Clinical Research Sites And Sponsors Do Not Have The Necessary Tools To Comply With The Medicare Secondary Payer Law In Clinical Trials

Verified Clinical Trials Offers Medicare Secondary Payer Law Compliance Capabilities For Clinical Trial Injuries

Verified Clinical Trials, the de-identified HIPAA compliant clinical trial database registry that promotes research and improved data quality offers an excellent solution to the Medicare Secondary Payer Law.  In cases where an adverse event or injury has occurred while in a clinical trial it is necessary to capture personal identifying information from the research volunteer in an effort to first determine, the participant’s Medicare eligibility, and then ultimately complete the required reporting or ORM (Ongoing Responsibilities for Medicals).  Clinical research sites lack the ability to collect and store the sensitive information that is needed for MSP reporting & compliance.  Verified Clinical Trials are experts in the collection of such information.  Moreover, the sites can not verify the accuracy of the information or identity unless they use a tool like Verified Clinical Trials.

The issue with pharmaceutical sponsors is that they have traditionally avoided obtaining any identifying personal information about the research volunteer.  In fact, this information is never passed on to the sponsor and the research subject remains anonymous and the study results are attached to de-identified information.

Verified Clinical Trials has created a system that allows the research site to prospectively verify the subject’s true identity and then instantly creates a de-identifed Unique Identification Code (UIC).  From this point on the pharmaceutical clinical trial sponsor will forward study related adverse events via a de-identified subject or randomization number that are felt to be causally linked to the investigational agent or device to VCT.  VCT will assess the Medicare status of the volunteer and then perform the required reporting for the Sponsor, which is the RRE (Responsible Reporting Entity).

VCT makes the process easy and the solution provided can maintain compliance to avoid significant fines or penalties.

 http://ccnmtl.columbia.edu/projects/cire/pac/foundation/#1_1

http://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Coordination-of-Benefits-and-Recovery-Overview/Medicare-Secondary-Payer/Medicare-Secondary-Payer.html