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 Intranet. Click on “I Need to Review A Policy,” then on Research Policies to access policies and forms for research billing:
- GR023 Billing Procedure for Outpatient Services, Inpatient Services and Ancillary Testing in Clinical Research Protocols
- Inpatient and Outpatient Research Registration Forms
- Core Lab Special Purpose Fund Account Set Up Form
- Standard of Care Subject Registration Form
Link to: Northwell Health Research Policies
(Note: You will be prompted for your Northwell Health username and password to access the Policies tab)
The ORC performs regular clinical research billing reviews. Contact us for any research billing compliance concerns.
Billing Compliance Tips
- Develop a detailed study budget & billing grid – that 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 (e.g. consent form, protocol, schedule of events, contract/agreement, etc.). This helps to ensure services promised free of charge to subjects are not billed to insurance.
- Perform a Medicare Coverage Analysis (MCA) – 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.
- Create an internal billing process map or SOP – that will allow you to work out the billing process logistically and ensure appropriate communication in the outpatient and/or inpatient settings with key people involved in the process (e.g. department administrators, research staff, registration staff, patient accounts, finance, CRS, etc.).
- Identify research subjects – by using research subject registration forms to notify registration/billing staff of procedures that will be covered by the research fund. Other ways to identify subjects are to provide a research card to the subject to present at registration or display a sign at the registration desk asking patients to let registration know if they are in a research study.
- Perform regular fiscal monitoring – to ensure that research procedures are reconciled and completed procedures billed appropriately, and in a timely manner.
- Have good documentation practices – by making sure your documentation is transparent and can withstand an audit. Any changes or corrections must accompany documentation about why something occurred and what was done to correct the error.
The Clinical Research Service (CRS) Finance Core can assist you with the above, such as developing a budget, billing grid, performing an MCA, and creating a process map for your study. They can also assist with research billing issues.
Please inform your finance contact who handles billing related to research and the CRS at firstname.lastname@example.org as appropriate to correct the charges. Registration or patient accounts may need to be notified as well to correct information and handle any changes. See health system policy on Compliance with Government-Funded Healthcare Claims and Cost Reporting Requirements for any overpayment to Medicare or Medicaid. Note that any overpayments must be returned within 60 days of identification.
Registration of Healthy (or Normal) Controls
Research teams must work with their registration staff to ensure that the correct information including diagnostic codes are provided when registering subjects. The diagnosis code (ICD-9 V70.7; ICD-10 Z00.6) is entered as the primary diagnosis for healthy controls and secondary for participants with a condition or diagnosed disorder.
Regulations and coverage policies for devices are separate. Investigational device (or IDEs) clinical studies, post-marketing approval studies or registries of carotid stents and proximal embolic protection devices in carotid artery stenting procedures require separate approvals from the Medicare Administrative Coordinator (MAC) for coverage, which must be done prior to billing. Devices are classified under category A (experimental/investigational) or B (non-experimental/non-investigational).
Information on Insurance and Denials
Coverage from commercial insurance carriers depends on their individual contracts, which may factor in the subject’s plan level coverage. You may need to obtain pre-authorization prior to provision of services or procedures to ensure coverage.