Overview
September 2014
Budget
&
Contract
ICF
Coverage
Analysis
Protocol
UB’s
Sponsors
Invoicing
Physician
office
Payer
Issues
© 2014 Kelly Willenberg, LLC
Investigator(s)
Research
Admin
CRO
Sponsor
FDA
Institution
PFS
Pharmacy
Payer
Patient
HIM
Ancillary
Registration
IRB/EC
© 2014 Kelly Willenberg, LLC
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FCA Violations
2
Double Dipping
3
Inducement
4
Kickback
Payments from sponsors and from 3rd party payers for same item/service
Investigator incentives may entice stacking of patients in studies
Residual research account balances
© 2014 Kelly Willenberg, LLC
Hospitals
Physicians/Investigators
Are conducting Clinical Trials Research financial compliance
independent of Hospitals
programs may not be
operationally effective and/or
efficient
Reasons:
Causes:
• Independence
External Parties
Are approaching the
investigator directly
• Lack confidence in Hospital’s ability
• Control of grants/study funds
• Circumvent hospital bureaucracy
• Decrease paperwork
conducting Clinical Trials
independent of Hospitals
• The PI knows sooner
• Immediate results
• Decrease paperwork
• Decrease costs
• Maintain control
• Reduce accountability and scrutiny
• Circumvent the hospital
approaching the investigator directly
• Ownership & Accountability
• Policies and Procedures
• Centralization
• Resources
• Physicians trust lacking
• Management of grant/study funds
research billing compliance Programs may
not be operationally effective and/or
efficient
Goals:
© 2014 Kelly Willenberg, LLC

Investigators will use the IRB submission as
the protocol
◦ Calendar of events “loose” which makes budgeting
a challenge, coverage analysis impossible
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Assume that everything in the protocol is
conventional care or “standard of care” and
therefore billable
Confusion about drug supplies
◦ In IIT trials the drugs are sometimes not billable
and reimbursable

Collaborating with team to decide on budget
© 2014 Kelly Willenberg, LLC
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Read the protocol and review the proposed
budget sent by the sponsor
Determine if the trial is qualified under
Medicare guidelines
Decide what are considered patient services
that are standard of care and what are
research patients services
Do a Coverage Analysis
September 2014
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Perform Qualifying Clinical Trial (QCT)
Analysis
Develop grid to match schedule of events
Identify items or services “hard-wired” free
into protocol
Determine items and services that are routine
costs
Determine if routine costs are covered by
Medicare
© 2014 Kelly Willenberg, LLC
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Check proposed contract to determine if
offered budget covers items and services that
are not billable
Negotiate contract/budget against the
Coverage Analysis
Finalize necessary sections of informed
consent
Finalize and lock grid once study approved to
be used as translation tool for billing and
reimbursement.
© 2014 Kelly Willenberg, LLC
© 2014 Kelly Willenberg, LLC
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Clinical Trials Policy – CMS Policy (July 2007) that provides guidance
regarding Medicare beneficiaries participating in Clinical Trials and routine
costs
http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html
Routine Costs: items and services that are provided to the patient
even if s/he was NOT in a clinical trial, conventional care
Routine Costs are defined, specified and documented in the
Trial documents prior to the beginning of the Trial: a
thorough coverage analysis
September 2014
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A Coverage Analysis will determine whether
any procedures may be billed to Medicare
(and by extension to other insurance
companies)
This presentation does not cover MCA’s but
demonstrates why doing an MCA important
when completing a budget
This is the first step to doing a proper budget
© 2014 Kelly Willenberg, LLC

Is the study “qualifying” under the guidelines?
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What are the “routine” costs?
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Which of the above are covered by Medicare?

How is the costs worded in the contract and
consent?
© 2014 Kelly Willenberg, LLC
• 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
©Kelly Willenberg, LLC 2014
14
• 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
©Kelly Willenberg, LLC 2014
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© 2013 Kelly Willenberg, LLC

The 8-digit clinical trial number must be reported
on all claims (Medicare beneficiaries, Traditional
and Managed Care) associated with clinical trial
participation
•
•
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Effective Date: Services on/after January 1, 2014
•
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National Clinical Trial (NCT) number NCT12345678
Also known as the Clinicaltrials.gov Identifier
Voluntarily reported since January 2008
Claim types: Both hospital/technical and
professional
September 2014
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CMS will use this number to identify all items and
services provided to Medicare beneficiaries
(Traditional and Managed Care) during their
participation in a Medicare qualifying clinical trial,
study, or registry
Permits CMS to:
•
•
•
September 2014
Better track payments
Ensure that the information gained from the research
is used to inform coverage decisions
Make certain that the research focuses on issues of
importance to the Medicare population
http://ClinicalTrials.gov
website
NCT Number
September 2014

ICD-9-CM Diagnosis Code V70.7 (Examination of a
participant in a clinical trial); ICD-10 coming 2015

Revenue Code 0624 for FDA Investigational Devices, as
applicable
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Condition Code 30
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Q0 and Q1 modifiers, as applicable (outpatient claims

NCT number

Report in UB-04 Form Locators 39-41
only)
September 2014

ICD-9-CM Diagnosis Code V70.7 (Examination of
a participant in a clinical trial); ICD-10 coming in
2015

Revenue Code 0624 for FDA Investigational
Devices, as applicable

Q0 and Q1 modifiers, as applicable (outpatient

NCT number

Report in CMS-1500 Field 19
claims only)
September 2014
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•
If some, but not all of the required elements (NCT #, ICD-9
code, modifiers, revenue codes, condition codes) are
reported, the claim will be stopped and returned to the
provider (RTP)
Possible RTP statements:
•
•
•
September 2014
“Claim lacks information which is needed for adjudication
…..”
“Missing/incomplete/invalid Investigational Device
Exemption number for FDA-approved clinical trial services”
“Your claim contains incomplete and/or invalid information,
and no appeal rights are afforded because the claim is
unprocessable ….”
Kelly Willenberg, MBA, BSN, CHRC, CHC
kelly@kellywillenberg.com
www.kellywillenberg.com
864-473-7209
© 2014 Kelly Willenberg, LLC