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10/31/2014
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©2014 Kelly Willenberg, LLC
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2014 IACRN Annual Conference
Research Compliance
Kelly Willenberg, MBA, BSN, CHRC, CHC
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Overview
Are there risks in research compliance?
How do I identify these risks?
What are some common concerns in compliance?
Are there tools to help identify or solve compliance risks?
How does compliance affect me in research?
©2014 Kelly Willenberg, LLC
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Points to keep in mind
In compliance always “Do the Right Thing”
Remember that the costs of non-compliance is high!
©2014 Kelly Willenberg, LLC 3
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What is Research Compliance?
Research compliance can help to ensure proper scientific, ethical and regulatory requirements are followed in research protocols and can promote research integrity through a standardized process.
Research compliance can address any or all of the following in an institution or hospital: Institutional Review Board and human subject protection, HIPAA, post approval monitoring, biohazard or radiation safety, billing, contracts, grants management, research overview, clinical trials conduct, personnel, award closeout and quality assurance.
Research Risks
The first step of research compliance is knowing which laws apply to your activity
The second step of research compliance is to figure out what that means
The third step is to assess your risks
©2014 Kelly Willenberg, LLC 5
The trouble with research regulations…..
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Confusing rules… ©2014 Kelly Willenberg, LLC 7
Contradictory rules… ©2014 Kelly Willenberg, LLC 8
Multiple rules to get to one answer…
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The Office of Research Integrity within the United States Department of Health and Human Services defines nine core areas in the responsible conduct of research:
1. Human subjects 2. Conflicts of interest and commitment 3. Mentor training and responsibility 4. Publication practices and responsible
authorship 5. Data management, acquisition, sharing &
ownership 6. Research involving animals 7. Research misconduct 8. Peer review 9. Collaborative Science
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Establish Basic Rules for the Conduct of Clinical Trials
Regulatory/HIPAA: OHRP, IRB, AHHRPP, NIH
Regulatory oversight for life of the study for both employed and non employed groups
Create a liaison to IRBs especially if you use commercial IRBs and establish guidelines for reporting
Assert research credentialing and training requirements for all staff
Establish criteria for claims review and reimbursement
Maintain enforcement with the rules by setting examples
Facilitating Compliance for Research Standardize SOP’s system wide
Provide mentoring to new clinical research coordinators
Network with sponsors/CRA’s about other areas in organization conducting research
Create consistent policies
Promote transparency to ensure credibility
Establish policies and procedures to make roles clear, responsibilities known and accountability validated
Perform compliance self monitoring of clinical research studies, both for-cause and not-for-cause
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Common Research Compliance Concerns
©2014 Kelly Willenberg, LLC 13
Best Compliance Program Operationally
There is not one, it’s yours because you are driving it
There is not an “ out of the box” or “one-size-fits-all” way to manage compliance and integrity
Institution Must Haves
Substance Structure
Commitment Responsibility
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Success or Barrier
Administrative Buy In
History of the Organization
Existing structure and culture
Size and scope of the research program
Size of the Institution
Availability of resources
Importance of research program
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Risks in Research
Research and related rules are complex
There is significant pressure on regulators to make things right where public perception is that they have gone very wrong
Education and ongoing training are lacking and sometimes unfunded
Physician-investigators do not understand compliance
Administrative support is sometimes absent
Non-compliance consequences are not appreciated
Priority for research is different for everyone
What is the PRICE of Non-
Compliance?
Potential financial risk
Regulatory issues and problems
Institutional values are lost are altered
Cultural priorities and fear of change limit growth
Exposure which can damage an Institution
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Payback, penalties or fines
Audits from other federal agencies
Accreditation status jeopardized
Loss of Federal Grants
Loss of Key Opinion or Thought Leaders
Bad Press and Public Relations
COST OF NON COMPLIANCE
Four Necessary Elements Pieces of the Compliance Paradigm
Pieces of the Compliance Paradigm
Communication Transparency
Enforcement Education
Compliance Paradigm
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Where Does the Clinical Research Coordinator Fit In?
