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I was told that you can use "off label" products for your own interest
only... BUT if you want to use it to change the standard of practice or use
it as case studies with documentation or written presentations then you need
informed consent and an IRB..
  I don't know the answer to this .. it really is a a very grey area.

> -----Original Message-----
> From: Michael, Dwight [SMTP:[log in to unmask]]
> Sent: Tuesday, November 19, 2002 12:33 PM
> To:   [log in to unmask]
> Subject:      Re: Renal Artery Duplex with Ultrasound Contrast
>
> I'm inquiring about this NOW.  Thanks for "waking me up" regarding this
> issue.  It's such a wide practice that I just never thought about it.
> Many
> "Things" that have become a standard of practice, (i.e., thrombin
> injection
> for pseudo) are "off label", that I just didn't think about it.  Neither
> did
> my medical director.  Thanks again.  As prevalent as this practice is,
> I've
> probably opened up a can of worms by soliciting input from QA/Risk
> Management. We've just used "informed" consent in the past.  But even with
> that is it truly "informed".  Does anyone show the patient the box that
> says
> in big. bold, letters, "NOT FOR INJECTION".
>
> -----Original Message-----
> From: Hodge, Megan D. [mailto:[log in to unmask]]
> Sent: Tuesday, November 19, 2002 10:13 AM
> To: [log in to unmask]
> Subject: Re: Renal Artery Duplex with Ultrasound Contrast
>
>
> Dwight:  what is your hospital policy for  "off label uses" for products
> approved in different departments?
> Do you require just a consent ? or do you need an IRB?
>
>
>
> > -----Original Message-----
> > From: Michael, Dwight [SMTP:[log in to unmask]]
> > Sent: Tuesday, November 19, 2002 9:53 AM
> > To:   [log in to unmask]
> > Subject:      Re: Renal Artery Duplex with Ultrasound Contrast
> >
> > Contrast for vascular is an "off label" use, like using thrombin for
> > pseudoaneurysm repair.  Except that thrombin is specifically labeled
> "NOT
> > FOR INJECTION".
> >
> > -----Original Message-----
> > From: Hodge, Megan D. [mailto:[log in to unmask]]
> > Sent: Tuesday, November 19, 2002 8:44 AM
> > To: [log in to unmask]
> > Subject: Re: Renal Artery Duplex with Ultrasound Contrast
> >
> >
> > yes.. in echo contrast is reimbursable.  in vascular... it has not even
> > been
> > approved and I have found some of the contrast companies won't even
> > consider
> > vascular contrast unless your institution has an IRB.
> >
> >       Is that true with those who are using it for vascular now ?
> >
> > > -----Original Message-----
> > > From: Stanley, Jeff [SMTP:[log in to unmask]]
> > > Sent: Tuesday, November 19, 2002 8:33 AM
> > > To:   [log in to unmask]
> > > Subject:      Re: Renal Artery Duplex with Ultrasound Contrast
> > >
> > > Do you eat the charge for using contrast for both renal art and echo
> > > studies?  Or just renal art studies?  The echo sonographers here are
> > > looking
> > > into contrast agents for the echo studies and are trying to find out
> > about
> > > reimbursement.  I asked the echo supervisor and she said that she has
> > > found
> > > ICD-9 and CPT codes for using contrast agents  ???
> > >
> > > Jeff Stanley BS,RVT
> > > The Heart Group
> > > Diagnostics-Vascular Lab
> > > 4230 Harding Road, Suite 330
> > > Nashville, Tennessee 37205
> > > (615) 565-6580
> > > [log in to unmask]
> > >
> > >
> > >
> > > -----Original Message-----
> > > From: Michael, Dwight [mailto:[log in to unmask]]
> > > Sent: Tuesday, November 19, 2002 6:52 AM
> > > To: [log in to unmask]
> > > Subject: Re: Renal Artery Duplex with Ultrasound Contrast
> > >
> > >
> > > NO!  We have to eat the charge.
> > >
> > > -----Original Message-----
> > > From: Kelly Estes [mailto:[log in to unmask]]
> > > Sent: Monday, November 18, 2002 7:14 PM
> > > To: [log in to unmask]
> > > Subject: Re: Renal Artery Duplex with Ultrasound Contrast
> > >
> > >
> > > Michael
> > >
> > >     How do you bill for it? Is it being reimbursed if you are billing?
> > >
> > > Kelly Estes RDMS, RDCS, RVT
> > > Technical Director
> > > MMG Cardiology/Carolinas Healthcare Center
> > > Charlotte, NC
> > >
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