Health Law Advisor

Our colleague Sharon L. Lippett, a Member of the Firm at Epstein Becker Green, has a post on the Financial Services Employment Law blog that will be of interest to many of our readers in the health care industry: “New DOL FAQs Provide Additional Guidance (and Comfort) for Plan Sponsors.”

Following is an excerpt:

Based on recent guidance from the Department of Labor (the “DOL”), many sponsors of employee benefit plans subject to the Employee Retirement Income Security Act of 1974, as amended (“ERISA Plans”) should have additional comfort regarding the impact of the ...

Each year between October and May, millions of people contract the flu. Recent estimates suggest that up to 111 million workdays are lost during the flu season each year — at an estimated $7 billion per year in sick days and lost productivity.[1]  In light of the significant impact the flu can have on human capital and workplace productivity, many employers – especially those with employees who frequently interact with members of the public through the course and scope of their employment, such as health care providers, retailers, and educators – are beginning to implement ...

Our colleagues Joshua A. Stein and Frank C. Morris, Jr., at Epstein Becker Green have a post on the Health Employment And Labor blog that will be of interest to many of our readers: "The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards."

Following is an excerpt:

As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the "Access Board") has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the ...

In a notable recent court decision highlighting transgender issues and employer sponsored benefit plans, on January 13, 2017, in Baker v. Aetna Life Ins. Co., 2017 U.S. Dist. LEXIS 5665, 2017 WL 131658 (N.D. Tex.), Aetna Life Insurance Co. (“Aetna”) defeated a claim by a transgender employee of L-3 Communications Integrated Systems LP (“L-3”) who alleged that Aetna’s denial of her disability benefits constituted discrimination based on her gender identity. The plaintiff, Charlize Marie Baker (“Baker”), is a participant in L-3’s Employee Retirement Income ...

As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the “Access Board”) has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”).  Published in the Federal Register on Monday, January 9, 2017, the MDE Standards are a set of design criteria intended to provide individuals with disabilities access to medical diagnostic equipment such as examination tables and chairs (including those used for dental or optical ...

Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If enacted, both would create significant new obligations for agencies such as CMS and the FDA, expand the scope of judicial review of rules, and would increase the potential for political influence over the rulemaking process. Both bills passed the House on party-line votes, and are under consideration by the Senate.

The first bill, H.R. 5, would overhaul multiple phases of the federal rulemaking process. These proposed changes would make the ...

On Monday, January 23^rd, Senators Bill Cassidy (R-LA) and Susan Collins (R-ME) introduced the Patient Freedom Act of 2017 ("PFA"), the first of what may be many Republican Affordable Care Act ("ACA") "replacement" alternatives. The PFA is notable for several reasons. It is the first replacement plan to be introduced in the 115^th Congress, it is sponsored by Senators who are considered comparatively moderate on health issues, and thus its content may represent an opportunity for compromise in the future, and, perhaps most interestingly, does not actually repeal the ACA. The ...

On his first day in office, President Trump issued an Executive Order entitled "Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal." The Executive Order is, in effect, a policy statement by the new administration that it intends to repeal the Patient Protection and Affordable Care Act (the "ACA" or the "Act") as promptly as possible. The Executive Order also directs the Secretary of Health and Human Services and the heads of all other executive departments and agencies that, pending repeal of the ACA, they are to exercise the full extent of ...

In the new issue of Take 5, our colleagues examine five employment, labor, and workforce management issues that will continue to be reviewed and remain top of mind for employers under the Trump administration:

• Change in Labor Landscape Is Not Likely to Come Quickly

• For Wage and Hour Changes, Look Locally

• Employer Group Health Plans Post-ACA: What’s Next for Employers and Workers?

• Examination of Retirement Plans Under a Trump Administration Microscope

• Cyber Threats Are Front and Center for Employers as the Trump Administration Takes Office

Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA's long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency's concession on proactive pre-approval communications with payors about investigational drugs and devices, allowing certain information to be provided to payors prior to a product's approval. FDA's guidance documents ...