Transcript Clinical Trials Billing - Clinical Trial Nurses SIG

Clinical Trials: Cost
Coverage and Implications
for the Clinical Trials Nurse
Objectives
• Discuss the costs and health care plan
coverage issues associated with clinical trial
participation.
• Identify the key components of the Medicare
2000 National Coverage Decision.
• Properly identify standard of care costs from
research costs per regulations and link it to the
budgeting, negotiation and payment process.
• Describe systems for accurate research billing
and common pitfalls
The Ties that Bind
• Clinical Research is important to cancer treatment
– Improved cancer care with new therapies
– Defined standards for optimal cancer treatment
– Provides options when there are no known treatments for a
disease
– Provides a potentially more effective and less toxic treatment
(American Society of Clinical Oncology, 2003; Association of Academic Health Centers, 2009)
Understanding the landscape
• Complex infrastructure
• Little noted and rarely studied
• Rapidly changing environment in recent years as a
result of
– Increased research activity
– Mounting regulatory requirements
– Escalating costs
(American Society of Clinical Oncology, 2003; Association of Academic Health Centers, 2009)
Costs & Coverage
• Cancer patients who enroll in clinical trials may face
the critical issue of how to cover the costs of care
• Health insurance coverage may not include some or all
of the costs associated with participation in a clinical
trial
• Some plans may define clinical trials as
“experimental” or “investigational”
(Association of Academic Health Centers, 2009; National Cancer Institute, U.S. National Institutes of Health, 2009)
What is the Legislation?
• Federal
– National Coverage Decision on Clinical Research (Clinical
Research Policy)
• Billing for Clinical Services in a Clinical Trial
• Notification to Subjects regarding Costs
• Local
– Local Medicare Review Policies (LMRP’s)
(CMS Medicare National Coverage Determinations Manual, 2009)
The Era of Managed Care
• Managed Care Organizations and Health Insurance
companies determine the services they will pay for by
developing a coverage policy that is applied to all
members
– Established Service
– Investigational Service
(Emanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003, National Cancer
Institute, U.S. National Institutes of Health, 2009)
Established Versus Investigational
•
Established:
–
A service is
designated
“established” if
there is sufficient
scientific data to
support that it is
safe and effective.
• Investigational:
– A service for which
the health plan
declares insufficient
scientific data to
support safety and
efficacy.
– Leads to payment
denial
– Lengthy and often
unsuccessful appeal
process
(Emanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003, National Cancer
Institute, U.S. National Institutes of Health, 2009)
Clinical Trial Criteria for Coverage
•
Sponsorship
–
Some plans may cover costs of trials sponsored by
organizations that provide rigorous scientific review and
regulatory oversight such as the NCI, according to
standards set by the health plan.
(National Cancer Institute, U.S. National Institutes of Health, 2009)
Clinical Trial Criteria for Coverage
•
Trial phase and type
–
Some plans may cover patient care costs only for
the clinical trials they judge to be "medically
necessary" on a case-by-case basis. The phase of
the trial may also affect coverage; for example,
while a plan may be willing to cover costs
associated with phase III, which include
treatments that have already been successful with
a certain number of people, the plan may require
some documentation of effectiveness before
covering a phase I or phase II trial.
(National Cancer Institute, U.S. National Institutes of Health, 2009)
Clinical Trial Criteria for Coverage
•
Cost "neutrality“
–
Some health plans may provide limited coverage for trials
they consider cost-neutral (i.e., not significantly more
expensive than the treatments considered standard).
(National Cancer Institute, U.S. National Institutes of Health, 2009)
Clinical Trials Billing
Rose Ermete RN, BSN, OCN, CCRP
Oncology Research Nurse
St. Mary Mercy Hospital
Clinical Trials Billing Overview
• The Importance of Compliance
• Billing Rules
• Systems to ensure appropriate billing
Note: Image courtesy of CartoonStock.com. Used with permission.
Why is this Important
• Data Mining by CMS
– Evaluation of all Claims with Modifiers
– Assessment across the institution
• The Cost of Non-Compliance
–
–
–
–
–
Criminal & Civil Penalties
Ability to conduct Federally Funded Research
Exclusions from Medicare/Medicaid
Adverse Public Relations
Qui Tam: Whistle blowers
(Meade , 2009; Pitler & Bloom 2006; Barnes & Korn 2005)
False Claims Settlements
• Compliance Rules = Fraud Rules
• The False Claims Act :Civil Penalties for persons who
knowingly make or cause to be made, false claims to
the government.
