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. 

Mental healthcare breakdown in Massachusetts

Government cuts to state- and federally funded mental healthcare are causing troubles for patients, families and their communities, according to a report by the Boston Globe’s famous investigative Spotlight Team. 

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Nearly a third of U.S. counties likely limited to a single exchange insurer in 2017

A preliminary analysis of insurer participation on the Affordable Care Act’s insurance exchanges said that 31 percent of counties in the U.S. are likely to have a single insurer marketplace in 2017.

PuraPly products now available for Medicare reimbursement in 10 states

Following the decision by the National Government Services to end its local coverage determination for both cellular and tissue-based products, Organogenesis’s PuraPly and PuraPly Antimicrobial products for wound management will be eligible for Medicare coverage and reimbursement in 10 states.

FDA recalls the INRatio and INRatio2 PT/INR monitoring systems

The FDA has announced that Alere has recalled their INRatio and INRatio2 PT/INR monitoring systems.

Princeton health economist says ACA death spiral has arrived

With rising premiums and the departure of major insurers, there’s been plenty of pessimism towards the Affordable Care Act’s health insurance exchanges, but Princeton University health economist Uwe Reinhardt, PhD, has an even harsher assessment on their future.

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6 ACA exchange reforms suggested by AHA

In a letter to HHS Secretary Sylvia Burwell, the American Hospital Association (AHA) suggested several possible changes to the Affordable Care Act’s health insurance exchanges, arguing “swift action” is needed to stabilize the markets.

FDA recommends Zika testing for all blood donations

The FDA is advising all U.S. states and territories to screen donated blood and blood components for the Zika virus, a major expansion of screening efforts to prevent spread of the mosquito-borne virus through blood supplies.

One-third of U.S. may be limited to one choice of insurer on exchanges in 2017

Nearly 36 percent of the exchange market rating regions in the U.S. may have only one insurance company participating in the Affordable Care Act’s exchanges, according to an analysis from Avalere.

Around the web

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. 

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

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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