Research on Reimbursement Management of Innovative Drugs Abroad and Its Enlightenment to China

Objective To analyze the reimbursement policies of innovative drugs in some developed countries,and to provide reference for future reimbursement management in China.Methods Literature research method was used to study the policies related to the reimbursement management of innovative drugs in Germany,France and Japan,and their successful experience was summarized.Results and Conclusion China should establish an open and transparent value evaluation standard to improve the medical insurance reimbursement management of innovative drugs.Besides,the value of innovative drugs should be taken as an important basis for reimbursement decisions,and an independent third-party value evaluation agency must be established.

Foreign Experience and Enlightenment of Reimbursement Management of Multi-indication Drugs

Objective To provide reference for China’s medical insurance reimbursement plan of multi-indication drugs.Methods By referring to relevant foreign literature,the implementation process and conditions of different reimbursement management modes of multi-indication drugs were analyzed to provide suggestions for reimbursement of multi-indication drugs in China.Results and Conclusion It is suggested to further explore the suitable conditions and select the corresponding mode in China.Payment standards should be set according to value pricing and budget impact analysis.Besides,data collection and analysis mechanism must be improved.Lastly,reward and punishment mechanism can be adopted to improve management efficiency.

Optimized Reimbursement Scheme of China's New Cooperative Medical System Using Monte Carlo Simulation

China＇s Rural Cooperative Medical System collapsed alongside communal farming at the end of the Maoist period in 1976, leaving most farmers vulnerable[1]. In rural areas, where 80% of people have been without health insurance of any kind, illness has emerged as a leading cause of poverty[24]. To address the poor state of health care among the rural population, in 2003 the Chinese government launched the New Rural Cooperative Medical System （NCMS）,

Lack of proper reimbursement is hampering adoption of minimally invasive gastrointestinal endoscopy in North America

Endoscopic submucosal dissection(ESD)and related procedures are minimally invasive and cost-effective alternates to surgery.However,there is no approved or listed current procedural terminology(CPT)for ESD.We aimed to review the current reimbursement process hurdles for ESD procedures in private practice model in United States.We reviewed the data of two advanced endoscopists(one in New York and other in Pennsylvania State)performing ESD in their private practice set-ups.We found the reimbursement process was complex,with number of refusals varied from 0-9 for ESD procedures.It was not paid at all in 8.3%of cases by the medical insurance.Endoscopic mucosal resection,which is considered inferior as compared to ESD,but has a listed CPT,was denied in only 0.83%cases.Our data highlights the billing hurdles by the endoscopists to adopt ESD-related procedures in private practice model.

Economic Impact of Clinical Research to Research Centers and Opportunity Cost for the Reimbursement System in Turkey

Introduction: Clinical research is a key component of drug development with a significant economic value. It has been reported that the development of a new molecule requires 10 - 15 years and costs almost $1.3 billion. Around 75% of the cost is spent on the Phase I-IV clinical research process. This study aimed to show the economic value of clinical research in Turkey. Methods: Clinical trial budgets were estimated from the raw data of the Report of Istanbul Medical Faculty Clinical Research (ITFKAR). In the research, the estimated cost of drugs used in the clinical trials for the Turkish reimbursement agency (SGK) was calculated to show the cost of medicines acquired through clinical research. Results: The total budget for sponsored pharmaceutical research was $107 million in Turkey, and the government saved close to $311,096,130 during 2006-2010, due to not reimbursing the patients for the drugs in the clinical trials. Conclusion: Despite the limitations of the study, the findings are unique for Turkey. The results can lead to revisiting the importance and economic value of clinical trials in Turkey.

