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Background: In January 2021, the Commonwealth of Massachusetts granted nurse practitioners (NPs) full practice authority (FPA). Little is known about how care delivery changed after FPA legislation., Purpose: To understand the NP perception of early implementation of FPA in Massachusetts., Methods: Qualitative descriptive design using inductive thematic analysis of open-ended responses to a web-based survey of NPs in Massachusetts from October to December 2021., Findings: Survey response rate was 50.3% (N = 144). Inductive thematic analysis of open-ended responses identified four themes, including: (a) internal and external barriers obstructed FPA implementation, (b) employer communication about scope-of-practice changes was minimal, (c) NPs led initiatives to implement FPA, and (d) some efforts effectively implemented FPA., Discussion: Almost 1 year after FPA was passed, external policies persisted that financially incentivized employers to not change NP scope-of-practice. Concerted efforts are needed to ensure that federal and payer policies, such as incident-to billing, are aligned with state law to encourage the implementation of FPA., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: In this nationwide register study, we examined the initiation of a second-line antidiabetic medicine (ADM) among new patients receiving regular metformin monotherapy in Finland during 2011-2022. We also reflected the second-line treatment patterns on changes in the reimbursement policy, and the national type 2 diabetes (T2D) care guidelines., Methods: Using register data on all reimbursed ADM purchases during 2010-2022, we defined nine annual cohorts of patients initiating regular metformin monotherapy during 2011-2019, each with a three-year follow-up. Descriptive methods were used to study the patterns of metformin monotherapy and second-line intensification over time. Proportional hazards models were used to analyse the take-up of the second-line ADM., Results: The share of new patients initiating metformin use (11-13% of all metformin users) and regular metformin use (83-85% of all new metformin users) remained stable. In all cohorts, 16-19% of the patients took up a second-line ADM (median time to intensification 1.5 years). With the 2011 cohort as reference, the highest proportion of new regular metformin users taking up a second ADM (hazard ratio 1.12. 95% confidence interval 1.07 ; 1.16, P < .0001) was in the 2019 cohort. In the 2017 cohort, the proportion of patients initiating sodium-glucose cotransporter 2 inhibitors as second-line treatment surpassed those initiating dipeptidyl peptidase-4 inhibitors. The reimbursement policy restricted the use of GLP-1-analogues., Conclusions: Second-line treatment intensification patterns over time paralleled the changes in the reimbursement system. Thus, our findings suggest that the reimbursement policy may influence the use of ADMs in Finland., (© 2024. The Author(s).)

Since the COVID-19 pandemic, nurses and nurse leaders are increasingly vocal about chronic understaffing and the impact the staffing crisis continues to have on nurses' well-being and patient outcomes. The American Nurses Association's Nurse Staffing Task Force addressed the importance of staffing standards as a critically needed step toward improving patient and population health outcomes. Against the backdrop of ongoing nursing shortages, hospital leaders have been hesitant to embrace staffing ratios, expressing concerns about their ability to hire and retain sufficient nursing staff, as operational revenue margins remain thin and nursing labor is costly. This article explicates structural issues within the current nursing reimbursement model that harms hospitals' business case for investments in nurse staffing and work environments. We argue that nurses must advocate for nursing reimbursement reform to increase the nursing workforce and improve nurse staffing and work environments. Such reform is necessary to support sustained hospital investments, financial philosophies, and approaches to meaningfully address and improve nurse staffing., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Katie Boston-Leary is an employee of the American Nurses Association where she serves as Director of Nursing Programs overseeing Nursing Practice and Work Environment and Healthy Nurse Healthy Nation. Opinions expressed here are her own and may not represent the American Nurses Association or any of its affiliates. Olga Yakusheva is Professor of Public Health and Nursing at the University of Michigan. She currently serves as a member of the Research Council of the American Nurses Association Enterprise and an independent expert for American Nurses Credentialing Center. All views are her own and do not necessarily reflect any of her affiliations.

