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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FDA to end alternative summary reporting

The FDA is putting an end to a program that allowed medical device companies to keep the public in the dark about reports of harm and malfunction. The program, called alternative summary reporting, was established in 1997 and its data has not been publicly available.

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Basing US drug prices on an international reference could save billions

Adopting the prices of other countries could potentially have helped save Medicare part D as much as $72.8 billion in 2018, as drug prices in the U.S. averaged 3.2 to 4.1 times higher after rebates compared to the U.K., Japan and Ontario, Canada, according to a study published in Health Affairs.

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Drug companies will publish prices in TV ads

HHS has finalized a rule that will require drug companies to publish the list prices of drugs in television ads. 

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FDA shares 2 guidance documents for imaging providers

The FDA has published two new guidance documents designed to align the agency’s requirements for x-ray imaging devices with various international standards.

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CMS speeds up Medicaid changes for states that apply

CMS is taking steps to streamline the review process for states that apply for section 1915 waivers and state plan amendments, CMS Administrator Seema Verma announced May 7.  

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Tennessee to ask for Medicaid block granting

Tennessee is poised to become the first state of the union to ask for Medicaid block granting from the Trump administration, Politico reported.

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CVS asks judge to block witness testimony in court battle over its $69B Aetna deal

CVS Health is still facing challenges from its $69 billion merger with health insurance giant Aetna, which closed in late 2018. While the deal was approved by all necessary state regulators and the Department of Justice, a federal judge is still mulling over the deal and looking at potential antitrust problems.

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FDA publishes 2 final guidance documents on x-ray devices

The FDA has issued two final guidance documents regarding x-ray devices designed to more closely align FDA requirements with internationally developed standards.