Management of Orphan Drug Reimbursement Abroad and Its Enlightenment to China

Objective To analyze relevant policies and measures on the management of orphan drug reimbursement in foreign countries to provide a reference for future reimbursement management in China.Methods According to the percentage of health care expenditure in GDP,the completeness of rare disease policies,and the total population,Russia,Australia,and India were selected as the reference.Based on the existing literature,the main content and characteristics of the reimbursement of rare disease drugs were analyzed.Results and Conclusion Russia manages rare diseases in the form of lists.Special rare diseases are reimbursed by federal or regional finances,and ordinary rare diseases are reimbursed by statutory medical insurance funds.Orphan drugs in Australia are included in the pharmaceutical benefits scheme(PBS)and the lifesaving drugs program(LSDP),LSDP provides fully reimbursed drugs for eligible rare disease patients.India’s proposal takes health system sustainability into consideration.China should carry out epidemiological research to legally determine the rare diseases,establish reasonable reimbursement standards,and improve the multi-level reimbursement system.

Framework and local experience of pharmaceutical reimbursement criteria policy (PRCP) in China

In the present study, we compared local policies in Chongqing, Zhejiang, Anhui, Fujian and Sanming and summarized connotation and framework of PRCP. Moreover, we proposed that China should make PRCP at the provincial level, strengthen connection with other health care reform policies under tripartite system reform, such as equivalence evaluation of quality and efficacy of generics, and evaluate policy effects timely to improve the policy.

Analysis of reimbursement policy for outpatient chronic diseases in basic medical insurance for urban residents in China provincial capitals

Reimbursement policy for outpatient chronic diseases is an important part of the basic medical insurance scheme in China. The reimbursement policy for outpatient chronic diseases in basic medical insurance for urban residents of provincial capitals in China were analyzed from the perspectives of disease types, benefits package, qualification and health service access. Proposals to improve policy design, establish standardized disease inclusion criteria and set reasonable benefits package, strengthen management and complete supporting policy, strengthen policy coordination were put forward according the existing problems such as fragmented policy, great difference in disease types and benefit package, supervision difficulty, incomplete policy framework and lack of policy coordination.

The impact of the provincial reimbursement scheme on the use of targeted anticancer medications in Zhejiang,China:a controlled interrupted time-series analysis

To alleviate problems with access and affordability,six targeted anticancer medications(TAMs)were listed in the Provincial Reimbursement Drug List(PRDL)for the first time in Zhejiang,China in February 2015.In the present study,we aimed to evaluate the implementation of the PRDL policy on TAMs use.Using the pharmaceutical procurement data of these six listed TAMs(study group)and four unlisted TAMs(control group)from 22 tertiary hospitals in Zhejiang,China dated between January 2014 and February 2017,interrupted time-series analysis was adopted to examine differences in the average hospital purchasing volume(HPV)and the average hospital purchasing spending(HPS)between the two groups.The average daily cost of listed TAMs in the study group was decreased after April 2015.After enlistment,the average HPV per month was significantly increased by 34.6 defined daily doses(DDDs)(P<0.001),and the average HPS per month was significantly increased by USD 6614.9(P<0.001)for the listed TAMs in the study group(n=6).Neither the average HPV nor the average HPS changed significantly for the unlisted TAMs in the control group(n=4).The PRDL policy showed positive effects on improving patients’affordability and promoting access to TAMs in Zhejiang.The government should conduct further price negotiations and include more TAMs with clinical benefits into reimbursement schemes to relieve patients’financial burden and promote access.

我国医院远程医疗服务收费情况分析

目的分析我国医院远程医疗服务收费情况,以完善远程医疗服务收费制度,推动远程医疗规范化发展。方法2020年10—11月面向全国26个省(自治区、直辖市)组织开展线上问卷调查。选取问卷中远程医疗服务收费项目及其与医疗保险对接情况、收费标准制定、收费依据、费用支付与结算方式等内容,统计分析不同地区医院远程医疗服务收费情况。结果71.3%的医院开展了远程医疗服务收费,收费项目主要为远程会诊、远程教育、远程病理诊断、远程影像诊断和远程心电诊断。主要按照医院级别和专家职称收费,分别有59.1%的东部地区医院、69.2%的中部地区医院和68.5%的西部地区医院收费标准由行政管理部门统一制定。此外,34.6%的收费医院将远程医疗纳入医疗保险报销范畴。结论大部分医疗机构开展了远程医疗服务收费,但收费机制相对模糊,与医疗保险的对接政策也相对缺乏,应加快远程医疗服务收费政策制定,合理化远程医疗服务收费,建立健全远程医疗服务收费机制,促进远程医疗服务收费工作的规范化发展。

