Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring
According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as researchers conducting clinical trials.
ACLU sues FDA over unanswered Freedom of Information Act request
The agency is accused of failing to respond to a records request related to its upcoming review of the legality of abortion pills and interstate prescribing practices. The ACLU is asking a federal judge to enforce FOIA law.
Trump’s former FDA commissioner joins board of UnitedHealth
Scott Gottlieb, MD, will take on the new position “effective immediately.” UnitedHealth Group did not say what, if any, steering committee the former FDA lead will sit on.
Siemens Healthineers issues correction for MRI systems affected by recent Class 1 recall
On Aug. 28, Siemens alerted customers about safety issues with nine different scanners from its Magnetom series of MRI offerings.
ASTRO releases new radiation therapy guidelines for gastric cancers
Many forms of the disease are identified at later stages, making treatment and management complex and multifaceted.

RadNet, cancer care advocates praise passage of bills to boost imaging coverage

The policy changes forbid insurers from saddling patients with out-of-pocket costs for services associated with lung and breast cancer.

healthcare value value-based care money dollar

ACR shares ‘concern’ after CMS yanks coverage for certain exams, retroactive to 2019

The college believes the move will sow confusion and is asking the agency to rescind its noncoverage determination.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

Radiologists propose resolution to protect specialty from prosecution in states that ban abortion

Twenty-five state societies have voiced their support for the proposal, being presented at the 2023 ACR Annual Meeting in D.C.

breast radiologist breast cancer mammography

American College of Radiology releases new breast cancer screening guidelines

“These evidence-based updates should spur more-informed doctor-patient conversations and help providers save more lives," the document's lead author said.

New CMS code could pave the way for coverage of virtual reality-based treatments

The determination places the device under the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) benefit category.

FDA clears toilet seat-based heart monitor as company targets product launch by end of year

Casana, the company behind the Heart Seat, is now pursuing approvals for additional indications.

Justice Department accuses radiologist of amassing $6.5M in improper Medicare payments

James McGuckin, MD, allegedly submitted more than 500 false claims for unnecessary vascular procedures between 2016 to 2019, the DOJ said.

Policy & Regulations

FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring

ACLU sues FDA over unanswered Freedom of Information Act request

Trump’s former FDA commissioner joins board of UnitedHealth

Siemens Healthineers issues correction for MRI systems affected by recent Class 1 recall

ASTRO releases new radiation therapy guidelines for gastric cancers