Research Subject Registration and Billing Manual

Research Subject Registration and Billing Manual San Francisco General Hospital Medical Center

UCSF School of Medicine Clinical Research Office

Version 2: June 24, 2002

Version 2, June 24, 2002 i

Table of Contents

INTRODUCTION...... 1 SECTION 1: OBTAINING PROCEDURE RATES FOR CREATING CLINICAL TRIAL BUDGETS...... 1 LABORATORY TESTING...... 1 RADIOLOGY...... 1 PHARMACY...... 2 FACILITY FEES AND ALL OTHER ANCILLARY SERVICES...... 2 PROFESSIONAL FEES...... 2 SECTION 2: CLINICAL TRIAL ACCOUNT SET-UP...... 2 SECTION 3: RESEARCH SUBJECT REGISTRATION AND ADMITTING...... 3 RESEARCH SUBJECT REGISTRATION...... 3 INPATIENT ADMITTING...... 3 SECTION 4: CHARGING TESTS, PROCEDURES, AND PROFESSIONAL FEES FOR RESEARCH SUBJECTS...... 4 CHARGING OUTPATIENT SERVICES TO A RESEARCH STUDY...... 4 CHARGING INPATIENT SERVICES TO A RESEARCH STUDY...... 5 ANCILLARY SPECIFIC ORDERING PROCEDURES...... 5 Laboratory Testing...... 5 Pharmacy...... 5 Radiology...... 5 ALL OTHER TESTS AND PROCEDURES...... 5 ATTACHMENT 1 - RATE CONTACT LIST...... 6 ATTACHMENT 2 - SPECIAL RESEARCH ACCOUNT APPLICATION FACILITY USE FEES FOR CLINICAL/ANCILLARY SERVICES FORM...... 7 ATTACHMENT 3 - ACCOUNT AND FUND REQUEST FORM...... 8 ATTACHMENT 4 - SFGH PROTOCOL APPLICATION...... 9 ATTACHMENT 5 - SFGH REQUEST FOR INDEX CODE/COST CENTER...... 12 ATTACHMENT 6 - RESEARCH PATIENT IDENTIFICATION CARD REQUEST...... 13 ATTACHMENT 7 – RESEARCH SUBJECT REGISTRATION AND ADMISSION...... 14 ATTACHMENT 8 - INVESTIGATIONAL DRUG SERVICES FORM...... 15 INDEX...... 16

Version 2, June 24, 2002 1

Introduction All services provided by San Francisco General Hospital (SFGH) must be charged to an appropriate account. The purpose of this manual is to provide guidance to UCSF employees to communicate appropriate billing of procedures for clinical research subjects at SFGH. This manual is comprised of four sections: Obtaining Procedure Rates for Clinical Trial Budgets, Clinical Trial Account Setup, Research Subject Registration and Admitting, and Charging Tests, Procedures, and Professional Fees for Research Subjects.

Section 1: Obtaining Procedure Rates for Creating Clinical Trial Budgets The information in this section pertains to obtaining any procedure or test rates for a clinical study. In addition to obtaining procedure and test published rates, rates lower than those published are available in certain instances for research purposes. These are referred to as "research rates" in this document, and, when available, this section describes how to obtain this rate. General instructions for obtaining procedures rates are presented followed by specific processes for some of the major ancillary services.

Laboratory Testing This section describes how to obtain research rates for Clinical Laboratory tests  Research prices are available on the “Research Study Order Form”. This form can be obtained by contacting the main lab at 206-8199. If the desired tests are not on the Research Study Order Form, contact one of the following people:  Chemistry: Susan Gross, 206-3538  Hematology: Mary Clancy, 206-3534  For questions regarding laboratory testing and pricing, contact Cassandra Simmons at 206-3496.

