North America

Obscure FDA Device Reporting Exemptions Draw Patient and Provider Concern

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

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Predictive Scheduling is Becoming the New Normal for Hospitality and Retail Industry

Taking the guesswork out of scheduling for wage workers is an attractive proposition for regulators. Laws that require employers to publish employee work schedules a certain amount of time in advance so that employees (especially those in the hospitality and retail industries) can have greater flexibility and work-time predictability to deal with family and other events and responsibilities are becoming more common in several cities, and the state of Oregon currently has predictive scheduling laws on the books, and the trend is growing, with proposed legislation in many jurisdictions across the country.

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NJ Employers and Out-of-State Employers with NJ Residents Prepare: State Updates Website on Employer Reporting for New Jersey Health Insurance Mandate

As employers are wrapping up their reporting under the Affordable Care Act (“ACA”) for the 2018 tax year (filings of Forms 1094-B/C and 1095-C/B with the IRS are due by April 1, 2019, if filing electronically), they should start preparing for new reporting obligations for the 2019 tax year.

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Utah Hopes That Third Time’s a Charm for Non-Compete Statute

The State of Utah on March 22, 2019 returned to the topic of non-competes for the third time in three years. It had passed that statute in 2016 (as we noted), and then amended in 2018 (as we also discussed here earlier), and now is at it again, by amending it once more. Maybe they are hoping that the third time’s a charm, as they say.

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Davis & Gilbert is proud to welcome Julie M. Makowski to the firm’s Corporate Practice Group

Julie Makowski is an associate in the Corporate Practice Group of Davis & Gilbert. She is involved in all aspects of the firm’s corporate practice, with an emphasis on mergers and acquisitions and general commercial matters. Ms. Makowski also assists clients in structuring and negotiating employment and non-competition agreements, purchase agreements, shareholder agreements and other general corporate matters.

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Breaking Brexit: Updates on the “no deal” scenario and how it will affect your European trademark rights

Since its June 2016 vote to leave the European Union (EU), the United Kingdom (UK) has struggled to agree on terms to implement a “Brexit” from the EU. As the looming March 29, 2019, deadline for the UK’s departure approached, the EU voted last week to delay Brexit and give the UK more time to agree on an exit plan. Depending on certain decisions within UK Parliament this week, the new Brexit date will either be April 12 or May 22 of this year.

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Take 5 Newsletter – The Future of Work: Five Developing Trends for Technology, Media, and Telecommunications Employers

Technology, media, and telecommunications organizations are at the forefront of tackling new challenges in handling employee information and managing employee populations. As legislatures (from the federal level down to states and cities) address how technology impacts today’s new workforce, employers must grapple with changes in managing data—from privacy concerns to the use of artificial intelligence in employment matters—and keeping workers happy, including dealing with wage increases, the rise in union activity, and contingent workers in the #MeToo era. A changing workplace landscape requires creative thinking and outside-the-box solutions.

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CMS Attempts to Curb Fraud in the HHA Industry by Limiting HHA Reimbursement

Despite recent welcome news to the home health agency (“HHA”) industry in Florida, Illinois, Michigan, and Texas following an end to Centers for Medicare & Medicaid Services’ (CMS’s) long-standing HHA provider enrollment moratoria, CMS subsequently announced that it would place some newly enrolled HHAs in a provisional period of enhanced oversight. The purpose of the enhanced oversight period and the corresponding additional restrictions placed on certain HHAs is to help CMS address and closely monitor fraud, waste, and abuse concerns in the HHA industry, thus signaling CMS’s ongoing industry-wide scrutiny.

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A Reminder from the DOL: Document A Plan’s Procedures for Designating Authorized Representatives

The information letter issued by the Department of Labor (the “DOL”) on February 27, 2019 (the “Information Letter”) provides a reminder to plan sponsors about the importance of disclosing the procedure for appointing authorized representatives in the benefit claim and appeal procedures for employee benefit plans subject to the Employee Retirement Income Security Act of 1976 (“ERISA”), as amended and also about the extent of the authority of the authorized representative. The Information Letter was in response to a query as to whether an entity that acts as a patient advocate and health care recovery expert for plan participants, in connection with initial benefit claims and appeals of adverse determinations (the “Entity”) could act as an authorized representative for claimants pursuant to Section 503 of ERISA.

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Centers for Medicare & Medicaid Services Proposes Changes to the Methodology for Calculating Medicare Advantage/Part D Civil Money Penalties

On March 15, 2019, the Centers for Medicare & Medicaid Services (CMS) released proposed changes to its methodology for calculating Civil Money Penalties (CMPs) for Medicare Advantage (MA) and Part D Prescription Drug Plan (MA and Part D) sponsors.  The proposed changes would impact both the calculation methodology for 2019 as well as the CMP amounts for 2019 and beyond in an effort to increase plan accountability.  CMS is accepting comments on these proposed changes until April 15, 2019 at 11:59 PM ET.

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