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.

What’s working against ACA repeal

The death of the Affordable Care Act (ACA) has looked all but certain since the election of Donald Trump. Debate has focused on how and when, not if, the law would be rolled back, but one Democratic healthcare lobbyist is offering a different scenario.

December 8, 2016

FDA releases new hearing aid guidance, in effect immediately

The FDA has issued a release that details ways to improve access to hearing aids for the 30 million Americans currently suffering from hearing loss. The guidance document will take effect immediately.

December 8, 2016

$6.3 billion 21st Century Cures Act passes in big win for drug companies, device makers

The U.S. Senate has approved a bill aimed at speeding up regulatory approval for pharmaceuticals and medical devices, as well as providing extra funding for medical research, the Precision Medicine Initiative, and the cancer “moonshot.”

December 8, 2016

Current ACA repeal plan carries $1.1 trillion increase in uncompensated care costs

The number of uninsured people would more than double and the individual insurance market would collapse if the Affordable Care Act (ACA) is repealed through a fast-track process called budget reconciliation.

December 7, 2016

Insurers want more time to decide on 2018 ACA exchange participation

With Congress and the next president promising repeal of the Affordable Care Act (ACA), the nation’s largest health insurance lobby wants a delay for insurers to submit plans to offer coverage on the law’s exchanges for 2018.

December 7, 2016

CMS reports ‘modest’ 2015 expenditures

A new report from CMS today shows healthcare spending in 2015 was modest compared to years before the Affordable Care Act (ACA) was passed.

December 2, 2016

6 things to know about AHA’s letter to Trump

The American Hospital Association (AHA) laid out some specific policy priorities for hospitals in a letter to President-elect Donald Trump, offering clues to where their lobbying efforts will focused once Trump takes office.

December 1, 2016

ACA replacement may be delayed until 2020

Republicans in Congress aim for immediate repeal of the Affordable Care Act (ACA) when President-elect Donald Trump takes office, but may give themselves up to three years to come up with a replacement plan.

December 1, 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.