This article addresses two components of the new governing architecture (NGA) that help to reform the delivery of health care and to control costs of the health care system: the Center for Medicare and Medicaid Innovation (CMMI) and the Independent Payment Advisory Board (IPAB). The republican controlled federal government has partially disassembled these two components, threatening the effectiveness of federal delivery system reform and cost control initiatives.

Mortality rates for middle-aged whites in the U.S. are rising due to drugs, alcohol, and depression. Unique to our country, these “deaths of despair” disproportionately occur among the under-educated, who are at particular risk for dying young. At one time, less-educated persons aspired to work in the same factory as their parents, at union wages, with benefits. Those jobs, and the sense of community and prosperity and security they allowed, are evaporating. Many former workers suffer from chronic pain, which underlies America's ongoing opioid overdose epidemic. The pain is not only physical. It is psychic, spiritual, and economic.

The Diagnosis Confirmation Model (DCM) includes a dual-pricing mechanism designed to support value-based pricing of novel antibiotics while improving the alignment of financial incentives with their optimal use in patients at high risk of drug-resistant infections. DCM is a market-based model and complementary to delinked models. Policymakers interested in stimulating antibiotic innovation could consider tailoring the DCM to their reimbursement systems and incorporating it into the suite of incentives to improve the economics of antibiotics.

Neither the range of potential results from genomic research that might be returned to participants nor future uses of stored data and biospecimens can be fully predicted at the outset of a study. Informed consent procedures require clear explanations about how and by whom decisions are made and what principles and criteria apply. To ensure trustworthy research governance, there is also a need for empirical studies incorporating public input to evaluate and strengthen these processes.

Buprenorphine is a form of opioid agonist treatment that has been demonstrated to be an effective medication for opioid addiction. It is available in different formulations and marketed under various trade names, including commonly as a buprenorphine/naloxone combination. This paper provides an overview of existing literature on the supply of buprenorphine treatment, the ability of people to access treatment with buprenorphine, and the quality of treatment received. We argue that better data for each of these aspects of treatment could inform policy to expand effective treatment with buprenorphine, and we suggest steps to obtain and act on such data.

The ability to sustain antibiotic efficacy is directly affected by incentive models aiming to stimulate antibiotic research and development. This paper analyzes the extent to which the models proposed by the Innovative Medicine Initiative-funded research project DRIVE-AB can be expected to support sustainable use, drawing on basic economic theory and the incentives that derive from it. It then discusses the use of minimal safeguards that will be needed to support sustainable use where industry incentives have not been re-aligned with those of public health.

The Patient Protection and Affordable Care Act (ACA), passed in 2010, is considered by many to be the most significant healthcare overhaul since the 1960s, but part of its promise — improvement of population health through requirements for non-profit hospitals to provide “community benefit” — has not been met. This paper examines the history of community benefit legislation, how community benefit dollars are allocated, and innovative practices by a few hospitals and communities that are addressing primarily non-medical factors that influence health such as social disadvantage, attitudes, beliefs, risk exposure, and social inequalities.

This article examines the past, present, and future of individual market policies in the Affordable Care Act (ACA). It does so, first, by reviewing the law's goals, scope, and set of individual market policies, collectively called the Health Insurance Marketplace. The Marketplace, along with the ACA's Medicaid expansion, was designed to fill in gaps to provide all Americans with accessible, affordable coverage. Second, it reviews evidence on the law's impact to date, including changes under a new administration. Third, it discusses the three main policy options for the Marketplace: do nothing, build on it, or replace it. Lastly, it discusses the factors which could determine which pathway policy makers follow.

Expanding buprenorphine access in the United States requires evidence-based decision-making that considers both the drug's potential dangers and its potential benefits. Risks associated with buprenorphine misuse and diversion highlight the need for careful, ongoing evaluation during each stage of increased access.

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research (CSER) Consortium. The authors then negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death.

The Trump Administration has exposed both the durability and vulnerability of the Patient Protection and Affordable Care Act's insurance reforms. One of the Administration's first strikes at “Obamacare” was to discontinue federal government payment of cost-sharing reductions, which insurers pay to low-income enrollees on the exchanges to reduce their out-of-pocket share of medical spending. The states struck back with a clever solution that could hold insurers and enrollees harmless. This article examines this strategy and why, while impressive, it reaffirms larger problems with the ACA's market-based approach to health reform and the need for new pathways forward.

Electronic informed consent represents an opportunity to redesign the way that participants understand and elect to enroll in clinical research studies. However, electronic consent faces certain barriers common to all informed consent processes and other barriers specific to the technical environment. At Sage Bionetworks, we designed an electronic consent process as a software product and released it as an open source tool. We believe that using contemporary design processes to intentionally create cognitive friction, where potential study participants are confronted with interfaces that require them to slow down and contemplate study concepts, offers a significant opportunity for ethical design as research increasingly uses smartphones and digital methodologies.

This article examines how federal law enforcement has responded to the opioid epidemic nationally and in a variety of locales. We focus in depth on two initiatives, including prosecution in opioid-death cases, undertaken by the U.S. Attorney's Office in Connecticut.

This study aimed to identify the antibiotic-relevant lessons from the controlled drug regimen for narcotics. Whereas several elements of the United Nations Single Convention on Narcotic Drugs (1961) could be advantageous for antibiotics, we doubt that an international legally binding agreement for controlling antibiotic consumption would be any more effective than implementing stewardship measures through national AMR plans.

Collecting and deploying poverty-related data is an important starting point for leveraging data regarding social determinants of health in precision medicine. However, we must rethink how we collect and deploy such data. Current modes of collection yield imprecise data that is unsuited for research. Better data can be collected by cross-referencing other sources such as employers and public benefit programs, and by incentivizing and encouraging patients and providers to provide more accurate information. Data thus collected can be used to provide appropriate individual-level clinical and non-clinical care, and to systematically determine what share of social resources healthcare should consume.

The United States relies on uncompensated family caregivers to provide most of the long-term care required by older adults as they age. But such care comes at a significant financial cost to these caregivers in the form of lower lifetime earnings and diminished (or even no) Social Security retirement benefits, ineligibility for Medicare coverage of their healthcare costs, and minimal retirement savings. To reduce the impact of uncompensated caregiving on the intergenerational transmission of poverty, this paper discusses three possible mechanisms of compensating family caregivers: public payments, deemed wage credits under Social Security, and income tax incentives.

Creating a single national health insurance pool is not likely to destabilize the economy by supplanting the private health insurance industry. This industry insures a relatively small percentage of the population and holds very little of the risk such insurance implies. In effect, insurance companies function as middlemen, bundling risk packages to distribute to other, larger companies and so serve a limited purpose. Were insurers to handle claims for a national pool as they do for the Medicare program, any destabilization to the economy more broadly would be further minimized.

This article seeks to document the latest danger in the opioid crisis: fentanyl and related synthetic opioids. Fifty times more potent than pure heroin, cheaper to manufacture in laboratories worldwide, and easily distributed by mail and couriers, fentanyl is flooding the illicit opioid markets throughout the country.

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features (adaptivity, flexibility, monitoring, responsiveness, reflexivity, and inclusiveness) and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless oversight activities by different stakeholders acquire a common substantive orientation.