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.

Nearly 600 U.S. clinics could be selling unregulated stem cell treatments

The risks of “stem cell tourism” might be overplayed, according to a new paper published June 30 in the journal Cell Stem Cell. But only because the real risks of unregulated stem cells might actually be within the U.S. 

July 1, 2016

1.6 million ACA exchange customers dropped out by March

Nearly 13 percent of the 12.7 million people who bought coverage on the Affordable Care Act’s health insurance marketplaces for 2016 had dropped out by the end of March.

July 1, 2016

AstraZeneca takes on FDA over Crestor patent

AstraZeneca’s cholesterol medicine Crestor’s patent protection is set to expire July 8, according to FDA standards, but the company has other plans for the drug. 

June 30, 2016

House committee subpoenas HHS over ACA reinsurance program

The House Energy and Commerce Committee has issued a subpoena to HHS Secretary Sylvia Burwell to turn over documents related to the Affordable Care Act’s reinsurance program, which Republican members on the committee claim has been improperly funded by the agency.

June 30, 2016

Biden rallies participants to double cancer progress in 'moonshot' kick-off

Vice President Joe Biden led a major step toward completing his “moonshot” task of curing cancer June 29, when he spoke at the first Cancer Moonshot Summit. 

June 30, 2016

FDA approves test for quicker detection of hospital ‘superbugs’

The Food and Drug Administration (FDA) has given a thumbs up to a test hospitals can use to identify certain types of antibiotic-resistant infections more quickly.

June 30, 2016

CMS’ Conway promises ‘adjustments’ to controversial Part B overhaul

While defending a proposal to test changes to how reimbursements are calculated under Medicare Part B, CMS Chief Medical Officer Patrick Conway, MD, told a panel of federal lawmakers the agency would alter the plan based on concerns from physicians and lawmakers.

June 29, 2016

HHS aims to reduce backlog of 700,000 Medicare appeals with new rule

A new rule proposed by HHS would attempt to reduce a large backlog of Medicare appeals cases, while encouraging new cases to be settled earlier in the process.

June 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.