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.

Uneven ground: Freestanding EDs face patchwork regulation

While freestanding emergency departments (EDs) are becoming more popular, regulations and requirements on these facilities vary widely between states, which may lead to facilities being built where they’re not needed.

October 4, 2016

UnitedHealthcare, Humana, CVS join new value-based prescription model

The participants in CMS’s Medicare Part D model designed to incentivize medication adherence programs will include some of the largest insurers in the U.S.

October 4, 2016

BioBridge Global-led biotech team awarded $7.8 million Army contract

SAN ANTONIO, Oct. 3, 2016 /PRNewswire-USNewswire/ -- A four-organization biotech group led by San Antonio-based nonprofit BioBridge Global (BBG) has been awarded a $7.8 million contract from the Medical Technology Enterprise Consortium (MTEC).

October 4, 2016

CDC: Physicians should confirm patients’ penicillin allergies

New research from the U.S. Center for Disease Control and Prevention (CDC) points to evidence that many patients who claim they have a penicillin allergy may actually not have one.

October 4, 2016

CDC updates recommendations on avoiding pregnancy after Zika

As researchers begin to understand more about the Zika virus, the CDC is updating its recommendations for the public based on new information. On Sept. 30, the agency changed its guidelines to recommend couples wait at least six months from the last possible exposure to Zika before trying to become pregnant. 

October 3, 2016

House Republicans to CMS: Bundled payments shouldn’t be mandatory

Some 179 members of Congress have accused CMS of overstepping its authority in making bundled payment models, like one for cardiac episodes, mandatory without getting their approval.

October 3, 2016

California enacts new laws on nurse staffing, balance billing

A flurry of legislative activity in California in September included several new laws that will impact healthcare in the state.

October 3, 2016

Research thwarted by unreliable antibodies

More than 100 scientists met in California to find a solution to the increasingly research-thwarting problem of unreliable antibodies, according to NPR. 

September 29, 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.