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.

Rural community decides if it should trust outside investor with bankrupt hospital

Kaiser Health News reports on one facility—a 26-bed hospital in Surprise Valley, California—that is $4 million in debt—and in desperate need of outside help. The community may have found reason for hope, in the form of a 34-year-old former bodybuilder named Beau Gertz. He’s proposing a plan to use telemedicine to help boost revenue.

June 4, 2018

ASCO 2018: FDA’s Gottlieb wants to streamline cancer patients’ access to treatments

FDA Commissioner Scott Gottlieb, MD, delivered the opening remarks at the American Society of Clinical Oncology’s 2018 annual meeting at McCormick Place in Chicago, emphasizing his organization’s goal of reducing the time needed to connect cancer patients with treatment.

June 4, 2018

‘Right-to-try’ sponsor: Law is meant to diminish the FDA’s power

Johnson said if FDA Commissioner Scott Gottlieb intends to limit the reach of the law through new FDA rules, that would go against his intent in writing the legislation.

June 1, 2018

CHS finalizes sale of 3 Tennessee hospitals

Community Health Systems’ selling spree continues, this time in its home state in Tennessee, as the for-profit hospital giant finalized the sale of three hospitals to West Tennessee Healthcare, a public, not-for-profit system.

June 1, 2018

Senator promotes price transparency, short-term insurance in healthcare plan

Sen. Bill Cassidy, MD, R-Louisiana, released a series of new healthcare proposals that would expand insurance which doesn’t comply with the Affordable Care Act, along with new ideas on requiring price transparency and incentivizing care settings that are less expensive than hospitals.

May 31, 2018

AMA touts leadership combating opioid epidemic as story labels group a barrier to reforms

The American Medical Association (AMA) released a report on May 31 detailing how “physician leadership” has led to progress fighting the epidemic of opioid abuse and addiction. Just two days earlier, however, a story published by the Daily Beast labeled the AMA as a main roadblock to Congress addressing the prescription of opioids.

May 31, 2018

New Jersey, Vermont enact their own individual mandates

New Jersey will maintain the penalty on a statewide level in 2019. Vermont's law will take more time, with a working group tasked with figuring out how to enforce the mandate beginning in 2020.

May 31, 2018

S&P: 340B cuts will weaken nonprofit hospitals

The $1.6 billion in cuts to Medicare payments made under the 340B drug discount programs could add to the financial stress of smaller not-for-profit hospitals and health systems, according to Standard & Poor (S&P)’s Global Ratings.

May 30, 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.