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Somatic gene editing (SGE) holds great promise for making genetic therapy possible for many monogenic conditions very soon. Is our current system of European market authorization and reimbursement ready for the expected tsunami of gene therapies? At a recent workshop of the Netherlands ZonMw consortium on ethical, legal, and social implications of personalized medicine, we discussed the current possibilities for bringing new gene therapies to the clinic. In Europe, it is not yet clear whether the route via the European medicines agency as an advanced therapy medicinal product is the most appropriate for evaluation of highly personalized SGE applications, although this may optimally guarantee safety and effectiveness. Compassionate use may ensure faster access than the centralized procedure but does not stimulate the commercial development of products. Prescription to named patients may only provide adequate access for single patients. Temporary authorization of use may allow access to medication half a year before formal market authorization has been granted, but may also have large budget impacts. Magistral compounding under a hospital exemption may be an attractive solution for rare, tailor-made applications at an acceptable price. To approve local experimental use of a therapy on a case-by-case basis may be fast, but does not guarantee optimal safety, effectiveness, and broad implementation. We argue that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments. A balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions., (© 2021. The Author(s).)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

The 2020 coronavirus disease pandemic in the United States has created a dramatic need for the rapid implementation of telehealth services in areas of the country where telehealth is limited in scope. This implementation would not be possible without changes in how the Centers for Medicare and Medicaid Services provide reimbursement for these services. Reimbursement options remain open to pharmacists, but depend on local regulation or the ability to alter practice at the site. Though pharmacists provide high-quality direct patient care, they are excluded from seeking compensation for providing this care, even as the nation expands the telehealth model. This overview shows that despite changes in telehealth service compensation for health care providers, pharmacists remain unable to seek appropriate compensation for their direct patient care services., (Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate spillover effects of Medicaid antipsychotic prior authorization (PA) policies among commercially insured youth., Methods: Commercially insured youth residing in nine US states that implemented PA exclusively for antipsychotics in 2011 or 2012 were identified using a 10% random sample of enrollees in the IQVIA PharMetrics Plus database spanning 2007 to 2015. Youth were included if they were ≤18 years, met the age criteria of the PA at the time of dispensing, and had at least 1 month of prescription drug coverage from 2007 to 2015. The primary outcome of interest was the monthly prevalence of antipsychotics. We implemented segmented regression of interrupted time series analysis to estimate changes in the monthly prevalence of targeted medications, overall and stratified by age. Trends were compared in the 4-year period before and the 3-year period after implementation of PA policies., Results: Antipsychotics prescribing significantly decreased 6.74/10 000 (95% CI, -9.04 to -4.44) enrollees per month immediately after PA implementation. However, PA was not associated with significant long-term trend changes (-0.06; 95% CI, -0.16 to 0.03). Antipsychotic prescribing in children <12 years-old significantly decreased 0.14/10 000 (95% CI, -0.21 to -0.07) enrollees per month after PA implementation, while prescribing in adolescents 12 to 18 years-old significantly increased 0.32/10 000 (95% CI, 0.16 to 0.47) enrollees per month., Conclusion: While Medicaid PA polices for antipsychotic oversight did not affect overall prescribing, there were spillover effects in U.S. commercially insured children <12 years-old. This suggests that state-level Medicaid policies intended to improve the quality of care and safe use of antipsychotics can have broad reach., (© 2020 John Wiley & Sons Ltd.)

