Billing Policy
Clinical Trials Billing Process
As the complexity of research billing increases, so do the associated risks of billing inaccurately. An example of what enforcement agencies expect and the consequences of non-compliance are the recent, well publicized, penalties incurred by non-compliant medical centers.
Since the inception of the Research Encounter Ticket process, the volume of tickets processed by both the FGP and NYUHC has not been what we expected. We fear that there may be significantly more activity than the tickets suggest and we feel that because of the significant risks associated with incorrect billing, that we need to put a process in place that provides assurance that any service billed to a clinical trial patient’s insurer is legitimate.
Therefore, we must gather from the PI’s in a central location the identity of those patients enrolled in clinical trials that are being sent out to receive services from providers where the medical center is the legal party providing the service. This includes any services provided by the FGP, GCRC or the hospital. We also need information from other providers such as Bellevue and voluntary physicians, but it is their responsibility to ensure that billing is proper.
PI’s must provide information on all patients that they are sending to have a medical service(s) on a given day and send this information to the Office of Clinical Trials on a daily basis. To facilitate this, we are simply adding a few additional elements to the tickets many of you are already submitting to OCT and the service providers. We are also requiring PI’s to submit monthly enrollment data on patients that were enrolled into a trial during the past month.
We will provide this information to the billing offices of the FGP, NYUHC and Bellevue. The respective billing offices will then ensure that any bill sent to an insurer accurately reflects services that are billable or, if the service is trial related, that the service gets billed back to the trial
As outlined in the Clinical Research Billing Policy signed by Dean Glickman in August 2004, the determination of the billable nature of a study remains the responsibility of the PI. It is also the responsibility of the PI to supply the necessary information to institutional service providers to be able to bill correctly for protocol-related services. It is also the PI’s responsibility to ensure that the information provided is in a reliable and auditable format.
Effective immediately, we are implementing the following two procedures with regards to clinical research data.
Research Encounter Ticket
The use of Tickets to inform providers of how to bill for services was implemented by the SOM as a required step last year. To increase the effectiveness of the ticket information and the compliance with ticket use the following changes are effective immediately.
The Research Encounter Ticket will follow the previous ticket procedure (printing out the ticket for outpatient services, etc.) and must be forwarded electronically to OCT (clinicaltrials@med.nyu.edu) no later than 4pm each day on the day of service for each actively-enrolling research project or project in protocol-required follow-up phases. Tickets sent in advance of services will not be accepted.
1. Research Encounter Ticket now includes all of the following fields:
a. PI Name and contact information (phone, email)
b. Coordinator or primary contact information (phone, email)
c. IRB#
d. Project Title, Sponsor, & Protocol #
e. FAME# (for studies billed to other than subject/subject's insurance)
f. Site of Service
g. Inpatient/Outpatient determination
h. Visit Name/Identifier
i. Location determination (inpatient/outpatient/FGP)
j. Research item
k. CPT or other applicable charge code
l. Billing category (SOC vs. research)
m. Charge to category (Pt/insurance/study/GCRC/non-billable)
n. Subject Name
o. Subject DOB
p. Subject MR#
q. Patient Gender
r. Qualified trial status (to reflect billing plan determination)
s. Device-specific trial information (category, billable nature, IDE#)
2. Once sorted by site, the Research Encounter Ticket will be emailed by OCT to the identified contacts (and associated distribution list)* by 8:00am the following morning.
a. Tisch Hospital/Rusk/HJD - Wes Smith / Sean McAleer / Debra Menaker
b. FGP - Andrew Rubin / Linda Harrison
c. Bellevue - Ernie Marrero
3. The respective providers will manually "pull" the identified patient records prior to billing for services.
4. The bill will be reviewed with OCT using the billing plan and protocol on file to confirm the research-related activities noted on the encounter form are appropriately billed to the School of Medicine, subject's 3rd party payer, or other research-related reimbursement source.
Monthly Milestone Form
1. The Monthly Milestone Form must be forwarded electronically to the Office of Clinical Trials (clinicaltrials@med.nyu.edu) by the 5th of every month for every open clinical research project. If no enrollment or visits occurred during the month, the form will be returned with a notice that no visits occurred for the month.
2. The Milestone data includes the following fields
a. Pt. Name
b. DOB
c. MR#
d. Trial ID
e. Visit Identification/Name
f. Visit Date
3. OCT will verify Research Encounter Ticket forms are present on all patients listed on Monthly Milestone Forms and forward enrollment data to the respective providers.
4. Enrollment data will be centrally kept by OCT.
Compliance
The importance of accurate billing requires the complete compliance of the researchers and coordinators.
Due to the significant institutional risks for NYUMC as well as the individual risk to the investigator associated with non-compliant research billing, PI's who fail to provide the enrollment and ticket encounter data in the time frames noted above will be subject to NYUMC Administrative Intervention.
1. The first episode of noncompliance will result in a formal request by OCT to provide the requested data immediately and the plan by the PI to insure compliance with submitting the requested data going forward. OCT will provide a monthly update of all noncompliance to the NYUMC AMC Operations Committee.
2. The second episode of noncompliance will result in the "freezing" of all clinical research accounts until the requested data is provided and a plan to insure compliance going forward is received and approved by NYUMC AMC Operations Committee.
3. The third episode of noncompliance will result in a revoking of privileges to conduct clinical research at NYUMC.
Last revised 6/14/06
