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An IOM committee focused on biomarkers for molecularly targeted therapies has issued recommendations about regulatory, reimbursement, and clinical practice issues, in order to guide precision medicine in advancing the care of patients with cancer and other diseases.

Evidence suggests that in-utero exposure to environmental chemicals, such as persistent organic pollutants (POPs), heavy metals, and radionuclides, that might bioaccumulate in the mother may increase a newborn's risk of adverse developmental, neurological, and immunologic effects. Chemical contamination of bodies of water and strong ocean currents worldwide can drive these chemicals from lower latitudes to Arctic waters where they accumulate in common traditional subsistence foods. In response to concerns of the people from Alaska of the effects of bio-accumulated chemicals on their children, the Maternal Organics Monitoring Study(MOMS) was developed. The objective of the study was to assess the risks and benefits associated with the population's subsistence diet. Data analysis of biological samples at the CDC's NCEH laboratory and maternal questionnaires is ongoing. Results will be provided to Alaska Native communities to help support public health actions and inform future interventions and research.

On January 19, 2017, the Federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the Common Rule) published a final rule amending the Common Rule. The Consumer Product Safety Commission (CPSC or Commission) adopts the Common Rule.

An editorial is presented which addresses the reasons why the author is opposed to the removal of sexual orientation questions from the U.S. National Survey of Older American Act Participants as of 2017, and it mentions health disparities and the ability to discern the health care needs of all Americans. The U.S. Administration for Community Living is examined, along with the American Department of Health and Human Services' (HHS) LGBT Issues Coordinating Council.

Mea culpa. In 1981 the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, of which I was the Executive Director, recommended to the President and Congress that all federal departments and agencies that conduct or support human subjects research adopt "as a common core" the HHS regulations, "while permitting additions needed by any department or agency that are not inconsistent with these core provisions." The commission believed-rightly, I still think-that having uniformity would ease administration, reduce regulatory burdens, simplify oversight, and make research more efficient. Yet our naïve expectation the task could be accomplished in 180 days meant that we failed to anticipate that if it took much longer-namely, the 10 years that passed before the Common Rule was issued-federal officials would thereafter be reluctant to change the regulations and that when they tried to do so twenty years later, with the issuance of the ANPRM in 2011, they would propose comprehensive revisions. I argue that was the wrong conclusion to draw from the difficulties in issuing the first Common Rule, and that the process of producing the new "final rule" on January 19, 2017-during which many of the proposed changes were either dumped or promulgated without being adequately vetted-reinforces the conclusion that a more incremental process, with ongoing involvement of the public through an advisory body like the President's Commission, would be a much better way to proceed.

An editorial is presented which addresses LGBT people-related data collection in America in relation to social and demographic changes involving the nation's LGBT community as of 2017. Sexual orientation and gender identity measurements in the U.S. are addressed, along with the American Department of Health and Human Services' National Health Interview Survey and the U.S. Department of Justice's National Crime and Victimization Survey. Homelessness among LGBT youth is assessed

U.S. executive-branch appointees Valerie Huber, Teresa Manning, Charmaine Yoest, and Katy Talento embrace false claims about contraception, abortion, sex education, and pregnancy. Such “alternative science” leads to bad policy.

As the GOP worked to pass ACA repeal legislation, HHS finalized a market stabilization rule, and the debate over cost-sharing reduction payments continued.

Background Immune reconstitution inflammatory syndrome (IRIS) can manifest with initiation or reintroduction of antiretroviral therapy (ART) in persons living with HIV (PLWH). In 2012, updated United States treatment guidelines recommended initiation of ART for all PLWH regardless of CD4 count. The objectives of this study were to quantify hospital usage attributable to IRIS and assess the reasons for hospitalization in PLWH before and after the guideline update. Methods Subjects were PLWH between 18–89 years of age who were hospitalized between November 1, 2009 and July 31, 2014. Equivalent time periods before and after updated treatment guidelines were considered, and designated as Time Period 1 and Time Period 2, respectively. IRIS-attributable hospitalizations were identified by ICD9 codes and electronic medical record searches with subsequent review and confirmation. For hospitalizations that were not confirmed as being IRIS-attributable, primary discharge diagnoses were reviewed. Results A total of 278 PLWH were hospitalized 521 times throughout the study period. Time Period 1 had 9 PLWH with 12 IRIS-attributable hospitalizations while Time Period 2 had 6 PLWH with 9 IRIS-attributable hospitalizations. A larger proportion of IRIS-attributable hospital days was observed in Time Period 1 compared to Time Period 2 (7.5 vs 4.2%; p

