Recent Regulatory Changes Research Articles

A Simple Tool for Recommending Postoperative Status After Lower Extremity Total Joint Replacement

There is an increasing impetus to perform primary total hip arthroplasty and total knee arthroplasty on an outpatient basis and in the outpatient setting. However, with recent federal regulatory changes, orthopedic surgeons must now evaluate patients on a case-by-case basis to determine whether an inpatient admission will be medically necessary and appropriate. We thus created our prototype Lower Extremity Inpatient-Outpatient (LET-IN-OUT) total joint replacement tool as a simple, consistent way for other clinicians to identify specific major preoperative patient comorbidities and thus to recommend independently and objectively to the orthopedic surgeon postoperative inpatient or outpatient status for a given patient.

The Check Is in the Mail: Can Disclosure Reduce Late Payments to Suppliers?

A common corporate cash management strategy is to delay payments owed to suppliers. We examine whether buyers pay suppliers faster in response to a recent regulatory change in the United Kingdom that mandates the public disclosure of buyers’ payment practices. We find that after the regulatory change, UK firms subject to this regulation shortened their payment periods relative to several control samples of firms that were not subject to the regulation. In cross-sectional tests, we predict and find that this shortening of the payment period is attenuated for firms that are less able to bear the costs of paying suppliers faster. Specifically, we find that the reduction in the payment period is smaller for buyers that (i) have longer operating cycles, (ii) depend more heavily on trade credit as a source of external financing, and (iii) pay dividends. In supplemental tests using proprietary data, we find that buyers subject to this regulation reduced their trade credit that is overdue by 30 days or more. However, this reduction is partially offset by an increase in the trade credit that is overdue by less than 30 days. Our findings are important in light of the ongoing debate in other regimes (e.g., the United States) on whether to require additional disclosures of trade credit.

Where Do We Go From Here? The Delivery of Addiction Treatment in a Post-COVID World.

Many healthcare institutions across the nation experienced significant disruptions in addiction treatment services as a result of COVID-19. As restrictions now begin to loosen, there is an opportunity to transition towards a new treatment structure informed by the experience from both the current public health crisis and precrisis operations. However, there is currently limited information on how best to do so, leaving many providers and specialty programs searching for answers. The permanent integration of recent regulatory changes into routine clinical practice, specifically regarding prescribing flexibility and use of telehealth, is yet to be determined, but implementation experience highlights the adaptability within this field of medicine. Providing patients with a spectrum of care that is both clinically informed and technologically supported should be at the forefront as we settle into a postcrisis world.

Direito sanitário: avaliação de marcos regulatórios sobre lançamento de medicamentos de base biotecnológica no Brasil

Introdução: Requerimentos regulatórios ligados à área farmacêutica têm sido crescentes nas últimas décadas, em função das novas alternativas terapêuticas que, em sua maioria, apresentam maior especificidade e menores efeitos colaterais, principalmente de medicamentos oriundos de base biológica. O sistema regulatório representa um problema para muitos países quando não há regras harmonizadas e, num contexto de mundo globalizado, nem sempre o ambiente produtivo está inserido no ambiente do usuário final. O presente trabalho avalia o painel regulatório brasileiro para produtos de origem biológica e sua consequência no desenvolvimento/lançamento desses produtos. Método: Foi realizado um levantamento com indústrias farmacêuticas, por meio de questionário, abrangendo empresas públicas e privadas, de capital nacional e estrangeiro. Resultados e considerações finais: Com base nesse levantamento, observou-se que os principais marcos regulatórios trouxeram mudanças para o lançamento de produtos biológicos no Brasil, sobretudo com maior participação das empresas privadas nacionais e incremento no setor industrial público brasileiro.

Telemedicine in Neurosurgery: Lessons Learned from a Systematic Review of the Literature for the COVID-19 Era and Beyond.

BACKGROUNDEvolving requirements for patient and physician safety and rapid regulatory changes have stimulated interest in neurosurgical telemedicine in the COVID-19 era.OBJECTIVETo conduct a systematic literature review investigating treatment of neurosurgical patients via telemedicine, and to evaluate barriers and challenges. Additionally, we review recent regulatory changes that affect telemedicine in neurosurgery, and our institution's initial experience.METHODSA systematic review was performed including all studies investigating success regarding treatment of neurosurgical patients via telemedicine. We reviewed our department's outpatient clinic billing records after telemedicine was implemented from 3/23/2020 to 4/6/2020 and reviewed modifier 95 inclusion to determine the number of face-to-face and telemedicine visits, as well as breakdown of weekly telemedicine clinic visits by subspecialty.RESULTSA total of 52 studies (25 prospective and 27 retrospective) with 45 801 patients were analyzed. A total of 13 studies were conducted in the United States and 39 in foreign countries. Patient management was successful via telemedicine in 99.6% of cases. Telemedicine visits failed in 162 cases, 81.5% of which were due to technology failure, and 18.5% of which were due to patients requiring further face-to-face evaluation or treatment. A total of 16 studies compared telemedicine encounters to alternative patient encounter mediums; telemedicine was equivalent or superior in 15 studies. From 3/23/2020 to 4/6/2020, our department had 122 telemedicine visits (65.9%) and 63 face-to-face visits (34.1%). About 94.3% of telemedicine visits were billed using face-to-face procedural codes.CONCLUSIONNeurosurgical telemedicine encounters appear promising in resource-scarce times, such as during global pandemics.

