Examining Unusual Patterns of Cancer and Environmental Concerns: The Importance of Community Input and Engagement.

CONTEXT: In fiscal year 2019, the Department of Health and Human Services (DHHS) received an appropriation from Congress specifically to update guidelines for investigating community cancer concerns. This resulted in the DHHS directing the Centers for Disease Control and Prevention (CDC) to fulfill this responsibility. PROGRAM: The CDC and the Agency for Toxic Substances and Disease Registry (ATSDR) provide guidance to state, tribal, local, and territorial (STLT) health departments and play important roles in supporting STLT programs in addressing community cancer concerns. IMPLEMENTATION: The updated guidelines offer enhancements addressing limitations and challenges regarding the process for investigating cancer clusters as expressed by STLT programs responsible for responding to inquiries and by communities impacted by unusual patterns of cancer. Additionally, the updated guidelines offer new tools and approaches associated with scientific advancements. Issues associated with improving communications and community engagement were a priority. Details in the updated guidelines provide suggestions for building and maintaining trust; provide resources via additional tools, templates, and methodology to facilitate sharing of information; provide suggestions for identifying agency and community points of contacts; and provide suggestions for establishing a community advisory committee. CONCLUSION: Enhancements to the previous guidelines were included to address advancements in statistical approaches and methods for understanding exposure pathways and also to respond to limitations described in the previous guidelines. Furthermore, these enhancements ensure communities have a voice in the process and offer methods to enhance transparency throughout the investigative process. Ultimately, the 2022 Guidelines are designed to ensure that community engagement, community input, and communication remains paramount to the process of assessing unusual patterns of cancer and environmental concerns.

The Community-Based Health Workforce in Public Health and Health Care Delivery.

CONTEXT: The "community-based workforce" is an umbrella term used by a workgroup of U.S. Department of Health and Human Services (HHS) leaders to characterize a variety of job titles and descriptions for positions in the public health, health care delivery, and human service sectors across local communities. APPROACH: Definitions, expectations of the scope of work, and funding opportunities for this workforce vary. To address some of these challenges, a workgroup of HHS agencies met to define the roles of this workforce and identify existing opportunities for training, career advancement, and compensation. DISCUSSION: The community-based workforce has demonstrated success in improving poor health outcomes and addressing the social determinants of health for decades. However, descriptions of this workforce, expectations of their roles, and funding opportunities vary. The HHS workgroup identified that comprehensive approaches are needed within HHS and via public health sectors to meet these challenges and opportunities. CONCLUSION: Using the common term "community-based workforce" across HHS can encourage alignment and collaboration. As the environment for this public health and health care community-based workforce shifts, it will be important to understand the value and opportunities available to ensure long-term sustainability for this workforce to continue to advance health equity.

The Initial Relationship Between the United States Department of Health and Human Services' Digital COVID-19 Public Education Campaign and Vaccine Uptake: Campaign Effectiveness Evaluation.

BACKGROUND: Over 1 million people in the United States have died of COVID-19. In response to this public health crisis, the US Department of Health and Human Services launched the We Can Do This public education campaign in April 2021 to increase vaccine confidence. The campaign uses a mix of digital, television, print, radio, and out-of-home channels to reach target audiences. However, the impact of this campaign on vaccine uptake has not yet been assessed. OBJECTIVE: We aimed to address this gap by assessing the association between the We Can Do This COVID-19 public education campaign's digital impressions and the likelihood of first-dose COVID-19 vaccination among US adults. METHODS: A nationally representative sample of 3642 adults recruited from a US probability panel was surveyed over 3 waves (wave 1: January to February 2021; wave 2: May to June 2021; and wave 3: September to November 2021) regarding COVID-19 vaccination, vaccine confidence, and sociodemographics. Survey data were merged with weekly paid digital campaign impressions delivered to each respondent's media market (designated market area [DMA]) during that period. The unit of analysis was the survey respondent-broadcast week, with respondents nested by DMA. Data were analyzed using a multilevel logit model with varying intercepts by DMA and time-fixed effects. RESULTS: The We Can Do This digital campaign was successful in encouraging first-dose COVID-19 vaccination. The findings were robust to multiple modeling specifications, with the independent effect of the change in the campaign's digital dose remaining practically unchanged across all models. Increases in DMA-level paid digital campaign impressions in a given week from -30,000 to 30,000 increased the likelihood of first-dose COVID-19 vaccination by 125%. CONCLUSIONS: Results from this study provide initial evidence of the We Can Do This campaign's digital impact on vaccine uptake. The size and length of the Department of Health and Human Services We Can Do This public education campaign make it uniquely situated to examine the impact of a digital campaign on COVID-19 vaccination, which may help inform future vaccine communication efforts and broader public education efforts. These findings suggest that campaign digital dose is positively associated with COVID-19 vaccination uptake among US adults; future research assessing campaign impact on reduced COVID-19-attributed morbidity and mortality and other benefits is recommended. This study indicates that digital channels have played an important role in the COVID-19 pandemic response. Digital outreach may be integral in addressing future pandemics and could even play a role in addressing nonpandemic public health crises.

Regional Differences in the Drugs Most Frequently Involved in Drug Overdose Deaths: United States, 2017.

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.

Narrowing but persisting gender pay gap among employees of the US Department of Health and Human Services during 2010-2018.

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.

A Novel Approach for Workforce Surveillance at the US Department of Health and Human Services.

