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.

Medicare competitive bidding process hurts patients

The Medicare bidding process is hurting patients, according to a new study from the Pacific Research Institute.

July 19, 2018

Amid revenue growth, UnitedHealth considers acquiring $2B Tenet subsidiary

UnitedHealth Group is exploring an acquisition of Tenet Healthcare’s healthcare management subsidiary, Conifer Health Solutions, according to the The Wall Street Journal.

July 19, 2018

CMS opens comment period for Kentucky Medicaid work requirements

After a federal judge blocked work requirements for Medicaid beneficiaries in Kentucky, CMS has opened a pathway for the policy.

July 19, 2018

Facing pressure from Trump, another drug manufacturer drops price hikes

Novartis, one of the world’s biggest pharmaceutical companies, has paused any price hikes on its drugs for the remainder of 2018.

July 19, 2018

FDA unveils plan to lower prices, boost competition among drug-makers

The FDA unveiled a new plan to enable market competition for biologics and biosimilars Wednesday, July 18, as part of a larger shift to lower drug prices across the healthcare system.

July 18, 2018

Humana hits highest share price ever

With a stake in two post-acute care companies under its belt, health insurer Humana saw its share price hit a new record high last week.

July 18, 2018

Amazon eyeing investment in Indian pharmacy chain

Retail giant Amazon is in early talk to invest in Medplus, India’s second-largest pharmacy chain, according to FactorDaily.

July 18, 2018

HHS diverts $40M to immigration crisis under Trump policy

President Donald Trump’s policy of “zero tolerance” on illegal immigration has led HHS to redirect millions in funding to house migrant children separated from their parents at the border.

July 18, 2018

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.