Policy for Compliance of Medical Billing in Clinical Research Studies

Purpose

This policy clarifies compliance requirements for the billing of clinical services, items, or tests provided to subjects who participate in a clinical study, regardless of source of funding. It is applicable to, and establishes uniform requirements for, all NYU Medical Center departments, practice groups, and centers.

Introduction to this Policy

The protocol for a clinical research study may include standard, conventional treatment for a patient’s medical condition.  Often, costs of standard care provided to a patient enrolled in a clinical study may be billed to third party insurers.  However, when the sponsor of the trial provides funding for services/procedures customarily designated as standard of care, these costs cannot be billed to Medicare, Medicaid, other third party insurers or the research subject.  There may also be services, items or tests that are purely experimental — not known to be effective, or, are required for investigational purposes only. As a general rule, costs for items and services that are experimental – not considered medically necessary, safe and effective – may not be billed to Medicare, Medicaid, other third party insurers, or the research subject.

Costs for services, drugs, devices and tests that are experimental are the responsibility of the sponsor or other entity funding the research (i.e., industry, government agency, non-profit, hospital providers, or departmental funds of the School of Medicine). Under certain limited circumstances, as provided in law and regulation, costs for experimental services or items required as part of a clinical trial may be billed to a third party or to the subject so long as these elements of cost are not reimbursed by the sponsor. It is essential that the Principal Investigator  determine early in the process which cost elements of a trial are standard of care and which are investigational and/or research-specific. For each clinical study the Principal Investigator must document which costs can be billed to third parties, and must be certain that safeguards are in place to ensure that all services and items are billed appropriately.

Policy Statement

It is the policy of The New York University School of Medicine and all departments of NYU Hospitals Center (collectively, NYU Medical Center) that its faculty, providers and staff have a responsibility to ensure that billing for costs incurred in the conduct of clinical studies occur only as appropriate and in compliance with relevant laws and regulations. Any billing to Medicare or Medicaid, to another third party insurer, or to the research subject, for professional or clinical services, drugs, devices or tests provided in the context of a clinical research study must be specifically allowable by applicable federal and state laws and regulations governing medical billing practices, by other third-party payor requirements; and must be consistent with the Informed Consent Document signed by the research subject.

As of the effective date of this Policy, each clinical study will be conducted pursuant to a documented billing plan that: 1) delineates the services, drugs, devices, and tests to be rendered in the context of the clinical study; 2) identifies which services, drugs, devices, and tests are standard of care and which are investigational; and 3) states who is responsible for paying for each service, drug, device, or test.   

Responsibilities for Compliance

Office of Clinical Trials

NYU Medical Center, through its Office of Clinical Trials, will document Standard Operating Procedures for clinical research billing compliance, disseminate it to principal investigators and other Medical Center personnel involved in clinical research billing, and provide guidance to principal investigators and billing personnel for compliance with these policies.

Department Chair, Center or Institute Director

The department chair, in collaboration with the center or institute director where applicable, is responsible for establishing and maintaining an environment for clinical research that requires all members of the research team to be both knowledgeable of and compliant with all policies and regulations governing the conduct of research. The approval of a protocol by the chair acknowledges that the Principal Investigator and research team are both knowledgeable and in compliance.

Principal Investigator

It is the responsibility of the Principal Investigator to understand and comply with rules for billing Medicare, Medicaid and third party insurers for services, drugs, devices, tests and procedures rendered in the clinical research context.  In particular, each Principal Investigator is responsible for developing a documented billing plan and for assuring that:

• Services, items and tests provided only for research purposes (for example, for the purpose of qualifying a study subject, or for data collection) will not be billed to any insurer.
• Services, items and tests paid for by the study sponsor are not billed to any insurer or to the subject.
• Medicare is billed only for costs permitted under the National Coverage Decision, which provides among other things, that Medicare will cover only the “routine costs” of “qualifying trials” and “reasonable and necessary items and services used to diagnose and treat complications arising from participation” in any clinical trial.
• For devices which are not FDA approved, Medicare will be billed only for “Category B” devices and only upon obtaining a prior coverage determination by the Medicare fiscal intermediary.
• No patient or insurer is billed for investigational medical devices or radiological health products unless the FDA has issued an Investigational Device Exemption (IDE); or, for investigational drugs and biologics not yet approved for marketing, without the FDA’s prior written approval.  When there is an IDE, or when the FDA gives prior written approval, charges to subjects must be described in the consent document.

It is the responsibility of the Principal Investigator or designee to maintain records related to the research study and to make such records available to the NYU Medical Center Audit and Compliance Office upon request.

Members of the Research Team

The primary responsibility for coordinating the billing and reimbursement decisions in a clinical research study rests with the Principal Investigator.  However, any faculty or staff member who is part of the research team has a responsibility to uphold this policy.  Each of these individuals is expected to monitor compliance with applicable billing rules.

All Employees

It is expected that all employees who become aware of noncompliance with this policy shall report it directly to their supervisors who in turn must report any incident to appropriate administrative officials.  The employee can also notify the Audit and Compliance Office and/or the Integrity Help Line directly if they feel the issue has not been addressed. 

Audit & Compliance

The Audit and Compliance Office will perform ongoing reviews and audits of clinical research to monitor compliance with this policy and applicable medical billing requirements. 

Enforcement

In any case where there is a report or reasonable indication of a violation of this Policy, the Compliance Office shall have the primary responsibility for conducting the investigation of the alleged situation or problem under the direction of the General Counsel. Possible disciplinary action will follow Medical Center’s existing disciplinary policies and procedures, including, for faculty of the school of medicine, the policies and procedures set forth in the New York University Faculty Handbook.

Effective:   August 12, 2004                     

ROBERT M.GLICKMAN, M.D.

CEO, NYU Hospitals Center

Dean, New York University School of Medicine