基于利益相关者分析的国家谈判药品“双通道”政策落地症结与对策研究

目的从利益相关者角度分析国家谈判药品“双通道”政策落地的动力及风险因素,为打通政策落地的最后环节提出政策建议。方法从药品目录、药店遴选、医疗保险经办、使用监管维度梳理各省(自治区、直辖市)“双通道”实施方案,结合文献分析和利益相关者访谈,从医疗保障部门、卫生健康行政部门、医疗机构、药品生产企业、药店5方角度分析政策落地的激励和风险因素。结果各省(自治区、直辖市)基本已发文落实建立“双通道”管理机制。该政策有利于医疗保障部门实现药品供应保障多元化,但基金控费风险、协议管理、医疗机构年度医疗保险总额调整等面临更大压力;有助于卫生健康部门实现医药分开,但政策协同性、医疗费用控制等面临更高要求;有利于缓解医院的药品配备和医疗服务压力,但增加了用药安全风险和管理难度,若外配处方不纳入总额预算,可缓解控费压力,否则不利于处方外流;有利于药店增加药品配备,扩大整体市场份额并向“双通道”药房集中,但加价空间减少,信息化、人员配备、药品管理、审核管理压力增大。同时,公众和医疗机构不信任依然存在。结论“双通道”政策的落地需要多方协同发力,采购与需求匹配,完善药品遴选和配备供应;政府与行业合力,优化“双通道”药房管理;药房与医院衔接,规范处方流转和药品使用;医疗保险和医疗协同,强化基金和药品使用监管。

Feasible economic strategies to improve screening compliance for colorectal cancer in Korea

ABM: While colorectal cancer (CRC) is an ideal target for population screening, physician and patient attitudes contribute to low levels of screening uptake. This study was carried out to find feasible economic strategies to improve the CRC screening compliance in Korea. METHODS: The natural history of a simulated cohort of 50-year-old Korean in the general population was modeled with CRC screening until the age of 80 years. Cases of positive results were worked up with colonoscopy. After polypectomy, colonoscopy was repeated every 3 years. Baseline screening compliance without insurance coverage by the national health insurance (NHI) was assumed to be 30%. If NHI covered the CRC screening or the reimbursement of screening to physicians increased, the compliance was assumed to increase. We evaluated 16 different CRC screening strategies based on Markov model. RESULTS: When the NHI did not cover the screening and compliance was 30%, non-dominated strategies were colonoscopy every 5 years (COL5) and colonoscopy every 3 years (COL3). In all scenarios of various compliance rates with raised coverage of the NHI and increased reimbursement of colonoscopy, COL10, COL5 and COL3 were non-dominated strategies, and COL10 had lower or minimal incremental medical cost and financial burden on the NHI than the strategy of no screening. These results were stable with sensitivity analyses. CONCLUSION: Economic strategies for promoting screening compliance can be accompanied by expanding insurance coverage by the NHI and by increasing reimbursement for CRC screening to providers. COL10 was a cost-effective and cost saving screening strategy for CRC in Korea.

