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.

FTC shuts down alleged health insurance fraud scheme involving the sale of low-quality plans
The owners of several telemarketing companies, along with the organizations themselves, have been named as defendants in a federal lawsuit. The Federal Trade Commission alleges that the group would sell bundled services as supposed “PPO” plans, leaving patients to discover that services were not covered.
FDA: CVS and MediHoney wound gels recalled after 14 serious injuries
The wound and burn gels are manufactured by Integra LifeSciences. Defective packaging could cause the sterile barrier to fail, exposing the gels to pathogens. Due to the risk of severe infections, all recalled products must be removed from where they are used and sold.
5 reasons not to (solely) blame insurance companies for what ails US healthcare
As this midterm-election year barrels toward decision day, health insurers continue taking punches from both political parties. The piling-on might be as unfair as it is understandable.
Medicare and FDA propose granting rapid coverage for breakthrough radiology devices
The two agencies on April 23 announced the rollout of the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway.
Radiology groups endorse bill to exempt physicians from $100,000 visa fee
ACR, ASNR and over 40 other organizations shared their support for the Healthcare Workforce Act in a letter to lawmakers written April 15.

David Magid, MD, MPH/MSPH, a professor of cardiology at the University of Colorado, explains attributing cardiac patient care to physicians in accountable care organizations.

Common methods for attributing cardiac care in ACOs may be falling short

As the United States continues to move toward quality-based care, ACOs need to rethink the way they attribute care to cardiologists and other members of the heart team.

Healthcare AI today: Healthcare AI ROI, Microsoft mainlines healthcare AI, Google gets slapped back from within, more

What good is AI in healthcare if it doesn’t improve financial margins? The question is getting posed in the C-suites of provider organizations and insurance companies.

cybersecurity hacker ransomware cyber data breach

FDA announces recall for Johnson & Johnson devices due to cybersecurity risk—customers urged to act

The FDA and Johnson & Johnson MedTech are telling customers to keep the devices in a secure environment until they can be disabled from all networks.

breast radiologist breast cancer mammography

90% of voters polled agree health insurers should cover all recommended breast imaging

A coalition of organizations including the Society of Breast Imaging are seeking support for the Access to Breast Cancer Diagnosis Act.

California passes law to regulate private equity activity in healthcare

California Gov. Gavin Newsom signed into law SB 351, which improves regulatory oversight of dental and physician clinics owned by investment firms.

The U.S. Food and Drug Administration (FDA) granted pre-market approval (PMA) clearance for Zoll Zenix defibrillator-monitor for EMS and hospital use. It incorporates new technology and features based on years of user feedback.

FDA approves Zoll's newest defibrillator-monitor

The device, based on years of user feedback, is now cleared for use in both EMS and hospital settings.

New expert guidelines examine the use of temporary MCS during heart surgery

Three leading medical societies collaborated on the new document, providing detailed recommendations that cover a wide variety of technologies and clinical scenarios.

Radiology groups endorse bipartisan bill to boost specialist counts in rural areas

ACR, SIR and ASTRO are voicing their support for the Specialty Physicians Advancing Rural Care (SPARC) Act, introduced in both the House and Senate.

Policy & Regulations

FTC shuts down alleged health insurance fraud scheme involving the sale of low-quality plans

FDA: CVS and MediHoney wound gels recalled after 14 serious injuries

5 reasons not to (solely) blame insurance companies for what ails US healthcare

Medicare and FDA propose granting rapid coverage for breakthrough radiology devices

Radiology groups endorse bill to exempt physicians from $100,000 visa fee