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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Pediatricians want non-medical vaccination exemptions eliminated

The American Academy of Pediatrics (AAP) says states should get rid of laws which allow children to go unvaccinated for diseases like measles for non-medical reasons and advises individual physicians to consider excluding families who continually refuse immunizations from their practice.

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.

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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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