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Research Compliance Awareness: Mandatory Reporting of an 8-Digit Clinical Trial Number on Medicare Claims

Dear Researcher-

Effective January 1, 2014, CMS will require providers and suppliers to report an 8-digit clinical trial number on claims for items or services furnished pursuant to clinical trials that qualify for coverage as set forth in the Medicare National Coverage Determination Manual. The reporting of this number is voluntary thru December 31, 2013.

The clinical trial number that CMS is making mandatory is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov website. CMS uses this number to identify all items/services provided to beneficiaries during their participation in a clinical trial, clinical study, or registry that may result from a study covered under coverage with evidence development (CED), the Medicare Clinical Trial Policy, or a CMS-approved investigational device exemption (IDE) study.  This number is listed prominently on each specific study’s page and is always preceded by the letters “NCT.”

CMS anticipates that the mandatory reporting will improve its tracking of Medicare payments, ensure that the information gained from the research is used to inform coverage decisions, and make certain that the research focuses on issues of importance to the Medicare population.

Providers and suppliers are required to implement the mandatory reporting by January 6, 2014. The CMS transmittal discussing the mandatory reporting requirement is available here.

Please work with Revenue Cycle Operations for Rush University Medical Group when requests are made to assist in achieving compliance with this mandatory requirement.  Should you have questions please email Dawn Preston or Carrie Gill.

Electronic Record (Epic) Access by Research Study Monitors - Rush Privacy Position

External access by study monitors are used to assure progress and accuracy in clinical trials by reviewing source documentation.  A large percentage of source verification is by reviewing a subject’s medical record.  Direct access to the legal medical record (LMR) through Epic presents a privacy risk to Rush patients as Epic (in its current version) does not have the capacity to restrict access to a discrete list of subjects and/or subject visits.

To address this issue with study sponsors, the Compliance Office has created a position statement letter that should be shared with monitors to communicate Rush’s position on the matter.  You can find this letter in the Rush Research Portal here.

If you have additional questions regarding study monitor and record access, please contact the Rush Privacy Office at 312-942-4416.

Annual Conflict of Interest Survey

The mission of Rush University Medical Center is to provide the very best care for its patients. As one of the nation’s leading academic medical centers, Rush University Medical Center is committed to ensuring its health care professionals carry out the mission in an objective and responsible manner.

To exemplify this commitment, Rush’s Board of Trustees, corporate officers, employees, faculty, students and members of the medical, nursing, professional and technical staffs must use their best efforts and judgment to avoid any influences which could compromise patient care, research, business transactions with integrity.  Compliance with completing the Conflict of Interest Annual Survey ensures Rush University Medical Center maintains transparency in its daily operations.
 
The Conflict of Interest Survey for FY2013 will be launched on July 8.  Research personnel are required to complete the survey, and will be notified by an e-mail from Rush_Conflict_Of_Interest_Survey@rsh.net which will provide additional information about how to login to the Rush Conflict of Interest survey portal at https://www.rush.edu/COI.  The current disclosure survey covers the time period of July 1, 2012 through June 30, 2013.
 
If you have any questions concerning the policy or completing the attached disclosure form, please contact the Conflicts of Interest survey team at:  Rush_Conflict_Of_Interest_Survey@rsh.net or 312-942-5303.


Important Changes to the Policy on Reporting Unanticipated Problems Involving Risk to Subjects or Others

The policy on reporting unanticipated problems involving risk to subjects or others, including serious adverse events, has been revised to make it easier for investigators to determine which events must be reported to the Rush IRB.  Under the revised policy, internal and external events should be screened identically for determination of whether to report to the Rush IRB.  That is, only those events that meet the criteria as an unanticipated problem, as defined by the policy, must be reported to the Rush IRB regardless of where the event occurred.

The revised policy effective date is December 11, 2012.  

Please review the policy with your research staff so that all members of the research team will be familiar with the change.

