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.

Survey: Consumers aren’t fond of the pharma industry

The reputation of the pharmaceutical industry is tanking among U.S. consumers, the latest Gallup poll reveals.

September 5, 2019

How insurers are grappling with million-dollar therapies

New gene therapies are carrying price tags in the millions, leaving insurers scrambling to figure out how to cover them and offer the treatments to enrollees, according to The Wall Street Journal.

September 5, 2019

$69B CVS-Aetna deal cleared by court

U.S. District Court Judge Richard Leon has approved the $69 billion acquisition of Aetna by CVS Health, he announced in an opinion on Sept. 4.

September 5, 2019

OIG audit reveals Medicare overpaid millions for prescription drugs in hospice care

Medicare Part D overpaid millions of dollars for prescription drugs that should have been covered by the Medicare Part A hospice benefit, according to a recent report from the Office of Inspector General (OIG), which conducted an audit from 2016 payments. In other words, CMS paid twice for the same drugs.

September 4, 2019

Purdue Pharma prepares for bankruptcy

Purdue Pharma, the maker of popular opioid OxyContin, is preparing to file for bankruptcy before the end of September if the company doesn’t reach a settlement over thousands of lawsuits against the company for its role in the opioid abuse epidemic, Reuters reported, citing people familiar with the matter.

September 4, 2019

CVS aims to avoid hyperinflated drugs

More than 3,400 drugs saw price hikes in the first half of 2019, with the average increase being more than five times the rate of inflation, according to CVS Caremark.

September 3, 2019

Hurricane Dorian prompts public health emergencies

HHS Secretary Alex Azar declared public health emergencies for Georgia and South Carolina on Sept. 2 in preparation for Hurricane Dorian.

September 3, 2019

Purdue Pharma opioid settlement between $10-$12B

A proposed settlement would see Purdue Pharma shell out between $10 billion and $12 billion to close thousands of lawsuits over the company’s role in the opioid abuse and overdose epidemic.

August 28, 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.