Radiology This section describes how to obtain rates for radiologic testing in studies, specifically X-rays, CTs and MRIs.  Contact the following person to obtain the current rates for the applicable study radiologic procedures: Katy Rau 206-4176  For all federal clinical trials, the Medicare rate will be provided. For industry sponsored clinical trials, the commercial rate is usually utilized. In rare cases, a discount for can be sought for industry sponsored trials via writing a memo to Ernie Ring and Richard Hollingsworth with the reasons the discount is necessary and send it to Katy Rau.

Pharmacy  All studies involving investigational drugs must utilize the Investigational Drug Service (IDS) for formulation, dispensing, and storage.  To obtain pharmacy services rates, contact Shelley Huang at 206-8406. Also include a $350 nonrefundable start up fee in all budgets.  Should drugs need to be ordered for the study, County overhead will need to be included in the budget if the drugs are ordered through IDS. Drugs may also be ordered through UCSF purchasing instead of IDS.

Facility Fees and All Other Ancillary Services  For all questions regarding facility fees and ancillary service prices other than lab, radiology, or pharmacy prices contact Robert Perry at 206-5425.  Research rates are available for facility fees and ancillary services and are generally the Medicare rate.  To obtain rates, complete a Special Research Account Application Facility Use Fees for Clinical/Ancillary Services form contained in Attachment 2 and available from Robert Perry. Identify the services and estimated number of cases and send it to Robert Perry who will send the form back with the prices for the indicated services.

Professional Fees To obtain rates for professional fees, contact the relevant department directly.

Section 2: Clinical Trial Account Set-up  Once the study is approved through the Contracts and Grants process, as indicated by the receipt of an Award Synopsis, obtain account and fund numbers for the study by faxing an Account and Fund Request Form (see Attachment 3) with a copy of the Award Synopsis to UCSF Accounting - Extramural Funds at fax number 502-1444.  For ordering supplies for the study through UCSF purchasing, obtain a speedchart number by completing and faxing a completed Speedchart Request Form (available at http://acctg.ucsf.edu/files/pc/spcht.xls) to Accounting at fax number 476-6168.  If SFGH patient medical information will be utilized in the study, contact Dr. Brody in SFGH Data Governance at 206-8267. Approval by the Data Governance Board is required for studies at SFGH utilizing patient information. Upon speaking with Dr. Brody, he will let you know whether expedited approval is possible or whether the study will need to be reviewed by the Data Governance Board. If the study requires review, the board meets the fourth Monday of each month and the investigator will need to attend the meeting.  Complete a San Francisco General Hospital Protocol Application available at http://sfghdean.ucsf.edu/forms.htm and contained in Attachment 4. Submit the application to the SFGH Dean’s office for approval.

 If the total amount of hospital charges in the study budget are greater than $2,500 a UCSF Purchase Order must be obtained from your Department by completing a PO requisition, available from UCSF Materiel Management.  Forward copies of the completed and signed Special Research Account Application Facility Use Fees for Clinical/Ancillary Services form (see facility fees section above) and the PO to Karen Sellers in the SFGH Business Office (206-8452). This must be done at least 10 days prior to enrolling the first research subject into the study. When available, Karen will contact the study investigator with an insurance plan code unique to the study. This code must be utilized to direct charges to the study account.  If supplies or facilities services will be required for the study, an index code must be obtained from SFGH Accounting. Complete a Request for Index Code/Cost Center for New Research Grants form contained in Attachment 5 and send it to SFGH Accounting in building 20 with a copy of the approved San Francisco General Hospital Protocol Application. If you have any questions, contact Archie Toledo (206-6573) or Tess Navarro (206-6974).

Section 3: Research Subject Registration and Admitting

Research Subject Registration When a new research subject has enrolled into a study, obtain a research patient identification card for the research subject with the study specific insurance plan code obtained from Karen Sellers (see section above). The contact for patient identification cards is Vanda Mendoza at 206-6686. To obtain the card, send a fax to Vanda at 206-8697 with the following information:  The subject’s Medical Record Number (MRN) if they are an existing patient  If the subject is new to the system, provide the subject’s demographic information (gender, race, date of birth, marital status, social security number, home address)  When you need the card  A contact name and number  Write “register research patient” across the top of the fax. A form is available in Attachment 6 to use for this purpose. All cards should be picked up on 3M.

