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.

White House makes major push for value-based payments

The Obama administration has announced a major goal to tie half of all Medicare payments to quality of care by 2018, reports The Washington Post. 

January 27, 2015

Obama’s SOTU address highlights ACA, new individualized medicine initiative

In his State of the Union address, President Barack Obama described the Affordable Care Act as part of the fabric of middle-class economic recovery as he spoke to a Republican-controlled Congress still working to dismantle the law, reports Clinical Innovation + Technology.

January 21, 2015

MedPAC seeks to freeze reimbursements

The Medicare Payment Advisory Commission has approved recommendations to Congress to either freeze reimbursements or make them site neutral, which would save Medicare billions of dollars, according to Modern Healthcare.  

January 20, 2015

FDA guidance offers clarity on wellness products

The FDA has released a draft guidance offering some clarity on how it defines a low-risk product: A general wellness product becomes a medical device when it refers to its use for a specific disease or condition, according to Medcity News. 

January 20, 2015

Tavenner to step down

Marilyn Tavenner, top administrator for Centers for Medicare & Medicaid Services, has announced plans to step down in February, reports Wall Street Journal. 

January 16, 2015

Analysis challenges argument in favor of repealing the medical device tax

An analysis from the Congressional Research Service challenges a common talking point among legislators that the medical device tax destroys jobs and encourages manufacturers to operate oversees, according to The New York Times. 

January 15, 2015

Protesting the ACA

Some U.S. consumers are turning down tax credits offered through the Affordable Care Act out of principle, opting to spend more on health insurance, reports U.S. News & World Report.

January 13, 2015

Legislators look to repeal medical device tax

Momentum is growing in Congress to repeal taxes on medical device sales, reports The Hill.

January 9, 2015

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.