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PURPOSE To increase awareness, outline strategies, and offer clinical guidance on navigating the complexities of treatment planning amid antineoplastic drug shortages. METHODS A multidisciplinary panel of oncologists, ethicists, and patient advocates was assembled to provide rapid clinical guidance to help providers navigate appropriate patient care in cases where rationing or alternative therapies must be considered. The groups of content experts developed general principles for resource allocation during shortages and clinical guidance on alternative therapies for specific disease sites. The recommendations are supported by evidence when available. RESULTS A total of 44 volunteers with content expertise formed the Advisory Group that developed general guidance on the prioritization of antineoplastic agents in limited supply. Disease site–specific clinical guidance was then produced by subgroups on the basis of members’ specialties and expertise. The majority of alternative treatment options were developed in consideration of cisplatin and carboplatin shortages. All guidance is posted on ASCO’s website. RECOMMENDATIONS The prioritization of antineoplastic agents in limited supply should be based on specific goals of the therapy where evidence-based medicine has shown survival outcome and life-extending benefit in both early and advanced stages. Recommendations for specific disease sites are presented. While management options vary according to the disease site, alternatives are presented. For settings in which there are no alternatives with comparable efficacy and safety, it is recommended that patients are referred to an area where the necessary drug is available or can be obtained [ABSTRACT FROM AUTHOR]

Pharmacogenomics is a pillar of personalized medicine that has the potential to deliver optimized treatment in many medical settings. Military medicine in the deployed setting is unique and therefore warrants separate assessment pertaining to its potential capabilities and impact. Pharmacogenomics for United States Active Duty Service Members medical care in the deployed setting has not, to our knowledge, been previously reviewed. We present potential applications of pharmacogenomics to forward medical care through two comprehensive references for deployed medical care, the Tactical Combat Casualty Care Guidelines (TCCC) and Emergency War Surgery (EWS) fifth edition. All drugs within the deployment manuals, TCCC guidelines and EWS book, were identified and the list was cross-referenced to the Clinical Pharmacogenetics Implementation Consortium guidelines and genes-drugs interactions list as well as the Food and Drug Administration Table of Pharmacogenomics Biomarkers in Drug Labeling. Ten pharmacologic categories were identified, consisting of 15 drugs, along with the classes, aminogylcosides, beta-blockers, and volatile anesthetics. Drugs and pharmacogenomics liabilities were tabulated. Eight specific drugs or classes are expounded upon given the belief of the authors of their potential for impacting future treatment on the battlefield in the setting of prolonged field care. This review outlines several genes with liabilities in the prolonged field care setting and areas that may produce improved care with further study. [ABSTRACT FROM AUTHOR]

The article presents information on the increase in lung cancer in the U.S. A focus is on the reviewing the benefits and harms of screening in lung cancer which uses low-dose computed tomography (LDCT). The self-funded study was conducted by multisociety initiatives which included American Cancer Society, American Society of Clinical Oncology and American College of Chest Physicians. The result of the study showed that LDCT is beneficial for patients at increased risk of lung cancer. The issues related to radiation exposure are also discussed. INSET: Box. Role of Computed Tomography Screening for Lung Cancer....

Why is it so politically difficult to obtain government investment in public health initiatives that are aimed at addressing chronic disease? This article examines the structural disadvantage faced by those who advocate for public health policies and practices to reduce chronic disease related to people's unhealthy lifestyles and physical environments. It identifies common features that make it difficult to establish and maintain initiatives to prevent or reduce costly illness and physical suffering: (1) public health benefits are generally dispersed and delayed; (2) benefactors of public health are generally unknown and taken for granted; (3) the costs of many public health initiatives are concentrated and generate opposition from those who would pay them; and (4) public health often clashes with moral values or social norms. The article concludes by discussing the importance of a new paradigm, "health in all policies," that targets the enormous health and economic burdens associated with chronic conditions and asserts a need for new policies, practices, and participation beyond the confines of traditional public health agencies and services. [ABSTRACT FROM AUTHOR]

In this article, the author discusses how the Patient Protection and Affordable Care Act (ACA) is an important step towards achieving the goals of population health in the U.S. The author says that ACA is a halfway technology for population health improvement which focuses on alleviating problematic symptoms instead of the root causes of poor health. It also promises development of an equitable and modestly efficient set of health insurance arrangements for Americans if it is successfully implemented.