Inpatient Admitting  Research inpatients must be registered through the registration process identified above and a research patient identification card obtained in addition to notifying admissions per the following instructions.  If a patient is being admitted who has been prospectively identified as a research subject and whose hospital stay should be charged to the research study, complete the Research Subject Registration and Admitting form contained in Attachment 7. Select “Research Admit” at the top of the form. Do not provide the subject’s insurance information. Send the completed form to Admitting. When the patient is admitted, the principal investigator or

designee must pick up the subject’s research inpatient card which will be utilized to direct charges to the research study.  If a research subject is in the hospital for care but is going to be kept in the hospital for research procedures whereby the rest of the patient’s stay should be charged to the research study, the Research Subject Registration and Admitting form must be completed and “Discharge and Research Admit” selected at the top of the form. The Principal Investigator and Attending Physician must sign the form in this situation. The “Date of Arrival” should be the date of the change in the patient’s status to a research admission. Complete the entire form. Bring the form with the patient’s inpatient card to the Admissions Office. You will be provided with a research inpatient card to direct charges to the research study.  If a research subject is admitted for care and only ancillary services need to be charged to the research study, the subject’s research outpatient card should be used on orders for services to be charged to the study. Admissions does not need to be notified if no portion of the subject’s stay needs to be charged to the study.  Please direct any questions regarding research subject admissions to Glynn Moses at 206-8471. If a research admit or discharge/readmit must happen outside of Monday through Friday, 8 AM to 5 PM, arrangements must be made in advance with Glynn Moses.

Section 4: Charging Tests, Procedures, and Professional Fees for Research Subjects The following instructions for ordering tests, procedures, or billing professional fees must be followed to assure proper billing. Should you encounter billing problems with procedures for research subjects, you may contact Karen Sellers, at 206-8452 for assistance.

Charging Outpatient services to a Research Study  When research subjects require tests or procedures which need to be directed to the research study, the subject must be registered utilizing the research patient identification card. This assures billing to the study account where appropriate rather than to the study subject or their insurance. This must be done each time they arrive for a study test or procedure.  If a research subject is receiving tests or procedures for care that must be directed to their insurance on the same day that the subject is having tests or procedures performed for the study, the patient must register for the tests for their care using their own patient identification card with their insurance information and their tests for the study using the study patient identification card.  If there is no activity with a research patient identification card in a 6 month period, a new card will need to be requested.

Charging Inpatient Services to a Research Study  Ancillary tests for inpatient research subjects should be charged to research accounts using the same method as for outpatients described above. A research patient identification card should be obtained from registration and used to direct study related charges to the research account.  Utilize the patient’s research inpatient card obtained from Admissions per instructions in the “Inpatient Admitting” section above if all inpatient charges are to be directed to the study account.

Ancillary Specific Ordering Procedures Laboratory Testing To order Clinical Laboratory tests for research subjects:  Upon approval of a study and prior to ordering any testing, complete a “Research Study Test Request Form” and a “Research Study Order Form”.  Fax the forms to Valerie Ng,MD at fax number 206-3045.  Do not order any tests until you receive a signed Research Study Test Request Form back from the lab.  To order tests that should be billed to the study, enter the 4 letter code you designated for the study on the Research Study Test Request Form in the “location” field of the laboratory requisition form.

Pharmacy  Upon approval of a study and prior to enrolling patients, complete an Investigational Drug Services Form (contained in Attachment 8) and submit it with a copy of the protocol to Shelly Huang per the instructions on the form.  IDS will provide an order form customized to the study. This order form must be utilized when ordering drugs for the study.

Radiology This section describes how to order radiologic testing for research subjects, specifically X-rays, CTs and MRIs.  Upon approval of the study, complete a Special Account Application. This form is available from Katy Rau at 206-4176.  The form will be sent back with a location code assigned to the study. When ordering radiologic procedures that should be billed to the study, this code must be entered in the “Referring Location” section of the requisition form.

