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.

U.S. healthcare spending growth slowest since 1960

U.S. healthcare spending rose 3.6 percent in 2013, which is the slowest rate on record since 1960, reports The Hill. 

December 4, 2014

HealthCare.gov’s small business insurance marketplace goes live

A year after postponing the launch of the small business part of HealthCare.gov, it has gone live with reports of only modest technical flaws, reports Washington Post.

December 2, 2014

CMS to issue draft ACO regulations

The Centers for Medicare & Medicaid Services is expected to publish draft regulations to revise and expand the use of accountable care contracts under the Medicare Shared Savings Program, reports Modern Healthcare. 

December 1, 2014

Burwell calls for transparency following enrollment data error

Health & Human Services Secretary Sylvia Mathews Burwell is calling for “a culture of increased transparency” after Affordable Care Act enrollment data accidentally were inflated with dental plan customers, according to Bloomberg Businessweek.

November 25, 2014

Obama sued by House Republicans over ACA

Republications in the House of Representatives have filed a lawsuit against President Obama over the Affordable Care Act, reports Los Angeles Times.

November 22, 2014

DOJ recovers $2.3B in false claims

The Department of Justice has recovered $2.3 billion from alleged healthcare fraud schemes during fiscal year 2014, reports Modern Healthcare. 

November 22, 2014

CMS launches new data and analytics office

The Centers for Medicare & Medicaid has formed a new Office of Enterprise Data and Analytics, which will help the agency better harness its vast data resources, reports Clinical Innovation + Technology.

November 19, 2014

HHS proposal would expand clinical trial data disclosure requirements

The Department of Health & Human Services has released a proposed rule that would require companies to report summary results for drugs and devices that are never approved and not just for products that reach the marketplace, reports the American Association for the Advancement of Science. 

November 19, 2014

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.