On March 8, the U.S. Food and Drug Administration and Amarin Pharma, Inc. entered into a settlement agreement resolving litigation brought by Amarin against the FDA related to Amarin's off-label promotion of Vascepa®...

The U.S. Food and Drug Administration (FDA) recently approved new regulations to modernize and improve the Nutrition Facts label that has been required on packaged foods and beverages for nearly 20 years. These new regulations represent the first major changes to the label since its inception.

On September 29, the Committee on Ways and Means of the U.S. House of Representatives approved a reconciliation measure seeking to repeal several key provisions of the Affordable Care Act (ACA).

Appearing before the American College of Rheumatology (ACR), Philadelphia-based Iroko Pharmaceuticals delivered clinical trial results of its Phase 2 research into the use of nano-formulations to deliver a large class of pain medicines known as NSAIDs (non-steroidal anti-inflammatory drugs).

As previously discussed here, the Centers for Medicare & Medicaid Services (CMS) has proposed a reimbursement pilot program for Part B drugs.

In its proposed 2016 physician fee schedule rule published on July 15 (the "Rule"), the Centers for Medicare & Medicaid Services (CMS) proposed new separate Medicare payment for two CPT codes (99497 and 99498) that describe advance care planning (ACP) services. (See page 41773 of the Rule.) However, the proposal falls short of creating a clear coverage policy.

On January 26, the U.S. Department of Health and Human Services (HHS) announced that it is testing new healthcare payment models to improve the quality of care and reduce the cost of providing it.

Health plans and clearinghouses are already subject to the privacy and security requirements of HIPAA...

Doctors in Sweden have implanted a permanent artificial trachea, or windpipe, into a 36-year old man. What's remarkable, is that the windpipe was made using nanocomposite materials that were developed and patented by Professor Alexander Seifalian at the University College of London.

The state survey resource is available exclusively to members of the AHLA Physician Organizations Practice Group.

On April 14, Florida became the latest state to protect consumers from "surprise" medical bills when Gov. Rick Scott signed into law HB 221, preventing balance billing by out-of-network healthcare providers...

On May 07, the U.S. Department of Health and Human Services (HHS) announced that New York-Presbyterian Hospital (NYP) and its affiliate, Columbia University Medical Center (CU), have paid a total of $4.8 million to settle charges that they violated the Health Insurance Portability and Accountability Act (HIPAA) by failing to secure thousands of patients’ electronic protected health information (ePHI).

On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health and Safety Research Strategy (the "Strategy"), and held a webinar to discuss the development of the Strategy and its main areas of focus.

Health Republic is one of many struggling or failed co-ops ("Consumer Operated and Oriented Plans") created under the ACA...

An often-ignored legal requirement that New York State-licensed physicians complete and regularly update an online Physician Profile is now being enforced in a new initiative by the State Department of Health’s Office of Professional Medical Conduct (OPMC).

Kaiser Health News recently reported that four New York urgent care centers have agreed to improve their disclosure of insurance and pricing information...

According to a report in The Hill, President Obama would "strongly oppose" any effort to repeal the Affordable Care Act's "Cadillac tax" on pricey health plans. In a briefing on December 9, White House spokesman Josh Earnest declined to confirm that this meant a veto.

The recent spike in the number of healthcare industry data breaches, many resulting from alleged HIPAA violations, has spawned a new federal government response.

Other examples of possible impermissible "information blocking" may include exclusive data sharing arrangements tied to software or information technology or required payments for data transmission.

The Centers for Disease Control and Prevention (CDC) recently released proposed voluntary guidelines on prescribing opioids for chronic pain...