I. ACCOUNT NOTIFICATION PROCESS

Office of Research Integrity 901 N. Lake Destiny Rd., Suite 400 Maitland, FL 32751 407-303-8793

RESEARCH ACCOUNT NOTIFICATION AND RECONCILIATION PROCESS

I. ACCOUNT NOTIFICATION PROCESS

Notification is required for the following situations in the subsequent order: 1. When initiating a new research study; prior to patient enrollment. 2. Upon patient enrollment and/or screen failure. 3. Prior to protocol required subsequent visits, when aware. For example, baseline and follow up visits regardless of whether visit assessment is all routine care, all research or a combination of both. 4. When a patient is removed from or completes a study.

Please note: When consenting/enrolling an inpatient, do not wait until the day of discharge to send a notification. Late/Absent notifications may lead to sponsor covered items being billed to patient or insurance.

When a physician performs a procedure/service or interprets/reads diagnostic exams, there is a professional fee attached to this service. It is important to email FHMG and FRI when a physician representing Florida Hospital performs a service related to research.

A. Email Notifications: To ensure account is flagged for the appropriate entity, please email based on the below info:

For FH Patient Financial Services (Hospital Account) - FH.PFS.Research.Studies@ For FHMG Revenue Cycle (Professional Fees) ? FHMG.Clinical.Trials@ For FRI Billing (Radiology Account for X-ray, CT, MRI or PET scans) ? FH.FRI.Billing@

Each research department shall make their own determination of the intradepartmental names to also include (i.e. manager/director, financial rep, etc....).

Helpful Hint: "CC" yourself in this initial email. This will prevent you from having to retype needed information in the 2nd phase. You will only need to reply all to this email and provide reconciliation information.

B. Email Subject Line for Initial Notification: In an effort to increase efficiency and consistency, please add "New Research Study", "Research Account Hold", "All Research-Create Account", "Research-Routine Care only" or "Research & Routine Care Services" to your subject line. This will help the Billing Department quickly identify the reason for your communication and will help you keep track of the information you send. See definitions below:

1. "New Research Study": This is a new research study being generated and PFS needs to be informed to create a study adjustment code which will be used for future patients enrolled in that study.

2. "Research Account Hold": The patient is being screened for and/or enrolled in a study and an account hold needs to take place until discharge. This would normally pertain to services that are inpatient/observation charges. a. If aware at this time, please indicate which charges will be Research (Covered by sponsor) and/or which charges are Routine Care (Billable to insurance).

Research Account Notification and Reconciliation Process ? Version 1

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Office of Research Integrity 901 N. Lake Destiny Rd., Suite 400 Maitland, FL 32751 407-303-8793

RESEARCH ACCOUNT NOTIFICATION AND RECONCILIATION PROCESS

3. "All Research-Create Account": All scheduled services are related to research. The Research Department will be held responsible for charges and no charges will be billed to insurance. Pre-access from PFS will update account to bill directly to research department. Upon services performed, Research Department will review account in SunPort to ensure all charges listed are still research only. Note: Upon discharge, if any charges are not related to research, PFS must be notified. (See Account Reconciliation Process)

4. "Research-Routine Care Only": Services performed are routine care and billable to insurance, no charges need to be removed from the account. PFS will add Project Name and NCT# on SunPort Memo along with appropriate codes and modifiers. Claim will be billed to the patient's insurance.

5. "Research & Routine Care Services": Services performed contain both Research related (Invoiceable to Department) and Routine care (Billable to insurance) services. Please indicate what services fit each category. Pre-Access from PFS will create a research account and transfer charges reimbursed by sponsor to this account. Remaining charges will be billed to insurance with NCT # and appropriate codes and modifiers.

NOTE: Please add patient MRN# after subject line statement to quickly identify research patient during reconciliation process.

Example...

C. Information to Include in Notification Email: If you are communicating the initiation of a new study, please include the below information in your email: ? Protocol long title or detailed study description (brief paragraph) & pneumonic (short name/IRBNet#/PI) ? Name of Research Department ? Point of contact for the study

For patient enrollment and all subsequent visits, notification must include the following

information listed below:

? Patient Name

? Pneumonic (Short name/IRBNet#/PI)

? Date of Birth

? NCT#

? MD Name

? Indicate the study visit (Visit 1, 2-week F/U,

? Account Number (FIN#)

6=month visit, etc.)