Site-neutral payment is a policy created by federal rule making and implemented by the Centers for Medicare and Medicaid Services (CMS) that aims to reduce healthcare costs by aligning payment rates for certain services provided in multiple care settings. Site-neutral payments are intended to eliminate the incentive for providers to acquire facilities, such as physician offices or ambulatory surgical centers (ASCs), that Medicare reimburses at the lower non-facility rate and convert those settings into hospital outpatient departments (HOPDs), where Medicare reimburses at the higher facility rate. Although initiated by Congress to address payment disparities in Medicare, similar payment discrepancies can be seen in the commercial market where individual and employer-sponsored health plans often pay more for certain outpatient services depending on their location. This analysis presents a simulation of the impact of applying site-neutral payments to the commercial market with respect to overall potential savings for consumers, health plans and the federal government. To conduct the analysis, we use an all-payer claims data base generalizable to the United States. The analysis focused on a select group of outpatient services identified by the Medicare Payment Advisory Commission (MedPAC). We mapped the MedPAC identified 68 Ambulatory Payment Classifications (APCs), the codes Medicare uses to reimburse facilities for outpatient services, to the relevant CPT4/HCPCS codes, which the commercial market uses for billing. The potential cost savings of applying the site-neutral payment policy to the commercial insurance market to be $58 billion for year 2022. We estimate the 10-year total (2024-2033) employer market premium reduction ranges from 5.35% to 5.0% and found that those premium reductions would result in employer-sponsored insurance (ESI) tax subsidy savings of $140 billion to the federal government over a 10-year period (2024-2033)., Competing Interests: Declaration of Conflicting InterestsThe author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The author received no financial support for this research from The Alliance to Fight for Health Care.

Background: The reimbursement for expensive medicines poses a growing challenge to healthcare worldwide. In order to increase its control over the costs of medicines, the Dutch government introduced the Coverage Lock (CL) policy in 2015. The CL postpones decisions regarding reimbursement of expensive medicines until detailed advice on i.e., cost-effectiveness has been given. The CL has been in place for six years, has raised many questions and concerns, but currently, no evaluation is known to the authors. A better understanding of the effects of the CL on all stakeholders involved may contribute to reflections on the CL process and help find ways to improve it. An evaluation of Dutch policy will also be relevant for other countries that aim to optimize reimbursement procedures for expensive treatments. To perform this evaluation, we focused on the CL procedure for the medicine nusinersen. Nusinersen is the first treatment for spinal muscular atrophy (SMA). Following EMA approval in May 2017, it was placed in the CL. The analysis of cost-effectiveness and added therapeutic value resulted in an advice for reimbursement limited to children younger than 9.5 years at the start of treatment; this was implemented from August 2018 onwards., Methods: Qualitative stakeholder perspective analysis of the CL procedure focusing on nusinersen with 15 stakeholders., Results: Stakeholders raised key issues of the CL based on their experience with nusinersen: emotional impact of the CL, duration of the CL procedure, appropriateness of the CL procedure for different types of medicines, transparency of the CL, a wish for patient-centred decision-making and the lack of uniformity of access to expensive treatments., Discussion: Stakeholders supported measures to control healthcare expenses and to ensure reasonable pricing. They considered the delay in access to therapies and lack of procedural transparency to be the main challenges to the CL. Stakeholders also agreed that the interests of patients deserve more attention in the practical implementation of the reimbursement decision. Stakeholders suggested a number of adjustments to improve the CL, such as a faster start with conditional reimbursement programs to ensure access and intensify European collaboration to speed up the assessment of the medicine., (© 2022. The Author(s).)

Aim: National health care expenditures have been increasing each year, although the Japanese government has annually revised official drug prices. Managing the health care system to pay for expensive drugs is a major concern. The reimbursement restriction, which is the only way that a drug can be implemented before market entry in Japan, is crucial for managing expenditures. Therefore, this study identifies the impact of the reimbursement restriction on drug market sales in Japan, particularly in the situation where health technology assessment or other market access regulations are not applicable before market entry., Method: All new drugs listed in fiscal years 2011-2019, along with their market size forecast, were identified using the materials from the Central Social Insurance Medical Council. We then calculated the percentage rate of reimbursement amounts based on the National Database of Health Insurance Claims relative to the predicted market size as a dependent variable. Using the reimbursement restriction for each drug as an independent variable, we performed descriptive and univariate analyses on each variable, followed by generalized linear mixed-effects model regression analysis., Results: We identified 211 drugs. The mean rates of drugs that required physicians, facilities, and patients to meet criteria for use were 30.85% ( n  = 2), 31.42% ( n  = 2), and 72.11% ( n  = 6), respectively. The mean rate of drugs that required diagnostic testing was 22.99% ( n  = 7), which was 3.7 times lower than the rate of drugs that did not require such testing ( p  < .05)., Conclusion: Our results indicate that the reimbursement restriction requiring diagnostic testing has a substantial impact on decreasing market sales. As the number of cases for each requirement is small, further study is needed to measure the impact of the other reimbursement restrictions.

