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.

5 things to know about Trump’s plan to lower drug prices

As a candidate, President Donald Trump had criticized pharma companies for “getting away with murder.” In remarks on Friday, May 11, he did bash the industry’s lobbying power while also lumping in insurance companies, distributors and pharmacy benefit managers (PBMs) as part of the “broken system” that has sent drug prices soaring.

May 11, 2018

Health spending, prices growing even as insurance coverage falls

Year-over-year price growth was 2.2 percent in April 2018, which Altarum said was fractionally above the March rate, setting a six-year high for price growth in the sector. Hospital price growth fell slightly to 3.7 percent.

May 11, 2018

3 things to know about ‘healthcare voters’ in 2018 elections

Four states held primary elections on May 8, kicking off a busy election season that will see most Tuesdays from now until mid-September having one or more states’ voters casting ballots. Judging by the latest poll from the Kaiser Family Foundation, healthcare will be a major issue for many in the coming months.

May 10, 2018

Trump’s pharma plan: Raise prices overseas to lower them in US

President Donald Trump is set to deliver a speech on pharmaceutical prices on May 11—but rather than matching his campaign rhetoric saying drug industry is “getting away with murder,” he’s expected to be cheered by pharma companies for calling for foreign countries to pay more for drugs, rather than bring down prices in the U.S.

May 10, 2018

Hospitals without competition have higher prices

When hospitals enjoy a monopoly in their market, their prices for privately insured patients are 12.5 percent higher on average, according to a study encompassing 88 million people covered by Aetna, Humana and UnitedHealthcare. The differences disappeared when consolidating facilities were located more than 25 miles apart.

May 9, 2018

Japan pharma giant Takeda to buy Shire for $62B

Japan’s Takeda Pharmaceuticals has announced it will acquire Shire, an Ireland-based drug company, for $62 billion, making Takeda one of the 10 largest pharma firms in the world.

May 9, 2018

ACA stabilization bill is dead, says Republican sponsor, as insurers propose major premium hikes

Sen. Lamar Alexander, R-Tennessee, has said he’s abandoning efforts to push a bipartisan bill meant to stabilize the Affordable Care Act (ACA) exchanges, putting the blame on Democrats’ resistance to making changes to the law. With no congressional action likely this far into an election year, exchange insurers are requesting some eye-popping hikes for 2019 premiums.

May 9, 2018

5 objectives in CMS’s rural health strategy

“For the first time, CMS is organizing and focusing our efforts to apply a rural lens to the vision and work of the agency,” CMS Administrator Seema Verma, MPH, said in a statement.

May 8, 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.