All Other Tests and Procedures All other tests and procedures that should be directed to the study account must be charged to the study insurance plan code.

Attachment 1 - Rate Contact List

SFGH Procedure Rate Contact List

Procedures Contact Phone Research Special Name Number Rates Available? Requirements Facility fees Robert Perry 206-5425 Yes (generally Special Research All ancillaries medicare rate) Account other than lab Application/Facility Use and radiology Fees for Clinical/Ancillary Services Lab work Cassandra Simmons 206-3496 Yes Research Study Test Request and Research Study Order forms required Pharmacy Shelia Huang 206-8460 NA IDS Form Radiology: Katy Rau 206-4176 Yes (Medicare rate for Special Account X-ray Richard federal, industry Application CT Hollingsworth commercial rate MRI unless exception made)

Attachment 2 - Special Research Account Application Facility Use Fees for Clinical/Ancillary Services Form COMMUNITY HEALTH NETWORK SAN FRANCISCO GENERAL HOSPITAL MEDICAL CENTER SPECIAL RESEARCH ACCOUNT APPLICATION FACILITY USE FEES FOR CLINICAL/ANCILLARY SERVICES

TO BE COMPLETED BY INVESTIGATOR

PROJECT/STUDY NAME

DEPARTMENT NAME INVESTIGATOR

CONTACT PHONE

ADDRESS BEGIN DATE

NIH GRANT YES NO

SIGNATURE DATE

EST # CASES DESCRIPTION OF SERVICES CPT CODE FULL PRICE RESEARCH RATE

CPT CODES AND PRICING ARE QUOTED BY THE BUSINESS OFFICE ONLY AND REQUIRE SIGN-OFF SIGNATURES

TO BE COMPLETED BY BUSINESS OFFICE

SIGNATURES:

FOR BUSINESS OFFICE DATE:

FOR DEPARTMENT DATE:

INVESTIGATORS: THIS FORM MUST BE COMPLETED PRIOR TO THE START DATE OF THE RESEARCH PROTOCOL AND SUBMITTED ALONG WITH A UCSF P.O. OR DEPARTMENT P.O. TO: KAREN SELLERS 206-8452 BUSINESS OFFICE, BLDG. 20 WARD 24

Attachment 3 - Account and Fund Request Form

To: Extramural Funds Manager Date

Fr: ______Dept. Ext. ______

Subject: Please check one of the following

Item__√ __1.) Request for a New Account/Fund Number

Item_____2.) Request for an Extension of Current Fund Year

Item_____3.) Request for Opening an Additional Fund Year

Due to a delay in the receipt of the formal award document for the item checked above, we request that appropriate action be taken by the Accounting Office in order to enable us to properly record expenses in the correct Account /Fund / Fund Year.

If, for any reason the award is not granted, this department will absorb any and all expenditures incurred. The expenditures will be charged to unrestricted funds available in this department. In the event that the starting date is later than what is indicated on this form or we intend to spend money in advance of the start date of the award, this department is responsible to request approval for pre-award cost from the Contracts and Grants Office.

The following information is provided to expedite the approval of our request.

This is a Grant______a Contract______a Clinical Trial______Agency Grant or Contract Number (if known) Principal Investigator Project Period ______(for Item 1 ). Current Acct./Fund/Fund Year______(for Item 2 or 3). Current expiration date ______(for Item 2 or 3). Extension Period: Number of Months .(for Item 2) From______To______Account to be coupled to new fund ______. Dept. code if known______.

Supporting documentation is attached______√ ______, not attached ______.

______Prepared By Approved By

======

For Accounting Use Only:

Request Approved by______, Date______.

Account/ Fund/ Fund Year Assigned______.

