Overview of Proposed Exchange, Medicaid and IRS Regulations

Explains the implications of draft regulations on Medicaid, health insurance exchanges, and premium tax credits under healthcare reform, including eligibility criteria, enrollment, and verification; minimum essential coverage; and credit computation

FISA Reform

Congress and the Executive Branch are poised to take up the issue of FISA reform in 2014. What has been missing from the discussion is a comprehensive view of ways in which reform could be given effect—i.e., a taxonomy of potential options. This article seeks to fill the gap. The aim is to deepen the conversation about abeyant approaches to foreign intelligence gathering, to allow fuller discussion of what a comprehensive package could contain, and to place initiatives that are currently under consideration within a broader, over-arching framework. The article begins by considering the legal underpinnings and challenges to the President\u27s Surveillance Program. It then examines how technology has altered the types of information available, as well as methods of transmission and storage. The article builds on this to develop a taxonomy for how a statutory approach to foreign intelligence gathering could be given force. It divides foreign intelligence gathering into two categories: front-end collection and back-end analysis and use. Each category contains a counterpoise structured to ensure the appropriate exercise of Congressionally-mandated authorities. For the front-end, this means balancing the manner of collection with requirements for approval. For the back-end, this means offsetting implementation with transparency and oversight. The article then considers the constituent parts of each category

Achieving Universal Coverage Through Comprehensive Health Reform: The Vermont Experience -- Report of Findings

Presents findings on the role of Vermont's health reform programs in increasing insurance coverage between 2005 and 2009. Examines changes by insurance type, contributing factors such as outreach campaigns, financial sustainability, and implications

The South African Regulatory System: Past, Present, and Future

The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decisionmaking practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies.Peer reviewe

Managing at the Speed of Light: Improving Mission-Support Performance

The House and Senate Energy and Water Development Appropriations Subcommittees requested this study to help DOE's three major mission-support organizations improve their operations to better meet the current and future needs of the department. The passage of the Recovery Act only increased the importance of having DOE's mission-support offices working in the most effective, efficient, and timely manner as possible. While following rules and regulations is essential, the foremost task of the mission-support offices is to support the department's mission, i.e., the programs that DOE is implementing, whether in Washington D.C. or in the field. As a result, the Panel offered specific recommendations to strengthen the mission-focus and improve the management of each of the following support functions based on five "management mandates":- Strategic Vision- Leadership- Mission and Customer Service Orientation- Tactical Implementation- Agility/AdaptabilityKey FindingsThe Panel made several recommendations in each of the functional areas examined and some overarching recommendations for the corporate management of the mission-support offices that they believed would result in significant improvements to DOE's mission-support operations. The Panel believed that adopting these recommendations will not only make DOE a better functioning organization, but that most of them are essential if DOE is to put its very large allocation of Recovery Act funding to its intended uses as quickly as possible