Partnership for Patients (PfP) was a national initiative sponsored by the Department of Health and Human Services, Centers for Medicare and Medicaid Services, to reduce preventable hospital acquired conditions (HACs) by 40% and readmissions (within 30 days) by 20%, by the end of 2013 (as compared to the baseline of CY2010). Along with partners across the nation, the Assistant Secretary of Defense for Health Affairs, Dr. Jonathan Woodson, pledged to support PfP in June 2011. Participation of the Military Health System (MHS) in PfP marked the implementation of the first enterprise-wide patient safety initiative.Three phases of the MHS initiative were developed to meet the aims of the national PfP initiative: (1) Planning and Design, (2) Implementation, and (3) Monitoring and Sustainment. The Planning and Design phase focused on the identification of evidence-based practices (Table III); the development of implementation guides; the implementation of various communication, education, and improvement strategies; and the development of methods by which to track progress and share successes. The implementation phase focused on identifying roles and responsibilities across all levels of care; creating, disseminating, and implementing evidence-based practices at participating military treatment facilities; and establishing a structured learning action network. Finally, during the monitoring and sustainment phase, per the guidance of the Agency for Healthcare Research and Quality, an overall HAC rate was developed for quarterly analysis. The HAC rate per 1,000 dispositions (i.e., discharges) was an aggregate of all PfP HACs. Using the HAC rate, the improvement rate was calculated by comparing the current quarter's HAC rate to the baseline (CY2010). This allowed the MHS to track the overall progress across the enterprise.The MHS achieved a number of accomplishments, including a 15.8% cumulative reduction in HACs by the end of 2013, an 11.1% reduction in readmissions, avoided nearly 500 harm events since PfP implementation, and approximately $13.5 million in cost avoidance (on the basis of national cost estimate data available at the beginning of the PfP initiative).The two most critical lessons learned for the MHS during the PfP initiative are (1) continuous leadership engagement and inspection is vital to ensure field workers are engaged with safety and quality expectations and (2) applying a "one-size-fits-all" approach to improve a large delivery system is not effective. In addition, it is most impactful when local military treatment facility-level teams are involved in determining strategies to implement evidence-based standard processes and protocols that reduce variation when integrating practice change into daily operations. The MHS will continue to integrate PfP efforts into improvement activities by leveraging lessons learned from this initiative and determining how they can be applied to other areas of care and/or patient safety and quality initiatives. The Patient Safety Improvement Collaborative has committed to oversee and support the establishment and implementation of ongoing, focused patient safety and quality initiatives across the MHS using a collaborative vision to engage all levels of leadership and staff, and to ensure sustained improvements.

The U.S. Department of Health and Human Services has revised the Common Rule governing the protection of patients who donate biospecimens for research. The final rule eliminates a controversial proposal that would have required researchers to obtain renewed consent for use of donated samples beyond their original purpose.

This article provides a brief overview of Federal guidelines developed by the Centers for Disease Control and Prevention and the United States Office of Population Affairs on how to deliver quality family planning services. This article describes how the recommendations were developed, summarizes key points, and outlines steps that will be taken to disseminate and increase the use of the recommendations by primary care providers.

Starting in 2014, the Affordable Care Act (ACA) will require private insurance plans sold in the individual and small-group markets to cover a roster of “essential health benefits.” Precisely which benefits should count as essential, however, was left to the discretion of the Department of Health and Human Services (HHS). The matter was both important and controversial. Nonetheless, HHS announced its policy by posting on the Internet a thirteen-page bulletin stating that it would allow each state to define essential benefits for itself. On both substance and procedure, the move was surprising. The state-by-state approach departed from the uniform, federal standard that the ACA appears to anticipate and that informed observers expected HHS to adopt. And announcing the policy through an Internet bulletin appeared to allow HHS to sidestep traditional administrative procedures, including notice and comment, immediate review in the courts, and White House oversight. This article explores two questions. First, is the state-by-state approach a lawful exercise of HHS's authority? Second, did HHS in fact evade the procedural obligations that are meant to shape the exercise of its discretion?

