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Abstract 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

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

The co-existence of external referencing pricing (ERP) and reimbursement policy is common in many countries. Thus, this research examines whether or not the imposition of ERP is socially desirable in the presence of reimbursement policy. For direct sales channel, we find that the home social welfare is worse-off with ERP if the home copayment rate is too high. Our main results are robust under indirect sales channel. Moreover, the home social welfare under the pharmacypurchasing- price (PPP) ERP is larger than that under the ex-factory-price (EFP) ERP if the home copayment rate is high enough. Finally, the profit of brand-name firm under indirect sales channel is higher than that under direct sales channel if the home copayment rate is too high. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. To understand the NP perception of early implementation of FPA in Massachusetts. 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. 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. 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. • Many employers did not communicate about full practice authority. • Physician influence and bureaucratic structure obstructs employer adoption of FPA. • External policies remained that financially incentivized employers to not adopt FPA. • Payer policies must align with state law to fully implement FPA. [ABSTRACT FROM AUTHOR]

Abstract 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.

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. 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. 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). 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. 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. 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). 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. [ABSTRACT FROM AUTHOR]

Umberto Maria Musazzi,1 Paolo Rocco,1 Cinzia Brunelli,2,3 Luisa Bisaglia,4 Augusto Caraceni,2,3 Paola Minghetti1 1Department of Pharmaceutical Sciences, University of Milan, Milan, Italy; 2Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milano, Italy; 3European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; 4Department of Statistical Sciences, University of Padua, Padua, Italy 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. Keywords: opioids sales, community pharmacy, reimbursement policy, legislation changes, breakpoint estimation

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. [ABSTRACT FROM AUTHOR]

BackgroundReimbursement policies influence access of patients to orphan drugs in the European countries.ObjectivesTo 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.MethodsFor 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).ResultsThe 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.ConclusionIn 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.

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.

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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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.

Background: Paralleling the growth of bariatric surgery, the demand for post-bariatric body-contouring surgery is increasing and placing additional burdens on already strained health care systems. In Austria, medically necessary body contouring is covered by public health care. In a sample of 622 women, we assessed the proportion of patients that underwent post-bariatric surgery at least 2 years after gastric bypass. Methods: Former bariatric patients were asked whether they had undergone post-bariatric surgery or were planning to do so by structured telephone interviews. For patients who had undergone body contouring, the degree of satisfaction with the results was inquired. Costs for bariatric and post-bariatric procedures were assessed. Results: Of 622 patients, 93 (14.9 %) had undergone body contouring and 68 (10.9 %) considered a procedure, while 454 (73 %) definitely stated that they did not want plastic surgery. Cost coverage was declined in 7 patients (1.1 %). Plastic procedures ( n = 101) included 65 abdominoplasties, 25 lower body lifts without thigh lifts, 7 brachioplasties, and 4 minor procedures. Forty-nine patients were very satisfied with the results, 28 were fairly satisfied, and 16 were not satisfied. Body contouring added about 6 % to the costs of surgical treatment for morbid obesity. Conclusions: Fewer patients than in other studies expressed a desire for post-bariatric surgery, 15 % actually proceeded to this step. The low demand was neither due to denied coverage nor to unfavourable results of plastic surgery. Additional costs for body contouring were less than expected. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Health care providers may vertically integrate not only to facilitate coordination of care, but also for strategic reasons that may not be in patients' best interests. Optimal Medicare reimbursement policy depends upon the extent to which each of these explanations is correct. To investigate, we compare the consequences of the 1997 adoption of prospective payment for skilled nursing facilities (SNF PPS) in geographic areas with high versus low levels of hospital/SNF integration. We find that SNF PPS decreased spending more in high integration areas, with no measurable consequences for patient health outcomes. Our findings suggest that integrated providers should face higher-powered reimbursement incentives, i.e., less cost-sharing. More generally, we conclude that purchasers of health services (and other services subject to agency problems) should consider the organizational form of their suppliers when choosing a reimbursement mechanism. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To inform efforts aimed at reducing Medicare hospice expenditures by describing the longitudinal use of hospice care in nursing homes (NHs) and examining how hospice provider growth is associated with use. DESIGN: Longitudinal study using NH resident assessment (Minimum Data Set) and Medicare denominator and claims data for 1999 through 2006. SETTING: NHs in the 50 U.S. states and the District of Columbia. PARTICIPANTS: Persons dying in U.S. NHs. MEASUREMENTS: Medicare beneficiaries dying in NHs, receipt of NH hospice, and lengths of hospice stay were identified. The number of hospices providing care in NHs was also identified, and a panel data fixed-effect (within) regression analysis was used to examine how growth in providers affected hospice use. RESULTS: Between 1999 and 2006, the number of hospices providing care in NHs rose from 1,850 to 2,768, and rates of NH hospice use more than doubled (from 14% to 33%). With this growth came a doubling of mean lengths of stay (from 46 to 93 days) and a 14% increase in the proportion of NH hospice decedents with noncancer diagnoses (69% in 1999 to 83% in 2006). Controlling for time trends, for every 10 new hospice providers within a state, there was an average state increase of 0.58% (95% confidence interval=0.383–0.782) in NH hospice use. Much state variation in NH hospice use and growth was observed. CONCLUSION: Policy efforts to curb Medicare hospice expenditures (driven in part by provider growth) must consider the potentially negative effect of changes on access for dying (mostly noncancer) NH residents. [ABSTRACT FROM AUTHOR]

