ECU Brody School of Medicine/Vidant Health

Financial Services Review Form for Research

Example With Instructions

Principal Investigator: John Smith

Study Coordinator (if applicable): Judy Jones

UMCIRB #: 13-001234

Research Title: ABC (study short name)

Sponsor: Glaxo

Please list the ECU/Vidant contact responsible for billing below:Where do claims/invoices for sponsor-paid services need to be sent? Include Mailstop #, if applicable.

Contact Person: Judy Jones

Address: 123 Heart Dr, Mailstop 234

Phone Number: 744-9999

National Clinical Trials Number (from ClinicalTrials.gov website): NCT12345678(If applicable, number begins with NCT; ALL “Qualified” clinical trials will have an NCT number)

Medicare Coverage Analysis: Qualifying Clinical Trial (See attached flow sheet for coverage analysis.)

Yes X No DeviceN/A

If No or N/A is selected here based on an analysis of the attached flow sheet, permission must be obtained from the MAC and/or insurance companies prior to billing Medicare or other 3rd party payors.

For studies involving Category B devices, patients cannot be enrolled in the study until approval from CMS has been received to bill for the device. Once IRB approval has been obtained, the Study Coordinator must contact Vidant Health Finance to complete the CMS packet. Vidant Health Finance will submit the packet to CMS and notify the Study Coordinator when approval for billing the device has been received. Once this has been completed, Vidant Health Finance will work with Materials and the Study Coordinator to set up a service code number for the device and patients can be enrolled in the study. For studies involving Category A devices, the sponsor must pay for the device and related charges. CMS does not pay for Category A devices since they are experimental (have no similar devices already on the market).

Are Study Services Promised at No Additional Cost to the Study Subject (i.e., free) in the Informed Consent

Yes X No

This question must be answeredYES if the Sponsor is paying for an item or service. These items or services cannot be billed to Medicare, Medicaid, patients, or insurance (any 3rd party payor) as routine even if they are normally routine costs.Only items or services that meet the requirements in the attached flow charts, applicable policies, and Medicare guidelines may be billed as routine costs to 3rd party payors or patients.

Procedures, tests, medications and all other study related requirements / Study Visit
# / Routine Cost (see attached flow sheet) – paid for by 3rd party payer / Paid for by
Sponsor / Provide CPT/Service Code for all non-routine procedures / Place of Service
(BSOM, ECHI-VMC, ECHI-ECU, FITT, LJCC, VMC, ECU, etc) / Additional
Comments
Can list multiple on same line IF: ALL are being done at the same visit #’s, ALL are either routine cost OR sponsor-paid—not a mix of both, AND ALL are taking place at the same POS. Otherwise, each must be listed on separate lines. / Corresponds to the visit # listed in the study protocol / Only one box (routine cost or sponsor-paid) checked per line / Only one box (routine cost or sponsor-paid) checked per line / Codes should be obtained when negotiating all non-routine pricing / Where service is being performed; only one POS per line; if multiple POS for the same procedure, there will need to be a separate line for each POS
EKG / 1, 3 / Yes X / Yes / 93005 / VMC
EKG / 2 / Yes / Yes X / 93005 / BSOM
CHEST XRAY / 1,5 / Yes / Yes X / 71020 / VMC
TEE / 4 / Yes / Yes X / 93312 / VMC / Considered routine but sponsor will be paying
Yes / Yes
Yes / Yes
Yes / Yes
Yes / Yes
Yes / Yes
Yes / Yes
Yes / Yes
Yes / Yes

By signing this document I acknowledge that the above information and conditions are accurate and true and if applicable I have permission from the appropriate 3rd party payors to bill routine costs as evidenced by the attached document(s).

HandwrittenSignature only Handwritten date only

PI signature (no electronic or typed signatures or dates accepted) Date

WHAT IS A “QUALIFYING CLINICAL TRIAL” UNDER MEDICARE?

(NOT APPLICABLE TO DEVICE TRIALS)

Yes

No No

Yes

No

Yes

No

Yes

ROUTINE COSTS UNDER A MEDICARE QUALIFYING CLINICAL TRIAL

(NOT APPLICABLE TO DEVICE TRIALS)

Yes

No

Yes to any

No to all statements No to all statements

Yes to any

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Revised 12/12/13