Integrated networks of doctors, patients, and hospitals are a major piece of cancer governance. They enable stakeholders to pool information and resources and achieve systematic learning. Two groups, the Children's Oncology Group in the United States and the Europe Against Cancer initiative, are examples of network governance. Both demonstrate learning processes, production and dissemination of new data, financial support, and engagement of all stakeholders. Why have these integrated networks been successful while so many others have failed? Because both are embedded within regulatory frameworks that ensure that the networks work properly. Integrated networks are vulnerable when the frameworks fail to provide the necessary resources, accountability, fairness, and participation. [ABSTRACT FROM AUTHOR]

The article offers information on Axel, a lightweight vehicle that can be used in planetary terrains due to its wheel design and tether. The Axel rover, which is a collaboration between the U.S. Jet Propulsion Laboratory (JPL) and the California Institute of Technology (CAltech) in Pasadena, is composed of two wheels, caster arm and tether. Moreover, the vehicle is tested at Mars Science Laboratory and is expected to be used for exploration missions in Mars and on natural satellites.

Discusses key issues concerning policy entrepreneurship aspects of the social transformation of medicine in the U.S. as cited in the book, "The Social Transformation of American Medicine," by Paul Starr. Rise of health maintenance organizations and managed competition; Primary threads of the corporate transformation of medicine; Implications on health politics, policy and law.

Over the past decade, state officials have pursued a variety of strategies to protect and expand health insurance coverage for their residents. This article examines the course of action in Maryland, where new initiatives were shaped around the state's unique hospital payment system and its reimbursement of uncompensated care, an evolving Medicaid and children's health program, and regulation of the small group health insurance market. Several important patterns emerge from the Maryland experience. First, even the most incremental initiatives—programs intended to aid a few thousand beneficiaries—bring into play the very issues that hamper comprehensive reforms: who is deserving of mutual aid and what is the proper role of government versus private entities in administering that aid. In Maryland, these issues generate conflict not only between Democrats and Republicans but also urban and rural interests. Second, all of the important reforms of the past decade were undertaken primarily in reaction to federal policy initiatives. Contrary to rhetoric lauding states as the ‘laboratories of democracy,’ the political impetus for reform and basic policy options emerge from interaction between federal and state debates. Third, even with budget surpluses and Democrats in control of the governorship and legislature, Maryland did not move aggressively toward universal health insurance. Now, with a much weaker economy and a new, Republican governor, the primary challenge will be to prevent further erosion of insurance coverage. The Maryland experience reiterates that each step toward greater health security, no matter how small, is a major technical and political challenge and that it will be difficult if not impossible to rely on states to secure coverage for all Americans in the foreseeable future. [ABSTRACT FROM AUTHOR]

Explores the alternative strategies for achieving universal insurance coverage and examines previous federal and state initiatives concerning the health care system of the U.S. Reason for the inability of the U.S. to achieve universal health insurance coverage; Role of state governments in the federalist strategy toward universal coverage; Advantages and limitations of the pincer strategy towards universal coverage which emphasizes the expansion of the Medicaid and State Children's Health Insurance Program.

Presents a framework for evaluating the State Children's Health Insurance Program (SCHIP) in the United States. Measures and data sources for reviewing program information in SCHIP applications; Characteristics of objectives and measures proposals; Tendency towards stressing program enrollment and access to services; Lack of emphasis on type and quality of service.

Comments on incremental reform efforts in individual health insurance in the United States. Market ideology of health policy; Importance of existing market conditions and customs affecting the insurers; Case study on market reform efforts in several states; Purpose of launching the state reforms; Role of policy makers in health insurance.