Abstract: The expenditures for hospital drugs are continuously increasing, and grow much faster than the global hospital budgets do. This explosive growth is caused mainly by a few so-called ‘expensive drugs’ of which the oncolytics form the main part. The global budgets should stimulate more effective provision of care (‘technical efficiency’), however the room for technical efficiency is decreasing. Hospitals thus have to make impossible choices, so that eventually equal access can no longer be guaranteed. If no other policies are applied, health care goals will no longer be met. This paper tries to map the contours of the current problem and its possible solutions. It is time governments take up their responsibility and take back control. [Copyright &y& Elsevier]

Background: Antimicrobial drug resistance continues to be a concern. Inappropriate use of antimicrobial agents is a well-documented contributory factor in the development of resistance. Canadian publicly funded drug insurance (pharmacare) programs have various approaches to reimbursement for antimicrobial drugs and promoting the appropriate prescribing of these agents.Objective: The objective of this study was to examine changes in antimicrobial use over a 3-year period in relation to the reimbursement policies of the public drug insurance programs for elderly persons in Manitoba, Nova Scotia, and Saskatchewan.Methods: The pharmacare databases of the 3 provincial drug insurance programs were accessed for fiscal years 1995/96, 1996/97, and 1997/98. Antimicrobial drug use was reported as mean age- and sex-standardized defined daily doses (DDDs) dispensed per 1000 beneficiaries per year. Provincial antimicrobial drug use was compared and related to provincial reimbursement policies.Results: The rates and types of antimicrobial drugs dispensed to elderly beneficiaries of the Manitoba, Nova Scotia, and Saskatchewan pharmacare programs varied. Between fiscal years 1995/96 and 1997/98, DDDs of antimicrobials per 1000 beneficiaries per year decreased by 11.5% in Saskatchewan and increased by 1.2% in Manitoba and 6.2% in Nova Scotia. Rates of use of broadspectrum agents such as amoxicillin/clavulanate, azithromycin, clarithromycin, and fluoroquinolones were lower in the provinces that had reimbursement guidelines. Even when reimbursement policies were similar, as for fluoroquinolones in Manitoba and Saskatchewan, rates of use varied markedly, possibly as a result of the method of implementing the reimbursement guidelines. Use of fluoroquinolones, macrolides, penicillins, beta-lactamase-resistant penicillins, and tetracyclines was lower and use of sulfonamides and trimethoprim was greater in Saskatchewan than in Nova Scotia and Manitoba.Conclusions: The reimbursement guidelines of provincial drug insurance programs are among the factors affecting the use of antimicrobial agents. Both the type of reimbursement policy and the policy implementation mechanism affected the rate of utilization. Further research is needed to link drug-use information with data such as antimicrobial resistance patterns, diagnoses, physician visits, and hospitalizations. [Copyright &y& Elsevier]

