The Clinical Trials Office Finance (CTO Finance) oversees the financial conduct of clinical research studies at Northwell health. We provide financial /operational services for the conduct of new pharmaceuticals and medical devices through interventional and non-interventional studies for industry-sponsored research. Our services include:
- Cost analysis & budgeting
- Medicare coverage analysis
- Expense reconciliation and coordination of inpatient and outpatient expenses to study funds
- Invoice study sponsors
- Clincard payments
- Obtain/ensure CMS approvals for IDEs and establish charge codes for Investigational devices.
- Billing compliance
- Billing for Coordinator support services
- Education and Training
- Develop Policies and new processes
- Process improvements involving Invision and Sorian
- Flagging research subjects in EHR
- External vendors invoicing such as Central IRBs, Greenphire, etc.
CTO Workflow Process
Investigator gets contacted by sponsor for potential study ↓
Coordinator or Sponsor emails email@example.com with CDA/NDA
Site qualifications: visits are either in person or via phone; visits may occur with the coordinator
Executed CDA will release protocol, contract, informed consent and sponsor budget ↓
Study coordinator uploads the sponsor’s contract/budget templates,
Study coordinator completes the routing form, IRB application,
Once budget is finalized, the CTO requests creation of PeopleSoft Project ID number ↓
Once CTA is executed and IRB approval is received, institutional approval is then released
Site Initiation Visit occurs – sponsor gives authorization to begin enrollment ↓
Enrollment of trial begins
The goal is to develop a budget that sufficiently meets the financial needs of performing the clinical research studies. Budget development involves accurately identifying the cost of the research items required for the study and assigning financial responsibility to each item.
Facilities & Administrative Fees (F&A) are also known as Institutional Overhead Fees, or Indirect Fees. The Northwell Health F&A Rate for industry sponsored clinical research is 36%. F&A is applied to all budgeted items except invoiceables.
Institutional Fees: These fees are typically paid for by clinical research industry sponsors at the start of the study (refer fee memo). For questions on the charge master, please contact firstname.lastname@example.org
Medicare Coverage Analysis (MCA)
Performing a Medicare coverage analysis allows Northwell Health to weigh the level of a trial’s financial/compliance risk to the Institution. As Medicare being one of the largest payers at Northwell Health, every effort is made to ensure compliance with billing. Medicare coverage analyses involves determining the underlying eligibility of the study for Medicare coverage and a review of the clinical events specified in the protocol to determine which can be billed and reimbursed by Medicare.
Research Billing Compliance
The CTO performs a real-time billing review of all research services. If the research study involves billing for services or procedures provided to subjects, appropriate process and registration forms must be used for correct billing to occur. Standardized research billing procedures for inpatient and outpatient services and ancillary testing are outlined in the enterprise’s research billing policy posted on Healthport.
Clincard (Debit Card) for Subject Compensation
The Clinical research service uses an interactive Greenphire software program to manage flow of payments between Northwell Health clinical research studies and the study patients. This process ensures efficient timing and tracking of patient compensation and allows patients to receive debit cards instead of paper checks.
Click here to access the Clincard application.
Research Expense Reconciliation
The CTO will review research services, authorize fund transfer and identify the appropriate fund/grant account/service provider. The Westbury Central Finance Office will then perform journal entries and reimburse the appropriate service providers.
The site must provide monthly enrollment logs to email@example.com. Based on the payment terms in the contract, the CTO will invoice sponsors. Any adverse events leading to subject injury or unscheduled visit paid for by sponsor or any other special payments must be identified on the enrollment logs.
Establish Charge Codes for Investigational Devices
The CTO Finance will initiate charge code establishment for investigational devices by engaging the PeopleSoft team, Revenue cycle and HIM.
Education and Training
Enterprise wide education and training is conducted through PREP courses, Navigating Clinical Research (bi-monthly) and In services etc.
Flagging Research Subjects in Allscripts EMR (AEHR)
Click here to view the Flagging Research Subjects policy on Healthport.