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.

Device and drug makers keep paying doctors disciplined for misconduct

Thousands of physicians who have been disciplined for serious misconduct, like having sex with patients, are still getting paid by pharmaceutical and medical device companies to act as advisers or promotional speakers, according to an analysis from ProPublica.

August 24, 2016

Tenn. regulator says state exchange ‘very near collapse’

The head of Tennessee’s insurance department said the state’s health insurance exchange is “very near collapse” after approving large rate increases for the three insurers offering coverage in 2017, according to The Tennessean.

August 24, 2016

N.J. hospital accused of false advertising, questionable business practices

Meadowlands Hospital Medical Center (MHMC) in Seacaucus, New Jersey, has been the subject of an investigative series from NJ Spotlight, accusing the facility of lying about the quality of its services and having a long record of safety violations.

August 23, 2016

Former Aetna CEO suggests separating special enrollment customers on exchanges

A separate risk pool for customers who purchase insurance from the Affordable Care Act (ACA) exchanges during the special enrollment period could help stabilize the market, argued former Aetna CEO and chairman Ronald Williams.

August 23, 2016

Senators want information on increases in price for EpiPens

The price of EpiPens, an injectable treatment for serious allergic reactions, has increased by more than 400 percent in the last nine years, and two U.S. Senators are asking the device manufacturer and federal regulators to explain why.

August 23, 2016

EpiPen's 400 percent price increase has consumers and Congress confused and concerned

U.S. lawmakers are joining concerned parents in demanding to know: What is up with the sudden increase in the price of an EpiPen? 

August 23, 2016

FDA, medical device companies agree to $1 billion in user fees

Medical device companies will pay the FDA nearly $1 billion in user fees for five years beginning in October 2017 under the fourth reauthorization of the Medical Device User Fee & Modernization Act (MDUFA).

August 23, 2016

Device companies agree to pay $1 billion in user fees to FDA

August 23, 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.