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 ...
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 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 ...
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 ...
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 ...
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) ...
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) ...
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 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”) ...
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 ...
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
International financial records recently stolen from two offshore services firms and 19 corporate registries maintained by governments were leaked to journalists and their details subsequently published around the world. But beyond the hype, however, we find no intelligent inferences of legal significance in the reporting. For example, the media draws attention to a United States Cabinet member's offshore financial transactions but does not allege that his shipping stake was illegal ...
Governor Jerry Brown approved California Senate Bill 798 on October 13, 2017. One provision of this bill imposes penalties for failure to file required reports under Business and Professions Code Section 805.01. Beginning January 1, 2018, individuals and entities with reporting obligations under Section 805.01 are subject to fines of up to $100,000 per violation for willful failures to file a Section 805 ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
IRS Announcement 2017-15 provides relief to employees who have been adversely affected by the recent wildfires in Northern California by allowing them to take loans or distributions from retirement plans to alleviate hardships caused by the wildfires. The Announcement also provides relief from verification procedures required under retirement plans with respect to loans and hardship distributions ...
An Important Israeli Court Decision for Dual-Listed Companies: The Liability for Breaches of Reporting Obligations by Dual-Listed Companies Is Governed by the Securities Laws of the Foreign Trading Jurisdiction. In 2017 the Tel Aviv District Court (Economic Division, Judge Kabub) issued a decision in Cohen v. Tower Semiconductor Ltd. et al., C.A ...
On October 13, 2017, Governor Brown signed SB 798, amending Business and Professions Code Section 805, Civil Code Sections 43.7 and 43.8, and Evidence Code Section 1157 to include licensed midwives within their scope. Notably, these changes only apply to licensed midwives, those professionals who pass the North American Registry of Midwives examination and are licensed by the Medical Board of California ...
View a PDF of the November 2017 edition of the Haynes and Boone Health Law Vitals newsletter. FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues, or organs with the goal of restoring or establishing normal function ...
Earlier this year, Michigan’s Department of Licensing and Regulatory Affairs (LARA) announced the formation of “work groups” to provide input as LARA adopts emergency rules to govern activities under the State’s new Medical Marihuana Facilities Licensing Act (MMFLA). Organized around the MMFLA’s five license types, those work groups met last month ...
If your estate plan was put in place more than 3 years ago, the plan is likely designed to save estate taxes at the sacrifice of income tax benefits. Estate tax is no longer a concern for married couples owning less than $11 million of assets. We recommend reviewing your estate plan to confirm that it has the flexibility to adapt to tax law changes and to secure income tax benefits ...
ILPA’s Paper Earlier this year the International Limited Partner's Association (ILPA) published its paper "Subscription Lines of Credit and Alignment of Interests: Considerations and Best Practices for Limited and General Partners." Since then there''s been a lack of on the record industry commentary from general partners (GPs) on this paper, but it has not gone unnoticed and has triggered much discussion behind closed doors ...
