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.

Americans have mixed feelings about value of medical care

Americans generally agree science has improved the quality of healthcare, but the vast majority consider it unaffordable, according to a recent Pew Research Center survey.

July 12, 2018

CMS cuts funding for marketplace navigators for 2nd consecutive year

CMS announced it will award $10 million to the Navigator Program starting in the fall of 2018—representing a sharp decrease from $63 million in 2016.

July 11, 2018

Pfizer backs down on drug price increases, announces split into three businesses

Following attacks by President Trump on Twitter, drugmaker Pfizer backed down on its previously announced plan to raise drug prices on a number of prescriptions. Pfizer also announced Wednesday it will reorganize into three businesses, effective in 2019.

July 11, 2018

Amazon’s OTC business offers pills at steep discount

Retail giant Amazon is selling over-the-counter (OTC) medicines at lower prices than its brick-and-mortar competitors.

July 11, 2018

Trump’s Supreme Court nominee could face questions on healthcare record

Brett Kavanaugh, President Donald Trump’s pick to replace Supreme Court Justice Anthony Kennedy and a D.C. Appeals Court judge, will likely face questions on his healthcare record during confirmation hearings.

July 11, 2018

CMS will allow participants to withdraw from new bundles in March 2019

CMS has announced participants in the Bundled Payment for Care Improvement (BPCI) Advanced model will be able to retroactively withdraw beginning in March 2019.

July 10, 2018

Trump attacks Pfizer after drug price increase

President Donald Trump lashed out at drug manufacturer Pfizer after the company raised prices for 100 drugs by an average of 9 percent, effective July 1.

July 10, 2018

Arizona law intended to limit opioid prescriptions may hurt chronic pain patients

States are desperate to act in the national opioid epidemic, but laws limiting opioid prescriptions and doses are negatively impacting chronic pain patients and leaving doctors conflicted about care delivery, NPR reported.

July 10, 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.