next research registration tutorial 1 yale medical group research registration tutorial november 30,...

NEXTResearch Registration TutorialResearch Registration TutorialResearch Registration TutorialResearch Registration Tutorial

1

Yale Medical GroupYale Medical Group Research Registration Tutorial Research Registration Tutorial

November 30, 2010


2

It is the Yale Medical Group’s (YMG) goal to register It is the Yale Medical Group’s (YMG) goal to register research studies and the patients enrolled in studies research studies and the patients enrolled in studies in the GE/IDX system. in the GE/IDX system.

This first step will enable us to bill clinical care This first step will enable us to bill clinical care services provided to our patients who are enrolled in services provided to our patients who are enrolled in clinical research studies correctly. Medicare, clinical research studies correctly. Medicare, Medicaid and the private insurance companies have Medicaid and the private insurance companies have special billing rules for their insured members who special billing rules for their insured members who are enrolled in human subject clinical research are enrolled in human subject clinical research studies. Clinical care services in research studies studies. Clinical care services in research studies may be:may be:

• 100% funded by a sponsor, 100% funded by a sponsor, • partially funded by a sponsor, orpartially funded by a sponsor, or• unfunded and/or non-sponsored.unfunded and/or non-sponsored.


3

Therefore, in our ongoing efforts to bill for Therefore, in our ongoing efforts to bill for clinical care services correctly and in concert clinical care services correctly and in concert with our Medical Billing Compliance with our Medical Billing Compliance Program, we are initiating a process to Program, we are initiating a process to register patients in human subject research register patients in human subject research studies in our GE/IDX billing system. studies in our GE/IDX billing system.

This tutorial will introduce you to the This tutorial will introduce you to the two two new formsnew forms that will be required before a that will be required before a research study is approved. These forms research study is approved. These forms are effective only for research studies are effective only for research studies approved by the IRB on or after Nov 1, approved by the IRB on or after Nov 1, 2007'.2007'.


4

Non-compliance with Human Subject Non-compliance with Human Subject Protection billing rules may expose our Protection billing rules may expose our institution, Principal Investigators and other institution, Principal Investigators and other research personnel to fines and also prohibit research personnel to fines and also prohibit them from participation in research activities. them from participation in research activities.

By registering all studies and patients By registering all studies and patients enrolled in the studies in the GE / IDX billing enrolled in the studies in the GE / IDX billing system, our practice will be better able to system, our practice will be better able to manage our billing compliance.manage our billing compliance.

The institutions listed next are just a few of The institutions listed next are just a few of the institutions that have paid fines as a the institutions that have paid fines as a result of research related enforcement result of research related enforcement activity.activity.


5

Rush University $1,000,000

UCONN $2,500,000

Beth Israel Deaconess $920,000

Medical College of Georgia $6,100,000

New York University $15,500,000

Thomas Jefferson University $2,600,000

University of California San Diego $4,700,000

University of California $625,000

University of Chicago $650,000

($400k from PI)

University of Minnesota $32,000,000

University of Utah $950,000


6

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.AThis form will be required whenever a new human subject research study involving billable clinical care services is opened. These studies will be identified when the PI responds to the following new question listed on the HIC Application for a new research project.

“Will your research study require rendering clinical care services to human subjects that may be billable to the subject, the sponsor or other third party payer?”

If “yes”, please complete the “Request to Create a New Clinical Research Study” form at: http://medicine.yale.edu/ymg/Images/10605-FM.A_NewStudyRequest%20rev%20011310_tcm371-39390.pdf

The clinical department is responsible for completing Section I and Section II on the form and faxing, emailing or filling out the form online and sending it to Manager, Awards Set-Up Unit at [email protected] # 785-4169


7

“Request to Create a New or Re- Approved Clinical Study in GE/IDX” Form 11100.FM.A

Section I of IIIOfficial Study Name – The official name that the sponsor assigns to the study.

Is this a: New Study or Re-Approved Study

Indicate if this is a NEW or Reapproved Study


8

Abbreviated Study Name – Since many studies have very long names, please provide the abbreviated name if relevant.

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.ASection I of III


9

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.ASection I of IIISponsor Protocol number – This is the number that the Sponsor has assigned to the study.


10


HIC # - Human Investigation Committee approval number (if known).


11


HIC Approval Date – This is the date that the HIC approved the study (if known).


12


IDE # - Investigational Device Exemption number if applicable.


13


IND # - Investigational Drug number if applicable.


14


Principal Investigator – First and last name of the lead Principal Investigator for the study.


15


PI’s Department – The clinical department that is sponsoring the study.


16


PI’s Phone – Phone number for the Principal Investigator.


17


Secondary Contact Name – First and last name of a contact familiar with the study and who can answer questions regarding routine services versus research only clinical services. A likely candidate may be an individual from the business office who assisted with the budget development.


18


Secondary Phone – Phone number for the secondary contact.


19


Email and Office Address for the secondary contact.

