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.

FDA announces recall of Pfizer's fast-tracked sickle cell drug
The drugmaker is voluntarily withdrawing Oxbryta from the market due to a higher-than-acceptable risk of death.
Public health coalition wins lawsuit against EPA for lack of fluoride oversight
A federal judge in California ruled existing evidence of the negative effects of fluoride in drinking water warrants an investigation and potential action from the Environmental Protection Agency.
Cardiology groups cheer new bill that would improve access to Medicare claims data
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.
Walmart workers sue over tobacco fees levied for health plan trust
The class action lawsuit argues employees cannot escape the fees even after they stop using tobacco, a violation of labor regulations.
HHS awards $75M for addiction and maternal health services in rural areas
The funds will be used to expand services and improve the financial stability of existing healthcare organizations located in underserved regions of the South.

3 Next Generation ACOs have left program since January

Three of the 21 participants in CMS’s newest accountable care organization (ACO) model have dropped out in the program’s first year, according to data released by the agency.

July 18, 2016

State news: Conn. may create health ‘super-agency,' Mich. hospital bans Pokémon Go

Here’s a roundup of the state healthcare news, including: a proposal in Connecticut to consolidate health agencies, a Michigan hospital telling Pokémon Go players to stay away, a patient-dumping lawsuit in California, a $2.7 million settlement over patient data breaches in Oregon and the end of a Colorado court case involving a surgery tech who could have exposed thousands to HIV.

July 15, 2016

Zika update: Congress doesn’t approve funding, first female-to-male transmission recorded

Members of Congress left Washington, D.C., for a seven-week recess without settling disputes over emergency funding to combat the Zika virus, which the Centers for Disease Control and Prevention said has been documented spreading from a woman to a man for the first time.

July 15, 2016

CDC worries about gonorrhea's growing antibiotic resistance

Amid growing public health concerns about antibiotic resistance, the Centers for Disease Control & Prevention (CDC) said July 14 that gonorrhea could be the next infection to see significantly decreased treatability.  

July 15, 2016

Q&A: Half of physicians in survey don’t know about MACRA

HealthExec spoke with Deloitte managing director Sarah Thomas about a recent survey that showed only half non-pediatric physicians were aware of the Medicare Access and CHIP Reauthorization Act (MACRA), despite the fact it will dramatically change Medicare reporting in 2017.

July 15, 2016

House panel debates greater FDA role in regulating health apps

The safety, effectiveness and data security of mobile healthcare applications were examined by a U.S. House subcommittee in a July 13 hearing, with lawmakers alternating between excitement over their potential and concern that consumers’ data isn’t being protected.

July 14, 2016

Senate passes anti-opioid abuse bill despite Dems’ funding concerns

A 92-2 vote in the U.S. Senate will send a legislative package aimed at fighting opioid addiction and abuse to President Barack Obama, who has promised to sign it even though it doesn’t contain the $1.1 billion in extra funding he requested for treatment and prevention programs.

July 14, 2016

Burwell: ACA too ingrained to repeal

There are only about six months left in President Obama’s tenure at the White House, which means his administration is about to lose their jobs too. But some of them have a lot of work to do before they go. 

July 13, 2016

Around the web

Cardiovascular Business

Cardiology groups cheer new bill that would improve access to Medicare claims data

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.

Cardiovascular Business

Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

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

Cardiovascular Business

Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

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.