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Medical Device Tax Next Steps
Advisory
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.
Final Regulations on Taxable Medical Devices
Advisory
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 wi
Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection in a Healthcare Setting
Advisory
This document provides interim guidance for infection control for healthcare facilities (e.g., hospitals, long-term care and outpatient facilities, and other settings where healthcare is provided).
Special Fraud Alert: Physician-Owned Entities
Advisory
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.
Alarm Safety Management
Issue Brief
This learning lab covers alarm safety management in the health care supply chain field.
Global Unique Device Identification Database (GUDID) Draft Guidance for Industry
Letter/Comment
This page provides information about submitting data to the database for device Labelers, entities responsible for providing the data to the GUDID.
Fact Sheet: Provider/Health Plan Contracting Provisions Reduce Access to Care
The Bipartisan Primary Care and Health Workforce Expansion Act (S. 2840) includes a provision that would prevent doctors and hospitals from negotiating reasonable agreements with commercial health insurance plans.
FDA Releases Proposed Rule on Unique Device System for Medical Devices
Advisory
The FDA UDI ruling has finally arrived - the proposed rule has published.