The USDA's Nutrition Evidence Library (NEL) specializes in conducting food- and nutrition-related systematic reviews that are used to inform federal government decision making. To ensure the utility of NEL systematic reviews, the most relevant topics must be addressed, questions must be clearly focused and appropriate in scope, and review frameworks must reflect the state of the science. Identifying the optimal topics and questions requires input from a variety of stakeholders, including scientists with technical expertise, as well as government policy and program leaders. The objective of this article is to describe the rationale and NEL methodology for identifying topics and developing systematic review questions implemented as part of the "Evaluating the evidence base to support the inclusion of infants and children from birth to 24 months of age in the Dietary Guidelines for Americans--the B-24 Project." This is the first phase of a larger project designed to develop dietary guidance for the birth to 24-mo population in the United States.

Background Healthcare-associated infections (HAIs) have long been the subject of research and prevention practice. When findings show potential to significantly impact outcomes, clinicians, policymakers, safety experts, and stakeholders seek to bridge the gap between research and practice by identifying mechanisms and assigning responsibility for translating research to practice. Objectives This paper describes progress and challenges in HAI research and prevention practices, as explained through an examination of Health and Human Services (HHS) Action Plan's goals, inputs, and implementation in each area. Research design We used the Context-Input-Process-Product evaluation model, together with an HAI prevention system framework, to assess the transformative processes associated with HAI research and adoption of prevention practices. Results Since the introduction of the Action Plan, HHS has made substantial progress in prioritizing research projects, translating findings from those projects into practice, and designing and implementing research projects in multisite practice settings. Research has emphasized the basic science and epidemiology of HAIs, the identification of gaps in research, and implementation science. The basic, epidemiological, and implementation science communities have joined forces to better define mechanisms and responsibilities for translating HAI research into practice. Challenges include the ongoing need for better evidence about intervention effectiveness, the growing implementation burden on healthcare providers and organizations, and challenges implementing certain practices. Conclusions Although these HAI research and prevention practice activities are complex spanning multiple system functions and properties, HHS is making progress so that the right methods for addressing complex HAI problems at the interface of patient safety and clinical practice can emerge.

BACKGROUND In response to the growing concern about healthcare-associated infections (HAIs), US Department of Health and Human Services (HHS) developed the National Action Plan to Prevent Healthcare-associated Infections. A key focus of the Action Plan is the setting of HAI metrics and targets and the enhancement and development of data systems to support HAI surveillance. OBJECTIVES To identify and assess the strengths and weaknesses of HHS data systems available for surveillance of catheter-associated urinary tract infections, surgical site infections, and Clostridium difficile infections. To present national data from each of the data systems and assess concordance in trends over time. RESEARCH DESIGN Literature review on data system characteristics and HAI measurement. Graphical and descriptive analyses of longitudinal HAI rates from HHS data systems. MEASURES HAI rate information expressed as prevalence rates or standardized infection ratios. RESULTS We identified four HHS data systems--Medicare claims data, Healthcare Cost and Utilization Project, Medicare Patient Safety Monitoring System, and National Healthcare Safety Network--capable of surveillance of at least one of the HAIs under study. Surgical site infection and Clostridium difficile infection rates display concordance in trends, although there is no evidence of concordance in catheter-associated urinary tract infections rates. We have identified a number of desirable HAI data system characteristics: clinically valid; provide information on a broad range of HAIs; have large sample size to support statistical inference; be representative of the United States; and display consistency in cohort, surveillance protocols, and data collection methodology. CONCLUSIONS Although the data systems included in this study vary along the desirable data system dimensions we identified, trends in HAI rates are generally concordant across the data systems. This increases confidence in observed trends.