Abstract Primary care has not secured a firm place within the US health services system. Since primary care lacks a strong research base, is not institutionalized in medical education or in policy-making and is marginalized in both proposed and actual reforms, it has not developed into a central component of the health care infrastructure. We discuss recent efforts that promised modest improvements, including the Clinton health care reform proposals and subsequent federal and state actions, in the role of primary care within the health services system. We also assess the likely fate of primary care given the accelerated growth of managed care and market competition, the dissatisfaction of large segments of the population with managed care and misperceptions of managed care as synonymous with primary care. We highlight how managed care fails to achieve the cardinal functions of primary care and summarize initiatives that, at a minimum, would be required to secure a stronger position for primary care in the future. [ABSTRACT FROM AUTHOR]

Focuses on health care reforms designed to make private health insurance accessible and affordable for workers in small companies in the United States. Background on the failure of US President Bill Clinton's 1990s health care reform initiative; Enhancement of access to health insurance; Community rating of insurance premiums; Health plan purchasing cooperatives.

Explores the possibilities of health care reform in states and communities in the United States. Assessment of the overall pattern of innovation in the health care sector; Illustration of different strategies that leaders in these states used to carry out the entrepreneurial tasks of identifying a market opportunity; Examination of the factors which create receptive markets for comprehensive health care reforms.

Presents a study concerning the relevance of accounting curricula to the expectations of employers from an accounting graduate. Categories of desired attributes; Methods use in the survey; Why the revision of accounting curriculum is not enough for today's job market.

Examines the Medicaid managed care program in Maryland, with focus on the economic and political issues which affect these programs. Importance of public policy innovation; Details on the three different systems of managed care for the Medicaid population; Indepth look a the policy-making process towards the implementation of these plans; Impact of this policy process on the design and performance of Medicaid managed care.

Pharmacogenomics is a pillar of personalized medicine that has the potential to deliver optimized treatment in many medical settings. Military medicine in the deployed setting is unique and therefore warrants separate assessment pertaining to its potential capabilities and impact. Pharmacogenomics for United States Active Duty Service Members medical care in the deployed setting has not, to our knowledge, been previously reviewed. We present potential applications of pharmacogenomics to forward medical care through two comprehensive references for deployed medical care, the Tactical Combat Casualty Care Guidelines (TCCC) and Emergency War Surgery (EWS) fifth edition. All drugs within the deployment manuals, TCCC guidelines and EWS book, were identified and the list was cross-referenced to the Clinical Pharmacogenetics Implementation Consortium guidelines and genes-drugs interactions list as well as the Food and Drug Administration Table of Pharmacogenomics Biomarkers in Drug Labeling. Ten pharmacologic categories were identified, consisting of 15 drugs, along with the classes, aminogylcosides, beta-blockers, and volatile anesthetics. Drugs and pharmacogenomics liabilities were tabulated. Eight specific drugs or classes are expounded upon given the belief of the authors of their potential for impacting future treatment on the battlefield in the setting of prolonged field care. This review outlines several genes with liabilities in the prolonged field care setting and areas that may produce improved care with further study., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2021. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Opioids are a critical component of pain relief strategies for the management of patients with cancer and sickle cell disease. The escalation of opioid addiction and overdose in the United States has led to increased scrutiny of opioid prescribing practices. Multiple reports have revealed that regulatory and coverage policies, intended to curb inappropriate opioid use, have created significant barriers for many patients. The Centers for Disease Control and Prevention, National Comprehensive Cancer Network, and ASCO each publish clinical practice guidelines for the management of chronic pain. A recent JAMA Oncology article highlighted perceived variability in recommendations among these guidelines. In response, leadership from guideline organizations, government representatives, and authors of the original article met to discuss challenges and solutions. The meeting featured remarks by the Commissioner of Food and Drugs, presentations on each clinical practice guideline, an overview of the pain management needs of patients with sickle cell disease, an overview of perceived differences among guidelines, and a discussion of differences and commonalities among the guidelines. The meeting revealed that although each guideline varies in the intended patient population, target audience, and methodology, there is no disagreement among recommendations when applied to the appropriate patient and clinical situation. It was determined that clarification and education are needed regarding the intent, patient population, and scope of each clinical practice guideline, rather than harmonization of guideline recommendations. Clinical practice guidelines can serve as a resource for policymakers and payers to inform policy and coverage determinations.