–
–
–
–
Services paid for by sponsor
Services promised for free in the Informed Consent
Services that are for research purposes only
Services that are part of a non-qualifying clinical Trial
• Fraudulent Claims :
– Liable to the US Government for civil penalty of not less than
$5,000 and not more than $10,000 plus 3 X the amount of
damages.
( Beach & Strehlow, 2006; Meade, 2006; FCA, 2007)
Partial List of OIG/DOJ Investigations
 Rush University
 New Jersey Medical
 Johns Hopkins
 Beth Israel Deaconess
 University of Alabama
 Cornell University
 UCSD
 Northwestern University
 Medical College of Georgia
 Mayo Clinic
 Yale University
1.0 million settlement
2.0 million settlement
2.6 million settlement
3.2 million settlement
3.4 million settlement
4.3 million settlement
4.7 million settlement
5.5 million settlement
6.1 million settlement
6.5 million settlement
7.6 million settlement
(Based on information from: Schwab, 2009 & TAF, 2008)
Lessons from Rush
• Inspection Findings:
– Billed third parties for sponsor paid services
– Billed for services promised for free in the informed consent
– Billed for services that did not meet the definition of routine
costs
• Coordination & Communication
– No Centralization of billing process
– Lack of Coordination between research and billing
department
• The settlement indicates what the government is
looking for from providers who conduct clinical trials.
– Centralization & documentation
– Oversight throughout institution
– Monthly account/reconciliation
(Schwab, 2009; Boyd & Meade, 2007; Pfadenhauer, 2006)
Note: Image courtesy of CartoonStock.com. Used with permission
Billing Rules
• Basic Rules:
– No double dipping
– If the service if provided free, you cannot bill for it
(Secondary-payer rule)
– Must be an already covered service
• The National Coverage Decision (NCD)
– Covers routine costs of qualifying clinical trials
– Coverage discretion is up to local Medicare contractors
• Medicaid is different – does not address research
•
Insurance Companies: 29 states require commercial
insurance cover clinical trials.
(Barnes & Korn, 2005 ;CMS Medicare National Coverage Determinations Manual, 2009; Meade 2006)
States Requiring Health Plans to Cover Patient
Care Costs in Clinical Trials
(National Cancer Institute, 2009)
The Patient Protection &
Affordable Care Act of 2010
• Signed into law March 23, 2010; Public Law No: 111-148
• In General – If a group health plan or a health insurance
issuer offering group or individual health insurance
coverage provides coverage to a qualified individual, then
such plan or issuer:
– May not deny the individual participation in a clinical trial referred
to in subsection (b)(2)
– Subject to subsection (c), may not deny (or limit or impose additional
conditions on) the coverage of routine patient costs for items and
services furnished in connection with participation in the trial; and
– May not discriminate against the individual on the basis of the
individual’s participation in such trial.
• Limitations – subsection (c)
HR 3590 Sec.10103 & 2709 retrieved from: http://frwebgate.access.gpo.gov
Pending Legislation
• Improving Access to Clinical Trials Act
(S.1674)
• Introduced by Senator Ron Wyden (D-Oregon),
• Exempt the first $2,000 a year in compensation
for clinical trial participation from determining
Social Security Insurance or Medicaid benefits
• Currently pending before the Senate Finance
Committee
Note: Image courtesy of CartoonStock.com. Used with permission.
What is a Qualifying Trial?
• Three Requirements
– The subject or purpose of the trial must be the evaluation of an item
or service that falls within a Medicare benefit category and is not
statutorily excluded from coverage
– The trial must not be designed exclusively to test toxicity or disease
pathophysiology. It must have therapeutic intent
– Trials of therapeutic interventions must enroll patients with
diagnosed disease rather than healthy volunteers
• Deemed Studies
– Trials funded by NIH, CDC, AHRQ, CMS, DOD and VA
– Supported by centers or cooperative groups that are funded by the
above
– Conducted under an IND reviewed by the FDA
– IND exempt studies
(Pitler & Bonomi, 2006; CMS National Coverage Determination Manual, 2009; Barnes & Korn, 2005)
What is a Qualifying Trial?