BACKGROUND The development of the Health and Human Services (HHS) Action Plan to eliminate healthcare-associated infections (HAIs) and the coordinated efforts of the federal and private sectors to address this patient safety problem present an unprecedented effort to "bend the cost curve" of delivering care through improving quality. Key to this strategy was a multipronged approach at the federal, state, and regional levels. OBJECTIVES To examine the impact of HHS's Regional Office projects in support of the implementation of the National Action Plan to Eliminate HAIs and to clarify the role played by HHS regions in the multipronged federal effort to combat HAIs. RESEARCH DESIGN Qualitative; 13 individual semistructured interviews with representatives from 9 regions. Eight interviews were conducted initially and follow-up interviews were conducted 1-year later with original participants. MEASURES Evaluated results against the modified Context-Input-Process-Product system functions and properties used to evaluate the HAI National Action Plan, including: HAI data and monitoring, knowledge development, infrastructure development, HAI prevention and practice adoption, prioritization, coordination and alignment, accountability and incentives, stakeholder engagement, and resources. RESULTS Results from the interviews were systematically coded against a framework that documents specific system and properties that characterize the roadmap laid out by the Action Plan. This review assesses progress toward Action Plan goals achieved by these OASH-funded regional projects and finds that these regional activities furthered the National Action Plan goals by addressing the key regional needs. CONCLUSIONS Key to the success of the National Action Plan was the multilevel approach to implementation of initiatives at the federal, regional, and state levels.

The US Secretary of Health and Human Services provides guidance to state newborn screening programs about which conditions should be included in screening (i.e., the “Recommended Uniform Screening Panel”). This guidance is informed by evidence-based recommendations from the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. This report describes the Advisory Committee’s revised decision-making process for considering conditions nominated to the panel. An expert panel meeting was held in April 2012 to revise the decision matrix, which helps to guide the recommendation process. In January 2013, the Advisory Committee voted to adopt the revised decision matrix. The revised decision matrix clarifies the approach to rating magnitude and certainty of the net benefit of screening to the population of screened newborns for nominated conditions, and now includes the consideration of the capability of state newborn screening programs for population-wide implementation by evaluating the feasibility and readiness of states to adopt screening for nominated conditions. The revised decision matrix will bring increased quality, transparency, and consistency to the process of modifying the recommended uniform screening panel and will now allow formal evaluation of the challenges that state newborn screening programs face in adopting screening for new conditions. Genet Med 16 2, 183–187.

Beginning in 2014, individuals and small businesses are able to purchase private health insurance through competitive Marketplaces. The Affordable Care Act (ACA) provides for a program of risk adjustment in the individual and small group markets in 2014 as Marketplaces are implemented and new market reforms take effect. The purpose of risk adjustment is to lessen or eliminate the influence of risk selection on the premiums that plans charge. The risk adjustment methodology includes the risk adjustment model and the risk transfer formula. This article is the second of three in this issue of the Review that describe the Department of Health and Human Services (HHS) risk adjustment methodology and focuses on the risk adjustment model. In our first companion article, we discuss the key issues and choices in developing the methodology. In this article, we present the risk adjustment model, which is named the HHS-Hierarchical Condition Categories (HHS-HCC) risk adjustment model. We first summarize the HHS-HCC diagnostic classification, which is the key element of the risk adjustment model. Then the data and methods, results, and evaluation of the risk adjustment model are presented. Fifteen separate models are developed. For each age group (adult, child, and infant), a model is developed for each cost sharing level (platinum, gold, silver, and bronze metal levels, as well as catastrophic plans). Evaluation of the risk adjustment models shows good predictive accuracy, both for individuals and for groups. Lastly, this article provides examples of how the model output is used to calculate risk scores, which are an input into the risk transfer formula. Our third companion paper describes the risk transfer formula.

The HHS and NIH have adopted new policies aimed at clarifying and expanding the reporting requirements for clinical trials and more quickly disseminating data to researchers and the public. Among the changes: requiring registration of trials that test experimental and early-stage therapies, and posting results for trials of unapproved drugs. The policies take effect January 18, 2017.

The steady decline in smoking rates among U.S. adults that began in the early 1960s has accelerated substantially during the Obama presidency — most likely owing to the implementation of an array of tobacco-control interventions.