Objectives: To estimate the impact on testosterone prescribing over 3 years following the 2015 tightening of Pharmaceutical Benefits Scheme (PBS) criteria., Design: Analysis of testosterone prescribing data from PBS and private (non-PBS) sources between 2012 and 2018 covering 2015 change in PBS prescribing criteria., Main Outcome Measures: New and total PBS testosterone prescriptions estimating usage by quarter analyzed by product type, patient age-group, indication and prescriber type. Total national testosterone prescriptions (private plus PBS) was verified from an independent data supplier (IQVIA)., Results: PBS usage peaked in 2014 declining by 30% in 2017-8 with PBS prescribing covering a fall from 97.6% by usage in 2014 to 74% in 2017-18 of all testosterone prescribing. The tighter 2015 PBS restrictions sustained the selective reduction in GP initiation of prescriptions for middle-aged men without pathological hypogonadism whereas specialist initiations and prescription for adult hypogonadism or pediatric/prepubertal indications were largely unaffected., Conclusions: The tightening of PBS criteria from 1 April 2015 to curb off-label prescribing remained effective and selective over 3 years yet total national testosterone prescribing continued with little change, reflecting a shift to private prescriptions. The continuation of off-label testosterone prescribing for unproven indications suggests that long-term androgen dependence is created in men without pathological hypogonadism who commence testosterone. This highlights the need to avoid prescribing testosterone to men without pathological hypogonadism in the absence of sound evidence of efficacy and safety, the latter including the little unrecognized risks of long-term androgen dependency when trying to quit., (© 2020 John Wiley & Sons Ltd.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Executive Summary: We sought to determine emergency medicine physicians' accuracy in designating patients' disposition status as "inpatient" or "observation" at the time of hospital admission in the context of Medicare's Two-Midnight rule and to identify characteristics that may improve the providers' predictions. We conducted a 90-day observational study of emergency department (ED) admissions involving adults aged 65 years and older and assessed the accuracy of physicians' disposition decisions. Logistic regression models were fit to explore associations and predictors of disposition. A total of 2,257 patients 65 and older were admitted through the ED. The overall error rate in physician designation of observation or inpatient was 36%. Diagnoses most strongly associated with stays lasting less than two midnights included diverticulitis, syncope, and nonspecific chest pain. Diagnoses most strongly associated with stays lasting two or more midnights included orthopedic fractures, biliary tract disease, and back pain. ED physicians inaccurately predicted patient length of stay in more than one third of all patients. Under the Two-Midnight rule, these inaccurate predictions place hospitals at risk of underpayment and patients at risk of significant financial liability. Further work is needed to increase providers' awareness of the financial repercussions of their admission designations and to identify interventions that can improve prediction accuracy.

In 1992, the use of relative value units to link a particular payments with specific services was initiated to replace traditional fee for service. The system incentivizes volume rather than quality. In 1997, initiatives were formalized to emphasize quality measures. Physicians must participate in the Merit-based Incentive Payment System (MIPS). Physicians can opt out of MIPS if they participate in an Alternative Payment Model such as Bundled Payments. Reimbursement based on an episode of care reduces perceived incentive to increase volumes, but may result in difficulty with access to care for patients with complex medical issues or significant comorbidities., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: Health-related quality of life (HRQoL) is one of the most important patient-relevant study end-points for the direct measurement of the benefit of cancer drugs. Therefore, our aim is to detect cancer indications with no published information on HRQoL at the time of European Medicines Agency (EMA) approval and monitor any reported HRQoL evidence updates after at least three years of follow-up., Methods: We included all cancer indications that were approved by the EMA between January 2009 and October 2015. Our main sources of information were the EMA website, clinicaltrials.gov and a systematic literature search in PubMed. Information on HRQoL outcomes was extracted alongside evidence on median overall survival., Results: In total, we identified 110 indications, of which more than half (n = 58, 53%) were lacking available information on HRQoL assessments at the time of EMA approval. After a monitoring period of at least three years, 24 updates were identified, resulting in 34 (31%) therapies where information on HRQoL was still not available. For the 76 therapies with reported information on HRQoL, cancer-specific instruments were mostly used (n = 49/76). Regarding cumulative evidence on median overall survival and HRQoL, 33 (n = 33/110, 30%) as well as 15 (n = 15/110, 14%) cancer drugs were lacking information on both study end-points at the time of approval and after monitoring, respectively., Conclusion: Our results demonstrate that there is an urgent need of routine re-evaluation of reimbursed cancer drugs with initially missing information on major outcomes. Standardisation of the typology and quality of HRQoL assessments need to be improved to allow better comparability of results., Competing Interests: Conflict of interest statement None to declare., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The regulation of telemedicine in the United States is evolving, with new legislation expanding reimbursement and cross-state licensing capabilities. As telemedicine grows, communities with limited access to traditional dermatologic care may find a solution in teledermatology. A search of the medical literature and online health care law resources published within the past decade was performed to assess the current status of telemedicine availability, health record integration and security, reimbursement policy, and licensure requirements in the United States, with a focus on teledermatology. The majority of states have implemented policies requiring private insurance coverage. Medicaid reimburses some form of telemedicine in all states but restricts which modalities can be used and by which specialties. Medicare places the heaviest limitations on telemedicine coverage. Twenty-four states and Guam are members of the Interstate Medical Licensure Compact (IMLC), and 27 states offer alternative cross-state practice options. With the advent of publicly and privately funded programs, volunteer efforts, and mobile applications, teledermatology is more readily available to rural and underserved communities., (Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The political action committee (PAC) of the American Association of Neurological Surgeons, known as NeurosurgeryPAC, was formed in August 2005 to strengthen neurosurgical advocacy efforts. Since its establishment, NeurosurgeryPAC has made nonpartisan, direct campaign contributions to hundreds of candidates for the U.S. Senate and U.S. House of Representatives., Methods: Historical contribution data for 2005-2018 was obtained from NeurosurgeryPAC. Data analyzed by year, and a 2-year election cycle included total amount raised, number of contributors, average donation, and percent participation. NeurosurgeryPAC contribution amounts for election cycles were also compared with those of other physician PACs., Results: NeurosurgeryPAC has raised $2,953,870 since its inception in 2005, for an average of $210,991 per year. For this fundraising, the average annual donation amount is $796 per donor. The number of unique contributors per cycle has varied from 316-504, with an average of 389 individuals per annum and a participation rate of 7.8%. To date, the total amount raised in election years ($1,605,940) is 16.1% higher than that raised in nonelection years ($1,347,930). Among 28 physician PACs, NeurosurgeryPAC has ranked as high as 13 and as low as 17 in total hard money contributions. The orthopedic, neurology and general surgery PACs have consistently ranked higher than NeurosurgeryPAC, whereas the otolaryngology, spine, and plastic surgery PACs have ranked lower., Conclusions: Since its creation, NeurosurgeryPAC has collected a steady stream of donations to support political candidates. These donations have helped lawmakers who are supportive of policy issues important to neurosurgery, particularly physician reimbursement, medical liability reform, and graduate medical education. However, there remains a significant opportunity to increase the neurosurgeon participation rate in this vital organization. It is truly through advocacy that we will be able to positively affect the future of neurologic surgery in the United States., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Workforce and reimbursement data were collected from a 2018 survey of Washington state advanced registered nurse practitioners (ARNPs). Survey results will be used to improve workforce planning and advocate for payment parity legislation requiring health plans to pay ARNPs the same as physicians for the same service.

