Added Therapeutic Benefit of Top-Selling Brand-name Drugs in Medicare.

Importance: The Inflation Reduction Act of 2022 authorizes Medicare to negotiate prices of top-selling drugs based on several factors, including therapeutic benefit compared with existing treatment options. Objective: To determine the added therapeutic benefit of the 50 top-selling brand-name drugs in Medicare in 2020, as assessed by health technology assessment (HTA) organizations in Canada, France, and Germany. Design, Setting, and Participants: In this cross-sectional study, publicly available therapeutic benefit ratings, US Food and Drug Administration documents, and the Medicare Part B and Part D prescription drug spending dashboards were used to determine the 50 top-selling single-source drugs used in Medicare in 2020 and to assess their added therapeutic benefit ratings through 2021. Main Outcomes and Measures: Ratings from HTA bodies in Canada, France, and Germany were categorized as high (moderate or greater) or low (minor or no) added benefit. Each drug was rated based on its most favorable rating across countries, indications, subpopulations, and dosage forms. We compared the use and prerebate and postrebate (ie, net) Medicare spending between drugs with high vs low added benefit. Results: Forty-nine drugs (98%) received an HTA rating by at least 1 country; 22 of 36 drugs (61%) received a low added benefit rating in Canada, 34 of 47 in France (72%), and 17 of 29 in Germany (59%). Across countries, 27 drugs (55%) had a low added therapeutic rating, accounting for $19.3 billion in annual estimated net spending, or 35% of Medicare net spending on the 50 top-selling single-source drugs and 11% of total Medicare net prescription drug spending in 2020. Compared with those with high added benefit, drugs with a low added therapeutic rating were used by more Medicare beneficiaries (median 387 149 vs 44 869) and had lower net spending per beneficiary (median $992 vs $32 287). Conclusions and Relevance: Many top-selling Medicare drugs received low added benefit ratings by the national HTA organizations of Canada, France, and Germany. When negotiating prices for these drugs, Medicare should ensure they are not priced higher than reasonable therapeutic alternatives.

Diagnóstico situacional do programa academia da saúde no estado de Mato Grosso do Sul: relatório técnico 2022 / Situational diagnosis of the health academy program in the state of Mato Grosso do Sul: technical report 2022

O Programa Academia na Saúde (PAS) é considerado como um programa estratégico para a execução das Política Nacional de Promoção da Saúde (PNPS) e da Política Nacional de Atenção Básica (PNAB), e o programa é apontado como uma das ações de prevenção e controle que integram o Plano de Ações Estratégicas para o Enfrentamento das Doenças Crônicas Não Transmissíveis (DCNT).

The Impact of the Declaration of the State of Emergency on the Spread of COVID-19: A Modeling Analysis.

When encountering the outbreak and early spreading of COVID-19, the Government of Japan imposed gradually upgraded restriction policies and declared the state of emergency in April 2020 for the first time. To evaluate the efficacy of the countering strategies in different periods, we constructed a SEIADR (susceptible-exposed-infected-asymptomatic-documented-recovered) model to simulate the cases and determined corresponding spreading coefficients. The effective reproduction number R t was obtained to evaluate the measures controlling the COVID-19 conducted by the Government of Japan during different stages. It was found that the strict containing strategies during the state of emergency period drastically inhibit the COVID-19 trend. R t was decreased to 1.1123 and 0.8911 in stages 4 and 5 (a state of emergency in April and May 2020) from 3.5736, 2.0126, 3.0672 in the previous three stages when the containing strategies were weak. The state of emergency was declared again in view of the second wave of massive infections in January 2021. We estimated the cumulative infected cases and additional days to contain the COVID-19 transmission for the second state of emergency using this model. R t was 1.028 which illustrated that the strategies were less effective than the previous state of emergency. Finally, the overall infected population was predicted using combined isolation and testing intensity; the effectiveness and the expected peak time were evaluated. If using the optimized control strategies in the current stage, the spread of COVID-19 in Japan could be controlled within 30 days. The total confirmed cases should reduce to less than 4.2 × 105 by April 2021. This model study suggested stricter isolating measures may be required to shorten the period of the state of emergency.

Positioning the National Health Insurance for financial sustainability and Universal Health Coverage in Ghana: A qualitative study among key stakeholders.