Does Gender Diversity on Board Promote Corporate Social Responsibility? An Empirical Analysis of Sustainable Development Goals

Recent regulatory changes in India require the firms to improve the appointment of female directors on corporate boards, and it is believed that such a regulation would prove to be a boon in terms of strategic decision making. The Board Capital Theory advocates that the appointment of women directors on board shall enhance various dimensions of the board capital breadth and help in better decision making. With growing consciousness for sustainable practices throughout the globe, it is pertinent to see whether the gender diverse boards can promote corporate social responsibility and create a business case for their upsurge, as it would give room for policy implications. This study investigates the impact of gender diverse boards on promoting corporate social responsibility, using multivariate regression with a sample of NIFTY 50 Index for the period 2014-2019. The study found insignificant positive relation among gender-diverse boards and sustainability. To check for the robustness of the study, we have used two diversity indices, Blau & Shannon index, to supplement our results.

The Effect of Transaction Cost Unbundling on Investors' Reliance on Investment Research: Evidence from Experimental Asset Markets

Recent regulatory changes within Europe (regulation MiFID II) mandate broker-dealers to charge clients explicitly for any investment research they provide. This new mandate replaces the common practice of bundling these charges with other variable fees, such as those for trade executions. Drawing on transaction decoupling theory, I examine how transaction cost unbundling influences investors’ reliance on investment research. Results from 16 experimental markets indicate that investors place greater weight on costly forecasts under a system of unbundled payments compared to bundled payments, but only if transaction costs are sufficiently high to provoke feelings of regret. Focusing on the forecast, investors also cede to reduce price errors over time. Additional analysis suggests that salient cost disclosure, a more cost-effective way to generate transparent transaction costs, does not similarly impact investor judgment. These results are important in light of recent SEC discussions on how to respond to Europe’s regulatory push for cost transparency.

Location, location, location! Real effects from the mandated removal of pension expected return from operating income

The accounting for defined-benefit (DB) pension expense in U.S. GAAP involves offsetting pension costs against an expected (rather than actual) return on pension assets. Pensions commentators argue that this expensing model tilts pension portfolios towards riskier assets – as sponsoring firms can benefit from assuming higher expected rates of return on riskier assets (which reduce pension expense and boost reported income), without bearing the cost of higher volatility in reported income. We examine a recent regulatory change in U.S. GAAP, which mandates the relocation of the expected return on pension assets from “above the line” of to “below the line” of operating income. Consistent with this change reducing the financial reporting incentives for risk-taking, we predict and find that a sample of U.S. firms subject to this mandate reduces risk-taking in pension assets following the change, relative to a control sample of Canadian firms not subject to the change. In cross-sectional tests, we find that the reduction in risk-taking is more pronounced in (1) firms where the financial reporting incentives for risk-taking were stronger in the pre-period, and in (2) firms where the regulatory change particularly reduced those benefits. Our findings imply that managers are willing to undertake real actions (i.e., invest in riskier assets) to report favorable operating income, and that these incentives are incremental to the incentives to report favorable net income. They also provide evidence that financial reporting incentives serve as a driver of pension asset allocation decisions.

The Market Structure of Dealer-to-Client Interest Rate Swaps

Following the Dodd-Frank Act, central clearing and centralized trading became mandatory for a class of the most liquid interest rate swaps (IRS). Nevertheless, IRS market making in the dealer-to-client sector remained concentrated at a few regulated banks that transfer their funding costs to end users. I develop an equilibrium model of IRS markets with imperfect competition among capital-constrained dealers. Using proprietary data on cleared IRS transactions and the dealers' daily margin requirements, I empirically investigate the impact of recent regulatory changes on market liquidity. By exploiting the variation in margin requirements across swaps with different risk profiles intermediated by bank-affiliated dealers, my estimates show that a 1 percentage point increase in the supplementary leverage ratio (SLR) leads to an increase of $1.5 billion in the annual cost of hedging for the end-users.

