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. 

Research thwarted by unreliable antibodies

More than 100 scientists met in California to find a solution to the increasingly research-thwarting problem of unreliable antibodies, according to NPR. 

3 things to know about CMS’s final long-term care rule

CMS has finalized its rule updating requirements for long-term care facilities participating in Medicare and Medicaid, the first such update since 1991.

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5 things to know from Hillary Clinton’s NEJM article

The New England Journal of Medicine invited both major presidential candidates to write articles about their healthcare policies, but only one took the editors up on the offer.

Zika funding fight resolved as Congress OKs $1.1 billion for vaccine, testing

The months-long battle in Congress over funding to help combat the Zika virus has ended, as both the House and Senate approved a $1.1 billion package Sept. 28 as part of a larger government spending bill.

Calif. will require doctors to check prescription drug databases

Before prescribing potentially addictive drugs, California physicians will be required to check whether patients have gotten the same drugs from other doctors in the state.

House passes individual mandate exemption for co-op enrollees

Legislation shielding customers of failed Affordable Care Act (ACA) co-ops from penalties for not buying health coverage has passed the House, offering a slim exemption from one of the law’s signature components, the individual mandate.

FDA drug reviewers often end up at pharma companies

More than a quarter (27 percent) of Food and Drug Administration (FDA) workers responsible for approving cancer and hematology drugs went on to work for the companies making those drugs, according to a new study published in The BMJ.

GAO: HHS oversight flaws leave EHR data vulnerable

A report from the Government Accountability Office (GAO) harshly criticized HHS’s guidance on privacy and security for health information, saying it fails to meet cybersecurity standards of other federal agencies and provides advice to covered entities that doesn’t help prevent future data breaches.

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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