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.

'Sterility failures' prompt FDA to threaten radiopharmaceutical producer with disciplinary action
Multiple issues that could raise the risk of product contamination were discovered during an inspection, according to an FDA warning letter.
How long will we accept patients languishing in the ER as normal? (asks a firsthand witness to ‘boarding’ who’s also a distinguished journalist and an erstwhile ER doctor)
Boarding is hospital-speak for when patients get left in the emergency department, typically on gurneys or in wheelchairs, for many hours—sometimes days—because no inpatient beds are available.
FDA, CMS unveil rapid Medicare coverage pathway for critical medical devices
Prior to the new “RAPID” program announced on Thursday, it could take a year or more for Breakthrough-designated medical devices to earn approval for Medicare coverage. Now regulators say that timeline could be reduced to as little as two months.
FDA approves 2 implantable heart devices from Biotronik
These devices were built to provide better patient data and improve clinician workflows. They will be on display at Heart Rhythm 2026 in Chicago.
Trump administration moves to speed up Medicare coverage for breakthrough cardiology devices
CMS and the FDA say the goal is to improve patient access to medical devices that address an unmet need.

Boston Scientific Farapoint pulsed field ablation (PFA) catheter

FDA approves Boston Scientific’s Farapoint PFA catheter

The newest addition to the company's Farapulse PFA Platform was specifically approved to perform cavotricuspid isthmus ablation.

Imaging providers must act to preserve higher CT pay, American College of Radiology warns

CMS previously announced it was temporarily reassigning payment codes for coronary CT angiography, resulting in a 104% higher technical fee.

Senate Report: UnitedHealth was aggressive in seeking higher Medicare Advantage payments

The Wall Street Journal obtained a copy of a report from the Senate Judiciary Committee, which reviewed more than 50,000 documents sent by UnitedHealth related to its Medicare Advantage patients. The outlet published the findings of the inquiry.

scale money prices shopping transparency reimbursement dollar coins

Cash prices frequently undercut insurance rates at Texas hospitals, study finds

Research from healthcare data analytics firm Trilliant Health found that negotiated rates carry a higher price tag for common services, calling into question the value of transparency regulations.

Take Care of Maya johns hopkins attorneys seek retrial

A spokesperson for the organization described such errors as “sincerely regrettable,” adding that the mistakes go against their aim “to provide the best and safest care possible for our patients.”

Medtronic has received U.S. Food and Drug Administration (FDA) clearance for the MiniMed Go Smart Multiple Daily Injection system.

FDA clears Medtronic’s new smart diabetes management app

Medtronic's MiniMed Go technology was designed to deliver real-time health data and recommendations to patients with type 1 and type 2 diabetes. It works with the Instinct sensors designed by Abbott.

The U.S. Food and Drug Administration (FDA) has announced that Modern Warrior is recalling all lots of its Modern Warrior Ready capsules, a dietary supplement marketed as a way to boost metabolism, improve brain function and reduce cravings.

‘Mental clarity’ supplement recalled due to risk of cardiovascular events, suicidal thoughts

This product was distributed throughout the United States from April 2022 to December 2025. Customers have been warned to stop taking it immediately.

Medicaid cuts under ‘One Big Beautiful Bill’ could result in over 1 million missed cancer screenings

Over the first two years of implementation, about 7.5 million Medicaid enrollees eligible for cancer screenings will lose coverage, researchers estimate.

Policy & Regulations

'Sterility failures' prompt FDA to threaten radiopharmaceutical producer with disciplinary action

How long will we accept patients languishing in the ER as normal? (asks a firsthand witness to ‘boarding’ who’s also a distinguished journalist and an erstwhile ER doctor)

FDA, CMS unveil rapid Medicare coverage pathway for critical medical devices

FDA approves 2 implantable heart devices from Biotronik

Trump administration moves to speed up Medicare coverage for breakthrough cardiology devices