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.

FTC, DOJ and HHS release report warning of private equity consolidation in healthcare
The agencies said private equity firms are rolling up healthcare sectors through serialized purchases that fly under the radar of regulators, creating an unsustainable level of consolidation.
FDA threatens Hologic with punishment for reported errors in making troubled breast device
Concerns stem from manufacturing and distribution of the BioZorb marker, with possible ramifications including "seizure, injunction and civil money penalties."
Several states propose legislation to bolster coverage for supplemental breast imaging
Those proposing breast imaging-related measures so far in 2025 have included Connecticut, Florida, Hawaii, Indiana, Missouri, New York, South Carolina, Utah and Virginia, ACR reports.
Report highlights flaws in FDA rapid approval of Alzheimer drug
A new report from the Office of the Inspector General found the FDA failed to properly record meetings with drug manufacturers, ultimately approving drugs later shown to have safety and efficacy issues.
FDA announces another recall for surgical devices over safety concerns—7 new injuries reported
Maquet Cardiovascular, a subsidiary of Getinge, is recalling two of its endoscopic vessel harvesting devices due to issues with different pieces bending, peeling or detaching during use. Some of the company's other EVH devices were recently involved in a separate recall for similar reasons.

New Cigna plan caps monthly out-of-pocket insulin costs at $25

Cigna and Express Scripts announced April 3 they’re launching a Patient Assurance Program that will ensure individuals with diabetes pay no more than $25 out-of-pocket for insulin each month.

April 4, 2019

Patient advocates, medical associations urge Congress to pass virtual colonoscopy bill

The bipartisan bill (HR 1969) was introduced into the U.S. House of Representatives Tuesday, April 2, by Reps. Danny Davis (D-IL) and Brad Wenstrup (R-OH) and would provide Medicare coverage for CT colonography screening.

April 3, 2019

There’s a better way to score hospitals with 1 to 5 stars, researchers say

The creators of CMS’s Overall Hospital Quality Star Rating ratings system—aka “Hospital Compare”—intended to present healthcare consumers with an easy, user-friendly way to choose a hospital. However, since the ratings went live in 2016, the system has proven both confusing to consumers and confounding to hospitals.

April 3, 2019

Legislation would help radiologists submit Medicare claims when RAs perform certain actions

New legislation has been introduced in the U.S. House of Representatives that would allow radiologists to submit Medicare claims for imaging services performed by radiologist assistants (RAs) in hospitals and non-imaging services performed in the hospital or an office setting.

April 2, 2019

Advocacy groups, healthcare organizations push for Congress to pass virtual colonoscopy bill

Patient advocacy groups and healthcare organizations, including the American College of Radiology (ACR), are urging Congress to pass HR 1969, the CT Colonography Screening for Colorectal Cancer Act.

April 2, 2019

Updated ACR Appropriateness Criteria includes 2 new topics

The American College of Radiology (ACR) published its latest updated Appropriateness Criteria to help radiologists improve care across 12 topic areas.

April 2, 2019

Federal judge rejects expansion of association health plans

A federal judge rejected the Trump administration’s efforts to expand access to association health plans March 29, throwing small businesses that rely on those plans into a state of uncertainty, the Washington Post reported.

April 1, 2019

Update to ACR Appropriateness Criteria released to public

The American College of Radiology (ACR) has released an update to its ACR Appropriateness Criteria.

April 1, 2019

Policy & Regulations

FTC, DOJ and HHS release report warning of private equity consolidation in healthcare

FDA threatens Hologic with punishment for reported errors in making troubled breast device

Several states propose legislation to bolster coverage for supplemental breast imaging

Report highlights flaws in FDA rapid approval of Alzheimer drug

FDA announces another recall for surgical devices over safety concerns—7 new injuries reported