Understanding VA's Use of and Relationships With Community Care Providers Under the MISSION Act.

BACKGROUND: Congress has enacted 2 major pieces of legislation to improve access to care for Veterans within the Department of Veterans Affairs (VA). As a result, the VA has undergone a major transformation in the way that care is delivered to Veterans with an increased reliance on community-based provider networks. No studies have examined the relationship between VA and contracted community providers. This study examines VA facility directors' perspectives on their successes and challenges building relationships with community providers within the VA Community Care Network (CCN). OBJECTIVES: To understand who VA facilities partner with for community care, highlight areas of greatest need for partnerships in various regions, and identify challenges of working with community providers in the new CCN contract. RESEARCH DESIGN: We conducted a national survey with VA facility directors to explore needs, challenges, and expectations with the CCN. RESULTS: The most common care referred to community providers included physical therapy, chiropractic, orthopedic, ophthalmology, and acupuncture. Open-ended responses focused on 3 topics: (1) Challenges in working with community providers, (2) Strategies to maintain strong relationships with community providers, and (3) Re-engagement with community providers who no longer provide care for Veterans. CONCLUSIONS: VA faces challenges engaging with community providers given problems with timely reimbursement of community providers, low (Medicare) reimbursement rates, and confusing VA rules related to prior authorizations and bundled services. It will be critical to identify strategies to successfully initiate and sustain relationships with community providers.

Especial COVID-19: debate "O papel da OSS na resposta à pandemia"

“Começa um problema se a gente assume que há organizações sociais que não sabem que elas são signatárias de um contrato, no qual está explícito o que recebem e o que devem fazer”, ressaltou Ana Maria Malik, da EAESP - FGV.

Especial COVID-19: debate "O papel da OSS na resposta à pandemia"

“Se existe um momento no qual o setor público e o setor privado necessitam trabalhar juntos, é quando se está em uma situação de envolvimento nacional importante.”, diz Ana Maria Malik, da EAESP-FGV

Barriers to the implementation of public-private partnerships in the healthcare sector in the Kingdom of Saudi Arabia.

BACKGROUND: Saudi Arabia is considering increasing the role of the private sector's participation in financing and delivering healthcare services through the adoption of Public-Private Partnerships (PPPs). However, the adoption and successful implementation of PPPs in the Saudi healthcare sector requires careful attention to overcome potential obstacles. OBJECTIVES: This study investigates and identifies potential barriers to the successful implementation of PPPs in the Saudi healthcare sector. METHODS: A pre-tested interviewer-administered questionnaire was used to collect data from 72 respondents over a two-month period. Respondents were asked to rate the degree of influence of potential key barriers using a five-point Likert scale. The collected data was analysed using descriptive and inferential statistics. RESULTS: The evidence showed that the top three barriers, as rated by the respondents, were legal barriers, including delays in receiving approval and permits and law and regulation changes, environmental barriers, including lack of transparency and accountability and technological barriers, including a shortage of professionals qualified to handle PPP projects. CONCLUSIONS: The barriers identified suggested that the government should ensure that PPPs are implemented in a timely manner to ensure that private sector involvement yields the intended benefits. Furthermore, a stable legal and regulatory framework must be established that is properly and easily enforced to avoid confusing stakeholders with too many changes. It is also important to ensure that transparency and accountability measures are strengthened.

Reducing Harm, Supporting Recovery: a partnership and evidence-informed approach to developing the new Irish health led, National Drug Strategy.

