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

Day 1 Day 8Day 15

Day 22 Day 43

Day 50

Day 57 Day 64

N/A No S This is not a billable item or service.N/A No S This is not a billable item or service.N/A No S This is not a billable item or service.N/A No S S S S S S S S S This is not a billable item or service.N/A No S S S S S S S S S This is not a billable item or service.

99201 - 99205; 99211 - 99215

G0463

Q1 M M M 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 anti-myeloma 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.

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 NA NA NA NA NA NA NA NA This is a bundled service, and is not billable.

N/A No NA This is a bundled service, and is not billable.

85025 or

85027 and 85007

Q1 M M M M M M M M M 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.

80053 Q1 M M M M M M M M M 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.

93000 - 93010 No S S S 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

J9999 Q0 NB NB NB NB NB NB NB NB 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

96365-96368 Q1 M M M M M M M M IV administration of the study drug is supported by NCD 310.1.

Study Medications

Comprehensive Metabolic Panel

Medical History

Time & Effort

Concomitant MedicationsAdverse Event Assessment

Evaluation & Management Services

Vital Signs

Complete Physical Exam

M: Medicare or Other Heath PlanS: Charged to Study Fund or SponsorNA: Bundled With Another Payment From Third PartyNB: Not Billed to Anyone, Not a Billed Event, No CPT Code

ALT-803 (IV)

Scans/Procedures

CBC with Differential

Electrocardiogram (EKG)

Coverage Code Key

Informed ConsentInclusion/Exclusion Criteria

Comments

IV Infusion (ALT-803)

Labs

Weight

Height

Items and Services CPT/HCPCS Codes

Q1/Q0 Mod Screening1 Month 1

Cycle 1Month 2Cycle 2

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