The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more
On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate...more
On October 1, 2014, the Departments of Labor, Health and Human Services and Treasury issued final regulations that address the treatment of dental, vision and employee assistance programs (EAP) as "Excepted Benefits" under...more
What Is a Health Plan Identifier (HPID)?
A health plan identifier is a standardized 10-digit number that is unique to a plan.
Who Must Obtain an HPID in the Coming Weeks?
Large “controlling health plans”...more
Sometimes your employee is the victim. If so, you may have someone who is distracted, scared, upset, or frequently absent because of physical injury or psychological trauma, or court appearances. She (or he – men can be...more
The Food and Drug Administration (FDA) released a draft guidance on April 23, 2014 titled Expedited Access for Premarket Approval [of] Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly...more
The Third Circuit Court of Appeals recently issued a decision holding that an employer's termination of an employee for violating a very broad and restrictive return to work agreement (RWA), which prohibited the employee from...more
On December 20, 2013, the Departments of Treasury, Labor, and Health and Human Services (collectively, the Departments) jointly issued proposed rules (Proposed Regulations) that would amend the regulations regarding excepted...more
Notice 2013-54 (the "Notice") provides guidance clarifying the impact of certain market reform provisions of the Affordable Care Act ("ACA") on health reimbursement arrangements ("HRAs") and other group health plans under...more
On September 13, 2013, the Internal Revenue Service, U.S. Department of Labor and U.S. Department of Health and Human Services, collectively, issued guidance (the "Health Funding Guidance") on the application of two of the...more
I blogged recently about IRS and Department of Labor (DOL) guidance restricting the ability of employers to subsidize individual health insurance premiums for their employees after December 31, 2013. That IRS and DOL guidance...more
On September 13, 2013, the Department of Labor and the Treasury Department/IRS (the “Departments”) issued coordinated guidance on a handful of items relating to the implementation of the Affordable Care Act (the “Act”),...more
Laws Providing Leaves of Absence -
Family and Medical Leave Act (FMLA) -
The FMLA, as relevant here, requires covered employers to provide eligible employees up to 12 weeks of unpaid leave due to a serious...more
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