Background: Plasmodium vivax malaria requires a 2-week course of primaquine (PQ) for radical cure. Evidence suggests that the hepatic isoenzyme cytochrome P450 2D6 (CYP2D6) is the key enzyme required to convert PQ into its active metabolite., Methods: CYP2D6 genotypes and phenotypes of 550 service personnel were determined, and the pharmacokinetics (PK) of a 30-mg oral dose of PQ was measured in 45 volunteers. Blood and urine samples were collected, with PQ and metabolites were measured using ultraperformance liquid chromatography with mass spectrometry., Results: Seventy-six CYP2D6 genotypes were characterized for 530 service personnel. Of the 515 personnel for whom a single phenotype was predicted, 58% had a normal metabolizer (NM) phenotype, 35% had an intermediate metabolizer (IM) phenotype, 5% had a poor metabolizer (PM) phenotype, and 2% had an ultrametabolizer phenotype. The median PQ area under the concentration time curve from 0 to ∞ was lower for the NM phenotype as compared to the IM or PM phenotypes. The novel 5,6-ortho-quinone was detected in urine but not plasma from all personnel with the NM phenotype., Conclusion: The plasma PK profile suggests PQ metabolism is decreased in personnel with the IM or PM phenotypes as compared to those with the NM phenotype. The finding of 5,6-ortho-quinone, the stable surrogate for the unstable 5-hydroxyprimaquine metabolite, almost exclusively in personnel with the NM phenotype, compared with sporadic or no production in those with the IM or PM phenotypes, provides further evidence for the role of CYP2D6 in radical cure., Clinical Trials Registration: NCT02960568., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.)

The objectives of this article are to describe the ASCO Resource-Stratified Guidelines and to provide background within the context of ASCO Guidelines and efforts to address the global cancer burden.

Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.

Introduction: In 2012, the Centers for Medicare and Medicaid Services (CMS) introduced the Quality Bonus Payment Demonstration, a pay-for-performance (P4P) program, into Medicare Advantage plans. Previous studies documented racial/ethnic disparities in receipt of care among participants in these plans. The objective of this study was to determine whether P4P incentives have affected these disparities in Medicare Advantage plans., Methods: We studied 411 Medicare Advantage health plans that participated in the Medicare Health Outcome Survey in 2010 and 2013. Preventive health care was defined as self-reported receipt of health care provider communication or treatment to reduce risk of falling, improve bladder control, and monitor physical activity among individuals reporting these problems. Logistic regression stratified by health care plan was used to examine racial/ethnic disparities in receipt of preventive health care before and after the introduction of the P4P program in 2012., Results: We found similar racial/ethnic differences in receipt of preventive health care before and after the introduction of P4P. Blacks and Asians were less likely than whites to receive advice to improve bladder control and more likely to receive advice to reduce risk of falling and improve physical activity. Hispanics were more likely to report receiving advice about all 3 health issues than whites. After the introduction of P4P, the gap decreased between Hispanics and whites for improving bladder control and monitoring physical activity and increased between blacks and whites for monitoring physical activity., Conclusion: Racial/ethnic differences in receipt of preventive health care are not always in the expected direction. CMS should consider developing a separate measure of equity in preventive health care services to encourage health plans to reduce gaps among racial/ethnic groups in receiving preventive care services.

