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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Maryland co-op suspended from individual market

Evergreen Health Cooperative won’t be able to issue or renew plans for 2017 until regulators decide whether it can convert into a for-profit insurer.

What’s working against ACA repeal

The death of the Affordable Care Act (ACA) has looked all but certain since the election of Donald Trump. Debate has focused on how and when, not if, the law would be rolled back, but one Democratic healthcare lobbyist is offering a different scenario.

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FDA releases new hearing aid guidance, in effect immediately

The FDA has issued a release that details ways to improve access to hearing aids for the 30 million Americans currently suffering from hearing loss. The guidance document will take effect immediately.

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$6.3 billion 21st Century Cures Act passes in big win for drug companies, device makers

The U.S. Senate has approved a bill aimed at speeding up regulatory approval for pharmaceuticals and medical devices, as well as providing extra funding for medical research, the Precision Medicine Initiative, and the cancer “moonshot.”

Current ACA repeal plan carries $1.1 trillion increase in uncompensated care costs

The number of uninsured people would more than double and the individual insurance market would collapse if the Affordable Care Act (ACA) is repealed through a fast-track process called budget reconciliation.

Insurers want more time to decide on 2018 ACA exchange participation

With Congress and the next president promising repeal of the Affordable Care Act (ACA), the nation’s largest health insurance lobby wants a delay for insurers to submit plans to offer coverage on the law’s exchanges for 2018.

CMS reports ‘modest’ 2015 expenditures

A new report from CMS today shows healthcare spending in 2015 was modest compared to years before the Affordable Care Act (ACA) was passed.

6 things to know about AHA’s letter to Trump

The American Hospital Association (AHA) laid out some specific policy priorities for hospitals in a letter to President-elect Donald Trump, offering clues to where their lobbying efforts will focused once Trump takes office.

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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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