Background: The phenomenon of excess charge, where a healthcare service provider bills Medicare beyond the limit allowed for a medical procedure, is quite common in the United States public healthcare system. For example, in 2014, healthcare providers charged an average of 3.27 times (and up to 528 times) the allowable limit for cataract surgery. Previous research contends that such excess charges may be indicative of the actual amount that providers bill to non-Medicare patients and subsequent cost-shifting behavior, where a healthcare provider tries to recoup underpayment by Medicare from privately insured, self-pay, out-of-network, and uninsured patients., Objectives: The objective of this study is to examine the drivers of a provider's excess charge patterns, especially the extent to which the degree of excess charges may be associated with physician characteristics, Medicare reimbursement policy, or socioeconomic status and demographics of a provider's patient base., Methods: Using data from the 2014 Medicare Provider Utilization files, we identify three procedures with the highest variation in Medicare reimbursements to study the excess charge phenomenon. We then employ a two-step cluster analysis within each procedure to identify distinct provider groups., Results: Each procedure code yielded distinct healthcare provider segments with specific patient demographics and related behavior patterns. Cluster silhouette coefficients indicate that these segments are unique. Three random subsamples from each procedure establish the stability of the clusters., Conclusions: For each of the three procedures investigated in this study, a sizeable number of healthcare providers serving poorer, riskier patients are often paid significantly lower than their peers, and subsequently have the highest excess charges. For some providers, excess charges reveal possible cost-shifting to private insurance. Patterns of excess charges also indicate an imbalance of market power, especially in areas with lower provider competition and access to health care, thus leading to urban-rural healthcare disparities. Our results reinforce the call for price transparency and an upper limit to overbilling.

Aims: The Japanese government reimburses patients for drugs at prices specified in the Drug Price Standard (DPS) published by the National Health Insurance (NHI) scheme. It revises reimbursements for most drugs on the basis of their market prices. This study thereby identifies factors related to drugs or disease that impact market prices for drugs using the DPS list., Materials and Methods: This study first examined the 2018 DPS list to identify all listed drugs, their prices, and their stipulated reimbursements. We then excluded from this study all the drugs for which prices are set per alternate rules. We calculated the percentage divergence between market prices and DPS prices and designated it our dependent variable. We performed descriptive and a univariate analysis on each variable and constructed multivariate regression models featuring independent variables for drug characteristics that might affect market prices., Results: We identified 1,775 drugs with prices revised only by the market. We observed higher percentage divergences between DPS and market prices for drugs with generic alternatives ( p  < 0.001), drugs listed in the Japanese Pharmacopoeia ( p  < 0.001), and drugs for which at least two new drugs entered the same therapeutic category ( p  < 0.001). Injectable drugs exhibited a more significant and negative correlation with percentage divergences ( p  = 0.009) than ingestible drugs. Drugs that treat specific organs ( p  < 0.001), affect metabolism ( p  = 0.001), and those prescribed for non-therapeutic purposes ( p  < 0.001) display significantly higher percentage divergence than drugs affecting the nervous system and sensory organs. Divergences are less for narcotics ( p  < 0.001) and drugs that counter pathologic microorganisms and parasites ( p  = 0.004)., Conclusions: Factors that elevate competition among pharmaceutical companies likely lower market prices for drugs, and the direction of prices under NHI in Japan is affected by the category of diseases a drug treats.