INTRODUCTION: The National Health Insurance Scheme (NHIS) was introduced in 2003 to reduce "out-of-pocket" payments for health care in Ghana. Over a decade of its implementation, issues about the financial sustainability of this pro-poor policy remains a crippling fact despite its critical role to go towards Universal Health Coverage. We therefore conducted this study to elicit stakeholders' views on ways to improve the financial sustainability of the operations of NHIS. METHODS: Twenty (20) stakeholders were identified from Ministry of Health, Ghana Health Services, health workers groups, private medical practitioners, civil society organizations and developmental partners. They were interviewed using an interview guide developed from a NHIS policy review and analysis. All interviews were recorded and transcribed verbatim. The data were analysed thematically with the aid of NVivo 12 software. RESULTS: Stakeholders admitted that the NHIS is currently unable to meet its financial obligations. The stakeholders suggested first the adoption of capitation as a provider payment mechanism to minimize the risk of providers' fraud and protection from political interference. Secondly, they indicated that rapid releases of specific statutory deductions and taxes for NHIS providers could reduce delays in claims' reimbursement which is one of the main challenges faced by healthcare providers. Aligning the NHIS with the Community-based Health Planning and Services and including preventive and promotive health is necessary to position the Scheme for Universal Health Coverage. CONCLUSION: The Scheme will potentially achieve UHC if protected from political interference to improve the governance and transparency that affects the finances of the scheme and the expansion of services to include preventive and promotive services and cancers.

Non-invasive prenatal diagnostics (NIPD) in the system of medical care. Ethical and legal issues.

The procedures of prenatal and preimplantation diagnostics are discussed critically again and again in our community. In addition to the permanently controversial issues of embryo protection and abortion, considerations that discrimination on the basis of disability could occur with problematic consequences also for already born people with disabilities and their relatives now play a central role.

How does it affect service delivery under the National Health Insurance Scheme in Ghana? Health providers and insurance managers perspective on submission and reimbursement of claims.

INTRODUCTION: In 2003, the Government of Ghana launched the National Health Insurance Scheme (NHIS) to enable all Ghanaian residents to have access to health services at the point of care without financial difficulty. However, the system has faced a number of challenges relating to delays in submission and reimbursement of claims. This study assessed views of stakeholders on claims submission, processing and re-imbursement under the NHIS and how that affected health service delivery in Ghana. METHODS: The study employed qualitative methods where in-depth interviews were conducted with stakeholders in three administrative regions in Ghana. Purposive sampling method was used to select health facilities and study participants for the interviews. QSR Nvivo 12 software was used to code the data into themes for thematic analysis. RESULTS: The results point to key barriers such as lack of qualified staff to process claims, unclear vetting procedure and the failure of National Health Insurance Scheme officers to draw the attention of health facility staff to resolve discrepancies on time. Participants perceived that lack of clarity, inaccurate data and the use of non-professional staff for NHIS claims vetting prolonged reimbursement of claims. This affected operations of credentialed health facilities including the provision of health services. It is perceived that unavailability of funds led to re-use of disposable medical supplies in health service delivery in credentialed health facilities. Stakeholders suggested that submission of genuine claims by health providers and regular monitoring of health facilities reduces errors on claims reports and delays in reimbursement of claims. CONCLUSION: Long delays in claims reimbursement, perceived vetting discrepancies affect health service delivery. Thus, effective collaboration of all stakeholders is necessary in order to develop a long-term strategy to address the issue under the NHIS to improve health service delivery.

Policy changes and physicians opting out from Medicare in Quebec: an interrupted time-series analysis.

BACKGROUND: In all Canadian provinces, physicians can decide to either bill the provincial public system (opt in) or work privately and bill patients directly (opt out). We hypothesized that 2 policy events were associated with an increase in physicians opting out in Quebec. METHODS: The 2 policy events of interest were the 2005 Supreme Court of Canada ruling on Chaoulli v. Quebec and a regulatory clampdown forbidding double billing that was implemented by Quebec's government in 2017. We used interrupted time-series analyses of the Quebec government's yearly list of physicians who chose to opt out from 1994 to 2019 to analyze the relation between these events and physician billing status. RESULTS: The number of family physicians who opted out increased from 9 in 1994 to 347 in 2019. Opting out increased after the Chaoulli ruling, and our analysis suggested that between 2005 and 2019, 284 more family physicians opted out than if pre-Chaoulli trends had continued. The number of specialist physicians who opted out rose from 23 in 1994 to 150 in 2019. Our analysis suggested that an additional 69 specialist physicians opted out after the 2017 clampdown on double billing than previous trends would have predicted. INTERPRETATION: We found that the number of physicians who opted out increased in Quebec, and increases after 2 policy actions suggest an association with these policy interventions. Opting out decisions are likely important inputs into decision-making by physicians, which, in turn may influence the provision of publicly funded health care.