• Seven Desirable Characteristics
– Principal purpose has to test if the intervention potentially improves
the subjects health outcomes
– Well-supported by available scientific and medical information or
intended to clarify or establish the health outcomes of interventions
already in common clinical use
– Does not unjustifiably duplicate existing studies
– Design is appropriate to answer the research question being asked
– Sponsored by a credible organization or individual capable of
executing the proposed trial successfully
– Compliance with Federal regulations relating to the protection of
human subjects
– Conducted according to the appropriate standards of scientific
integrity
• Deemed Clinical Trials are deemed by CMS as inherently
having these characteristics
(Boyd & Meade, 2007; CMS Medicare National Coverage Determinations Manual, 2009; Lanter, 2008)
Coverage under the NCD (CTP)
• What is Covered
– Items and services provided absent of a clinical trial
– Required solely for the provision of the investigational item
– Reasonable and necessary care for the diagnosis or treatment
of an illness or injury
• What is not Covered
– Data Collection and analysis
– Items and services customarily provided by the research
sponsors free of charge
– Items and services provided solely to determine trial eligibility
– The investigational item or service itself, unless otherwise
covered outside the clinical trial
– A Medicare benefit category does not exist for the service
(Barnes & Korn, 2005; CMS National Coverage Determination Manual, 2009)
Routine vs. Standard of Care
• Routine Care:
– Services that would take place as a result of a regular course
of treatment for cancer care, However:
– Consistency doesn’t always exist, just because it is routine in
one practice, does not mean it will be covered.
– National Therapeutic Standards
• NCCN Guidelines
• ACOS Guidelines
• Peer Reviewed Journal
– Not all routine care is covered
• Routine Costs also include:
– Reasonable & necessary to diagnose or treat
– Services required for the clinically appropriate monitoring or
diagnosis of the effects of the item or service, or prevention of
complications.
(Barnes & Korn, 2005, Meade, 2009; MLN Matters MM6431, 2009; Pitler & Ponomi, 2006; Seiner &
Murtha, 2006; Turgon & Welter, 2008)
Gratuitous services
• Items provided gratuitously without regard to
beneficiaries ability to pay
• Anti- Kickback Statute 42 U.S.C. § 1320a-7b
– Provides for penalties against anyone who knowingly and
willfully receives, gives, solicits or offer any payment or other
form of remuneration with the intent to induce or influence the
purchase, order, or referral of drugs, devices, products, services
or other items reimbursable under a federal health care program
– Penalties for violations of the statue include a fine of not more
than $25,000 or imprisonment for up to five years, or both.
(AKS, 2007; CMS Medicare Benefit Policy Manual, 2009; MLN Matters SE0822., 2009)
Coding Rules
• Secondary diagnosis code: V70.7
– Examination of participant in a clinical trial
– Used for inpatient & outpatient
• Healthcare Common Procedure Coding System
(HCPCS) modifier:
– Q0: Investigational clinical services defined as those items
and services that are being investigated as an objective within
the study.
– Q1: Constitute medically necessary routine patient care or
treatment of complications arising from a Medicare
beneficiary's participation in a Medicare-covered clinical
trial.
– HCPCS modifiers are only used in the outpatient setting
• 8 Digit clinical trial number is optional
– Inpatient or outpatient
(CMS Medicare Claims Processing Manual, 2009; Creighton University, Use of the Q0 & Q1 Modifiers)
Strategies for Compliance
• Challenges
–
–
–
–
Billing systems
Decentralization
Identifying the research patient
Budgets
• Part of Institutional Compliance Program
– Communication and Coordination are essential!
– Identify Team members: everyone needs to know their role
• Centralization
– Institution wide process
– Research Billing Effects all phases of a research project
– Centralized around the institution’s core values of integrity,
accountability and quality
– DOCUMENTATION
(Lester, 2009;Nelson, 2009; Pfadenhauer, 2006; Steiner & Murtha, 2006)
Developing a Process
• Mapping the Process – Flowchart
– Step by step process
– Who pays for what, and how are charges routed to the
appropriate payer
– Patient identification
– Specify payment procedures
• Coverage Analysis
– A systematic review of study related documents to determine
which items are billable to Medicare (Billing Plan)
– Standardized throughout institution, all team members should
have access to.
