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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Study: ACA stopped expansion of physician-owned hospitals

The Affordable Care Act’s restrictions on physician-owned hospitals (POHs) appear to have worked, as a new study published in Health Affairs said the law “effectively eliminated” the formation of new POHs.

NYT: Preliminary evidence says the ACA makes people healthier

Many in the Obama administration bemoan the fact that 19 states have opted out of Medicaid expansion under the Affordable Care Act. But the program’s patchwork implementation might have helped prove the law’s value, according to the New York Times. 

Carestream Reduces Energy Consumption, Boosts Recycling Efforts At Oregon and Colorado Manufacturing Facilities

ROCHESTER, N.Y., Aug. 9 — Carestream Health reduced energy consumption and enhanced recycling at its facilities in Oregon and Colorado as part of an ongoing effort to trim its environmental footprint.

FDA guidance addresses when device makers need to report changes

Draft guidance from the Food and Drug Administration is seeking to clarify when medical device manufacturers need the agency’s approval to make changes to their products, potentially replacing guidance that had remained unchanged since 1997.

NIH closes drug production facility blamed for contamination issues

The National Institutes of Health (NIH) has permanently closed its facility which manufactured investigational drugs a year after “a series of deficiencies” were found in the unit by Food and Drug Administration (FDA) inspectors.The National Institutes of Health (NIH) has permanently closed its facility which manufactured investigational drugs a year after “a series of deficiencies” were found in the unit by Food and Drug Administration inspectors.

Calif. physicians, hospitals quarrel over nurse-midwives legislation

The California Medical Association (CMA) is opposing a bill which would allow certified nurse-midwives to practice without physician supervision, but not because of the main goal of the legislation, according to Kaiser Health News.

Zika fight continues with insecticide, reproductive research grants

The fight against Zika continued to pick up steam this week after reports of 15 local transmissions in Miami. 

Study: Only 15% of device companies ready for Sept. 24 UDI compliance deadline

A September 24 deadline set by the Food and Drug Administration is looming for Class II medical devices, such as condoms or wheelchairs, to be outfitted with unique device identifier (UDI) barcodes, but in a survey of device makers, only a few said their companies were currently compliant with the standard.

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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