Ensures that studies are billed for research specific procedures
Institutional Roles/Responsibilities
Jefferson Clinical Research Institute (JCRI)
Facilitates the relationship between TJU faculty investigators and the various
sponsors of scientific and scholarly knowledge; ensuring sponsored projects are
administered in accordance with sponsor regulations and TJU policies.
Physician Business Services (PBS)
Provides central revenue cycle functions including registration, charge entry, coding
(for certain clinical departments), claim submission to payors and accounts receivable
follow-up.
Jefferson University Physicians (JUP) and Thomas Jefferson University Hospital (TJUH)
Provide clinical services to patients including research participants.
Principal Investigator (& his/her designee)
Complete required documentation to support charges for each research participant.
Accurately bill medical professional and technical research charges to appropriate
payor source (e.g., grant; third party payor; or to the research participant).
Clinical Trials Billing Compliance
• Services reimbursed by study sponsors CAN NOT be billed
to third party payors.
• Third party payors usually only pay for services that are
accepted in the medical community & frequently exclude
payment for experimental or investigational services.
• Study participants should be aware of any out- of-pocket
costs resulting from participation in the study.
Medicare Coverage Analysis (MCA)
• Medicare Coverage Analysis / Compliance Grid is a document
that determines the appropriate payor (i.e. Sponsor,
Medicare or third party payor) for each item and service
required by a clinical research trial
• JCRI receives all study materials from the study team
• Create a grid that reflects all clinical events and time points in
the protocol
• Review clinical guidelines along with CMS (Centers for Medicare
& Medicaid Services) national and local coverage determinations
to identify the appropriate payor for each event
• Send the MCA to PI/SC for review and approval
• Approve or revise the MCA as necessary
Items and Services
CPT/HCPCS
Codes
Time & Effort
Informed Consent
N/A
Inclusion/Exclusion Criteria
N/A
Medical History
N/A
Concomitant Medications
N/A
Adverse Event Assessment
N/A
Evaluation & Management Services
Complete Physical Exam
99201 - 99205;
99211 - 99215
G0463
Cycle 1
Month 1
Day
Day 1 Day 8
15
Q1/Q0
Mod
Screening1
No
No
No
No
No
S
S
S
S
S
S
S
Q1
M
M
S
S
S
S
Cycle 2
Month 2
Day
Day Day
Day 43
Day 64
22
50
57
S
S
S
S
S
S
S
S
S
S
This
This
This
This
This
is
is
is
is
is
not
not
not
not
not
a billable item
a billable item
a billable item
a billable item
a billable item
or service.
or service.
or service.
or service.
or service.
Vital Signs
N/A
No
NA
NA
NA
NA
NA
NA
NA
NA
NA
According to the NCCN Clinical Practice Guidelines in Oncology Multiple Myeloma
Version 2.2014 "NCCN Guidelines" a physical exam is considered conventional
care at workup (NCCN Guidelines, p. 6). Patients in this trial have a confirmed
diagnosis of relapsed/refractory multiple myeloma after treatment with at least two
different previous regimens. Prior treatment must include at least two standard antimyeloma therapies or induction therapy followed by autologous stem cell transplant
(Protocol, p. 23). The study drug given in this trial has unknown side effects. A
physical exam at screening, once per cycle and at response assessments appear
reasonable and necessary for the clinical management of the patient in order to
monitor disease progression and potential side effects. Coverage supported by NCD
310.1.
This is a bundled service, and is not billable.
Weight
N/A
No
NA
NA
NA
NA
NA
NA
NA
NA
NA
This is a bundled service, and is not billable.
N/A
No
NA
85025
or
85027 and 85007
Q1
M
M
M
M
M
M
M
M
M
80053
Q1
M
M
M
M
M
M
M
M
M
93000 - 93010
No
S
S
J9999
Q0
NB
NB
NB
NB
NB
NB
NB
NB
96365-96368
Q1
M
M
M
M
M
M
M
M
Height
Labs
CBC with Differential
Comprehensive Metabolic Panel
Scans/Procedures
Electrocardiogram (EKG)
Study Medications
ALT-803 (IV)
IV Infusion (ALT-803)
Coverage Code Key
M: Medicare or Other Heath Plan
S: Charged to Study Fund or Sponsor
NA: Bundled With Another Payment From Third Party
NB: Not Billed to Anyone, Not a Billed Event, No CPT Code
M
Comments
This is a bundled service, and is not billable.
S
A CBC with differential is considered conventional care at initial workup (NCCN
Guidelines, p. 6).
The study drug, ALT-803, caused an increase in white blood cell counts in animal
studies (Protocol, p. 18-19). Patients in this trial have multiple myeloma which also
affects blood counts. CBC testing throughout treatment appears to be done both for
the clinical management of the patient and to monitor, assess and treat for
potential complications associated with the study drug. Coverage supported by
NCD 310.1 and NCD 190.15.
The study drug, ALT-803, caused a decrease in total protein and albumin levels in
the blood, as well as decreased blood calcium levels in animal studies (Protocol, p.
18-19). CMP testing throughout treatment appears to be done both for the clinical
management of the patient and to monitor, assess and treat for potential
complications associated with the study drug. Coverage supported by NCD 310.1.
The study drug does not appear to have cardiac side effects, and states that "no
dose related abnormalities based on ECG or ophthalmic evaluations were
The study drug will be provided by the sponsor. The protocol states: "ALT-803 is an
investigational drug supplied to investigators by the Altor Bioscience Corporation at
Miramar, Florida. Sufficient study drug will be available for this protocol to treat all of
IV administration of the study drug is supported by NCD 310.1.
Clinical Trial Billing
Entities
• Jefferson University Physicians (JUP)
• Bills related to clinical services sent monthly from JUP
Business Services
• Hospital
• Bills related to clinical services sent regularly from Hospital
Business Services
Jefferson University Physician (JUP) Bills
- Physician professional fees
- Examples: Physical exam, evaluation of MRI, ECG
interpretation, etc.
- Services get billed to grant or patient’s insurance for JUP
services. Review billing and compliance grid as reference
- Contact for JUP Billing
-
Merle Charlton, 3-3311
Hospital Bills
• Technical Fees for clinical trial services
• i.e. MRI cost, CT scan cost, some clinical labs, ECG cost, etc.
• Billed to grant or patient insurance as designated by
billing and compliance grid
• Contact for hospital billing
•
Ed Dunigan, 5-2521
Clinical Trial Billing Process
• Create a Clinical Trial Case with the JUP Business Office/
Registration. A Case Number will be assigned.
Clinical Trial Billing Process
• The Case Number will be part of the Patient record in the
IDX section of Allscripts
• All Procedures completed at Jefferson as part of the Clinical
Trial need to have the Case information attached to the
Appointment and Orders/Prescription (if applicable)
• The Orders/Prescription paperwork must have the Case
Number listed, and MUST be stamped with “Clinical Trials”
Clinical Trial Billing Process
•
Clinical Research Coordinator’s Role
• Keep the billing and compliance grid available
• JCRI and the Billing Departments will use the grid to
determine if the procedure should be billed to the grant
(clinical trial) or to patient insurance
• Be prepared to answer questions your Clinical Research
Administrator may have