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Dykema | December 2018

On December 4, 2018, the Michigan Legislature pared back the minimum wage and paid sick leave laws it passed last September in an effort to preclude those issues from being on the November ballot. Had the Legislature not adopted the language of the ballot initiatives legislation, the measures would have been on the November ballot and it would have needed a vote of three-fourths of each house to amend the law if adopted by the voters ...

Dinsmore & Shohl LLP | December 2018

On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway.  In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...

Dinsmore & Shohl LLP | December 2018

On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...

Hanson Bridgett LLP | December 2018

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 ...

Dykema | December 2018

Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars ...

Dykema | December 2018

Executives and in-house counsel should be aware that traveling with sensitive data can lead to its seizure—with potentially severe consequences worldwide. Recently, Parliament in the United Kingdom seized from a traveling executive a USB drive containing data that had been produced in a United States lawsuit between Six4Three, a software company, and Facebook. Put simply, that data was in the wrong place at the wrong time ...

Dykema | December 2018

Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...

Dinsmore & Shohl LLP | December 2018

Often, board of education members believe what happens in executive session, stays in executive session. However, you and your board’s members, both new and old, are well-served to remember that many issues, including those involving personnel, discussed in executive session are communications that may be subject to discovery in a deposition or other legal proceeding by an affected employee ...

Simonsen Vogt Wiig AS | December 2018

Regulation (EU) 2018/302 of February 28, 2018, on addressing geo-blocking and other forms of discrimination based on customers' nationality, place of residence or place of establishment within the internal market (the "Regulation") came into force, December 3, 2018. The Regulation seeks to increase access for customers in the EU and EEA to goods and services by preventing unjustified geo-discrimination due to the customer's nationality, place of residence or establishment ...

Dykema | December 2018

As in previous years, the California legislature kept busy in 2018. As a result, a number of new and noteworthy employment laws will go into effect on January 1, 2019, and beyond. Much of the legislation stems from the #MeToo movement by strengthening harassment and discrimination protection, imposing broader anti-harassment training obligations, updating lactation accommodations and mandating female presence on boards of public companies ...

Heuking | November 2018

Since the GDPR has been in force, almost every company has, among other things, dealt with issues of the permissibility of direct marketing and other marketing activities under data protection law. At their data protection conference on Nov. 07-08, 2018, the German data protection supervisory authorities issued a new "orientation guide" on this topic (as of November 2018) ...

Dinsmore & Shohl LLP | November 2018

The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...

Hanson Bridgett LLP | November 2018

New State Minimum Wage Effective January 1, 2019, the State minimum wage increases to $12.00 per hour for employers with 26 or more employees, and $11.50 per hour for employers with 25 or fewer employees. New Local Minimum Wages Additionally, several California cities and counties have passed their own minimum wage ordinances with a more aggressive schedule of minimum wage increases ...

Dinsmore & Shohl LLP | November 2018

In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...

Karanovic & Partners | November 2018

In light of the new EU data protection scheme, shaped by the GDPR, Serbia has enacted a new Data Protection Law earlier this year, with its' applicability postponed for 21 August 2019. The new law was long-awaited: it has been 10 years since the existing law was passed, which was even at that moment already outdated (e.g. it recognized only consent in the written form and almost completely restricted data transfers to non-European countries) ...

Dykema | November 2018

Obviously, they are all natural disasters that climate scientists believe will increase in severity and intensity in the coming years. And they are all events that nursing homes and assisted living facilities (and all Medicare/Medicaid certified health care providers) are legally required to prepare for in order to protect their residents and patients. More pointedly, though, they are all events which the U.S ...

Haynes and Boone, LLP | November 2018

The Department of Labor issued an opinion letter that provides guidance to employers paying exempt employees an hourly wage or other extra compensation in addition to a guaranteed weekly salary.SeeU.S. Department of Labor, Wage and Hour Div., Opinion Letter (Fair Labor Standards Act), FLSA2018-25 (Nov. 8, 2018) (“Opinion Letter”) ...

Dinsmore & Shohl LLP | November 2018

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...

Dinsmore & Shohl LLP | November 2018

In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program ...

Dinsmore & Shohl LLP | November 2018

In the last quarter of 2018, the Department of Labor (DOL) issued an opinion letter ending what had become known as the “80/20 rule” for tipped employees. The new rule, which eases restrictions on an employer’s application of the tip credit, is a reissuance of a 2009 opinion letter that had been supplanted by contrary guidance since 2011 ...

Haynes and Boone, LLP | November 2018

In an about-face from prior guidance, the Department of Labor issued a revised opinion letter on Thursday rescinding the so-called “20 Percent Rule” and expanding employers’ ability to claim the tip credit.SeeU.S. Dept. of Labor, Wage & Hour Div., Opinion Letter (Fair Labor Standards Act), FLSA2018–27 (Nov. 8, 2018) (“Opinion Letter”) ...

Afridi & Angell | November 2018

In an order dated at the end of 2018, the DIFC Court accepted that a party seeking an anti-suit injunction against proceedings in a foreign court must show that proceeding before the foreign court is or would be “vexatious or oppressive” to that party ...

Haynes and Boone, LLP | November 2018

Download the November 2018 edition of the Haynes and Boone OSHA Newsletter PDF. OSHA States that Most Instances of Workplace Drug Testing are Permissible In a memorandum dated October 11, 2018, OSHA clarified its position on drug testing under 29 C.F.R. § 1904.35(b)(1)(iv) ...

Dinsmore & Shohl LLP | November 2018

Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...

Deacons | November 2018

In less than a decade, China has become the largest e-commerce market in the world, accounting for over 40% of global e-commerce according to a recent report by McKinsey. The breath-taking speed of development has left law makers scrambling to regulate the booming e-commerce industry ...

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