(Barnes & Korns, 2005; Kulko, 2009; Nelson, 2009; Pitler & Bonomi, 2006; Steiner & Murtha, 2006)
Coverage Analysis con’t
• Maintain a current list of hospital charges for frequent
tests and procedures
• Identify sources of funding for each item/service
•
•
•
•
Protocol
Contract
Informed Consent
Budget
• Identify costs not covered
• Non-routine costs
• Costs with no Medicare benefit category
• Data Management costs
Hypothetical MCA: Manage the Information
Code
Physical
Exam
9920199215
EKG
93000
Drug 123
Infusion 1
Infusion 2
2 weeks
M
M
M
M
M
J0123
S
S
Infusion
96400
M
M
Urinalysis
81000
Ultrasound
93990
Patient Diary
N/A
NB
12 weeks
24 weeks
M
M
NB
NB
Comment
NB
ICF
NB
NB
M=Medicare
S=Sponsor
ICF=Free in Informed Consent
NB=Not billable to Medicare
Note: Figure courtesy of Meade, 2009. Used with Permission.
34
Billing Grid Example
Clinical Trial Internal Budget Template EXAMPLE of Payer Determinations
Study Calendar
Visit Days
Screen -1
0
1
2
3
10
28
90
120 180
x
Consent
x
Inc/Exc
x
x
Md Hx
x
x
x
x
x
x
x
x
x
x
x
Vital signs
x
x
x
x
x
x
x
x
x
x
x
PE
x
x
x
x
x
x
x
x
x
x
x
AE
x
x
x
x
x
x
x
x
x
x
x
Heme §
x
x
x
x
x
Coag ¶
x
x
x
x
x
x
x
x
x
x
x
Chem *
x
x
x
x
x
x
x
x
UA
EKG
x
x
CXR
xx
x
Angio
x
Med Disp.
x
x
x
x
Research Related or Paid for by the Sponsor
Standard of Care
Note: Figure courtesy of Lanter, 2008. Used with permission
270
365
x
x
x
x
x
x
x
x
x
x
x
x
x
Protocol Budget Calendar
Contract No: 10000
Protocol Target Accrual: 10
Protocol No: XYZ
Department: Research
PI: Investigator, Principal
Accrual to Date:
Sponsor: Pharma
Status: Feasibility Assessment
Study Title: SAMPLE: Phase II, Double-Blind, Placebo-Controlled, Randomized, Multicenter Efficacy trial of XXX in participants with acute decompensated ischemic congenstive heart failure.
A. PER PARTICIPANT / PER ARM COSTS
Schedule of Events
Standard of Care (SOC)
Vs. Research (R)
ITEMS & SERVICES
Informed Consent
Inclusion/Exclusion
Chart Review
Medical History
Physicial Exam*
Vital Signs
Concominant Meds
A/E Reporting
Clinic Visit
Pharmacy Fees
Chest X-Ray
EKG
Cardiac Angiogram
Drug Accountability Logs
CK-MB
EKG Professional Read
Study Coordinator Time
PI Time*
Dry Ice
Participant Stipends
Participant Travel/Parking
Central Lab Processing Time
Sub-Total Per Participant Costs
Plus F&A Overhead Rate
TOTAL PER PARTICIPANT COSTS
Visit 1/ Day 0 = Hosp
IP
R
R
R
R
SOC
SOC
R
R
R
R
SOC & R
SOC & R
R
R
SOC & R
R
SOC & R
SOC & R
SOC & R
R
SOC & R
SOC & R
R
R
R
R
R
R
R
SOC
SOC
SOC
R
SOC
SOC
R
R
R
$0.00
$0.00
$0.00
Visit 2/ Day 1
SOC
R
R
R
SOC
R
R
R
R
R
R
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Note: Figure courtesy of Lanter, 2008. Used with permission
Visit 3 / Mth 1
Visit 4 / Mth 3
R
R
R
R
R
R
SOC
SOC
R
R
SOC
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Visit 5 / Mth 6
SOC
SOC
R
R
SOC
R
SOC
R
Visit 6 / Yr 1 = Final
Visit
R
R
SOC
R
R
R
R
R
R
SOC
SOC
R
R
SOC
R
SOC
SOC
R
R
R
SOC
R
R
R
R
R
R
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Row Totals
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Charge Identification Models
• Front-end Process
– Identifies patient upfront
– Study specific order forms / charts
– Coverage Analysis in chart with central repository
• Back-end Process
– Review charges after service rendered
– Hold on patient’s account for review against coverage
analysis
– Designated reviewers
(Boyd & Meade, 2007; Kulko, 2009; Nelson, 2009)
Evaluation
• Audit Mechanisms
• Include a sample of active and past years accounts and
protocols
• Compare accrual information and protocol documents
to funds billed and received.
