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June 11, 2010
I am writing to update you of some new developments and changes regarding the JHM Clinical Research billing process.
1) Maryland Medicaid and Clinical Trial Coverage Update
The Maryland state Medicaid regulations provide standard of care reimbursement for patients enrolled in Maryland Fee for Service Medicaid who are participating in clinical trials. I hope this helps with accrual into our protocols of a diverse sample of research participants. Insurance coverage must still be confirmed prior to obtaining consent.
2) Clinical Research Management System (CRMS) Enrollment Report and eIRB continuing review
The CRMS is the primary source of information on enrollment in research protocols for which a Prospective Reimbursement Analysis (PRA) is required. For these studies, it is expected that the CRMS-generated enrollment report is to be uploaded to the eIRB at the time of continuing review. CRMS will generate an automated e-mail with the attached enrollment report eight weeks and again at six weeks prior to your study’s continuing review date with the IRB. This report can be uploaded directly into the eIRB for yearly IRB continuing review, avoiding additional manual effort by study teams. For additional questions please contact CRMShelp@jhmi.edu.
3) Online CRMS training required for PIs and identification of CRMS study team responsibility
Effective July 1, 2010, all PIs will be required to complete the onetime online CRMS training prior to Clinical Research Support Services (CRSS) uploading the PI approved PRA. Without a PI approved draft PRA uploaded into the eIRB, the IRB will not approve the study. To access the online CRMS training directly please click the following link: Online CRMS Training
Also, the PI for a study will be asked to identify the study team member(s) who will be responsible for ensuring CRMS use. This person must be trained on the use of CRMS (if not already) and be the point of contact should there be questions about the CRMS participant registry.
I am very pleased that the number of clinical research protocols continues to grow despite increasing regulatory oversight of clinical research. I believe our program for billing of services provided in clinical studies has reduced our risk and made the process clearer for researchers and research participants. I encourage you to complete all of the training and ask questions so you can understand the entire program for clinical research billing. If you have suggestions for improving the clinical research billing process please let us know.
If you have additional questions please do not hesitate to contact Scott Streibich, Associate Director, Clinical Research Revenue Cycle, at 410-502-0124 email@example.com (updated: 3/27/14).
Daniel E. Ford
Vice Dean for Clinical Investigation