Hi Linda,
This is an interesting interpretation of 'Standard of Care'. Is your
rogue department saying that they routinely inject patients with
investigational drugs? Sorry for the sarcastic tone. I would not
consider this a standard of care procedure unless there was an approved
drug involved or other justifiable need for the IV.
A few things to consider before ordering orange jumpsuits in assorted
sizes.
1. The Medicare National Coverage Decision for Clinical Trials (Sept,
19, 2000) does allow Medicare to cover research related costs (including
the costs of administering an investigational article) for qualified
clinical trials. Note that I said 'allows', not 'requires'. This is a
common misinterpretation of the NCD. See
http://www.cms.hhs.gov/coverage/8d.asp for details. Check with your
Medicare contractor for details and authorization to bill (special
billing code modifiers are also needed, -QV, I think). As far as the
insurance billing goes, your mileage may vary. Coverage will depend on
the individual carrier and their contract with your institution. Some
will follow Medicare's lead and others won't. Denial of coverage could
get pricey for the subject's parents and messy for the institution if
pre-approval of the procedure with the subject's carrier or Medicare
could be inferred from the consent form. The parents do have the option
to pay out of pocket for anything except the investigational drug, but
that would have to be very clearly spelled out in the consent process.
2. Is the IV medically indicated for another purpose (e.g., hydration,
electrolyte balance, etc) unrelated to the administration of the
investigational drug? If so, the research could be piggy-backed through
the side port and the rest billed as SOC. However, that doesn't seem to
be the case.
Hope that helps,
Bruce Steinert, PhD, CCRA
Director, Clinical Trials Administration
The Children's Mercy Hospital
Kansas City, MO
-----Original Message-----
From: Linda Ward [mailto:xxxxxx@CHILDRENSHC.ORG]
Sent: Thursday, February 24, 2005 1:40 PM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] SOC vs study related costs
Hello folks - I've got a clinical trial question for you.
We have a rogue department trying to say that while the study drug is
obviously study related, the method to inject the drug (IV, conscious
sedation (for babies/children), etc.) is standard of care and the
department is trying to bill insurance/medicare for these costs. To me,
this seems inappropriate.
The rationale provided by the department is that in the absence of the
study drug, the patient would have received a non-study drug, and so the
method of injection should be SOC (standard of care).
1. What are your opinions on this situation?
2. Can anyone cite a source backing up their viewpoint?
Thank you all for any input you can provide!!
Linda Ward, MBA
Sr. Accountant
Research Administration 35-123A
Children's Hospitals and Clinics
2910 Centre Pointe Dr.
Roseville, MN 55113
651-855-2603
651-855-2690 Fax
email: xxxxxx@childrenshc.org
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