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 report defends ACA as ‘historic progress’

A report on the “economic record” of the Obama Administration’s healthcare reforms credited the Affordable Care Act (ACA) for lower uninsured rates, increased access to care and slowed growth in healthcare spending.

December 14, 2016

HHS Secretary: Healthcare reform must ‘continue to endure’

HHS Secretary Sylvia Burwell defended the Affordable Care Act (ACA) and the broader efforts of changing healthcare payments, delivery systems and health IT in a Health Affairs blog post.

December 13, 2016

Aura Labs settles with FTC for inaccurate blood pressure app

Aura Labs has agreed to settle charges from the Federal Trade Commission (FTC) relating to its Instant Blood Pressure (IBP) mobile application, which came under fire for claims that is was as effective as a conventional blood pressure cuff.

December 13, 2016

52 million with pre-existing conditions could be denied coverage if ACA repealed

If pre-Affordable Care Act (ACA) health insurance regulations returned with a repeal of the law, 52 million people under the age of 65—27 percent of the U.S. population—could be denied coverage on the individual market due to pre-existing conditions.

December 12, 2016

Physicians likely to have an ally in Tom Price at HHS

The nominee to run HHS under President-elect Donald Trump has a history of putting doctors’ interests first.

December 12, 2016

‘Dramatic slowdown’ in value-based care transition—and how Congress can jumpstart it

Members of the American Medical Group Association (AMGA) reported the transition to value-based care is slower than expected, with more multispecialty medical groups and integrated systems predicting fee-for-service (FFS) payments will take up a greater percentage of revenues in the next few years than originally projected.

December 9, 2016

Medicaid expansion in New York now covers transgender healthcare

Youths in New York are now covered by Medicaid to receive gender-transition care, according to a recent report from the Wall Street Journal.

December 9, 2016

Maryland co-op suspended from individual market

Evergreen Health Cooperative won’t be able to issue or renew plans for 2017 until regulators decide whether it can convert into a for-profit insurer.

December 9, 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.