Government strategies to ensure the human right to adequate and healthy food facing the Covid-19 pandemic in Brazil. / Estratégias governamentais para a garantia do direito humano à alimentação adequada e saudável no enfrentamento à pandemia de Covid-19 no Brasil.

The Covid-19 pandemic revealed a concrete and immediate threat to food and nutrition security (FNS), especially for vulnerable groups. This study aimed to identify government strategies implemented in Brazil to provide the Human Right to Adequate and Healthy Food in high social vulnerability contexts during the Covid-19 pandemic. A cross-sectional study was carried out, with analysis of official documents published between March 20 and July 30, 2020, by the Federal Government, Federal District, Brazilian states, and capitals, focusing on measures to ensure availability and physical or financial access to food. Strategies implemented mainly involve food distribution and minimum income assurance. The following were implemented: Basic Emergency Income (Federal Government); Food Acquisition Program (PAA), and emergency financial aid (states); emergency food donation programs (states and municipalities). Existing measures were adapted to the pandemic, such as the National School Food Program (PNAE), the National Food Acquisition Program (PAA), and the distribution of food and staple food baskets. While essential, these strategies have limited scope and are insufficient to ensure FNS.

A pandemia de Covid-19 revelou a existência de ameaça concreta e imediata à segurança alimentar e nutricional (SAN), em especial de grupos vulnerabilizados. O estudo buscou identificar as estratégias governamentais implementadas no Brasil para prover o Direito Humano à Alimentação Adequada e Saudável em contextos de elevada vulnerabilidade social frente à Covid-19. Foi realizado um estudo transversal, com análise de documentos oficiais publicados entre 20 de março e 30 de julho de 2020 pela União, Distrito Federal, estados e capitais brasileiras, com foco em medidas que assegurem disponibilidade e acesso físico ou financeiro a alimentos. As estratégias implementadas envolvem fundamentalmente distribuição de alimentos e garantia de renda mínima. Foram instituídas: Renda Básica Emergencial (União); Programa de Aquisição de Alimentos (PAA) e auxílio financeiro emergencial (estados); programas de doação emergencial de alimentos (estados e municípios). Medidas existentes foram adaptadas frente à pandemia, como o Programa Nacional de Alimentação Escolar (PNAE), o Programa de Aquisição de Alimentos (PAA) nacional, a distribuição de alimentos e de cestas básicas. Embora importantes, essas estratégias têm alcance limitado e são insuficientes para assegurar a SAN.

Estratégias governamentais para a garantia do direito humano à alimentação adequada e saudável no enfrentamento à pandemia de Covid-19 no Brasil / Government strategies to ensure the human right to adequate and healthy food facing the Covid-19 pandemic in Brazil

Resumo A pandemia de Covid-19 revelou a existência de ameaça concreta e imediata à segurança alimentar e nutricional (SAN), em especial de grupos vulnerabilizados. O estudo buscou identificar as estratégias governamentais implementadas no Brasil para prover o Direito Humano à Alimentação Adequada e Saudável em contextos de elevada vulnerabilidade social frente à Covid-19. Foi realizado um estudo transversal, com análise de documentos oficiais publicados entre 20 de março e 30 de julho de 2020 pela União, Distrito Federal, estados e capitais brasileiras, com foco em medidas que assegurem disponibilidade e acesso físico ou financeiro a alimentos. As estratégias implementadas envolvem fundamentalmente distribuição de alimentos e garantia de renda mínima. Foram instituídas: Renda Básica Emergencial (União); Programa de Aquisição de Alimentos (PAA) e auxílio financeiro emergencial (estados); programas de doação emergencial de alimentos (estados e municípios). Medidas existentes foram adaptadas frente à pandemia, como o Programa Nacional de Alimentação Escolar (PNAE), o Programa de Aquisição de Alimentos (PAA) nacional, a distribuição de alimentos e de cestas básicas. Embora importantes, essas estratégias têm alcance limitado e são insuficientes para assegurar a SAN.

