NYU Grossman School of Medicine’s Clinical Research Support Unit follows uniform requirements for billing items or services linked to subjects who participate in research studies and provides an efficient basis for charge review using consistent and well-documented practices. Our Clinical Research Coverage Analysis policy ensures adherence to all applicable laws, regulations, and contractual obligations governing research billing. The policy is based on current Medicare clinical research billing guidance provided by the Centers for Medicare and Medicaid Services.

This policy applies to all human subjects research studies conducted at NYU Langone. Each human subjects research study is assessed by the Clinical Research Support Unit within the Office of Science and Research to determine whether the study includes protocol-related billable items or services.

The policy defines responsibilities for principal investigators, study teams, and our Clinical Research Support Unit as follows: 

• It provides a framework for labeling procedures as standard of care or solely for research purposes in trials with chargeable items or services. This will determine billing to insurance companies or patients versus a research account.
• It places responsibility on principal investigators to provide initial standard of care determinations based on clinical expertise. Initial determinations are expected early in the trial start-up process via interaction with Clinical Research Support Unit staff.
• It uses guidance from Medicare to justify coverage of certain services that are linked to “qualifying clinical trials.”
• It drives a more thorough billing grid development process based on institutional policies and procedures. 

If you have questions or would like more information about any of our clinical research billing policies and procedures, please contact one of our specialists or email us at clinicaltrials@nyulangone.org.