the NIH. These strategies were found to be complementary, together catalyzing important new science, partnerships, coordination, and returns on investment. Additional complementary actions to accelerate federal nutrition research were identified at the USDA. Conclusions The need and opportunities for strengthened federal nutrition research are clear, with specific identified options to help create the new leadership, strategic planning, coordination, and investment the nation requires to address the multiple nutrition-related challenges and grasp the opportunities before us.

Introduction The new initiative by the Department of Health and Human Services (DHHS) aims to decrease new HIV infections in the U.S. by 75% within 5 years and 90% within 10 years. Our objective was to evaluate whether the U.S. military provides a good example of the benefits of such policies. Materials and methods We conducted an analysis of a cohort of 1,405 active duty military personnel with HIV enrolled in the Natural History Study who were diagnosed between 2003 and 2015 at six U.S. military medical centers. The study was approved by institutional review boards at the Uniformed Services University of the Health Sciences and each of the sites. We evaluated the impact of Department of Defense (DoD) HIV care policies, including screening, linkage to care, treatment eligibility, and combined antiretroviral therapy (cART) initiation on achieving viral suppression (VS) within 3 years of diagnosis. As a secondary outcome, we evaluated the DoD’s achievement of UNAIDS 90-90-90 targets. Results Nearly all (99%) were linked to care within 60 days. Among patients diagnosed in 2003–2009, 77.5% (95% confidence intervals (CI) 73.9–80.6%) became eligible for cART within 3 years of diagnosis, 70.6% (95% CI 66.6–74.1%) overall initiated cART, and 64.2% (95% CI 60.1–68.0%) overall achieved VS. Among patients diagnosed in 2010–2015, 98.7% (95% CI 96.7–99.5%) became eligible for cART within 3 years of diagnosis, 98.5% (95% CI 96.4–99.4%) overall initiated cART, and 89.8% (95% CI 86.0–92.5%) overall achieved VS. Conclusions U.S. military HIV policies have been highly successful in achieving VS goals, exceeding the UNAIDS 90-90-90 targets. In spite of limitations, including generalizability, this example demonstrates the feasibility of the DHHS initiative to decrease new infections through testing, early treatment, and retention in care.

To protect both patients and staff, healthcare personnel (HCP) were among the first groups in the United States recommended to receive the COVID-19 vaccine. We analyzed data reported to the U.S. Department of Health and Human Services (HHS) Unified Hospital Data Surveillance System on COVID-19 vaccination coverage among hospital-based HCP. After vaccine introduction in December 2020, COVID-19 vaccine coverage rose steadily through April 2021, but the rate of uptake has since slowed; as of September 15, 2021, among 3,357,348 HCP in 2,086 hospitals included in this analysis, 70.0% were fully vaccinated. Additional efforts are needed to improve COVID-19 vaccine coverage among HCP.

HIPAA at 25 — A Work in Progress HIPAA is best viewed as a framework of evolving regulation that’s revised periodically in response to demands of biomedical innovation and public health in the digi...

Venous thromboembolism (VTE) is an important cause of morbidity and mortality in the United States (US). The increasing rates of VTE in the US resulted in the surgeon general issuing a call to action to reduce VTE in 2008. The objective of our study was to analyze the national trends of inpatient VTE in the US from 2004 to 2013 (5 years before and after 2008). We used the dataset National Inpatient Sample, Healthcare Cost and Utilization Project and measured trends of inpatient VTE by annual % change using joinpoint regression software. From 2004 to 2013 the National Inpatient Sample contained data on 78 million hospitalizations (weighted n = 385 million). In these 1.6 million had a diagnosis of VTE (2.0%, weighted n = 7.7 million) including 1.2 million with deep venous thrombosis (DVT) (1.53%, weighted n = 5.9 million) and 588,878 with pulmonary embolism (PE) (0.74%, weighted n = 2.8 million). Joinpoint regression analysis showed that rates of DVT and PE are increasing consistently from 2004 to 2013(1.27% to 1.80% for DVT and 0.52% to 0.92% for PE). The increasing rates of DVT and PE were consistent in all subgroups except few exceptions. In conclusion inpatient VTE rates continue to rise even after 5 years from the surgeon general's a call to action except in certain high-risk patients. Further research is needed to curb the VTE in patients especially among those perceived to be at lower risk of VTE.

The institutional review board (IRB) is a group federally mandated to review and monitor research involving humans to ensure protection of their rights and welfare as research participants. Clinicians engaged in research require IRB approval for all research involving human participants, whether living individuals, data, or specimens. The process for obtaining IRB approval may seem like a daunting task. However, it is critical for clinical researchers to conduct research in a manner that protects human participants, and it is the mission of the IRB to help researchers accomplish this task. The purpose of this article is to review the role and purpose of the IRB, highlight federal and regulatory standards in human research participants protection, and help clinical researchers have a broader understanding of IRB functions that will help them conduct high-quality research with human participants.

