Clinical Research Billing &
Compliance
September 2010
Executive Memorandum
• President Clinton signed an executive
memorandum on June 7, 2000 directing the
Secretary of Health and Human Services to
“explicitly authorize (Medicare) payment for
routine patient care costs. . .and costs due to
medical complications associated with
participation in clinical trials”.
Source: CMS Transmittal AB-00-89
2
Covered Routine Costs
• All items and services that are otherwise
generally available to Medicare beneficiaries,
including:
– Those provided absent a clinical trial (e.g.,
conventional care)
– Those required solely for the provision of the
investigational item or service (e.g., administration
of a non-covered chemotherapeutic agent)
– Those required for clinically appropriate monitoring
of effects of investigational item or service, or
prevention of complications
– Those needed for reasonable and necessary care,
for diagnosis or treatment of complications
3
What Happens When
You Don’t Get It Right?
•
•
•
•
•
•
•
•
•
•
•
•
•
Northwestern University
John Hopkins
Hospital Settlement
TJU
Univ of Louisville
Beth Israel Deaconess
Medical College of Georgia
Univ of CA at San Diego
Mayo
University of Alabama
Dr LaHaye
Yale University
Rush University
$5.5 million settlement
$2.6 million settlement
$5.4 million cardiac device settlement
$2.6 million settlement
Mandated to review 1,151 open studies
$920,000 settlement
$6.1 million settlement
$4.7 million settlement
$6.5 million
$3.4 million
$1.1 million settlement
194,000
More than $ 1 million
* Exclusion from government contracting, subcontracting or involvement in procurement
programs can also be imposed
4
Clinical Research Improvements
•
Instituted steeper clinical discounts for professional and hospital fees for clinical
research
•
Reduced turnaround time on new applications to IRBMED and redesigned
internal processes, enabling more timely launch of studies
•
Launched clinical research pricing tool to assist study teams in preparing study
budgets
•
Offered training workshops for faculty on the nuts and bolts of billing calendars
•
Improved access to clinical research support services by moving MICHR,
IRBMED, CRAO and CCC Clinical Trials Office to NCRC
•
Implemented lean initiative to remove bottlenecks and increase efficiency of
billing calendar workflow
•
Partnered with Hospital to fund mechanism for payment for subject injury when
not covered by sponsor (includes NIH)
•
Established CRAO as a module within eResearch
•
Concluded strategic assessment of clinical research enterprise. Plans now
underway:
o Virtual home for study coordinators to enhance their knowledge, ability, and impact
o Clinical Research Support Unit to establish best practices, tools, and resources
o Demonstration project with DRDA to reduce the contract and regulatory approval
processes timelines
•
Signed contract with eThority to provide robust clinical trials software
application
5
Clinical Research Improvement
Patient Complaints 2007-2010
250
200
Count of Patients
Calendar Year Quarter # of Complaints
2007
Q1
51
Q2
66
Q3
168
Q4
199
2007 Total
484
2008
Q1
171
Q2
97
Q3
67
Q4
80
2008 Total
415
2009
Q1
28
Q2
55
Q3
40
Q4
15
2009 Total
138
2010
Q1
12
Q2
18
Q3
3
2010 Total
33
Total
Complaints
1070
Patient Complaints
2007-2010
150
Q1
Q2
Q3
100
Q4
50
0
2007
2008
2009
2010
Note: data prior to 2007 was not being tracked with any regularity.
How do we get there?
What is eThority?
• Clinical trials software application for budgeting, billing
calendar, enrollment, reporting, and analysis for all
clinical trials activity
• Easy-to-use, Citrix-based software for large,
experienced investigative teams; individual junior
investigators; and everyone in between
• Vendor with successful track record of software
implementations at UMHS
8
Why?
•
Enable researchers to create more timely and accurate
budgets, improving negotiation with sponsors
•
Develop standard and consistent work to enable faster review
and reduce administrative burden
•
Ensure appropriate billing for items and services, enhancing
compliance
•
Provide researchers with single application in which to build
budgets and billing calendars
– Provide direct access to CPT and CDM codes and discounted
pricing
– Enable study budget and billing calendar to be automatically
populated
•
Enable researchers to look at financial feasibility of protocol
and understand changes required to improve financial
performance
•
Provide improved reporting capabilities for better ongoing
management of activity
9
When?
Evaluated vendors
Summer and Fall 2009
Signed contract with eThority
Jan 2010
Work with vendor to customize software to meet
UMHS needs
Spring and Summer 2010
Launch communication program for investigative teams
re: new application
Summer 2010
Redesign internal workflow/processes as necessary,
e.g., make decisions about interface/integration with
existing systems, continuing use of other systems, etc.
Summer 2010
Launch pilots: Neurology, Radiology, Orthopaedic
Surgery, Internal Medicine/Pulmonary (with assistance
from eThority)
Oct 2010
Communication and training across UMHS re: new
application launch
Fall 2010 and on going
Launch application across UMHS
Jan 2011
10
How?
•
Executive Sponsors: D Spahlinger, S Kunkel
•
Project Leads: S Silver, T Grieb
•
Steering Committee: S Silver, T Grieb, J Bell, M Ceo, B
Davies, D Gipson, G Hiller, B Johnson, A Lok, T Marks, A
Milliman, T Shanely, G Vuocolo-Branch
•
Development & Implementation: Members from MSA/FGP,
CRAO, ProFee Billing, Internal Medicine, MSIS, MICHR,
eThority
•
Several sub-teams focused on Clinical Systems,
Calendar/Budget Design & Subject Enrollment,
Education/Training, IT Implementation, CRB Database,
Charge Master & Bundling, and Communications
11
Future State
• Uniform budget/billing calendar development with
single entry
• User-obvious design with built-in wizards
• Searchable pricing with smart charge master
• Subject enrollment and reporting
• Enhanced financial analysis and reporting capabilities
• Improved billing compliance and reduced subject
complaints
12
Thank you for your advice
and guidance!