Introduction: The Best Practice Tariff (BPT) in major trauma awards Major Trauma Centres (MTCs) a financial incentive when predefined standards of care are met. However, no tailored criteria exist with regards to the reimbursement policy in paediatric major trauma. In this study, we aim to examine the utility of the paediatric Major Trauma BPT and identify predictors of additional resource utilisation., Materials and Methods: This cohort study encompassed all paediatric major trauma calls (N = 682) presenting to a designated combined adult and paediatric MTC between July 2014 and June 2017. Patient demographics, admission pattern, injury parameters, length of stay (LOS) and the need for operative management were collected. Patients approved for the BPT uplift payment (BPT group) were compared with the cohort of children not qualifying (non-BPT group)., Results: Overall, less than a quarter (23.2%) of the trauma population qualified for the BPT. The proportion of patients requiring operative intervention and CT scanning in the BPT group was significantly higher (p<0.001). These children also attained a higher ISS (median, 13.5 vs. 0, p <0.001) and required longer hospitalisation. Following a Receiver Operator Characteristic (ROC) curve analysis, a cut off ISS score > 8 demonstrated an excellent predictive value in identifying children qualifying for BPT (true positive and false positive rates: 90% and 10.7%). However, a subgroup analysis including the more severely injured children (ISS >8) not qualifying for the uplift payment revealed that equally substantial resource went into their management - 42.9% needed surgical intervention and 57.1% a CT scan., Discussion: This study demonstrated that BPT in paediatric major trauma is a valuable reimbursement; however, our findings also unveiled a cohort deemed ineligible for BPT despite the high costs accrued. Re-evaluation of the remuneration criteria of paediatric major trauma networks with an alternative, more inclusive reimbursement policy is needed., Competing Interests: Declaration of Competing Interest All authors declare that they have no conflict of interest and received no financial support for this submission., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Big infectious diseases do harm to the whole society, and it is highly crucial to control them on time. The major purpose of this article is to theoretically demonstrate that the Chinese government's intervention in large-scale infectious diseases is successful and efficient. Two potential strategies were considered: strategy 1 was infectious disease without government intervention, and strategy 2 was infectious disease with government intervention. By evolution model, this article illustrates the efficiency of big infectious disease reimbursement policy in China. Without government reimbursement, this article finds that high expenditures accelerate the disease infection. The number of infected persons decreases under big infectious disease reimbursement policy in China. The higher the treatment costs, the more important the government intervention. Big infectious disease reimbursement policy in China can serve as an efficient example to cope with big infectious diseases.

The most common fracture in primary care is metatarsal fracture, but it is controversial whether to treat this fracture conservatively or surgically. We performed a cohort study to contrast metatarsal fractures that heal normally with fractures that show delayed healing. We analyzed 5% Medicare Standard Analytic Files, selecting all metatarsal fractures in 2011 to 2013, excluding patients with multiple fractures. Delayed healing was defined as treatment >14 days postfracture with either low-intensity pulsed ultrasound or surgery. Treatment for delayed healing was identified using the Current Procedural Terminology and International Classification of Diseases, Revision 9, Clinical Modification codes. Among 9482 metatarsal fractures, 256 (2.7%) showed delayed healing. Patients with delayed healing were younger (p < .0001); more likely to receive specialist referral (p < .001); more likely to have obesity (p = .005), psychosis (p = .003), chronic lung disease (p = .012), or iron deficiency anemia (p = .016); and more likely to receive surgery before ultrasound (p < .0001). Patients more likely to be treated with surgery than ultrasound included younger patients (p < .0001), obese patients (p = .02), and patients who first see a specialist (p < .05)., (Copyright © 2019. Published by Elsevier Inc.)

Purposes: To assess the impact of a government-sponsored reimbursement policy for cholinesterase inhibitors (ChEIs) on trends in physician visits with a diagnosis of Alzheimer's disease (AD)., Methods: Longitudinal population-based study using interrupted time series methods. British Columbia outpatient claims data for individuals aged 65 and older were used to compute monthly AD visit rates and examine the impact of the ChEI reimbursement policy on the coding of AD. We examined trends in the number of patients with AD visits, the number of AD visits per patient, and visits with "competing" diagnoses (mental, neurological, and cerebrovascular disorders and accidental falls). Finally, we described demographic and clinical features of diagnosed patients., Results: We analyzed 1.9 million AD visits. Faster growth in recorded AD visits was observed after the policy was implemented, from monthly growth of 7.5 visits per 100 000 person-months before the policy (95% confidence interval [CI], 6.1-8.9) to monthly growth of 16.5 per 100 000 person-months after the policy (95% CI, 14.8-18.3). After the implementation of the policy, we observed increased growth in the number of patients with recorded AD visits and the number of AD visits per patient, as well as a shift in diagnoses away from mental diseases and accidental falls to AD (diagnosis substitution)., Conclusions: British Columbia's reimbursement policy for ChEIs was associated with a significant acceleration in Alzheimer's visits. Evaluations of health services utilization and clinical outcomes following drug policy changes need to consider policy-induced influences on the reliability of the data used in the analysis., (© 2019 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.)