We reviewed the public comments submitted in response to the Department of Health and Human Services’ (DHHS’s) original and revised proposal for mandated single-IRB review of federally funded multisite research to see who responded to the proposed mandate and to determine what they said and how the agency addressed the public comments in its revised proposal. Our analysis indicates that support for the single-IRB mandate was limited. The most common argument against the proposed mandate came from those concerned with the loss of site-specific institutional review board (IRB) review of the protocol for a multisite study to address issues relevant to local context. Concerns were also raised that the single-IRB approach would replace one inefficient system (that entails, for example, multiple reviews of a single study) with another potentially inefficient system (involving the negotiation and management of multiple interinstitutional agreements). Empirical research about the implementation of DHHS’s final rule—and the separate rule of the National Institutes of Health—mandating single-IRB review is needed to determine whether the single-IRB model achieves the stated goals.

Objective To assess the validity of the US Department of Health and Human Services (DHHS) definition of multimorbidity using International Classification of Diseases, ninth edition (ICD-9) codes from administrative data. Design Cross-sectional comparison of two ICD-9 billing code algorithms to data abstracted from medical records. Setting Olmsted County, Minnesota, USA. Participants An age-stratified and sex-stratified random sample of 1509 persons ages 40–84 years old residing in Olmsted County on 31 December 2010. Study measures Seventeen chronic conditions identified by the US DHHS as important in studies of multimorbidity were identified through medical record review of each participant between 2006 and 2010. ICD-9 administrative billing codes corresponding to the 17 conditions were extracted using the Rochester Epidemiology Project records-linkage system. Persons were classified as having each condition using two algorithms: at least one code or at least two codes separated by more than 30 days. We compared the ICD-9 code algorithms with the diagnoses obtained through medical record review to identify persons with multimorbidity (defined as ≥2, ≥3 or ≥4 chronic conditions). Results Use of a single code to define each of the 17 chronic conditions resulted in sensitivity and positive predictive values (PPV) ≥70%, and in specificity and negative predictive values (NPV) ≥70% for identifying multimorbidity in the overall study population. PPV and sensitivity were highest in persons 65–84 years of age, whereas NPV and specificity were highest in persons 40–64 years. The results varied by condition, and by age and sex. The use of at least two codes reduced sensitivity, but increased specificity. Conclusions The use of a single code to identify each of the 17 chronic conditions may be a simple and valid method to identify persons who meet the DHHS definition of multimorbidity in populations with similar demographic, socioeconomic, and health care characteristics.

Criticism of the Centers for Disease Control and Prevention (CDC) and its efforts to put forth recommendations and data based on core public health practice and principles is contrary to the realities of the work that the CDC has done on preparedness in past decades In 2001, the CDC funded a project intended to facilitate the development of an integrated national system of Academic Centers for Public Health Preparedness (CPHPs) to train frontline public health professionals who respond to bioterrorist incidents and other emerging infectious diseases Nineteen CPHPs were funded until the program was discontinued in August 2010 and replaced by 14 Preparedness and Emergency Response Learning Centers, whose funding ended in 2018 2 CPHPs worked to identify core principles for public health preparedness and response, strategies for local and state data collection, and curricula and best practices for educating the public health and first responder workforce

Background The gender pay gap in the United States (US) has narrowed over the last several decades, with the female/male earnings ratio in the US increased from about 60% before the 1980s to about 79% by 2014. However, the gender pay gap among the healthcare workforce persists. The objective of this study is to estimate the gender pay gap in the US federal governmental public health workforce during 2010–2018. Methods We used an administrative dataset including annual pay rates and job characteristics of employees of the US Department of Health and Human Services. Employees’ gender was classified based on first names. Regression analyses were used to estimate the gender pay gap using the predicted gender. Results Female employees of the DHHS earned about 13% less than men in 2010, and 9.2% less in 2018. Occupation, pay plan, and location explained more than half of the gender pay gap. Controlling for job grade further reduces the gap. The unexplained portion of the gender pay gap in 2018 was between 1.0 and 3.5%. Female employees had a slight advantage in terms of pay increase over the study period. Conclusions While the gender pay gap has narrowed within the last two decades, the pay gap between female and male employees in the federal governmental public health workforce persists and warrants continuing attention and research. Continued efforts should be implemented to reduce the gender pay gap among the health workforce.

