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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Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA

Regulatory Roundup: FDA clears AI-powered Apple Watch competitor, grants breakthrough designation to new heart failure device

Ancora Heart received the FDA’s breakthrough device designation for its AccuCinch Ventricular Restoration System, a new minimally invasive transcatheter device designed for the treatment of heart failure.

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Amazon’s $4B takeover of One Medical is already under fire

Within hours of Amazon announcing its intention to acquire healthcare provider One Medical for $3.9 billion in cash, lawmakers took aim at the retail giant to pursue blocking the deal.

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Providers ask for higher payments in OPPS proposed rule

The proposed payment increase of 2.7% doesn't make up for sequestration cuts, inflation, and other factors hitting hospitals, medical groups say. 

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Autoimmune patients caught in crossfire of Supreme Court's Roe decision

Some patients with certain autoimmune diseases are finding it difficult to obtain their prescriptions for methotrexate as a result of changing abortion care laws.

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Abortion care still protected in emergency situations for all Americans, Biden administration clarifies

The Biden administration has seemingly found a way to federally protect abortion care services in all states in some circumstances.

Medtronic recalls more than 1M dialysis catheters

This is a Class I recall, which means using the devices could cause "serious adverse health consequences or death."

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FDA to consider OTC birth control application

The application comes just weeks after the Supreme Court overturned Roe v. Wade, which guaranteed the right to abortion care in the U.S. for nearly 50 years.

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Theranos exec found guilty on 12 counts of fraud, conspiracy

The chief operating officer of the now defunct blood-testing company was found guilty of 12 counts of wire fraud and conspiracy. 

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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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