Review of updated regulations and product license categories for veterinary vaccines in the United States.

The USDA continues to consider and implement regulatory pathways for evolving scenarios, needs, and technologies. The intent of this report is to make veterinarians and other users of veterinary biologics aware of recent regulatory additions and changes, particularly in the area of veterinary vaccines. These include new licensure pathways to increase product availability, standardization of labeling, and increased transparency regarding adverse event reports and the efficacy and safety studies accepted by the USDA for product licensure. This report did not undergo scientific peer review.

Cannabidiol: pharmacology and therapeutic targets.

Cannabidiol (CBD) products lacking regulatory approval are being used to self-treat a myriad of conditions and for their unsubstantiated health benefits. The scientific evidence supporting these claims largely arises not from controlled clinical trials, but from the recognition that CBD has numerous biological targets. Yet, CBD is commonly consumed and often in over-the-counter products that are unapproved and of unknown composition. Epidiolex® is the only product that has undergone rigorous pharmacokinetic assessment and testing in clinical trials; it was approved as a non-scheduled drug by the U.S. Food and Drug Administration for the treatment of intractable childhood-onset seizures. However, studies investigating CBD for other medical conditions are limited in number and often lack the scientific rigor, controls, or sample sizes required to draw clinically meaningful conclusions. Although Epidiolex® is safe for human consumption, recent changes in regulation of commercially available CBD products have resulted in limited quality control and products marketed with unknown CBD bioavailability. Even scientifically rigorous studies have used different sources of CBD and different suspension vehicles for administration, making it difficult to compare results among studies and resolve mixed outcomes. This paper reviews the molecular targets, pharmacokinetics, and safety and abuse liability of CBD; additionally, the extant evidence on its potential therapeutic effects for neurological disorders, pain, inflammation, conditions related to immune function, psychiatric disorders, and substance use are described.

Do minimum trading capacities for the cross-zonal exchange of electricity lead to welfare losses?

Within flow-based market coupling, the EU's preferred method for calculating cross-border trading capacities, recent regulatory changes stipulate minimum trading capacities, so-called minRAMs which have to be provided to electricity markets. Effectively, high predicted flows on considered electricity grid elements have to be reduced to reserve a minimum of the elements' capacities for cross-zonal trading. This analysis investigates if the adjustments made to meet this criterion, in the form of augmented trading domains, lead to higher amounts of curative congestion management. To quantify the effect of increasing minRAMs on overall welfare, the markets and grids of Central Western Europe are analyzed during two representative weeks of 2016. The results show the increasing market coupling welfare is more than offset by rising congestion management costs, leading to net welfare losses. In the best case, the generation plus congestion management costs within Central Western Europe rise by 7.25% when increasing the minRAMs from the current 20%–45% and a minRAM of 70% is 6.28% more expensive compared to a minRAM of 20%. The analysis derives policy recommendations for implementing the minRAM stipulation, with a particular focus on a cost-minimizing selection of generation shift keys, in general as well as situation-dependent terms.

Markov chain lumpability and applications to credit risk modelling in compliance with the International Financial Reporting Standard 9 framework

The aim of this paper is threefold. Firstly, we define the necessary quantities associated to the lumpability of a Markov chain and study their fundamental properties. Secondly, we examine the case of approximate lumpability of a non-lumpable Markov and an efficient method of minimizing the error in the approximation. Finally, we introduce a family of general minimization problems that can be approached using this method and examine applications in credit risk modelling, particularly under recent regulatory changes related to loan classification and provision calculations under IFRS 9.

Sustainable development and urban planning regulations in the context of climate change management measures

The purpose of this paper is to evaluate recent and upcoming changes in urban planning legislation in the Republic of Lithuania, which acknowledge the necessity of introducing climate change management tools. Sustainable development is a core principle of the Spatial Planning Law of the Republic of Lithuania since 2014. Special attention to the management of climate change is given at the national and municipal levels, and recent legislative initiatives are proof of this. Methodology – this analysis is based on evaluating the main applicable documents and introduced amendments. The theoretical publications, statistical data, and judicial practice are also observed while interpreting the given normative rules. This paper specifically analyses the legal requirements enshrined in Lithuanian law that are intended to foster sustainable development. New amendments to manage climate change are also analysed. In addition, the solutions of the Vilnius Master Plan are presented, as they introduced the principle of sustainable development before it became a national rule, as well as climate change management measures. Findings – the analysis reveals that national regulation only sets out the principles for spatial planners, and it is left to local governments to make final decisions on what exact measures may be introduced for the purpose of ensuring sustainable development and climate change management via spatial planning. This is a cause for concern and should lead to renewed calls for a coherent and ambitious approach to introduce the specific measures at the national level – at least in the by – laws to ensure consistent and unified application. Despite the vague wording employed by the regulations, the Vilnius Master Plan actively encourages the introduction of measures which could help in ensuring sustainable development and climate change management via spatial planning. Originality/value – this article is the first to analyse the newly adopted principle of sustainable development in the light of climate change management via spatial planning regulations in the Republic of Lithuania. In addition, the present analysis contributes to worldwide studies on sustainable development and climate change measures by filling a gap from Lithuania’s side, showing recent regulatory changes as a good practice to other jurisdictions.

