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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Device companies agree to pay $1 billion in user fees to FDA

Medical device companies will pay the FDA nearly $1 billion in user fees for five years beginning in October 2017 under the fourth reauthorization of the Medical Device User Fee & Modernization Act (MDUFA).

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Zika could be harmful to adult brains, spread to other Gulf states

The U.S. should brace itself for even more Zika headaches, according to the National Institutes of Health (NIH), because the virus could be around for a while and spread to even more areas. One study found it could be even more harmful than scientists originally believed.   

OIG: States may be pocketing federal funds meant for hospitals

State governments may be profiting off Medicaid funds meant for hospitals that are publicly-owned but managed privately, according to a report from HHS’s Office of Inspector General (OIG).

One patient’s story of being uninsured in Texas

Although the Affordable Care Act provided health insurance to many people throughout the country, some are still stuck without insurance, particularly those in southern states.

CMS may punish providers that steer patients into ACA plans to boost reimbursement

CMS is asking for comments on what it should do about healthcare providers that steer Medicare and Medicaid-eligible patients towards marketplace plans in order to receive higher reimbursement.

Study: Latinos, low-income adults most likely to remain uninsured post-ACA

While the Affordable Care Act (ACA) and its expansion of Medicaid lowered the number of Americans without health coverage, millions are still uninsured, and a new study from the Commonwealth Fund aimed to identify who they are and why they aren’t covered.

Arizona, Southeast US will feel greatest impact from ACA exits

The effects of major insurers—such as UnitedHealth, Humana and, most recently, Aetna—departing from some state health insurance exchanges will depend largely on where consumers live.

Duke professors argue ACOs haven’t worked

Duke University professors Kevin Schulman, MD, and Barak Richman, JD, PhD, called on the CMS Innovation Center to focus on telemedicine and wearable devices, rather than accountable care organizations (ACOs) which integrate hospitals, to reduce the cost of care.

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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