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.

Capping resident payments could save Medicare more than $1.2B

Medicare may be shelling out an extra $1.2 billion in overpayments for graduate medical education (GME), which trains medical residents, according to a study published in JAMA Internal Medicine.

October 10, 2019

Johnson & Johnson ordered to pay $8B in drug harm case

Johnson & Johnson was hit with an $8 billion judgment and ordered to pay a Maryland man after the company failed to sufficiently warn users that its antipsychotic drug Risperdal could cause breast growth in men.

October 10, 2019

Cities with the highest and lowest uninsured rates

The healthcare uninsured rate in the U.S. is rising, but not all cities are seeing the same decline. WalletHub took a look at 548 U.S. cities to compare insurance coverage rates, ranking the highest and lowest cities by uninsured rate.

October 10, 2019

54M Americans have a pre-existing condition

Nearly 54 million Americans have a pre-existing condition, according to a new statistic from the Kaiser Family Foundation. The finding comes at a time when a court of appeals is considering a case that could impact those with pre-existing conditions.

October 9, 2019

HHS proposes reforms to kickback laws

HHS proposed anticipated changes to kickbacks regulations and the physician self-referral law, known as the Stark Law, Oct. 9.

October 9, 2019

AMA ramps up pressure to limit sale of e-cigarettes

The American Medical Association sent a letter to the CEOs of five of the largest commerce companies in the U.S. urging them to take action against the sale of illicit e-cigarette products on their platforms.

October 8, 2019

Trump to keep out immigrants without healthcare coverage

Signing a proclamation on Oct. 4, President Trump suspended and limited entry of immigrants who will put a financial burden on the U.S. healthcare system unless they are covered by approved health insurance.

October 7, 2019

Hospital profits on the decline

Hospitals are seeing a drop in profitability, according to a flash report from Kaufman Hall.

October 4, 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.