• Review invoice details to confirm that services were
not billed to Medicare or other third party payers in
error
• Document findings, and implement procedures to
correct problems
• Self- Report errors
(Meade, 2006; Turgon & Welter, 2008)
Clinical Trial Budgeting
& Negotiations
Denise Friesema, MS, RN, OCN
Director, Clinical Research Operations
University of Chicago Medical Center
Types of Trials & Sponsorship
• Types
–
–
–
–
Drug Studies
Device Studies
Registry Studies
Observational
Studies
• Sponsorship
– Cooperative
Agreements (eg
CALGB, SWOG,
GOG, RTOG)
– Industry Sponsored
– Investigator Initiated
– Federal Grants &
Subcontracts
Three Main Types of Support Provided by a
Sponsor
• $$$
• Drug
• Device
Support = Contract
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
What is a Clinical Trial Agreement?
“The Contract”
• A legally binding formal agreement between
the “Sponsor” and the “Institution”
• Sponsor may provide
– Study drug or device
– Financial Support
– Proprietary Information
• Institution may provide
– Data
– Publication/Input into Publication
– Intellectual Property
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
Why do we need a contract?
• Define the scope of work
– Parties, performance period, Responsibilities
• Protect rights of all parties
– Publication, Patents/Inventions/Intellectual Property
• Secure Confidential Information
– HIPAA, Confidentiality
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
Why do we need a Contract?
• Payment for work completed
– Budget/Staff support
• Compliance
– Indemnification, Best efforts/Protocol compliance
• Preparation for the Unexpected
– Subject Injury, Termination
Bottom Line = Reconcile Institutional policies with
the needs of the Sponsor
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
Sections of the Agreement
• Acknowledgments &
Responsibility
• Terms &
Termination Clause
• Payment/
Reimbursement of
Costs
• HIPAA
• Publication
• Intellectual Property
• Confidentiality/
Proprietary
Information
• Indemnification
• Insurance
• Subject Injury
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
Clinical Trial Budget Basics
Important Questions
– Are the scientific value
and ethical quality of the
study acceptable?
– Do I have an adequate
pool of potential
subjects?
– Does the proposed
budget support the work
described in the
protocol?
If the answer to any of these
questions is no, decline
the trial.
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
Clinical Trial Budget Basics
• Important to remember: the budget should
reflect the proposed work in the protocol not
the sponsor’s proposed budget
• Review the schedule of visits in the protocol
and begin drafting a budget (note: perform this
step regardless of whether or not you have
received the sponsor’s budget)
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
4 Components of a Budget
1) Study Initiation / Start
Up Fees
a) IRB
b) CCTO
c) Pharmacy
d) CRC
e) Other…
2) Clinical Care Expenses
Items deemed research
related on the schema
by PI
3) Study Implementation &
Oversight Expenses
a) Staff time
b) Supplies
c) Parking stickers
d) Other….
4) Indirect Costs
25% Non-Federally
Funded
53.5% Federally Funded
Identify the Costs
• Administrative Costs
• Patient Care Costs
• Trial Costs
Administrative Costs
• Clinical Trial Office
Fees
– Additional regulatory
submissions
(amendments, SAEs)
• Institutional Fees
– IRB
– Pharmacy Fees
– Indirects
• Non-refundable!
