Scalpel Weekly News

Week of: July 09, 2018

IN THE NEWS


First Epilepsy Drug Derived from Marijuana Approved by FDA

On June 25, 2018, the FDA granted GW Research Ltd. approval to market Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. Click title to continue reading...


 
MEDICAL ALERTS


Healthcare Fraud for Medically Unnecessary Compounded Drugs

On June 28, 2018, the United States Department of Justice announced numerous healthcare fraud enforcement actions targeting schemes billing reimbursors for medically unnecessary compounded drugs, including compounded pain and scar creams. Compounding pharmacies allegedly included specific combinations of ingredients in compounded creams to increase the billing amount. Click title to continue reading...



Novel Device Treats Breathing Difficulty from Severe Emphysema

On June 29, 2018, the FDA granted Pulmonx Inc. approval to market a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema. “Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients,” said Tina Kiang, Ph.D., acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA’s Center for Devices and Radiological Health. “This novel device is a less invasive treatment that expands the options available to patients.” Click title to continue reading...



Fatal Sepsis from Bacterial Contamination of Transfusion Platelets

On June 29, 2018, the CDC published a report that described two separate clusters of platelet transfusion–associated bacterial sepsis in Utah and California during August 2017. Four of five transfused patients died, though the cause of one of those deaths was not definitively the platelet transfusion–associated bacterial sepsis. Investigations of the blood suppliers and the hospitals revealed no procedural deviations. Click title to continue reading...


  CASE ALERTS


Surgeon Fails to Review Tests; Lost Chance of Better Outcome

A surgeon ordered pre-operative tests including a chest x-ray and an electrocardiogram (EKG) before performing a non-emergency gallbladder surgery (cholecystectomy) on a patient. The tests were performed. The tests revealed that the patient had previously undiagnosed congestive heart failure, possible left atrial enlargement, nonspecific intraventricular block, and two possible prior heart attacks. Click title to continue reading...



Genetic Testing Lab Found to be Licensed Health Care Provider

A pediatric patient experienced seizures. The treating physician sent the patient’s DNA to a genetic testing laboratory for the purpose of diagnosing the patient’s disease or disorder. After the test results were received by the treating physician, the patient died. Click title to continue reading...



Hospitals May Challenge Medicare Standardized Amounts Set in 1983

The Medicare program provides federally-funded health insurance to qualifying elderly and disabled individuals. In 1983, Congress created a Prospective Payment System, under which hospitals are paid a fixed amount for each beneficiary treated, regardless of their actual costs. Prospective payment amounts are determined annually, under a statutory formula that depends in part on base rates known as standardized amounts. The standardized amounts were calculated in 1983, based on hospitals’ cost-reporting data from 1981, specifically the operating costs per discharge of inpatient hospital services. Accordingly, contemporary Medicare payments for inpatient services depend in part on factual determinations derived from 1981 data and embedded in 1983 calculations, including the calculation of allowable operating costs per discharge. Click title to continue reading...


FEATURE


Complaint: Recovery Room Injury

As a special feature for our Premium subscribers, we have included this feature containing an illustrative complaint for negligence regarding a patient’s injury resulting from the patient’s post-surgical recovery room care. In this illustrative situation, a man was transferred to the recovery room after undergoing spinal surgery. Neither the surgeon nor the anesthesiologist checked on the man while the man was in the recovery room. The man was left in the sole care of a recovery room nurse who did not have sufficient training or experience to handle post-operative spine surgery patients. As a result, the recovery room nurse failed to ensure the man’s airway remained opened, the man did not get an adequate supply of oxygen while in recovery, and the man suffered paralysis and permanent brain damage. Click title to continue reading...