A few reminders about reporting unanticipated problems:

1)  An Unanticipated Problem (UP) includes any incident, experience, or outcome that meets all of the following criteria:

a) unanticipated or unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

b) related, probably related or possibly related to participation in the research; and

c) suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Any event that meets the criteria as an unanticipated problem (including serious adverse events and/or unanticipated adverse device effects) must be reported to the Rush IRB within 10 working days of notification of the event.

2) An internal problem or event is defined as an event or occurrence with a study subject recruited at Rush University Medical Center, Rush Oak Park, or by an investigator working on behalf of Rush University Medical Center or Rush Oak Park at another location.  It also includes subjects recruited for studies of which the Rush IRB is the IRB of Record

An external problem or event is defined as an event or occurrence that does not meet the criteria as an internal problem or event.

3) If an external Sponsor still forwards event reports that do not meet the reporting criteria above, the Principal Investigator must document that the event reports were reviewed but not reported because they did not meet the reporting criteria set out in this policy (RA-IRB-209).  Documentation can be in the form of a letter, spreadsheet, or physical signature on copies of each event report.  Depending on the terms of the study contract, the study team may still seek reimbursement from the Sponsor for the review of reports, as this activity constitutes review of events even if the events were not reportable under this policy.

4) Please only forward reports to the Rush IRB that meet the criteria set forth in the policy.  Submitting every received report without determining whether the event meets reporting criteria creates a large amount of backlog that could potentially prevent more serious reports from being reviewed promptly.  However, if an event has been screened as not reportable and the Investigator  wishes to report the event as part of the reportable event application, these events will be reviewed. The Investigator should document the concerns the IRB should consider.


CHANGES TO IRB APPLICATION
 

The Research and Clinical Trials Administration Office (RCTA) has received accreditation of our human research protection program with the Association for the Accreditation of Human Research Protection Programs (AAHRPP).  AAHRPP is a non-profit organization that works with organizations that conduct human research to raise the level of protection for research participants and therefore increase the public trust in research. AAHRPP accredits organizations that can demonstrate they provide participant safeguards that surpass the threshold of state and federal requirements.

 As part of the accreditation process, as well as changes in federal guidance, the Rush IRB is required to meet specific federal and accreditation-specific standards regarding how IRB review is conducted.  For this reason, revisions to the IRB Application and the Continuing Review Application have been implemented in order to collect information necessary for IRB review.

On both applications, you will see additional questions in certain sections of the Portal. For the IRB application, you will see an updated drop-down menu but this change requires nothing additional from the user.

Please contact the IRB Administrative staff with any questions about the revisions.


Research and Clinical Trials Office (RCTA)
 

The RCTA is located in the lower level, Annex Building, 707 S. Wood. The following units are housed in the RCTA:  grant submissions, research contracts, budget personnel, coverage analysis, IRB, research administrative core, Rush Research Portal support and intellectual property.

RCTA Consultation Service:

Each division in the Research and Clinical Trials Administration will meet with researchers and/or their staff to provide an individual consultation.  We encourage the use of this service during protocol design to help maximize the support available to you.   Fridays are encouraged for the appointments, however if this is not possible we will accommodate your schedule whenever possible.

To arrange a consultation please call a representative from the division from which you wish to receive assistance.  Or, if you are new to research at Rush, please contact Elanda Shannon at elanda_t_shannon@rush.edu  or (312) 563-2721 to set up consultations with all divisions.

RCTA Hotline:

The RCTA provides a hotline (312-942-7777) for all researchers and staff within RUSH.  This hotline is available for you to contact the RCTA if you have a problem reaching someone specifically in the RCTA, you have a complaint, a suggestion, or any other feedback or question you need assistance with.  This hotline is monitored daily and you will receive a return call by the next business day. 



CONFLICT OF INTEREST
 

As of early August, 2011, the Conflict of Interest (COI) module was implemented within this system.  At this time, only key personnel and select individuals have been required to complete a disclosure survey.  Only if you are required to complete a COI survey, you will see a link for Conflict of Interest Disclosure along the left hand side within your My Home section.  The Conflict of Interest Disclosure section will work similar to other inboxes you may have.  Pending Submission will be your 'inbox' for any disclosures that you have not completed.  Submitted Disclosures will be the disclosure for the current year, and Archived Disclosure will contain previous years. 