Email Address Office Address


20

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.ASection II of IIIIs this a Medicare qualifying research study? To determine Medicare coverage status, fill out the Qualifying Study Checklist located at :http://ycci.yale.edu/comply/billing/qualifyingtrials.aspx


21

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.A

Section II of III

Medicare has certain criteria that need to be met before they will pay for routine care services in a research study. A Medicare qualifying checklist is available on the Compliance website to help researchers determine whether a study qualifies for Medicare reimbursement. http://ycci.yale.edu/comply/


22

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.A

Section I of III


23


24


25

Signature of person completing this form

Sign:_________________________Date: ______________


26

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.ASection II of IIIDoes this study require a PTAEO?

PTAEO # - The number the University assigns to the research study account. Professional services reimbursed by the sponsor get billed to the PTAEO #.


27

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.ASection II of IIIDoes this study require a YNHH T-Account number?

T- Account # -The financial accounting number assigned by YNHH to the research study and used for billing technical charges back to the PTAEO.


28

Services are 100% standard of care, billable to the patient’s insurance. Check this box if the study is a qualifying Medicare study or will receive pre-authorization from private insurance companies and all services are standard of care.

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.ASection II of III


29

Services are 100% Sponsor Paid nothing billable to the patient’s medical insurance – Check this box where the sponsor is reimbursing all costs associated with the study.



30

Services are a mixture of Standard of Care and Sponsor Paid. Check this box if the study is a qualifying Medicare study or will receive pre-authorization from private insurance companies and some services are paid by the sponsor (example Study Drug) and other clinical care services qualify for insurer reimbursement.



31

“Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.ASection III– To be completed by YSM Financial Business OfficeContract approval date – The date the research contract was approved by Grants and Contracts.

PTAEO # - The number the University assigns to the research study account. Professional services reimbursed by the sponsor get billed to the PTAEO #.

YNHH T-account – The financial accounting number assigned by YNHH to the research study and used for billing technical charges back to the PTAEO.


32

“Request to Create a New or Re-Approved Clinical Study in GE/IDX” Form 11100.FM.ASection III

The Director of Business Services is responsible for filling out Section III and sending the completed form to Patient Financial Services at [email protected]

You can find a PDF copy of this form to print out at this URL:

http://medicine.yale.edu/ymg/forms/

Scroll down to form 10605.F.M.A

If this is a NEW study, a copy should also be sent to: [email protected]


33

Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B

This form will be required whenever a patient is enrolled or Terminated/Completed in a human subject research study involving billable clinical care services.

The clinical department is responsible for filling out this form and faxing, emailing or filling out the form online and sending it to the Case Manager in Patient Financial Services.

The user may want to retain a copy of the form in the patient file when adding a patient so that when the patient is Terminated/completed, most of the information required is already on the form.


34

Notification of Patient Enrollment/Term/Completein a Clinical Study in GE/IDX 11100.FM.B Section I of II

Abbreviated Study Name - Since many studies have very long names, please provide the abbreviated name if relevant. If there is no abbreviated name, enter the official name of the study.


35


HIC # - Human Investigation Committee approval number.


36

Notification of Patient Enrollment/Term/Completein a Clinical Study in GE/IDX 11100.FM.B Section I of IIContact’s Name – Employee’s first and last name designated by the clinical department to enroll, Term/Complete patients.


37


Contact’s Phone - Employee’s phone number designated by the clinical department to enroll, Term/Complete patients.


38


Contacts Email - Employee’s email designated by the clinical department to enroll, Term/Complete patients.


39

Notification of Patient Enrollment/Term/Completein a Clinical Study in GE/IDX 11100.FM.B Section II

Patient Name: First and last name of the subject who is being enrolled, Term/completed or who was a screening failure.

MRN # - Yale Medical Group Medical Record Number.


40


Enroll – Check if enrolling a patient.

Terminated / completed – Check if terminating or completing a patient.

Not eligible-ex: (screen failure ) Check if the patient did not meet the eligibility criteria.


41


Start Date – Only use for Not eligible ‘screening failures’. Indicate the date the subject initially started going through the eligibility process.

End Date: Only use for Not eligible ‘screening failures’. Indicate the date the subject was classified as ‘ineligible’ for participation in the study.


42


Effective date – the date the patient was enrolled in a research study.

End Date – the date the patient was Terminated/completed in a research study.


43

11100.FM.BNotification of Patient

Enrollment/Term/Complete in a Clinical Study in GE/IDX

How to Submit This Form

A PDF Version of this form can be printed, saved and emailed as an attachment to:

[email protected]


44

You can find a PDF copy of this form to print out at this URL:

http://medicine.yale.edu/ymg/Images/PatientEnroll_tcm371-39402.pdf

Scroll down to form 10605.F.M.B


45

How to receive credit for this tutorial

If you have accessed this presentation through the TMS training page located at http://www/yale.edu/training

scroll down in that window, there is an “I agree” button to select and submit the page for credit.

If not, use the attestation at the link on the next page


46

To print off a paper copy of the attestation,

To fill out and submit attestation by email, http://ycci.yale.edu/comply/ctc/reg_attestation.aspx

Another way is to use the attestation, print it off and fax or mail it to the Compliance Department:

Attention: Tony Fusco at 203-737-5785

Thank you for completing this training!

next research registration tutorial 1 yale medical group research registration tutorial november 30,...

Documents

human subject research

research personnel

research activities

research study

result of research relat

geidx billing system

clinical care services

special billing rules