Background: Harmonized requirements apply for the marketing authorization of medicinal products in the EU Member States. On the contrary, the national legislations on the drug reimbursement are not harmonized. The aim of this study was to find out if they are robust enough to ensure high standards of public health protection with focus on the symptomatic treatment of dementia in the elderly., Methods: A computerized search of authorized therapeutic indications of haloperidol and trihexyphenidyl in the national databases of 8 EU member states and an analysis of the national legislation on reimbursement policies in Lithuania and Latvia was performed., Results: There is a discrepancy in the decisions on the marketing authorization vs the reimbursement in Lithuania and Latvia (reimbursement of haloperidol and trihexyphenidyl for the off-label treatment of dementia)., Conclusions: National legislation on the drug reimbursement in Lithuania and Latvia does not provide safeguards for public health at the same level as the marketing authorization does. Absence of a revision of former decisions in the light of new evidence is a critical weakness of the drug reimbursement in Lithuania and Latvia. Reimbursement for the off-label indications may pose a risk to public health.

Background: Reimbursement policies influence access of patients to orphan drugs in the European countries., Objectives: To provide a comprehensive description of orphan drug reimbursement policies and to assess reimbursement decision-making process in the EU-CEE countries as well as the impact of the type of approval and disease on reimbursement decisions., Methods: For each drug, the information regarding conditional approval or approval under exceptional circumstances was obtained from the EMA website. The reimbursement status for analyzed drugs was collected in a questionnaire survey performed in a group of experts in reimbursement policy. The agreement between countries was assessed using the κ coefficient, nominal variables tests were compared using the χ2 test or the Fisher exact test. The impact of the EMA's conditional approval and approval under exceptional circumstances was assessed using logistic regression and presented as an odds ratio (OR)., Results: The analysis revealed that most orphan drugs were authorized for the treatment of oncological or metabolic diseases [36 drugs (38%) and 22 drugs (23%), respectively]. The shares of reimbursed orphan drugs varied significantly ( p = 0.0031) from 6.3% in Latvia to 27.4% in Poland. No correlation ( r = 0.02; p = 0.9583) with GDP per capita was observed. The highest agreement in reimbursement decisions was observed between Estonia and Lithuania, and the lowest - between Estonia and Latvia, with kappa of 0.69 and 0.11, respectively. Significant impact of the type of approval and reimbursement status was observed for Czechia, Lithuania and Slovakia where conditional approval and exceptional circumstances negatively influenced reimbursement decision. Type of disease has significant influence on reimbursement decision in 4 out of 10 analyzed countries with significant outweigh of positive decisions for oncological diseases., Conclusion: In considered countries specific regulations on reimbursement of orphan drugs are valid but in Lithuania and Romania no formal HTA process was employed; in case of some countries higher ICER values for orphans are used. The share of reimbursed orphan drugs varied significantly across the countries, but it was not associated with GDP per capita.

