News & Analysis as of

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

Getting The Best Medical Care: A Newsletter From Patrick Malone - March 2015

In This Issue: - Aging and Accidents - Heading for a Fall - Mind Your Meds - Exercise to Prevent Falls - Smart Home Design - Eating Right - Excerpt from Mind Your Meds: Discuss the risks...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

The Unhealthy Side Effects of Employer Wellness Programs

I love wellness programs. I am a sucker for discounts of any sort, and I especially like the idea of rewarding healthy behavior. My bicycle has a tag that logs my work commute when I pass the electronic stations throughout...more

EEOC Files Two Recent Lawsuits Challenging Employer Wellness Programs

The Affordable Care Act creates new incentives to promote employer wellness programs. However, employers should not rush to establish such programs without first considering the implications of the Americans with...more

Is The EEOC Off The Rails With This New “Wellness” Lawsuit? Don’t Think So.

Last week, the Equal Employment Opportunity Commission filed suit against Wisconsin-based Orion Energy Systems, Inc., over its wellness program and its treatment of ex-employee Wendy Schobert, who was not a fan of the...more

Employee Benefits: Important Wellness Plan and Mental Health/Substance Use Disorder Parity Effective Dates Have Arrived!

Employers and insurers offering medical plans: take note! Two important final regulations issued jointly by the IRS, DOL and HHS (the “Departments”) apply to plan years (or, in the individual market, policy years) beginning...more

Coming Soon To A (Computer) Screen Near You: Your Doctor

Both wellness visits and behavioral health visits would be added to the list of Medicare-covered telemedicine services. And it’s not just follow-up wellness visits that would be covered. Even initial visits qualify,...more

Another Benefits Grab Bag of Guidance and Reminders – Health and Retirement Plans

Preventive Care Expansion for Calendar Plan Year 2015 for Non-Grandfathered or Non-Exempt Plans - The preventive care coverage requirements were updated in September 2013 to include a requirement that there must be...more

Does Your Wellness Plan Need a (Legal) Check-Up?

Wellness plans must comply with complex final regulations that were issued last year by the Departments of Labor, Health and Human Services, and the Treasury (collectively, the “Departments”). To help plans from falling off...more

Welcomed Guidance on Wellness Programs

On June 3, 2013, the Departments of Treasury, Labor and Health and Human Services (Agencies) issued final regulations regarding nondiscriminatory wellness programs in group health coverage under the Affordable Care Act and...more

Recent Guidance on Wellness Programs Clarifies Premium Surcharges for Tobacco Use

As previously reported, the federal agencies responsible for drafting the rules implementing the Affordable Care Act (ACA) (the U.S. Labor Department, the U.S. Department of Health and Human Services and the U.S. Treasury...more

The Affordable Care Act—Countdown to Compliance for Employers, Week 50: Wellness Programs, Affordability, and Premium Tax Credits

The Affordable Care Act imposes a series of interrelated requirements on individuals, employers and providers. Individuals must maintain coverage or face the prospect of a tax penalty; carriers must offer and renew coverage....more

Group Health Plans: Year-End Action Items and Upcoming Changes

Group health plan sponsors turn their attention to completing 2013 tasks, implementing upcoming 2014 changes, preparing for the ACA Shared Responsibility requirement in 2015, and documenting recent extensive plan changes....more

Scripts - November 2013

In this issue: - New Wellness Program Rules for 2014 - Now That We Know The Basic Rules… Drafting Covenants Not To Compete To Maximize The Likelihood Of Enforcement - Excerpt from New Wellness Program...more

Workplace Wellness Programs

Recognizing that unhealthy lifestyles affect people of all ages, including those in the workforce, employers are using legally sanctioned incentives in an attempt to change behavior toward better and healthier choices through...more

ACA Not Enough to Save Penn State’s Employee Wellness Program

Recent negative media reports caused Pennsylvania State University to modify its employee wellness program, making clear that considering compliance with the Patient Protection and Affordable Care Act of 2010 (ACA) alone is...more

WANTED: EEOC Guidance On Wellness Plans Under The ACA

Employee wellness plans have been in the spotlight lately. This is because new wellness plan rules published in the Patient Protection and the Affordable Care Act (informally called Obamacare) are slated to take effect in...more

The Key to a Healthy Corporate Wellness Program

As employers and lawmakers seek creative solutions to rising health-care costs, corporate wellness programs have exploded in popularity. Many employers have embraced corporate wellness programs as a means of controlling...more

Carrot Or Stick? When Does A Voluntary Wellness Program Become Involuntary?

Employer wellness programs, which are designed to stem rising health care costs by encouraging healthy behaviors among employees, are rising in popularity. Such programs will receive another boost when certain provisions of...more

eAlert - How to Comply with the Affordable Care Act: Four Things a California Employer Needs to Know

It’s the single most controversial law passed by Congress in the last 10 years. Business groups spent hundreds of millions of dollars to defeat it in Congress and to have it overturned in the courts. But now, the Patient...more

Healthcare Gamification - Regulation of Wellness Programs

Gamification has become pervasive in many every day activities, including health and wellness programs. For companies involved in these activities, you should make sure you are aware of the final Affordable Care Act ("ACA")...more

Final Wellness Regulations Create New Program Categories and Complications

The Departments of Labor, Treasury and Health and Human Services (the “Departments”) recently published final Affordable Care Act (“ACA”) regulations on wellness programs, effective in 2014. The regulations retain the...more

Employers Must Abide By GINA Regulations When Providing Health Screenings

Workplace health and wellness programs are becoming increasingly popular throughout the country, and this is not surprising at all, given how beneficial such programs can be for both employers and employees....more

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