1) Who what and when needs to be reported?
All injuries (AEs & SAEs) that arise out of a clinical trial whether it be a device or drug trial that has a causal relationship to the study compound or device following review by the PI of the trial and the sponsor company. Initial required information is name, DOB, gender, and HCIN or social security number to check Medicare status. Thereafter proper ICD-9 codes will be required for reporting (ORM). Reporting must occur within the quarter following the use of the study compund or implantation of the medical device. Reporting takes place once every 3 months (quarter).
2) How does the sponsor (RRE) obtain this information?
VCT collects and verifies this information for the sponsor at screening of every subject screened for the study utilizing the VCT databse registry. Each subject is also verified to assure they are not “dual enrolled” in another study or in a lockout period to improve safety and data quality as well. When it is time to check Medicare eligibility and report VCT already has the accurate & verified required information thereby reducing study site workload.
2) How do I know or determine who is a Medicare Beneificary? Typically these subjects are;
- People aged 65 or older
- Individual of ANY age with certain disabilities
- Individuals of ANY age with End Stage Renal Disaease (ESRD)
- This must be confirmed with Center For Medicare Services (CMS) by Verified Clinical Trials
Ultimately each subject that experiences an AE or SAE with probable causality to the study medication or device needs to be verified through the CMS website. This is the intial step.
Medicare (CMS) Town Hall Updates April 2013
- Yearly sponsor (RRE) Recertification is delayed for now but will be required sometime later in 2013.
- ICD-10 codes to be implemented and repalce ICD-9 codes as of Ocober 2014. RREs will have one year to submit testing cases beginning October 2013 with these new codes.
By using VCT, the clinical trial is protected from dual enrollment and has all of the added safety, compliance, and recruitment features that VCT offers available for use as part of the package.
Call VCT at (516) 998-7499 to learn more about our complete solution or visit
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