Patient Care

84 views
Skip to first unread message

olso...@umn.edu

unread,
Aug 16, 2017, 12:20:18 PM8/16/17
to CACoP Clinical Trials
Checking to see who has experience determining if a cost is "Patient Care" versus "Lab Services"... 

Mary Olson, Epidemiology

Seth Goldberg

unread,
Aug 16, 2017, 2:31:40 PM8/16/17
to CACoP Clinical Trials
In my humble opinion.

Patient care would generally be something you would receive on an invoice from Fairview, UMP or UAP. Lab services performed by UMP or Fairview would be included as this lab work is almost entirely related to patient care and would be billed to insurance / medicare if the test was performed as standard of care. I generally exempt IDS Start Up from that.

I would consider lab services to be lab work billed directly to the study by a lab, usually an ISO, UMN faculty lab or a 3rd party lab that is entirely research related. IE, the testing is in general not a part of standard of care treatment, not specifically for the subject, but overall.


Seth

Anne Mockovak

unread,
Aug 16, 2017, 4:48:42 PM8/16/17
to CACoP Clinical Trials
I would say that if the results of the lab test were used by health care professionals to determine treatment of the patient, it could be patient care even if the results were also used by researchers.  However, if the results are used solely by researchers, it would be lab services.

David Hagen

unread,
Aug 17, 2017, 3:30:53 PM8/17/17
to CACoP Clinical Trials
Hi Mary,

Ed Wink drafted the following guidance back in 2011:


Patient Care Costs Involving University of Minnesota Human Subjects

 

Services must be performed by University of Minnesota Medical Center-Fairview or another hospital with patient care rates (VA, HCMC, etc.) for research subjects who are being seen at the hospital.
 
·        Laboratory Services

·        Procedures:

 

o   MRI’s

o   X-rays (Radiology)

o   Ultrasounds, etc.

 


Not Patient Care Costs

 

·         Laboratory services performed on samples collected from patients of other hospitals, centers or projects, cell lines, or animal studies

 ·         IDS (Investigational Drug Service) – University of Minnesota Medical Center -Fairview only.  SPA management would need to review and determine status of IDS charges for other hospitals
 
·         Laboratory work sent to an outside laboratory

·         Laboratory work/tests performed through ARDL (Laboratory Medicine & Pathology)

·         Other services/procedures NOT performed by a hospital

·         UMP services

·         CTSI services

·         Patient parking


 

Seth Goldberg

unread,
Aug 17, 2017, 3:38:09 PM8/17/17
to CACoP Clinical Trials
Would it be fair to assume with the addition of the CSC that MHealth charges would now be applicable in the same way Fairview charges are?

David Hagen

unread,
Aug 17, 2017, 3:52:36 PM8/17/17
to CACoP Clinical Trials
That's a good question. The NIH definition begins with "Research Patient Care Costs. The costs of routine and ancillary services provided by hospitals to individuals participating in research programs."  Ed's definition reiterated that point and referred specifically to hospital-based services as being patient care.  Per Ed, clinical services provided by UMP (or other clinics) didn't count as patient care and therefore didn't have to be excluded from F&A recovery.  Although MHealth and CSC are affiliated with the University and with UMP, I don't think they are considered to be part of the hospital.  I would suggest bringing this question to Kevin McKoskey when he is back in the office next week since this is more of his area than mine.Ed drafted the definition I posted back in 2011, so it would probably be worth revisiting.

David
Reply all
Reply to author
Forward
0 new messages