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.

HHS launches safe importation action plan for prescription drugs

HHS is launching a new action plan for the safe importation of certain prescription drugs to bring in medications from foreign markets. The Safe Importation Action Plan extends recent initiatives from the Trump administration to make prescription drugs cheaper in the U.S.

July 31, 2019

CMS launches new data pilot program aimed at clinicians

Just a day after announcing three new payment proposals for 2020, CMS introduced a new pilot program for clinicians focusing on data.

July 30, 2019

CMS proposal would force hospitals to post negotiated rates

CMS unleashed a slew of proposals July 29, including 2020 payment rule proposals and a requirement for hospitals to publish the payer-specific negotiated prices of healthcare services.

July 30, 2019

Pfizer to combine drugs business with Mylan

Pfizer, one of the nation’s largest pharmaceutical companies, is merging its off-patent and generic drug business with Mylan, a global generic and specialty pharmaceutical company based in the Netherlands. The spinoff deal is expected to close mid-2020, pending shareholder and regulatory approvals.

July 29, 2019

White House prepping another exec order on drug prices

President Trump is reportedly working on another executive order targeting rising drug prices, according to Reuters.

July 26, 2019

Behavioral healthcare M&A pace picks up

The behavioral healthcare services space is gaining traction in the larger healthcare sector, supported by higher mergers and acquisition activity year to date.

July 26, 2019

Tenet to spin off Conifer business into separate entity

Tenet Healthcare, a Dallas-based healthcare services company that operates 65 hospitals and 500 other healthcare facilities with 110,000 employees, will spin off its revenue cycle subsidiary, Conifer, into a separate entity.

July 25, 2019

Ciox Health raises $30M from Merck, New Mountain

Clinical data exchange and health technology company Ciox Health has raised $30 million in equity investment in a funding round led by Merck Global Health Innovation Fund and private equity owner New Mountain Capital.

July 25, 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.