Aims In many countries, governments and third parties find themselves paying for (reimbursing) unproven, inadequate products limiting their ability to invest in therapies with evidence of relevant patient benefit. We examined how three characteristics, level of therapeutic evidence, susceptibility of inappropriate prescribing, and intercountry variation can be used to identify inefficiencies in pharmaceutical reimbursement among four European Union countries, Austria, Belgium, the Netherlands and Sweden. Methods Specific classes of medicines were chosen to provide useful examples of how healthcare resources could be reallocated. A high level of therapeutic evidence was defined as a substantial body of evidence in at least one indication with clear-cut support of relevant patient benefit. The susceptibility of inappropriate prescribing was defined as the likelihood of prescribing a drug outside the scenario for which clear-cut evidence (if any) has been documented to produce relevant benefit for the patient. The intercountry variation represents the variation in utilization of reimbursed drugs across the four countries. Results The combination of these characteristics provides a useful tool for assessing appropriate reimbursement decisions. It would be beneficial to healthcare payers as well as patients to move resources from products that have a low level of therapeutic evidence and a high susceptibility of inappropriate prescribing to products with a high level of therapeutic evidence and low susceptibility of inappropriate prescribing, and to use intercountry variation as a signal of drug classes that should be subject to further scrutiny. Conclusions A method is presented to help policy-makers identify inefficiencies in the spending of limited health care resources, and to reallocate resources to products that have been shown to improve patient care through evidence-based medicine. [ABSTRACT FROM AUTHOR]

Current reimbursement policy of health insurance for therapeutic plasmapheresis requires proof of efficacy using the concept of evidence-based medicine. The aim of this paper is to review the outcome of plasmapheresis used to treat thrombotic microangiopathy (TMA)-associated syndromes in the last decade to provide scientific evidence to back up reimbursement applications. The strength of evidence of each reviewed study was assessed using the five levels of evidence criteria as defined by the American Society of Hematology in 1996 for assessment of the treatment of immune thrombocytopenia. The level Experimental indication was added for situations where only case reports or small series supported by pathophysiological reasoning are available. The definitions of evidence used in this paper are as follows: Level I, randomized clinical trial with low rates of error (p < 0.01); Level II, randomized clinical trial with high rates of error (p < 0.05); Level III, nonrandomized studies with concurrent control group; Level IV, nonrandomized studies with historical control group; Level V, case series without a control group or expert opinion; and Experimental, case reports and pathophysiological reasoning. The results of this analysis based on the published data is summarized as follows: The indication of plasmapheresis is assigned to Level IV evidence for thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS); cancer/chemotherapy-associated TTP/HUS is assigned to Level V evidence; and TTP/HUS refractory to standard plasma exchange and post-bone marrow transplantation TTP/HUS are assigned to Experimental indication. For both subsets, protein A immunoadsorption is reportedly successful. The other TMA-associated syndromes, hemolysis elevated liver enzymes low platelets and HUS in early childhood, are no indication of plasmapheresis. Two randomized clinical trials were performed in order to demonstrate the superiority of plasma exchange/fresh frozen plasma... [ABSTRACT FROM AUTHOR]

Objective: To analyze the additive costs and revenues resulting from expansion of a medical residency and associated subspecialty programs.Methods: Direct and indirect costs of the residency program were analyzed as was reimbursement for the costs of the residency. To determine whether expansion of the residency affected cost of care, the authors compared the costs of care on the teaching service and nonteaching services.Results: The number of residents increased from 18 medical resident and subspecialty fellows in the 1988 academic year to 36 medical residents and 12 subspecialty fellows in the 1991 academic year. Total measured costs increased by $2,036,570 to $3,911,196. Reimbursement increased to $5,319,117, of which $2,290,221 was attributed to the increase in the number of residents. Net income from the residency after subtracting costs increased by $815,714 to a total of $1,407,971, excluding any higher costs at the authors' hospital that were an indirect result of the teaching program. Costs for the same diagnosis-related groups (DRGs) were not significantly different on the teaching and nonteaching services.Conclusions: Expanding the medical residency increased the net income available to offset the higher costs per DRG at the hospital. These costs did not increase in proportion to the increase in resident numbers. Increased revenue came primarily from Medicare indirect cost reimbursement. A reduction in this rate from 7.7% to less than 4.1% would have resulted in a net loss for medical education costs. Present reimbursement policy is not aligned with actual costs or public policy goals. This may have undesired effects both now and in the future. [ABSTRACT FROM AUTHOR]

Telehealth innovation has brought important improvements in access to quality healthcare for American Indian and Alaska Native communities. Despite these improvements, substantive work remains before telehealth capability can be more available and sustainable across Indian healthcare. Some of this work will rely on system change guided by new care model development. Such care model development depends on expansion of telehealth reimbursement. The U.S. Indian healthcare system is an ideal framework for implementing and evaluating large-scale change in U.S. telehealth reimbursement policy. [ABSTRACT FROM AUTHOR]