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. 

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Bharath Krishnamurthy, a director of Health Policy and Analytics at the American Hospital Association (AHA), explains explains how drug shortages and supply chain issues are negatively impacting U.S. healthcare.

Drug shortages jeopardize patient access to quality hospital care

American Hospital Association Director of Health Policy and Analytics Bharath Krishnamurthy explains how drug shortages and supply chain issues are negatively impacting U.S. healthcare.

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.

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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