February 18, 2016
Ig Safety: Viral Inactivation and Elimination
With the recent outbreak of the Zika virus, many of our patients and their families are asking questions again about the potential viral transmission via IVIG. Since the Hepatitis C transmissions from 1994 ALL manufacturers of Ig are required by the Us and European FDA’s to incorporate viral inactivation AND viral elimination steps. Inactivation steps in the manufacturing process include solvent detergents, pasteurization, low ph additives, and caprylic additives. ALL these steps involve ORGANIC compounds so there is no potential risk of allergic reactions. In the early 2000’s ZLB Bioplasma introduced nano filtration to the final fine fractionation process to eliminate any viruses or viral components that may “survive” any inactivation processes. Viral diameters are larger than immune globulins so there is no risk of filtering out any of the essential antibodies from the final fractionation process. Of particular concern right now is the Zika virus. The Zika virus is a lipid enveloped virus and as such, makes it very vulnerable to all the inactivation modalities. Additionally, the Zika virus is 40 nanometers in size and the nano filtration pore diameters utilized in the industry are between 15-20 nanometers.
Your Corinthian Health Services team stays at the forefront of emerging technologies and information so that all of our physician partners, nurses and patients can feel confident that their infusion therapies are SAFE and LIFE ALTERING!
Bucky Staggs, RN
CHS Clinical Science Liason
IVIG Documentation Requirements
The beginning of the year is always busy for our Care Management Team as we check each patient's benefits to ensure coverage. Moving forward, I wanted to offer a few reminders to expedite IVIG authorizations in 2016:
Documentation requirements from insurance carriers for IVIG approval:
- MS must be specified as Relapsing-Remitting.
- The progress note must include a statement of how the patient is benefitting from the treatment.
- United patients with MS must have an EDSS documented.
- For initial approval, MS patients must have positive MRIs and failed Interferon therapy.
- CIDP patients must have a positive EMG & documentation of the progression of their disease.
Wishing you good health and happiness in the coming year,
Gretchen Matteson, RN, CCM