Frequently Asked Questions
What is the approved intended us for AcellFX?
This amniotic membrane disc is intended for homologous use and can be used in a variety of orthopedic, surgical, ophthalmology, spinal and wound covering applications. For specific instructions on the use and risks of AcellFX products, please refer to the Instructions For Use product insert.
Is AcellFX regulated by the FDA?
AcellFX is an allograft tissue and is regulated by the FDA by 21 CFR Part 1271 and Section 361 of the PHS act. It is not a device and is not regulated as such.
What billing code is used for AcellFX?
Code 65778 is used for placement of amniotic membrane on the ocular surface without sutures. Average Medicare reimbursement is $1,389. This information does not guarantee payment and is not legal advice. It is the provider’s responsibility for proper coding and billing. Always check your Medicare LCD.
Does AcellFX require refrigeration?
No, AcellFX does not require refrigerated storage. It is a room temperature stable acellular amniotic allograft that can be stored safely at temperatures up to 98 degrees Fahrenheit.
What is the shelf life of AcellFX?
AcellFX has a 5-year shelf life when stored at less than 98 degrees Fahrenheit.