Journal of Health Politics Policy and Law最新文献_第7页

Industry Payments to Physicians Are Kickbacks. How Should Stakeholders Respond? 行业向医生支付的费用属于回扣。利益相关者应如何应对？

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-12-01 DOI: 10.1215/03616878-10041205

Aaron Mitchell, Ameet Sarpatwari, Peter B Bach

{"title":"Industry Payments to Physicians Are Kickbacks. How Should Stakeholders Respond?","authors":"Aaron Mitchell, Ameet Sarpatwari, Peter B Bach","doi":"10.1215/03616878-10041205","DOIUrl":"10.1215/03616878-10041205","url":null,"abstract":"Payments from the pharmaceutical industry to US physicians are common. In determining which payments rise to the level of an illegal kickback under the Anti-Kickback Statute (AKS), the Department of Health and Human Services' Office of Inspector General (OIG) has stated in nonbinding guidance that influencing or \"swaying\" physician prescribing is key. OIG has highlighted as a compliance standard the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Professions, which stipulates that permissible payments are those that do not interfere with prescribing. However, recent evidence has shown that most payments influence physician prescribing, driving higher prescription drug costs by increasing use of brand-name and low-value drugs. This evidence implies that many payments that are currently commonplace could be subject to prosecution under AKS. Given that these payments increase costs to patients and the health care system, there is a public interest in curtailing them. This article proposes a range of actions available to stakeholders-including industry, providers, regulators, and payers-to mitigate the cost-increasing effect of industry payments to physicians.","PeriodicalId":54812,"journal":{"name":"Journal of Health Politics Policy and Law","volume":"47 6","pages":"815-833"},"PeriodicalIF":4.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11107028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10451487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review. 支持FDA药物批准的证据质量趋势:来自文献综述的结果。

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-12-01 DOI: 10.1215/03616878-10041093

Beatrice L Brown, Mayookha Mitra-Majumdar, Krysten Joyce, Murray Ross, Catherine Pham, Jonathan J Darrow, Jerry Avorn, Aaron S Kesselheim

{"title":"Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review.","authors":"Beatrice L Brown, Mayookha Mitra-Majumdar, Krysten Joyce, Murray Ross, Catherine Pham, Jonathan J Darrow, Jerry Avorn, Aaron S Kesselheim","doi":"10.1215/03616878-10041093","DOIUrl":"https://doi.org/10.1215/03616878-10041093","url":null,"abstract":"Context: New drug approvals in the United States must be supported by substantial evidence from \"adequate and well-controlled\" trials. The Food and Drug Administration (FDA) has flexibility in how it applies this standard.Methods: The authors conducted a systematic literature review of studies evaluating the design and outcomes of the key trials supporting new drug approvals in the United States. They extracted data on the trial characteristics, endpoint types, and expedited regulatory pathways.Findings: Among 48 publications eligible for inclusion, 30 covered trial characteristics, 23 covered surrogate measures, and 30 covered regulatory pathways. Trends point toward less frequent randomization, double-blinding, and active controls, with variation by drug type and indication. Surrogate measures are becoming more common but are not consistently well correlated with clinical outcomes. Drugs approved through expedited regulatory pathways often have less rigorous trial design characteristics.Conclusions: The characteristics of trials used to approve new drugs have evolved over the past two decades along with greater use of expedited regulatory pathways and changes in the nature of drugs being evaluated. While flexibility in regulatory standards is important, policy changes can emphasize high-quality data collection before or after FDA approval.","PeriodicalId":54812,"journal":{"name":"Journal of Health Politics Policy and Law","volume":"47 6","pages":"649-672"},"PeriodicalIF":4.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10817508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

The Bayh-Dole Act at 40: Accomplishments, Challenges, and Possible Reforms. 《贝-多尔法案》40周年:成就、挑战和可能的改革。

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-12-01 DOI: 10.1215/03616878-10041247

