Introduction - UCSF School of Medicinemedschool2.ucsf.edu/clinical_research/manuals/sfgh... · Web...

Research Subject Registration and Billing ManualSan Francisco General Hospital Medical Center

UCSF School of Medicine Clinical Research Office

Version 2: June 24, 2002

Version 2, June 24, 2002

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Table of ContentsINTRODUCTION............................................................................................................................ 1SECTION 1: OBTAINING PROCEDURE RATES FOR CREATING CLINICAL TRIAL BUDGETS...................................................................................................................................... 1

LABORATORY TESTING.................................................................................................................. 1RADIOLOGY.................................................................................................................................. 1PHARMACY................................................................................................................................... 2FACILITY FEES AND ALL OTHER ANCILLARY SERVICES...................................................................2PROFESSIONAL FEES.................................................................................................................... 2

SECTION 2: CLINICAL TRIAL ACCOUNT SET-UP.....................................................................2SECTION 3: RESEARCH SUBJECT REGISTRATION AND ADMITTING..................................3

RESEARCH SUBJECT REGISTRATION..............................................................................................3INPATIENT ADMITTING................................................................................................................... 3

SECTION 4: CHARGING TESTS, PROCEDURES, AND PROFESSIONAL FEES FOR RESEARCH SUBJECTS................................................................................................................4

CHARGING OUTPATIENT SERVICES TO A RESEARCH STUDY............................................................4CHARGING INPATIENT SERVICES TO A RESEARCH STUDY...............................................................5ANCILLARY SPECIFIC ORDERING PROCEDURES..............................................................................5

Laboratory Testing................................................................................................................. 5Pharmacy............................................................................................................................... 5Radiology............................................................................................................................... 5

ALL OTHER TESTS AND PROCEDURES...........................................................................................5

ATTACHMENT 1 - RATE CONTACT LIST....................................................................................6ATTACHMENT 2 - SPECIAL RESEARCH ACCOUNT APPLICATION FACILITY USE FEES FOR CLINICAL/ANCILLARY SERVICES FORM..........................................................................7ATTACHMENT 3 - ACCOUNT AND FUND REQUEST FORM.....................................................8ATTACHMENT 4 - SFGH PROTOCOL APPLICATION................................................................9ATTACHMENT 5 - SFGH REQUEST FOR INDEX CODE/COST CENTER................................12ATTACHMENT 6 - RESEARCH PATIENT IDENTIFICATION CARD REQUEST.......................13ATTACHMENT 7 – RESEARCH SUBJECT REGISTRATION AND ADMISSION......................14ATTACHMENT 8 - INVESTIGATIONAL DRUG SERVICES FORM............................................15INDEX........................................................................................................................................... 16


IntroductionAll 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 BudgetsThe 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 TestingThis 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.

RadiologyThis 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 Rau206-4176

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.


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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 FeesTo 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.


http://sfghdean.ucsf.edu/forms.htm

http://acctg.ucsf.edu/files/pc/spcht.xls

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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 RegistrationWhen 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


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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 SubjectsThe 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.


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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 ProceduresLaboratory TestingTo 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.

RadiologyThis 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 ProceduresAll other tests and procedures that should be directed to the study account must be charged to the study insurance plan code.


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Attachment 1 - Rate Contact List


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Attachment 2 - Special Research Account Application Facility Use Fees for Clinical/Ancillary Services Form

COMMUNITY HEALTH NETWORKSAN FRANCISCO GENERAL HOSPITAL MEDICAL CENTER

SPECIAL RESEARCH ACCOUNT APPLICATIONFACILITY USE FEES FOR CLINICAL/ANCILLARY SERVICES

TO BE COMPLETED BY INVESTIGATOR

PROJECT/STUDY NAME

DEPARTMENT NAME INVESTIGATOR

CONTACT PHONE

ADDRESS BEGIN DATE

NIH GRANT YESNO

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 206-8452BUSINESS OFFICE, BLDG. 20 WARD 24


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Attachment 3 - Account and Fund Request FormTo: 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


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Attachment 4 - SFGH Protocol ApplicationSan Francisco General Hospital

PROTOCOL APPLICATIONProtocol 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 onlySource of funding (e.g., NIH, industry, other)__________________________________________

2 Subjects seen for research and for established medical careSource of funding (e.g., NIH, industry, other)__________________________________________

BRIEF DESCRIPTION OF PROTOCOLPlease provide a brief description of the nature and goals of the study

___________________________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________

UTILIZATIONIndicate 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.


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SFGH SIGNATURE AND SPECIAL RESEARCH ACCOUNTINFORMATION 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)


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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


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Attachment 5 - SFGH Request for Index Code/Cost Center


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Attachment 6 - Research Patient Identification Card Request

RESEARCH PATIENT

FaxTo: Vanda Mendoza From:

Fax: 206-8697 Pages: 1

Phone: 206-6686 Date: 5/6/2023

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

Race:

Date of birth:

Marital status: Single Married

SS#:

Home address:

Date card needed:

Study contact name:

Study contact phone number:


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Attachment 7 – Research Subject Registration and Admission


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Attachment 8 - Investigational Drug Services Form


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Index

Aaccount, 1, 2accounts, 2, 3, 8Award Synopsis, 2

Bbilling, 1, 4billing problems, 4budget, 1

Ccharges, 3, 4Chemistry, 1Contracts and Grants, 2, 8cost center, 3CT, 1, 5

DData Governance Board, 2

Ffacilities, 3fund, 2, 8

HHematology, 1

Iinpatient, 4, 9inpatient card, 4

insurance, 3, 4, 5insurance plan code, 3, 5

Llaboratory, 1, 5

Mmedical record number, 3, 13MRI, 1, 5

Oordering, 2, 4, 5, 8outpatient, 9

Ppharmacy, 1, 5, 9, 11Protocol Application, 2, 3, 9, 10purchase order, 3purchasing, 2

Rradiology, 1, 5, 11rates, 1, 2registration, 3, 4research account, 4research inpatient card, 4

Sservices, 1, 2, 3, 4, 10speedchart, 2supplies, 2, 3


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