BACKGROUND: Policy development by partnership is difficult, however, 'Reducing Harm, Supporting Recovery- A health led response to drug and alcohol use in Ireland 2017-2025' hailed a new era. This policy was based on an agreed philosophy and core values across a 21-member partnership and has stated a common commitment to a health-led response. METHODS: To drive strategy development, a cross-discipline committee with an independent Chair was created by the Minister. Members came from statutory, voluntary, community, research and service-user organisations. A consensus-based, partnership approach was taken to developing the policy and the action plan. Over 18 months of debate, a public consultation, focus groups, evidence reviews and an external expert review were conducted. Evidence was reviewed by the committee and following a very robust debate, a set of priority actions and responsible organisations were established. RESULTS: Nineteen meetings were held. Epidemiological indicators illustrated that cannabis use, young people, chronic opiate use, mortality and geography were a priority. Almost 3000 individuals/organisations responded to the public consultation and themes arising were, supply-reduction, prevention, treatment, rehabilitation and research. The evidence review found that evidence was weak or lacking. The focus groups addressed priorities in supply, education, prevention, continuum of care, evidence and best practice. Finally, the expert review examined structures. Significant contentious debate arose around the initial terms of reference and the authority of a member to agree to an action on behalf of a ministry. While not all members were fully satisfied with the strategy, all welcomed the commitment to the health-led approach. An implementation committee was established, a tender for the first medically supervised injecting facility was issued and a sub-committee to explore decriminalisation was formed. CONCLUSION: A key recommendation from the process was to ensure that all voices had an equal opportunity to be heard and to ensure that priority actions identified from the wider sources of evidence were not lost during the extended process. The breath of the partnership aided this. While we have succeeded in developing a sound strategy, success will depend on continuing support from the partnership and appropriate resourcing from the ministries.

Unlocking the Hidden Hunger Crises: The Power of Public-Private Partnerships.

The global burden of malnutrition remains unacceptably high. Malnutrition is a universal issue restricting development and slowing progress. Malnutrition is responsible for more illness and ill-health than any other cause worldwide. Despite underlying determinants of undernutrition being well understood for decades, millions of children worldwide face multiple malnutrition burdens, and women face a higher burden than men when it comes to malnutrition due to higher nutrient needs. Despite these alarming statistics, significant strides are being made. Globally, stunting rates among children have declined and many countries are on their way to achieving at least one nutritional status target for 2025. However, a broader range of stakeholders must be more fully engaged if malnutrition is to be reduced in a sustainable manner, including increased engagement from the private sector. To support achievement of the 2030 Sustainable Development Goal of ending all forms of malnutrition (goal 2.2), there must be urgent and decisive actions by all stakeholders to address existing data gaps, present new food systems innovations, ensure nutritious diets for all, fully finance nutrition action, and adhere to global commitments.

ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) "is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable." In 2012, the Medical Device Innovation Consortium (MDIC) was formed as a public-private partnership bringing together government, industry, and nonprofit organizations to advance approaches that promote patient access to safe, innovative medical technologies. With a focus on regulatory science, the MDIC has been assessing how to apply real-world evidence (RWE) regulatory science to medical devices. A key goal of this project is to review the history of RWE regulatory science, define terms, and explain why and how RWE is being considered across the total product life cycle, including regulatory assessment. Unique considerations of real-world data for in vitro diagnostics are also taken into account. We envision that these activities will help ensure a high level of rigor and integrity of RWE necessary for regulatory use cases and demonstrate where RWE can be successfully used for regulatory decision making. The ISPOR, FDA, and MDIC are providing the needed leadership in ensuring that diverse stakeholders share a meaningful voice in determining RWE use and, by so doing, are improving the quality and efficiency of care, enhancing health outcomes, and addressing broader societal concerns of reducing health disparities and costs.

Guidance for the governance of public-private collaborations in vaccine post-marketing settings in Europe.

INTRODUCTION: The 2009 influenza pandemic highlighted challenges for vaccine post-marketing monitoring in Europe, particularly the need to have appropriate infrastructures to strengthen public-private collaborations (PPCs) with suitable processes to improve stakeholder interactions and collection and analysis of safety and effectiveness data. The ADVANCE consortium comprises public and private stakeholders who have worked together to build and test new system components for vaccine post-marketing projects, one component being a governance framework for efficient, transparent and trustworthy PPCs. METHODS: Based on the results of a landscape analysis and screening of formalised existing governance structures, we identified the elements of a governance framework and developed recommendations to support stakeholders willing and able to implement collaborative projects. These proposals and their implementation were discussed by 70 experts during a workshop to gain from their experience. RESULTS: We identified core governance principles and defined five fundamental functions (decision-making, scientific advice, quality control and audit, implementation and management, and financial administration) that can be attributed to individual partner organisations or to a committee with representatives from more than one partner organisation. We propose a generic governance model with options for its adaptation to specific contexts and projects. The advantages and disadvantages of PPCs were also examined. Stakeholders' concerns (e.g. scientific integrity and public trust) were addressed through recommendations about transparent decision-making rules and conflict of interest management. CONCLUSIONS: No one-size-fits-all solution for PPC governance exists but our recommendations could be used to set-up a tailored-made and fully transparent governance structure supporting collaborative projects in the European vaccine post-marketing environment. To allow the rapid establishment of robust projects, the next steps will involve this guidance being used by real-world collaborations to assess what works and what does not work and what added-value can be obtained from these collaborations.

Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance.

Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review ("IPR") proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation--particularly for discoveries made upstream in the innovation pipeline--thus imperiling the development of new drug therapies. But a fascinating solution has emerged: invoking tribal immunity to shield pharmaceutical patents from IPR before the Patent Trial and Appeal Board ("PTAB"). This serves two critically important objectives: promoting tribal self-sufficiency, and encouraging investment in life-saving and life-improving new drugs. Contractual partnerships between Native American tribes and pharmaceutical companies not only provide the tribes with a steady stream of royalty revenue, but also insulate biopharmaceutical patents from challenge in IPR proceedings through the invocation of long-established principles of tribal sovereign immunity. This Note is the first piece of scholarship to comprehensively analyze, and advocate for, the right to invoke tribal sovereign immunity in IPR proceedings.

The Foundation for the National Institutes of Health Biomarkers Consortium: Past Accomplishments and New Strategic Direction.

The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) is a public-private partnership that aims to facilitate drug development with biomarkers across a range of therapeutic areas. The BC is organized to address specific precompetitive biomarker projects, giving participating stakeholders a role in the design and conduct of projects and making the results freely public. Ultimately, the goals of the BC are to accelerate the development of new medicines, inform regulatory decision making, and improve patient care. Here, we describe how the BC works and briefly highlight its accomplishments. The BC has had many notable successful biomarker projects in the past 12 years, including I-SPY2, which has improved clinical trials and biomarker use for breast cancer, and an evidentiary framework for biomarker qualification. Recently, the BC has undergone a strategic expansion of its scope to include related drug development tools along the lines of the Biomarkers, Endpoints, and other Tools (BEST) resource.

[The local organization of health equity or the mistakes of intersectorality]. / L'organisation locale de l'équité en santé ou les errements de l'intersectorialité.

In recent years, there has been a new institutional set of developments in France aimed at promoting the adoption of partnership-based, cross-sectoral and modulated health policies based on the health status of the population. Nevertheless, because addressing the challenge of health equity depends largely on the mobilization of a large number of protagonists with very heterogeneous initiatives, interests and values, the conduct of such policies potentially opens up a space for confrontation between those who wish to promote it and those who refuse, challenge, circumvent or neutralize the reconfigurations of public action and the work routines it inevitably induces. This company can therefore be marked by tensions and additional constraints for the actors. In this context, it remains largely conditional.

The National Trust: A viable model of care for adults with intellectual disabilities in India.

The longevity of people with intellectual disabilities is increasing in developing nations. However, developing nations lack a proper system of care for aging persons with intellectual disabilities. Until now the care has been provided by parents and relatives in the home environment in developing countries, but this scenario is also changing; therefore, there is a strong need to explore a plan of care for this population which is also feasible and replicable. The National Trust is an autonomous body of the Government of India which has developed a comprehensive plan of care for adults with intellectual disabilities. In this article, the National Trust is discussed using a socioecological model. The replicability and suitability of this model for other developing countries are discussed.

Alzheimer's disease research in the context of the national plan to address Alzheimer's disease.

In 2012, the first National Plan to Address Alzheimer's Disease in the United States (U.S.) was released, a component of the National Alzheimer's Project Act legislation. Since that time, there have been incremental increases in U.S. federal funding for Alzheimer's disease and related dementia research, particularly in the areas of biomarker discovery, genetic link and related biological underpinnings, and prevention studies for Alzheimer's. A central theme in each of these areas has been the emphasis of cross-sector collaboration and private-public partnerships between government, non-profit organizations and for-profit organizations. This paper will highlight multiple private-public partnerships supporting the advancement of Alzheimer's research in the context of the National Plan to Address Alzheimer's.