A large number of medical devices (MDs) is available in Europe. Procedures for market approval and reimbursement have been adopted over recent years to promote accelerating patient access to innovative MDs. However, there remains uncertainty and non-transparency regarding these procedures. We provide a structured overview of market approval and reimbursement procedures and practices regarding access to MDs in the EU. Market approval procedures were found to be uniformly described. Data on reimbursement procedures and practices was both heterogeneous and incomplete. Time to MD access was mainly determined by reimbursement procedures. The influence of the patient on time to access was not reported. Prescription practices varied among device types. Barriers to and facilitators of early patient access that set the agenda for policy implications were also analyzed. Barriers were caused by unclear European legislation, complex market approval procedures, lack of data collection, inconsistency in evidence requirements between countries, regional reimbursement and provision, and factors influencing physicians' prescription including the device costs, waiting times and hospital-physician relationships. Facilitators were: available evidence that meets country-specific requirements for reimbursement, diagnosis-related groups, additional payments and research programs. Further research needs to focus on creating a complete overview of reimbursement procedures and practices by extracting further information from sources such as grey literature and interviews with professionals, and defining clear criteria to objectify time to access., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Off-label use (OLU) of a drug reflects a perceived unmet medical need, which is common in oncology. Cancer drugs are often highly expensive and their reimbursement is a challenge for many healthcare systems. OLU is frequently regulated by reimbursement restrictions. For evidence-based healthcare, treatment ought to be reimbursed if there is sufficient clinical evidence for treatment benefit independently of patient factors not related to the treatment indication. However, little is known about the reality of OLU reimbursement and its association with the underlying clinical evidence. Here, we aim to investigate the relationship of reimbursement decisions with the underlying clinical evidence., Methods/ Design: We will extract patient characteristics and details on treatment and reimbursement of cancer drugs from over 3000 patients treated in three Swiss hospitals. We will systematically search for clinical trial evidence on benefits associated with OLU in the most common indications. We will describe the prevalence of OLU in Switzerland and its reimbursement in cancer care, and use multivariable logistic regression techniques to investigate the association of approval/rejection of a reimbursement requests to the evidence on treatment effects and to further factors, including type of drug, molecular predictive markers and the health insurer., Discussion: Our study will provide a systematic overview and assessment of OLU and its reimbursement reality in Switzerland. We may provide a better understanding of the access to cancer care that is regulated by health insurers and we hope to identify factors that determine the level of evidence-based cancer care in a highly diverse western healthcare system., Competing Interests: Competing interests: BK declares consultant activities for Roche and Siemens, research grants from Roche/AbbVie, travel support from Riemser, AbbVie and Amgen. UN declares consultation or advisory role for Roche, Astra, Gilead and Celgene, and honoraria (congress participations) from Amgen, Novartis, Takeda and Roche., (© Author (s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)

