 |
 |
 |
 |
Yesterday I was given a peice of paper by my hospital asking me to sign
a statement that we do not perform any experimental tests, or use reagents
labeled for research use only. Well as you all know most monoclonal ab. are
labeled as such, and only a few manufactures have decided to go through FDA
certification. The ones that have gone through seem to be the T cell
antibodies. very few myeloid markers, and b cell markers have been approved
for diagnositc use. I know about two years ago there was a grace period put on
monoclonals for diagnostic use.
When is that schedualed to run out, because it turns out that the feds
are not willing to reimburse for procedures that use non FDA approved
monoclonal ab. This will put a real damper on Flow cytometry. I talked with
just about all the manufactures, and to date only BD and Coulter have gotten a
small subset of their AB approved. Others nicely skirt the issue, or claim
that they have no intentions of getting their antibodies approved.
I would like to know what others plan to do when the FDA claims that AB
can no longer be used, and if they have any solutions to medicare/aid not
paying. You know other insurers will soon follw suit. Well just a freindly
not to chear up you day. take care -- rr
-- Robert O. Rainer, M.D. drwho@pandoras-box.bgsm.wfu.edu Department of Pathology Bowman Gray School of Medicine phone (910) 716-4311 Winston-Salem, North Carolina Fax (910) 716-7595 27157
|
|
|
|