This article describes the origins and drafting of the Belmont Report by members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The Belmont Report has provided a useful and virtually universal framework for protecting human subjects from research abuses. However, it provides little to no guidance on the substance of human research. In an environment where major decisions concerning health-care access, funding, and regulation hinge on human research, this omission leaves downstream users of human research virtually unprotected and with few tools or frameworks to protect against a variety of practices that compromise the social value of human research. This essay advocates for the addition of a fourth principle to the Belmont three: "scientific integrity." Such a principle would seek to train human research on important social objectives while maximizing the accessibility, credibility, and generalizability of findings.

Essential but Undefined Safety-net hospitals provide essential care to patients regardless of their insurance coverage, financial circumstances, or immigration status, and they often operate with t...

A new federal agency—approved last month by the United States Congress—is already off to a rocky start. The Advanced Research Projects Agency for Health (ARPA-H), proposed by President Biden in 2021, aims to tackle the most intractable biomedical problems by funding innovative, high-risk, high-reward research and swiftly turning discoveries into treatments and cures. But Congress gave the agency a much smaller budget than sought by the administration—$ 1 billion over 3 years, a fraction of the $6.5 billion requested. And as happens whenever there is new money and a new federal agency, a political scrum has erupted over who should control ARPA-H. It is now expected to answer to both the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS). If it is to deliver on its mission, ARPA-H needs to be an autonomous entity that approaches biomedical research in a way never done before by the federal government. The stakes are high: If ARPA-H fails to produce new clinical advances relatively quickly, it will erode trust in US science. It’s time for clear thinking and action about what it will take to make ARPA-H successful.

Bridging the Gap at Warp Speed In addition to its goal of delivering safe and effective vaccines quickly, Operation Warp Speed aims to combat Covid-19 by improving the use of existing therapies and...

Policy Lessons from Our Covid Experience As the U.S. economy reopens, it’s important to assess how we can be better prepared to stave off such enormous economic losses during the next Covid-19 wave...

The American response to the pandemic involves a prominent volume of federal resources, especially for developing and acquiring products for internal use, such as diagnostics or vaccines. Investment mechanisms and historical aspects justify this expenditure. Thus, the social construction of nationalism in American society hinders access to health technologies. The review of such aspects shows how the United States (U.S.) secured a large number of potential products, ensuring excessive local production. This unilateral foreign policy has influenced other countries or regional blocs and undermined global cooperation and solidarity, affecting the collective health of several nations.A resposta americana à pandemia envolve um proeminente volume de recursos federais, em especial destinados ao desenvolvimento e aquisição de produtos no uso interno, como diagnósticos ou vacinas. As justificativas para esse desembolso se baseiam em mecanismos de investimentos e aspectos históricos. Assim, a construção social do nacionalismo na formação na sociedade americana prejudica o acesso a tecnologias em saúde. A revisão desses aspectos demonstra como os Estados Unidos (EUA) garantiram compra de grande quantitativo de produtos em potencial, inclusive assegurando excessiva produção local. Essa política externa unilateral tem influenciado outros países ou blocos regionais e prejudicado a cooperação e a solidariedade global com impacto na saúde coletiva de diversas nações.

Medicaid is uniquely equipped to serve low-income populations. We identify four features that form the “soul” of Medicaid, explain how the administration is testing them, and explore challenges in accountability contributing to this struggle. We highlight the work of watchdogs acting to protect Medicaid and conclude with considerations for future health reform.

Background Healthcare systems and public health agencies use different methods to measure the impact of substance use (SU) on population health. We studied the ability of systems to accurately capture data on drug use-associated infective endocarditis (DUA-IE). Methods We conducted a retrospective analysis of patients with IE discharge diagnosis from an academic medical center, 2011–2017, comparing data from hospital Electronic Health Record (EHR) to State Uniform Hospital Discharge Data Set (UHDDS). To identify SU we developed a composite measure. Results EHR identified 472 IE discharges (430 of these were captured in UHDDS); 406 (86.0%) were correctly coded based on chart review. IE discharges increased from 57 to 92 (62%) from 2012 to 2017. Hospitalizations for the subset of DUA-IE identified by any measure of SU increased from 10 to 54 (440%). Discharge diagnosis coding identified 128 (60.7%) of total DUA-IE hospitalizations. The composite measure identified an additional 65 (30.8%) DUA-IE hospitalizations and chart review an additional 18 (8.5%). Conclusions The failure of discharge diagnosis coding to identify DUA-IE in 40% of hospitalizations demonstrates the need for better systems to capture the impact of SU. Collaborative data sharing could help improve surveillance responsiveness to address an emerging public health crises.

A foreshadowing of changes for other populations and nursing specialties?

