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.

Hospital use probably won’t rise due to Medicare for all

With Medicare for all on the lips of many Democratic presidential candidates and public support for universal healthcare coverage at its highest ever, concerns about healthcare usage under such a system have arisen. However, hospital use isn’t likely to rise under a Medicare-for-all plan, according to research published in the Annals of Internal Medicine.

July 23, 2019

Amazon’s fight over patient data could lead to lawsuit

Amazon is in a fight for patient health data after a pharmacy industry player worked to block the e-commerce giant’s online pharmacy business, PillPack, from accessing the information.

July 23, 2019

Civica Rx partners with Hikma Pharma to launch 14 injectables

Civica Rx, the not-for-profit drug company startup created by hospital and healthcare organizations to reduce the impact of rising drug costs and shortages, has found another pharmaceutical partner to manufacture and supply 14 essential sterile injectable medications.

July 23, 2019

Fewer ACOs sign up, but more are taking on risk

Changes to the accountable care organization shared savings program by CMS are having the desired effect, but fewer ACOs are participating in 2019. The declaration comes from CMS Administrator Seema Verma, who recently penned a blog post in Health Affairs outlining the recent outcomes of the ACO shared savings program.

July 22, 2019

Short-term health plans expansion upheld in court

The Trump administration’s expansion of short-term limited-duration health plans has held up in court after a legal challenge.

July 19, 2019

Merger talks are over for Care New England, Lifespan

Merger talks between Care New England, one of the largest healthcare systems in Rhode Island, Brown University and Lifespan, operator of Rhode Island Hospital, are over.

July 18, 2019

HHS will not push rebate rule forward

A proposed rule to eliminate drug rebates will not be pushed through. However, President Trump could still take on the pharmaceutical industry in other ways.

July 12, 2019

CVS expands HealthHub concept to new markets

After introducing its new HealthHub concept store in Texas, CVS Health is spreading the store model to Boston, Dallas/Fort Worth, Maryland, North Carolina, Ohio and Virginia, the company announced.

July 11, 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.