Vision Screening in the Pediatrician’s Office

Objective: To assess current practices, attitudes, and perceived barriers toward pediatric vision screening. Patients and Methods: A link to a 9-question survey was electronically distributed to a national sample of 6000 pediatricians through Medical Marketing Services Inc. Data were collected using Survey Monkey. Results: Email open rate was 11%;37% of those who opened the email responded (225 respondents). Over ninety percent of respondents perform some type of vision screening at least yearly, although age at which screening began varied, with two thirds of respondents instituting formal vision screening after three years. Fifty eight percent of respondents were either extremely unsatisfied, unsatisfied or only somewhat satisfied with their current screening method. Preferred methods of screening and confidence of pediatricians in their ability to detect pathology varied for children under versus over age three. The least frequently used methods for all age groups were autorefraction and photoscreening. The most commonly reported barriers to screening were inadequate training (48%), time required for exam (42%), and inadequate reimbursement (32%). Conclusions: Perceived barriers to vision screening in the pediatrician office have been previously identified, and photoscreening and autorefraction have been identified as a possible means to circumvent them. In spite of the addition of new procedural codes, pediatricians continue to report similar barriers to screening.

The impact of the New Cooperative Medical Scheme in Sangzhi County,Hunan Province

In August 2011,the Sangzhi County government,Hunan Province,adopted a series of new health care policies as a national pilot of the New Cooperative Medical Scheme(referred to as 2011 NCMS).These policies were designed to further resolve illness-led poverty and the poor state of health care in the local area.The program had a positive impact and spread to other regions in Hunan Province.This paper will discuss the progress made as a result of the policies and several issues that challenge the scheme in practice.A total sample of 1212 individuals and 303 households were included in the analysis,and98 interviews were conducted with people related to the scheme.Our major findings indicate that the 201!NCMS has significantly reduced the out-of-pocket medical payment of rural residents,and also increased the township hospitals'patient flow.However,the medical scheme still faces many challenging issues during the implementation.With the increasing interest among the Chinese policy makers in strengthening and promoting the Sangzhi Model,the impacts of the scheme deserve greater attention in practice so as to further improve NCMS in rural China.

Economic factors in the future delivery of spinal healthcare

The current trajectory of healthcare-related spending in the United States is unsustainable. Currently, the predominant form of reimbursement is the form of a fee-for-service system in which surgeons are reimbursed for each discrete unit of care provided. This system does factor the cost, quality, or outcomes of service provided. For the purposes of cost containment, the bundled episode reimbursement has gainedpopularity as a potential alternative to the current feefor-service system. In the newer model, the spinal surgeon will become increasingly responsible for controlling costs. The bundled payment system will initially offer financial incentives to initiate a meaning-ful national transition from the fee-for-service model. The difficulty will be ensuring- that the services of surg-eons continue to be valued past this initiation period. However, g-reater financial responsibilities will be placed upon the individual surgeon in this new system. Over time, the evolving interests of hospital systems could result in the devaluation of the surgeons' services. Significant cooperation on behalf of all involved healthcare providers will be necessary to ensure that quality of care does not suffer while efforts for cost containment continue.

Dermatomyositis and polymyositis in total hip arthroplasty

BACKGROUND Idiopathic inflammatory myopathies(IIM)are systemic autoimmune disorders such as dermatomyositis(DM),polymyositis(PM),inclusion body myopathy,and autoimmune necrotizing myopathy that,similar to osteoarthritis,affect quality of life and activities of daily living.Moreover,these patients are often burdened with chronic pain and disability;however,the outcomes and risk of total hip arthroplasty(THA)in this patient population remain unclear.AIM To evaluate 90-d complications and costs in patients with these conditions.METHODS A retrospective case control study was designed by accessing data from the Medicare dataset available on the PearlDiver server.Patients with IIM,here,those with DM and PM were matched based on possible confounding variables to a cohort without these diseases and with the same 10-year risk of mortality as defined by the Charlson Comorbidity Index Score(CCI).Univariate and multivariate analysis were performed to evaluate complications and t-tests to evaluate 90-d Medicare reimbursements as markers of costs after THA.RESULTS The total sample was 1090 patients with each cohort comprised of 545.Females were 74.9%of the population.The mean CCI was 5.89(SD 2.11).Those with IIM had increased rates of pneumonia[odds ratio(OR)1.45,P<0.001]and pulmonary embolism(OR 1.46,P=0.035)and decreased hematoma risks(OR 0.58,P=0.00).90-d costs were on average$1411 greater for those with IIM yet not significantly different(P=0.034).CONCLUSION Patients with IIM have an increased 90-d rate of pneumonia and pulmonary embolism concomitant with a decreased hematoma rate consistent with their procoagulatory state.Further attention to increased resource utilization in these patients is also warranted.

