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.

Piedmont, Georgia BCBS settle contract dispute after governor gets involved

One of the largest health systems in Atlanta and one of Georgia’s biggest insurers have settled a months-long dispute over a new contract after Georgia Gov. Nathan Deal threatened to take executive action to push the sides to negotiate.

April 18, 2018

FDA releases plan for improving medical device safety

“Although medical devices provide great benefits to patients, they also present risks,” said FDA Commissioner Scott Gottlieb, MD. “And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”

April 18, 2018

Hospitals have the most to lose from healthcare’s blurring lines

The wave of megamergers involving health insurers could place the greatest pressure on both not-for-profit and for-profit hospitals, according to a report from Moody’s Investors Service, if these new combinations steer patients away from hospital-owned facilities.

April 17, 2018

What pharma fears about Trump’s upcoming speech on drug prices

President Donald Trump will deliver a speech on April 26 focused on ways to lower prescription drug prices, but the pharmaceutical industry doesn’t expect it to include the more dramatic reforms Trump espoused on the campaign trail.

April 17, 2018

Amazon won’t sell drugs to hospitals, but may still compete with pharma in other ways

Amazon has reportedly shelved plans to sell and distribute pharmaceuticals to hospitals and health systems through its Amazon Business unit, a move which analysts said illustrates the difficulty outside companies face in disrupting the existing healthcare supply chain.

April 17, 2018

Healthcare price growth hits 6-year high

Prices across the healthcare sector rose 2.2 percent year-over-year in March 2018, the highest annual growth rate recorded by Altarum since January 2012, with the report warning rapid price growth is likely to continue.

April 13, 2018

Chicago’s Rush calls off merger with suburban hospital

The Rush hospital system based in Chicago has ended plans to acquire Little Company of Mary of Evergreen Park, Illinois, which would’ve merged 12 facilities with Rush University Medical Center and its 2,500-student health sciences college.

April 12, 2018

Drug competition didn’t stop sharp increase in MS spending

The report from the Health Care Cost Institute (HCCI) examined claims for people with multiple sclerosis (MS) from 2009 to 2015 covered by individual market, employer-sponsored or Medicare Advantage plans. It found total spending per MS patient rose from around $23,900 to $39,628 by 2015. During the same time period, the share of spending spent towards injectable and oral disease modifying therapies (DMTs) rose from 39 percent to 53 percent.

April 12, 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.