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.

CDC director, chief medical officer ousted as RFK shakes up agency
CDC Director Susan Monarez, PhD, was less than a month into her role, having been confirmed by the U.S. Senate on July 30. Her lawyers said the staffing shakeup was a result of HHS Secretary Robert F. Kennedy Jr. “weaponizing public health for political gain.”
Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS
Radiologists and other physicians recently wrote to Administrator Mehmet Oz, MD, asking for changes related to contrast-enhanced ultrasound.
FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death
This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.
Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval
Gadoquatrane is now set to go through the regulatory review process on its trek to earning full FDA approval.
Looming end of Medicare rural pay adjustment raises concerns about doctor shortages
Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains why Congress needs to renew the Medicare geographic pay adjustments in rural areas—to make payments competitive with urban areas and help retain physicians in those communities.

CDC director, chief medical officer ousted as RFK shakes up agency

CDC Director Susan Monarez, PhD, was less than a month into her role, having been confirmed by the U.S. Senate on July 30. Her lawyers said the staffing shakeup was a result of HHS Secretary Robert F. Kennedy Jr. “weaponizing public health for political gain.”

Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS

Radiologists and other physicians recently wrote to Administrator Mehmet Oz, MD, asking for changes related to contrast-enhanced ultrasound.

warning safety alert recall healthcare issue

FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.

Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval

Gadoquatrane is now set to go through the regulatory review process on its trek to earning full FDA approval.

Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA) explained the need to renew the Medicare geographic pay adjustments in rural areas to make payments more competitive than urban areas. He said this is vital to help retain physicians in rural areas who otherwise could find higher paying jobs in larger cities.

Looming end of Medicare rural pay adjustment raises concerns about doctor shortages

Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains why Congress needs to renew the Medicare geographic pay adjustments in rural areas—to make payments competitive with urban areas and help retain physicians in those communities.

Report: DOJ investigating business practices of UnitedHealth’s Optum Rx

Bloomberg said the pharmacy benefit manager is being probed as part of a larger look into the “prescription management services” of UnitedHealth. According to sources, this may be related to an ongoing investigation into alleged instances of Medicare Advantage upcoding.

New $6B Eversana looks to bypass PBMs and lower drug prices

A merger between Eversana and Waltz Health will create a new entity that CEO Mark Thierer says will upend the “existing oligopoly that I helped build.”

Dispute between Johns Hopkins and UnitedHealthcare pushes patients out-of-network

The two said they’ve been negotiating terms for eight months. Sticking points include denied claims and coverage disputes, with both the insurer and health system pointing fingers.