Are Serological Antibody Tests the Next Step in Countering the Spread of COVID-19?

In order to determine how widespread COVID-19 has become, medical laboratories and In Vitro Diagnostics (IVD) companies are in the midst of developing serological survey testing. This type of testing would be able to detect whether a person’s immune system has developed antibodies to counteract the SARS-CoV-2 virus. In turn, this could also give insight into the infection rates of entire populations.  Because of the delay from the time of infection to when the body begins developing antibodies, these tests...

FDA Relaxes Rules Around Drugs Needed for COVID-19 Ventilator Patients

In light of a shortage of drugs needed for COVID-19 ventilator patients, the Food and Drug Administration (FDA) is not taking action against compounding pharmacies that make copies of approved drugs, use bulk ingredients that are unapproved, or fail to meet manufacturing requirements for stability. The primary reason for relaxing these regulations is to make treatment options available to hospitals that can not obtain FDA-approved drugs. The new rules apply only to outsourcing facilities, and not to smaller compounders that...

The FDA Swiftly Shuts Down Direct-to-Consumer Testing Options for COVID-19

The U.S. Food and Drug Administration took action just ten days after learning about new direct-to-consumer (DTC) testing schemes. Lab companies were selling COVID-19 tests straight to consumers who were promised that the samples they collected themselves would be tested at Clinical Laboratory Improvement Amendments (CLIA)-certified labs.  Although the at-home tests for COVID-19 would seem to be a good option to increase nation-wide testing, the problem lies with the collection of the sample by the consumer. Specimen quality concerns are...

COVID-19 Pandemic Prompts DEA to Lift Restrictions on Hospitals, Pharmacies

The U.S. Drug Enforcement Administration (DEA) has issued three exceptions for registered hospitals and clinics in light of the COVID-19 pandemic. These exceptions will endure for the duration of the pandemic and include the following: DEA-registered hospitals and clinics are temporarily allowed to handle controlled substances at their satellite locations, provided that certain conditions are met. Distributors also have the flexibility to ship these substances directly to these set locations if the right conditions are met. Narcotic treatment programs are...

PIVO Enables Needle-less Blood Samples for Hospital Patients

Patient satisfaction is driving medicare scoring. That means an increase in interest for technologies that are able to reduce - or completely remove -  pain from the patient experience. One such technology is Velano Vascular’s PIVO device. When blood is drawn with one of these devices, a small, flexible flow tube is pushed through an IV line and directly into the vein in order to collect the needed amount of blood - causing no pain to the patient.  According to...

COVID-19: Original Response Plan Framework

Since January 2020, when an influx of news reports detailed an unknown pneumonia-like outbreak sickening residents of Wuhan, China - speculations on how this outbreak of the virus known as COVID-19  would be handled in the U.S. began forming. Nationwide response efforts at hospitals and health system tributaries had their response plans organized into seven main categories: leadership, screening, triage, communication, education and training, supply chain, and telehealth. We are seeing many of these plans in their full fruition as...

Point-of-Care Preventative Health Services to be Added in Retail Chain Pharmacies Across the Country

Blood testing and other CLIA-waived preventative health services will be offered in retail chain pharmacies. Clinical laboratory companies such as eTrueNorth are beginning to offer more testing in non-traditional locations with non-traditional delivery systems. The idea behind the shift is to make healthcare delivery more convenient than ever - alleviating overbooked healthcare providers and empowering local pharmacists to administer standard healthcare screenings.  The company eTrueNorth has already partnered with Walmart, Winn-Dixie, Kroger, and several other known retailers to begin offering...

Lab Offshore Billing Could be Costly in the Long Run

Attempting to cut costs of clinical laboratory test billing, a number of labs and pathology groups have moved billing and collections to overseas companies. These companies are charging nearly half of what American billing companies charge; yet, along with the cheaper rates the groups are experiencing a sharp drop in revenue - up to 30-40% or more.  This decline in revenue is due to the fact that most of these offshore companies may not resubmit rejected claims or go after...

340B Savings Programs Imperative to Hospitals Maintaining Levels of Care

When interviewed about how they were able to use their 340B savings, hospitals ranging in size from eighteen to five-hundred beds reported that they would not be able to continue to provide the same level of care to low-income patients without the 340B program. Hospitals reported they would not be able to maintain the services they currently provide without the 340B program. Hospitals around the country were interviewed and all reported the difference the savings had made in the quality...

2.1 Billion Genetic Testing Fraud

The Department of Justice (DOJ) charged 35 people for fraudulently selling unnecessary medical tests to thousands of elderly patients who were using Medicare. This ultimately cost Medicare 2.1 billion. Those charged worked for a variety of telemedicine and cancer genetic testing laboratories (CGx). MedTechDive reported that CMS took administrative action against CGx testing companies and providers who filed more than $1.7 billion in Medicare claims.  The HHS Office Of Inspector General put out a warning to the public back in...