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.

CMS rejects Idaho’s plans to expand non-ACA-compliant insurance

Idaho’s plan to allow health insurers to offer coverage which doesn’t comply with the Affordable Care Act (ACA) would result in CMS fining insurance companies and taking over the state’s role in enforcing the law, essentially denying the state’s proposal to violate the ACA—but also offering the state some guidance on how it could approve the plans in the future.

March 9, 2018

Cigna to buy Express Scripts for $67B

Cigna announced this morning it will buy Express Scripts in a deal worth a total of $67 billion. The health insurer will assume $15 billion in debt from the pharmacy benefits manager (PBM) in addition to the $52 billion stock-and-cash transaction.

March 8, 2018

Massachusetts officials give thumbs-up to Beth-Israel-Lahey merger

A potential merger of 13 hospitals in Massachusetts, led by Beth-Israel Deaconess Medical Center and Lahey Health, has been endorsed by state health officials, claiming it will improve services for patients.

March 7, 2018

HIMSS18: 6 key data points from US leadership, workforce survey

As the healthcare professionals touch down in Las Vegas for the 2018 Healthcare Information and Management Systems Society (HIMSS), the organization released its annual survey of the marketplace. HIMSS published the 2018 U.S. HIMSS Leadership and Workforce Survey on March 6, which examines trends in employment, technology and expectations.

March 6, 2018

HIMSS18: CMS's Verma warns information blocking will no longer be tolerated

CMS Administrator Seema Verma, MPH, announced at HIMSS18 in Las Vegas new agency initiatives aimed at promoting interoperability and giving patients easier access to health records, drawing applause for talk about reforming regulations while the audience of health IT professionals sat silent when she warned of a crackdown on information blocking.

March 6, 2018

HIMSS18: Out-of-pocket costs increased 11% in 2017

The trend of costs increasingly being shifted onto patients continued in 2017 with average out-of-pocket costs hitting $1,813 in 2017, an 11 percent jump from the year before, according to an analysis released by TransUnion Healthcare at the HIMSS18 conference in Las Vegas.

March 5, 2018

Who’s the boss? Atrium-UNC Health merger killed over leadership structure

Discussions for a blockbuster merger between Atrium Health (formerly Carolinas Healthcare) and UNC Health Care have ceased, according to the Charlotte Observer, because executives were unable to solve disagreements on the structure of the joint operating company’s leadership.

March 5, 2018

HHS Secretary against using medical marijuana as alternative to opioid for treating pain

In a visit to the Dayton, Ohio area, HHS Secretary Alex Azar was asked by Yellow Spring News what role he’d envision for medical marijuana as an alternative to prescription opioids for pain relief.

March 5, 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.