A UNIT OF THE U-M MEDICAL SCHOOL OFFICE OF RESEARCH
Quarterly Newsletter
April 30th, 2015
 

QUICKLINKS





Clinical Research Billing
How to Reconcile Research Patient Charges:

Wendi E. Schumacher of the CRAO and Sarah K. Weathers of the Cancer Center Clinical Trials Office (CTO) have combined their magical reconciling powers to create a presentation on Patient Charge Reconciliation. Check it out here: How to Reconcile Study Accounts!    

Analyst News
New Centralized Approval Process for Investigational Device Exemption Studies:
Process affects all new studies submitted after January 1, 2015

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 allowed Medicare payment of the routine costs of care furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies.

As of January 1, 2015, the Center for Medicare & Medicaid Services (CMS) made changes to the process of obtaining coverage approval for standard of care items and services in a device trial. Previously handled by local Medicare Administrative Contractors (MACs), this process is now managed centrally by CMS.

 

Investigators should note the following changes as a result of this new process:

  • Study teams submitting IDE studies for approval AFTER January 1, 2015 must now go through the central CMS office to obtain CMS Approval Letters.Detailed submission requirements are available here.
  • IDE studies approved by MACs PRIOR to January 1, 2015 will continue to be administered by the MAC. Study sponsors should continue to follow the process established by the MAC for any site additions or protocol changes.
  • Study sponsors do NOT have to submit their protocol to CMS if the participating study investigator sites have already received approval from their MAC.
  • CMS will post information on their website each week for IDE studies approved after January 1, 2015. Study teams are encouraged to check the CMS website to see if their site has already been approved prior to submitting a new application. 

To speed up the submission process, CMS has released a Checklist and Sample Crosswalk. Submitters are encouraged to submit the crosswalk along with the request packet to facilitate CMS' review. CMS will review each complete submission within approximately 30 days, and e-submissions (emails and/or electronic documents) are preferred over hardcopies.

 

Questions?

Please contact the Clinical Research Calendar Review & Analysis Office via email or phone at (734) 998-6880, or visit the CMS website for more information.  

 

Subject Injury Language:
Under certain conditions UMHS will assume financial and treatment responsibility for research-related adverse events that may result in emergency medical care or hospitalization that are a direct result of the study drug, device, or procedure.

  

CRAO has identified opportunities for process improvements to Subject Injury:

 

Not only can we now recognize, track, query, and perform audits on this information, providing valuable data that lets the study teams, CRAO, and the Office of Research know if we are making impactful decisions where Subject Injury is concerned, we've also made the process easy to identify and enact when needed.

 

Our study teams may notice the

following changes:

 

Amendment and Application Approval letters will indicate we've accepted responsibility for Subject Injury and direction is provided in the letter on what to do when a Research Subject is injured.
 

CRAO works collaboratively with all parties to coordinate this process and to ultimately reach an agreeable resolution. We gather the Informed Consent, Contract, Protocol, the Adverse Event Report, and we review the Medical Record of the Subject. CRAO and Revenue Cycle are in contact to ensure all aspects of the event are covered. 

 

Of Note
CRAO Newsletter
The CRAO newsletter will be published quarterly. Please feel free to send your suggestions to CRAO. We look forward to hearing from our research partners!
Office of Research
The Clinical Research Calendar Review & Analysis Office is part of the Office of Research, where our mission is to foster an environment of innovation and efficiency that serves the U-M Medical School community and supports biomedical science from insight to impact.