Among Medicare beneficiaries, Affordable Care Act coverage expansions reduced utilization of ambulatory care, particularly among duals.

We leveraged local area variation in the size of the Affordable Care Act (ACA) expansions of Medicaid and nongroup coverage and measured changes in Medicare utilization and spending from 2010 through 2018 using the universe of Medicare fee-for-service claims. We found that the ACA coverage expansions led to decreases in the share of Medicare beneficiaries receiving ambulatory care and decreases in spending per beneficiary on ambulatory care. The reductions in ambulatory care were larger among beneficiaries enrolled in both Medicare and Medicaid ("duals").

A holistic view of innovation incentives and pharmaceutical policy reform.

The Inflation Reduction Act is set to transform how Medicare pays for prescription drugs, most notably by enabling Medicare to negotiate for the prices of certain high-cost medications. The pharmaceutical industry argues it will drastically reduce innovation, but a full analysis of its impacts on innovation requires considering not merely the number of new drugs produced but their clinical value. Several features of the negotiation process aim to minimize its impacts on innovation, particularly for drugs with high clinical value.

Opportunity for Reduction of Intensive Care Unit Resource Utilization in Pediatric Blunt Liver and Spleen Injuries: A National Trauma Data Bank Analysis.

Introduction: Guidelines for blunt liver and spleen injury (BLSI) by the Arizona-Texas-Oklahoma-Memphis-Arkansas Consortium (ATOMAC) emphasize hemodynamic stability over injury grade when considering non-operative management (NOM). In this study, we examined rates of intensive care unit (ICU) admission for children with isolated low-risk BLSI among US hospitals.

Methods: The National Trauma Data Bank (NTDB) was queried for patients ages 1-15 admitted between 2017 and 2019 with BLSI.

Metal Ion-Induced Large Fragment Deactivation: A Different Strategy for Site-Selectivity in a Complex Molecule.

Complex natural product functionalizations generally involve the use of highly engineered reagents, catalysts, or enzymes to react exclusively at a desired site through lowering of a select transition state energy. In this communication, we report a new, complementary strategy in which all transition states representing undesirable sites in a complex ionophore substrate are simultaneously energetically increased through the chelation of a metal ion to the large fragment we wish to neutralize. In the case of an electrophilic, radical based fluorination reaction, charge repulsion (electric field effects), induced steric effects, and electron withdrawal provide the necessary deactivation and proof of principle to afford a highly desirable natural product derivative.

Spending on and Use of Clinician-Administered Drugs in Medicare.

Importance: Medicare Part B drug expenditures have increased in recent years. This trend is likely to persist given the increased use and availability of biologics.

Objectives: To assess the extent to which Medicare Part B spending growth was associated with changes in price vs quantity, and how these trends interacted with entry of new drugs into the marketplace.

Mathematical Aspects of a New Synergy Theory Applicable to Malstressor-Dominated Mixtures which Include Damage-Ameliorating Countermeasures.

In radiobiology, and throughout translational biology, synergy theories for multi-component agent mixtures use 1-agent dose-effect relations (DERs) to calculate baseline neither synergy nor antagonism mixture DERs. The most used synergy theory, simple effect additivity, is not self-consistent when curvilinear 1-agent DERs are involved, and many alternatives have been suggested. In this paper we present the mathematical aspects of a new alternative, generalized Loewe additivity (GLA).

Extending the US Food and Drug Administration's Postmarket Authorities.

Importance: The US Food and Drug Administration (FDA) has expansive regulatory flexibility regarding the quality and quantity of evidence it deems sufficient to approve new drugs, which has been increasingly used to grant approval based on less certain evidence of benefit. However, the FDA's regulatory flexibility with respect to standards for approval has not been matched by sufficient stringency in its exercise of postmarket safeguards, including the FDA's authority and willingness to require confirmation of benefit through postmarket efficacy studies or to withdraw approval when benefit is not confirmed.

Objective: To identify and evaluate opportunities for the FDA to extend its authority to require postmarket efficacy studies and use expedited withdrawal procedures for drugs approved despite substantial residual uncertainty outside the accelerated approval pathway.

Reforming Reimbursement for the US Food and Drug Administration's Accelerated Approval Program to Support State Medicaid Programs.

Importance: The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA's oversight of the program but also for its implications for payers.

Observations: State Medicaid programs' legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry's changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA's accelerated approval pathway and product regulation without taking into account the implications of this pathway for state Medicaid programs.

Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval.

Importance: State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs.

Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits.

Many state Medicaid officials are concerned about rising prescription drug spending, particularly drugs approved through the Food and Drug Administration's (FDA) accelerated approval pathway. The authors examined how much of Medicaid programs' accelerated approval spending is attributable to products that have demonstrated clinical benefits versus those that have not. Their findings provide support for states' concerns that pharmaceutical companies often fail to complete their required postapproval confirmatory studies within the FDA's requested timeline.

Quantitative modeling of carcinogenesis induced by single beams or mixtures of space radiations using targeted and non-targeted effects.

Ionizing radiations encountered by astronauts on deep space missions produce biological damage by two main mechanisms: (1) Targeted effects (TE) due to direct traversals of cells by ionizing tracks. (2) Non-targeted effects (NTE) caused by release of signals from directly hit cells. The combination of these mechanisms generates non-linear dose response shapes, which need to be modeled quantitatively to predict health risks from space exploration.

Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure.

This cross-sectional study examines changes in hydroxyprogesterone caproate fills from 2010 through 2020.

The evolving role of advanced practice providers in transplantation: a literature review.

Purpose Of Review: Solid organ transplantation is a life-saving procedure, often performed in critically ill patients, and advanced practice providers (APPs) have increasingly been incorporated into the multidisciplinary transplant team. A literature review was performed and reinforces the value of transplant APPs, details their evolving roles and responsibilities, and highlights innovative solutions created to address complex problems.

Recent Findings: The literature review revealed a deficit of quality quantitative data supporting the utilization of APPs in transplantation.