The finance core manages, plans and organizes financial activities of the Clinical Research Service (CRS) and research occurring at the health system. This includes, but is not limited to, feasibility review, cost analysis & budgeting, Medicare coverage analysis, expense reconciliation, coordination of inpatient and outpatient charges to grant funds, and subject payments. There is no direct charge to Investigators (usually charges are covered within the study budget).
Budget Development: 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. A detailed budget/billing grid indicates where procedures or services should be billed (e.g. study fund, subject or their insurance, or sponsor) and is consistent with study related documents. This helps to ensure services promised free of charge to subjects are not billed to insurance/patient.
Research billing: If your research study involves billing for services or procedures provided to subjects, you must ensure that the appropriate process and forms are used for correct billing to occur. Standardized research billing procedures for inpatient and outpatient services and ancillary testing are outlined in the health system research policy on research billing posted on Health Port. Click on the Policies tab in Health Port, then on Research Policies to access policies and forms (see “forms” tab) and research billing brochure. Click here to view the Huron-Northwell Health Research Billing presentation.
Medicare Coverage Analyses (MCA): Performing a Medicare coverage analyses 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. if you have any study procedures that may potentially generate a claim to Medicare or other insurers this analysis should be performed up front to determine routine cost coverage. Note that separate MCAs may need to be done for separate arms of a study. Medicare will not pay for items/services in non-qualifying trials. This will also ensure that subject injury costs are billed appropriately and does not violate the Medicare secondary payer rule. The Clinical Research Service (CRS) can assist you in identifying qualifying clinical trials and developing a MCA for your study.
Obtain CMS coverage approval for IDE device trials: CRS can assist in requesting CMS consideration for coverage and associated payment of hospital services (Part A) /physician professional services (Part B) for Investigational device exemption studies in accordance with section 68.2 of the Medicare Claims Processing Manual chapter 32.
In service training & education for research staff: Provide research education training at Public Research Education Program (PREP) and or when requested by site. Contact email@example.com to set up an in service training.
Feasibility Review: All human subject research studies that utilize drugs/devices conducted at Northwell Health will be reviewed for scientific merit, operational and financial feasibility, resources and compliance adherence.
Study initiation & consultation: CRS will provide guidance and administrative oversight to operationalize research studies.
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. The funding amount of each card is based on study visits completed by the patient.
Expense reconciliation: Allows review of research services and routing the charges to the appropriate fund/grant.
|Contact the Finance Core Team|
|Sumathy Sundarababu, PhD
Manager, Financial Operations
Phone: (516) 562-3642
|Danny Halfant, BS
Phone: (516) 562-1253
Analyst, Research Billing
Phone: (516) 562-1003