Ambulatory blood pressure monitoring (ABPM) is considered the best means of diagnosing hypertension. However, it is rarely used and is reimbursed only under narrow conditions. We sought to gain insight into the perceived value of ABPM among stakeholders who responded to the Centers for Medicare and Medicaid Services' (CMS) request for comments to inform the first revision of ABPM reimbursement policy in over 15 years. We found that most comments were classifiable in two main themes, current coverage and future coverage. Individuals and institutions representing multiple disciplines and specialties were highly supportive of expanding the current CMS coverage of ABPM, including for a wide range of clinical indications and populations. It is clear from the comments reviewed that there is wide support for expanding CMS coverage for ABPM. Broad support for a change in ABPM reimbursement policy may lead to changes in the way this technology is used in the United States., (© 2019 Wiley Periodicals, Inc.)

Objectives : The current study aims to analyze, from a historical perspective, the regulatory framework of prices and reimbursement in Bulgaria with emphasis on the introduction of economic evaluation. Methods : The study explores all regulatory changes during the period 1995-2016 combining the macroeconomic and regulatory analysis on medicines pricing and reimbursement. A roadmap summarizing the current regulatory requirements for the medicinal product entrance on national market and access to public funding was elaborated. Results : Demographic processes in the country have been negative for the past decade. On the other hand, health care and pharmaceutical expenditures experienced a growth up to 8.6% and 3% of total GDP, respectively. The total pharmaceutical market permanently grew from 309 to 1409 million of Euro. During the last 20 years, the pricing and reimbursement legislation of medicines in Bulgaria was changed extensively. Conclusion : Pricing policy remains oriented toward the lowest European prices and reimbursement policy impose cost containment measures. Appraisal of the obligatory Health Technology Assessment Dossiers and pharmacoeconomic analysis is in accordance with world recommendations. Main regulatory issues that still remain to be tackled are the slower entrance of medicines on the national market and lower national prices that often lead to parallel import.

Objectives: This study aimed to identify the barriers and facilitators to improve the use of health technology assessment (HTA) for the selection of medicines listed in the e-Catalogue and the national formulary in Indonesia., Methods: Semi-structured interviews were conducted to collect qualitative data. Purposive sampling was used to recruit the stakeholders consisting of policymakers, a pharmaceutical industry representative, healthcare providers, and patients. The data were analyzed using directed content analysis and following the COnsolidated criteria for REporting Qualitative studies (COREQ)., Results: The twenty-five participants interviewed agreed with the use of HTA for supporting the e-Catalogue and the national formulary and perceived the advantages of HTA implementation outweighed the disadvantages. Barriers mentioned were a lack of capability of local human resources, financial incentives, a clear framework and insufficient data. Strategies suggested to overcome the barriers were establishing (inter)national networks to build up capacity, setting up departments of HTA in several universities in Indonesia, and introducing a clear HTA framework. Facilitators mentioned were the ambition to achieve universal health coverage, the presence of legal frameworks to implement HTA in the e-Catalogue and the national formulary, and the demands for appropriate medicine policies., Conclusions: Several barriers are currently hampering broad implementation of HTA in medicine pricing and reimbursement policy in Indonesia. Solutions to these issues appear feasible and important facilitators exist., Competing Interests: The authors have declared that no competing interests exist.

Competing Interests: Der Autor gibt an, dass kein Interessenkonflikt besteht.