This section will continue to grow as we begin to develop protocol specific disclosures.  This will allow a centralized location to electronically manage all COI disclosures and protocol specific disclosures.  Should you have any questions, please contact Research Compliance at 312-942-1296.


 


NEW FEATURES ADDED TO THE RUSH RESEARCH PORTAL

  • Budget Billing Grid (BBG) Performance Enhancement – We have implemented changes to the system to help enhance the performance of the BBG smartform page.
  • Clinical Trial Participant Tracking (CTPT) Role – There is now a new role added that can be accessed from a user’s personal workspace. The new role provides a better way for users to manage CTPT studies.
  • Sponsor Billing Address – A new page has been added within the Budget smartform.  This page will now capture the sponsor billing address so that invoicing can be automated.
  • CTPT Visit Logging – The states that represent the subjects visit have been expanded.  We can now help you identify which visits are certified as complete and if the CRF is complete.  This is visible in tabs located in the new Clinical Trial Participant Tracking (CTPT) Role. Visits that are complete and have completed a CRF (if applicable) will ultimately generate an invoice through the system.
  • Mark One-Time and Per-Occurrence Items for Invoicing – Two activities have been added to the budget summary workspace.  These activities, when performed, identify which items are ready for invoicing.
  • Master Project Change to Study Staff – The page that captures the PI, Co-I, study coordinator, etc., has been changed to mimic the look of the IRB.  Ultimately, our vision is that this will allow us to update the Master Project staff, title, etc. when an IRB amendment is approved.
  • Creating Projects Off the Master Project – The automatic creation of the Grant / Contract and Coverage Analysis has been removed from the Master Project.  Users will add only the projects that need to be added to the master project. Once the Master Project is created, the staff will click on the create buttons for the project types they would need to create for that specific project.
  • Master Project Related Projects List – The Master Project summary workspace has been changed to allow a quick view of all related projects within that Master Project.  This quick view will also allow users to access their related projects and/or their smartform pages quicker.
  • Key Personnel Listed in the Master Project – The Master Project now helps to identify key personnel in anticipation of incorporating protocol specific financial disclosures into the system.
  • New Questions in the Master Project – The Master Project will now collect information regarding drug, device, biologic and combination products.  This is important information necessary to ensure that any financial relationships are disclosed and managed, if needed.
 
UPDATED HIPAA PRIVACY PROCEDURES FOR RESEARCH
 
The Human Subjects’ Protection Division of the Research and Clinical Trials Administration Office has been working closely with the HIPAA Privacy and Security Office in the Corporate Compliance department to provide the research community with clear, concise policies and procedures regarding HIPAA rules for the use of PHI in research.
 
Therefore, we are pleased to announce that improved “HIPAA Privacy Procedures for Research” are now posted on the Rush Research Portal and the Research at Rush webpage.
In response to requests by members of the research community, we are also releasing several new HIPAA forms that we hope will facilitate research at Rush:
 
• The current HIPAA Authorization form has been revised and is now available as two separate forms; one for studies involving blinded treatments and another for studies that do not involve blinded treatment.   Additionally, at the request of researchers who do not do biomedical research, a HIPAA Authorization form for SocioBehavioral research is now available. 
 
• The form previously known as “HIPAA Waiver to Access Names and Contact Them” has been revised and re-titled “Preparatory to Research and Recruitment Form”.  As before, this form should be used when reviewing information on or recruiting from populations to which you do not have a pre-existing relationship (“natural access”).  Please see the revised policy and procedures for more information.
 
These forms are available on the Rush Research Portal.
 
Study teams should delete any saved templates and begin using the revised forms (Version IV April 2011) with submission of any new protocols from this date forward.
 
If you have any questions about HIPAA and Research, please contact the Research and Clinical Trials Administration Office at 312-942-5498. Comments or concerns may also be provided by calling the Rush Privacy Hotline at (312) 942-4416.

 



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