? MRN

? Date of Service

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Office of Research Integrity 901 N. Lake Destiny Rd., Suite 400 Maitland, FL 32751 407-303-8793

RESEARCH ACCOUNT NOTIFICATION AND RECONCILIATION PROCESS

II. ACCOUNT RECONCILIATION PROCESS

To provide updates on emails sent during the notification process, reply all or print out your original email sent which will include all necessary patient/study information. Note: Remember to update your subject line and include any new information you are trying to communicate. (i.e. Patient has been taken off study. Please remove account hold.) NOTE: Action must be completed within 5 days of discharge or completion of scheduled assessments.

A. Email Subject Line for Account Reconciliation: In an effort to increase efficiency and consistency, please add "Release Bill", "Research-Routine Care only" or "Charges Related to Research" or Research & Routine Care charges" to your subject line. This will help the Billing Department quickly identify the reason for your follow up communication and will help you keep track of the information you send. See definitions below:

1."Release Bill": Patient not enrolled due to screen failure, removed or completed research study.

2. "Research-Routine Care Only": All services performed are routine care and billable to insurance, no charges need to be removed from the account. PFS to add Project Name and NCT# on SunPort Memo.

3. "Charges Related to Research": Communication of charges that need to be invoiced to research and removed from the billable account.

4. "Research & Routine Care Charges": Communication of charges for same visit that are both research (Invoiced to Sponsor) and routine care (Billed to insurance) charges

Please Note: If a patient is a "Screen Failure", notify all entities included in the initial notification as soon as

possible. If you have access to RS42, please indicate any research related charges that the patient received prior to screen failure. (Circle charges and Place an "R" next to them) If you do not have access to RS42, then list charges related to research in the body of the email. All other charges will be normally billed to insurance.

B. "Research-Routine Care Only": (No Charges to be deleted from account): Upon discharge or completion of scheduled assessments, if you have access to the RS42 Panel (Patient charge screen) in Sunport, review charges to ensure all charges are routine care only. If there are no adjustments required reply to original "Account Notification" email and include the statement "No charges related to research, release bill to insurance" in the body of the email.

C. "Charges Related to Research" :(Charges need to be removed from billable account and placed on research account): Upon discharge or completion of scheduled assessments, if you have access to the RS42 Panel (Patient charge screen) in Sunport, review charges to ensure all charges are research related services only. If there are no adjustments required reply to original "Account Notification" email and include the statement "All charges are related to research" in the body of the email.

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Office of Research Integrity 901 N. Lake Destiny Rd., Suite 400 Maitland, FL 32751 407-303-8793

RESEARCH ACCOUNT NOTIFICATION AND RECONCILIATION PROCESS

1. After review, if any charges are identified as routine care (billable to insurance) you will need to update your subject line to "Research & Routine Care" services and follow the steps in Roman Numeral II, letter D below.

D. "Research & Routine Care" :(Charges need to be removed from billable account and placed on research account): Upon discharge or completion of scheduled assessments, if you have access to the RS42 panel in (Patient Charge Screen) Sunport, review charges and identify those related to research and those that are routine care and billable to insurance. Please indicate what services fit each category. Pre-Access from PFS will create a research account and transfer charges reimbursed by sponsor to this account. Remaining charges will be billed to insurance with NCT # and appropriate codes and modifiers. Follow the steps below:

1. Print RS42 screen 2. Circle charges that are billable to research and place an "R" next to the corresponding charge

line. 3. Next circle charges that are Routine Care and billable to insurance and place an "RC" next to

the corresponding charge line. 4. Reply to original "Account Notification" email and attach RS42 page with the charge removal

detail. Please Note:

If you don't have access to the RS42 screen, please indicate the charges that are Research and those that are Routine care in the body of your email.

If you have any questions or need any clarification regarding this document, please contact the Office of Research Integrity via phone at 407-303-8793 or email at FH.ORI@.

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