If you blinked you may have missed it. The Department of Health and Human Services published its strategic plan for the 2018-2022 fiscal years, which includes the statement that HHS accomplishes its mission through programs and initiatives that serve and protect "Americans at every stage of life, from conception." Of note, the "from conception" language is new and, depending on the direction President Trump's administration plans to go, could have profound implications for the regulation of reproductive services ranging from abortion to in vitro fertilization (IVF).

On May 2, 2019, the US Department of Health and Human Services (HHS) and Office of Civil Rights (OCR) released a final rule that heightens the rights of hospitals and health workers to refuse to participate in patients’ medical care based on religious or moral grounds. The rule covers OCR’s authority to investigate and enforce violations of 25 federal “conscience protection” laws. Tied to the US Constitution’s spending power, the rule applies to state and local governments, as well as public and private health care professionals and entities if they receive federal funds such as Medicare or Medicaid. The rule applies to a range of important health services such as abortions, sterilizations, assisted suicide, and advance directives — extending to sex reassignment and HIV treatment.

On June 10, 2013, an eight-year debate over access to emergency contraceptives abruptly ended when the U.S. Attorney for the Eastern District of New York served notice that the federal government would withdraw its appeal and comply with the federal district court’s order to allow Plan B One-Step® to be sold over-the-counter without age or point-of-sale restrictions. In this Commentary, we review the litigation and regulatory history of this controversy. Using the Plan B One-Step® controversy as a backdrop, we trace threads of political influence in past FDA actions, and reflect on the position of the FDA as an executive agency caught between politics and science.

In January 2015 the current Secretary of the Department of Health and Human Services (HHS) outlined a bold initiative to shape the delivery of healthcare through a set of strategies aimed at improving the quality of care and reducing the growth of healthcare costs. The strategies include increasing payment incentives tied to higher value care, increasing care coordination and integration, and increasing access to information to guide patients and clinicians. Significantly, the proposal includes specific goals for alternative payment models and value-based payments for the first time in the history of the Medicare program.

In 2001, the Quality Initiative from the Department of Health and Human Services resulted in the development of a set of core measures focused on five patient populations. Although not part of the original list of providers able to document core measures involving medications, pharmacists were added to the list in November 2007. Within the set of core measures, there are 22 of 44 (50%) that are medication related. The authors’ purpose is to describe the role of a pharmacist in meeting core measurements and provide an example of how a pharmacist is utilized at our institution.

Infection with the hepatitis B virus (HBV) is a significant public health concern in the US, disproportionately affecting Americans of Asian, Native Hawaiian and Pacific Islander descent, despite the availability of a simple blood test, approved treatments, and an effective vaccine. Hep B United, a national campaign to support and leverage the success of community-based HBV coalitions, convened a partner summit in 2012 to develop a strategic response to the HHS Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis. The resulting community action plan focuses on advancing three areas of the HHS plan: educating providers and communities to reduce health disparities; improving testing and linkage to care to prevent HBV-related liver disease and cancer; and eliminating perinatal HBV transmission.

In 2001, 14 national standards on Culturally and Linguistically Appropriate Services (CLAS) in health care were issued by the US Department of Health and Human Services Office of Minority Health to guide outcomes specific to disparities affecting patients with limited English proficiency. Additionally, demographic changes are rapidly occurring throughout the United States leading to more culturally and racially diverse communities, which have increased language barriers in the health care environment. This nonrandomized, cross-sectional study assessed changes and attitudes and applications of CLAS in an academic health care setting over a 5-year period (2006 to 2011). Results indicated that, in 2006, 72.6% participants reported they were "not at all familiar with CLAS" in comparison with 28.8% in 2011. In 2006, 16.5% participants strongly agreed to the question, "I know how to work with medical interpreters" compared with 24.9% in 2011. The same trend is seen with the question, "I use medical interpreters when I have a Spanish-speaking patient," in 2006, 25.5% strongly agreed in comparison with 35.4% in 2011. This study suggests that significant improvements occurred in the use of medical interpreters and understanding of CLAS as a result of educational activities implemented from 2006 to 2011.