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 expands Zika blood testing period for pregnant women to 14 days

Updated guidance from the Centers for Disease Control and Prevention (CDC) instructs physicians to test pregnant women for Zika up to 14 days after symptoms begin. It also adds new recommendations based on the first documented female-to-male transmission of the virus.

Florida providers going to trial in $360 million antitrust case against HealthFirst

Several healthcare providers and physicians in Florida are planning on going to trial with integrated system HealthFirst, seeking more than $360 million in damages for alleged antitrust violations.

Study: ACA cut hospital charity care, stabilized bad debt expenses

An analysis of CMS data by the Pittsburgh Post-Gazette said hospitals spent less on charity care and unrecoverable debt once the Affordable Care Act was implemented.

New FDA draft guidance seeks to clarify UDI forms

A new draft guidance from the U.S. Food and Drug Administration (FDA) seeks to clarify how Unique Device Identifiers (UDIs) are included on medical devices.

Stolen laptop costs the University of Mississippi Medical Center $2.75 million

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has reached a settlement of $2.75 million with the University of Mississippi Medical Center in Jackson concerning the matter of a missing laptop.

CMS star rating system coming "shortly"

Medicare patients who are trying to pick a provider will soon have a more straight-forward, visual way to compare nearly 4,000 hospitals. CMS will assign each hospital an overall rating of between one to five stars, the distribution of which it announced in a statement July 21. 

State news: Ill. requires 3D mammography coverage, Mont. health workers fired for giving data to lawmakers

Here’s a roundup of state healthcare news, including complaints over slow payments in Iowa’s privately managed Medicaid program and California overhauling its cancer database.

Medical groups lobbying for fewer OpenPayments requirements

The American Medical Association and the American College of Radiology are among the groups pushing members of Congress to roll back laws requiring groups to disclose financial ties to doctors in the federal government’s OpenPayments database.

Around the web

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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