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.

Experts update AUC for amyloid, tau PET imaging for first time in more than a decade
The new appropriate use criteria define 17 specific clinical scenarios, guiding providers on situations when amyloid or tau imaging are and are not appropriate.
$49B in medical debt to be erased from credit reports
A new final rule from the Consumer Financial Protection Bureau bans reporting agencies from including medical debts on credit reports or factoring them into credit scores.
$3.3B merger of UnitedHealth and Amedisys delayed by DOJ lawsuit
The new deadline for the deal to be finalized is Dec. 31, 2025. However, the ultimate fate of UnitedHealth's acquisition of Amedisys will be decided in a federal court.
FDA sees value in no-implant heart failure device
The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research.
CDC considers letting nurse practitioners, physician assistants read X-rays under federal program
The agency's “B Reader Program” trains and certifies physicians to classify chest radiographs of workers participating in federal health surveillance programs.

GoodRx slapped with $1.5M fine by FTC over patient privacy

According to the FTC, the company failed to notify consumers it had disclosed personal health information to Facebook, Google and other companies.

February 1, 2023

Healthcare industry reacts to PHE ending in May

MGMA and AHA discuss how the end of the PHE will impact healthcare stakeholders.

February 1, 2023

New rule aims to claw back overcharges from MA plans

The move could reclaim overpayments of an estimated $479 million from 2018 and $4.7 billion over 10 years.

January 31, 2023

CardiacSense, an Israel-based healthcare technology company, gained FDA clearance for its CSF-3 medical watch

Regulatory Roundup: FDA clears new medical watch, considers empagliflozin for CKD and much more

Our monthly review of FDA-related news items in the world of cardiology includes updates from CardiacSense, MedAlliance, Lupin, Realize Medical and Eli Lilly and Company.

January 31, 2023

Portable orthopedic tomosynthesis cleared for U.S. sales

The FDA has cleared U.K.-based Adaptix to market a 3D X-ray system that, according to the company, images hands, feet and elbows “at a fraction of the radiation dose and per-study cost of traditional CT.”

January 31, 2023

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HHS proposes new rule to expand birth control access under the ACA

The Department of Health and Human Services (HHS) proposed a new rule that would expand access to contraception under the ACA “so that all women who need or want birth control are able to obtain it."

January 31, 2023

Example of various breast MRI protocol sequences that offer different types of soft tissue enhancement. Imaging performed on a Siemens Magnetom system. Breast MRI can help see through dense breast tissue to better detect cancers. #densebreasts #Breastdensity #BreastMRI

MRI a 'far superior' modality for dense breast imaging

The modality outperformed digital breast tomosynthesis, handheld ultrasound and automated breast ultrasound for cancer detection in a large cohort of women with dense breast tissue.

January 31, 2023

Novavax NVX-CoV2373 COVID-19 vaccine myocarditis

COVID-19 public health emergency to end in May

"If the PHE were suddenly terminated, it would sow confusion and chaos into this critical wind-down," the White House said.

January 31, 2023

Policy & Regulations

Experts update AUC for amyloid, tau PET imaging for first time in more than a decade

$49B in medical debt to be erased from credit reports

$3.3B merger of UnitedHealth and Amedisys delayed by DOJ lawsuit

FDA sees value in no-implant heart failure device

CDC considers letting nurse practitioners, physician assistants read X-rays under federal program