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CRN’s Should Take the CREDIT!
Communication
Regulation
Education
Determination
Integrity
Transparent
Which Rules Apply?
Studies that involve
drugs or devices
(Industry OR PI Initiated)
Behavioral/Social Science Research
21 CFR – FDA (GCP, GMP
or GTP Regs)
ICH GCP
Institutional Policies
IRB rules
45 CFR 46 – DHHS
NIH Guidelines
45 CFR 46 – DHHS
Institutional Policies
IRB rules
NIH guidelines
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Challenging Roadmap Ahead Requires careful review, periodic assessment and diligent
effort
Research represents an area that is often targeted as high risk at many organizations
Risks can change as research changes
Ever increasing focus on translational research and new ways of advancing science
Research compliance is a specialty and a liability as the risks in this space are considerable
Fragmented Information in Clinical Trials Management
Budget Contract Coverage Analysis
Protocol UB’s Invoices
to Sponsors
Physician office
IRB
Two Hot Areas of Research Compliance for CRNs
Human Subjects Protection
Clinical Trial Billing
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Ongoing priorities for the OHRP’s Division of Compliance Oversight
Findings in recent determination letters….
◦ Research conducted without IRB review and/or approval
◦ Failure of IRB to review HHS grant applications
◦ Lacking sufficient information to make determinations required for approval
◦ Approval of research not approved by the IRB
◦ Inadequate continuing review
◦ Failure to report unanticipated problems, noncompliance, suspensions, terminations, etc. to IRB, IO, or OHRP
◦ Failure of Investigator to obtain legally effective and/or to document Informed Consent or of the IRB to waive requirements
◦ Failure to provide a copy of the signed ICF to the subject (or their representative)
©2014 Kelly Willenberg, LLC 28
Common Clinical Trial Billing Errors
• Billing for services not rendered
• Billing for services that are already paid by the sponsor or promised free in the informed consent
• Billing for services that are for research-purposes only or are part of a non-qualifying clinical trial
• Billing Medicare for device trials without MAC approval letter in hand
• Bill Medicare Advantage Plans (Part C) when claims should be directed to the Medicare Administrative Contractor
©2014 Kelly Willenberg, LLC 29
Common Clinical Trial Billing Errors
• Billing for items or services not supported by required documentation
• A proper, signed order
• Adequate documentation of medical necessity for the item or service
• Documentation of study participation, as required
• Billing without proper codes, modifiers or NCT#
• Waiving/paying/reimbursing subject co-pay or deductible obligations
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Clinical Trial
Billing Process
Coverage Analysis
Performed
Budget, Contract,
Consent Review
Subject Registration and
Tracking
Medical Documentation
for Medical Necessity
Charge Capture, Segregation,
Research Pricing
Medicare MAP Commercial
Payers
Audit and Review
31 ©Kelly Willenberg, LLC
WHAT IS A COVERAGE ANALYSIS (CA)?
Systematic review of research-related documents to determine the Medicare billing status of both the study itself and the items and services provided to the research subjects that are outlined in the research documents over the course of the study
Review based on thorough research, supported by industry guidelines which meet the “generally accepted in the medical community” standard and are compliant with government regulations
Provides subjects with an accurate accounting of their financial liability before they enroll
Provides an accurate assessment of the true costs of the clinical trial with potential increased revenue
Protects your institution from violations of the False Claims Act and other regulations by showing due diligence
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IDE COVERAGE PRINCIPLES SUMMARY Category A Category B
• Trials involve immediately life-threatening condition
(if trial was initiated before January 1, 2010)
• All trials
• Device not covered
• Device covered if not provided free by sponsor or promised free
• Reimbursement may not exceed amount for comparable
marketed device
• Routine care services covered • Routine care services covered
• Medicare contractor approval required • Medicare contractor approval required
Device is never covered
Services
• IDE Number
• ICD-9 Code V70.7 (Secondary diagnosis)
• Q0 or Q1 Modifier
• Physician Services
• Outpatient Services
• Condition Code 30 (outpatient only)
• NCT#
Device
• IDE number
• HCPCS device code (if applicable) (Physician and outpatient)
• Q0 (Physician and outpatient)
• Charges or token charge (outpatient)
Services
• IDE Number
• ICD-9 Code V70.7 (Secondary diagnosis)
• Q0 or Q1 Modifier
– Physician Services
– Outpatient Services
• Condition Code 30 (outpatient only)
• NCT# 34
Routine Costs
Items or services that are typically provided absent a clinical trial (e.g., conventional care);
Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service, in particular, for the diagnosis or treatment of complications.