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson,
J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)
Direct versus Indirect
• Direct costs
– Expenses directly related to the trial
• Personnel
• Supplies & Equipment
• Laboratory Costs
• Indirect costs
– Costs incurred not directly related to the trial
– Referred to as institutional overhead
•
•
•
•
Building maintenance
Departmental administration
Basic utilities
Rent for office/laboratory space
– Vary from institution to institution
• Average is about 20-40%
(
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher
Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)
Patient Care Costs
• Procedures by Coordinator,
PI, and Hospital Costs/Fees
• Example: lab draw
- Coordinator collects sample
- Hospital analyzes sample
- PI interprets analysis
- Core or Central Labs
• Hospital Procedures-know
the contact for prices;
research rates, if any; costs
to the research, i.e. charge
vs. cost
• Profee costs
• Assign costs to the ENTIRE
procedure
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Trial Costs
• Screening Logs
• Screen Failures
• Electronic Data
Management Training
• Recruitment
• Storage
• Other study visits
• Monitor visits
• Study initiation (allinclusive)
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Trial Costs: Investigator
• Protocol
Development
• Site Initiation Visit
• Protocol amendment
management
• External safety
reports
• Monitor site visits
• Conference Calls
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Trial Costs: The Coordinator
• Regulatory
• Files-electronic and
hard copy binders
• Communication-phone,
fax, email
• Case Report Form-data
entry and maintenance
• Scheduling-subject visits
and procedures
• Sponsor queries
• Tracking
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Staff Labor & Training
• Hardest portion of budget to estimate
• Potentially greatest source of error
• Considerations:
–
–
–
–
Complexity of studies
Data Monitoring
Reporting of Unexpected Problems
Patient Follow-up
(Johnson, G.P., 2003; O’Brien, J.A., 2007)
Staffing
• Published literature is lean
• No guidance on what maximum workload is in
terms of coordinator to subject or coordinator
to protocol ratios
• Questions to Ponder
–
–
–
–
What number of staff do you need?
When is it time to add additional staff?
How do you allocate resources fairly?
What is the maximum number of studies or subjects
that can be safety and effectively managed by one
person?
(Gwede, C.K., Johnson, D., & Trotti.A, 2000a; Johnson, G.P., 2003; O’Brien, J.A., 2007)
Staffing
• Current Methods
– Trial & Error
– Crisis Management
• Burnout
• Staff turn over
• Juggling of studies from one coordinator to the next
– Appearance
(Fowler, D.R., & Thomas, C.J., 2003; Gwede, C.K., Johnson, D.J., Roberts, C., Cantor, A.B., 2005;
Gwede, C.K., Johnson, D., & Trotti.A, 2000a; Johnson, G.P., 2003; O’Brien, J.A., 2007)
Staffing
• Current methods are suboptimal
• Current methods lead to plummeting morale
• Current methods lead to training and retraining which is costly and time-consuming
• Current methods result in regulatory noncompliance & poor quality work
• Current methods are inequitable measures
(Fowler, D.R., & Thomas, C.J., 2003; Gwede, C.K., Johnson, D.J., Roberts, C., Cantor, A.B., 2005;
Gwede, C.K., Johnson, D., & Trotti.A, 2000a; Johnson, G.P., 2003; O’Brien, J.A., 2007)
Staffing
• Use a quantitative approach
• A business approach is needed based on
information and a decision making process
• Use activity based costing (the bean counters
way)
– Estimate costs
– Allocate the FULL cost of the project (direct labor,
material, fixed and variable overhead)
– Allocate staff on the basis of how the product
actually consumes or causes activities
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Studies on Workload Management
• Literature is sparse
• Utilization of accrual data (numbers)
• Acuity or Points scale/system
• Time and Task
• Variables
Utilization of Accrual Data
• Simply the numbers
– How many studies
– How many accruals
– How many staff
• Does not account for
– Time required for tasks
– Screen failures
– Drop outs
(Gwede, C.K., Johnson, D.J., Roberts, C., Cantor, A.B., 2005; Gwede, C.K., Johnson, D., & Trotti.A,
2000a)
Publicized Benchmarks
• NIH/NCI
– 1 FTE manages 25
patients on study and
50 in follow up
– Not clear if this is
data management
along or also
includes nursing and
regulatory tasks
• Society of Clinical
Research Associates
(SoCRA)
– 1 FTE handling ALL
responsibilities
(regulatory, patient
care, data
management,
sponsor audits) could
effectively manage @
30 new patients per
year
Acuity, Complexity or Points?
