The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner.
Below is the FDA press release:
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Sample landscaping services request for proposal (RFP).
November is Critical Infrastructure Security and Resilience Month.
The final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act.
A sample of a laundry Construction, consultant RFP covering all the basics. Download the document and tailor it to your needs.
Recent Guidance on Meaningful Use of EHRs Makes Compliance More Difficult.
View a copy of the survey report (PDF)
A sample of a bed management RFP covering all the basics. Download the document and tailor it to your needs.
A sample of a CT scanner RFP covering all the basics. Download the document and tailor it to your needs.
Sample request for proposal for face-to-face spoken language and American Sign Language (ASL) interpreter services.
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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 supply chain leaders have until May 7, 2012, to comment on the way in which the Internal Revenue Service (IRS) intends to implement this new tax.
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.
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).
A sample of medical transcription services request for proposal.
An overview of the Centers for Medicare & Medicaid Services' three final rules for calendar year 2011 the outpatient prospective payment system and ambulatory surgical center rule, the Medicare Physician Fee Schedule rule and the Home Health PPS rule.
How to write a constructive, information-rich comment that clearly communicates and supports its claims to have an impact on regulatory decision making.
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.
Please see a sample of a Reprocessing Single Use Devices (SUD), RFP below - you will find this short document and the Reprocessing Narrative Evaulation example covers all the basics, and you can tailor it to your needs.
Managing contract pricing more effectively—from creation to renewal or expiration—can deliver real operational and financial benefits for healthcare organizations. Yet because of its complexity, contract price management may be one of the most underutilized tools for maximizing cost savings in healthcare. Disparate information technology (IT) systems that do not share information and lack of widespread adoption of industry data standards for product and organizational/location identification all contribute to this complexity.