It is being set up as a lab however he states a "full service tissue/blood bank that works in the areas of stem cell collection, process, preservation and delivery of products to hospitals and physicians.
I am not familiar, at all, with NON-pharmacy set ups and health insurance companies.
My main issue is keeping my certification and leading this guy in the right direction. He informed me the prior billing company could not obtain a BC/BS provider number just to submit claims because his company wasn’t required by the state to have a Laboratory license since blood was not being mixed or manipulated etc. and the product is not considered a DME therefore BC/BS did not have a classification for his entity. He was told to obtain a CLIA/CLIA waiver and CAP certificate,to set up a lab. A blood bank does not fall under any of BC/BS categories and an independent lab was the closest category they could associate his services with. He provided BC/BS the documentation from the state clearly showing there is no equivalent license for a blood/tissue bank as FDA requires therefore no CAP certificate or CLIA/CLIA waiver could be issued. The Chief Compliance Officer of the State clearly wrote "Since your organization is not manipulating the cells collected to make a pharmaceutical drug nor supplying the patient or doctor with a medical device, no drug or device distributor or manufacturer license is required! He had no problems previously with Cigna or UHC so I’m not sure what to do.
I have done some investigation and I have seen where companies have registered as NON Pharmacy, DME and also Lab? I’m curious because the prior company he worked with, same scenario, BC/BS would not pay because he couldn’t obtain a provider number with BC/BS. The reason was BC/BS states your a clinic or lab. He wrote to the state as he would purchase it from another company and sell it to the surgeon therefore since he wasn’t officially manipulating blood products, he wasn’t classified as a lab and this type of product is also not considered DME.
If you have any knowledge, please let me know as I’d like to get this contract but do not want to mislead him. Thanks s