AFP Input Prepared by ______, Date______cc: Contracts / Grants Office revised 10/97

Attachment 4 - SFGH Protocol Application San Francisco General Hospital PROTOCOL APPLICATION

Protocol Title ______

Grant Title (if different) ______Grant No. if available Beg. Date of Grant End Date of Grant Prin. Investigator Additional Contact

Phone Phone Mailing Address Mailing Address

IRB STATUS

 Approved CHR No.______Exp. Date______

SUBJECT CATEGORY (Please circle appropriate classification)

1 Subjects seen for research purposes only Source of funding (e.g., NIH, industry, other)______2 Subjects seen for research and for established medical care Source of funding (e.g., NIH, industry, other)______BRIEF DESCRIPTION OF PROTOCOL Please provide a brief description of the nature and goals of the study ______UTILIZATION Indicate number of subjects per year Year 1 ______2______3______4______5______ Total number of outpatient visits per subject ______ Total number of inpatient visits per subject ______

Will this study be conducted entirely in the SFGH General Clinical Research Center (GCRC)? Yes  No  If “Yes”, proceed to “Pharmacy Utilization” section on the last page and contact SFGH GCRC 206-8239 for required forms. If “No”, please complete all parts of the attached “SFGH Signature and Special Research Account Information” form. Version 2, June 24, 2002 10

SFGH SIGNATURE AND SPECIAL RESEARCH ACCOUNT INFORMATION FORM

Please submit this form with the Protocol Application if research at SFGH will be conducted outside of the SFGH GCRC. In addition to the required signatures from the Departments listed below, please note any other SFGH equipment, services, or personnel needed, and department(s) involved and the investigator should sign all sections where “NA” is indicated.

DATA GOVERNANCE (206-8267) Use of SFGH patient information is approved: Yes  No  NA 

______Signature/Date: SFGH IS Administration Or attach email approval from SFGH IS Admin.

HUMAN RESOURCE / SPACE UTILIZATION (approval from the Unit where research will occur)

Where will this study be conducted?______

Building______

Room______Please describe any and all tasks which SFGH staff may be asked to perform which they would not perform but for this protocol:______I have approved the above: Yes  No 

______Signature/Date:Unit Head Nurse / Manager Or attach email approval from Unit Head Nurse / Manager

************If this is a chart review only, stop here.************

CLINICAL LABORATORY UTILIZATION (206-8588) A SFGH Special Research Account has been established? Yes  NA 

______Signature/Date: SFGH Clinical Lab Administration Or attach email approval from SFGH Clinical Lab Admin.

If applicable, refer to Procedure for Establishing and Using a Research and Special Study Account.

RADIOLOGY UTILIZATION (206-5196 or 206-6130) Version 2, June 24, 2002 11 A SFGH Special Research Account has been established? Yes  NA 

______Signature/Date: SFGH Radiology Administration Or attach email approval from SFGH Radiology Admin.

If applicable, refer to Procedure for Establishing and Using a Research and Special Study Account. PHARMACY UTILIZATION (206-8460)

Does this study involve the administration of any medications? Yes  No  A SFGH Pharmacy Investigational Drug Service (IDS) form has been completed? Yes ____NA 

______Signature/Date: SFGH Pharmacy Administration Or attach email approval from SFGH Pharmacy Admin.

ADMINISTRATIVE APPROVAL

______Philip Hopewell, M.D. (Date) Gene O’Connell (Date) Associate Dean, SFGH Executive Administrator

Attachment 5 - SFGH Request for Index Code/Cost Center Research/Project Information Research/Project Name: Approx. Budget:

Research/Project Period: From: To:

Research/Project Manager: Phone: Research/Project Principal Phone: Investigator:

Office and Billing Information Office Location: Phone:

Billing Address: Fax:

Billing Address:

Billing Address: Required Information to bill Insurance Plan No.: (such as PO # or Contract #)

Authorized Signers (for Requisition of Supplies and/or Services) Print Name and Title: Signature:

Print Name and Title: Signature:

Signatures Requested By: Date:

Research/Project Manager: Date: Research/Project Principal Date: Investigator: Send completed form to Accounting Office, Building 20, ASAP. Attach a copy of signed SFGH Protocol Application form. Index code shall not be set up without this form.