The Role of Cannabis in Orthopedic Surgery

Cannabis use has increased dramatically in America with recent regulatory policy changes. Despite growing access and prevalence of use of cannabinoids both medically and recreationally, scientific evidence describing its safety and efficacy are limited, especially in the context of treating musculoskeletal pathology. The purpose of this review is to present data evaluating the role of cannabinoids as an adjunct in multimodal pain management, as a modulator in bone metabolism, and as a potential agent in combating the opioid epidemic.

Institutional bricolage and the application of the No Net Loss policy in Quebec: can we really engender ‘social fit' for more sustainable land use planning?

ABSTRACT Offsetting and, more broadly speaking, the mitigation hierarchy have been widely studied in terms of decreasing the impacts of economic activities on biodiversity. There has been considerable tendency to anchor these mechanisms in science, promoting the idea that they are scientifically constructed. Building on Quebec’s recent regulatory changes concerning the introduction of offsetting and the mitigation hierarchy for wetlands and streams, we argue that their implementation relies strongly on political and social constructs. Using institutional bricolage, we highlight the implication of power relations, dominant views and path dependency in this new institutional setting. Indeed, the No Net Loss principle seems to raise historical tensions in water management policies, especially those between strong centralized governance and fragmented territorial management. But No Net Loss application also confronts powerful traditional land use planning with a long history of promoting development interests. To overcome these tensions, No Net Loss can be viewed as an opportunity for innovation towards more sustainable land use planning that acknowledges collective values. To investigate the potential for a novel social fit for wetland offsetting, we call upon Actor-Network Theory to rethink land use planning for a collective vision of the territory.

Patients seeking treatment for opioid use disorder face more challenges during pandemic

Patients seeking treatment for opioid use disorder face more challenges during pandemic

Innovation in open banking: Lessons from the recent wave of payment institutions that have been authorised to provide payment initiation and account information services

The Revised Payment Services Directive (PSD2) came into force in all EU member states in 2018. One stated aim of this legislation was to create room for innovations in technology and business models in order to give account holders more choices and more direct control regarding access to their account information and ways of initiating payment transactions. Although an evolving array of new services and service providers has emerged over the past few years, the market remains in an early phase of experimentation. Nevertheless, information about the range of newly licensed service providers in the EU, and their business models, provides some insights into how the market is evolving and how it is reacting to recent regulatory and market infrastructure changes introduced through the PSD2 and open banking architecture. This paper reviews the population of payment institutions that have recently obtained authorisation to provide payment initiation or account information services in the EEA. It examines the (1) geographic reach, (2) company origins and investors, and (3) business function of these new actors to provide early insights into the changing economics of banking and payments.

Do single‐stock circuit breakers provide a safety net for Canadian investors?

AbstractThis study looks at the market impact of recent regulatory changes in Canada that provide for trading halts on individual stocks that experience large upside or downside movements. The focus is on all stocks traded on the Toronto Stock Exchange since the inception of the single‐stock circuit breaker rule (SSCB) in February 2012, to replace the short‐sale uptick rule. The results support pricing efficiency: material information that caused the circuit breaker is incorporated in stock prices on the day of the halt (neither overreaction nor underreaction), with no decline in market liquidity. Using trade‐by‐trade data constructed on five‐minute trading intervals, we refine the daily results, and show that shocks in realized volatility are focused in the 10‐minute trading interval surrounding the halts. While circuit breakers provide a limited safety net for investors when their stocks are subject to severe volatility, they do not allow for a quick turnaround for stocks experiencing severe price decline events.

Commentary on the coronavirus pandemic: Anticipating a fourth wave in the opioid epidemic.

Experiencing the COVID-19 pandemic simultaneously with the U.S. opioid epidemic is anticipated to have a profound mental health impact on some of our most vulnerable populations. Recent federal and state regulatory changes have been made under the state of emergency in order to ameliorate the some of the challenges faced in maintaining access to substance use and addiction services during such times. There are currently considerable limitations in quantifying the impact of COVID-19 among those with substance use disorders, however, it is imperative that health care systems continue to serve this population in order to prevent associated morbidity and mortality. (PsycInfo Database Record (c) 2020 APA, all rights reserved).