Regulations and Regulatory Advocacy
This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.
This paper provides a case-study on what Banner has done to implement and continuously improve this initiative. Three key components to successful supply utilization savings are reviewed.
In 2015, AHRMM convened the AHRMM Thought Leader Task Force, an exploratory group tasked with uncovering applications of the Cost, Quality, and Outcomes (CQO) Movement across the healthcare field.
The Task Force objectives were developed based on recommendations from the first ever Thought Leader…
AHRMM comments to the FDA regarding an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).
This Special Fraud Alert focuses on the specific attributes and practices of PODs that OIG believes produce substantial fraud and abuse risk and pose dangers to patient safety.
Recent Guidance on Meaningful Use of EHRs Makes Compliance More Difficult.
New Guidance on Humidity Levels in the Operating Room
The medical device excise tax is a feature of the Affordable Care Act. It is important to be knowledgeable about the tax and its effects.
The Medical Device Excise Tax, a component of the Affordable Care Act, is approaching implementation at the beginning of 2013. The tax is intended to provide an estimated $20 billion in tax revenues to help pay for the expansion of health coverage to 32 million uninsured Americans. Healthcare…
An announcement of the Final Rule issued by the IRS.