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.

4 points crucial to the nimble regulation of GenAI
With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.
FDA recalls infant incubators due to risk of door falling off
A loose screw on the Giraffe OmniBed is to blame. With updated use instructions and repairs, the incubators are safe to use.
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT
CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.
Kentucky AG launches criminal probe after conscious man nearly has organs harvested
Three years ago Anthony Hoover was declared brain dead—until he woke up on the operating room table, moments before his organs were removed. His story has spurred a criminal investigation by Kentucky's attorney general.
FDA announces Class I recall of ventilators after 3 patient injuries
An unexpected nickel coating on the breathing circuits of Percussionaire Phasitron 5 ventilators is being blamed for the recall. The FDA is asking providers to stop using them immediately.

Hospital groups file lawsuit to block price transparency rule

A group of prominent hospital associations have filed a lawsuit against HHS to stop the implementation of a rule that requires hospitals to post their prices for services online and update it regularly.

December 4, 2019

Trump may loosen drug patent protections to push trade pact

The pharmaceutical industry could be in for a loss as the Trump administration considers easing patent protection rules in order to garner support from Democrats for a new trade pact between the U.S., Mexico and Canada––USMCA, The Wall Street Journal reported.

December 4, 2019

HHS to make HIV prevention medication free for uninsured

HHS has announced a new initiative to make a medication taken to prevent HIV, pre-exposure prophylaxis, or PrEP, available for free to those without prescription drug insurance coverage.

December 4, 2019

CVS enters new deal with Centene

CVS Health is acquiring Centene’s Illinois health plan subsidiary, IlliniCare Health Plan, the companies announced Dec. 2. Financial terms of the transaction were not disclosed.

December 3, 2019

Global medical costs will rise again in 2020

Medical care costs are set to rise again in 2020, with a projected increased of 6.8%, according to the 2020 Global Medical Trends Survey Report from Willis Towers Watson.

December 2, 2019

Reconciliation limitations led CMS to overpay hospitals $500M

Hospitals were overpaid by roughly $502 million from 2011 to 2014, according to a report from the Office of Inspector General (OIG), which blamed the overpayment on CMS limitations on the reconciliation period.

December 2, 2019

Trump’s drug importation plan faces news challenges

President Trump’s plan to allow the importation of certain drugs from Canada is facing new challenges from the Canadian government, according to The Hill.

December 2, 2019

Feds open criminal probe into opioid makers

Pharmaceutical companies are under fire again for their role in the national opioid abuse epidemic, and this time, it could be criminal. Federal prosecutors have opened a criminal probe to determine if pharmaceutical companies intentionally allowed the flow of opioid drugs, The Wall Street Journal reported.

November 27, 2019

Around the web

AI in Healthcare

4 points crucial to the nimble regulation of GenAI

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

Cardiovascular Business

Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

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.

Cardiovascular Business

Cardiologist compensation still rising, especially in invasive and interventional cardiology

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.