Last Updated: September 28, 2006
ADVENTIST HEALTHCARE, INC.Clinical Trial Billing Tool
SECTION I
(to be completed by the Principal Investigator)
Protocol Acronym:
Principal Investigator:
Phone: / Fax:
E-mail: / Date:
On the next page, list all procedures, tests, exams, visits, medications, devices, equipment, supplies, hospitalizations, etc. that are part of the clinical trial, whether or not there is a cost to the patient or third party payer. Indicate who will be paying for each cost associated with the proposed clinical trial. Even if an individual subject may not receive all the items or services in a particular trial (e.g., in multiple-arm studies or randomized drug trials), all items and services relating to the clinical trial must be identified on this form.
Procedures, tests, exams, visits, medications, devices, equipment, supplies, hospitalizations, etc. / Provided by study sponsor free of charge / Paid by study sponsor (or paid using study funds) / Billed as standard care to patient or his/her insurer / Cost assumed by hospital / Cost of test/ procedure[1] / Comments1. / $
2. / $
3. / $
4. / $
5. / $
6. / $
7. / $
8. / $
9. / $
10. / $
11. / $
12. / $
13. / $
14. / $
15. / $
16. / $
17. / $
18. / $
19. / $
20. / $
Patient Stipend Information
An IRS Form W-9 will be obtained from each study participant whose Patient Stipend is equal to or greater than $600 annually. The total stipend for each patient in this study is $______annually per patient, and (check appropriate box):
- An IRS Form W-9 will notbe obtained from study patients because the stipend is less than $600 annually per patient; or
- An IRS Form W-9 will be obtained from study patients because the stipend is equal to or greater than $600 annually per patient, and AHC Accounts Payable will be notified.
To the best of my knowledge, the information provided in this form is complete and accurate. If I learn of any additional information that may affect the completeness or accuracy of this form, I will promptly notify the Administrative Director of the Clinical Research Programand provide updated information.
______
Signature of Principal InvestigatorDate
______
Printed Name
Please Note:
After completing Section 1 above, fax the Clinical Trial Billing Tool to the PFS Billing Compliance Coordinator.
SECTION II
(to be completed by PFS Billing Compliance Coordinator)
1.Is there a Medicare National Coverage Determination (“NCD”) prohibiting or otherwise limiting Medicare coverage? (In other words, are there any NCDs regarding any of the procedures, drugs, or devices that are part of the clinical trial, and if so, how do these NCDs affect coverage?)Search the Medicare Coverage Database ( to determine if there are any national coverage policies that would prohibit, or in any way affect, Medicare coverage of any of the items or services identified above in Section I.
YES, there is an applicable NCD prohibiting or otherwise limiting coverage. Stop here and notify Director of Patient Financial Services.
NO, there are no applicable NCDs. (Proceed to step 2.)
Not Applicable, as the study is purely data collection only.
______Date of search ______Name of PFS Representative
Comments (if any):
2.Is there a Local Coverage Determination (“LCD”) prohibiting or otherwise limiting Medicare coverage? (In other words, are there any LCDs regarding any of the procedures, drugs, or devices that are part of the clinical trial, and if so, how do these LCDs affect coverage?)Search both the CareFirst of Maryland fiscal intermediary website ( and the Medicare Coverage Database ( to determine if there are any applicable local coverage policies that would prohibit, or in any way affect, Medicare coverage of the investigational drug, device, and/or related procedures.
YES, there is an applicable LCD prohibiting or otherwise limiting coverage. Stop here and notify Director of Patient Financial Services.
NO, there are noapplicable LCDs. (Proceed to step 3 for device trials or step 4 for drug trials.)
Not Applicable, as the study is purely data collection only.
______Date of search ______Name of PFS Representative
Comments (if any):
3.Device Trials: Has the devicereceived an Investigational Device Exemption (IDE) and a “Category B” designation from the FDA?The IDE number and category designation should have been provided by the principal investigator on the Investigational Drug and/or Device Form. If there is more than one investigational device involved in this trial, a separate Investigational Drug and/or Device Form should have been provided for each device.
YES, the device received an IDE andwas designated as a “Category B” device by the FDA(Proceed to step 5).
NO, the device did not receive both an IDE and a “Category B” designation by the FDA. Stop here and notify Director of Patient Financial Services.
Not Applicable, as the study is purely data collection only.
4.Drug Trials: Is there an Investigational Drug Application (IND) on file with the FDA? If so, the IND number should have been provided by the principal investigator on the Investigational Drug and/or Device Form. If there is more than one investigational drug involved in this trial, a separate Investigational Drug and/or Device Form should have been provided for each drug.
YES, the investigator provided the IND number for the drug(Proceed to step 5).
NO, there is no evidence that an IND number exists for this investigational drug. Stop here and notify Director of Patient Financial Services.
Not Applicable, as the study is purely data collection only.
5.The drug and/or device trial is potentially covered pursuant to Medicare rules. Based on the information provided by the PI in Section I above, PFSmust determine the extent to which the investigational drug(s) and/or device(s) and the related procedures meet the requisite conditions for coverage. The following coverage rules apply:
Drug Trials. Adventist may not bill Medicare for:
- the investigational item or service itself;
- items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., additional CT scans and lab tests);
- items and services customarily provided by the research sponsors free of charge for any enrollee in the trial; or
- items and services not medically necessary for the individual patient.
Device Trials. Adventist may not bill Medicare for items and services that are:
- provided by the research sponsor free of charge;
- funded by research monies;
- not medically necessary to diagnose or treat a condition (e.g., tests performed for study data collection purposes only); or
- not medically necessary for the individual patient.
Determinations/Comments for consideration by Director of Patient Financial Services:
Please Note:
After completing Section 2 above,fax the completed Clinical Trial Billing Review Form to the Administrator/Director of the clinical research unit.
Clinical Trial Billing ToolPage 1 of 6
[1] Contact AHC Patient Financial Services to obtain cost of test/procedure.