• CCIRC Algorithm
• Fowler & Thomas
• NCI Trial Complexity Elements & Scoring Model
CCIRC Algorithm
• Cancer Clinical Investigations Review Committee,
1992
• For use in cooperative groups to determine budget
allotments
• Inappropriately adopted by sites to assess productivity
and make day to day staffing decisions
• Credits based on number of patients and phase of study
• 1 credit for each treatment accrual (including supportive care,
chemoprevention)
• .5 credit for non-treatment accrual (survey & lab)
• .25 for each follow up case (data submitted at least once a year)
– 1.0 FTE = 40-50 credits (new accruals and/or follow up)
(Gwede, C.K., Johnson, D., & Trotti, A., 2000a)
Fowler & Thomas: Acuity Scoring
• Task Time
• Procedures
• Time involved to enroll 1 subject
• Protocol Acuity Score
– Multiplied by contracted/anticipated number of subjects to
determine a score
– Coordinator workload evaluated by score and new
protocols assigned accordingly
(Fowler, D.R., & Thomas, C.J., 2003)
Time & Task
• Gwede et al
– Self reported workload study of CRC’s affiliated
with RTOG
• 265 coordinators, 107 responded
• 40.4 % response rate
– Time required to complete tasks over number of
patients
– Intensity over effort spent
– No clear recommendation on formula
– Urgent need for practical and meaningful tools
(Gwede, C.K., Johnson, D., & Trotti, A., 2000b)
Time & Task
• Devine et al
– Percentage of time spent on tasks
– Focusing on tasks rather than accruals is correct approach
– No definitive recommendation on tool
(Devine, S., Nagel, K., Benson, L., & Krailo, M., 2005)
NCIC study (Roche et al)
• Task Oriented Time Measures
• In general, NCIC study supports
that workload varies by task, phase
of study, sponsor type, and stage of
protocol
(Roche, K., Paul, N., Smuck, B., Whitehead, M., Zee, B., Pater, J., et al., 2002)
NCIC Study
• NCIC study, treatment stage of
protocol:
– Handling of special procedures (35.9
min +/- 39.6) and documentation
(35.3 min +/- 40.5) were most time
consuming tasks
– Industry studies were more labor
intensive than studies with other
sponsors (p<.0002 pair-wise)
(Roche, K., Paul, N., Smuck, B., Whitehead, M., Zee, B., Pater, J., et al., 2002)
NCIC Study
– Local studies required significantly
less time (p<.0001)
– Phase I, I/II, II studies most intensive
compared to phase III (p<.0001)
(Roche, K., Paul, N., Smuck, B., Whitehead, M., Zee, B., Pater, J., et al., 2002)
EORTC
• Berridge & Coffey
– Most recently published work…June 2008
– Time spent on activities
– Identify all main tasks and subtasks from beginning to end
Berridege, J., & Coffey, M., 2008)
NCI Complexity & Scoring
• Recommendation from the Clinical Trials Working
Group (CTWG)
• Align reimbursement with trial complexity
• Standardized list of key trial elements
– Most time consuming and complex components of the work
– Each elements has a standard, moderate and high level
• Total complexity score is utilized to compare and rate
trial complexity
http://restructuringtrials.cancer.gov/
Complexity Elements
• Number of Study Arms
• Informed Consent
Process
• Registration/
Randomization
• Complexity of
Investigational
Treatment
• Length of
Investigational
Treatment
http://restructuringtrials.cancer.gov/
• Feasibility &
Personnel Impact
• Data Collection
Complexity
• Follow-Up
Requirements
• Ancillary Studies
• Participant
Feasibility &
Enrollment
Utilization
• Assists evaluation of need for new staff
• Balances workload between current staff
– Those with high acuity give registration potentials to those with
lower level
• Management assessment tool
• Staff Effort Calculations for budget
Budget Considerations
• Pre-initiation work
• Start-up meetings
• Monitoring visits
• Close-out visits
Variables…the hidden work
• Screen Failures
• Queries
• Long-term follow-up
• Phone calls
• Re-consenting
• Enrollment logs
Clinical Care Expenses
The Separation of Charges
Research Related Services
versus
Clinically Indicated Services
(Standard of Care- SOC)
(CMS Medicare National Coverage Determinations Manual, 2009).
Types of Charges
• Research (RES) Items- on the schema needed only for research
purposes
– Either due to nature of service or frequency
• Standard of Care (SOC) Items- usual & necessary services &
costs
• Q1- SOC as called for by Schema- usual and customary services
that are also called for by the Schema.
– Referred to as SOC as a component of a research study
– At discharge, requires the use of a Q1 modifier and the diagnosis
code V70.7 (listed as secondary diagnosis)
– These are the items left UNCIRCLED on the reviewed schema
(CMS Medicare National Coverage Determinations Manual, 2009).
Billing Rules
•
All services rendered should be charged.
•
A Cost associated with a trial can only be recovered in its entirety once.
•
Sponsors should be considered the payer of choice for all trial related
charges and ideally, should cover all of the costs of conducting the
clinical trial.
