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. 

Mylan to pay $465 million to settle claims of overcharging CMS on EpiPens

Mylan, the manufacturer of EpiPen, will pay $465 million to the federal government to “resolve questions” about whether the autoinjector was misclassified as a generic drug, therefore reducing the quarterly rebates Mylan owed.

OIG recommends adding medical device info to CMS claims forms

Adding fields for medical device information on claims reimbursement forms would help CMS better track how much Medicare spends on recalled or defective devices, according to HHS’s Office of the Inspector General (OIG).

LA County will require 'superbug' reports

A new law in California will require hospitals in Los Angeles County to report incidence of certain “superbugs,” the Los Angeles Times reported. California is one of roughly half the U.S. states that had not required the reporting in the past. 

CMS: Mylan overcharged government for EpiPens for years

The controversy over the price increases for EpiPens isn’t going away, as Mylan is now being accused by CMS of overcharging Medicare and Medicaid by classifying the autoinjector as a generic drug.

Tracing the history of Trump and Clinton’s health plans

While much of the 2016 presidential election appears to defy historical trends, the origins of the health policies put forward by the two candidates can easily be traced back to the mid-20th century, according to a column in the New England Journal of Medicine.

Anthem-Cigna trial split up for faster ruling

The national and local market implications of the $54 billion proposed merger of Anthem and Cigna will be considered separately, potentially expediting the court decision on the case.

FTC recommends rejecting Virginia hospital merger

Virginia regulators should deny the proposed merger of Mountain States Health Alliance and Wellmont Health System, according to testimony from the Federal Trade Commission (FTC).

2.5 million people may be missing out on ACA subsidies

An analysis from HHS said millions of additional customers could qualify for subsidies if they purchased plans off the Affordable Care Act (ACA) marketplace.

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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