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Achieving Compliance: The 3 C’s
◦ Coordination of study information
◦ Communication of study information
◦ Collaboration and clarity of study documents
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Roles & Responsibilities
Research compliance is a community effort: ◦ Hospital
◦ Physician
◦ CRO
◦ Academic Institution
◦ Sponsor
All have different responsibilities and obligations arise from different sources: ◦ Statutes
◦ Regulations
◦ Government guidance
◦ Contracts
◦ Ethics responsibilities
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Other Areas for Research Compliance
Scientific Misconduct
Conflict of Interest
©2014 Kelly Willenberg, LLC 38
Example of Scientific Misconduct
Bryan William Doreian, Ph.D., Case Western Reserve University
ORI found that the respondent engaged in RM by falsifying data related to studies funded by NIH, National Heart, Lung and Blood Institute, and NINDS.
His research must be supervised indefinitely, his employer must certify the accuracy of his experiments, he may not provide advisory services to PHS and his paper was retracted.
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Example of Conflict of Interest
A researcher conducts a clinical trial which is sponsored by any person or organization with a financial interest in the results of the trial.
©2014 Kelly Willenberg, LLC 40
Protocol Adherence
A procedure, treatment, or visit called for by the protocol is conducted outside of the required time frame and this has clinical consequence; poses risk of harm to subject or others and/or is thought to be impactful to the scientific integrity of the study.
©2014 Kelly Willenberg, LLC 41
Tools to Assess Risks ©2014 Kelly Willenberg, LLC 42
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Risk Area Identified
Improper
Payment or
Legal/
Regulatory
Violation
Adverse
Publicity
Possible
Financial
Impact
Government
Focus
Overall Risk
Measurement
Priority
Ranking
RANKING SCALE Low 1 </=1% of Gross Revenue
2 1-3% of Gross Revenue
Medium 3 3-5% of Gross Revenue
4 5-7% of Gross Revenue
High 5 >7% of Gross Revenue
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Topic Repu
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Like
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Dete
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Vuner
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Cont
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Ris
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Sco
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Who Do We Need At the Table?
Hospital Areas
Principal Investigator
Clinical Research Coordinator
IRB process
Budget negotiators
Clinical Trial Agreement negotiators
Grant administration
Health Information Management/IT
Registration/Scheduling/Authorizations
Medical center billing and coding
Physician professional fee billing and coding
Study fund managers
Managed care contract negotiators ….and others!
©2014Kelly Willenberg, LLC 46
Village People
Construction Worker
We have lots of work to do…
Harley Rider
We are way cool…
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We fight with the Cowboys….
Indian ©2014Kelly Willenberg, LLC 49
Cowboys rule….
Cowboy ©2014Kelly Willenberg, LLC 50
Navy Corpsman ©2014Kelly Willenberg, LLC 51
We fight with the Cowboys….
We have structure, but….
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https://www.youtube.com/watch?v=CS9OO0S5w2k
Feeling the Pulse of Clinical Research Nursing: Impact and Value Through Caring, Communication and Compliance
©2014Kelly Willenberg, LLC 52
Questions?
©2014 Kelly Willenberg, LLC 53
Kelly Willenberg, MBA, BSN, CHRC, CHC
Kelly Willenberg, LLC
864-473-7209