BACKGROUND: Expert groups have recommended ongoing monitoring of the public health workforce to determine its ability to execute designated objectives. Resource- and time-intensive surveys have been a primary data source to monitor the workforce. We evaluated an administrative data source containing US Department of Health and Human Services (HHS) aggregate federal civil service workforce-related data to determine its potential as a workforce surveillance system for this component of the workforce. METHODS: We accessed FedScope, a publicly available online database containing federal administrative civilian HHS personnel data. Using established guidelines for evaluating surveillance systems and identified workforce characteristics, we evaluated FedScope attributes for workforce surveillance purposes. RESULTS: We determined FedScope to be a simple, highly accepted, flexible, stable, and timely system to support analyses of federal civil service workforce-related data. Data can be easily accessed, analyzed, and monitored for changes across years and draw conclusions about the workforce. FedScope data can be used to calculate demographics (eg, sex, race or ethnicity, age group, and education level), employment characteristics (ie, supervisory status, work schedule, and appointment type), retirement projections, and characterize the federal workforce into standard occupational categories. CONCLUSIONS: This study indicates that an administrative data source containing HHS personnel data can function as a workforce surveillance system valuable to researchers, public health leaders, and decision makers interested in the federal civil service public health workforce. Using administrative data for workforce development is a model that can be applicable to federal and nonfederal public health agencies and ultimately support improvements in public health.

Tracking Substance Use Complications: A Collaborative Analysis of Public Health and Academic Medical Center Records on Drug Use-Associated Infective Endocarditis.

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.

Who's on third? Regulation of third-party genetic interpretation services.

In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services' Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

The Time Is Now to End the HIV Epidemic.

In his State of the Union Address on February 5, 2019, President Donald J. Trump announced his administration's goal to end the domestic HIV epidemic. Following the announcement of the Ending the HIV Epidemic: A Plan for America initiative, the president proposed $291 million in new funding for the fiscal year 2020 Department of Health and Human Services (HHS) budget to implement a new initiative to reduce the number of new HIV infections by 75% in the next five years (2025) and by 90% in the next 10 years (2030). This is in addition to the $20 billion the US government already spends each year, domestically, for HIV prevention and care.With this initiative, HHS recognizes that the time to end the HIV epidemic is now: we have the right data, the right biomedical and behavioral tools, and the right leadership. With the new resources, the goal is achievable.This article outlines how this initiative will be accomplished through the implementation of four fundamental strategies that will be tailored by local communities on the basis of their own needs and strengths.

Designing and Disseminating Metrics to Support Jurisdictional Efforts to End the Public Health Threat Posed by HIV Epidemics.

The US Department of Health and Human Services has launched a large-scale plan that aims to "End the HIV Epidemic" (EtHE) in America, including ambitious goals and targets over the next 5 to 10 years.To be successful, the EtHE Plan will require timely dissemination of relevant metrics to inform the broad array of stakeholders who are in a position to act in support of the plan's goals. Metrics should include both population health outcome metrics and implementation metrics that track the deployment and uptake of specific intervention delivery strategies. In addition to the usual HIV care continuum metrics that include all people living with HIV in the denominator, metrics dedicated to those not yet reached (i.e., as the denominator) are essential to help target EtHE implementation efforts. Special attention is required around metrics and targets that inform and drive action on HIV-related health disparities.Well-chosen metrics and a well-designed dissemination system can serve as important tools to assess the progress of the EtHE Plan, and to identify and disseminate lessons learned quickly within and across jurisdictions aiming to end HIV as a local public health threat.

Perspectives on donor lung allocation from both sides of the Atlantic: The United States.

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 toward 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 1-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.

The Origins and Drafting of the Belmont Report.

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.

What Is Human Research For? Reflections on the Omission of Scientific Integrity from the Belmont Report.

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.

Creating a Robust Digital Communications Strategy for the US Department of Health & Human Services.

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.

The Secretary Shall . . . : Implementing the Affordable Care Act's Private Insurance Expansions.

The federal bureaucracy played a critical role in implementing most aspects of the Affordable Care Act's private insurance coverage expansion. Through brief case studies, the authors review three dimensions of this role: the development of the Center for Consumer Information and Insurance Oversight, rulemaking in the formulation of the essential health benefits package, and the implementation of the federal website. They relate these to themes in the public administration literature. Politics-both through state decisions and through continuing congressional action (and inaction)-pervaded the implementation process. The challenges of staffing and situating the new bureaucracy effectively changed vertical boundaries within the Department of Health and Human Services, with long-lasting consequences. Finally, the complex design of the policy itself made passage of the legislation easier but implementation much more difficult. Ultimately, however, implementation was remarkably successful, achieving improvements in coverage consistent with the Congressional Budget Office's projections.

Mass Air Medical Repatriation of Coronavirus Disease 2019 Patients.

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.

Medicaid Expansion and Work Requirements in Georgia.

Georgia's Section 1115 waiver application, titled "Georgia Pathways to Coverage," seeks to simultaneously expand the state's Medicaid program and condition eligibility on work requirements. Though Section 1115 waivers have become a common vehicle for state Medicaid expansion, the imposition of work requirements is a novel departure. This article explores whether approval of Georgia Pathways to Coverage by the U.S. Department of Health and Human Services can withstand judicial review. Recent precedent, beginning with the seminal Stewart v. Azar case, strongly suggests that a legal challenge would be successful on the merits. The features and justifications of Georgia Pathways to Coverage, examined in light of current data on work requirements in entitlement programs, make it likely that approval of the program would be found arbitrary and capricious under the Administrative Procedure Act. However, unique aspects of Georgia Pathways to Coverage, as compared with similar state waivers, raise significant hurdles related to constitutional standing requirements and the appropriate judicial remedy.