The Newly Established Unified Healthcare Fund (EOPYY): Current Situation and Proposed Structural Changes, towards an Upgraded Model of Primary Health Care, in Greece

Background: The National Organization for Healthcare Provision (EOPYY) constitutes simultaneously the monopsonistic healthcare insurer and a main provider of PHC in Greece. Currently, EOPYY is threatened by financial distress hence emerging a critical discussion on structural issues, providers’ reimbursement and gatekeeping revision. Objectives: To conduct a detailed analysis of the Greek social health insurance and PHC in order to propose consolidation policies. Methods: Search for raw data domestically and best practices internationally. Results: In Greece, PHC provision is fragmented leading patients to more expensive hospital care. Family physicians are a small portion of total physicians which, in combination with the free choice policy, results in non-gate-keeping despite growing co-payments. This necessitates the creation of a PHC network between EOPYY’s and NHS’s units and contracted professionals. This first evaluation has also revealed an irrational use of consolidated resources, which we propose to normalize through a new global budget system. Conclusions: Greek health insurance needs an immediate reform through which EOPYY would become an efficient pool of public and social health inflows. Besides, we suggest gate-keeping to be activated, proclaiming new EOPYY contracts with general practitioners and family pediatricians, applying a stricter referral system and reforming the reimbursement system.

Georgian Social Insurance Fund Management Problems and Probabilistic and Statistical Analysis of Fund Capital Management

A mathematical model of management of a social insurance fund with exponential insurance reimburse and financing determined social programs is represented and analyzed; A probability density function and fund＇s functioning probabilistic characteristics are obtained, that makes it possible to determine the sufficiency of fund capital at all levels of its management. With the help of conclusion it is possible for particular period of time determine in insurance fund change of cash flow movement speed, on what basis in determined from state tax revenues assigns acceptance necessity and capacity.

Hospital Length of Stay Reduction: A Long-Term Study

This study evaluated length of stay reduction for adult medicine and adult surgery in the combined hospitals of Syracuse, New York between 1998 and 2016. The study was based on the All Patients Refined Severity of Illness System. Through this approach, it controlled for changes in the degree of illness of hospital populations. The study data indicated that reductions in adult medicine and adult surgery stays in the Syracuse hospitals between 1998 and 2012 reduced the annual number of excess days compared with severity adjusted national averages by 49,000, or an average daily census of 134.2. It appeared that the shift to reimbursement by discharges initiated by Medicare was a major cause of these reductions. The impact of this change was accompanied by length of stay reduction initiatives by the Syracuse hospitals, especially relating to long-term care. Between January-April 2012 and 2016, additional reductions brought the lengths of stay for adult medicine and adult surgery in the combined Syracuse hospitals close to the national average. The study suggested that remaining opportunities for length of stay reductions in Syracuse involved patients with high severity of illness and those discharged to nursing homes.

Off-label use of targeted therapies in oncology

Off-label use is defined by the prescription of a marketed drug outside the conditions described in the summary of product characteristics.In oncology,off-label prescribing of targeted therapies may occur in patients with other tumor types expressing the same target.Agents associated to phenotypic approaches such as therapies against the tumoral vasculature(anti-angiogenic drugs) and new immunotherapies(checkpoint inhibitors) also carry the potential of alternative indications or combinations.Off-label use of targeted therapies is little documented and appears to be in the same range than that regarding older drugs with wide variations among agents.When compared with older agents,off-label use of targeted therapies is probably more rational through tumoral genotyping but is faced with a limited clinical support,reimbursement challenges related to the very high pricing and the cost of genotyping or molecular profiling,when applicable.