Clinical Trials at BMC. Alexandria Hui Clinical Trials Financial Analyst Grants Administration

Transcription

1 Clinical Trials at BMC Alexandria Hui Clinical Trials Financial Analyst Grants Administration October 29, 2007

2 Overview 1. Why are we doing this? 2. Pre-Award Process Budgets, Billing Grids, Cost Analysis, Rates 3. Post-Award Process Set ups, Registration, Billing, Forms, Reconciliations 4. Closeouts, Compliance and Audits?

3 Internal Reviews Sept 2006, E&Y conducted an internal review of the current business processes and internal controls related to clinical trial billings. Recommendations were made: Develop a centralized budget development infrastructure/process that all departments must utilize. Standardize the process for assigning costs research grant vs Standard of Care (SOC)

4 SOC vs. RESEARCH Institutional Position Principal Investigator (PI) makes the determination from feedback from the study staff and Clinical Trial Financial Analyst (CTFA) CTFA is a reference for PI on Medicare Guidelines. CTFA goes through each item on the protocol flowchart at each visit. All SOC vs. Grant determinations are made before the budget is developed.

5 Cost Analysis Budget Determines the break even point for a given clinical trial -- answers the question: can the institution afford to do this trial? Takes into consideration that a trial is NOT based on cost alone -- valid reasons of strategic/scientific interest are also considered. Sets minimum standard for negotiation parameters Procedure Cost CTFA uses the minimum of the salary range

6 Optimal Budget Use same analysis method to develop Optimal Budget as used for the Cost Analysis Budget Use the maximum of the salary ranges Submit to PI for review, along with the Cost Analysis Budget Variance between Cost Analysis and Optimal Budget is the negotiating parameter

7 What rates are being used? Federal grants (NIH, Federal pass-thru, etc) use the federal rate agreement Industry sponsored studies use BMC s research rates RESEARCH RATES and MEDICARE RATES are not the same

8 CPT4 Codes Unit Cost Baseline Week 1 Week 2 Week 3 Week 4 Month 2 Month 4 Budget Worksheet Clinical Trial Budget Treatment Follow -Up Procedures Initial Visit (MD Visit Level4) $ SOC Physical Exam (MD Visit Level 2) $ SOC SOC SOC Vital Signs (RN Level 1) $ SOC $41.72 $41.72 $41.72 SOC SOC SOC ECG $ $86.31 HIV $ $ Hep A Ab $ $85.29 Hep B Ab $ $71.46 Hep C Ab $ $ Complete CBC Auto $ SOC $35.54 Creatinine $ SOC $27.65 AST $ SOC $28.39 ALT $ SOC $28.39 Sodium $ $25.73 $25.73 $25.73 Potassium $ $25.73 $25.73 $25.73 Serum Pregnancy Test (HCG) $ $87.36 Chest CT $ 1, SOC SOC SOC Pelvis CT $ 1, SOC SOC SOC Abdomen CT $ 1, SOC SOC SOC Concomitant Medication N/A N/A SOC SOC SOC SOC SOC Study Drug Admin (IV Infusion 30 min) $ $ $ $ $ Personnel Principal Investigator $ $ $ $ $ $ $ Research Nurse $ $ $ $ $ $ $ Study Coordinator $ $ $ $ $ $ $ Other Misc Admin $75.00 Totals Total Direct Cost / Visit $1, $ $ $ $1, $ $ Indirect 30% $ $ $ $ $ $ $ Total Cost Per Visit $1, $1, $1, $1, $1, $ $ Total Cost of Baseline, Treatment, & Follow-Up For Each Patient $8,775.69

9 PI and Study Team s Approval The PI and Administrator must approve budget before submission. CTFA will submit budgets to either the BU or BMC office for submission with the contract.

10 Final Budget CTFA submits the Optimal Budget to either the BU or BMC office for review. Budgets are reviewed and negotiated between Institution and Sponsor. The Final Budget should fall between the Optimal Budget and the Cost Analysis Budget.

11 Billing Grid Details each subject visit, each charge and ancillary, related charges Labels each charge as SOC or Research Create Billing Grid for each study participant Can become vital tool when reconciling studies

12 CPT4 Codes Baseline Week 1 Week 2 Week 3 Week 4 Month 2 Month 4 Billing Grid Clinical Trial Budget Treatment Follow -Up Procedures Initial Visit (MD Visit Level4) SOC Physical Exam (MD Visit Level 2) SOC SOC SOC Vital Signs (RN Level 1) SOC GRANT GRANT GRANT SOC SOC SOC ECG GRANT HIV GRANT Hep A Ab GRANT Hep B Ab GRANT Hep C Ab GRANT Complete CBC Auto SOC GRANT Creatinine SOC GRANT AST SOC GRANT ALT SOC GRANT Sodium GRANT GRANT GRANT Potassium GRANT GRANT GRANT Serum Pregnancy Test (HCG) GRANT Chest CT SOC SOC SOC Pelvis CT SOC SOC SOC Abdomen CT SOC SOC SOC Concomitant Medication N/A SOC SOC SOC SOC SOC Study Drug Admin (IV Infusion 30 min) GRANT GRANT GRANT GRANT SOC - Billed to the Patient's Insurance GRANT - Billed to the Research Grant & Paid by the Sponsor *If any SOC procedures are denied by a patient s insurance, please contact the clinical trial financial analyst as soon as possible.

13 Are you ready to start? Contract has been signed. Budget has been approved. IRB approval letter received. Account number has been assigned by BMC/BU. Study team is ready to begin research protocol. What s next???