Shari Barnett
Rick Bluhm
Kerri Briesmiester
David Browning
John Burnett
Maria Ceo
Karis Crawford
Sarah Faix
Mary Greer
Jaimee Gauthier
Steve Gendler
Debbie Gipson
David Golden
Teri Grieb
Cathy Handyside
Jan Hewett
Diane Hilfinger
Mary Hill
Glen Hiller
Mei-Lan Huang
Rebecca Hughes
Mat Innes
Benjie Johnson
Andree Joyaux
Melissa Karjala
Jack Kufahl
Sarah Kyle
Kim Leppert
Anna Lok
Jill Malayang
Tom Marks
Jim Maszatics
Brett Miller
Amy Milliman
Samya Nasr
Sandy O’Holleran
Carolyn Pappas
Paulina Radenbaugh
Judy Rotthoff
Marifelice Roulo
Tom Shanley
Nan-Sheng Sheng
Jane Sierra
Sam Silver
Monica Stiddom
Karen Strode
Gina Vuocolo-Branch
Mariella Wells
Peg White
Sandy Wilcock
13
APPENDIX
14
CRAO Ancillary Committee
Useful Tips
• 5 core documents required at time of IRB
application submission
–
–
–
–
–
Billing Calendar
Informed Consent
Protocol
Budget (internal/external) when applicable
Contract when applicable
Note: Draft versions accepted and satisfactory
for CRAO review
15
CRAO Ancillary Committee
Useful Tips (cont’d)
• All applicable documents are reviewed for
harmony
– Revisions are made to BC and inconsistencies are
shared with study team
• Budgets assist the CRAO review with the
assignment of routine care vs. study
– Assist in determining study is exempt from CRAO
review and no BC is needed
• If your study does not have a budget and/or
contract, note in correspondence within
eRRM , e.g., internally funded and/or NIH
16
Compliance Challenges
• Recovery Audit Contractor (RAC) Program
– Authorized by Congress to identify improper Medicare
payments (overpayments and underpayments)
• Office of Inspector General (OIG)
– OIG duties carried out through nationwide network of
audits, investigations, inspections and other missionrelated functions performed by OIG components
– OIG has an annual work plan and targets specific
issues, etc.
17
Compliance Risks
• CMS-False Claim Act (highlights)
(a) Any person who…
(1) knowingly presents, or causes to be presented, to an officer
or employee of the United States Government or a member of
the Armed Forces of the United States a false or fraudulent
claim for payment or approval;
(2) knowingly makes, uses, or causes to be made or used, a
false record or statement to get a false or fraudulent claim paid
or approved by the Government;
(3) conspires to defraud the Government by getting a false or
fraudulent claim paid or approved by the Government
is liable to the United States Government for a civil penalty of
not less than $5,000 and not more than $10,000, plus 3 times
the amount of damages which the Government sustains
because of the act of that person . . . .
http://www.cms.gov/transmittals/downloads/R1723CP.pdf
18
Compliance Wake Up Call
• Rush University Settlement
– Allegations
•
Improperly billed Medicare for physician and hospital
research services as routine care costs under NCD
•
Absence of “synchronization of the Medicare rules, the
compensation arrangements with the sponsors, and
the financial discussion in the informed consent”
– Voluntary self-disclosure to DOJ
•
•
•
Refund Medicare overpayments plus 50% penalty ($1
million)
3-year Certification of Compliance Agreement (CCA)
Require clinical trials to receive a coverage analysis
19
2010 FGP Compliance Work Plan
2010 FGP Compliance Workplan - WORK IN PROGRESS
Department/Compliance Area:
No. Regulatory Body: Category: Category
Billing,
1
OIG
Complaint Clinical
Research
2
Professional Billing
Item
Notes/Detail/Follow-up required
Accurate billing of professional services
Research Billing (CMS)
to the appropriate accounts. Process
issue.
RAC assigned for Michigan. Efforts to
Documentation
Recovery Audit Contractors (RACs/CMS) respond to requests coordinated with
Coding
UMHS RAC work group.
Risk Risk
UMHS Responsi Individual Risk Probabili Assessm
Division ble Party Lead Impact ty
ent
All Clin
Depts
CRB
Team
Strickland
Johnson
4
4
16
RAC
All Clin
Strickland
Workgrou
Depts
Koopmann
p
4
4
16
RISK KEY
Risk Impact
Critical
Risk Probability
4
Very High
Very High Risk
Risk Assessment
4
Priority 1
12-16
20
Routine Costs Do NOT Include
• Investigational item or service itself
• Items & Services:
– For which there is no Medicare benefit category or are
statutorily excluded
– Furnished solely to satisfy data collection and analysis
not used in clinical management
– Customarily provided by research sponsor
– Provided solely to determine eligibility
21
Clinical Research Billing
• Accurate billing of I/S for participants in
clinical trials
– Standard of Care I/S billed to 3rd party payers
– Research I/S billed to trial sponsors
• Billing Calendar (BC) also used to allocate
appropriate modifier (Q0,Q1) to subject’s
medical claim to reflect and investigational
device or routine care services provided
during approved clinical trial
22
Billing for Routine Clinical
Research
• Q0 – For investigational item or service
provided during or as part of an approved
clinical research study
• Q1 – For routine item or service provided
during or as part of an approved clinical
research study
Pub. 100-04, Transmitttal:1418, January 18, 2008, Change
Request:5805 Effective Date January 1, 2008.
23