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. 

Recor Medical's Paradise Ultrasound Renal Denervation System

Momentum continues for renal denervation as CMS considers national Medicare coverage

CMS is accepting public comments on the topic for a period of 30 days. Recor Medical and Medtronic have both shared statements in support of the potential policy shift.

4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

johnson & johnson branding

Johnson & Johnson buys depression drug and its manufacturer for $15B

The drug Caplyta, owned by Intra-Cellular Therapies, is being used to treat bipolar disorder and schizophrenia. In 2024, it brought in more than $481 million in sales. 

the words "FDA recall" on a board

FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

HRS President Ken Ellenbogen, MD, FHRS, explains the need for the Heart Rhythm Advocates lobby group in Washington, D.C. to push for policies in Congress over reimbursements.

Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.

Optum UnitedHealthcare UnitedHealth Group HQ

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.

Massachusetts Governor Maura Healey

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. 

Reimbursement update: What hospitals need to know about new Medicare payments for cardiac CT

CMS finalized a significant policy change when it increased the Medicare payments hospitals receive for performing CCTA exams. What, exactly, does the update mean for cardiologists, billing specialists and other hospital employees?

Around the web

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?