Objective-This report describes regional differences in the specific drugs most frequently involved in drug overdose deaths in the United States in 2017. Methods-Data from the 2017 National Vital Statistics System-Mortality files were linked to electronic files containing literal text information from death certificates. Drug overdose deaths were identified using International Classification of Diseases, 10th Revision underlying cause-of-death codes X40-X44, X60-X64, X85, and Y10-Y14. Drug mentions were identified using established methods for searching the literal text from death certificates. Deaths were assigned to 1 of 10 U.S. Department of Health and Human Services (HHS) regions based on the decedent's state of residence. The number and age-adjusted death rate was determined for the 10 drugs most frequently involved in drug overdose deaths in 2017, both nationally and for each HHS region. Deaths involving more than one drug were counted in all relevant drug categories (i.e., the same death could be counted in more than one drug category). Results-Among drug overdose deaths in 2017 that mentioned at least 1 specific drug on the death certificate, the 10 drugs most frequently involved included fentanyl, heroin, cocaine, methamphetamine, alprazolam, oxycodone, morphine, methadone, hydrocodone, and diphenhydramine. Regionally, 6 drugs (alprazolam, cocaine, fentanyl, heroin, methadone, and oxycodone) were found among the 10 most frequently involved drugs in all 10 HHS regions, although the relative ranking varied by region. Age-adjusted rates of drug overdose deaths involving fentanyl or deaths involving cocaine were higher in the regions east of the Mississippi River, while age-adjusted rates for drug overdose deaths involving methamphetamine were higher in the West. The regional patterns observed did not change after adjustment for differences in the specificity of drug reporting. Conclusions-The drugs most frequently involved in drug overdose deaths in 2017 varied by HHS region. Understanding the regional differences can help inform local prevention and policy efforts.

Public health needs up-to-date information for surveillance and response. As healthcare application programming interfaces become widely available, a novel data gathering mechanism could provide public health with critical information in a timely fashion to respond to a fast-moving epidemic. In this article, we extrapolate from our experiences using a Fast Healthcare Interoperability Resource-based architecture for infectious disease surveillance for sexually transmitted diseases to its application to gather case information for an outbreak. One of the challenges with a fast-moving outbreak is to accurately assess its demand on healthcare resources, since information specific to comorbidities is often not available. These comorbidities are often associated with poor prognosis and higher resource utilization. If the comorbidity data and other clinical information were readily available to public health workers, they could better address community disruption and manage healthcare resources. The use of FHIR resources available through application programming and filtered through tools such as described herein will give public health the flexibility needed to investigate rapidly emerging disease while protecting patient privacy.

Donor lung allocation in the United States focuses on decreasing waitlist mortality and improving recipient outcomes. The implementation of allocation policy to match deceased donor lungs to waitlisted patients occurs through a unique partnership between government and private organizations, namely the Organ Procurement and Transplantation Network under the Department of Health and Human Services and the United Network for Organ Sharing. In 2005, the donor lung allocation algorithm shifted towards the prioritization of medical urgency of waitlisted patients instead of time accrued on the waitlist. This led to the Lung Allocation Score, which weighs over a dozen clinical variables to predict a one-year estimate of survival benefit, and is used to prioritize waitlisted patients. In 2017 the use of local allocation boundaries was eliminated in favor of a 250 nautical mile radius from the donor hospital as the first unit of distance used in allocation. The next upcoming iteration of donor allocation policy is expected to use a continuous distribution algorithm where all geographic boundaries are eliminated. There are additional opportunities to improve donor lung allocation, such as for patients with high antibody titers with access to a limited number of donors..

Recent coronavirus disease 2019 (COVID-19) events have presented challenges to health care systems worldwide. Air medical movement of individuals with potential infectious disease poses unique challenges and threats to crews and receiving personnel. The US Department of Health and Human Services air medical evacuation teams of the National Disaster Medical System directly supported 39 flights, moving over 2,000 individuals. Infection control precautions focused on source and engineering controls, personal protective equipment, safe work practices to limit contamination, and containment of the area of potential contamination. Source control to limit transmission distance was used by requiring all passengers to wear masks (surgical masks for persons under investigation and N95 for known positives). Engineering controls used plastic sheeting to segregate and treat patients who developed symptoms while airborne. Crews used Tyvek (Dupont Richmond, VA) suits with booties and a hood, a double layer of gloves, and either a powered air-purifying respirator or an N95 mask with a face shield. For those outside the 6-ft range, an N95 mask and gloves were worn. Safe work practices were used, which included mandatory aircraft surface decontamination, airflow exchanges, and designated lavatories. Although most patients transported were stable, to the best of our knowledge, this represents the largest repatriation of potentially contagious patients in history without infection of any transporting US Department of Health and Human Services air medical evacuation crews.

Current treatments for patients with HIV are not only effective at controlling viral replication but are also associated with a more favorable adverse reaction profile, may often be taken once daily, and are increasingly available in combination single-tablet regimens. This article provides an overview and prescribing considerations for several primary drugs currently recommended by the US Department of Health and Human Services.