CU Home
Home
News and Events

-->
05/30/2008 7:00 AM - 4:00 PM Alumni Auditorium
New York Metro Chapter of ACRP presents: Tools for Improving Site Performance.
Presented by John Rowell, RN, MSN, CCRC.
02/26/2008 3:30 PM Alumni Auditorium  Compliance for Clinical Trials.
Presented by Debra Fitzpatrick, Manager, Risk and Research Compliance, Clinical Trials Office.
01/15/2008 08:00 AM Alumni Auditorium  Fifth annual Leahey Lecture.
Barry S. Coller, M.D., will present the fifth annual lecture honoring Michael Leahey and Dr. Edward Leahey, Jr.
11/20/2007 Budgeting for Clinical Trials – Best Practices (IRB Monthly Investigator Meeting)
3:30-4:30PM, Pharmacology Library, Black Building 7-724
Presenters:  Richard Hlenski, Director of Finance
Lourdes Vasquez, Senior Project Officer - Budgets
10/15/2007 Medicare Centralization of IDE requests for Investigational Device Trials.
06/07/2007 CTO Telephone and E-mail Directory.
06/06/2007 Medicare Coverage and Payment of Investigational Device Trials

Category B FDA approval confirms a device's eligibility for Medicare coverage and reimbursement, it does not result in automatic reimbursement by Medicare contractors. Our local Medicare contractor National Government Services (NGS) is responsible for the hospital services at New York Presbyterian and the physician services at Columbia University Medical Center. NGS must review the device and its use to make a final determination on reimbursement during the clinical trial. Click here for details.

To facilitate their review of our request for reimbursement approval, you should use this template to develop the cover letter that is jointly submitted by the Principal Investigator and New York-Presbyterian Hospital.
03/12/2007 Investigators and Coordinators: this document summarizes basic information required when preparing to participate in an investigational device trial. Instructions include
  • how to do the CTO submission
  • the need for open communication between the PI and the hospital chargemaster team
  • compliant billing instructions
Clinical Trials and Investigational Devices
11/09/2006 On Thursday, October 26, 2006, Dr. Paul Deutsch, Carrier Medical Director for Empire Medicare Services, gave an in-service to our clinical research community involved in investigational device clinical trials.  The topic was "Medicare Coverage of IDE and Clinical Trials".  Attendees included researchers, coordinators, and administrative staff from Anesthesiology, Cardiology, Neurology and Neurosurgery, Ophthalmology, Orthopedics, Pediatrics, Radiology, and Surgery.  Topics discussed were: Investigational Device Exemptions - Catetory B and Category A, Humanitarian Devices and routine costs and requesting reimbursement for clinical trials.  Medicare is permitted to reimburse for the routine costs of qualifying clinical trials as well as certain FDA-approved and IRB-approved investigational devices.  Dr. Deutsch's presentation was thorough, including many references to outside sources for additional information.

To view the presentation, click here.  If you have further questions or comments, please contact the Clinical Trials Office at ctoriskmanager.
11/08/2006 Browse studies recruiting healthy volunteers.  More...
09/19/2006
The Clinical Trials Office has established a dedicated Help Desk for online submissions at 212-305-5223.
06/21/2006   Medicare regulations for FDA-approved Investigational Device Exemption (IDE) Studies.
04/17/2006   Investigators and coordinators: you may now submit study-related documents that require
  Spanish translation to the Hispanic Translation Center. See instructions here.
01/30/2006   Investigators: you may now grant your coordinators, or other designated staff, access to your
  Pre- and Post- award Reports.
01/24/2006   NIH , in conjunction with Grants.gov , has prepared a training video and related documents
  for the upcoming electronic submission, now known as the SF424 (R&R).   More . . .
01/09/2006   RASCAL User's Guide v2.1   More . . .
12/02/2005   RASCAL HIPAA Manual   More . . .
09/20/2005   Recent settlements between medical institutions and the U.S. Department of Justice over
  alleged misuse of federal grant money   More . . .
06/20/2005   RASCAL User's Guide   More . . .
05/10/2005   Insurance Coverage and Clinical Trials   More . . .
03/01/2005   Western IRB multi-center trial submission instructions   More . . .
02/02/2005   CTO announces Biostatistical Consulting Service (BCS).   More . . .

 
© 2009 Columbia University   Contact webmaster Site designed by RCS6