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.

Proposed Legislation Promotes Medicare Patients’ Access to ASCs

The Ambulatory Surgery Center Association (ASCA) announced its support for new legislation titled “The ASC Quality and Access Act of 2019” (H.R. 4350). U.S. Representatives Devin Nunes (R-CA) and John Larson (D-CT) introduced the legislation in the U.S. House of Representatives.

ASCs are health care facilities focused on providing same-day surgical care, including diagnostic and preventive health care procedures such as colonoscopies. Last year, more than 5,700 ASCs provided 10 million outpatient surgeries to Medicare beneficiaries. Currently, on average, ASCs are reimbursed by Medicare at 50 percent of the amount paid to HOPDs for identical services. This disparity continues to grow from year to year. As recently as 2003, Medicare paid ASCs 86 percent of the amount it paid HOPDs.

Provisions in the legislation would

  • require use of the same inflation update for ASCs and hospital outpatient departments (HOPD);
  • require the Centers for Medicare & Medicaid Services (CMS) to publish relevant quality data in a way that allows patients to compare quality across sites of service;
  • statutorily require CMS to add an ASC representative to its Advisory Panel on Hospital Outpatient Payment, which makes decisions that affect both HOPD and ASC facility fees and eligible procedures; and
  • require CMS to disclose which criteria trigger the exclusion of a procedure from the ASC approved list.

“The sponsors of the ASC Quality and Access Act recognize the importance of decreasing Medicare beneficiaries’ out-of-pocket costs and putting the program on more stable footing,” said Ambulatory Surgery Center Association Chief Executive Officer William Prentice. “This bill addresses those priorities by making a permanent fix to Medicare’s reimbursement structure that will increase our seniors’ access to the high-value care provided in ASCs, while also increasing transparency so they and their families have the information they need to be informed decision makers.”



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