Background: Unintended pregnancies, occurring in nearly 1 out of every 2 (45%) pregnancies in the United States, are associated with adverse health and social outcomes for the infant and the mother. The risk of unintended pregnancies is significantly reduced when women use long-acting reversible contraceptives, namely intrauterine devices and implants. Inadequate reimbursement for long-acting reversible contraceptive devices may be an access barrier to long-acting reversible contraceptive uptake. In 2014, the Louisiana Department of Health Bureau of Health Services Financing implemented a policy change that increased the Medicaid reimbursement rates for acquiring long-acting reversible contraceptive devices to the wholesale acquisition cost., Objective: To examine the association of a Medicaid policy change that increased the long-acting reversible contraceptive device reimbursement rate to the wholesale acquisition cost (ie, price set by the manufacturers) on long-acting reversible contraceptive uptake among women at risk for unintended pregnancy., Materials and Methods: This retrospective, repeated cross-sectional study used 2013-2015 Louisiana Medicaid claims data and contraceptive provision measures to assess associations between patient (age, race, urban/rural residence, postpartum status) and provider (urban/rural location, specialty) characteristics and long-acting reversible contraceptive uptake among contraceptive users (N = 193,623) using bivariate and logistic regression analyses., Results: After long-acting reversible contraceptive reimbursement increased, there was a 2-fold likelihood increase in use in 2015 vs 2013 (odds ratio, 2.08; 95% confidence interval, 1.69-2.55). Long-acting reversible contraceptive uptake was more likely across all patient and provider subgroups in 2015 vs 2013 but notably among patients receiving contraceptive care from family planning clinics (odds ratio, 3.93; 95% confidence interval, 2.34-6.62)., Conclusion: Removal of a provider-level financial barrier to long-acting reversible contraceptive provision was associated with increased long-acting reversible contraceptive uptake among women at risk for unintended pregnancy. Efforts to improve long-acting reversible contraceptive access should focus on equitable healthcare reimbursement for healthcare providers of reproductive-aged women., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

The cost of health care within the United States has continued to increase, whereas the quality of patient care has generally decreased in some areas. With the continued use of Medicare's former physician reimbursement algorithm, termed sustainable growth rate, national expenditures within the United States have been expected to increase 5.6% annually. To modernize the delivery and financing of care, Congress has introduced the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which has permanently eliminated and replaced the sustainable growth rate. The purpose of this study was to review MACRA and its implementation to determine how it would financially impact rural hospitals. Two reimbursement pathways have been created for physicians under the MACRA. In addition, the financing and competition among facilities created by the act have been expected to impact physicians and health care organizations. Rural hospitals have been set to receive reduced government reimbursements and have been predicted to compete poorly with larger hospitals and health care corporations. Furthermore, the payment tracks available through the act have been projected to impact solo and small practice physicians negatively.

In the United States, there is an increased interest to understand the value of health technologies. Cost-effectiveness analysis is arguably the most appropriate framework to quantify value and to inform reimbursement decision making regarding medical interventions; however, a thorough analysis is resource intensive and complex. In many countries, the cost-effectiveness of medical interventions is evaluated by expert agencies at the national level, but in the United States, reimbursement decision making occurs at the local level. This raises the question of how we can provide a means to transparent cost-effectiveness analysis that reflects the local context and patient population and is based on the latest evidence and scientific insights. In other words, how can we maximize the relevance and credibility of cost-effectiveness evaluations in the context of a decentralized decision-making environment? Published cost-effectiveness analyses typically fail on these dimensions. Access to transparent open-source models that can be adapted to reflect the local setting in a relatively straightforward manner is an essential step toward such a goal. However, no model for cost-effectiveness analysis is ever truly "right" or "complete," and it must evolve along with clinical evidence and improvements in scientific methodology to ensure that its credibility remains. We propose a transparent approach of iterative development and collaboration between content and methodology experts to produce up-to-date, open-source consensus-based cost-effectiveness models that account for parameter and structural uncertainty to help local decision makers understand the confidence with which they might make a decision. Our proposed approach provides a way to adapt formal assessments of value-long the province of centralized health care systems-into the decentralized U.S. health care landscape. DISCLOSURES: This research was funded through the Innovation and Value Initiative, a nonprofit multistakeholder research organization. The Innovation and Value Initiative contracted with Precision Medicine Group for research activities related to this article. Jansen and Incerti are salaried employees and shareholders of Precision Medicine Group. Curtis is a paid consultant for the Innovation and Value Initiative. Curtis also reports consulting fees and grants from Amgen, AbbVie, BMS, Corrona, Janssen, Lilly, Myriad, Pfizer, Roche/Genentech, Radius, and UCB, unrelated to this article.

