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 recall. The medications involved are atenolol, which treats hypertension, and the antiplatelet agent clopidogrel, which reduces the risk of an acute myocardial infarction (AMI) or stroke among patients with a history of AMI, severe chest pain or circulation problems.

Patients face a risk of adverse events if they mistakenly take the wrong medication, according to a new warning from the FDA. 

The Society of Cardiovascular Computed Tomography developed and published the new document to help educate healthcare providers who regularly treat acute chest pain in the emergency department. 

AMA analysis of Medicare Trustee data shows Medicare updates compared to inflation 2001-2021.

More than 120 medical societies have joined the AMA in a letter urging congressional leaders to enact long-term solutions to the systemic problems in the Medicare physician payment system and to address cuts that are going into effect in 2023.

Medicare money payment physician

Dozens of medical societies have signed a new letter urging Congress to stop upcoming Medicare payment cuts. “The Medicare payment system remains on an unsustainable path threatening beneficiaries’ access to physicians," they wrote. 

The Abbott MitraClip is the primary structural heart device used in transcatheter edge-to-edge repairs (TEER) of the mitral valve leaflets.

When these malfunctions occur, the FDA explained, it leads to an increased risk of additional interventions.

Though removal of the affected CIED is typically the smartest treatment option—and one supported by specialty groups all over the world—a majority of patients keep living with the device, often resulting in hospitalization or even death.

The American College of Cardiology and American Heart Association have collaborated on a new update to the much-discussed 2021 chest pain guidelines. The American College of Emergency Physicians and Society for Cardiac Angiography and Interventions also contributed to the document.

The American College of Cardiology and American Heart Association have collaborated on a new update to the much-discussed 2021 chest pain guidelines. The American College of Emergency Physicians and Society for Cardiac Angiography and Interventions also contributed to the document.

Coronary CT Angiography (CCTA) has evolved into a much more helpful resource than interventional cardiologists may have originally believed. In fact, the Society of Cardiovascular Computed Tomography (SCCT) emphasized in a new expert consensus statement that CCTA provides specialists with an effective tool in the preparation and optimization of coronary procedures.

A new consensus statement from the Society of Cardiovascular Computed Tomography emphasized the increasing importance of CCTA among interventional cardiologists. It is no longer seen as “a mere diagnostic tool," the group observed. 

Recall | Product recall

This latest recall was initiated because electrical faults could cause the batteries to stop working, which leads to a risk of serious injury or death.

The U.S. Preventive Services Task Force (USPSTF) has finalized its new recommendations on the use of statins to prevent cardiovascular disease (CVD) in August 2022. The USPSTF recommends statin use for high-risk patients between the ages of 40 to 75 to help prevent a first heart attack or stroke. This received the group’s “B” recommendation, which means there is high certainty that there is net benefit. #statins

The USPSTF recommends statin use for high-risk patients between the ages of 40 to 75 to help prevent a first heart attack or stroke. Other patients in that same age group may also benefit, the group noted, but physician input is needed. 

Echo:Prio represents the latest addition to Dyad Medical's cloud-based Libby platform. Image courtesy of Dyad Medical.

The FDA has had a busy month, overseeing the recall of nearly 88,000 implantable cardiac devices, juggling the continued rise of monkeypox cases in the United States and maintaining an active Breakthrough Devices program. This rundown covers some of the agency's biggest moves during that time. 

Product Recall

The recall is related to short circuit protection (SCP) alerts that were causing the devices to send reduced-energy electric shocks. There have been 27 customer complaints about the issue so far.

Around the web

Validation and testing of all algorithms is needed to eliminate any biases in the data used to train the AI, according to Julius Bogdan, vice president and general manager of the HIMSS Digital Health Advisory Team for North America.

More than 120 medical societies have joined the AMA in a letter urging congressional leaders to enact long-term solutions to the systemic problems in the Medicare physician payment system and to address cuts that are going into effect in 2023.

Three medical journals are investigating possible manipulation of data in heart studies led by researchers from Temple University that found favorable health impacts of blood thinners.

   
   
   
   
   
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