Interventions: Targeted therapies have been proven to provide clinical benefits to patients with metastatic non-small cell lung cancer (NSCLC). Gefitinib was initially approved and reimbursed as a third-line therapy for patients with advanced NSCLC by the Taiwan National Health Insurance (NHI) in 2004; subsequently it became a second-line therapy (in 2007) and further a first-line therapy (in 2011) for patients with epidermal growth factor receptor mutation-positive advanced NSCLC. Another targeted therapy, erlotinib, was initially approved as a third-line therapy in 2007, and it became a second-line therapy in 2008., Objectives: This study is aimed towards an exploration of the impacts of the Taiwan NHI reimbursement policies (removing reimbursement restrictions) related to accessibility of targeted therapies., Setting: We retrieved 2004-2013 claims data for all patients with lung cancer diagnoses from the NHI Research Database., Design and Outcome Measures: Using an interrupted time series design and segmented regression, we estimated changes in the monthly prescribing rate by patient number and market shares by cost following each modification of the reimbursement policy for gefitinib and erlotinib for NSCLC treatment., Results: Totally 92 220 patients with NSCLC were identified. The prescribing rate of the targeted therapies increased by 15.58%, decreased by 10.98% and increased by 6.31% following the introduction of gefitinib as a second-line treatment in 2007, erlotinib as a second-line treatment in 2008 and gefitinib as as first line treatment in 2011, respectively. The average time to prescription reduced by 65.84% and 41.59% following coverage of erlotinib by insurance and gefitinib/erlotinib as second-line treatments in 2007-2008 and following gefitinib as the first-line treatment in 2011., Conclusions: The changes in reimbursement policies had a significant impact on the accessibility of targeted therapies for NSCLC treatment. Removing reimbursement restrictions can significantly increase the level and the speed of drug accessibility., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: In Lombardia, one of the 20 Italian administrative Regions, small-bowel capsule endoscopy (SBCE) was introduced in 2001. In January 2011, the Regional Health Authorities established a reimbursement for outpatient SBCE., Aim: To prospectively record data on SBCE between 2011-2013 and compare them to similar data retrospectively collected from the same geographical area (covering the period 2001-2008) and published in 2008., Methods: Consecutive SBCEs performed between January 2011 and December 2013 in Lombardia were prospectively collected., Results: In 3 years, 3142 SBCEs were collected; the diagnostic yield (DY) and the overall complication rate were 48.4 and 0.9%, respectively. The main indication was suspected small-bowel bleeding (76.6% of patients); complete small-bowel inspection was achieved in 2796 (89.0%) patients. SBCE was performed as an outpatient procedure in 1945 patients (61.9%). A significant increase in the rate of patients undergoing SBCE for suspected small-bowel bleeding was observed from 2001-2008 to 2011-2013 (67.3 vs. 76.1%; p < 0.001). There was an increase in the number of complete small-bowel examinations (81.2 vs. 89.0%; p < 0.001) and of outpatient SBCEs (6.7 vs. 61.9%; p < 0.001). Conversely, both the retention rate (2.1 vs. 0.8%; p < 0.001) and the rate of patients undergoing SBCE for Crohn's disease (11.5 vs. 5.5%; p < 0.001) decreased significantly. The overall DY remained stable (50.6 vs. 48.4%; p = 0.089)., Conclusion: Our study shows that, over 13 years, the SBCE safety profile and completion rate significantly improved over time; a change in the spectrum of clinical indications was also observed.

Purpose: In Italy, where the adoption of opioid analgesics in pain management has been historically poor, an increase in opioids consumption occurred between 2000 and 2015. The aim of this study is to assess, through specific time series analyses for trend changes, the impact of different intervening factors - such as the availability of new drugs, the observance of clinical guidelines, changes in prescription regulations, and in reimbursement policies - on opioids sales to community pharmacies in Italy, focusing on the time period 2000-2010., Materials and Methods: Five opioids were considered: codeine, tramadol, buprenorphine, morphine, and fentanyl. The analysis is based on sales data collected at wholesale distributors. For each one of the five drugs, time series of the number of Defined Daily Doses per thousand inhabitants per day in the period 2000-2010 were analyzed, and an estimation of breakpoints was performed using segmented linear regression., Results: Drug sales underwent a sharp increase in 2000-2010, although on different scales. Segmented regression analysis highlighted different potential breakpoints, corresponding to either a significant change in value and/or in slope. Sales of the five opioids were affected by at least one relevant event, often due to a synergy of regulatory, marketing, and technological factors. The effect of reimbursement changes has proved important., Conclusion: Between 2000 and 2010, regulatory, technological, and reimbursement changes significantly influenced opioid sales to community pharmacies in Italy. The sales of relatively new drug products seem to be less influenced by changes in reimbursement and regulatory policies than that of more established products, suggesting that physicians are more comfortable with "old" drugs, since their clinical use is supported by established clinical guidelines and protocols., Competing Interests: Disclosure CB has received consultancy fees from Molteni Farmaceutici and from Mundipharma Pharmaceuticals. AC has received consultancy fees from Italfarmaco, Prostrakan, Mundipharma Pharmaceuticals, Amgen, Grunenthal, Molteni farmaceutici, Novartis. CB has received a training grant from the Floriani Foundation - Milan (del.CDA 22/11/12). The authors report no other conflicts of interest in this work.