Characteristics of joint use agreements in school districts in the United States: findings from the School Health Policies and Practices Study, 2012.

INTRODUCTION: Joint use or shared use of public school facilities provides community access to facilities for varied purposes. We examined a nationally representative sample of school districts in the United States to identify characteristics associated with having a formal joint use agreement (JUA) and with the kinds of uses to which JUAs apply. METHODS: We analyzed data from the 2012 School Health Policies and Practices Study. The response rate for the module containing questions about formal JUAs was 60.1% (N = 630). We used multivariate logistic regression models to examine the adjusted odds of having a formal JUA and χ(2) analyses to examine differences in district characteristics associated with the uses of the JUA. RESULTS: Among the 61.6% of school districts with a formal JUA, more than 80% had an agreement for the use of indoor and outdoor recreation facilities; other uses also were identified. JUAs were more common in urban than rural areas, in large than small school districts, and in the West compared with the Midwest, South, and Northeast. CONCLUSION: In many districts, school facilities appear to be an untapped resource for community members. Formal JUAs provide an opportunity for shared use while addressing issues of liability, cost, and logistics.

[Cloning and law in Hungary]. / Klónozás és jog Magyarországon.

Reproductive human cloning is prohibited in Hungary, as in many other countries. Therapeutic human cloning is not prohibited, just like in many other countries. Stem cell therapy is also allowed. Article III, paragraph (3) of the Hungarian basic law (constitution) strictly forbids total human cloning. Article 1 of the Additional Protocol to the Oviedo Convention, on the Prohibition of Cloning Human Beings (1998) stipulates that any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited. In Hungary, according to Article 174 of the Criminal Code, total human cloning constitutes a crime. Article 180, paragraph (3) of the Hungarian Act on Health declares that embryos shall not be brought about for research purposes; research shall be conducted only on embryos brought about for reproductive purposes when this is authorized by the persons entitled to decide upon its disposal, or when the embryo is damaged. Article 180, paragraph (5) of the Hungarian Act on Health stipulates that multiple individuals who genetically conform to one another shall not be brought about. According to Article 181, paragraph (1) of the Hungarian Act on Health, an embryo used for research shall be kept alive for not longer than 14 days, not counting the time it was frozen for storage and the time period of research.

The Innovative Medicines Initiative: an engine for regulatory science.

Since its launch in 2008, the Innovative Medicines Initiative has catalysed the formation of many consortia to address challenges in drug development and regulation. As it moves into its second phase, we highlight key outcomes so far and the lessons learned.

Medical Director Responsibilities to the ESRD Network.

The 18 regional ESRD Networks are established in legislation and contract with the Centers for Medicare and Medicaid Services to improve the quality and safety of dialysis, maximize patient rehabilitation, encourage collaboration among and between providers toward common quality goals, and improve the reliability and the use of data in pursuit of quality improvement. The Networks are funded by a $0.50 per treatment fee deducted from the reimbursement to dialysis providers, and their deliverables are determined by a statement of work, which is updated in a new contract every 3 years. The Conditions for Coverage require dialysis providers to participate in Network activities, and failure to do so can be the basis for sanctions against the provider. However, the Networks attempt to foster a collegial relationship with dialysis facilities by offering tools, educational activities, and other resources to assist the facilities in meeting the evolving requirements by the Centers for Medicare and Medicaid Services on the basis of national aims and domains for quality improvement in health care that transcend the ESRD program. Because of his/her responsibility for implementing the quality assessment and performance improvement activities in the facility, the medical director has much to gain by actively participating in Network activities, especially those focused on quality, safety, patient grievance, patient engagement, and coordination of care. Membership on Network committees can also foster the professional growth of the medical director through participation in quality improvement activity development and implementation, authorship of articles in peer-reviewed journals, creation of educational tools and presentations, and application of Network-sponsored materials to improve patient outcomes, engagement, and satisfaction in the medical director's facility. The improvement of care of patients on dialysis will be beneficial to the facility in achieving its goals of quality, safety, and financial viability.