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.

Six hospital groups urge UnitedHealth to take responsibility for Change Healthcare hack notifications
In a public letter, the groups are urging UnitedHealth Group to announce a timeline for notifying patients about what personal data was stolen in the breach of Change Healthcare's systems.
Ohio doctor gets 7 years in prison for violating Controlled Substances Act
The Department of Justice said Thomas Romando, MD, illegally prescribed over 137,000 pills to nine patients over a five-year period.
UPMC settles $38M whistleblower lawsuit for Medicare fraud
Surgeons at the health system were accused of performing unnecessary procedures and receiving bonuses as kickbacks. UPMC does not admit wrongdoing.
FDA announces new recall of delivery catheters after patient’s death
The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.
FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls
The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible.

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

HealthCare.gov attracts steady traffic on first live weekday

The first weekday of the sign-up season for HealthCare.gov attracted plenty of traffic, although some users did encounter a few minor bumps, reports ABC News.

November 18, 2014

Early praise for Healthcare.gov

Healthcare.gov opened for browsing over the weekend, and users are offering some early praise on the design improvements, reports Bloomberg Businessweek.  

November 13, 2014

Feds lower expectations for open enrollment period

The Department of Health & Human Services has lowered its prediction for the number of enrollees from 13 million to 9-9.9 million for coverage through state and federal exchanges for 2015, reports Modern Healthcare. 

November 11, 2014

Multi-year health insurance plans hold promise

Multi-year insurance products on health insurance exchanges could prompt insurers to invest in more services with long-term benefits. This in turn, would reduce healthcare costs and some of those savings could result in lower premiums for consumers, according to a Health Affairs blog written by a senior scientist and policy researcher at Rand Corp.

November 10, 2014

Around the web

Cardiovascular Business

FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

Cardiovascular Business

FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible.

Cardiovascular Business

The push for an independent cardiology board continues

Jeffrey Kuvin, MD, one of the leading voices behind efforts to create a new Board of Cardiovascular Medicine, spoke with Cardiovascular Business about where things stand today.