Rates of short-interval pregnancies that result in unintended pregnancies remain high in the United States and contribute to adverse reproductive health outcomes. Long-acting reversible contraception methods have annual failure rates of <1%, compared with 9% for oral contraceptive pills, and are an effective strategy to reduce unintended pregnancies. To increase access to long-acting reversible contraception in the immediate postpartum period, several State Medicaid programs, which include those in Iowa and Louisiana, recently established reimbursement policies to remove the barriers to reimbursement of immediate postpartum long-acting reversible contraception insertion. We used a mixed-methods approach to analyze 2013-2015 linked Medicaid and vital records data from both Iowa and Louisiana and to describe trends in immediate postpartum long-acting reversible contraception provision 1 year before and after the Medicaid reimbursement policy change. We also used data from key informant interviews with state program staff to understand how provider champions affected policy uptake. We found that the monthly average for the number of insertions in Iowa increased from 4.6 per month before the policy to 6.6 per month after the policy; in Louisiana, the average number of insertions increased from 2.6 per month before the policy to 45.2 per month. In both states, the majority of insertions occurred at 1 academic/teaching hospital. In Louisiana, the additional increase may be due to the engagement of a provider champion who worked at both the state and facility level. Recruiting, training, engaging, and supporting provider champions, as facilitators, with influence at state and facility levels, is an important component of a multipart strategy for increasing successful implementation of state-level Medicaid payment reform policies that allow reimbursement for immediate postpartum long-acting reversible contraception insertions., (Published by Elsevier Inc.)

Objectives: Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes., Methods: This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017., Results: Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders., Conclusions: Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.

In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers' innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland., Competing Interests: The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere. Creativ-Ceutical is a consulting company that provides pricing and reimbursement-related services worldwide, including Poland.

Telemedicine is an emerging field in healthcare that provides services from different medical specialties to patients all around the world. One of the specialties in telemedicine, teledermatology, has grown exponentially as a cost-effective way to implement dermatological healthcare to underserved areas and populations. This article reviews the literature that pertains to the cost-effectiveness, reliability, public access, patient satisfaction, and reimbursement policies of teledermatology. Teledermatology was found to be cost-effective and reliable in reducing in-person visits and time away from work, and allows for the faster delivery of care. However, reimbursement policies for teledermatology services are rather new and vary significantly from state to state. As public interest in and access to teledermatology continue to grow, the future of teledermatology depends on the development of new technology as well as quality improvement strategies and the evolution of sustainable reimbursement policies.

The Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices constitutes a major change of the reimbursement policy in Poland. The main aims of this Act were to rationalize the reimbursement policy and to reduce spending on reimbursed drugs. The Act seems to have met these goals: reimbursement policy (including pricing of reimbursed drugs) was overhauled and the expenditure of the National Health Fund on reimbursed drugs saw a significant decrease in the year following the Act's introduction. The annual savings achieved since then (mainly due to the introduction of risk sharing schemes), have made it possible to include new drugs into the reimbursement list and improve access to innovative drugs. However, at the same time, the decrease in prices of reimbursed drugs, that the Act brought about, led to an uncontrolled outflow of some of these drugs abroad and shortages in Poland. This paper analyses the main changes introduced by the Reimbursement Act and their implications. Since the Act came into force relatively recently, its full impact on the reimbursement policy is not yet possible to assess., (Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Background: Endocrine therapy is one of the standard treatments for estrogen-receptor-positive breast cancer patients. Letrozole is the only aromatase inhibitor (AI) included in Thailand's essential drug list since the change of reimbursement policy in 2008, when patients had to change their AIs (other than letrozole) to letrozole. This study aimed to prove that the efficacy of anastrozole plus letrozole is not less than anastrozole alone., Methods: All medical records of breast cancer patients taking anastrozole between 2004 and 2013 were reviewed. Some patients were initially treated with anastrozole and then changed to letrozole (A-LTZ group), whereas the other patients were continuously treated with anastrozole until completion of therapy (ANZ group)., Results: In a total of 180 (55.9%) out of the 322 cases, anastrozole was replaced with letrozole. The mean age of patients in the ANZ group was 54.9 years and that of those in the A-LTZ group was 54.2 years. Clinical stages (1-4) of the ANZ versus A-LTZ patients were four versus four, 76 versus 116, 46 versus 46, and 16 versus 14, respectively. ANZ patients took AI monotherapy (46.5%) and switching strategy (53.5%), while A-LTZ patients took AI monotherapy (53.9%) and switching strategy (46.1%). The overall survival (OS) of A-LTZ patients was longer than that of ANZ patients. Stage 2 and 4 patients in the A-LTZ group also had better OS than those in the ANZ group, but stage 3 patients had similar OS in both groups., Conclusion: Anastrozole can be replaced by letrozole any time during endocrine therapy. The patients taking anastrozole plus letrozole surprisingly seemed to have better OS than patients taking anastrozole alone.