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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Trump quietly signs FDA user fee reauthorization

With almost zero fanfare, President Donald Trump signed the FDA Reauthorization Act (FDARA) of 2017 into law on Aug. 18, approving the user fee agreements paid by pharmaceutical and medical device companies to the Food and Drug Administration (FDA).

Past HHS chiefs urge Congress, Trump to focus on stabilizing ACA markets

The immediate healthcare policy goal for Republicans should be dispelling uncertainty around the Affordable Care Act (ACA) marketplace, according to three former secretaries of HHS.

More than 800 ICD-10 code changes introduced for 2017

Two years after the introduction of ICD-10, the ICD-10 Coordination and Maintenance Committee has introduced more than 800 code changes set to take effect in October.

Majority of Americans now support universal health coverage

60 percent of Americans believe it’s the government’s responsibility to provide universal health coverage, representing a major shift in opinion since 2013, according to an analysis published in the New England Journal of Medicine.

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Hospital groups split on CMS canceling mandatory bundles

CMS confirmed Tuesday it will cancel two mandatory bundled payment programs and scale back another—and not all hospitals are happy about it.

HHS has ‘slammed on the brakes’ with ACA outreach

Groups which have previously partnered with HHS to promote open enrollment on the Affordable Care Act (ACA) exchanges say there have been no signs that work will continue in the first enrollment period under President Donald Trump.

Trump pushing for another ACA repeal attempt in September

September to set to be a busy month for Congress, with deadlines approaching on the next federal budget, the debt ceiling and the question of continuing insurer subsidies under the Affordable Care Act (ACA). President Donald Trump wants to add another item to that large agenda: another try at repealing the ACA.

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CMS to cancel mandatory bundles

A rule title posted to the Federal Register on Aug. 10 indicates CMS will cancel two mandatory bundled payment programs, the Advancing Care Coordination through Episode Payment Models (EPMs) and Cardiac Rehabilitation Incentive (CRI) Payment Models, while changing a separate payment program on joint replacements.

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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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