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Aims: This study examines the effects of recent changes in Medicare long-term care hospital (LTCH) payments on treatment patterns and outcomes for severe wound patients discharged from short-term acute care hospitals (STACHs)., Materials and Methods: The rolling implementation of a new Medicare payment policy was used to develop a difference-in-difference model. The study population consisted of Medicare beneficiaries subjected to the payment policy changes and hospitalized for stage 3, 4, or unstageable wounds; non-healing surgical wounds; and fistula. Using 2015-Q1-2017 Medicare claims data, changes in outcomes were examined for severe wound patients exposed to the new policy (treatment) and those that were not (comparison). All outcomes were modeled using linear regressions and adjusted for patient clinical characteristics. Analysis was conducted in a full sample and a sample with high-LTCH-use propensity., Results: Severe wound patients exposed to the new policy experienced 4.1 and 7.5 percentage point (pp) reductions in LTCH use relative to the comparison group in the full sample and high-LTCH-propensity sample, respectively (p < .01 and p = .039). No statistically significant change was found in 60-day mortality or Medicare spending after the policy change in the treatment group as compared to the comparison group (p > .10). However, among severe wound patients who are exposed to the new policy in the high-LTCH-propensity sample, readmission and post-discharge sepsis rates increased after the policy change relative to the comparison group (readmission rate = 8.1 pp, p = .075; sepsis rate = 7.0 pp, p = .033)., Limitations: The findings are based on data from a limited timeframe around the policy change and, thus, provide only early evidence on the effects of the new policy., Conclusion: The new LTCH payment policy is associated with no changes in Medicare spending and mortality, but higher readmissions and post-discharge sepsis rates among severe wound patients with a high likelihood to use an LTCH.

Background: Since 2012, the pharmaceutical reimbursement legislation in Germany has been applying external reference pricing that uses country-specific economic weights for foreign prices. However, the law does not specify technical details. Therefore, we develop a proposal on how national income weights can be taken into consideration., Areas Covered: We develop weighting schemes that draw on gross domestic product per capita and adjust for purchasing power parities and exchange rates. In a second step, we populate the weighting schemes with economic data as well as with the price data for a pharmaceutical product (abiraterone acetate). Weighting the price of abiraterone acetate by gross domestic product per capita indicates potential price differentials of up to 43 percentage points across European prices in the German basket., Expert Commentary: The weighting of foreign pharmaceutical prices by economic indicators, i.e. gross domestic product per capita, can capture economic differences across countries. It would also allow for differential Ramsey pricing which might foster innovation.

The Medicare Access and CHIP Reauthorization Act of 2015 was signed into law on April 16, 2015, fundamentally altering the way clinicians are reimbursed for the treatment of Medicare patients starting in 2017. Under this new pay-for-performance model, reimbursement will be tied to multiple metrics related to quality and cost of care. A scaled scoring system will require providers to compete for positive reimbursement adjustments, while also penalizing poor performers with negative adjustments. A firm understanding of this new system will be essential for all physicians looking to maximize their reimbursement, particularly diagnostic radiologists and members of other highly focused fields where special considerations lead to alterations in the scoring system., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Organized medicine long yearned for the demise of Medicare's Sustainable Growth Rate (SGR) formula for updating physician fees. Congress finally obliged in 2015, repealing the SGR as part of the Medicare Access and CHIP Reauthorization Act (MACRA). MACRA established value-based metrics for physician payment and financial incentives for doctors to join alternative delivery models like patient-centered medical homes. Throughout the law's initial implementation, the politics of accommodation prevailed, with federal officials crafting final rules that made MACRA more favorable for physicians. However, the era of accommodation could be short-lived. The discretion that the Centers for Medicare and Medicaid Services had during the first two years of implementation is ending. Additionally, euphoria over the SGR's repeal has given way to concerns over the new program's value-based purchasing arrangements and uncertainty over their sustainability. MACRA eliminated the SGR, but not the politics of physician payment., (Copyright © 2018 by Duke University Press.)