Abstract The Covid-19 pandemic revealed a concrete and immediate threat to food and nutrition security (FNS), especially for vulnerable groups. This study aimed to identify government strategies implemented in Brazil to provide the Human Right to Adequate and Healthy Food in high social vulnerability contexts during the Covid-19 pandemic. A cross-sectional study was carried out, with analysis of official documents published between March 20 and July 30, 2020, by the Federal Government, Federal District, Brazilian states, and capitals, focusing on measures to ensure availability and physical or financial access to food. Strategies implemented mainly involve food distribution and minimum income assurance. The following were implemented: Basic Emergency Income (Federal Government); Food Acquisition Program (PAA), and emergency financial aid (states); emergency food donation programs (states and municipalities). Existing measures were adapted to the pandemic, such as the National School Food Program (PNAE), the National Food Acquisition Program (PAA), and the distribution of food and staple food baskets. While essential, these strategies have limited scope and are insufficient to ensure FNS.

[Treatment of disease-related malnutrition: status of regulation in the Spanish National Health System. An exploratory study through focus groups]. / Tratamiento de la desnutrición relacionada con la enfermedad: situación de la regulación en el Sistema Nacional de Salud. Un estudio exploratorio mediante grupos focales.

INTRODUCTION: Background: the legislation currently regulating the inclusion of Food for Special Medical Purposes (FSMP) among the benefits of the National Health System (SNS) was made approximately 15 years ago. The evolution of the technical characteristics of the FSMP justifies an analysis of the current regulation and the consideration of possible regulatory modifications that would allow the incorporation of the progress achieved. Material and methods: four successive focus groups of experts, mostly doctors (91%), hospital specialists in disciplines related to nutrition (73%), from 8 different hospitals and 6 autonomous communities. Previously, 4 documents summarizing different technical aspects of the regulation on FSMP in Spain were sent to the participants. The audio of the meetings was transcribed anonymously and its content was codified. Results: the contents of the focus groups were grouped into 9 codes: 1) problems and regulation; 2) clinical benefits and evidence of efficacy or effectiveness; 3) clinical indications; 4) international context and comparisons with other countries; 5) budgetary impact; 6) cost-effectiveness; 7) risks and reasons for maintaining current regulation; 8) proposals for progress, feasibility and aspects that make implementation difficult; and 9) other issues. Conclusions: based on the technological development and clinical application of the FSMP carried out in recent years, an update of the regulation of these products can be proposed for financing by the National Health System in Spain. Most of these changes do not imply an increase in expenditure if current conditions regarding indications and maximum prices are maintained.

INTRODUCCIÓN: Antecedentes: la normativa que regula la inclusión de alimentos para usos médicos especiales (ADUME) entre las prestaciones del Sistema Nacional de Salud (SNS) fue elaborada hace unos 15 años, si bien la nutrición enteral domiciliaria se comenzó a regular en 1998. La evolución de las características técnicas de los ADUME justifica un análisis de la actual normativa y la consideración de posibles modificaciones que permitan la incorporación de avances tecnológicos. Material y métodos: reuniones estructuradas siguiendo la metodología del grupo focal, con expertos en su mayoría médicos (91 %), mujeres (55 %) y especialistas hospitalarios en disciplinas relacionadas con la nutrición (73 %) de 8 hospitales y 6 comunidades autónomas. Previamente, los participantes recibieron 4 documentos resumen de diferentes aspectos técnicos de la regulación sobre ADUME en España. Se transcribió de forma anonimizada el audio de las reuniones y se codificó su contenido en 9 códigos: 1) problemática y regulación; 2) beneficios clínicos y evidencia de eficacia o efectividad; 3) indicaciones clínicas; 4) contexto internacional y comparaciones con otros países; 5) impacto presupuestario; 6) coste-efectividad; 7) riesgos y motivos para mantener la regulación actual; 8) propuestas de avance, factibilidad y aspectos que dificultan la implementación; y 9) otros temas. Resultados: los grupos señalaron la necesidad de modificar aspectos regulatorios relacionados con la exclusión de financiación de las fórmulas de densidad calórica superior a 2,1 kcal/ml, exclusión de la financiación de los ADUME obtenidos total o parcialmente a partir de alimentos ordinarios, preferencia por la alimentación por sonda y exclusividad de la financiación de fórmulas completas para los ADUME que se empleen por vía oral como complemento de una ingesta insuficiente. Conclusiones: sobre la base del desarrollo tecnológico y la aplicación clínica de los ADUME en los últimos años, el SNS debería actualizar la regulación de la financiación de estos productos. La mayor parte de estos cambios no implican incremento del gasto si se mantienen las condiciones actuales en cuanto a indicaciones y precios máximos.