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,
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.
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
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
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.
items and tests paid for by the study sponsor are not billed
to any insurer or to the subject.
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
devices which are not FDA approved, Medicare will be billed
only for “Category
and only upon obtaining a prior coverage determination by the
Medicare fiscal intermediary.
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
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.
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.
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