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Protocol Billing Grid PBG

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Protocol Billing Grid PBG

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    1. Protocol Billing Grid (PBG) Clinical Research Compliance and Education University of Utah Lisa Weaver, Director

    3. Federal Fines and Sanctions As of today, numerous Academic Medical Centers have been fined millions of dollars for billing non-compliance Totals are in the billions AMC have been fined for a variety of forms of fraud: fraudulent Medicare billing but also time and effort reporting fraud. In addition to levying fines, AMCs have been placed under restrictive Corporate Integrity Agreements

    4. PBG An excel spreadsheet developed by the CRCE to chart clinical services Services are divided into billable and non-billable. A billable item is one the could potentially be billed by University Health Care, even if it is not. Services are marked as SOC, STUDY, or GCRC, to indicate the responsible source. To mirror the protocol, the billing grid is charted by visit

    5. Usual Patient Care Usual Patient Care - All routine and investigational clinical services, supplies, and procedures that would be provided to a study participant for diagnosis and treatment if the participant was not enrolled in a Clinical Research study. - UUHSC Policy

    6. Purpose of the PBG Documents compliance with federal regulations regarding billing of clinical procedures, services (including time and effort), supplies, and related items Provides a tool for building clinical research budgets, reviewing monthly study accounts for accuracy of billing, reviewing and clearing clinical research charges (on new billing website) Acts as an audit trail for clinical research billing

    7. When is a PBG required? All studies that consent participants and include a clinical item (e.g. a blood draw) Exemptions: retrospective chart reviews and registries that include no clinical items Once in the course of the study, unless a protocol change alters billing At IRB submission or renewal

    8. Billing Non-compliance, continued Improper billing includes: Billing a participant/insurance company for research-only procedures or services (anything not SOC) Billing a participant/insurance company for services covered in study budget or study grant. Billing a federal grant at a higher rate than federal allowable rates Billing a commercial or non-profit organization at a lower rate than that billed to a federal grant Billing a grant for time and effort that is not spent on the project covered by the grant.

    9. Billing Compliance and the PBG Billing compliance requires institutional due diligence PBGs themselves are not required, but are conveniently designed documents because they mimic the protocols schedule of events Numerous university heath science centers are using a PBG. The UUHSC PBG adopts the main features of other universities PBGs

    10. IRB and Billing Compliance The billing practice of the clinical research study must follow the dictates of the informed consent form (ICF) of that study At the moment, no other UUHSC clinical research gatekeeper is recognized by the research community. Thus no other viable gatekeeper for submission of a PBG yet exists. Thus the IRB has agreed to collect the required PBGs. The IRB (staff or panels) will not review PBGs.

    11. ICF and Billing: The Upshot Failure to bill as stipulated by the consent form constitutes fraud. Scenario 1: billing the pt/insurance company for provisions stated to be provided by study is prohibited by law Scenario 2: billing the study when an insurance company refuses payment is prohibited (federal insurers can not be primary if there is another payor)

    12. Examples of billing non-compliance A study includes 5 lab analyses, 3 of which are SOC. All 5 analyses are charged to the participants insurance A study includes an SOC physician visit. At the visit, research-only items are included. The physician bills for a visit length that includes the research-only items.

    13. Examples, continued The NIH funds a research nurse for 50% time and effort in Study A, but the nurse spends more than 50% of her time on other projects, or seeing clinic patients. A study bills Medicare for procedure A for participant X, but pays for procedure A for participant Y

    14. CRCE contact For more information regarding PBGs, please contact Karen Mottola, Clinical Research Analyst, CRCE karen.mottola@hsc.utah.edu 3-3603 207Medical Research and Education Building (MREB is attached to Wintrobe; it can be accessed by bridges connecting to the SOM)

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