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. 

‘Simple choice plans’ will be available for 2017 exchange customers

Insurance coverage with standardized deductibles, out-of-pocket spending limits and co-pays will be available during the next open enrollment period for health insurance marketplaces, according to Kaiser Health News.

CMS has plan to end dual enrollment in exchange plans and Medicare

CMS has told members of Congress it will contact customers who are enrolled in both Medicare and a subsidized insurance plan purchased through the Affordable Care Act’s exchanges, and tell them to leave their exchange plan immediately.

Why lawmakers keep making ‘compassionate use’ requests for controversial doctor

Requesting access to experimental, unapproved treatments from the FDA can sometimes save a patient’s life when no other treatment has worked. But as STAT’s Sheila Kaplan writes, there is a dark side to “compassionate use.”

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NIH Director Collins preaches optimism and big ideas to medical researchers in Chicago

National Institutes of Health Director Francis Collins, MD, PhD, told a crowd of medical researchers in Chicago he has a “sense of optimism” about the ability to offer more grants through the agency, while encouraging them not to shy away from bold projects.

Ebola remained in semen for 565 days—far longer than previously thought possible

A study of Liberian men found previous estimates of how long the Ebola virus could remain in semen were significantly too low, as one man was found to still carry the virus 565 days after he recovered from the illness.

Congressmen want investigation of Purdue Pharma and other opioid makers

Two members of Congress from California, Democrat Reps. Ted Lieu and Mark DeSaulnier, are calling for a congressional investigation into manufacturers of opioid painkillers.

Mylan offers EpiPen generic in attempt to quell price controversy

Mylan, manufacturer of the allergic reaction treatment EpiPen, has announced it will sell a generic version of the autoinjector at half the price of the branded device after federal lawmakers and consumer groups questioned why its price has gone up 400 percent since Mylan acquired it.

Risk adjustment gets overhauled for 2018 under CMS proposal

CMS proposed a series of adjustments it intends to strengthen the Affordable Care Act’s insurance exchanges for 2018, including some initiatives insurers have been pushing for, such as pooling high-cost enrollees and adjusting for special enrollment customers. 

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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