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FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

Ambulatory Surgery Center Association Applauds ASC Payment Transparency Act

The Ambulatory Surgery Center Association (ASCA) applauds the U.S. House of Representatives for passing the Ambulatory Surgical Center (ASC) Payment Transparency Act of 2018 (H.R. 6138). This important legislation will improve access to high-quality outpatient health care.

H.R. 6138 comprises the following critical provisions.

  1. Add an ASC Representative to the Advisory Panel on Hospital Outpatient Payment. This provision will add an ASC industry representative to the Centers for Medicare & Medicaid Services’ (CMS) Advisory Panel on Hospital Outpatient Payment (HOP) – a 15-member panel that helps determine payment policies for hospital outpatient departments and ASCs. Currently, statute requires all HOP members be employed by a hospital or health system.
  2. Disclose Criteria Used to Determine ASC Procedure List. CMS can exclude a procedure from the ASC procedure list because of a general concern for specific criteria (42 CFR 416.166). CMS, however, is not required to disclose which criteria it uses to exclude a given procedure. Adding procedures that can be performed safely in an ASC to this list saves Medicare and its beneficiaries money.

“Data show that ASCs deliver excellent patient outcomes at a lower cost than similar sites of service,” stated ASCA Chief Executive Officer William Prentice. “This legislation will assure better communication between ASCs and government agencies that regulate us, leading to better decisions that will benefit Medicare beneficiaries requiring outpatient surgery. We are grateful that these provisions have bipartisan support in the House and look forward to their consideration in the Senate soon.”

The ASC Payment Transparency Act of 2018 will help ASCs, specialty societies and other health care stakeholders engage CMS as it considers changes to the ASC Payment System. Further, H.R. 6138 will support Medicare beneficiaries as they seek the high-quality, efficient and cost-effective care ASCs deliver.

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