With less than 30 days to go before the new MiFID II regime will be rolled out, funds and management companies/AIFM are increasingly concerned as to how they will be impacted: product governance inducements and payment for research increased client information requirements complex and non-complex products classification How will you be impacted by the new regime? We can help you to get ready! At Arendt, we have built up significant expertise in assisting clients
Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances ...
The draft laws implementing AMLD 4 set out strict rules to allow for protection against improper access to the information on BOs. At the of 2017, the Luxembourg Parliament published two draft laws to implement new transparency measures provided by Directive 2015/849 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing (“AMLD 4”) ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
The Minister of State in the Department of Justice and Equality, Mr. David Stanton, has expressed an intention to bring forward the long awaited Gambling Control Bill (the GCB) by the end of 2017. The Government's Legislation Programme for Autumn 2017 notes that work is underway on the GCB. However, there has been no further information on when the draft of the GCB will be published, which is the next substantive step ...
The federal agency now well-known as the Consumer Financial Protection Bureau was established by Congress in the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. The CFPB is a uniquely independent agency, shielded from the executive branch in a way that other agencies are not. Doing away with that independence has the potential to significantly alter the CFPB and its regulatory work ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
Earlier this week, the European Supervisory Authorities (ESAs) published draft amendments to EMIR-related regulatory technical standards (RTS) that align the treatment of variation margin (VM) for FX forwards with the supervisory guidance applicable in other key jurisdictions. More specifically the draft amendments propose that the requirement to exchange VM for physically settled FX forwards shall only target transactions between institutions (credit institutions and investment firms) ...
As seen in Bank Director The process of establishing a de novo bank always has been complicated and time-consuming, and occasionally even painful. But since the beginning of the financial crisis, it seems that obtaining deposit insurance for a de novo bank has become a nearly impossible task. The Federal Deposit Insurance Corp. received 1,738 applications for deposit insurance from 2000 through 2008, and approved 1,258 of those applications—an approval rate of 72 percent ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
Sen. Cornyn (R-TX), along with co-sponsors Sen. Feinstein (D-CA), Sen. Burr (R-NC), Sen. Peters (D-MI), Sen. Rubio (R-FL), and Sen. Klobuchar (D-MN), introduced the “Foreign Investment Risk Review Modernization Act of 2017” (FIRRMA) November 8, 2017. This proposed bill, and a companion bill of the same name introduced in the House of Representatives by Rep ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
MoneyGram International Inc. (MGI) and Ant Financial, a subsidiary of Alibaba Group Holding Ltd. (BABA), announced last week the Committee on Foreign Investment in the United States (CFIUS or the Committee) failed to approve their proposed merger. CFIUS is an inter-executive agency committee which reviews, and has the authority to reject, certain transactions that may affect the national security of the United States ...
The end of 2017 saw a number of changes in the regulatory framework of the Rwandan financial sector, the most significant of which included a change in the law governing the regulator of the financial sector (the National Bank of Rwanda) and the enactment of the New Banking Act governing the organisation of banking, both of which were gazetted in October 2017 ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
This week we learned that Amazon, Berkshire Hathaway and J.P. Morgan Chase have joined forces to tackle employee healthcare costs. This announcement marks yet another chapter in some employers' frustration with our nation’s healthcare system. Employees are equally tired of the increasing cost of healthcare eating away what should be their wage increases even as employers pay for ever increasing health insurance premiums ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
SECTION 1: Market Overview 1.1 Please provide an overview of the project finance market in your jurisdiction. Project financing is a well-established finance scheme in Israel, widely implemented in the last 15-20 years. It is used for debt financing in a variety of sectors, particularly where public private partnership (PPP) projects are involved ...
On February 7, 2018 the SEC Office of Compliance Inspections and Examinations (OCIE) issued the 2018 National Exam Program Examination Priorities. In introducing the examination priorities for 2018, OCIE describes the four pillars upon which the work of OCIE is based: promoting compliance; preventing fraud; identifying and monitoring risk; and informing policy. OCIE includes in the examination priorities factual data relating to the increase in examinations of investment advisers ...
As described in our earlierclient alert, dated September 13, 2016, under certain specific circumstances, section 1129 of title 11 of the United States Code (the “Bankruptcy Code”) permits a bankruptcy court to confirm a Chapter 11 plan and rewrite the terms of a debt instrument (including mortgage debt or mezzanine debt), including the interest, amortization, and maturity ...
As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena. The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C ...
Earlier this year the enhanced Nurse Licensure Compact (eNLC) was implemented in all 29 participating states including Colorado, West Virginia and Kentucky. Illinois[1] and Michigan[2] are among the states with current legislation pending to adopt the eNLC, while Indiana, Ohio, Pennsylvania, California and a handful of other states do not yet have pending legislation ...
The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses. Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process ...
Hidden in the details of the Bipartisan Budget Act of 2018 are some key telehealth provisions that are receiving praise from many industry groups and could mark a significant development for Medicare telehealth policy. The new legislation promotes telehealth in several ways. Tele-stroke. Medicare currently only covers tele-stroke services for patients located in rural health professional shortage areas and counties not classified as a metropolitan statistical area ...