Introduction: Multisector partnerships are promoted as a mechanism to improve population health. This study explored the types and salient features of multisector partnerships in US counties with improving population health metrics., Methods: We used the "Framework for Understanding Cross-Sector Collaborations" proposed by Bryson, Crosby, and Stone to guide data collection and interpretation. Comparative case studies were conducted in 4 counties selected on the basis of population, geographic region, an age-adjusted mortality decline better than the US average, and stable per capita income. Data were collected through website and report reviews and through in-depth interviews with key informants (N = 59) representing multiple sectors. County reports were developed and cross-case themes related to partnership types and salient features were derived., Results: Multisector collaboration was common in all 4 counties despite substantial variations in population, geographic size, demographic diversity, and other characteristics. Most partnerships were formed by professionals and organizations to improve delivery of health and social services to vulnerable populations or to generate policy, system, and environment changes. Multisector collaboration was valued in all cases. Outcomes attributed to partnerships included short- and long-term effects that contributed to improved population health., Conclusion: The Bryson, Crosby, and Stone model is a useful framework for conducting case study research on multisector partnerships. Outcomes attributed to the multisector partnerships have the potential to contribute to improvement in population health. Further study is needed to confirm whether multisector partnerships are necessary for improving population health within counties and to understand which partnership characteristics are critical for success.

Purpose: An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to the ASCO membership after publication or presentation of potentially practice-changing data from major studies. This PCO addresses the role of prostate-specific antigen (PSA) testing in the screening of men for prostate cancer., Clinical Context: Prostate cancer is the second leading cause of cancer deaths among men in the United States. The rationale for screening men for prostate cancer is the potential to reduce the risk of death through early detection., Recent Data: Evidence from a 2011 Agency for Healthcare Research and Quality systematic review primarily informs this PCO on the benefits and harms of PSA-based screening. An update search was conducted to March 16, 2012, for additional evidence related to the topic., Results: In one randomized trial, PSA testing in men who would not otherwise have been screened resulted in reduced death rates from prostate cancer, but it is uncertain whether the size of the effect was worth the harms associated with screening and subsequent unnecessary treatment. Although there are limitations to the existing data, there is evidence to suggest that men with longer life expectancy may benefit from PSA testing. Adverse events associated with prostate biopsy are low for the majority of men; however, several population-based studies have shown increasing rates of infectious complications after prostate biopsy, which is a concern.

Politics, for better or worse, plays a critical role in health affairs. The purpose of this article is to articulate a role for political analysis of public health issues, ranging from injury and disease prevention to health care reform. It begins by examining how health problems make it onto the policy agenda. Perceptions regarding the severity of the problem, responsibility for the problem, and affected populations all influence governmental responses. Next, it considers how bounded rationality, fragmented political institutions, resistance from concentrated interests, and fiscal constraints usually lead political leaders to adopt incremental policy changes rather than comprehensive reforms even when faced with serious public health problems. It then identifies conditions under which larger-scale transformation of health policy can occur, focusing on critical junctures in policy development and the role of policy entrepreneurs in seizing opportunities for innovation. Finally, it reviews the challenges confronting officials and agencies who are responsible for implementing and administering health policies. Public health professionals who understand the political dimensions of health policy can conduct more realistic research and evaluation, better anticipate opportunities as well as constraints on governmental action, and design more effective policies and programs.

This article examines the history of efforts to add prescription drug coverage to the Medicare program. It identifies several important patterns in policymaking over four decades. First, prescription drug coverage has usually been tied to the fate of broader proposals for Medicare reform. Second, action has been hampered by divided government, federal budget deficits, and ideological conflict between those seeking to expand the traditional Medicare program and those preferring a greater role for private health care companies. Third, the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 reflect earlier missed opportunities. Policymakers concluded from past episodes that participation in the new program should be voluntary, with Medicare beneficiaries and taxpayers sharing the costs. They ignored lessons from past episodes, however, about the need to match expanded benefits with adequate mechanisms for cost containment. Based on several new circumstances in 2003, the article demonstrates why there was a historic opportunity to add a Medicare prescription drug benefit and identify challenges to implementing an effective policy.