For Community Health Network Use Only Index Code Number: Date Added to FAMIS:

Index Code Description: Date Copy Sent to MM:

Accounting Approval: Approval Date:

Attachment 6 - Research Patient Identification Card Request RESEARCH PATIENT Fax

To: Vanda Mendoza From:

Fax: 206-8697 Pages: 1

Phone: 206-6686 Date: 4／7／2018

Re: Research Patient Identification Card CC:

 Urgent  For Review  Please Comment  Please Reply  Please Recycle

 Comments: Subject MRN: (existing patients)

New Patients: Gender: Male Female

Date of birth:

Marital status: Single Married

Home address:

Date card needed:

Study contact name:

Study contact phone number:

Attachment 7 – Research Subject Registration and Admission

Attachment 8 - Investigational Drug Services Form San Francisco General Hospital Medical Center Department of Pharmaceutical Services (DPS) Investigational Drug Service Form

Please complete/sign table 1 and send a copy of the CHR approved protocol to DPS; complete both tables, sign table 2, and send/fax a copy of CHR approved protocol to DPS if the services are required.

Principal Investigator (PI)______Phone #______Pager # ______Campus Address______

Protocol Title______

______CHR Approval #______Exp. Date______Medications involved in the study (if the drug is chemotherapy agent please specify): Drug Name Route Pharmacy service required Yes No Person responsible for if pharmacy not involved Receiving/Storage/Return Accountability/Inventory Prepare/Dispense/Labeling Dispensing Recordkeeping Other

PI Signature ______Date ______======A copy of the protocol is received by the DPS for file. Signature ______IDS Pharmacist Date______

SERVICE REQUEST AND AGREEMENT Service Requested (please check): ___ Protocol review ___ Randomization ___ Study Regimen Blinding ___Single Blinded or ___Double Blinded ___ Drug Receiving /Storage/Return ___ Drug Accountability/Inventory ___ Drug Preparation/Dispensing/Labeling ___ Maintenance of Dispensing Records ___ Correspondence with Monitors/Meetings ___ Others (e.g., drug procurement, placebo preparation - specify) ======Proposed Financial Reimbursement: Management Fee (one time charge per study) ______Preparation/Dispensing Fee ______/patient or ______/dose Others ______Account Information: Account No. ______Type (e.g., UCSF) ______

Billing Address ______

Contact Person ______Phone No. ______

Signature ______Date ______Principal Investigator Signature ______Date ______IDS Pharmacist Signature ______Date ______Director of Pharmaceutical Services Sheila Huang, PharmD Investigational Drug Pharmacist - SFGHMC (415) 206-8460 (Inpatient Pharmacy) (415) 206-4926 (voice) FAX (415) 206-5472 Sheila_Huang @sfgh.org

Version 2, June 24, 2002 16 Index

A account, 1, 2 accounts, 2, 3, 8 insurance, 3, 4, 5 Award Synopsis, 2 insurance plan code, 3, 5

B L billing, 1, 4 laboratory, 1, 5 billing problems, 4 budget, 1 M C medical record number, 3, 13 MRI, 1, 5 charges, 3, 4 Chemistry, 1 Contracts and Grants, 2, 8 O cost center, 3 ordering, 2, 4, 5, 8 CT, 1, 5 outpatient, 9

D P Data Governance Board, 2 pharmacy, 1, 5, 9, 11 Protocol Application, 2, 3, 9, 10 F purchase order, 3 purchasing, 2 facilities, 3 fund, 2, 8 R H radiology, 1, 5, 11 rates, 1, 2 Hematology, 1 registration, 3, 4 research account, 4 I research inpatient card, 4 inpatient, 4, 9 S inpatient card, 4 services, 1, 2, 3, 4, 10 speedchart, 2 supplies, 2, 3

Version 2, June 24, 2002