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
The Food and Drug Administration (FDA) released a draft guidance on April 23, 2014 titled Expedited Access for Premarket Approval [of] Medical Devices Intended for Unmet Medical Need for Life Threatening or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
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