14 Registration Process Prior to enrolling first patient, the study must be set up in SDK. New Research Carrier Request Form for SDK Pre-register the patient in the system Research Registration Form Fax the information to registration, visit number will be assigned and faxed back to you.

15 New Research Carrier Request Form For SDK Boston Medical Center New Research Insurance Carrier Request for SDK Date: Form initiated by: Phone: Admin/Study Coordinator: Grant Title: PI: IRB Protocol # Department: Section: Plan Name Mnemonic (up to 16 characters): Is this Inpatient, Outpatient or Both? drop down Is this a Federal agreement? drop down Payor ID# (the 7-digit AU number for BMC or the last 5-digits of the BU source code): Effective Start Date: Effective End Date: **Please attach a copy of the budget with all the clinical tests being performed ** Address Information: (Only applicable if billing on paper UB92) Bill To: Telephone: ( ) Street Address: Town/City: State: Zip Code a copy of the form to Alexandria Hui (Alexandria.hui@bmc.org) and Laura Olson (Laura.Olson@bmc.org ) so all applicable forms may be updated. For FIS Use Only: Carrier: Research Grant No: (check one) Research Plan Mnemonic (Primary Insurance Plan): Date Completed in SDK: Initials:

16 Outpatient Registration Form Date: Boston Medical Center Research Registration Form Form initiated by: Phone: Fax: Research Patient Information: Subject Name: MRN #: (Leave blank if a new patient) SS#: DOB: / / Sex: M F If a new patient or if information has changed, fill in address information below: Street Address: Town/City: State: Zip: Day Telephone: ( ) Evening Telephone: ( ) SDK Insurance Set Up Information: Carrier: Research Grant No: (check one) Title of Study: Research Plan Mnemonic (Primary Insurance Plan): (16 Characters max) Primary Insurance Policy # (Payor ID#): (use if unknown) (This will be either the 7-digit AU number for BMC grants or the 5-digit Source Code for BU grants) Visit/Admit Date: / / Time: Clinical Research Investigation ICD9: V70.7 Service Area Location: Building/Address Attending Physician: Tel#: Please fax completed form to: Central Registration - Yawkey Pavilion: SDK Account # **Registration will assign an account number and fax back to sender listed above. **

17 Non-Research Related Visits Example: Study subject arrives for a research related MRI. The subject also has flu-like symptoms and the PI wants to make sure it s nothing. MRI= Charge to research grant Flu-like symptoms= patient s insurance

18 Non-Research Related Visits (Cont.) Charges must be separated in SDK A second visit number must now be created using the Registration Request Form Non-Research Visit This form is only needed when a Research visit also has SOC components.

19 Inpatient Registration Charges related to inpatient stays are usually covered by third party payors, unless the patient is also part of a clinical research study If research charges are generated during an inpatient stay, these charges can not be released with the regular inpatient claims.

20 Inpatient Registration (Cont.) Research charges must be flagged in the system so they are not released with the regular claims to third party payors Study Coordinators must inform the CTFA of any charges that should not be released by using the Inpatient Notification Form Communication between the Study Coordinator and the CTFA is vital!

21 Inpatient Notification Form

22 Patient Care Report and Invoice A monthly patient care report is generated by the CTFA and distributed to the Administrator of each study. This report contains: Detail grant charges for each date of service Detail grant charges for each patient Compare these reports to Billing Grid only Grant charges should appear on these reports Verify accuracy of charges Are SOC charges being charged to Grant? Are Grant charges being charged to SOC? Problems!! - Contact the CTFA

23 Example Patient Care Report INSURANCE INSURANCE INSURANCE POLICY ACCOUNT ADMIT PAID VIA JE OR BU BALA CARRIER PLAN NUMBER NUMBER PATIENT NAME DATE AMOUNT SOURCE ADJ. NCE RESEARCH GRANT #2 STUDY JANE SMITH 3/11/ RESEARCH GRANT #2 STUDY RUSSELL LEE 3/23/ RESEARCH GRANT #2 STUDY JOHN KING 1/18/ RESEARCH GRANT #2 STUDY BRAD PITT 8/1/ subtotal Total Amount to charge the grant REV ENU E CO DE SERVICE SERVICE CODE CPT COMMENT CODE DESCRIPTION CODE Approved by Alex CHEST;2V,AP&LAT Approved by Alex CHEST;2V,AP&LAT Approved by Alex CHEST;2V,AP&LAT Approved by Alex CHEST;2V,AP&LAT REVENU E CODE DESCIPT ION INSURA NCE PLAN PAYOR ID DX X- RAY ACTIVE DX X- RAY ACTIVE DX X- RAY ACTIVE DX X- RAY ACTIVE

24 Monthly Reconciliation A monthly reconciliation of charges is a crucial step in preventing billing errors and ensuring receipt of all funds due from the Sponsor. This process requires good communication between the CTFA, the departmental Research Administrator, and the Study Team personnel managing the administrative aspects of the treatment of subjects.

25 Things to watch out for Are these patients truly part of the study? Are there any patients that you do not see on your list that you know participated? Are there any charges missing? Are some of these charges not grant related? Contact the CTFA if there are any issues

26 Close Outs and Audits Has everything been billed to the sponsor? Have we received all payments? Have salaries been allocated properly? Have we been billed for all subjects? Have all reports been submitted to the sponsor? Cash balance after everything should be close to break even point

27 Any questions????