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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FDA approves new AI-powered imaging software from Nanox subsidiary

According to Nanox.AI, previously known as Zebra Medical Vision, the updated software helps "bridge the divide between radiology and cardiology."

pharmaceutical drug approval process

Drugmaker to ‘challenge’ FDA after only receiving tentative approval for inhaled PAH treatment

An exclusivity agreement is stopping Liquidia Corporation from gaining full FDA approval of its new inhalation powder for pulmonary arterial hypertension. The company said it is disappointed with the agency's decision and plans to "take quick action."

Ron Blankstein, MD, FACC, FASNC, MSCCT, FASPC, associate director, cardiovascular imaging program, director, cardiac computed tomography, Brigham and Women’s Hospital, and a professor of medicine and radiology, Harvard Medical School, explains why Medicare is proposing increased coronary computed tomography angiography (CCTA) payments to hospitals.

Higher payments for CCTA could bring considerable change to cardiology

Ron Blankstein, MD, explains how and why Medicare is proposing an increase to hospital payments for coronary CT angiography.

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Reduce, reuse, recycle: How cath labs can lower cardiology’s colossal carbon footprint

Cath labs, like radiology suites and operating rooms, are leading contributors to the world’s growing carbon footprint.

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FDA approves hydrogel to stop severe, life-threatening bleeding

Traumagel is applied to wounds using a syringe and can be used even on traumatic injuries, such as those from gunshots.

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.

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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.

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Around the web

Cardiovascular Business
Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiovascular Business
Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Cardiovascular Business
Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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