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Member

Trump Administration Issues Additional Deregulation Orders and Notices

The Trump administration April 9 released a series of executive orders (EOs) and took other administrative actions aimed at reducing regulatory burden.
Member

Guidance for Hospitals on HHS’ Rescission of the ‘Richardson Waiver’ Affecting Public Comment

he Department of Health and Human Services (HHS) Feb. 28 issued a notice in the Federal Register rescinding its 1971 policy known as the “Richardson Waiver.”
Member

Member Advisory: Trump Administration Issues Executive Orders

In its first week, the Trump administration issued an unprecedented series of executive orders (EOs) and administrative actions that reinforce their administration priorities.

Guidance on Humidity Levels in the Operating Room

Advisory
New Guidance on Humidity Levels in the Operating Room
Member

HRSA Finalizes 340B Administrative Dispute Resolution Process

The Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) April 19 published the 340B Administrative Dispute Resolution (ADR) final rule establishing a process that was required under the Affordable Care Act.

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

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.

EtO Quality Advisory

Advisory
EtO Quality Advisory Overview: The AHA and AHRMM have released a Quality Advisory on ethylene oxide sterilization of medical devices.

FDA Releases Proposed Rule on Unique Device System for Medical Devices

Advisory
The FDA UDI ruling has finally arrived - the proposed rule has published.