Scalpel Weekly News

Week of: August 22, 2016

IN THE NEWS


RNA/DNA Testing Recall; False Negatives, Invalid Results

BioMerieux recalled the NucliSENS easyMAG Magnetic Silica (MagSil) system because of effects on nucleic acids extraction performance. On August 10, 2016, bioMerieux sent Urgent Product Safety Correction Notices to affected customers. Kits with the affected lots of the Magnetic silica have exhibited a decrease of extraction performance with certain downstream applications. The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death. Click title to continue reading...


 
MEDICAL ALERTS


FDA Reducing Dietary Supplement Consumer Risk: Premarket Safety Notifications

The FDA, on August 11, 2016, issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers. Click title to continue reading...



Unchanged Medical Costs Show Strength of Affordable Care Act

On August 11, 2016, the Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) released the first data on how the Affordable Care Act’s individual market risk pool evolved between 2014 and 2015.The report shows that per-enrollee medical costs in the ACA individual market were essentially unchanged in 2015, even as costs in the broader insurance market continued to rise. Moreover, the states with the highest enrollment growth saw significant reductions in per-enrollee medical costs. Click title to continue reading...



Significant Disparities in Cardiovascular Health Among Occupational Groups

Cardiovascular disease (CVD) accounts for one of every three deaths in the United States, making it the leading cause of mortality in the country. The American Heart Association established seven ideal cardiovascular health behaviors or modifiable factors to improve CVD outcomes in the United States. These cardiovascular health metrics (CHMs) are: (1) not smoking, (2) being physically active, (3) having normal blood pressure, (4) having normal blood glucose, (5) being of normal weight, (6) having normal cholesterol levels, (7) eating a healthy diet. Click title to continue reading...


  CASE ALERTS


Expert Witness Licensed in Mexico Qualified to Testify on U.S. Standard of Care; TOS

A woman presented to a surgeon with longstanding complaints of intense pain in her right shoulder and scapula, numbness and swelling, painful grip, and weakness when raising her right elbow. After examining her and reviewing the MRI results, the surgeon diagnosed her as having severe thoracic outlet syndrome (TOS), compression of blood vessels or brachial plexus nerves in the space between the clavicle and the first rib (i.e., the thoracic outlet) causing a variety of symptoms. Click title to continue reading...



Limitations Not Tolled-Misidentified Defendants; No Notice of Malpractice Suit

A woman underwent a surgical procedure at her surgeon’s surgical practice group’s facility. Complications arose in the middle of the surgery preventing the surgeon from completing the surgery and requiring the woman to be transferred to a hospital and admitted to the intensive care unit (ICU). The woman remained in the ICU for three days. She continued having difficulties following discharge and had further surgery at a different hospital five days later. Click title to continue reading...



Medicare Advantage Organization Can Sue Primary Insurer for Reimbursement

A woman was injured at a condominium. She sought medical treatment for her injury. Her medical care providers billed her insurer, a Medicare Advantage Organization (MAO), which provides Medicare Part C coverage (also known as a Medicare Advantage plan) to Medicare-eligible enrollees and receiving in return a per capita fee from the Centers for Medicare & Medicaid Services (CMS). Her insurer paid the medical care providers $19,155.41. Click title to continue reading...


FEATURE


Striking Stroke Complaint

As a special feature for our Premium subscribers we have included this feature containing an illustrative Opposition to Motion to Strike Complaint in a medical malpractice and an Emergency Medical Treatment and Active Labor Act, 42 U.S.C.A. § 1395dd (EMTALA), violation action involving the care and treatment of a patient suffering a catastrophic brain stem stroke. Click title to continue reading...