Scalpel Weekly News

Week of: July 11, 2016

IN THE NEWS


First Test of Genetic Markers for Antibiotic-Resistant Bacteria

On June 29, 2016, the FDA cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S. Click title to continue reading...


 
MEDICAL ALERTS


Drug for Chronic Hepatitis C Approved; HCV Genotypes

On June 28, 2016, the FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of Hepatitis C Virus (HCV). Click title to continue reading...



Implantable Device to Change Cornea Shape to Correct Near Vision

On June 29, 2016, the FDA approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision. Click title to continue reading...



Suicide Rate Increased from 2000 to 2012; Occupations Analyzed

On July 1, 2016, the CDC reported that, in 2012, approximately 40,000 suicides were reported in the United States, making suicide the 10th leading reported cause of death for people 16 years old or older. From 2000 to 2012, rates of suicide among persons in this age group increased 21.1%, from 13.3 per 100,000 to 16.1. Click title to continue reading...


  CASE ALERTS


Patient Failed to Disclose Sickle Cell Trait Before Cataract Surgery

In preparation to undergo cataract extraction surgery, an ophthalmologist took a woman’s medical history. The woman did not disclose that she carried the sickle cell trait. The woman underwent cataract extraction surgery. The anesthesiologist used a retrobulbar anesthetic injection. The woman developed an arterial occlusion. An MRI showed the woman had not suffered a retrobulbar hemorrhage. Click title to continue reading...



Psychiatrist’s Consent Agreement with State Disciplinary Agency Inadmissible; Suicide

A man began to be treated by a prescribing physician who diagnosed the man with major depression, obsessive-compulsive disorder, and generalized anxiety disorder. The prescribing physician prescribed 20 mg of Paxil and eventually discontinued the man’s anti-anxiety Klonopin medication, previously prescribed by his family physician. Six months later, the prescribing physician tapered off the man’s Paxil dosage and instructed him to discontinue it the following month, and to call him if there were any problems. Click title to continue reading...



HHS Enjoined from Enforcing 2014 Rule Eliminating Stand-alone Fixed Indemnity Plans

The Public Health Service Act, 42 U.S.C. § 201 (“PHSA”), establishes coverage requirements for all health insurance plans except those it deems “excepted benefits.” Only those forms of insurance specifically enumerated in the PHSA can qualify as an excepted benefit and, for the benefits at issue in this case, that status is further conditioned on specific requirements: (1) the insurance plans must be “provided under a separate policy, certificate, or contract of insurance,” and (2) they must be “offered as independent, noncoordinated benefits.” See 42 U.S.C. §§ 300gg-63(b), 300gg-91(c)(3), and 300gg-21(c)(2). Click title to continue reading...


FEATURE


Employment Policies: Genetic Information and Testing

As a special feature for our Premium subscribers we have included this feature, illustrative employment policies regarding employee genetic information and testing. Click title to continue reading...