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. 

CBO significantly lowers estimate for health insurance coverage

The Congressional Budget Office has reduced its estimate of the cost for providing health insurance coverage under the Affordable Care Act, reports The New York Times. 

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White House makes major push for value-based payments

The Obama administration has announced a major goal to tie half of all Medicare payments to quality of care by 2018, reports The Washington Post. 

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Obama’s SOTU address highlights ACA, new individualized medicine initiative

In his State of the Union address, President Barack Obama described the Affordable Care Act as part of the fabric of middle-class economic recovery as he spoke to a Republican-controlled Congress still working to dismantle the law, reports Clinical Innovation + Technology.

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MedPAC seeks to freeze reimbursements

The Medicare Payment Advisory Commission has approved recommendations to Congress to either freeze reimbursements or make them site neutral, which would save Medicare billions of dollars, according to Modern Healthcare.  

FDA guidance offers clarity on wellness products

The FDA has released a draft guidance offering some clarity on how it defines a low-risk product: A general wellness product becomes a medical device when it refers to its use for a specific disease or condition, according to Medcity News. 

Tavenner to step down

Marilyn Tavenner, top administrator for Centers for Medicare & Medicaid Services, has announced plans to step down in February, reports Wall Street Journal. 

Analysis challenges argument in favor of repealing the medical device tax

An analysis from the Congressional Research Service challenges a common talking point among legislators that the medical device tax destroys jobs and encourages manufacturers to operate oversees, according to The New York Times. 

Protesting the ACA

Some U.S. consumers are turning down tax credits offered through the Affordable Care Act out of principle, opting to spend more on health insurance, reports U.S. News & World Report.

Around the web

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. 

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.

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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