– Never bill insurance first to see if that will pay- Charges are either
Standard of Care or Research related- there is no “if then” in
research billing, that is considered:
• Double Dipping
• Fraud
•
NEVER bill a patient or their insurance for a research related charge
(
(CMS Medicare National Coverage Determinations Manual, 2009, O’Brien, J.A., 2007)
Schema Review Memo
Designation of Charges
Utilizing the attached treatment schema, please circle the tests and/or procedures that
are research only related for the medical condition being researched in this
trial.
The identified tests/procedures will not be billed to the patient's third party payer and
will be billed to the sponsor/trial. The identified tests and/or procedures are
considered to be research only and required by the trial and not part of the usual
care of a patient with this medical condition.
All other services are considered usual/standard patient care. Services considered
“billable” (usual/standard) should meet criteria such as:
 The services are considered safe and effective based on authoritative
evidence as generally accepted by the medical community
 The services are considered customary, reasonable and necessary
 The services are not unproven or experimental in nature.
In addition, services identified as billable must be supported by past billing
practice. That is, upon review, the composite of patient records of patients not on
a clinical trial would indicate the same services (and level of services) rendered.
Schema
Internal Budget
Patient Care Costs
Internal Budget
Staff Effort
Models for Effort Calculation
Sponsor’s Budget
• Compare with your
budget
• Is Per Subject costs
equivalent?
• Is overhead accurately
represented?
• Are costs at the study
level comparable?
• Review
• Negotiate-be sure to
provide flexibility for renegotiation
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Sponsor Budget
Negotiating Tips
• Provide detailed, line-item cost for each activity.
• Use the words, “Our costs of participating in the trial”
• Remember, the Sponsor wants the site and the PI
involved in the trial as a thought leader.
(Business-Higher Education Forum,Washington D.C., 2001; Mello, M.M., Phil, M., Clarridge, B.R.,
Studdert, D.M., 2005; Paller, M.S., Hostetler, L.,Dykhuis, D.A., 2002)
Budgets Basics Summary
• All costs must be funded
–
–
–
–
Investigators time
Staff time
Supplies
Other resources
• Laboratory
• Clinic space
• Pharmacy
Budget Reminders
• Accrual targets
– If you can’t meet or exceed your target don’t open
it!
– Don’t open it for < 5 subjects per year
• Amendments & Safety Reports
– Expect multiple
• Adversely affects budget and human resources
– Negotiate for additional payments with significant
revisions or quantity of external reports
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Budget Reminders
• For multi-year trials, consider adding an inflation rate
of 10% to the per-completed-subject cost.
• Cost of providing health care services increases over
time so you need to cover future expenses
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Payment Terms
• Schedule of payments
(e.g. annually, quarterly,
after CRF completion,
after monitor visit)
• Determine what
payments can be
invoiced (e.g. invoice for
per subject payments,
invoice one-time costs)
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Payment Terms
• It is reasonable and
common to have the
sponsor make a 1st
payment including:
– One-time nonrefundable start up
fees
– Full price for 1-3
completed patients
up front
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Tracking Payments
• Maintain a running
financial statement
• Electronic calendar
of when payments
are due
• Prepare invoices for
all payments
• Communicate with
Grants and
Contracts
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Projections
• Done at least quarterly
– Allows for balance & ability to accept new studies
– Achieve balance between overextending resources
or having underutilized personnel
• Components:
–
–
–
–
Number of staff
Study intensity
Personnel needed for upcoming studies
Anticipated study revenues
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003;
Johnson, G.P., 2003; O’Brien, J.A., 2007)
Common Problems & Concerns
• Documentation
• Billing Errors
• Auditing for Compliance
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; O’Brien, J.A., 2007)
Documents
•
•
•
•
•
Sponsor Contract & Budget
Protocol
Delineated Schema of Events
Institutional Line Item Budget
IRB approved Informed Consent
Harmonization
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; O’Brien, J.A., 2007)
Billing Errors
• Type A—Research
– Items reimbursed by the sponsor or deemed not medically
necessary during the schema review were billed to the
subject/insurance
• Type B
– Standard of Care services are billed and paid by research
Auditing for Compliance
• Initiated after study commences
• All documentation reviewed to establish harmonization
and note any inconsistencies
• Utilize a subject list and audit all or a selection of
subjects bills from date of informed consent to
determine accuracy with research delineated schema
(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum,
Washington D.C., 2001; O’Brien, J.A., 2007)