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 approves Bayer's finerenone to treat wide range of heart failure patients
Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.
FDA details multiple Class I recalls for Edwards Lifesciences surgical devices
Edwards Lifesciences has recalled more than 61,000 medical devices due to the risk of a small piece of wire becoming exposed. No patient injuries have been reported at this time.
The FDA has cleared more than 1,200 clinical AIs—and submissions are increasing
In the past year, there has been a record number of new medical AI submissions, resulting in 300 new clinical AI clearances. The number of submissions has been steadily rising over the past decade.
AI algorithm that diagnoses depression from MRI scans gains key regulatory approval
Experts are hopeful the software can bring more objectivity to the diagnostic process by giving providers visual evidence of alterations in brain activity.
Software glitch triggers FDA recall of nearly 2,000 GE SPECT and CT systems
According to the notification, the issue can cause the scanners to inadvertently move during imaging.

Legislation aims to improve patient access to diagnostic radiopharmaceuticals

Reps. Scott Peters, Bobby L. Rush and George Holding introduced a bipartisan bill this week that would increase patient access to key diagnostic radiopharmaceuticals used to help treat Alzheimer’s disease, Parkinson’s disease and numerous cancers.

ACR shares ‘serious concerns’ with surprise billing legislation

The American College of Radiology (ACR) has issued a statement sharing “serious concerns” with HR 3630, the No Surprises Act, which is currently scheduled to be considered by the House Energy and Commerce Committee.

HHS will not push rebate rule forward

A proposed rule to eliminate drug rebates will not be pushed through. However, President Trump could still take on the pharmaceutical industry in other ways.

CVS expands HealthHub concept to new markets

After introducing its new HealthHub concept store in Texas, CVS Health is spreading the store model to Boston, Dallas/Fort Worth, Maryland, North Carolina, Ohio and Virginia, the company announced.

5 new payment models proposed for kidney care

HHS and CMS are following through on an executive order from President Trump to overhaul kidney care in the nation by proposing five new payment models.

ASTRO: Proposed radiation oncology APM can improve patient care

CMS revealed details for their newly proposed alternative payment model for radiation oncology on July 10. The American Society of Radiation Oncology (ASTRO) believes the model, with adjustments, "will incentivize higher quality, more convenient radiation treatments for patients and support their journey toward a cure."

ACOs are slow to adopt downside risk

Only 28% of ACOs formed in 2012 have taken on downside risk, while just 33% had at least one contract with downside risk in 2018, according to a study published in Health Affairs.

Trump preparing another exec order on drug prices

President Trump is preparing to issue an executive order that would declare a favored nations clause for drug prices, ensuring the U.S. would not pay higher prices than other countries for prescription medications, CNBC reported.

Policy & Regulations

FDA approves Bayer's finerenone to treat wide range of heart failure patients

FDA details multiple Class I recalls for Edwards Lifesciences surgical devices

The FDA has cleared more than 1,200 clinical AIs—and submissions are increasing

AI algorithm that diagnoses depression from MRI scans gains key regulatory approval

Software glitch triggers FDA recall of nearly 2,000 GE SPECT and CT systems