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.

Telehealth execs face 20 years for $100M Adderall prescription fraud

The CEO and the medical director of telehealth platform Done have both been arrested for allegedly running a virtual pill mill.

Money court lawsuit judge ruling scales of justice

Radiology accounts for the 2nd most IDR payment determinations under the No Surprises Act

Emergency medicine services accounted for the majority at 59%, followed by radiology at 14%, according to new data from CMS released Thursday.

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American College of Radiology asks CMS to create new alternative payment pathway for high-value AI

ACR’s June comments come in response to the 2025 Hospital Inpatient Prospective Payment System rule released by CMS in April.

UnitedHealth needs to be solely responsible for HIPAA notifications after Change Healthcare breach, letters demand

The ONC has fallen short of plainly stating that UnitedHealth is required to send the notifications, leaving providers in regulatory limbo.

There has been a growing shortage of cardiologists the past several years, but this has accelerated due to burnout from the pandemic, falling reimbursements and increasing administrative burdens. This prompted a joint session on this topic with the ACC and the Heart Rhythm Society at HRS 2024, with ACC President Cathie Biga, MSN, FACC, president and CEO of Cardiovascular Management of Illinois, former ACC president Ed Fry, MD, chair of the Ascension National Cardiovascular Service Line, and EP Parin Patel.

Addressing staffing shortages in cardiology

ACC President Cathie Biga, MSN, RN, Edward Fry, MD, and electrophysiologist Parin Patel, MD, discuss the growing cardiologist shortage.

Insurers eventually approve most denials, though payer-mandated changes may be compromising care

Across over 200 radiation therapy denials at a single institution, 98% eventually led to the delivery of RT with delays sometimes as long as 49 days.

Biden administration proposes banning medical bills from credit reports

The Consumer Financial Protection Bureau also wants to stop credit reporting companies from sharing medical debt information with lenders, among other changes.

CVS Health announces $10.6B acquisition of Oak Street Health

CVS generic drugs twice as likely to be recalled over safety concerns, investigation finds

CVS generics have been linked to more than 15 manufacturers cited for producing allegedly contaminated drugs.

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