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. 

money business cash flow dollar

White House unveils lower prices for popular heart, diabetes drugs after Medicare negotiations

Apixaban, empagliflozin, rivaroxaban and sacubitril/valsartan are just some of the medications included in this initial round of Medicare price negotiations. Their new prices were reduced by 56%, 66%, 62% and 53%, respectively. 

Medicare Money dollar payment reimbursement

Medicare negotiates lower price for 10 vital drugs, saving seniors $1.5B

The move will save the Medicare $6 billion in just one year, an announcement from the Biden administration said.

private equity corporatization business consolidation

Steward sells physician group to private equity firm for $245M

Stewardship Health, a group represented by 3,500 doctors, will be sold to Rural Healthcare Group, owned by private equity firm Kinderhook Industries.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Patient risks persist for insulin pump caught in Class I recall

A software update for the pump's mobile app was expected to fix ongoing battery issues, but the problem remains. 

Artificial intelligence sign in the United Imaging booth. The Chinese company wants to break into the U.S. market and has a massive booth footprint at RSNA 2023. This included a section for its own AI development division. Photo by Dave Fornell #RSNA

FDA on track to clear 1,000+ clinical AI algorithms by end of the year

As of July 2024, the FDA reports it has cleared 950 AI algorithms to aid in direct clinical decision making.

Dana Smetherman, MD, ACR CEO, explains AUC may be better than prior authorizations.

ACR CEO discusses solution to fight burdensome prior authorizations in medical imaging

Dana Smetherman, MD, MBA, outlines a possible remedy for the growing number of these roadblocks in the specialty. 

MDMA Ecstasy

FDA rejects ‘ecstasy’ as treatment for PTSD

The agency has asked for an additional phase 3 study before it considers another application from manufacturer Lykos.

Recor Medical's Paradise Ultrasound Renal Denervation System

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting. 

Around the web

Compensation for heart specialists continues to climb. What does this say about cardiology as a whole? Could private equity's rising influence bring about change? We spoke to MedAxiom CEO Jerry Blackwell, MD, MBA, a veteran cardiologist himself, to learn more.

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”