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.

Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation
A new catheter from Johnson & Johnson MedTech is now approved to treat cardiac arrhythmias in Europe. Could FDA approval be on the horizon?
FDA has now approved more than 1,000 clinical AI applications, most aimed at radiology
Radiology products lead the way for AI approvals by a long shot, accounting for more than 70% of all applications on the list.
UnitedHealth, Amedisys ask federal judge to dismiss DOJ lawsuit blocking $3.3B merger
The companies argue that the U.S. Department of Justice has failed to adequately demonstrate how, and in which regions of the country, the merger would harm competition. They are asking a federal court to throw out the case.
Practice managers demand ‘immediate action’ on physician Medicare pay cut
The Medical Group Management Association made its demands in a letter to newly appointed leaders in the U.S. House and Senate sent Tuesday.
Healthcare private equity reporting act signed into law by Mass. governor
The new law will require private equity firms to make disclosures related to organizational structure and finances if they intend to operate a medical facility or provider organization in the state.

Medicare Advantage plans failing to collect info on imaging referrers, opening door for fraud

CMS must take action to address this issue, including rejecting records that do not identify referrers, the OIG urged.

August 27, 2020

Patient who suffered ‘life-changing’ gadolinium reaction awaits jury’s medical malpractice decision

The Pennsylvania man's attorneys argued that the hospital and radiologist involved did not follow policies and procedures that would have mitigated his injuries.

August 25, 2020

Protective barriers thought to be safe may place providers in greater danger, FDA warns

It was back in May that the FDA first gave its emergency OK for the use of these transparent devices, designed to cover a patient’s head and upper body to prevent the spread of germs during procedures.

August 24, 2020

Insurer wants radiology practice’s class-action suit tossed: ‘COVID-19 damages lungs, not property’

It was back in April that Alliance Radiology first sued Continental Casualty Co., claiming it had lost business as leaders looked to comply with state orders.

August 19, 2020

Researchers clarify: Don’t dismiss the neck gaiter as a facemask failure

Remember the Duke study that seemed to suggest a neck gaiter can spread more COVID than no mask at all? Its authors now say their findings were misconstrued. Gaiters may be OK after all.

August 19, 2020

Due date arrives for Medicare cash advances as docs plead for extension: ‘Many practices will fail’

CMS first launched the offering back in March to help smooth over cash flow concerns for providers hobbled by the pandemic.

August 19, 2020

Standard operating procedures start chugging back to life at Medicare, Medicaid

As part of its Monday announcement, CMS released inspection guidance for state agencies and a toolkit for nursing homes.

August 17, 2020

FDA clearance news: Hyperfine’s portable MRI nod, RapidAI takes on LVOs, and more market moves

Also, Bayer receives the go-ahead for its MRI contrast bulk packaging option and United Imaging unveils a new PET noise-reduction platform.

August 14, 2020

Policy & Regulations

Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation

FDA has now approved more than 1,000 clinical AI applications, most aimed at radiology

UnitedHealth, Amedisys ask federal judge to dismiss DOJ lawsuit blocking $3.3B merger

Practice managers demand ‘immediate action’ on physician Medicare pay cut

Healthcare private equity reporting act signed into law by Mass. governor