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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

340 Organizations Send Letter to Congress Urging Action on Telehealth

On Tuesday 340 organizations signed a letter urging Congressional leaders to make telehealth flexibilities created during the COVID-19 pandemic permanent. Those signing this multi-stakeholder letter include national and regional organizations representing a full range of health care stakeholders and all 50 states, the District of Columbia, and Puerto Rico.

Congress quickly waived statutory barriers to allow for expanded access to telehealth at the beginning of the COVID-19 pandemic, providing federal agencies with the flexibility to allow healthcare providers to deliver care virtually. If Congress does not act before the COVID-19 public health emergency expires, current flexibilities will immediately disappear.

Therefore, 340 stakeholders have sent a powerful message to Congress outlining the immediate actions necessary to ensure CMS has the authority to continue to make telehealth services available once the national health emergency is rescinded:

  • Remove obsolete restrictions on the location of the patient to ensure that all patients can access care at home, and other appropriate locations;
  • Maintain and enhance HHS authority to determine appropriate providers and services for telehealth;
  • Ensure Federally Qualified Health Centers and Rural Health Clinics can furnish telehealth services after the public health emergency; and
  • Make permanent Health and Human Services (HHS) temporary waiver authority for future emergencies.

While federal agencies can address some of these policies going forward, the Centers for Medicare and Medicaid (CMS) does not have the authority to make changes to Medicare reimbursement policy for telehealth under the outdated Section 1834(m) of the Social Security Act. Following these priorities will allow CMS to build on the experience gained during the pandemic and expand access to telehealth in a thoughtful, data-driven way.

Read the letter to Congress, including the list of 340 stakeholders, here.

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