Ameet Sarpatwari, Aaron S Kesselheim, Robert Cook-Deegan

{"title":"The Bayh-Dole Act at 40: Accomplishments, Challenges, and Possible Reforms.","authors":"Ameet Sarpatwari, Aaron S Kesselheim, Robert Cook-Deegan","doi":"10.1215/03616878-10041247","DOIUrl":"https://doi.org/10.1215/03616878-10041247","url":null,"abstract":"More than 40 years have passed since the enactment of the Patent and Trademark Amendment (Bayh-Dole) Act, which authorized institutions to patent inventions arising from federally funded research. Although some experts have heralded the Bayh-Dole Act as ushering in a new era of technological advances, others have been less sanguine about its impact. In recent years, the high price of prescription drugs and the patenting of COVID-19 therapeutics and vaccines developed with substantial federal government support have rekindled the debate over whether companies should receive more restricted rights to products originating with government funding. This article traces the history leading to the enactment of the Bayh-Dole Act and critically assesses its strengths and weaknesses as well as unresolved questions concerning its scope. Based on this analysis, the authors propose reforms to better align the Bayh-Dole Act with public values and health outcomes, including clarifying government-use rights, making it easier to invoke march-in rights for failure to meet health and safety needs, increasing transparency in how patents are licensed, and testing different approaches to foster the development and application of inventions.","PeriodicalId":54812,"journal":{"name":"Journal of Health Politics Policy and Law","volume":"47 6","pages":"879-895"},"PeriodicalIF":4.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10508197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Value-Based Insurance Design: Clinically Nuanced Consumer Cost Sharing to Increase the Use of High-Value Medications. 基于价值的保险设计:临床细致入微的消费者成本分担以增加高价值药物的使用。

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-12-01 DOI: 10.1215/03616878-10041191

Nicholas K Smith, A Mark Fendrick

{"title":"Value-Based Insurance Design: Clinically Nuanced Consumer Cost Sharing to Increase the Use of High-Value Medications.","authors":"Nicholas K Smith, A Mark Fendrick","doi":"10.1215/03616878-10041191","DOIUrl":"https://doi.org/10.1215/03616878-10041191","url":null,"abstract":"Consumer cost sharing is widely employed by payers in the United States in an effort to control spending. Most cost-sharing strategies set patient contributions on the basis of costs incurred by payers and often do not consider medical necessity as a coverage criterion. Available evidence suggests that increases in cost sharing worsen health disparities and adversely affect patient-centered outcomes, particularly among economically vulnerable individuals, people of color, and those with chronic conditions. A key question has been how to better engage consumers while balancing appropriate access to essential services with increasing fiscal pressures. Value-based insurance design (VBID) is a promising approach designed to improve desired clinical and financial outcomes, in which out-of-pocket costs are based on the potential for clinical benefit, taking into consideration the patient's clinical condition. For more than two decades, broad multistakeholder support and multiple federal policy initiatives have led to the implementation of VBID programs that enhance access to vital preventive and chronic disease medications for millions of Americans. A robust evidence base shows that when financial barriers to essential medications are reduced, increased adherence results, leading to improved patient-centered outcomes, reduced health care disparities, and in some (but not most) instances, lower total medical expenditures.","PeriodicalId":54812,"journal":{"name":"Journal of Health Politics Policy and Law","volume":"47 6","pages":"797-813"},"PeriodicalIF":4.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10451486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Scripting Death: Stories of Assisted Dying in America 死亡脚本:美国协助死亡的故事

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-11-23 DOI: 10.1215/03616878-10358710

V. Rodwin

引用次数: 3

The Next Shift: The Fall of Industry and the Rise of Health Care in Rust Belt America 下一个转变:美国铁锈地带工业的衰落和医疗保健的崛起

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-11-23 DOI: 10.1215/03616878-10358766

P. Rocco

引用次数: 13

Health Policy in Asia: A Policy Design Approach 亚洲卫生政策:政策设计方法

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-11-23 DOI: 10.1215/03616878-10358780

R. Gauld

引用次数: 0

Medicare for All—Running Down a Dream 全民医保——梦想破灭了

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-11-23 DOI: 10.1215/03616878-10358752

J. Oberlander

引用次数: 0

The Privatized State: Why Government Outsourcing of Public Powers Is Making Us Less Free 私有化的国家:为什么政府外包公共权力使我们更不自由

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-09-27 DOI: 10.1215/03616878-10234254

L. Morales

引用次数: 0

Dreamscapes of World Health and the History of the World Health Organization 世界卫生的幻景和世界卫生组织的历史

IF 4.2 3区医学

Journal of Health Politics Policy and Law Pub Date : 2022-09-27 DOI: 10.1215/03616878-10234240

L. T. Larsen

引用次数: 0