Protocol Billing Grid PBG

1
Protocol Billing Grid(PBG)

• Clinical Research Compliance and Education
• University of Utah
• Lisa Weaver, Director

2
Background

• Center for Medicare and Medicaid Services (CMS)
• In 2000, new federal regulations allowed the
  billing of federal insurance for standard-of-care
  (SOC) charges in clinical research.
• Research dollars can be stretched legitimately
  when SOC procedures are included in the protocol.
  However, billing as SOC requires extra attention
  to billing compliance
• Because Medicare and other federal insurance
  programs pay for clinical research provisions,
  the federal government may audit clinical
  research studies for compliance with the rules
  governing SOC as part of research protocol

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

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CRCE contact

• For more information regarding PBGs, please
  contact Karen Mottola, Clinical Research Analyst,
  CRCE
• karen.mottola_at_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)